Sara Freeman

BRIGHTON, ENGLAND – The gait of patients with rheumatoid arthritis undergoes significant variation throughout the day, judging from findings from the DIVIGN study.

There was a 54% improvement in gait velocity overall from the start to the end of a 12-hour assessment period. The mean improvement ranged from -41% to +397%.

The findings suggest that gait velocity should be measured at the same time of day in each patient when used as an outcome measure in clinical practice or in research.

"We all know about morning stiffness and how frequently patients report this, but this is really the first attempt to quantify the effects of early morning stiffness on gait," Michael Backhouse, a podiatrist and Arthritis Research UK doctoral student at the University of Leeds, England, said at the annual meeting of the British Society for Rheumatology.

Mr. Backhouse explained that patients with rheumatoid arthritis (RA) are known to have marked gait abnormalities. This includes decreased gait velocity, reduced stride length, and more time spent in a walking phase called double support where both feet are on the ground before one or the other leg swings forward to take the next step.

To quantify the diurnal variation in gait velocity, the investigators enrolled 31 patients with RA with a median age of 67 years and 10.5 years’ disease duration who were being treated as inpatients at the Chapel Allerton Hospital in Leeds. All patients reported morning stiffness for at least 30 minutes or more every day.

Each patient was asked to walk along a 5.2-m instrumented walkway (GAITRite, CIR Systems Inc.) at five time points throughout the study day; soon after waking (0 hour) at 7 am then at 1-, 3-, 6- and 12-hour intervals. Patients were asked to walk at a self-selected pace and were allowed to use walking sticks or other aids if required.

A visual analog scale was used to determine morning stiffness, and the Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS) 28 were used to see how changes in gait velocity might influence these disease outcome measures.

The sharpest increases in gait velocity were seen in the first hour of each patient assessment, with continued improvement throughout the day. At baseline, the mean gait velocity for all patients was 37.8 cm/sec., with values at 1, 3, 6, and 12 hours of 43.8 cm/sec., 45.5 cm/sec., 48.1 cm./sec., and 53 cm/sec. These translated into overall improvements of 20.4%, 32.9%, 37.8%, and 54.1% improvements, compared with baseline.

Although no control group of similarly aged individuals without RA was assessed, Mr. Backhouse observed that the expected gait velocity of healthy elderly individuals would be about 80-100 cm/sec.

In addition, stride length increased throughout the day, and patients were better able to steady themselves between steps (i.e., longer duration of the double support walking phase) before moving forward.

"When we looked at absolute gait velocity, that’s how fast patients were actually walking, we found that it did correlate with HAQ, that’s patient-reported physical function, at all time points, but it didn’t correlate at all with DAS28 or current disease activity," Mr. Backhouse reported.

"Gait velocity is perhaps one of the most widely used clinical outcome measure in studies of RA," Mr. Backhouse further observed. "This is probably because gait velocity can be so easily and objectively measured," he continued.

However, as the results of the DIVIGN study show, "there is marked diurnal variation of gait velocity ... and repeat measures should be made at the same time of day to exclude its effects," Mr. Backhouse concluded.

Arthritis Research UK and the National Institute for Health Research (London) funded the study. Mr. Backhouse said he had no conflicts of interest.

BRIGHTON, ENGLAND – The gait of patients with rheumatoid arthritis undergoes significant variation throughout the day, judging from findings from the DIVIGN study.

There was a 54% improvement in gait velocity overall from the start to the end of a 12-hour assessment period. The mean improvement ranged from -41% to +397%.

The findings suggest that gait velocity should be measured at the same time of day in each patient when used as an outcome measure in clinical practice or in research.

"We all know about morning stiffness and how frequently patients report this, but this is really the first attempt to quantify the effects of early morning stiffness on gait," Michael Backhouse, a podiatrist and Arthritis Research UK doctoral student at the University of Leeds, England, said at the annual meeting of the British Society for Rheumatology.

Mr. Backhouse explained that patients with rheumatoid arthritis (RA) are known to have marked gait abnormalities. This includes decreased gait velocity, reduced stride length, and more time spent in a walking phase called double support where both feet are on the ground before one or the other leg swings forward to take the next step.

To quantify the diurnal variation in gait velocity, the investigators enrolled 31 patients with RA with a median age of 67 years and 10.5 years’ disease duration who were being treated as inpatients at the Chapel Allerton Hospital in Leeds. All patients reported morning stiffness for at least 30 minutes or more every day.

Each patient was asked to walk along a 5.2-m instrumented walkway (GAITRite, CIR Systems Inc.) at five time points throughout the study day; soon after waking (0 hour) at 7 am then at 1-, 3-, 6- and 12-hour intervals. Patients were asked to walk at a self-selected pace and were allowed to use walking sticks or other aids if required.

A visual analog scale was used to determine morning stiffness, and the Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS) 28 were used to see how changes in gait velocity might influence these disease outcome measures.

The sharpest increases in gait velocity were seen in the first hour of each patient assessment, with continued improvement throughout the day. At baseline, the mean gait velocity for all patients was 37.8 cm/sec., with values at 1, 3, 6, and 12 hours of 43.8 cm/sec., 45.5 cm/sec., 48.1 cm./sec., and 53 cm/sec. These translated into overall improvements of 20.4%, 32.9%, 37.8%, and 54.1% improvements, compared with baseline.

Although no control group of similarly aged individuals without RA was assessed, Mr. Backhouse observed that the expected gait velocity of healthy elderly individuals would be about 80-100 cm/sec.

In addition, stride length increased throughout the day, and patients were better able to steady themselves between steps (i.e., longer duration of the double support walking phase) before moving forward.

"When we looked at absolute gait velocity, that’s how fast patients were actually walking, we found that it did correlate with HAQ, that’s patient-reported physical function, at all time points, but it didn’t correlate at all with DAS28 or current disease activity," Mr. Backhouse reported.

"Gait velocity is perhaps one of the most widely used clinical outcome measure in studies of RA," Mr. Backhouse further observed. "This is probably because gait velocity can be so easily and objectively measured," he continued.

However, as the results of the DIVIGN study show, "there is marked diurnal variation of gait velocity ... and repeat measures should be made at the same time of day to exclude its effects," Mr. Backhouse concluded.

Arthritis Research UK and the National Institute for Health Research (London) funded the study. Mr. Backhouse said he had no conflicts of interest.

BRIGHTON, ENGLAND – The gait of patients with rheumatoid arthritis undergoes significant variation throughout the day, judging from findings from the DIVIGN study.

There was a 54% improvement in gait velocity overall from the start to the end of a 12-hour assessment period. The mean improvement ranged from -41% to +397%.

The findings suggest that gait velocity should be measured at the same time of day in each patient when used as an outcome measure in clinical practice or in research.

"We all know about morning stiffness and how frequently patients report this, but this is really the first attempt to quantify the effects of early morning stiffness on gait," Michael Backhouse, a podiatrist and Arthritis Research UK doctoral student at the University of Leeds, England, said at the annual meeting of the British Society for Rheumatology.

Mr. Backhouse explained that patients with rheumatoid arthritis (RA) are known to have marked gait abnormalities. This includes decreased gait velocity, reduced stride length, and more time spent in a walking phase called double support where both feet are on the ground before one or the other leg swings forward to take the next step.

To quantify the diurnal variation in gait velocity, the investigators enrolled 31 patients with RA with a median age of 67 years and 10.5 years’ disease duration who were being treated as inpatients at the Chapel Allerton Hospital in Leeds. All patients reported morning stiffness for at least 30 minutes or more every day.

Each patient was asked to walk along a 5.2-m instrumented walkway (GAITRite, CIR Systems Inc.) at five time points throughout the study day; soon after waking (0 hour) at 7 am then at 1-, 3-, 6- and 12-hour intervals. Patients were asked to walk at a self-selected pace and were allowed to use walking sticks or other aids if required.

A visual analog scale was used to determine morning stiffness, and the Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS) 28 were used to see how changes in gait velocity might influence these disease outcome measures.

The sharpest increases in gait velocity were seen in the first hour of each patient assessment, with continued improvement throughout the day. At baseline, the mean gait velocity for all patients was 37.8 cm/sec., with values at 1, 3, 6, and 12 hours of 43.8 cm/sec., 45.5 cm/sec., 48.1 cm./sec., and 53 cm/sec. These translated into overall improvements of 20.4%, 32.9%, 37.8%, and 54.1% improvements, compared with baseline.

Although no control group of similarly aged individuals without RA was assessed, Mr. Backhouse observed that the expected gait velocity of healthy elderly individuals would be about 80-100 cm/sec.

In addition, stride length increased throughout the day, and patients were better able to steady themselves between steps (i.e., longer duration of the double support walking phase) before moving forward.

"When we looked at absolute gait velocity, that’s how fast patients were actually walking, we found that it did correlate with HAQ, that’s patient-reported physical function, at all time points, but it didn’t correlate at all with DAS28 or current disease activity," Mr. Backhouse reported.

"Gait velocity is perhaps one of the most widely used clinical outcome measure in studies of RA," Mr. Backhouse further observed. "This is probably because gait velocity can be so easily and objectively measured," he continued.

However, as the results of the DIVIGN study show, "there is marked diurnal variation of gait velocity ... and repeat measures should be made at the same time of day to exclude its effects," Mr. Backhouse concluded.

Arthritis Research UK and the National Institute for Health Research (London) funded the study. Mr. Backhouse said he had no conflicts of interest.

BRIGHTON, ENGLAND – The gait of patients with rheumatoid arthritis undergoes significant variation throughout the day, judging from findings from the DIVIGN study.

There was a 54% improvement in gait velocity overall from the start to the end of a 12-hour assessment period. The mean improvement ranged from -41% to +397%.

The findings suggest that gait velocity should be measured at the same time of day in each patient when used as an outcome measure in clinical practice or in research.

"We all know about morning stiffness and how frequently patients report this, but this is really the first attempt to quantify the effects of early morning stiffness on gait," Michael Backhouse, a podiatrist and Arthritis Research UK doctoral student at the University of Leeds, England, said at the annual meeting of the British Society for Rheumatology.

Mr. Backhouse explained that patients with rheumatoid arthritis (RA) are known to have marked gait abnormalities. This includes decreased gait velocity, reduced stride length, and more time spent in a walking phase called double support where both feet are on the ground before one or the other leg swings forward to take the next step.

To quantify the diurnal variation in gait velocity, the investigators enrolled 31 patients with RA with a median age of 67 years and 10.5 years’ disease duration who were being treated as inpatients at the Chapel Allerton Hospital in Leeds. All patients reported morning stiffness for at least 30 minutes or more every day.

Each patient was asked to walk along a 5.2-m instrumented walkway (GAITRite, CIR Systems Inc.) at five time points throughout the study day; soon after waking (0 hour) at 7 am then at 1-, 3-, 6- and 12-hour intervals. Patients were asked to walk at a self-selected pace and were allowed to use walking sticks or other aids if required.

A visual analog scale was used to determine morning stiffness, and the Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS) 28 were used to see how changes in gait velocity might influence these disease outcome measures.

The sharpest increases in gait velocity were seen in the first hour of each patient assessment, with continued improvement throughout the day. At baseline, the mean gait velocity for all patients was 37.8 cm/sec., with values at 1, 3, 6, and 12 hours of 43.8 cm/sec., 45.5 cm/sec., 48.1 cm./sec., and 53 cm/sec. These translated into overall improvements of 20.4%, 32.9%, 37.8%, and 54.1% improvements, compared with baseline.

Although no control group of similarly aged individuals without RA was assessed, Mr. Backhouse observed that the expected gait velocity of healthy elderly individuals would be about 80-100 cm/sec.

In addition, stride length increased throughout the day, and patients were better able to steady themselves between steps (i.e., longer duration of the double support walking phase) before moving forward.

"When we looked at absolute gait velocity, that’s how fast patients were actually walking, we found that it did correlate with HAQ, that’s patient-reported physical function, at all time points, but it didn’t correlate at all with DAS28 or current disease activity," Mr. Backhouse reported.

"Gait velocity is perhaps one of the most widely used clinical outcome measure in studies of RA," Mr. Backhouse further observed. "This is probably because gait velocity can be so easily and objectively measured," he continued.

However, as the results of the DIVIGN study show, "there is marked diurnal variation of gait velocity ... and repeat measures should be made at the same time of day to exclude its effects," Mr. Backhouse concluded.

Arthritis Research UK and the National Institute for Health Research (London) funded the study. Mr. Backhouse said he had no conflicts of interest.

BRIGHTON, ENGLAND – The gait of patients with rheumatoid arthritis undergoes significant variation throughout the day, judging from findings from the DIVIGN study.

There was a 54% improvement in gait velocity overall from the start to the end of a 12-hour assessment period. The mean improvement ranged from -41% to +397%.

The findings suggest that gait velocity should be measured at the same time of day in each patient when used as an outcome measure in clinical practice or in research.

"We all know about morning stiffness and how frequently patients report this, but this is really the first attempt to quantify the effects of early morning stiffness on gait," Michael Backhouse, a podiatrist and Arthritis Research UK doctoral student at the University of Leeds, England, said at the annual meeting of the British Society for Rheumatology.

Mr. Backhouse explained that patients with rheumatoid arthritis (RA) are known to have marked gait abnormalities. This includes decreased gait velocity, reduced stride length, and more time spent in a walking phase called double support where both feet are on the ground before one or the other leg swings forward to take the next step.

To quantify the diurnal variation in gait velocity, the investigators enrolled 31 patients with RA with a median age of 67 years and 10.5 years’ disease duration who were being treated as inpatients at the Chapel Allerton Hospital in Leeds. All patients reported morning stiffness for at least 30 minutes or more every day.

Each patient was asked to walk along a 5.2-m instrumented walkway (GAITRite, CIR Systems Inc.) at five time points throughout the study day; soon after waking (0 hour) at 7 am then at 1-, 3-, 6- and 12-hour intervals. Patients were asked to walk at a self-selected pace and were allowed to use walking sticks or other aids if required.

A visual analog scale was used to determine morning stiffness, and the Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS) 28 were used to see how changes in gait velocity might influence these disease outcome measures.

