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VIDEO: Interventions target opioid overprescribing after gynecologic surgery
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
NEW ORLEANS – U.S. clinicians prescribe opioid tablets to postsurgical patients too often and at too high a pill count, according to results from two independent studies that examined prescribing patterns and opioid use in patients following gynecologic surgery.
In addition, “setting preoperative expectations about pain management led to increased compliance at discharge,” said Dr. Mark, a gynecologic oncologist at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y.
Findings from the second study, of 122 women who underwent gynecologic surgery at Women and Infants Hospital in Providence, R.I., showed that 32% did not use any opioids for pain following hospital discharge, and that opioid use during hospitalization was a significant predictor of postdischarge opioid needs. This finding provided a way to devise a new prescribing guide for postsurgical patients based on their opioid use while hospitalized, said Erica Weston, MD, a gynecologic oncologist at Johns Hopkins University, Baltimore.
“No question, we are overprescribing,” Dr. Dowdy said, and described a program he and his colleagues at Mayo recently put in place that capped routine opioid pill prescriptions following various surgeries based on historic patient needs. For example, most laparotomy patients receive a prescription for 10 opioid doses on discharge. Based on the first 6 months of this program, it’s on track to cut the annual number of opioid tablets prescribed to postsurgical patients at Mayo by 35,000 for all gynecologic surgeries and by 1.5 million tablets for all Mayo surgical subspecialties, he said.
The study reported by Dr. Mark ran after the Roswell Park gynecologic oncology department implemented new guidelines for dispensing pain control medications following surgery. The guidelines called for comprehensive teaching for patients about pain expectations and pain management both before and after surgery and also established four dispensing categories:
- Patients undergoing minimally invasive or outpatient surgery and with no history of chronic pain and low opioid need while hospitalized received the default dispense of 600 mg ibuprofen every 6 hours as needed for 7 days and 500 mg acetaminophen every 6 hours as needed for 7 days.
- Patients who underwent this surgery but required 5 or more opioid tablets while hospitalized or those with a history of chronic pain and opioid use received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply with 1 tablet taken every 6 hours as needed.
- Patients who underwent laparotomy and had no chronic pain and opioid history and low opioid use while hospitalized received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply.
- Patients who underwent laparotomy and showed a higher opioid need based on their use during the 24 hours before discharge received the ibuprofen and acetaminophen regimen plus 24 opioid tablets for 3 days so they could take 2 tablets every 6 hours as needed.
Dr. Mark and his associates collected data from 337 patients managed with these guidelines during June 2017–January 2018 and compared them with 626 patients who underwent gynecologic surgery at Roswell Park during July 2016–June 2017. The data showed the average number of opioid tablets dispensed per patient for all discharges fell from 31.7 before the new guideline to 3.5, an 89% reduction. For the subgroup of patients who had undergone a laparotomy, the average pill number fell from 43.6 to 11.6, a 72% drop. Among patients treated with minimally invasive or outpatient surgery, average tablets dispensed fell from 28.1 before to 0.9 after, a 97% reduction. The reduction among opioid-naive patients was 90%, and it was 83% among patients who used opioids prior to their surgery.
Under the new program, patients requested an opioid refill 14% of the time after laparotomy and 8% of the time after minimally invasive surgery, rates that did not significantly differ from the prior era. Average postoperative pain scores were identical among patients treated under the new dispensing guidelines and those treated during the prior years, and 96% of patients said they were satisfied with the care they received during the new, restricted dispensing period, Dr. Mark reported.
The single-center experience reviewed by Dr. Weston tracked opioid use by 122 women who underwent a minimally invasive hysterectomy at Women and Infants both as inpatients and out to both 1-2 weeks and 4-6 weeks following discharge. The patients were an average age of 61 years, and included 16% who reported chronic pain and 5% with a history of chronic opioid use.
During the inpatient phase, median opioid use was three doses, with 25% of the patients using no opioids. During the first 1-2 weeks following discharge, median opioid use was nine tablets, with 37% of the patients using no opioids. By the 4- to 6-week follow-up (which collected data from 114 of the patients), median opioid use was a cumulative 11 tablets with 67% of the patients reporting no opioid use during the time between their first and second follow-up visit. During the total postdischarge period, 90% of the patients used 30 or fewer opioid tablets.
A multivariate analysis of the findings showed that opioid use while in hospital was the only significant predictor of opioid use after discharge. Age of 65 years or older showed a nonsignificant trend toward less postdischarge opioid use.
Based on these data Dr. Weston and her associates proposed a formula for estimating a patient’s opioid needs at discharge: Gynecologic surgery patients who needed no opioid medication as inpatients could receive 1-5 opioid tablets at discharge, patients who used opioids at or below the median level should receive 10-15 tablets at discharge, and those who used more than the median number of opioid tablets as inpatients should receive 25-30 tablets at discharge. For patients who undergo surgery as outpatients and have no record of pain medication needs, Dr. Weston recommended discharging them with a prescription for 25-30 tablets, possibly reducing this to 10-15 tablets for patients aged 65 years or older.
Dr. Mark, Dr. Weston, and Dr. Dowdy had no disclosures.
SOURCE: Mark J et al. SGO 2018, Abstract 7. Weston E et al. SGO 2018, Abstract 8.
The important and thought provoking reports by Dr. Mark and by Dr. Weston and their associates present innovative ways for clinicians to address the opioid crisis by prescribing fewer narcotics to postsurgical patients when they leave the hospital. Their work suggests that doing this can have little or no negative impact on patient satisfaction with their care. Their findings give us important documentation for prescribing fewer opioid tablets, while still giving patients adequate pain relief.
Their findings also provide clear documentation that, in current practice, without guidance like this opioids are often overprescribed, not out of negligence but because clinicians are simply not sure what a patient will need once they go home following gynecologic surgery. By reviewing the pain medication a patient needed in hospital we can better estimate what patients will need when they go home, and we can better avoid giving patients more opioid tablets than they will really need.
Brent Smith, MD , is a gynecologic oncologist at Ohio State University, Columbus. He had no disclosures. Dr. Smith made these comments in a video interview.
The important and thought provoking reports by Dr. Mark and by Dr. Weston and their associates present innovative ways for clinicians to address the opioid crisis by prescribing fewer narcotics to postsurgical patients when they leave the hospital. Their work suggests that doing this can have little or no negative impact on patient satisfaction with their care. Their findings give us important documentation for prescribing fewer opioid tablets, while still giving patients adequate pain relief.
Their findings also provide clear documentation that, in current practice, without guidance like this opioids are often overprescribed, not out of negligence but because clinicians are simply not sure what a patient will need once they go home following gynecologic surgery. By reviewing the pain medication a patient needed in hospital we can better estimate what patients will need when they go home, and we can better avoid giving patients more opioid tablets than they will really need.
Brent Smith, MD , is a gynecologic oncologist at Ohio State University, Columbus. He had no disclosures. Dr. Smith made these comments in a video interview.