The sharpest increases in gait velocity were seen in the first hour of each patient assessment, with continued improvement throughout the day. At baseline, the mean gait velocity for all patients was 37.8 cm/sec., with values at 1, 3, 6, and 12 hours of 43.8 cm/sec., 45.5 cm/sec., 48.1 cm./sec., and 53 cm/sec. These translated into overall improvements of 20.4%, 32.9%, 37.8%, and 54.1% improvements, compared with baseline.

Although no control group of similarly aged individuals without RA was assessed, Mr. Backhouse observed that the expected gait velocity of healthy elderly individuals would be about 80-100 cm/sec.

In addition, stride length increased throughout the day, and patients were better able to steady themselves between steps (i.e., longer duration of the double support walking phase) before moving forward.

"When we looked at absolute gait velocity, that’s how fast patients were actually walking, we found that it did correlate with HAQ, that’s patient-reported physical function, at all time points, but it didn’t correlate at all with DAS28 or current disease activity," Mr. Backhouse reported.

"Gait velocity is perhaps one of the most widely used clinical outcome measure in studies of RA," Mr. Backhouse further observed. "This is probably because gait velocity can be so easily and objectively measured," he continued.

However, as the results of the DIVIGN study show, "there is marked diurnal variation of gait velocity ... and repeat measures should be made at the same time of day to exclude its effects," Mr. Backhouse concluded.

Arthritis Research UK and the National Institute for Health Research (London) funded the study. Mr. Backhouse said he had no conflicts of interest.

BRIGHTON, ENGLAND – The gait of patients with rheumatoid arthritis undergoes significant variation throughout the day, judging from findings from the DIVIGN study.

There was a 54% improvement in gait velocity overall from the start to the end of a 12-hour assessment period. The mean improvement ranged from -41% to +397%.

The findings suggest that gait velocity should be measured at the same time of day in each patient when used as an outcome measure in clinical practice or in research.

"We all know about morning stiffness and how frequently patients report this, but this is really the first attempt to quantify the effects of early morning stiffness on gait," Michael Backhouse, a podiatrist and Arthritis Research UK doctoral student at the University of Leeds, England, said at the annual meeting of the British Society for Rheumatology.

Mr. Backhouse explained that patients with rheumatoid arthritis (RA) are known to have marked gait abnormalities. This includes decreased gait velocity, reduced stride length, and more time spent in a walking phase called double support where both feet are on the ground before one or the other leg swings forward to take the next step.

To quantify the diurnal variation in gait velocity, the investigators enrolled 31 patients with RA with a median age of 67 years and 10.5 years’ disease duration who were being treated as inpatients at the Chapel Allerton Hospital in Leeds. All patients reported morning stiffness for at least 30 minutes or more every day.

Each patient was asked to walk along a 5.2-m instrumented walkway (GAITRite, CIR Systems Inc.) at five time points throughout the study day; soon after waking (0 hour) at 7 am then at 1-, 3-, 6- and 12-hour intervals. Patients were asked to walk at a self-selected pace and were allowed to use walking sticks or other aids if required.

A visual analog scale was used to determine morning stiffness, and the Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS) 28 were used to see how changes in gait velocity might influence these disease outcome measures.

The sharpest increases in gait velocity were seen in the first hour of each patient assessment, with continued improvement throughout the day. At baseline, the mean gait velocity for all patients was 37.8 cm/sec., with values at 1, 3, 6, and 12 hours of 43.8 cm/sec., 45.5 cm/sec., 48.1 cm./sec., and 53 cm/sec. These translated into overall improvements of 20.4%, 32.9%, 37.8%, and 54.1% improvements, compared with baseline.

Although no control group of similarly aged individuals without RA was assessed, Mr. Backhouse observed that the expected gait velocity of healthy elderly individuals would be about 80-100 cm/sec.

In addition, stride length increased throughout the day, and patients were better able to steady themselves between steps (i.e., longer duration of the double support walking phase) before moving forward.

"When we looked at absolute gait velocity, that’s how fast patients were actually walking, we found that it did correlate with HAQ, that’s patient-reported physical function, at all time points, but it didn’t correlate at all with DAS28 or current disease activity," Mr. Backhouse reported.

"Gait velocity is perhaps one of the most widely used clinical outcome measure in studies of RA," Mr. Backhouse further observed. "This is probably because gait velocity can be so easily and objectively measured," he continued.

However, as the results of the DIVIGN study show, "there is marked diurnal variation of gait velocity ... and repeat measures should be made at the same time of day to exclude its effects," Mr. Backhouse concluded.

Arthritis Research UK and the National Institute for Health Research (London) funded the study. Mr. Backhouse said he had no conflicts of interest.

BRIGHTON, ENGLAND – Survival from scleroderma is improving, but major organ-based complications are still a significant reason for premature death, according to the results of a long-term outcomes study that were presented at the annual meeting of the British Society for Rheumatology.

The 10-year survival rates were 81% for patients with limited cutaneous systemic sclerosis (SSc) and 70% for patients with diffuse cutaneous SSc (P = .006).

Survival was significantly reduced (39%) in those who developed major heart, lung, or kidney complications, compared with 71% for those who developed no complications at 15 years' follow-up (P less than .001).

"The 10-year survival is impressive when you consider that not so long ago, we had a 5-year morality approaching 50% in the worst cases. So clearly there has been overall progress in managing the disease," commented study investigator Dr. Christopher Denton.

"Although outcomes are improving, we're still dealing with a disease that has very high case-specific mortality," added Dr. Denton, who is a professor of experimental rheumatology at University College London and a consultant rheumatologist at the Royal Free Hospital, London.

"Around 60% of patients actually die as a direct consequence of their scleroderma, and this is mostly from cardiorespiratory complications of the disease," he added.

Almost 400 patients with scleroderma – of whom 252 (63.3%) had limited cutaneous SSc and 146 (36.7%) had diffuse cutaneous SSc – were studied from their diagnosis in 1995 to 1999 (Rheumatology [Oxford] 2011;50 [suppl. 3]:iii129-iii37, abstract 223). The percentage of men with diffuse cutaneous SSc vs. limited cutaneous SSc disease was higher (17.9% vs. 9.9%; P = .037) and the mean age of onset was 50 years for limited cutaneous SSc patients and 46 years for diffuse cutaneous SSc patients (P = .003).

An important point of the study was that the frequency and timing of the major complications of scleroderma have now been defined over a 10- to 15-year period. Complications of scleroderma can be life threatening, and include pulmonary arterial hypertension (PAH), pulmonary fibrosis, renal disease, and cardiac problems.

At the 10-year follow-up, the incidences of PAH in the limited cutaneous SSc and diffuse cutaneous SSc groups were similar (15% vs. 13%), with the earliest cases seen 2 years after diagnosis. Patients who developed this complication later in the course of their disease tended to have higher 5-year survival rates than did those who had PAH earlier (49% vs. 24%), but this did not reach statistical significance.

Clinically significant pulmonary fibrosis was identified in a higher percentage of patients with diffuse than with limited disease at 10 years (45% vs. 21%; P less than .001), with almost half of patients developing lung disease within the first 3 years, and more than three-quarters within the first 5 years.

Patients with diffuse cutaneous SSc were more likely than those with limited cutaneous SSc to experience renal crisis (12% vs. 4%) at 10 years, with the higher rates occurring in the first 3 years (10% vs. 3%). Similarly, cardiac disease was more common in diffuse cutaneous SSc than in limited cutaneous SSc patients early on (7% vs. 1% at 5 years; P less than .001), but remained unchanged at 10 years.

"Whereas the limited or diffuse distinction is very relevant in the first 5 years, after the 5 years it doesn’t really matter which type of scleroderma you've got; you have an equally high frequency of complications," Dr. Denton observed in an interview.

He added that this "is a treated cohort that received standard management, so I think it's very important to start to understand the timing and frequency of the major heart, lung, and kidney complications, so that you can really identify when in the course of the disease you should be particularly vigilant."

Dr. Denton disclosed financial relationships with Actelion, Aspreva, BioVitrum, Digna, Dyax, Encysive, Genzyme, GlaxoSmithKline, Medimmune, Pfizer, and Sanofi-Aventis.

BRIGHTON, ENGLAND – Survival from scleroderma is improving, but major organ-based complications are still a significant reason for premature death, according to the results of a long-term outcomes study that were presented at the annual meeting of the British Society for Rheumatology.

The 10-year survival rates were 81% for patients with limited cutaneous systemic sclerosis (SSc) and 70% for patients with diffuse cutaneous SSc (P = .006).

Survival was significantly reduced (39%) in those who developed major heart, lung, or kidney complications, compared with 71% for those who developed no complications at 15 years' follow-up (P less than .001).

"The 10-year survival is impressive when you consider that not so long ago, we had a 5-year morality approaching 50% in the worst cases. So clearly there has been overall progress in managing the disease," commented study investigator Dr. Christopher Denton.

"Although outcomes are improving, we're still dealing with a disease that has very high case-specific mortality," added Dr. Denton, who is a professor of experimental rheumatology at University College London and a consultant rheumatologist at the Royal Free Hospital, London.

"Around 60% of patients actually die as a direct consequence of their scleroderma, and this is mostly from cardiorespiratory complications of the disease," he added.

Almost 400 patients with scleroderma – of whom 252 (63.3%) had limited cutaneous SSc and 146 (36.7%) had diffuse cutaneous SSc – were studied from their diagnosis in 1995 to 1999 (Rheumatology [Oxford] 2011;50 [suppl. 3]:iii129-iii37, abstract 223). The percentage of men with diffuse cutaneous SSc vs. limited cutaneous SSc disease was higher (17.9% vs. 9.9%; P = .037) and the mean age of onset was 50 years for limited cutaneous SSc patients and 46 years for diffuse cutaneous SSc patients (P = .003).

An important point of the study was that the frequency and timing of the major complications of scleroderma have now been defined over a 10- to 15-year period. Complications of scleroderma can be life threatening, and include pulmonary arterial hypertension (PAH), pulmonary fibrosis, renal disease, and cardiac problems.

At the 10-year follow-up, the incidences of PAH in the limited cutaneous SSc and diffuse cutaneous SSc groups were similar (15% vs. 13%), with the earliest cases seen 2 years after diagnosis. Patients who developed this complication later in the course of their disease tended to have higher 5-year survival rates than did those who had PAH earlier (49% vs. 24%), but this did not reach statistical significance.

Clinically significant pulmonary fibrosis was identified in a higher percentage of patients with diffuse than with limited disease at 10 years (45% vs. 21%; P less than .001), with almost half of patients developing lung disease within the first 3 years, and more than three-quarters within the first 5 years.

Patients with diffuse cutaneous SSc were more likely than those with limited cutaneous SSc to experience renal crisis (12% vs. 4%) at 10 years, with the higher rates occurring in the first 3 years (10% vs. 3%). Similarly, cardiac disease was more common in diffuse cutaneous SSc than in limited cutaneous SSc patients early on (7% vs. 1% at 5 years; P less than .001), but remained unchanged at 10 years.

"Whereas the limited or diffuse distinction is very relevant in the first 5 years, after the 5 years it doesn’t really matter which type of scleroderma you've got; you have an equally high frequency of complications," Dr. Denton observed in an interview.

He added that this "is a treated cohort that received standard management, so I think it's very important to start to understand the timing and frequency of the major heart, lung, and kidney complications, so that you can really identify when in the course of the disease you should be particularly vigilant."

Dr. Denton disclosed financial relationships with Actelion, Aspreva, BioVitrum, Digna, Dyax, Encysive, Genzyme, GlaxoSmithKline, Medimmune, Pfizer, and Sanofi-Aventis.

BRIGHTON, ENGLAND – Survival from scleroderma is improving, but major organ-based complications are still a significant reason for premature death, according to the results of a long-term outcomes study that were presented at the annual meeting of the British Society for Rheumatology.

The 10-year survival rates were 81% for patients with limited cutaneous systemic sclerosis (SSc) and 70% for patients with diffuse cutaneous SSc (P = .006).

Survival was significantly reduced (39%) in those who developed major heart, lung, or kidney complications, compared with 71% for those who developed no complications at 15 years' follow-up (P less than .001).

"The 10-year survival is impressive when you consider that not so long ago, we had a 5-year morality approaching 50% in the worst cases. So clearly there has been overall progress in managing the disease," commented study investigator Dr. Christopher Denton.

"Although outcomes are improving, we're still dealing with a disease that has very high case-specific mortality," added Dr. Denton, who is a professor of experimental rheumatology at University College London and a consultant rheumatologist at the Royal Free Hospital, London.

"Around 60% of patients actually die as a direct consequence of their scleroderma, and this is mostly from cardiorespiratory complications of the disease," he added.

Almost 400 patients with scleroderma – of whom 252 (63.3%) had limited cutaneous SSc and 146 (36.7%) had diffuse cutaneous SSc – were studied from their diagnosis in 1995 to 1999 (Rheumatology [Oxford] 2011;50 [suppl. 3]:iii129-iii37, abstract 223). The percentage of men with diffuse cutaneous SSc vs. limited cutaneous SSc disease was higher (17.9% vs. 9.9%; P = .037) and the mean age of onset was 50 years for limited cutaneous SSc patients and 46 years for diffuse cutaneous SSc patients (P = .003).

An important point of the study was that the frequency and timing of the major complications of scleroderma have now been defined over a 10- to 15-year period. Complications of scleroderma can be life threatening, and include pulmonary arterial hypertension (PAH), pulmonary fibrosis, renal disease, and cardiac problems.

At the 10-year follow-up, the incidences of PAH in the limited cutaneous SSc and diffuse cutaneous SSc groups were similar (15% vs. 13%), with the earliest cases seen 2 years after diagnosis. Patients who developed this complication later in the course of their disease tended to have higher 5-year survival rates than did those who had PAH earlier (49% vs. 24%), but this did not reach statistical significance.

Clinically significant pulmonary fibrosis was identified in a higher percentage of patients with diffuse than with limited disease at 10 years (45% vs. 21%; P less than .001), with almost half of patients developing lung disease within the first 3 years, and more than three-quarters within the first 5 years.

Patients with diffuse cutaneous SSc were more likely than those with limited cutaneous SSc to experience renal crisis (12% vs. 4%) at 10 years, with the higher rates occurring in the first 3 years (10% vs. 3%). Similarly, cardiac disease was more common in diffuse cutaneous SSc than in limited cutaneous SSc patients early on (7% vs. 1% at 5 years; P less than .001), but remained unchanged at 10 years.