The important and thought provoking reports by Dr. Mark and by Dr. Weston and their associates present innovative ways for clinicians to address the opioid crisis by prescribing fewer narcotics to postsurgical patients when they leave the hospital. Their work suggests that doing this can have little or no negative impact on patient satisfaction with their care. Their findings give us important documentation for prescribing fewer opioid tablets, while still giving patients adequate pain relief.
Their findings also provide clear documentation that, in current practice, without guidance like this opioids are often overprescribed, not out of negligence but because clinicians are simply not sure what a patient will need once they go home following gynecologic surgery. By reviewing the pain medication a patient needed in hospital we can better estimate what patients will need when they go home, and we can better avoid giving patients more opioid tablets than they will really need.
Brent Smith, MD , is a gynecologic oncologist at Ohio State University, Columbus. He had no disclosures. Dr. Smith made these comments in a video interview.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
NEW ORLEANS – U.S. clinicians prescribe opioid tablets to postsurgical patients too often and at too high a pill count, according to results from two independent studies that examined prescribing patterns and opioid use in patients following gynecologic surgery.
In addition, “setting preoperative expectations about pain management led to increased compliance at discharge,” said Dr. Mark, a gynecologic oncologist at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y.
Findings from the second study, of 122 women who underwent gynecologic surgery at Women and Infants Hospital in Providence, R.I., showed that 32% did not use any opioids for pain following hospital discharge, and that opioid use during hospitalization was a significant predictor of postdischarge opioid needs. This finding provided a way to devise a new prescribing guide for postsurgical patients based on their opioid use while hospitalized, said Erica Weston, MD, a gynecologic oncologist at Johns Hopkins University, Baltimore.
“No question, we are overprescribing,” Dr. Dowdy said, and described a program he and his colleagues at Mayo recently put in place that capped routine opioid pill prescriptions following various surgeries based on historic patient needs. For example, most laparotomy patients receive a prescription for 10 opioid doses on discharge. Based on the first 6 months of this program, it’s on track to cut the annual number of opioid tablets prescribed to postsurgical patients at Mayo by 35,000 for all gynecologic surgeries and by 1.5 million tablets for all Mayo surgical subspecialties, he said.
The study reported by Dr. Mark ran after the Roswell Park gynecologic oncology department implemented new guidelines for dispensing pain control medications following surgery. The guidelines called for comprehensive teaching for patients about pain expectations and pain management both before and after surgery and also established four dispensing categories:
- Patients undergoing minimally invasive or outpatient surgery and with no history of chronic pain and low opioid need while hospitalized received the default dispense of 600 mg ibuprofen every 6 hours as needed for 7 days and 500 mg acetaminophen every 6 hours as needed for 7 days.
- Patients who underwent this surgery but required 5 or more opioid tablets while hospitalized or those with a history of chronic pain and opioid use received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply with 1 tablet taken every 6 hours as needed.
- Patients who underwent laparotomy and had no chronic pain and opioid history and low opioid use while hospitalized received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply.
- Patients who underwent laparotomy and showed a higher opioid need based on their use during the 24 hours before discharge received the ibuprofen and acetaminophen regimen plus 24 opioid tablets for 3 days so they could take 2 tablets every 6 hours as needed.
Dr. Mark and his associates collected data from 337 patients managed with these guidelines during June 2017–January 2018 and compared them with 626 patients who underwent gynecologic surgery at Roswell Park during July 2016–June 2017. The data showed the average number of opioid tablets dispensed per patient for all discharges fell from 31.7 before the new guideline to 3.5, an 89% reduction. For the subgroup of patients who had undergone a laparotomy, the average pill number fell from 43.6 to 11.6, a 72% drop. Among patients treated with minimally invasive or outpatient surgery, average tablets dispensed fell from 28.1 before to 0.9 after, a 97% reduction. The reduction among opioid-naive patients was 90%, and it was 83% among patients who used opioids prior to their surgery.
Under the new program, patients requested an opioid refill 14% of the time after laparotomy and 8% of the time after minimally invasive surgery, rates that did not significantly differ from the prior era. Average postoperative pain scores were identical among patients treated under the new dispensing guidelines and those treated during the prior years, and 96% of patients said they were satisfied with the care they received during the new, restricted dispensing period, Dr. Mark reported.
The single-center experience reviewed by Dr. Weston tracked opioid use by 122 women who underwent a minimally invasive hysterectomy at Women and Infants both as inpatients and out to both 1-2 weeks and 4-6 weeks following discharge. The patients were an average age of 61 years, and included 16% who reported chronic pain and 5% with a history of chronic opioid use.
During the inpatient phase, median opioid use was three doses, with 25% of the patients using no opioids. During the first 1-2 weeks following discharge, median opioid use was nine tablets, with 37% of the patients using no opioids. By the 4- to 6-week follow-up (which collected data from 114 of the patients), median opioid use was a cumulative 11 tablets with 67% of the patients reporting no opioid use during the time between their first and second follow-up visit. During the total postdischarge period, 90% of the patients used 30 or fewer opioid tablets.
A multivariate analysis of the findings showed that opioid use while in hospital was the only significant predictor of opioid use after discharge. Age of 65 years or older showed a nonsignificant trend toward less postdischarge opioid use.
Based on these data Dr. Weston and her associates proposed a formula for estimating a patient’s opioid needs at discharge: Gynecologic surgery patients who needed no opioid medication as inpatients could receive 1-5 opioid tablets at discharge, patients who used opioids at or below the median level should receive 10-15 tablets at discharge, and those who used more than the median number of opioid tablets as inpatients should receive 25-30 tablets at discharge. For patients who undergo surgery as outpatients and have no record of pain medication needs, Dr. Weston recommended discharging them with a prescription for 25-30 tablets, possibly reducing this to 10-15 tablets for patients aged 65 years or older.
Dr. Mark, Dr. Weston, and Dr. Dowdy had no disclosures.
SOURCE: Mark J et al. SGO 2018, Abstract 7. Weston E et al. SGO 2018, Abstract 8.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
NEW ORLEANS – U.S. clinicians prescribe opioid tablets to postsurgical patients too often and at too high a pill count, according to results from two independent studies that examined prescribing patterns and opioid use in patients following gynecologic surgery.
In addition, “setting preoperative expectations about pain management led to increased compliance at discharge,” said Dr. Mark, a gynecologic oncologist at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y.
Findings from the second study, of 122 women who underwent gynecologic surgery at Women and Infants Hospital in Providence, R.I., showed that 32% did not use any opioids for pain following hospital discharge, and that opioid use during hospitalization was a significant predictor of postdischarge opioid needs. This finding provided a way to devise a new prescribing guide for postsurgical patients based on their opioid use while hospitalized, said Erica Weston, MD, a gynecologic oncologist at Johns Hopkins University, Baltimore.
“No question, we are overprescribing,” Dr. Dowdy said, and described a program he and his colleagues at Mayo recently put in place that capped routine opioid pill prescriptions following various surgeries based on historic patient needs. For example, most laparotomy patients receive a prescription for 10 opioid doses on discharge. Based on the first 6 months of this program, it’s on track to cut the annual number of opioid tablets prescribed to postsurgical patients at Mayo by 35,000 for all gynecologic surgeries and by 1.5 million tablets for all Mayo surgical subspecialties, he said.