"Whereas the limited or diffuse distinction is very relevant in the first 5 years, after the 5 years it doesn’t really matter which type of scleroderma you've got; you have an equally high frequency of complications," Dr. Denton observed in an interview.

He added that this "is a treated cohort that received standard management, so I think it's very important to start to understand the timing and frequency of the major heart, lung, and kidney complications, so that you can really identify when in the course of the disease you should be particularly vigilant."

Dr. Denton disclosed financial relationships with Actelion, Aspreva, BioVitrum, Digna, Dyax, Encysive, Genzyme, GlaxoSmithKline, Medimmune, Pfizer, and Sanofi-Aventis.

BRIGHTON, ENGLAND – Survival from scleroderma is improving, but major organ-based complications are still a significant reason for premature death, according to the results of a long-term outcomes study that were presented at the annual meeting of the British Society for Rheumatology.

The 10-year survival rates were 81% for patients with limited cutaneous systemic sclerosis (SSc) and 70% for patients with diffuse cutaneous SSc (P = .006).

Survival was significantly reduced (39%) in those who developed major heart, lung, or kidney complications, compared with 71% for those who developed no complications at 15 years' follow-up (P less than .001).

"The 10-year survival is impressive when you consider that not so long ago, we had a 5-year morality approaching 50% in the worst cases. So clearly there has been overall progress in managing the disease," commented study investigator Dr. Christopher Denton.

"Although outcomes are improving, we're still dealing with a disease that has very high case-specific mortality," added Dr. Denton, who is a professor of experimental rheumatology at University College London and a consultant rheumatologist at the Royal Free Hospital, London.

"Around 60% of patients actually die as a direct consequence of their scleroderma, and this is mostly from cardiorespiratory complications of the disease," he added.

Almost 400 patients with scleroderma – of whom 252 (63.3%) had limited cutaneous SSc and 146 (36.7%) had diffuse cutaneous SSc – were studied from their diagnosis in 1995 to 1999 (Rheumatology [Oxford] 2011;50 [suppl. 3]:iii129-iii37, abstract 223). The percentage of men with diffuse cutaneous SSc vs. limited cutaneous SSc disease was higher (17.9% vs. 9.9%; P = .037) and the mean age of onset was 50 years for limited cutaneous SSc patients and 46 years for diffuse cutaneous SSc patients (P = .003).

An important point of the study was that the frequency and timing of the major complications of scleroderma have now been defined over a 10- to 15-year period. Complications of scleroderma can be life threatening, and include pulmonary arterial hypertension (PAH), pulmonary fibrosis, renal disease, and cardiac problems.

At the 10-year follow-up, the incidences of PAH in the limited cutaneous SSc and diffuse cutaneous SSc groups were similar (15% vs. 13%), with the earliest cases seen 2 years after diagnosis. Patients who developed this complication later in the course of their disease tended to have higher 5-year survival rates than did those who had PAH earlier (49% vs. 24%), but this did not reach statistical significance.

Clinically significant pulmonary fibrosis was identified in a higher percentage of patients with diffuse than with limited disease at 10 years (45% vs. 21%; P less than .001), with almost half of patients developing lung disease within the first 3 years, and more than three-quarters within the first 5 years.

Patients with diffuse cutaneous SSc were more likely than those with limited cutaneous SSc to experience renal crisis (12% vs. 4%) at 10 years, with the higher rates occurring in the first 3 years (10% vs. 3%). Similarly, cardiac disease was more common in diffuse cutaneous SSc than in limited cutaneous SSc patients early on (7% vs. 1% at 5 years; P less than .001), but remained unchanged at 10 years.

"Whereas the limited or diffuse distinction is very relevant in the first 5 years, after the 5 years it doesn’t really matter which type of scleroderma you’ve got; you have an equally high frequency of complications," Dr. Denton observed in an interview.

He added that this "is a treated cohort that received standard management, so I think it’s very important to start to understand the timing and frequency of the major heart, lung, and kidney complications, so that you can really identify when in the course of the disease you should be particularly vigilant."

Dr. Denton disclosed financial relationships with Actelion, Aspreva, BioVitrum, Digna, Dyax, Encysive, Genzyme, GlaxoSmithKline, Medimmune, Pfizer, and Sanofi-Aventis.

BRIGHTON, ENGLAND – Survival from scleroderma is improving, but major organ-based complications are still a significant reason for premature death, according to the results of a long-term outcomes study that were presented at the annual meeting of the British Society for Rheumatology.

The 10-year survival rates were 81% for patients with limited cutaneous systemic sclerosis (SSc) and 70% for patients with diffuse cutaneous SSc (P = .006).

Survival was significantly reduced (39%) in those who developed major heart, lung, or kidney complications, compared with 71% for those who developed no complications at 15 years' follow-up (P less than .001).

"The 10-year survival is impressive when you consider that not so long ago, we had a 5-year morality approaching 50% in the worst cases. So clearly there has been overall progress in managing the disease," commented study investigator Dr. Christopher Denton.

"Although outcomes are improving, we're still dealing with a disease that has very high case-specific mortality," added Dr. Denton, who is a professor of experimental rheumatology at University College London and a consultant rheumatologist at the Royal Free Hospital, London.

"Around 60% of patients actually die as a direct consequence of their scleroderma, and this is mostly from cardiorespiratory complications of the disease," he added.

Almost 400 patients with scleroderma – of whom 252 (63.3%) had limited cutaneous SSc and 146 (36.7%) had diffuse cutaneous SSc – were studied from their diagnosis in 1995 to 1999 (Rheumatology [Oxford] 2011;50 [suppl. 3]:iii129-iii37, abstract 223). The percentage of men with diffuse cutaneous SSc vs. limited cutaneous SSc disease was higher (17.9% vs. 9.9%; P = .037) and the mean age of onset was 50 years for limited cutaneous SSc patients and 46 years for diffuse cutaneous SSc patients (P = .003).

An important point of the study was that the frequency and timing of the major complications of scleroderma have now been defined over a 10- to 15-year period. Complications of scleroderma can be life threatening, and include pulmonary arterial hypertension (PAH), pulmonary fibrosis, renal disease, and cardiac problems.

At the 10-year follow-up, the incidences of PAH in the limited cutaneous SSc and diffuse cutaneous SSc groups were similar (15% vs. 13%), with the earliest cases seen 2 years after diagnosis. Patients who developed this complication later in the course of their disease tended to have higher 5-year survival rates than did those who had PAH earlier (49% vs. 24%), but this did not reach statistical significance.

Clinically significant pulmonary fibrosis was identified in a higher percentage of patients with diffuse than with limited disease at 10 years (45% vs. 21%; P less than .001), with almost half of patients developing lung disease within the first 3 years, and more than three-quarters within the first 5 years.

Patients with diffuse cutaneous SSc were more likely than those with limited cutaneous SSc to experience renal crisis (12% vs. 4%) at 10 years, with the higher rates occurring in the first 3 years (10% vs. 3%). Similarly, cardiac disease was more common in diffuse cutaneous SSc than in limited cutaneous SSc patients early on (7% vs. 1% at 5 years; P less than .001), but remained unchanged at 10 years.

"Whereas the limited or diffuse distinction is very relevant in the first 5 years, after the 5 years it doesn’t really matter which type of scleroderma you’ve got; you have an equally high frequency of complications," Dr. Denton observed in an interview.

He added that this "is a treated cohort that received standard management, so I think it’s very important to start to understand the timing and frequency of the major heart, lung, and kidney complications, so that you can really identify when in the course of the disease you should be particularly vigilant."

Dr. Denton disclosed financial relationships with Actelion, Aspreva, BioVitrum, Digna, Dyax, Encysive, Genzyme, GlaxoSmithKline, Medimmune, Pfizer, and Sanofi-Aventis.

BRIGHTON, ENGLAND – Survival from scleroderma is improving, but major organ-based complications are still a significant reason for premature death, according to the results of a long-term outcomes study that were presented at the annual meeting of the British Society for Rheumatology.

The 10-year survival rates were 81% for patients with limited cutaneous systemic sclerosis (SSc) and 70% for patients with diffuse cutaneous SSc (P = .006).

Survival was significantly reduced (39%) in those who developed major heart, lung, or kidney complications, compared with 71% for those who developed no complications at 15 years' follow-up (P less than .001).

"The 10-year survival is impressive when you consider that not so long ago, we had a 5-year morality approaching 50% in the worst cases. So clearly there has been overall progress in managing the disease," commented study investigator Dr. Christopher Denton.

"Although outcomes are improving, we're still dealing with a disease that has very high case-specific mortality," added Dr. Denton, who is a professor of experimental rheumatology at University College London and a consultant rheumatologist at the Royal Free Hospital, London.

"Around 60% of patients actually die as a direct consequence of their scleroderma, and this is mostly from cardiorespiratory complications of the disease," he added.

Almost 400 patients with scleroderma – of whom 252 (63.3%) had limited cutaneous SSc and 146 (36.7%) had diffuse cutaneous SSc – were studied from their diagnosis in 1995 to 1999 (Rheumatology [Oxford] 2011;50 [suppl. 3]:iii129-iii37, abstract 223). The percentage of men with diffuse cutaneous SSc vs. limited cutaneous SSc disease was higher (17.9% vs. 9.9%; P = .037) and the mean age of onset was 50 years for limited cutaneous SSc patients and 46 years for diffuse cutaneous SSc patients (P = .003).

An important point of the study was that the frequency and timing of the major complications of scleroderma have now been defined over a 10- to 15-year period. Complications of scleroderma can be life threatening, and include pulmonary arterial hypertension (PAH), pulmonary fibrosis, renal disease, and cardiac problems.

At the 10-year follow-up, the incidences of PAH in the limited cutaneous SSc and diffuse cutaneous SSc groups were similar (15% vs. 13%), with the earliest cases seen 2 years after diagnosis. Patients who developed this complication later in the course of their disease tended to have higher 5-year survival rates than did those who had PAH earlier (49% vs. 24%), but this did not reach statistical significance.

Clinically significant pulmonary fibrosis was identified in a higher percentage of patients with diffuse than with limited disease at 10 years (45% vs. 21%; P less than .001), with almost half of patients developing lung disease within the first 3 years, and more than three-quarters within the first 5 years.

Patients with diffuse cutaneous SSc were more likely than those with limited cutaneous SSc to experience renal crisis (12% vs. 4%) at 10 years, with the higher rates occurring in the first 3 years (10% vs. 3%). Similarly, cardiac disease was more common in diffuse cutaneous SSc than in limited cutaneous SSc patients early on (7% vs. 1% at 5 years; P less than .001), but remained unchanged at 10 years.

"Whereas the limited or diffuse distinction is very relevant in the first 5 years, after the 5 years it doesn’t really matter which type of scleroderma you’ve got; you have an equally high frequency of complications," Dr. Denton observed in an interview.

He added that this "is a treated cohort that received standard management, so I think it’s very important to start to understand the timing and frequency of the major heart, lung, and kidney complications, so that you can really identify when in the course of the disease you should be particularly vigilant."

Dr. Denton disclosed financial relationships with Actelion, Aspreva, BioVitrum, Digna, Dyax, Encysive, Genzyme, GlaxoSmithKline, Medimmune, Pfizer, and Sanofi-Aventis.

BRIGHTON, ENGLAND – Survival from scleroderma is improving, but major organ-based complications are still a significant reason for premature death, according to the results of a long-term outcomes study that were presented at the annual meeting of the British Society for Rheumatology.

The 10-year survival rates were 81% for patients with limited cutaneous systemic sclerosis (SSc) and 70% for patients with diffuse cutaneous SSc (P = .006).

Survival was significantly reduced (39%) in those who developed major heart, lung, or kidney complications, compared with 71% for those who developed no complications at 15 years' follow-up (P less than .001).

"The 10-year survival is impressive when you consider that not so long ago, we had a 5-year morality approaching 50% in the worst cases. So clearly there has been overall progress in managing the disease," commented study investigator Dr. Christopher Denton.

"Although outcomes are improving, we're still dealing with a disease that has very high case-specific mortality," added Dr. Denton, who is a professor of experimental rheumatology at University College London and a consultant rheumatologist at the Royal Free Hospital, London.

"Around 60% of patients actually die as a direct consequence of their scleroderma, and this is mostly from cardiorespiratory complications of the disease," he added.

Almost 400 patients with scleroderma – of whom 252 (63.3%) had limited cutaneous SSc and 146 (36.7%) had diffuse cutaneous SSc – were studied from their diagnosis in 1995 to 1999 (Rheumatology [Oxford] 2011;50 [suppl. 3]:iii129-iii37, abstract 223). The percentage of men with diffuse cutaneous SSc vs. limited cutaneous SSc disease was higher (17.9% vs. 9.9%; P = .037) and the mean age of onset was 50 years for limited cutaneous SSc patients and 46 years for diffuse cutaneous SSc patients (P = .003).

An important point of the study was that the frequency and timing of the major complications of scleroderma have now been defined over a 10- to 15-year period. Complications of scleroderma can be life threatening, and include pulmonary arterial hypertension (PAH), pulmonary fibrosis, renal disease, and cardiac problems.

At the 10-year follow-up, the incidences of PAH in the limited cutaneous SSc and diffuse cutaneous SSc groups were similar (15% vs. 13%), with the earliest cases seen 2 years after diagnosis. Patients who developed this complication later in the course of their disease tended to have higher 5-year survival rates than did those who had PAH earlier (49% vs. 24%), but this did not reach statistical significance.

Clinically significant pulmonary fibrosis was identified in a higher percentage of patients with diffuse than with limited disease at 10 years (45% vs. 21%; P less than .001), with almost half of patients developing lung disease within the first 3 years, and more than three-quarters within the first 5 years.

Patients with diffuse cutaneous SSc were more likely than those with limited cutaneous SSc to experience renal crisis (12% vs. 4%) at 10 years, with the higher rates occurring in the first 3 years (10% vs. 3%). Similarly, cardiac disease was more common in diffuse cutaneous SSc than in limited cutaneous SSc patients early on (7% vs. 1% at 5 years; P less than .001), but remained unchanged at 10 years.