The study reported by Dr. Mark ran after the Roswell Park gynecologic oncology department implemented new guidelines for dispensing pain control medications following surgery. The guidelines called for comprehensive teaching for patients about pain expectations and pain management both before and after surgery and also established four dispensing categories:
- Patients undergoing minimally invasive or outpatient surgery and with no history of chronic pain and low opioid need while hospitalized received the default dispense of 600 mg ibuprofen every 6 hours as needed for 7 days and 500 mg acetaminophen every 6 hours as needed for 7 days.
- Patients who underwent this surgery but required 5 or more opioid tablets while hospitalized or those with a history of chronic pain and opioid use received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply with 1 tablet taken every 6 hours as needed.
- Patients who underwent laparotomy and had no chronic pain and opioid history and low opioid use while hospitalized received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply.
- Patients who underwent laparotomy and showed a higher opioid need based on their use during the 24 hours before discharge received the ibuprofen and acetaminophen regimen plus 24 opioid tablets for 3 days so they could take 2 tablets every 6 hours as needed.
Dr. Mark and his associates collected data from 337 patients managed with these guidelines during June 2017–January 2018 and compared them with 626 patients who underwent gynecologic surgery at Roswell Park during July 2016–June 2017. The data showed the average number of opioid tablets dispensed per patient for all discharges fell from 31.7 before the new guideline to 3.5, an 89% reduction. For the subgroup of patients who had undergone a laparotomy, the average pill number fell from 43.6 to 11.6, a 72% drop. Among patients treated with minimally invasive or outpatient surgery, average tablets dispensed fell from 28.1 before to 0.9 after, a 97% reduction. The reduction among opioid-naive patients was 90%, and it was 83% among patients who used opioids prior to their surgery.
Under the new program, patients requested an opioid refill 14% of the time after laparotomy and 8% of the time after minimally invasive surgery, rates that did not significantly differ from the prior era. Average postoperative pain scores were identical among patients treated under the new dispensing guidelines and those treated during the prior years, and 96% of patients said they were satisfied with the care they received during the new, restricted dispensing period, Dr. Mark reported.
The single-center experience reviewed by Dr. Weston tracked opioid use by 122 women who underwent a minimally invasive hysterectomy at Women and Infants both as inpatients and out to both 1-2 weeks and 4-6 weeks following discharge. The patients were an average age of 61 years, and included 16% who reported chronic pain and 5% with a history of chronic opioid use.
During the inpatient phase, median opioid use was three doses, with 25% of the patients using no opioids. During the first 1-2 weeks following discharge, median opioid use was nine tablets, with 37% of the patients using no opioids. By the 4- to 6-week follow-up (which collected data from 114 of the patients), median opioid use was a cumulative 11 tablets with 67% of the patients reporting no opioid use during the time between their first and second follow-up visit. During the total postdischarge period, 90% of the patients used 30 or fewer opioid tablets.
A multivariate analysis of the findings showed that opioid use while in hospital was the only significant predictor of opioid use after discharge. Age of 65 years or older showed a nonsignificant trend toward less postdischarge opioid use.
Based on these data Dr. Weston and her associates proposed a formula for estimating a patient’s opioid needs at discharge: Gynecologic surgery patients who needed no opioid medication as inpatients could receive 1-5 opioid tablets at discharge, patients who used opioids at or below the median level should receive 10-15 tablets at discharge, and those who used more than the median number of opioid tablets as inpatients should receive 25-30 tablets at discharge. For patients who undergo surgery as outpatients and have no record of pain medication needs, Dr. Weston recommended discharging them with a prescription for 25-30 tablets, possibly reducing this to 10-15 tablets for patients aged 65 years or older.
Dr. Mark, Dr. Weston, and Dr. Dowdy had no disclosures.
SOURCE: Mark J et al. SGO 2018, Abstract 7. Weston E et al. SGO 2018, Abstract 8.
REPORTING FROM SGO 2018
Key clinical point: Patients who underwent gynecologic surgery received adequate pain relief when receiving fewer opioid tablets.
Major finding: A protocol that restricted opioid dispensing successfully cut the discharge allotment of opioid tablets by 89%.
Study details: A single-center review of 337 patients, and a second single-center experience with 122 patients.
Disclosures: Dr. Mark, Dr. Weston, and Dr. Dowdy had no disclosures.
Source: Mark J et al. SGO 2018, Abstract 7. Weston E et al. SGO 2018, Abstract 8.
Video: SHM provides resources and community for practice administrators
ORLANDO – In a video interview, Ms. Tiffani Panek, SFHM, CLHM, who is the division manager of administration at the Johns Hopkins Bayview Medical Center, Baltimore, discussed the scope of SHM resources available for practice administrators.
She details how there are “an incredible number of resources for practice administrators that are available from SHM,” and she recommends the SHM website’s practice administrator’s page, with helpful links, including to their mentorship program. She describes how, just this year, “we are launching a podcast series called ‘The Leadership Launchpad Essentials.’ ”
In addition: “We [also] have our own HMX [Hospital Medicine Exchange] community, and I would say of any resource the practice administrator should access on a regular basis, that would be the one.” That’s the place that practice managers can go to network with their community, according to Ms. Panek.
ORLANDO – In a video interview, Ms. Tiffani Panek, SFHM, CLHM, who is the division manager of administration at the Johns Hopkins Bayview Medical Center, Baltimore, discussed the scope of SHM resources available for practice administrators.
She details how there are “an incredible number of resources for practice administrators that are available from SHM,” and she recommends the SHM website’s practice administrator’s page, with helpful links, including to their mentorship program. She describes how, just this year, “we are launching a podcast series called ‘The Leadership Launchpad Essentials.’ ”
In addition: “We [also] have our own HMX [Hospital Medicine Exchange] community, and I would say of any resource the practice administrator should access on a regular basis, that would be the one.” That’s the place that practice managers can go to network with their community, according to Ms. Panek.
ORLANDO – In a video interview, Ms. Tiffani Panek, SFHM, CLHM, who is the division manager of administration at the Johns Hopkins Bayview Medical Center, Baltimore, discussed the scope of SHM resources available for practice administrators.
She details how there are “an incredible number of resources for practice administrators that are available from SHM,” and she recommends the SHM website’s practice administrator’s page, with helpful links, including to their mentorship program. She describes how, just this year, “we are launching a podcast series called ‘The Leadership Launchpad Essentials.’ ”
In addition: “We [also] have our own HMX [Hospital Medicine Exchange] community, and I would say of any resource the practice administrator should access on a regular basis, that would be the one.” That’s the place that practice managers can go to network with their community, according to Ms. Panek.
REPORTING FROM HM18
Video: The SHM Physicians in Training Committee – increasing the hospitalist pipeline
ORLANDO – In a video interview, Brian Kwan, MD, SFHM, of the University of California, San Diego, discusses the role of the SHM Physicians in Training Committee in “increasing the hospitalist pipeline.”
In discussing the work of the committee, Dr. Kwan describes how “a lot of our initiatives really focus on the training and development and basically nurturing them from becoming students to residents to early-career hospitalists.”