"Whereas the limited or diffuse distinction is very relevant in the first 5 years, after the 5 years it doesn’t really matter which type of scleroderma you’ve got; you have an equally high frequency of complications," Dr. Denton observed in an interview.

He added that this "is a treated cohort that received standard management, so I think it’s very important to start to understand the timing and frequency of the major heart, lung, and kidney complications, so that you can really identify when in the course of the disease you should be particularly vigilant."

Dr. Denton disclosed financial relationships with Actelion, Aspreva, BioVitrum, Digna, Dyax, Encysive, Genzyme, GlaxoSmithKline, Medimmune, Pfizer, and Sanofi-Aventis.

BRIGHTON, ENGLAND – Survival from scleroderma is improving, but major organ-based complications are still a significant reason for premature death, according to the results of a long-term outcomes study that were presented at the annual meeting of the British Society for Rheumatology.

The 10-year survival rates were 81% for patients with limited cutaneous systemic sclerosis (SSc) and 70% for patients with diffuse cutaneous SSc (P = .006).

Survival was significantly reduced (39%) in those who developed major heart, lung, or kidney complications, compared with 71% for those who developed no complications at 15 years' follow-up (P less than .001).

"The 10-year survival is impressive when you consider that not so long ago, we had a 5-year morality approaching 50% in the worst cases. So clearly there has been overall progress in managing the disease," commented study investigator Dr. Christopher Denton.

"Although outcomes are improving, we're still dealing with a disease that has very high case-specific mortality," added Dr. Denton, who is a professor of experimental rheumatology at University College London and a consultant rheumatologist at the Royal Free Hospital, London.

"Around 60% of patients actually die as a direct consequence of their scleroderma, and this is mostly from cardiorespiratory complications of the disease," he added.

Almost 400 patients with scleroderma – of whom 252 (63.3%) had limited cutaneous SSc and 146 (36.7%) had diffuse cutaneous SSc – were studied from their diagnosis in 1995 to 1999 (Rheumatology [Oxford] 2011;50 [suppl. 3]:iii129-iii37, abstract 223). The percentage of men with diffuse cutaneous SSc vs. limited cutaneous SSc disease was higher (17.9% vs. 9.9%; P = .037) and the mean age of onset was 50 years for limited cutaneous SSc patients and 46 years for diffuse cutaneous SSc patients (P = .003).

An important point of the study was that the frequency and timing of the major complications of scleroderma have now been defined over a 10- to 15-year period. Complications of scleroderma can be life threatening, and include pulmonary arterial hypertension (PAH), pulmonary fibrosis, renal disease, and cardiac problems.

At the 10-year follow-up, the incidences of PAH in the limited cutaneous SSc and diffuse cutaneous SSc groups were similar (15% vs. 13%), with the earliest cases seen 2 years after diagnosis. Patients who developed this complication later in the course of their disease tended to have higher 5-year survival rates than did those who had PAH earlier (49% vs. 24%), but this did not reach statistical significance.

Clinically significant pulmonary fibrosis was identified in a higher percentage of patients with diffuse than with limited disease at 10 years (45% vs. 21%; P less than .001), with almost half of patients developing lung disease within the first 3 years, and more than three-quarters within the first 5 years.

Patients with diffuse cutaneous SSc were more likely than those with limited cutaneous SSc to experience renal crisis (12% vs. 4%) at 10 years, with the higher rates occurring in the first 3 years (10% vs. 3%). Similarly, cardiac disease was more common in diffuse cutaneous SSc than in limited cutaneous SSc patients early on (7% vs. 1% at 5 years; P less than .001), but remained unchanged at 10 years.

"Whereas the limited or diffuse distinction is very relevant in the first 5 years, after the 5 years it doesn’t really matter which type of scleroderma you’ve got; you have an equally high frequency of complications," Dr. Denton observed in an interview.

He added that this "is a treated cohort that received standard management, so I think it’s very important to start to understand the timing and frequency of the major heart, lung, and kidney complications, so that you can really identify when in the course of the disease you should be particularly vigilant."

Dr. Denton disclosed financial relationships with Actelion, Aspreva, BioVitrum, Digna, Dyax, Encysive, Genzyme, GlaxoSmithKline, Medimmune, Pfizer, and Sanofi-Aventis.

BRIGHTON, ENGLAND – Survival from scleroderma is improving, but major organ-based complications are still a significant reason for premature death, according to the results of a long-term outcomes study that were presented at the annual meeting of the British Society for Rheumatology.

The 10-year survival rates were 81% for patients with limited cutaneous systemic sclerosis (SSc) and 70% for patients with diffuse cutaneous SSc (P = .006).

Survival was significantly reduced (39%) in those who developed major heart, lung, or kidney complications, compared with 71% for those who developed no complications at 15 years' follow-up (P less than .001).

"The 10-year survival is impressive when you consider that not so long ago, we had a 5-year morality approaching 50% in the worst cases. So clearly there has been overall progress in managing the disease," commented study investigator Dr. Christopher Denton.

"Although outcomes are improving, we're still dealing with a disease that has very high case-specific mortality," added Dr. Denton, who is a professor of experimental rheumatology at University College London and a consultant rheumatologist at the Royal Free Hospital, London.

"Around 60% of patients actually die as a direct consequence of their scleroderma, and this is mostly from cardiorespiratory complications of the disease," he added.

Almost 400 patients with scleroderma – of whom 252 (63.3%) had limited cutaneous SSc and 146 (36.7%) had diffuse cutaneous SSc – were studied from their diagnosis in 1995 to 1999 (Rheumatology [Oxford] 2011;50 [suppl. 3]:iii129-iii37, abstract 223). The percentage of men with diffuse cutaneous SSc vs. limited cutaneous SSc disease was higher (17.9% vs. 9.9%; P = .037) and the mean age of onset was 50 years for limited cutaneous SSc patients and 46 years for diffuse cutaneous SSc patients (P = .003).

An important point of the study was that the frequency and timing of the major complications of scleroderma have now been defined over a 10- to 15-year period. Complications of scleroderma can be life threatening, and include pulmonary arterial hypertension (PAH), pulmonary fibrosis, renal disease, and cardiac problems.

At the 10-year follow-up, the incidences of PAH in the limited cutaneous SSc and diffuse cutaneous SSc groups were similar (15% vs. 13%), with the earliest cases seen 2 years after diagnosis. Patients who developed this complication later in the course of their disease tended to have higher 5-year survival rates than did those who had PAH earlier (49% vs. 24%), but this did not reach statistical significance.

Clinically significant pulmonary fibrosis was identified in a higher percentage of patients with diffuse than with limited disease at 10 years (45% vs. 21%; P less than .001), with almost half of patients developing lung disease within the first 3 years, and more than three-quarters within the first 5 years.

Patients with diffuse cutaneous SSc were more likely than those with limited cutaneous SSc to experience renal crisis (12% vs. 4%) at 10 years, with the higher rates occurring in the first 3 years (10% vs. 3%). Similarly, cardiac disease was more common in diffuse cutaneous SSc than in limited cutaneous SSc patients early on (7% vs. 1% at 5 years; P less than .001), but remained unchanged at 10 years.

"Whereas the limited or diffuse distinction is very relevant in the first 5 years, after the 5 years it doesn’t really matter which type of scleroderma you’ve got; you have an equally high frequency of complications," Dr. Denton observed in an interview.

He added that this "is a treated cohort that received standard management, so I think it’s very important to start to understand the timing and frequency of the major heart, lung, and kidney complications, so that you can really identify when in the course of the disease you should be particularly vigilant."

Dr. Denton disclosed financial relationships with Actelion, Aspreva, BioVitrum, Digna, Dyax, Encysive, Genzyme, GlaxoSmithKline, Medimmune, Pfizer, and Sanofi-Aventis.

LONDON - The daily, long-term use of low-dose aspirin cuts the risk of death from several types of cancer, according to a large meta-analysis.

In a meta-analysis of eight randomized clinical trials involving 25,570 patients, low-dose aspirin taken for 5 years or longer reduced mortality from esophageal, pancreatic, brain, stomach, colorectal, prostate, and even lung cancer, with doses as low as 75 mg/day having an effect.

This is the first time that low-dose aspirin has been linked to a reduction in cancer mortality other than colorectal cancer, said Dr. Peter M. Rothwell, who conceived and coordinated the research.

Dr. Rothwell of the John Radcliffe Hospital and the University of Oxford, United Kingdom, and his associates in October 2010 showed that low-dose aspirin reduced the 20-year risk of new colon cancer cases by approximately one-quarter and deaths by a third (Lancet 2010;376:1741-50).

The current study looked at all deaths from cancer that occurred during or after completion of eight randomized clinical trials that had been performed to look at the effects of daily aspirin vs. control for the primary or secondary prevention of vascular events (Lancet 2010 [doi:10.1016/S0140-6736(10)62110-1]).

Across all eight trials, 674 cancer deaths occurred in 25,570 patients, with aspirin treatment significantly reducing the risk of death, compared with no aspirin treatment (pooled odds ratio [OR] 0.79, 95% confidence interval [CI] 0.68-0.92, P = .003).

Using individual patient data available for seven of the trials and in which 657 cancer deaths occurred in 23,535 patients, the benefit of aspirin therapy was apparent only after 5 years or more of follow-up. The hazard ratio (HR) for death from all types of cancer was 0.66 (95% CI 0.50-0.87, P =.003), with a greater effect seen in patients with gastrointestinal tumors (HR 0.46, 95% CI 0.27-0.77, P =.003).

"We found that within the trials, while people were still on aspirin vs. no aspirin, the aspirin group had about a 30%-40% reduction in cancer deaths between year 5 and the end of the trial," Dr. Rothwell said at a press briefing.

To determine the longer-term effects of aspirin on cancer mortality, the team looked more closely at data from three of the trials. These had all been conducted in the United Kingdom and continued to collect information on cancer deaths via national death certification and cancer registration systems long after the trials had concluded.

In all, individual patient data were obtained on 1,634 cancer deaths that had occurred in 12,659 patients. Aspirin was found to reduce the 20-year risk of death from all solid cancers by 20% (HR 0.80, 95% CI 0.72-0.88, P less than .0001). Again, the effect on gastrointestinal cancer was greater (HR 0.65, 95% CI 0.54-0.78, P less than .0001), but there was no effect on hematologic malignancies.

At least 5 years of therapy were needed to reduce the risk of death from esophageal, pancreatic, brain, or lung cancer, with 10 years or more treatment required to see an effect on stomach and colorectal cancer death rates, and 15 years or more for prostate cancer. With regard to both lung and esophageal cancer, the effect of aspirin was limited to adenocarcinomas.

While the findings do not mean that everyone over the age of 40 years should now start taking daily aspirin to prevent cancer, given the increased risk of bleeding in some individuals, "We should probably stop taking people off aspirin unless they've got side effects," Dr. Rothwell said in an interview, adding "We probably shouldn't discourage those who want to take aspirin as actively as we have been doing."

"There is a fundamental difference between the treatment and the prevention of a disease," said Dr. Peter Elwood, professor of epidemiology at Cardiff University, Wales. Dr. Elwood suggested that deciding to take a daily dose of aspirin to prevent cancer could be another choice patients make once they have all the relevant facts, much as lifestyle changes are advised but not prescribed for cardiovascular disease prevention.

Dr. Rothwell has received honoraria from pharmaceutical companies with an interest in antiplatelet therapy, including AstraZeneca and Bayer.

LONDON - The daily, long-term use of low-dose aspirin cuts the risk of death from several types of cancer, according to a large meta-analysis.

In a meta-analysis of eight randomized clinical trials involving 25,570 patients, low-dose aspirin taken for 5 years or longer reduced mortality from esophageal, pancreatic, brain, stomach, colorectal, prostate, and even lung cancer, with doses as low as 75 mg/day having an effect.

This is the first time that low-dose aspirin has been linked to a reduction in cancer mortality other than colorectal cancer, said Dr. Peter M. Rothwell, who conceived and coordinated the research.

Dr. Rothwell of the John Radcliffe Hospital and the University of Oxford, United Kingdom, and his associates in October 2010 showed that low-dose aspirin reduced the 20-year risk of new colon cancer cases by approximately one-quarter and deaths by a third (Lancet 2010;376:1741-50).

The current study looked at all deaths from cancer that occurred during or after completion of eight randomized clinical trials that had been performed to look at the effects of daily aspirin vs. control for the primary or secondary prevention of vascular events (Lancet 2010 [doi:10.1016/S0140-6736(10)62110-1]).

Across all eight trials, 674 cancer deaths occurred in 25,570 patients, with aspirin treatment significantly reducing the risk of death, compared with no aspirin treatment (pooled odds ratio [OR] 0.79, 95% confidence interval [CI] 0.68-0.92, P = .003).

Using individual patient data available for seven of the trials and in which 657 cancer deaths occurred in 23,535 patients, the benefit of aspirin therapy was apparent only after 5 years or more of follow-up. The hazard ratio (HR) for death from all types of cancer was 0.66 (95% CI 0.50-0.87, P =.003), with a greater effect seen in patients with gastrointestinal tumors (HR 0.46, 95% CI 0.27-0.77, P =.003).

"We found that within the trials, while people were still on aspirin vs. no aspirin, the aspirin group had about a 30%-40% reduction in cancer deaths between year 5 and the end of the trial," Dr. Rothwell said at a press briefing.

To determine the longer-term effects of aspirin on cancer mortality, the team looked more closely at data from three of the trials. These had all been conducted in the United Kingdom and continued to collect information on cancer deaths via national death certification and cancer registration systems long after the trials had concluded.

In all, individual patient data were obtained on 1,634 cancer deaths that had occurred in 12,659 patients. Aspirin was found to reduce the 20-year risk of death from all solid cancers by 20% (HR 0.80, 95% CI 0.72-0.88, P less than .0001). Again, the effect on gastrointestinal cancer was greater (HR 0.65, 95% CI 0.54-0.78, P less than .0001), but there was no effect on hematologic malignancies.

At least 5 years of therapy were needed to reduce the risk of death from esophageal, pancreatic, brain, or lung cancer, with 10 years or more treatment required to see an effect on stomach and colorectal cancer death rates, and 15 years or more for prostate cancer. With regard to both lung and esophageal cancer, the effect of aspirin was limited to adenocarcinomas.