Two of the key programs he discusses are the Student Scholarship Program and the “new-this-year” Resident Travel Grant, among other initiatives that the committee is exploring.
ORLANDO – In a video interview, Brian Kwan, MD, SFHM, of the University of California, San Diego, discusses the role of the SHM Physicians in Training Committee in “increasing the hospitalist pipeline.”
In discussing the work of the committee, Dr. Kwan describes how “a lot of our initiatives really focus on the training and development and basically nurturing them from becoming students to residents to early-career hospitalists.”
Two of the key programs he discusses are the Student Scholarship Program and the “new-this-year” Resident Travel Grant, among other initiatives that the committee is exploring.
ORLANDO – In a video interview, Brian Kwan, MD, SFHM, of the University of California, San Diego, discusses the role of the SHM Physicians in Training Committee in “increasing the hospitalist pipeline.”
In discussing the work of the committee, Dr. Kwan describes how “a lot of our initiatives really focus on the training and development and basically nurturing them from becoming students to residents to early-career hospitalists.”
Two of the key programs he discusses are the Student Scholarship Program and the “new-this-year” Resident Travel Grant, among other initiatives that the committee is exploring.
REPORTING FROM HOSPITAL MEDICINE 2018
A Peek at Our April 2018 Issue
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
VIDEO: Triple-antihypertensive pill nails early therapy
ORLANDO – Hypertensive adults started on a triple-drug, single daily pill regimen as either initial or early treatment had a sharply better rate of reaching their goal blood pressure after 6 months, compared with usual-care controls, in a multicenter, randomized trial with 700 patients.
“Early use of a low-dose, three-in-one blood pressure lowering pill is safe and provides faster and better control of blood pressure compared with usual care,” Ruth Webster, PhD, said at the annual meeting of the American College of Cardiology.
The tested polypill contained half the standard doses of the angiotensin receptor blocker telmisartan (20 mg), the calcium channel blocker amlodipine (2.5 mg), and the diuretic chlorthalidone (12.5 mg). After 6 months on this regimen, 70% of patients were at their goal blood pressure, compared with 55% of the control patients, and patients on the polypill had on average a 10/5 mm Hg greater reduction in their blood pressure than did patients on usual care, reported Dr. Webster, head of research programs at the George Institute for Global Health in Sydney. Rates of total and serious adverse events and withdrawals because of adverse events were similar in the two study arms, and both arms also had nearly identical levels of treatment adherence, about 95%.
“No prior trial has evaluated a triple, low-dose pill for initial or early treatment,” she noted.
“This is a home run,” said Karol E. Watson, MD, professor of medicine and director of the Women’s Cardiovascular Health Center at the University of California, Los Angeles. “In the past, clinicians were told to pick one drug and push it as hard as you could and then maybe think about adding a second drug. Experience has shown that this does not increase efficacy, but it does increase adverse events, so current guidelines say start with two drugs. Now they are showing for the first time that you should start with three drugs. That goes with what we know.”
“Triple-drug therapy for the masses makes complete sense,” especially now that the blood pressure goal for most patients is less than 130/80 mm Hg, said William B. White, MD, professor of medicine and chief of hypertension and clinical pharmacology at the University of Connecticut in Farmington. Plus, “compliance is vastly improved when you use a combination-drug pill,” he noted. 
The blood pressure targets that Dr. Webster and her associates used were less than 140/90 mm Hg except in patients with diabetes or chronic kidney disease, who had a target of less than 130/80 mm Hg. At the time researchers designed the trial the generally accepted blood pressure target for antihypertensive treatment was less than 140/90 mm Hg, Dr. Webster noted.
She also stressed that she did not believe the three specific drugs selected for the polypill made a difference. “The specific drugs we used was not that important. We would probably get the same result with different drugs. It’s about the strategy of using triple, low-dose therapy,” Dr. Webster suggested. Dr. Watson agreed.
The TRIUMPH (Triple Pill vs. Usual Care Management for Patients with Mild to Moderate Hypertension) study enrolled patients at 11 hospital outpatient clinics in Sri Lanka. The average age of the patients was 56 years. The average blood pressure was 154/90 mm Hg. About 59% of patients were not on any antihypertensive drug at baseline, with the rest on a single drug. The study protocol excluded patients on two or more drugs at entry. Roughly 30% of enrolled patients had diabetes, and 1%-2% had chronic kidney disease. Their target blood pressure on treatment during the study was less than 130/80 mm Hg.
The study’s primary endpoint was the percentage of patients at their goal blood pressure after 6 months. Patients in the triple-drug polypill group achieved their goal blood pressure 23% more often relative to the control, usual care patients, a statistically significant difference. The between group difference in achievement of goal blood pressure was apparent by the end of the first 6 weeks in the study. Patients in the control arm generally received either one or two drugs during the study, but often at full dose rather than the half doses used in the triple-drug patients. The study’s design specified that patients in the triple-drug arm who were not at their target blood pressure after 6 weeks could, at the discretion of their treating physician, switch to a second formulation that doubled the dosage of each of the three drugs. Patients in the usual care arm could have their treatment adjusted after 6 or 12 weeks as long as they continued to receive either one or two drugs. After 6 weeks, 68% of patients in the triple-drug arm and 44% receiving usual care were at their blood pressure goal. After 12 weeks, the percentages at goal were 73% of patients on the triple-drug pill and 47% on usual care.
Dr. Webster hypothesized that the triple-drug, low-dose strategy for initial or early treatment would surpass usual care not only in low- and middle-income countries, like Sri Lanka, but also in high-income, industrialized countries such as the United States.
TRIUMPH received no commercial funding. Dr. Webster had no disclosures. Dr. Watson has been a consultant to Amgen, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, and GlaxoSmithKline. Dr. White has been a consultant to Novartis.
SOURCE: Webster R. ACC 2018. Webster R et al. ACC 18 late breaker.
The TRIUMPH results showed the feasibility and efficacy of achieving good blood pressure control with a single pill containing low doses of three different antihypertensive drugs that are well tolerated and have different mechanisms of action. This strategy avoids the adverse effects from drugs used at their maximum dose.
An attraction of this strategy is how seamless it is for patients. They take a single pill with three drugs, which can enhance compliance and in routine practice can reduce their copay. It’s much easier for patients to take a single pill.
Eileen M. Handberg, PhD , is a research professor of medicine and director of the Clinical Trials Program at the University of Florida in Gainesville. She had no relevant disclosures. She made these comments in an interview.
The TRIUMPH results showed the feasibility and efficacy of achieving good blood pressure control with a single pill containing low doses of three different antihypertensive drugs that are well tolerated and have different mechanisms of action. This strategy avoids the adverse effects from drugs used at their maximum dose.
An attraction of this strategy is how seamless it is for patients. They take a single pill with three drugs, which can enhance compliance and in routine practice can reduce their copay. It’s much easier for patients to take a single pill.
Eileen M. Handberg, PhD , is a research professor of medicine and director of the Clinical Trials Program at the University of Florida in Gainesville. She had no relevant disclosures. She made these comments in an interview.