While the findings do not mean that everyone over the age of 40 years should now start taking daily aspirin to prevent cancer, given the increased risk of bleeding in some individuals, "We should probably stop taking people off aspirin unless they've got side effects," Dr. Rothwell said in an interview, adding "We probably shouldn't discourage those who want to take aspirin as actively as we have been doing."

"There is a fundamental difference between the treatment and the prevention of a disease," said Dr. Peter Elwood, professor of epidemiology at Cardiff University, Wales. Dr. Elwood suggested that deciding to take a daily dose of aspirin to prevent cancer could be another choice patients make once they have all the relevant facts, much as lifestyle changes are advised but not prescribed for cardiovascular disease prevention.

Dr. Rothwell has received honoraria from pharmaceutical companies with an interest in antiplatelet therapy, including AstraZeneca and Bayer.

LONDON - The daily, long-term use of low-dose aspirin cuts the risk of death from several types of cancer, according to a large meta-analysis.

In a meta-analysis of eight randomized clinical trials involving 25,570 patients, low-dose aspirin taken for 5 years or longer reduced mortality from esophageal, pancreatic, brain, stomach, colorectal, prostate, and even lung cancer, with doses as low as 75 mg/day having an effect.

This is the first time that low-dose aspirin has been linked to a reduction in cancer mortality other than colorectal cancer, said Dr. Peter M. Rothwell, who conceived and coordinated the research.

Dr. Rothwell of the John Radcliffe Hospital and the University of Oxford, United Kingdom, and his associates in October 2010 showed that low-dose aspirin reduced the 20-year risk of new colon cancer cases by approximately one-quarter and deaths by a third (Lancet 2010;376:1741-50).

The current study looked at all deaths from cancer that occurred during or after completion of eight randomized clinical trials that had been performed to look at the effects of daily aspirin vs. control for the primary or secondary prevention of vascular events (Lancet 2010 [doi:10.1016/S0140-6736(10)62110-1]).

Across all eight trials, 674 cancer deaths occurred in 25,570 patients, with aspirin treatment significantly reducing the risk of death, compared with no aspirin treatment (pooled odds ratio [OR] 0.79, 95% confidence interval [CI] 0.68-0.92, P = .003).

Using individual patient data available for seven of the trials and in which 657 cancer deaths occurred in 23,535 patients, the benefit of aspirin therapy was apparent only after 5 years or more of follow-up. The hazard ratio (HR) for death from all types of cancer was 0.66 (95% CI 0.50-0.87, P =.003), with a greater effect seen in patients with gastrointestinal tumors (HR 0.46, 95% CI 0.27-0.77, P =.003).

"We found that within the trials, while people were still on aspirin vs. no aspirin, the aspirin group had about a 30%-40% reduction in cancer deaths between year 5 and the end of the trial," Dr. Rothwell said at a press briefing.

To determine the longer-term effects of aspirin on cancer mortality, the team looked more closely at data from three of the trials. These had all been conducted in the United Kingdom and continued to collect information on cancer deaths via national death certification and cancer registration systems long after the trials had concluded.

In all, individual patient data were obtained on 1,634 cancer deaths that had occurred in 12,659 patients. Aspirin was found to reduce the 20-year risk of death from all solid cancers by 20% (HR 0.80, 95% CI 0.72-0.88, P less than .0001). Again, the effect on gastrointestinal cancer was greater (HR 0.65, 95% CI 0.54-0.78, P less than .0001), but there was no effect on hematologic malignancies.

At least 5 years of therapy were needed to reduce the risk of death from esophageal, pancreatic, brain, or lung cancer, with 10 years or more treatment required to see an effect on stomach and colorectal cancer death rates, and 15 years or more for prostate cancer. With regard to both lung and esophageal cancer, the effect of aspirin was limited to adenocarcinomas.

While the findings do not mean that everyone over the age of 40 years should now start taking daily aspirin to prevent cancer, given the increased risk of bleeding in some individuals, "We should probably stop taking people off aspirin unless they've got side effects," Dr. Rothwell said in an interview, adding "We probably shouldn't discourage those who want to take aspirin as actively as we have been doing."

"There is a fundamental difference between the treatment and the prevention of a disease," said Dr. Peter Elwood, professor of epidemiology at Cardiff University, Wales. Dr. Elwood suggested that deciding to take a daily dose of aspirin to prevent cancer could be another choice patients make once they have all the relevant facts, much as lifestyle changes are advised but not prescribed for cardiovascular disease prevention.

Dr. Rothwell has received honoraria from pharmaceutical companies with an interest in antiplatelet therapy, including AstraZeneca and Bayer.

LONDON - The daily, long-term use of low-dose aspirin cuts the risk of death from several types of cancer, according to a large meta-analysis.

In a meta-analysis of eight randomized clinical trials involving 25,570 patients, low-dose aspirin taken for 5 years or longer reduced mortality from esophageal, pancreatic, brain, stomach, colorectal, prostate, and even lung cancer, with doses as low as 75 mg/day having an effect.

This is the first time that low-dose aspirin has been linked to a reduction in cancer mortality other than colorectal cancer, said Dr. Peter M. Rothwell, who conceived and coordinated the research.

Dr. Rothwell of the John Radcliffe Hospital and the University of Oxford, United Kingdom, and his associates in October 2010 showed that low-dose aspirin reduced the 20-year risk of new colon cancer cases by approximately one-quarter and deaths by a third (Lancet 2010;376:1741-50).

The current study looked at all deaths from cancer that occurred during or after completion of eight randomized clinical trials that had been performed to look at the effects of daily aspirin vs. control for the primary or secondary prevention of vascular events (Lancet 2010 [doi:10.1016/S0140-6736(10)62110-1]).

Across all eight trials, 674 cancer deaths occurred in 25,570 patients, with aspirin treatment significantly reducing the risk of death, compared with no aspirin treatment (pooled odds ratio [OR] 0.79, 95% confidence interval [CI] 0.68-0.92, P = .003).

Using individual patient data available for seven of the trials and in which 657 cancer deaths occurred in 23,535 patients, the benefit of aspirin therapy was apparent only after 5 years or more of follow-up. The hazard ratio (HR) for death from all types of cancer was 0.66 (95% CI 0.50-0.87, P =.003), with a greater effect seen in patients with gastrointestinal tumors (HR 0.46, 95% CI 0.27-0.77, P =.003).

"We found that within the trials, while people were still on aspirin vs. no aspirin, the aspirin group had about a 30%-40% reduction in cancer deaths between year 5 and the end of the trial," Dr. Rothwell said at a press briefing.

To determine the longer-term effects of aspirin on cancer mortality, the team looked more closely at data from three of the trials. These had all been conducted in the United Kingdom and continued to collect information on cancer deaths via national death certification and cancer registration systems long after the trials had concluded.

In all, individual patient data were obtained on 1,634 cancer deaths that had occurred in 12,659 patients. Aspirin was found to reduce the 20-year risk of death from all solid cancers by 20% (HR 0.80, 95% CI 0.72-0.88, P less than .0001). Again, the effect on gastrointestinal cancer was greater (HR 0.65, 95% CI 0.54-0.78, P less than .0001), but there was no effect on hematologic malignancies.

At least 5 years of therapy were needed to reduce the risk of death from esophageal, pancreatic, brain, or lung cancer, with 10 years or more treatment required to see an effect on stomach and colorectal cancer death rates, and 15 years or more for prostate cancer. With regard to both lung and esophageal cancer, the effect of aspirin was limited to adenocarcinomas.

While the findings do not mean that everyone over the age of 40 years should now start taking daily aspirin to prevent cancer, given the increased risk of bleeding in some individuals, "We should probably stop taking people off aspirin unless they've got side effects," Dr. Rothwell said in an interview, adding "We probably shouldn't discourage those who want to take aspirin as actively as we have been doing."

"There is a fundamental difference between the treatment and the prevention of a disease," said Dr. Peter Elwood, professor of epidemiology at Cardiff University, Wales. Dr. Elwood suggested that deciding to take a daily dose of aspirin to prevent cancer could be another choice patients make once they have all the relevant facts, much as lifestyle changes are advised but not prescribed for cardiovascular disease prevention.

Dr. Rothwell has received honoraria from pharmaceutical companies with an interest in antiplatelet therapy, including AstraZeneca and Bayer.

LONDON - The daily, long-term use of low-dose aspirin cuts the risk of death from several types of cancer, according to a large meta-analysis.

In a meta-analysis of eight randomized clinical trials involving 25,570 patients, low-dose aspirin taken for 5 years or longer reduced mortality from esophageal, pancreatic, brain, stomach, colorectal, prostate, and even lung cancer, with doses as low as 75 mg/day having an effect.

This is the first time that low-dose aspirin has been linked to a reduction in cancer mortality other than colorectal cancer, said Dr. Peter M. Rothwell, who conceived and coordinated the research.

Dr. Rothwell of the John Radcliffe Hospital and the University of Oxford, United Kingdom, and his associates in October 2010 showed that low-dose aspirin reduced the 20-year risk of new colon cancer cases by approximately one-quarter and deaths by a third (Lancet 2010;376:1741-50).

The current study looked at all deaths from cancer that occurred during or after completion of eight randomized clinical trials that had been performed to look at the effects of daily aspirin vs. control for the primary or secondary prevention of vascular events (Lancet 2010 [doi:10.1016/S0140-6736(10)62110-1]).

Across all eight trials, 674 cancer deaths occurred in 25,570 patients, with aspirin treatment significantly reducing the risk of death, compared with no aspirin treatment (pooled odds ratio [OR] 0.79, 95% confidence interval [CI] 0.68-0.92, P = .003).

Using individual patient data available for seven of the trials and in which 657 cancer deaths occurred in 23,535 patients, the benefit of aspirin therapy was apparent only after 5 years or more of follow-up. The hazard ratio (HR) for death from all types of cancer was 0.66 (95% CI 0.50-0.87, P =.003), with a greater effect seen in patients with gastrointestinal tumors (HR 0.46, 95% CI 0.27-0.77, P =.003).

"We found that within the trials, while people were still on aspirin vs. no aspirin, the aspirin group had about a 30%-40% reduction in cancer deaths between year 5 and the end of the trial," Dr. Rothwell said at a press briefing.

To determine the longer-term effects of aspirin on cancer mortality, the team looked more closely at data from three of the trials. These had all been conducted in the United Kingdom and continued to collect information on cancer deaths via national death certification and cancer registration systems long after the trials had concluded.

In all, individual patient data were obtained on 1,634 cancer deaths that had occurred in 12,659 patients. Aspirin was found to reduce the 20-year risk of death from all solid cancers by 20% (HR 0.80, 95% CI 0.72-0.88, P less than .0001). Again, the effect on gastrointestinal cancer was greater (HR 0.65, 95% CI 0.54-0.78, P less than .0001), but there was no effect on hematologic malignancies.

At least 5 years of therapy were needed to reduce the risk of death from esophageal, pancreatic, brain, or lung cancer, with 10 years or more treatment required to see an effect on stomach and colorectal cancer death rates, and 15 years or more for prostate cancer. With regard to both lung and esophageal cancer, the effect of aspirin was limited to adenocarcinomas.

While the findings do not mean that everyone over the age of 40 years should now start taking daily aspirin to prevent cancer, given the increased risk of bleeding in some individuals, "We should probably stop taking people off aspirin unless they've got side effects," Dr. Rothwell said in an interview, adding "We probably shouldn't discourage those who want to take aspirin as actively as we have been doing."

"There is a fundamental difference between the treatment and the prevention of a disease," said Dr. Peter Elwood, professor of epidemiology at Cardiff University, Wales. Dr. Elwood suggested that deciding to take a daily dose of aspirin to prevent cancer could be another choice patients make once they have all the relevant facts, much as lifestyle changes are advised but not prescribed for cardiovascular disease prevention.

Dr. Rothwell has received honoraria from pharmaceutical companies with an interest in antiplatelet therapy, including AstraZeneca and Bayer.

LONDON - The daily, long-term use of low-dose aspirin cuts the risk of death from several types of cancer, according to a large meta-analysis.

In a meta-analysis of eight randomized clinical trials involving 25,570 patients, low-dose aspirin taken for 5 years or longer reduced mortality from esophageal, pancreatic, brain, stomach, colorectal, prostate, and even lung cancer, with doses as low as 75 mg/day having an effect.

This is the first time that low-dose aspirin has been linked to a reduction in cancer mortality other than colorectal cancer, said Dr. Peter M. Rothwell, who conceived and coordinated the research.

Dr. Rothwell of the John Radcliffe Hospital and the University of Oxford, United Kingdom, and his associates in October 2010 showed that low-dose aspirin reduced the 20-year risk of new colon cancer cases by approximately one-quarter and deaths by a third (Lancet 2010;376:1741-50).

The current study looked at all deaths from cancer that occurred during or after completion of eight randomized clinical trials that had been performed to look at the effects of daily aspirin vs. control for the primary or secondary prevention of vascular events (Lancet 2010 [doi:10.1016/S0140-6736(10)62110-1]).

Across all eight trials, 674 cancer deaths occurred in 25,570 patients, with aspirin treatment significantly reducing the risk of death, compared with no aspirin treatment (pooled odds ratio [OR] 0.79, 95% confidence interval [CI] 0.68-0.92, P = .003).

Using individual patient data available for seven of the trials and in which 657 cancer deaths occurred in 23,535 patients, the benefit of aspirin therapy was apparent only after 5 years or more of follow-up. The hazard ratio (HR) for death from all types of cancer was 0.66 (95% CI 0.50-0.87, P =.003), with a greater effect seen in patients with gastrointestinal tumors (HR 0.46, 95% CI 0.27-0.77, P =.003).

"We found that within the trials, while people were still on aspirin vs. no aspirin, the aspirin group had about a 30%-40% reduction in cancer deaths between year 5 and the end of the trial," Dr. Rothwell said at a press briefing.

To determine the longer-term effects of aspirin on cancer mortality, the team looked more closely at data from three of the trials. These had all been conducted in the United Kingdom and continued to collect information on cancer deaths via national death certification and cancer registration systems long after the trials had concluded.

In all, individual patient data were obtained on 1,634 cancer deaths that had occurred in 12,659 patients. Aspirin was found to reduce the 20-year risk of death from all solid cancers by 20% (HR 0.80, 95% CI 0.72-0.88, P less than .0001). Again, the effect on gastrointestinal cancer was greater (HR 0.65, 95% CI 0.54-0.78, P less than .0001), but there was no effect on hematologic malignancies.