The TRIUMPH results showed the feasibility and efficacy of achieving good blood pressure control with a single pill containing low doses of three different antihypertensive drugs that are well tolerated and have different mechanisms of action. This strategy avoids the adverse effects from drugs used at their maximum dose.
An attraction of this strategy is how seamless it is for patients. They take a single pill with three drugs, which can enhance compliance and in routine practice can reduce their copay. It’s much easier for patients to take a single pill.
Eileen M. Handberg, PhD , is a research professor of medicine and director of the Clinical Trials Program at the University of Florida in Gainesville. She had no relevant disclosures. She made these comments in an interview.
ORLANDO – Hypertensive adults started on a triple-drug, single daily pill regimen as either initial or early treatment had a sharply better rate of reaching their goal blood pressure after 6 months, compared with usual-care controls, in a multicenter, randomized trial with 700 patients.
“Early use of a low-dose, three-in-one blood pressure lowering pill is safe and provides faster and better control of blood pressure compared with usual care,” Ruth Webster, PhD, said at the annual meeting of the American College of Cardiology.
The tested polypill contained half the standard doses of the angiotensin receptor blocker telmisartan (20 mg), the calcium channel blocker amlodipine (2.5 mg), and the diuretic chlorthalidone (12.5 mg). After 6 months on this regimen, 70% of patients were at their goal blood pressure, compared with 55% of the control patients, and patients on the polypill had on average a 10/5 mm Hg greater reduction in their blood pressure than did patients on usual care, reported Dr. Webster, head of research programs at the George Institute for Global Health in Sydney. Rates of total and serious adverse events and withdrawals because of adverse events were similar in the two study arms, and both arms also had nearly identical levels of treatment adherence, about 95%.
“No prior trial has evaluated a triple, low-dose pill for initial or early treatment,” she noted.
“This is a home run,” said Karol E. Watson, MD, professor of medicine and director of the Women’s Cardiovascular Health Center at the University of California, Los Angeles. “In the past, clinicians were told to pick one drug and push it as hard as you could and then maybe think about adding a second drug. Experience has shown that this does not increase efficacy, but it does increase adverse events, so current guidelines say start with two drugs. Now they are showing for the first time that you should start with three drugs. That goes with what we know.”
“Triple-drug therapy for the masses makes complete sense,” especially now that the blood pressure goal for most patients is less than 130/80 mm Hg, said William B. White, MD, professor of medicine and chief of hypertension and clinical pharmacology at the University of Connecticut in Farmington. Plus, “compliance is vastly improved when you use a combination-drug pill,” he noted.
The blood pressure targets that Dr. Webster and her associates used were less than 140/90 mm Hg except in patients with diabetes or chronic kidney disease, who had a target of less than 130/80 mm Hg. At the time researchers designed the trial the generally accepted blood pressure target for antihypertensive treatment was less than 140/90 mm Hg, Dr. Webster noted.
She also stressed that she did not believe the three specific drugs selected for the polypill made a difference. “The specific drugs we used was not that important. We would probably get the same result with different drugs. It’s about the strategy of using triple, low-dose therapy,” Dr. Webster suggested. Dr. Watson agreed.
The TRIUMPH (Triple Pill vs. Usual Care Management for Patients with Mild to Moderate Hypertension) study enrolled patients at 11 hospital outpatient clinics in Sri Lanka. The average age of the patients was 56 years. The average blood pressure was 154/90 mm Hg. About 59% of patients were not on any antihypertensive drug at baseline, with the rest on a single drug. The study protocol excluded patients on two or more drugs at entry. Roughly 30% of enrolled patients had diabetes, and 1%-2% had chronic kidney disease. Their target blood pressure on treatment during the study was less than 130/80 mm Hg.
The study’s primary endpoint was the percentage of patients at their goal blood pressure after 6 months. Patients in the triple-drug polypill group achieved their goal blood pressure 23% more often relative to the control, usual care patients, a statistically significant difference. The between group difference in achievement of goal blood pressure was apparent by the end of the first 6 weeks in the study. Patients in the control arm generally received either one or two drugs during the study, but often at full dose rather than the half doses used in the triple-drug patients. The study’s design specified that patients in the triple-drug arm who were not at their target blood pressure after 6 weeks could, at the discretion of their treating physician, switch to a second formulation that doubled the dosage of each of the three drugs. Patients in the usual care arm could have their treatment adjusted after 6 or 12 weeks as long as they continued to receive either one or two drugs. After 6 weeks, 68% of patients in the triple-drug arm and 44% receiving usual care were at their blood pressure goal. After 12 weeks, the percentages at goal were 73% of patients on the triple-drug pill and 47% on usual care.
Dr. Webster hypothesized that the triple-drug, low-dose strategy for initial or early treatment would surpass usual care not only in low- and middle-income countries, like Sri Lanka, but also in high-income, industrialized countries such as the United States.
TRIUMPH received no commercial funding. Dr. Webster had no disclosures. Dr. Watson has been a consultant to Amgen, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, and GlaxoSmithKline. Dr. White has been a consultant to Novartis.
SOURCE: Webster R. ACC 2018. Webster R et al. ACC 18 late breaker.
ORLANDO – Hypertensive adults started on a triple-drug, single daily pill regimen as either initial or early treatment had a sharply better rate of reaching their goal blood pressure after 6 months, compared with usual-care controls, in a multicenter, randomized trial with 700 patients.
“Early use of a low-dose, three-in-one blood pressure lowering pill is safe and provides faster and better control of blood pressure compared with usual care,” Ruth Webster, PhD, said at the annual meeting of the American College of Cardiology.
The tested polypill contained half the standard doses of the angiotensin receptor blocker telmisartan (20 mg), the calcium channel blocker amlodipine (2.5 mg), and the diuretic chlorthalidone (12.5 mg). After 6 months on this regimen, 70% of patients were at their goal blood pressure, compared with 55% of the control patients, and patients on the polypill had on average a 10/5 mm Hg greater reduction in their blood pressure than did patients on usual care, reported Dr. Webster, head of research programs at the George Institute for Global Health in Sydney. Rates of total and serious adverse events and withdrawals because of adverse events were similar in the two study arms, and both arms also had nearly identical levels of treatment adherence, about 95%.
“No prior trial has evaluated a triple, low-dose pill for initial or early treatment,” she noted.
“This is a home run,” said Karol E. Watson, MD, professor of medicine and director of the Women’s Cardiovascular Health Center at the University of California, Los Angeles. “In the past, clinicians were told to pick one drug and push it as hard as you could and then maybe think about adding a second drug. Experience has shown that this does not increase efficacy, but it does increase adverse events, so current guidelines say start with two drugs. Now they are showing for the first time that you should start with three drugs. That goes with what we know.”
“Triple-drug therapy for the masses makes complete sense,” especially now that the blood pressure goal for most patients is less than 130/80 mm Hg, said William B. White, MD, professor of medicine and chief of hypertension and clinical pharmacology at the University of Connecticut in Farmington. Plus, “compliance is vastly improved when you use a combination-drug pill,” he noted.