At least 5 years of therapy were needed to reduce the risk of death from esophageal, pancreatic, brain, or lung cancer, with 10 years or more treatment required to see an effect on stomach and colorectal cancer death rates, and 15 years or more for prostate cancer. With regard to both lung and esophageal cancer, the effect of aspirin was limited to adenocarcinomas.

While the findings do not mean that everyone over the age of 40 years should now start taking daily aspirin to prevent cancer, given the increased risk of bleeding in some individuals, "We should probably stop taking people off aspirin unless they've got side effects," Dr. Rothwell said in an interview, adding "We probably shouldn't discourage those who want to take aspirin as actively as we have been doing."

"There is a fundamental difference between the treatment and the prevention of a disease," said Dr. Peter Elwood, professor of epidemiology at Cardiff University, Wales. Dr. Elwood suggested that deciding to take a daily dose of aspirin to prevent cancer could be another choice patients make once they have all the relevant facts, much as lifestyle changes are advised but not prescribed for cardiovascular disease prevention.

Dr. Rothwell has received honoraria from pharmaceutical companies with an interest in antiplatelet therapy, including AstraZeneca and Bayer.

LONDON - The daily, long-term use of low-dose aspirin cuts the risk of death from several types of cancer, according to a large meta-analysis.

In a meta-analysis of eight randomized clinical trials involving 25,570 patients, low-dose aspirin taken for 5 years or longer reduced mortality from esophageal, pancreatic, brain, stomach, colorectal, prostate, and even lung cancer, with doses as low as 75 mg/day having an effect.

This is the first time that low-dose aspirin has been linked to a reduction in cancer mortality other than colorectal cancer, said Dr. Peter M. Rothwell, who conceived and coordinated the research.

Dr. Rothwell of the John Radcliffe Hospital and the University of Oxford, United Kingdom, and his associates in October 2010 showed that low-dose aspirin reduced the 20-year risk of new colon cancer cases by approximately one-quarter and deaths by a third (Lancet 2010;376:1741-50).

The current study looked at all deaths from cancer that occurred during or after completion of eight randomized clinical trials that had been performed to look at the effects of daily aspirin vs. control for the primary or secondary prevention of vascular events (Lancet 2010 [doi:10.1016/S0140-6736(10)62110-1]).

Across all eight trials, 674 cancer deaths occurred in 25,570 patients, with aspirin treatment significantly reducing the risk of death, compared with no aspirin treatment (pooled odds ratio [OR] 0.79, 95% confidence interval [CI] 0.68-0.92, P = .003).

Using individual patient data available for seven of the trials and in which 657 cancer deaths occurred in 23,535 patients, the benefit of aspirin therapy was apparent only after 5 years or more of follow-up. The hazard ratio (HR) for death from all types of cancer was 0.66 (95% CI 0.50-0.87, P =.003), with a greater effect seen in patients with gastrointestinal tumors (HR 0.46, 95% CI 0.27-0.77, P =.003).

"We found that within the trials, while people were still on aspirin vs. no aspirin, the aspirin group had about a 30%-40% reduction in cancer deaths between year 5 and the end of the trial," Dr. Rothwell said at a press briefing.

To determine the longer-term effects of aspirin on cancer mortality, the team looked more closely at data from three of the trials. These had all been conducted in the United Kingdom and continued to collect information on cancer deaths via national death certification and cancer registration systems long after the trials had concluded.

In all, individual patient data were obtained on 1,634 cancer deaths that had occurred in 12,659 patients. Aspirin was found to reduce the 20-year risk of death from all solid cancers by 20% (HR 0.80, 95% CI 0.72-0.88, P less than .0001). Again, the effect on gastrointestinal cancer was greater (HR 0.65, 95% CI 0.54-0.78, P less than .0001), but there was no effect on hematologic malignancies.

At least 5 years of therapy were needed to reduce the risk of death from esophageal, pancreatic, brain, or lung cancer, with 10 years or more treatment required to see an effect on stomach and colorectal cancer death rates, and 15 years or more for prostate cancer. With regard to both lung and esophageal cancer, the effect of aspirin was limited to adenocarcinomas.

While the findings do not mean that everyone over the age of 40 years should now start taking daily aspirin to prevent cancer, given the increased risk of bleeding in some individuals, "We should probably stop taking people off aspirin unless they've got side effects," Dr. Rothwell said in an interview, adding "We probably shouldn't discourage those who want to take aspirin as actively as we have been doing."

"There is a fundamental difference between the treatment and the prevention of a disease," said Dr. Peter Elwood, professor of epidemiology at Cardiff University, Wales. Dr. Elwood suggested that deciding to take a daily dose of aspirin to prevent cancer could be another choice patients make once they have all the relevant facts, much as lifestyle changes are advised but not prescribed for cardiovascular disease prevention.

Dr. Rothwell has received honoraria from pharmaceutical companies with an interest in antiplatelet therapy, including AstraZeneca and Bayer.

LONDON - The daily, long-term use of low-dose aspirin cuts the risk of death from several types of cancer, according to a large meta-analysis.

In a meta-analysis of eight randomized clinical trials involving 25,570 patients, low-dose aspirin taken for 5 years or longer reduced mortality from esophageal, pancreatic, brain, stomach, colorectal, prostate, and even lung cancer, with doses as low as 75 mg/day having an effect.

This is the first time that low-dose aspirin has been linked to a reduction in cancer mortality other than colorectal cancer, said Dr. Peter M. Rothwell, who conceived and coordinated the research.

Dr. Rothwell of the John Radcliffe Hospital and the University of Oxford, United Kingdom, and his associates in October 2010 showed that low-dose aspirin reduced the 20-year risk of new colon cancer cases by approximately one-quarter and deaths by a third (Lancet 2010;376:1741-50).

The current study looked at all deaths from cancer that occurred during or after completion of eight randomized clinical trials that had been performed to look at the effects of daily aspirin vs. control for the primary or secondary prevention of vascular events (Lancet 2010 [doi:10.1016/S0140-6736(10)62110-1]).

Across all eight trials, 674 cancer deaths occurred in 25,570 patients, with aspirin treatment significantly reducing the risk of death, compared with no aspirin treatment (pooled odds ratio [OR] 0.79, 95% confidence interval [CI] 0.68-0.92, P = .003).

Using individual patient data available for seven of the trials and in which 657 cancer deaths occurred in 23,535 patients, the benefit of aspirin therapy was apparent only after 5 years or more of follow-up. The hazard ratio (HR) for death from all types of cancer was 0.66 (95% CI 0.50-0.87, P =.003), with a greater effect seen in patients with gastrointestinal tumors (HR 0.46, 95% CI 0.27-0.77, P =.003).

"We found that within the trials, while people were still on aspirin vs. no aspirin, the aspirin group had about a 30%-40% reduction in cancer deaths between year 5 and the end of the trial," Dr. Rothwell said at a press briefing.

To determine the longer-term effects of aspirin on cancer mortality, the team looked more closely at data from three of the trials. These had all been conducted in the United Kingdom and continued to collect information on cancer deaths via national death certification and cancer registration systems long after the trials had concluded.

In all, individual patient data were obtained on 1,634 cancer deaths that had occurred in 12,659 patients. Aspirin was found to reduce the 20-year risk of death from all solid cancers by 20% (HR 0.80, 95% CI 0.72-0.88, P less than .0001). Again, the effect on gastrointestinal cancer was greater (HR 0.65, 95% CI 0.54-0.78, P less than .0001), but there was no effect on hematologic malignancies.

At least 5 years of therapy were needed to reduce the risk of death from esophageal, pancreatic, brain, or lung cancer, with 10 years or more treatment required to see an effect on stomach and colorectal cancer death rates, and 15 years or more for prostate cancer. With regard to both lung and esophageal cancer, the effect of aspirin was limited to adenocarcinomas.

While the findings do not mean that everyone over the age of 40 years should now start taking daily aspirin to prevent cancer, given the increased risk of bleeding in some individuals, "We should probably stop taking people off aspirin unless they've got side effects," Dr. Rothwell said in an interview, adding "We probably shouldn't discourage those who want to take aspirin as actively as we have been doing."

"There is a fundamental difference between the treatment and the prevention of a disease," said Dr. Peter Elwood, professor of epidemiology at Cardiff University, Wales. Dr. Elwood suggested that deciding to take a daily dose of aspirin to prevent cancer could be another choice patients make once they have all the relevant facts, much as lifestyle changes are advised but not prescribed for cardiovascular disease prevention.

Dr. Rothwell has received honoraria from pharmaceutical companies with an interest in antiplatelet therapy, including AstraZeneca and Bayer.

LONDON - The daily, long-term use of low-dose aspirin cuts the risk of death from several types of cancer, according to a large meta-analysis.

In a meta-analysis of eight randomized clinical trials involving 25,570 patients, low-dose aspirin taken for 5 years or longer reduced mortality from esophageal, pancreatic, brain, stomach, colorectal, prostate, and even lung cancer, with doses as low as 75 mg/day having an effect.

This is the first time that low-dose aspirin has been linked to a reduction in cancer mortality other than colorectal cancer, said Dr. Peter M. Rothwell, who conceived and coordinated the research.

Dr. Rothwell of the John Radcliffe Hospital and the University of Oxford, United Kingdom, and his associates in October 2010 showed that low-dose aspirin reduced the 20-year risk of new colon cancer cases by approximately one-quarter and deaths by a third (Lancet 2010;376:1741-50).

The current study looked at all deaths from cancer that occurred during or after completion of eight randomized clinical trials that had been performed to look at the effects of daily aspirin vs. control for the primary or secondary prevention of vascular events (Lancet 2010 [doi:10.1016/S0140-6736(10)62110-1]).

Across all eight trials, 674 cancer deaths occurred in 25,570 patients, with aspirin treatment significantly reducing the risk of death, compared with no aspirin treatment (pooled odds ratio [OR] 0.79, 95% confidence interval [CI] 0.68-0.92, P = .003).

Using individual patient data available for seven of the trials and in which 657 cancer deaths occurred in 23,535 patients, the benefit of aspirin therapy was apparent only after 5 years or more of follow-up. The hazard ratio (HR) for death from all types of cancer was 0.66 (95% CI 0.50-0.87, P =.003), with a greater effect seen in patients with gastrointestinal tumors (HR 0.46, 95% CI 0.27-0.77, P =.003).

"We found that within the trials, while people were still on aspirin vs. no aspirin, the aspirin group had about a 30%-40% reduction in cancer deaths between year 5 and the end of the trial," Dr. Rothwell said at a press briefing.

To determine the longer-term effects of aspirin on cancer mortality, the team looked more closely at data from three of the trials. These had all been conducted in the United Kingdom and continued to collect information on cancer deaths via national death certification and cancer registration systems long after the trials had concluded.

In all, individual patient data were obtained on 1,634 cancer deaths that had occurred in 12,659 patients. Aspirin was found to reduce the 20-year risk of death from all solid cancers by 20% (HR 0.80, 95% CI 0.72-0.88, P less than .0001). Again, the effect on gastrointestinal cancer was greater (HR 0.65, 95% CI 0.54-0.78, P less than .0001), but there was no effect on hematologic malignancies.

At least 5 years of therapy were needed to reduce the risk of death from esophageal, pancreatic, brain, or lung cancer, with 10 years or more treatment required to see an effect on stomach and colorectal cancer death rates, and 15 years or more for prostate cancer. With regard to both lung and esophageal cancer, the effect of aspirin was limited to adenocarcinomas.

While the findings do not mean that everyone over the age of 40 years should now start taking daily aspirin to prevent cancer, given the increased risk of bleeding in some individuals, "We should probably stop taking people off aspirin unless they've got side effects," Dr. Rothwell said in an interview, adding "We probably shouldn't discourage those who want to take aspirin as actively as we have been doing."

"There is a fundamental difference between the treatment and the prevention of a disease," said Dr. Peter Elwood, professor of epidemiology at Cardiff University, Wales. Dr. Elwood suggested that deciding to take a daily dose of aspirin to prevent cancer could be another choice patients make once they have all the relevant facts, much as lifestyle changes are advised but not prescribed for cardiovascular disease prevention.

Dr. Rothwell has received honoraria from pharmaceutical companies with an interest in antiplatelet therapy, including AstraZeneca and Bayer.

LONDON – Cognitive behavioral therapy and graded exercise therapy are both safe and effective to use in combination with specialist medical care for chronic fatigue syndrome, according to the results of a large randomized, controlled trial.

In contrast, adapted pacing therapy (APT), which several patient organizations have advocated as the preferred treatment choice together with specialist medical care, offers no real benefit – leading some experts to suggest that perhaps APT should no longer be used.

The findings were reported online Feb. 17 in the Lancet.

Cognitive behavioral therapy (CBT) and graded exercise therapy (GET) – but not APT – significantly lowered fatigue and raised physical function scores when compared with specialist medical care (SMC) alone.

At 1-year follow-up, the respective changes in fatigue and physical function scores versus SMC alone were –3.4 and +7.1 for CBT, and –3.2 and +9.4 for GET, all of which were statistically significant differences. In contrast, the changes in those scores for APT were –0.7 and –3.4, respectively, differences that weren’t statistically significant.

Although the effects of CBT and GET on chronic fatigue syndrome (CFS) are still rather moderate, "the bottom line is that patients given CBT and GET showed more improvement than the other two groups," said Trudie Chalder, Ph.D., one of the study’s authors and a professor of cognitive behavioral psychotherapy at King’s College London (Lancet 2011 Feb. 17 [doi:10.1016/S0140-6736(11)60096-2]).

CFS affects around a quarter of a million people in the United Kingdom. Symptoms include severe fatigue, poor concentration and memory, disturbed sleep, and muscle and joint pain. Effective treatments for the condition are limited, with debate over the use of CBT and GET versus the more frequently used APT.

CBT and GET offer a more hopeful approach to CFS treatment than APT, because they focus on patients’ abilities rather than their disabilities, the investigators noted. APT is based on a more nihilistic premise, focusing on coming to terms with the illness and optimizing activities accordingly, they added.

The Pacing, Graded Activity, and Cognitive Behaviour Therapy: a Randomised Evaluation (PACE) trial was a prospective, multicenter, randomized trial of 640 outpatients with CFS comparing four parallel treatment arms: SMC alone, SMC plus APT, SMC plus CBT, and SMC plus GET. Patients were given individual therapy sessions once a month and group interventions every 3 months. Interventions were given for up to 24 weeks, with follow-up assessments at 1 year.

More than 3,100 patients were originally screened for the trial, but only those who met the Oxford criteria for CFS were enrolled. Those criteria require fatigue to be the predominant symptom, accompanied by significant physical disability in the absence of any other psychiatric or organic brain disorder.

Approximately 75% of the study participants were women, and the majority (93%) of patients was white. The mean age was 38 years, and the mean duration of illness was 32 months. The coprimary end points of fatigue and physical functioning were measured using the patient-reported Chalder fatigue questionnaire and the Short Form-36 physical function subscale.

"The take-home message is that we now have robust evidence of the effectiveness, and importantly for patients, the safety of CBT and GET, as long as they are given by properly trained people," said Dr. Michael Sharp, a study coauthor who is a professor of psychological medicine and director of psychological medicine research at the University of Edinburgh, Scotland.

Funding for the PACE trial was provided by the U.K. Medical Research Council, Department of Health for England, Scottish Chief Scientist Office, and Department for Work and Pensions. Dr. Chalder and Dr. Sharp reported no relevant conflicts of interest.

"Although the PACE trial shows that recovery from chronic fatigue syndrome is possible, there is clearly room for improvement with both interventions (cognitive behaviour therapy and graded exercise therapy)," noted Dr. Gijs Bleijenberg and Dr. Hans Knoop of Radboud University Nijmegen (Netherlands) Medical Centre in an accompanying editorial (Lancet 2011 Feb. 17 [doi:10.1016/S0140-6736(11)60172-4]).

"Both interventions could be improved if more was known about the mechanisms of change," they added. "Future studies into mechanisms of change are urgently needed and could help to improve the efficacy of the interventions, by focusing on the elements that are crucial for change."

Other independent experts welcomed the findings of the PACE study, commending the trial for finally answering a long-held dilemma.

"This study matters – it matters a lot," said Dr. Willie Hamilton, a primary care practitioner and professor of primary care diagnostics at the Peninsula College of Medicine and Dentistry in Exeter, England.

"Until now, we have known that only CBT and GET work for some people. We didn’t know if pacing worked," Dr. Hamilton said. "This caused a real dilemma – especially for those in primary care. We didn’t know whether to recommend pacing or to refer for CBT or GET. This study should solve that."

His words were echoed by Dr. Derick Wade, a consultant in neurological rehabilitation and clinical director at the Oxford Center for Enablement. "The trial design in this study was very good, and it means that the conclusions drawn can be drawn with confidence," Dr. Wade said.

While the study’s findings confirm the safety and effectiveness of CBT and GET, Dr. Wade noted, the findings on the use of APT show that "one commonly used intervention is not effective and therefore should not be used."

LONDON – Cognitive behavioral therapy and graded exercise therapy are both safe and effective to use in combination with specialist medical care for chronic fatigue syndrome, according to the results of a large randomized, controlled trial.

In contrast, adapted pacing therapy (APT), which several patient organizations have advocated as the preferred treatment choice together with specialist medical care, offers no real benefit – leading some experts to suggest that perhaps APT should no longer be used.

The findings were reported online Feb. 17 in the Lancet.

Cognitive behavioral therapy (CBT) and graded exercise therapy (GET) – but not APT – significantly lowered fatigue and raised physical function scores when compared with specialist medical care (SMC) alone.

At 1-year follow-up, the respective changes in fatigue and physical function scores versus SMC alone were –3.4 and +7.1 for CBT, and –3.2 and +9.4 for GET, all of which were statistically significant differences. In contrast, the changes in those scores for APT were –0.7 and –3.4, respectively, differences that weren’t statistically significant.

Although the effects of CBT and GET on chronic fatigue syndrome (CFS) are still rather moderate, "the bottom line is that patients given CBT and GET showed more improvement than the other two groups," said Trudie Chalder, Ph.D., one of the study’s authors and a professor of cognitive behavioral psychotherapy at King’s College London (Lancet 2011 Feb. 17 [doi:10.1016/S0140-6736(11)60096-2]).

CFS affects around a quarter of a million people in the United Kingdom. Symptoms include severe fatigue, poor concentration and memory, disturbed sleep, and muscle and joint pain. Effective treatments for the condition are limited, with debate over the use of CBT and GET versus the more frequently used APT.

CBT and GET offer a more hopeful approach to CFS treatment than APT, because they focus on patients’ abilities rather than their disabilities, the investigators noted. APT is based on a more nihilistic premise, focusing on coming to terms with the illness and optimizing activities accordingly, they added.

The Pacing, Graded Activity, and Cognitive Behaviour Therapy: a Randomised Evaluation (PACE) trial was a prospective, multicenter, randomized trial of 640 outpatients with CFS comparing four parallel treatment arms: SMC alone, SMC plus APT, SMC plus CBT, and SMC plus GET. Patients were given individual therapy sessions once a month and group interventions every 3 months. Interventions were given for up to 24 weeks, with follow-up assessments at 1 year.

More than 3,100 patients were originally screened for the trial, but only those who met the Oxford criteria for CFS were enrolled. Those criteria require fatigue to be the predominant symptom, accompanied by significant physical disability in the absence of any other psychiatric or organic brain disorder.

Approximately 75% of the study participants were women, and the majority (93%) of patients was white. The mean age was 38 years, and the mean duration of illness was 32 months. The coprimary end points of fatigue and physical functioning were measured using the patient-reported Chalder fatigue questionnaire and the Short Form-36 physical function subscale.

"The take-home message is that we now have robust evidence of the effectiveness, and importantly for patients, the safety of CBT and GET, as long as they are given by properly trained people," said Dr. Michael Sharp, a study coauthor who is a professor of psychological medicine and director of psychological medicine research at the University of Edinburgh, Scotland.

Funding for the PACE trial was provided by the U.K. Medical Research Council, Department of Health for England, Scottish Chief Scientist Office, and Department for Work and Pensions. Dr. Chalder and Dr. Sharp reported no relevant conflicts of interest.

"Although the PACE trial shows that recovery from chronic fatigue syndrome is possible, there is clearly room for improvement with both interventions (cognitive behaviour therapy and graded exercise therapy)," noted Dr. Gijs Bleijenberg and Dr. Hans Knoop of Radboud University Nijmegen (Netherlands) Medical Centre in an accompanying editorial (Lancet 2011 Feb. 17 [doi:10.1016/S0140-6736(11)60172-4]).

"Both interventions could be improved if more was known about the mechanisms of change," they added. "Future studies into mechanisms of change are urgently needed and could help to improve the efficacy of the interventions, by focusing on the elements that are crucial for change."

Other independent experts welcomed the findings of the PACE study, commending the trial for finally answering a long-held dilemma.

"This study matters – it matters a lot," said Dr. Willie Hamilton, a primary care practitioner and professor of primary care diagnostics at the Peninsula College of Medicine and Dentistry in Exeter, England.

"Until now, we have known that only CBT and GET work for some people. We didn’t know if pacing worked," Dr. Hamilton said. "This caused a real dilemma – especially for those in primary care. We didn’t know whether to recommend pacing or to refer for CBT or GET. This study should solve that."

His words were echoed by Dr. Derick Wade, a consultant in neurological rehabilitation and clinical director at the Oxford Center for Enablement. "The trial design in this study was very good, and it means that the conclusions drawn can be drawn with confidence," Dr. Wade said.

While the study’s findings confirm the safety and effectiveness of CBT and GET, Dr. Wade noted, the findings on the use of APT show that "one commonly used intervention is not effective and therefore should not be used."

LONDON – Cognitive behavioral therapy and graded exercise therapy are both safe and effective to use in combination with specialist medical care for chronic fatigue syndrome, according to the results of a large randomized, controlled trial.

In contrast, adapted pacing therapy (APT), which several patient organizations have advocated as the preferred treatment choice together with specialist medical care, offers no real benefit – leading some experts to suggest that perhaps APT should no longer be used.

The findings were reported online Feb. 17 in the Lancet.

Cognitive behavioral therapy (CBT) and graded exercise therapy (GET) – but not APT – significantly lowered fatigue and raised physical function scores when compared with specialist medical care (SMC) alone.

At 1-year follow-up, the respective changes in fatigue and physical function scores versus SMC alone were –3.4 and +7.1 for CBT, and –3.2 and +9.4 for GET, all of which were statistically significant differences. In contrast, the changes in those scores for APT were –0.7 and –3.4, respectively, differences that weren’t statistically significant.

Although the effects of CBT and GET on chronic fatigue syndrome (CFS) are still rather moderate, "the bottom line is that patients given CBT and GET showed more improvement than the other two groups," said Trudie Chalder, Ph.D., one of the study’s authors and a professor of cognitive behavioral psychotherapy at King’s College London (Lancet 2011 Feb. 17 [doi:10.1016/S0140-6736(11)60096-2]).

CFS affects around a quarter of a million people in the United Kingdom. Symptoms include severe fatigue, poor concentration and memory, disturbed sleep, and muscle and joint pain. Effective treatments for the condition are limited, with debate over the use of CBT and GET versus the more frequently used APT.

CBT and GET offer a more hopeful approach to CFS treatment than APT, because they focus on patients’ abilities rather than their disabilities, the investigators noted. APT is based on a more nihilistic premise, focusing on coming to terms with the illness and optimizing activities accordingly, they added.

The Pacing, Graded Activity, and Cognitive Behaviour Therapy: a Randomised Evaluation (PACE) trial was a prospective, multicenter, randomized trial of 640 outpatients with CFS comparing four parallel treatment arms: SMC alone, SMC plus APT, SMC plus CBT, and SMC plus GET. Patients were given individual therapy sessions once a month and group interventions every 3 months. Interventions were given for up to 24 weeks, with follow-up assessments at 1 year.

More than 3,100 patients were originally screened for the trial, but only those who met the Oxford criteria for CFS were enrolled. Those criteria require fatigue to be the predominant symptom, accompanied by significant physical disability in the absence of any other psychiatric or organic brain disorder.

Approximately 75% of the study participants were women, and the majority (93%) of patients was white. The mean age was 38 years, and the mean duration of illness was 32 months. The coprimary end points of fatigue and physical functioning were measured using the patient-reported Chalder fatigue questionnaire and the Short Form-36 physical function subscale.

"The take-home message is that we now have robust evidence of the effectiveness, and importantly for patients, the safety of CBT and GET, as long as they are given by properly trained people," said Dr. Michael Sharp, a study coauthor who is a professor of psychological medicine and director of psychological medicine research at the University of Edinburgh, Scotland.

Funding for the PACE trial was provided by the U.K. Medical Research Council, Department of Health for England, Scottish Chief Scientist Office, and Department for Work and Pensions. Dr. Chalder and Dr. Sharp reported no relevant conflicts of interest.

"Although the PACE trial shows that recovery from chronic fatigue syndrome is possible, there is clearly room for improvement with both interventions (cognitive behaviour therapy and graded exercise therapy)," noted Dr. Gijs Bleijenberg and Dr. Hans Knoop of Radboud University Nijmegen (Netherlands) Medical Centre in an accompanying editorial (Lancet 2011 Feb. 17 [doi:10.1016/S0140-6736(11)60172-4]).

"Both interventions could be improved if more was known about the mechanisms of change," they added. "Future studies into mechanisms of change are urgently needed and could help to improve the efficacy of the interventions, by focusing on the elements that are crucial for change."

Other independent experts welcomed the findings of the PACE study, commending the trial for finally answering a long-held dilemma.

"This study matters – it matters a lot," said Dr. Willie Hamilton, a primary care practitioner and professor of primary care diagnostics at the Peninsula College of Medicine and Dentistry in Exeter, England.

"Until now, we have known that only CBT and GET work for some people. We didn’t know if pacing worked," Dr. Hamilton said. "This caused a real dilemma – especially for those in primary care. We didn’t know whether to recommend pacing or to refer for CBT or GET. This study should solve that."

His words were echoed by Dr. Derick Wade, a consultant in neurological rehabilitation and clinical director at the Oxford Center for Enablement. "The trial design in this study was very good, and it means that the conclusions drawn can be drawn with confidence," Dr. Wade said.

While the study’s findings confirm the safety and effectiveness of CBT and GET, Dr. Wade noted, the findings on the use of APT show that "one commonly used intervention is not effective and therefore should not be used."

LONDON – Cognitive behavioral therapy and graded exercise therapy are both safe and effective to use in combination with specialist medical care for chronic fatigue syndrome, according to the results of a large randomized, controlled trial.

In contrast, adapted pacing therapy (APT), which several patient organizations have advocated as the preferred treatment choice together with specialist medical care, offers no real benefit – leading some experts to suggest that perhaps APT should no longer be used.

The findings were reported online Feb. 17 in the Lancet.

Cognitive behavioral therapy (CBT) and graded exercise therapy (GET) – but not APT – significantly lowered fatigue and raised physical function scores when compared with specialist medical care (SMC) alone.

At 1-year follow-up, the respective changes in fatigue and physical function scores versus SMC alone were –3.4 and +7.1 for CBT, and –3.2 and +9.4 for GET, all of which were statistically significant differences. In contrast, the changes in those scores for APT were –0.7 and –3.4, respectively, differences that weren’t statistically significant.

Although the effects of CBT and GET on chronic fatigue syndrome (CFS) are still rather moderate, "the bottom line is that patients given CBT and GET showed more improvement than the other two groups," said Trudie Chalder, Ph.D., one of the study’s authors and a professor of cognitive behavioral psychotherapy at King’s College London (Lancet 2011 Feb. 17 [doi:10.1016/S0140-6736(11)60096-2]).

CFS affects around a quarter of a million people in the United Kingdom. Symptoms include severe fatigue, poor concentration and memory, disturbed sleep, and muscle and joint pain. Effective treatments for the condition are limited, with debate over the use of CBT and GET versus the more frequently used APT.

CBT and GET offer a more hopeful approach to CFS treatment than APT, because they focus on patients’ abilities rather than their disabilities, the investigators noted. APT is based on a more nihilistic premise, focusing on coming to terms with the illness and optimizing activities accordingly, they added.