The blood pressure targets that Dr. Webster and her associates used were less than 140/90 mm Hg except in patients with diabetes or chronic kidney disease, who had a target of less than 130/80 mm Hg. At the time researchers designed the trial the generally accepted blood pressure target for antihypertensive treatment was less than 140/90 mm Hg, Dr. Webster noted.
She also stressed that she did not believe the three specific drugs selected for the polypill made a difference. “The specific drugs we used was not that important. We would probably get the same result with different drugs. It’s about the strategy of using triple, low-dose therapy,” Dr. Webster suggested. Dr. Watson agreed.
The TRIUMPH (Triple Pill vs. Usual Care Management for Patients with Mild to Moderate Hypertension) study enrolled patients at 11 hospital outpatient clinics in Sri Lanka. The average age of the patients was 56 years. The average blood pressure was 154/90 mm Hg. About 59% of patients were not on any antihypertensive drug at baseline, with the rest on a single drug. The study protocol excluded patients on two or more drugs at entry. Roughly 30% of enrolled patients had diabetes, and 1%-2% had chronic kidney disease. Their target blood pressure on treatment during the study was less than 130/80 mm Hg.
The study’s primary endpoint was the percentage of patients at their goal blood pressure after 6 months. Patients in the triple-drug polypill group achieved their goal blood pressure 23% more often relative to the control, usual care patients, a statistically significant difference. The between group difference in achievement of goal blood pressure was apparent by the end of the first 6 weeks in the study. Patients in the control arm generally received either one or two drugs during the study, but often at full dose rather than the half doses used in the triple-drug patients. The study’s design specified that patients in the triple-drug arm who were not at their target blood pressure after 6 weeks could, at the discretion of their treating physician, switch to a second formulation that doubled the dosage of each of the three drugs. Patients in the usual care arm could have their treatment adjusted after 6 or 12 weeks as long as they continued to receive either one or two drugs. After 6 weeks, 68% of patients in the triple-drug arm and 44% receiving usual care were at their blood pressure goal. After 12 weeks, the percentages at goal were 73% of patients on the triple-drug pill and 47% on usual care.
Dr. Webster hypothesized that the triple-drug, low-dose strategy for initial or early treatment would surpass usual care not only in low- and middle-income countries, like Sri Lanka, but also in high-income, industrialized countries such as the United States.
TRIUMPH received no commercial funding. Dr. Webster had no disclosures. Dr. Watson has been a consultant to Amgen, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, and GlaxoSmithKline. Dr. White has been a consultant to Novartis.
SOURCE: Webster R. ACC 2018. Webster R et al. ACC 18 late breaker.
REPORTING FROM ACC 18
Key clinical point: Starting hypertensive patients on a single, triple-drug pill produced excellent control.
Major finding: After 6 months, 70% of patients on the triple-drug pill reached target blood pressure, compared with 55% of control patients.
Study details: TRIUMPH, a multicenter, randomized trial with 700 hypertensive adults.
Disclosures: TRIUMPH received no commercial funding. Dr. Webster had no disclosures. Dr. Watson has been a consultant to Amgen, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, and GlaxoSmithKline. Dr. White has been a consultant to Novartis.
Source: Webster R et al. ACC 18 late breaker.
Video : The SHM Research Committee: Expanding the role and footprint of research in hospital medicine
ORLANDO – In a video interview, Stephanie Mueller, MD, SFHM, of Brigham and Women’s Hospital, Boston, discusses the scope and importance of the SHM Research Committee.
One of its most important roles is overseeing the yearly Scientific Abstract and Poster Competition, known as the Research, Innovations and Clinical Vignettes (RIV) portion of the annual conference, which brings the best of current research in hospital medicine, especially in the increasingly important area of value in patient care, to the members.
In discussing the work of the committee, Dr. Mueller – who is in her third year as a member – adds that they “are working to expand the research footprint within the Society of Hospital Medicine,” including implementing initiatives such as the VIP program, which is a visiting professorship in which junior and mid-level faculty can do an exchange program between institutions.
ORLANDO – In a video interview, Stephanie Mueller, MD, SFHM, of Brigham and Women’s Hospital, Boston, discusses the scope and importance of the SHM Research Committee.
One of its most important roles is overseeing the yearly Scientific Abstract and Poster Competition, known as the Research, Innovations and Clinical Vignettes (RIV) portion of the annual conference, which brings the best of current research in hospital medicine, especially in the increasingly important area of value in patient care, to the members.
In discussing the work of the committee, Dr. Mueller – who is in her third year as a member – adds that they “are working to expand the research footprint within the Society of Hospital Medicine,” including implementing initiatives such as the VIP program, which is a visiting professorship in which junior and mid-level faculty can do an exchange program between institutions.
ORLANDO – In a video interview, Stephanie Mueller, MD, SFHM, of Brigham and Women’s Hospital, Boston, discusses the scope and importance of the SHM Research Committee.
One of its most important roles is overseeing the yearly Scientific Abstract and Poster Competition, known as the Research, Innovations and Clinical Vignettes (RIV) portion of the annual conference, which brings the best of current research in hospital medicine, especially in the increasingly important area of value in patient care, to the members.
In discussing the work of the committee, Dr. Mueller – who is in her third year as a member – adds that they “are working to expand the research footprint within the Society of Hospital Medicine,” including implementing initiatives such as the VIP program, which is a visiting professorship in which junior and mid-level faculty can do an exchange program between institutions.
REPORTING FROM HOSPITAL MEDICINE 2018
Video: SHM President Nasim Afsar seeks an “unrelenting focus on delivering value”
ORLANDO – In a video interview, Nasim Afsar, MD, SFHM, details the career road that led her to the “tremendous honor” of becoming president of the Society of Hospital Medicine.
Having been on the board of directors for 6 years was a profound experience, according to Dr. Afsar, and now as president she looks to take what she has learned and focus on the future of the field.
When asked about her overall vision for the coming year for the Society, Dr. Afsar said that she is committed to “an unrelenting focus on delivering value to our patients, our institutions, and society, and the way we do that is through population health management.”
ORLANDO – In a video interview, Nasim Afsar, MD, SFHM, details the career road that led her to the “tremendous honor” of becoming president of the Society of Hospital Medicine.
Having been on the board of directors for 6 years was a profound experience, according to Dr. Afsar, and now as president she looks to take what she has learned and focus on the future of the field.
When asked about her overall vision for the coming year for the Society, Dr. Afsar said that she is committed to “an unrelenting focus on delivering value to our patients, our institutions, and society, and the way we do that is through population health management.”
ORLANDO – In a video interview, Nasim Afsar, MD, SFHM, details the career road that led her to the “tremendous honor” of becoming president of the Society of Hospital Medicine.
Having been on the board of directors for 6 years was a profound experience, according to Dr. Afsar, and now as president she looks to take what she has learned and focus on the future of the field.
When asked about her overall vision for the coming year for the Society, Dr. Afsar said that she is committed to “an unrelenting focus on delivering value to our patients, our institutions, and society, and the way we do that is through population health management.”