The Pacing, Graded Activity, and Cognitive Behaviour Therapy: a Randomised Evaluation (PACE) trial was a prospective, multicenter, randomized trial of 640 outpatients with CFS comparing four parallel treatment arms: SMC alone, SMC plus APT, SMC plus CBT, and SMC plus GET. Patients were given individual therapy sessions once a month and group interventions every 3 months. Interventions were given for up to 24 weeks, with follow-up assessments at 1 year.

More than 3,100 patients were originally screened for the trial, but only those who met the Oxford criteria for CFS were enrolled. Those criteria require fatigue to be the predominant symptom, accompanied by significant physical disability in the absence of any other psychiatric or organic brain disorder.

Approximately 75% of the study participants were women, and the majority (93%) of patients was white. The mean age was 38 years, and the mean duration of illness was 32 months. The coprimary end points of fatigue and physical functioning were measured using the patient-reported Chalder fatigue questionnaire and the Short Form-36 physical function subscale.

"The take-home message is that we now have robust evidence of the effectiveness, and importantly for patients, the safety of CBT and GET, as long as they are given by properly trained people," said Dr. Michael Sharp, a study coauthor who is a professor of psychological medicine and director of psychological medicine research at the University of Edinburgh, Scotland.

Funding for the PACE trial was provided by the U.K. Medical Research Council, Department of Health for England, Scottish Chief Scientist Office, and Department for Work and Pensions. Dr. Chalder and Dr. Sharp reported no relevant conflicts of interest.

"Although the PACE trial shows that recovery from chronic fatigue syndrome is possible, there is clearly room for improvement with both interventions (cognitive behaviour therapy and graded exercise therapy)," noted Dr. Gijs Bleijenberg and Dr. Hans Knoop of Radboud University Nijmegen (Netherlands) Medical Centre in an accompanying editorial (Lancet 2011 Feb. 17 [doi:10.1016/S0140-6736(11)60172-4]).

"Both interventions could be improved if more was known about the mechanisms of change," they added. "Future studies into mechanisms of change are urgently needed and could help to improve the efficacy of the interventions, by focusing on the elements that are crucial for change."

Other independent experts welcomed the findings of the PACE study, commending the trial for finally answering a long-held dilemma.

"This study matters – it matters a lot," said Dr. Willie Hamilton, a primary care practitioner and professor of primary care diagnostics at the Peninsula College of Medicine and Dentistry in Exeter, England.

"Until now, we have known that only CBT and GET work for some people. We didn’t know if pacing worked," Dr. Hamilton said. "This caused a real dilemma – especially for those in primary care. We didn’t know whether to recommend pacing or to refer for CBT or GET. This study should solve that."

His words were echoed by Dr. Derick Wade, a consultant in neurological rehabilitation and clinical director at the Oxford Center for Enablement. "The trial design in this study was very good, and it means that the conclusions drawn can be drawn with confidence," Dr. Wade said.

While the study’s findings confirm the safety and effectiveness of CBT and GET, Dr. Wade noted, the findings on the use of APT show that "one commonly used intervention is not effective and therefore should not be used."

Dr. Fergus Macbeth, director of the Centre for Clinical Practice at the National Institute for Health and Clinical Excellence, London, said, "We welcome the findings of the PACE trial, which further support cognitive behavioural therapy and graded exercise therapy as safe and effective treatment options for people who have mild/moderate chronic fatigue syndrome or myalgic encephalomyelitis. These findings are in line with our current recommendations on the management of this condition.

"We will now analyze the results of this important trial in more detail before making a final decision on whether there is a clinical need to update our guideline," Dr. Macbeth said.

LONDON – Cognitive behavioral therapy and graded exercise therapy are both safe and effective to use in combination with specialist medical care for chronic fatigue syndrome, according to the results of a large randomized, controlled trial.

In contrast, adapted pacing therapy (APT), which several patient organizations have advocated as the preferred treatment choice together with specialist medical care, offers no real benefit – leading some experts to suggest that perhaps APT should no longer be used.

The findings were reported online Feb. 17 in the Lancet.

Cognitive behavioral therapy (CBT) and graded exercise therapy (GET) – but not APT – significantly lowered fatigue and raised physical function scores when compared with specialist medical care (SMC) alone.

At 1-year follow-up, the respective changes in fatigue and physical function scores versus SMC alone were –3.4 and +7.1 for CBT, and –3.2 and +9.4 for GET, all of which were statistically significant differences. In contrast, the changes in those scores for APT were –0.7 and –3.4, respectively, differences that weren’t statistically significant.

Although the effects of CBT and GET on chronic fatigue syndrome (CFS) are still rather moderate, "the bottom line is that patients given CBT and GET showed more improvement than the other two groups," said Trudie Chalder, Ph.D., one of the study’s authors and a professor of cognitive behavioral psychotherapy at King’s College London (Lancet 2011 Feb. 17 [doi:10.1016/S0140-6736(11)60096-2]).

CFS affects around a quarter of a million people in the United Kingdom. Symptoms include severe fatigue, poor concentration and memory, disturbed sleep, and muscle and joint pain. Effective treatments for the condition are limited, with debate over the use of CBT and GET versus the more frequently used APT.

CBT and GET offer a more hopeful approach to CFS treatment than APT, because they focus on patients’ abilities rather than their disabilities, the investigators noted. APT is based on a more nihilistic premise, focusing on coming to terms with the illness and optimizing activities accordingly, they added.

The Pacing, Graded Activity, and Cognitive Behaviour Therapy: a Randomised Evaluation (PACE) trial was a prospective, multicenter, randomized trial of 640 outpatients with CFS comparing four parallel treatment arms: SMC alone, SMC plus APT, SMC plus CBT, and SMC plus GET. Patients were given individual therapy sessions once a month and group interventions every 3 months. Interventions were given for up to 24 weeks, with follow-up assessments at 1 year.

More than 3,100 patients were originally screened for the trial, but only those who met the Oxford criteria for CFS were enrolled. Those criteria require fatigue to be the predominant symptom, accompanied by significant physical disability in the absence of any other psychiatric or organic brain disorder.

Approximately 75% of the study participants were women, and the majority (93%) of patients was white. The mean age was 38 years, and the mean duration of illness was 32 months. The coprimary end points of fatigue and physical functioning were measured using the patient-reported Chalder fatigue questionnaire and the Short Form-36 physical function subscale.

"The take-home message is that we now have robust evidence of the effectiveness, and importantly for patients, the safety of CBT and GET, as long as they are given by properly trained people," said Dr. Michael Sharp, a study coauthor who is a professor of psychological medicine and director of psychological medicine research at the University of Edinburgh, Scotland.

Funding for the PACE trial was provided by the U.K. Medical Research Council, Department of Health for England, Scottish Chief Scientist Office, and Department for Work and Pensions. Dr. Chalder and Dr. Sharp reported no relevant conflicts of interest.

"Although the PACE trial shows that recovery from chronic fatigue syndrome is possible, there is clearly room for improvement with both interventions (cognitive behaviour therapy and graded exercise therapy)," noted Dr. Gijs Bleijenberg and Dr. Hans Knoop of Radboud University Nijmegen (Netherlands) Medical Centre in an accompanying editorial (Lancet 2011 Feb. 17 [doi:10.1016/S0140-6736(11)60172-4]).

"Both interventions could be improved if more was known about the mechanisms of change," they added. "Future studies into mechanisms of change are urgently needed and could help to improve the efficacy of the interventions, by focusing on the elements that are crucial for change."

Other independent experts welcomed the findings of the PACE study, commending the trial for finally answering a long-held dilemma.

"This study matters – it matters a lot," said Dr. Willie Hamilton, a primary care practitioner and professor of primary care diagnostics at the Peninsula College of Medicine and Dentistry in Exeter, England.

"Until now, we have known that only CBT and GET work for some people. We didn’t know if pacing worked," Dr. Hamilton said. "This caused a real dilemma – especially for those in primary care. We didn’t know whether to recommend pacing or to refer for CBT or GET. This study should solve that."

His words were echoed by Dr. Derick Wade, a consultant in neurological rehabilitation and clinical director at the Oxford Center for Enablement. "The trial design in this study was very good, and it means that the conclusions drawn can be drawn with confidence," Dr. Wade said.

While the study’s findings confirm the safety and effectiveness of CBT and GET, Dr. Wade noted, the findings on the use of APT show that "one commonly used intervention is not effective and therefore should not be used."

Dr. Fergus Macbeth, director of the Centre for Clinical Practice at the National Institute for Health and Clinical Excellence, London, said, "We welcome the findings of the PACE trial, which further support cognitive behavioural therapy and graded exercise therapy as safe and effective treatment options for people who have mild/moderate chronic fatigue syndrome or myalgic encephalomyelitis. These findings are in line with our current recommendations on the management of this condition.

"We will now analyze the results of this important trial in more detail before making a final decision on whether there is a clinical need to update our guideline," Dr. Macbeth said.

LONDON – Cognitive behavioral therapy and graded exercise therapy are both safe and effective to use in combination with specialist medical care for chronic fatigue syndrome, according to the results of a large randomized, controlled trial.

In contrast, adapted pacing therapy (APT), which several patient organizations have advocated as the preferred treatment choice together with specialist medical care, offers no real benefit – leading some experts to suggest that perhaps APT should no longer be used.

The findings were reported online Feb. 17 in the Lancet.

Cognitive behavioral therapy (CBT) and graded exercise therapy (GET) – but not APT – significantly lowered fatigue and raised physical function scores when compared with specialist medical care (SMC) alone.

At 1-year follow-up, the respective changes in fatigue and physical function scores versus SMC alone were –3.4 and +7.1 for CBT, and –3.2 and +9.4 for GET, all of which were statistically significant differences. In contrast, the changes in those scores for APT were –0.7 and –3.4, respectively, differences that weren’t statistically significant.

Although the effects of CBT and GET on chronic fatigue syndrome (CFS) are still rather moderate, "the bottom line is that patients given CBT and GET showed more improvement than the other two groups," said Trudie Chalder, Ph.D., one of the study’s authors and a professor of cognitive behavioral psychotherapy at King’s College London (Lancet 2011 Feb. 17 [doi:10.1016/S0140-6736(11)60096-2]).

CFS affects around a quarter of a million people in the United Kingdom. Symptoms include severe fatigue, poor concentration and memory, disturbed sleep, and muscle and joint pain. Effective treatments for the condition are limited, with debate over the use of CBT and GET versus the more frequently used APT.

CBT and GET offer a more hopeful approach to CFS treatment than APT, because they focus on patients’ abilities rather than their disabilities, the investigators noted. APT is based on a more nihilistic premise, focusing on coming to terms with the illness and optimizing activities accordingly, they added.

The Pacing, Graded Activity, and Cognitive Behaviour Therapy: a Randomised Evaluation (PACE) trial was a prospective, multicenter, randomized trial of 640 outpatients with CFS comparing four parallel treatment arms: SMC alone, SMC plus APT, SMC plus CBT, and SMC plus GET. Patients were given individual therapy sessions once a month and group interventions every 3 months. Interventions were given for up to 24 weeks, with follow-up assessments at 1 year.

More than 3,100 patients were originally screened for the trial, but only those who met the Oxford criteria for CFS were enrolled. Those criteria require fatigue to be the predominant symptom, accompanied by significant physical disability in the absence of any other psychiatric or organic brain disorder.

Approximately 75% of the study participants were women, and the majority (93%) of patients was white. The mean age was 38 years, and the mean duration of illness was 32 months. The coprimary end points of fatigue and physical functioning were measured using the patient-reported Chalder fatigue questionnaire and the Short Form-36 physical function subscale.

"The take-home message is that we now have robust evidence of the effectiveness, and importantly for patients, the safety of CBT and GET, as long as they are given by properly trained people," said Dr. Michael Sharp, a study coauthor who is a professor of psychological medicine and director of psychological medicine research at the University of Edinburgh, Scotland.

Funding for the PACE trial was provided by the U.K. Medical Research Council, Department of Health for England, Scottish Chief Scientist Office, and Department for Work and Pensions. Dr. Chalder and Dr. Sharp reported no relevant conflicts of interest.

"Although the PACE trial shows that recovery from chronic fatigue syndrome is possible, there is clearly room for improvement with both interventions (cognitive behaviour therapy and graded exercise therapy)," noted Dr. Gijs Bleijenberg and Dr. Hans Knoop of Radboud University Nijmegen (Netherlands) Medical Centre in an accompanying editorial (Lancet 2011 Feb. 17 [doi:10.1016/S0140-6736(11)60172-4]).

"Both interventions could be improved if more was known about the mechanisms of change," they added. "Future studies into mechanisms of change are urgently needed and could help to improve the efficacy of the interventions, by focusing on the elements that are crucial for change."

Other independent experts welcomed the findings of the PACE study, commending the trial for finally answering a long-held dilemma.

"This study matters – it matters a lot," said Dr. Willie Hamilton, a primary care practitioner and professor of primary care diagnostics at the Peninsula College of Medicine and Dentistry in Exeter, England.

"Until now, we have known that only CBT and GET work for some people. We didn’t know if pacing worked," Dr. Hamilton said. "This caused a real dilemma – especially for those in primary care. We didn’t know whether to recommend pacing or to refer for CBT or GET. This study should solve that."

His words were echoed by Dr. Derick Wade, a consultant in neurological rehabilitation and clinical director at the Oxford Center for Enablement. "The trial design in this study was very good, and it means that the conclusions drawn can be drawn with confidence," Dr. Wade said.

While the study’s findings confirm the safety and effectiveness of CBT and GET, Dr. Wade noted, the findings on the use of APT show that "one commonly used intervention is not effective and therefore should not be used."

Dr. Fergus Macbeth, director of the Centre for Clinical Practice at the National Institute for Health and Clinical Excellence, London, said, "We welcome the findings of the PACE trial, which further support cognitive behavioural therapy and graded exercise therapy as safe and effective treatment options for people who have mild/moderate chronic fatigue syndrome or myalgic encephalomyelitis. These findings are in line with our current recommendations on the management of this condition.

"We will now analyze the results of this important trial in more detail before making a final decision on whether there is a clinical need to update our guideline," Dr. Macbeth said.