REPORTING FROM HOSPITAL MEDICINE 2018
VIDEO: Cervical cancer laparotomy outperforms minimally invasive surgery
NEW ORLEANS – Use of minimally invasive radical hysterectomy to treat early-stage cervical cancer has grown over the past decade, and in current U.S. practice, roughly half of these cases are done with a minimally-invasive approach, with the rest done by conventional laparotomy. But the first data ever reported from a large, prospective trial that compared the efficacy of both methods for cervical cancer had the unexpected finding that disease-free survival following minimally invasive procedures significantly lagged behind radical hysterectomies done by open laparotomy, Pedro T. Ramirez, MD, said at the annual meeting of the Society of Gynecologic Oncology.
Just after this report came results from a second study that used propensity score–adjusted observational data from the National Cancer Database and found significantly worse overall survival following minimally invasive radical hysterectomy for early-stage cervical cancer, compared with laparotomy, said J. Alejandro Rauh-Hain, MD, a gynecologic oncologist at the University of Texas MD Anderson Cancer Center in Houston.
Both findings were “very surprising,” said Dr. Rauh-Hain in a video interview. “I was pretty sure we’d see no difference” in outcomes between minimally invasive radical hysterectomies and the same surgery either done by laparoscope or robotically assisted.
Prior prospective comparisons of minimally invasive and open surgical methods for other cancer types, including endometrial, gastric, and ovarian, showed no differences in cancer recurrences and survival, which led to widening use of minimally invasive surgery (MIS) for cervical cancer despite no direct evidence supporting equivalence, Dr. Rauh-Hain noted. “We adopted it with no data. It made sense that cervical cancer would be the same as endometrial cancer,” he explained.
The Laparoscopic Approach to Cervical Cancer (LACC) trial ran at 33 centers in 12 countries, including six U.S. centers. The study randomized women during 2008-2017 who had stage 1A1, 1A2, or 1B1 cervical cancer to either MIS or open surgery for a radical hysterectomy. Each participating center had to submit to a trial review committee full case records for 10 patients and unedited surgical videos of two patients who had previously undergone a minimally invasive radical hysterectomy at the center to document local prowess with MIS.
Dr. Ramirez and his colleagues designed LACC to prove the noninferiority of MIS and calculated an expected enrollment of 740 patients based on statistical expectations, but the study stopped early after enrolling 631 patients because of the adverse outcomes identified in the MIS patients, with a median follow-up of 2.5 years instead of the planned follow-up of 4.5 years. The study reached the 4.5-year follow-up in about 39% of patients. Of the 312 patients randomized to undergo laparotomy, 88% actually underwent the surgery; of the 319 patients randomized to MIS, 91% received this surgery, with 16% of the MIS procedures done using robotic assistance.
The study’s primary endpoint was disease-free survival at 4.5 years, which occurred in 86% of the MIS patients and in 96.5% of the laparotomy patients, a difference that failed to meet the study’s prespecified definition of noninferiority for MIS, reported Dr. Ramirez, a professor of gynecologic oncology and director of Minimally Invasive Surgery Research and Education at the MD Anderson Cancer Center. In addition, several secondary analyses of the data all showed starkly superior outcomes in the laparotomy subgroup.
Disease-free survival among all patients regardless of follow-up duration occurred in 98% of laparotomy patients and 92% of MIS patients, which translated into a 3.74 hazard ratio (P = .002) for disease recurrence or death among the MIS patients when compared with laparotomy patients. The all-cause mortality rates were 1% in the laparotomy patients and 6% among the MIS patients, a hazard ratio of 6.00 (P = .004). The risk of local or regional recurrences was more than fourfold higher in the MIS patients. A blinded, central panel adjudicated all recurrences identified during the study.
The LACC results “should be discussed with patients scheduled to undergo radical hysterectomy” for cervical cancer, Dr. Ramirez concluded.
The observational data from the National Cancer Database used in the analysis led by Dr. Rauh-Hain came from 2,221 patients hospitalized and treated with radical hysterectomy and pelvic lymph node dissection at a U.S. center during 2010-2012 for either stage 1A2 or 1B1 cervical cancer. Among these patients, 47.5% underwent MIS, with 79% of those procedures done with robotic assistance, while the other 52.5% underwent open laparotomy, Dr. Rauh-Hain reported. Additional analysis of data from this database by the researchers showed that, although the first report of MIS for radical hysterectomy appeared in 1992, the approach remained largely unused in U.S. practice until 2007, when use of MIS began to sharply rise. By 2010, about a third of radical hysterectomies for cervical cancer involved MIS, and usage increased still further during 2011 and 2012 to produce a nearly 48% rate during the 3-year study period.
The primary endpoint of Dr. Rauh-Hain’s analysis was overall survival following propensity-score matching of the MIS and laparotomy patients using 13 demographic and clinical criteria. The analysis showed 4-year mortality rates of 5.8% among the laparotomy patients and 8.4% among the MIS patients, which calculated to a relatively increased mortality hazard from MIS of 48% (P = .02).
Dr. Rauh-Hain also reported results from an interrupted time series analysis using data from the Surveillance, Epidemiology, and End Results database of the National Cancer Institute. This analysis compared annual 4-year relative survival rates among women undergoing radical hysterectomy for cervical cancer and found that, after survival rates showed a gradual, steady rise during the years culminating in 2006, once MIS began being more widely used in 2007 survival rates began to drop, with a statistically significant annualized decline of 1% through 2010.
Based on the results from both studies, “at MD Anderson we discuss the results with patients,” with the consequence that the percentage of patients treated with laparotomy is now increasing, Dr. Rauh-Hain said. The results from both studies “are concerning,” he explained.
SOURCE: Ramirez PT and Rauh-Hain JA. SGO 2018, Late-Breaking Abstracts 1 and 2.
The findings from these studies appear valid and should be discussed with patients.
The findings raise a major question: Why has minimally invasive surgery (MIS) led to worse survival rates than laparotomy? Several possible explanations can be hypothesized: The uterine manipulator used in MIS led to local spread of cancer cells; MIS involves a learning curve and initial attempts at MIS did not remove enough of the tumor; and MIS led to increased exposure of the peritoneal cavity to the cancer. The findings also raise another question: Why has MIS for cervical cancer performed less well than MIS for cancers from other organs, such as endometrial and prostate?
The overall survival results from the LACC trial calculate out to 4.75 added deaths per year for every 1,000 patients treated with MIS, compared with laparoscopy. But the National Inpatient Sample data suggest that MIS cuts mortality by about two deaths per year per 1,000 patients, compared with laparotomy, and mortality data from a different analysis (Gynecol Oncol. 2012 Oct;127[1]:11-7) suggest that MIS might prevent six deaths annually for every 1,000 patients, compared with laparotomy. Overall, these three sets of findings suggest roughly comparable mortality outcomes from MIS and laparotomy, but with MIS having the bonus of fewer complications and less need for transfusions.
The cautions and concerns raised by the LACC trial and Dr. Rauh-Hain’s analysis of observational data cannot be easily dismissed. We need to figure out why the results from both studies show worse survival and recurrence rates with MIS, and we need to identify whether subgroups of patients exist who might clearly benefit from either the MIS or open-surgery approach.
Shitanshu Uppal, MD , is a gynecologic oncologist at the University of Michigan in Ann Arbor. He made these comments as designated discussant for the two studies. He had no disclosures.
The findings from these studies appear valid and should be discussed with patients.
The findings raise a major question: Why has minimally invasive surgery (MIS) led to worse survival rates than laparotomy? Several possible explanations can be hypothesized: The uterine manipulator used in MIS led to local spread of cancer cells; MIS involves a learning curve and initial attempts at MIS did not remove enough of the tumor; and MIS led to increased exposure of the peritoneal cavity to the cancer. The findings also raise another question: Why has MIS for cervical cancer performed less well than MIS for cancers from other organs, such as endometrial and prostate?
The overall survival results from the LACC trial calculate out to 4.75 added deaths per year for every 1,000 patients treated with MIS, compared with laparoscopy. But the National Inpatient Sample data suggest that MIS cuts mortality by about two deaths per year per 1,000 patients, compared with laparotomy, and mortality data from a different analysis (Gynecol Oncol. 2012 Oct;127[1]:11-7) suggest that MIS might prevent six deaths annually for every 1,000 patients, compared with laparotomy. Overall, these three sets of findings suggest roughly comparable mortality outcomes from MIS and laparotomy, but with MIS having the bonus of fewer complications and less need for transfusions.
The cautions and concerns raised by the LACC trial and Dr. Rauh-Hain’s analysis of observational data cannot be easily dismissed. We need to figure out why the results from both studies show worse survival and recurrence rates with MIS, and we need to identify whether subgroups of patients exist who might clearly benefit from either the MIS or open-surgery approach.
Shitanshu Uppal, MD , is a gynecologic oncologist at the University of Michigan in Ann Arbor. He made these comments as designated discussant for the two studies. He had no disclosures.
The findings from these studies appear valid and should be discussed with patients.
The findings raise a major question: Why has minimally invasive surgery (MIS) led to worse survival rates than laparotomy? Several possible explanations can be hypothesized: The uterine manipulator used in MIS led to local spread of cancer cells; MIS involves a learning curve and initial attempts at MIS did not remove enough of the tumor; and MIS led to increased exposure of the peritoneal cavity to the cancer. The findings also raise another question: Why has MIS for cervical cancer performed less well than MIS for cancers from other organs, such as endometrial and prostate?
The overall survival results from the LACC trial calculate out to 4.75 added deaths per year for every 1,000 patients treated with MIS, compared with laparoscopy. But the National Inpatient Sample data suggest that MIS cuts mortality by about two deaths per year per 1,000 patients, compared with laparotomy, and mortality data from a different analysis (Gynecol Oncol. 2012 Oct;127[1]:11-7) suggest that MIS might prevent six deaths annually for every 1,000 patients, compared with laparotomy. Overall, these three sets of findings suggest roughly comparable mortality outcomes from MIS and laparotomy, but with MIS having the bonus of fewer complications and less need for transfusions.
The cautions and concerns raised by the LACC trial and Dr. Rauh-Hain’s analysis of observational data cannot be easily dismissed. We need to figure out why the results from both studies show worse survival and recurrence rates with MIS, and we need to identify whether subgroups of patients exist who might clearly benefit from either the MIS or open-surgery approach.
Shitanshu Uppal, MD , is a gynecologic oncologist at the University of Michigan in Ann Arbor. He made these comments as designated discussant for the two studies. He had no disclosures.
NEW ORLEANS – Use of minimally invasive radical hysterectomy to treat early-stage cervical cancer has grown over the past decade, and in current U.S. practice, roughly half of these cases are done with a minimally-invasive approach, with the rest done by conventional laparotomy. But the first data ever reported from a large, prospective trial that compared the efficacy of both methods for cervical cancer had the unexpected finding that disease-free survival following minimally invasive procedures significantly lagged behind radical hysterectomies done by open laparotomy, Pedro T. Ramirez, MD, said at the annual meeting of the Society of Gynecologic Oncology.
Just after this report came results from a second study that used propensity score–adjusted observational data from the National Cancer Database and found significantly worse overall survival following minimally invasive radical hysterectomy for early-stage cervical cancer, compared with laparotomy, said J. Alejandro Rauh-Hain, MD, a gynecologic oncologist at the University of Texas MD Anderson Cancer Center in Houston.
Both findings were “very surprising,” said Dr. Rauh-Hain in a video interview. “I was pretty sure we’d see no difference” in outcomes between minimally invasive radical hysterectomies and the same surgery either done by laparoscope or robotically assisted.
Prior prospective comparisons of minimally invasive and open surgical methods for other cancer types, including endometrial, gastric, and ovarian, showed no differences in cancer recurrences and survival, which led to widening use of minimally invasive surgery (MIS) for cervical cancer despite no direct evidence supporting equivalence, Dr. Rauh-Hain noted. “We adopted it with no data. It made sense that cervical cancer would be the same as endometrial cancer,” he explained.
The Laparoscopic Approach to Cervical Cancer (LACC) trial ran at 33 centers in 12 countries, including six U.S. centers. The study randomized women during 2008-2017 who had stage 1A1, 1A2, or 1B1 cervical cancer to either MIS or open surgery for a radical hysterectomy. Each participating center had to submit to a trial review committee full case records for 10 patients and unedited surgical videos of two patients who had previously undergone a minimally invasive radical hysterectomy at the center to document local prowess with MIS.
Dr. Ramirez and his colleagues designed LACC to prove the noninferiority of MIS and calculated an expected enrollment of 740 patients based on statistical expectations, but the study stopped early after enrolling 631 patients because of the adverse outcomes identified in the MIS patients, with a median follow-up of 2.5 years instead of the planned follow-up of 4.5 years. The study reached the 4.5-year follow-up in about 39% of patients. Of the 312 patients randomized to undergo laparotomy, 88% actually underwent the surgery; of the 319 patients randomized to MIS, 91% received this surgery, with 16% of the MIS procedures done using robotic assistance.
The study’s primary endpoint was disease-free survival at 4.5 years, which occurred in 86% of the MIS patients and in 96.5% of the laparotomy patients, a difference that failed to meet the study’s prespecified definition of noninferiority for MIS, reported Dr. Ramirez, a professor of gynecologic oncology and director of Minimally Invasive Surgery Research and Education at the MD Anderson Cancer Center. In addition, several secondary analyses of the data all showed starkly superior outcomes in the laparotomy subgroup.
Disease-free survival among all patients regardless of follow-up duration occurred in 98% of laparotomy patients and 92% of MIS patients, which translated into a 3.74 hazard ratio (P = .002) for disease recurrence or death among the MIS patients when compared with laparotomy patients. The all-cause mortality rates were 1% in the laparotomy patients and 6% among the MIS patients, a hazard ratio of 6.00 (P = .004). The risk of local or regional recurrences was more than fourfold higher in the MIS patients. A blinded, central panel adjudicated all recurrences identified during the study.
The LACC results “should be discussed with patients scheduled to undergo radical hysterectomy” for cervical cancer, Dr. Ramirez concluded.
The observational data from the National Cancer Database used in the analysis led by Dr. Rauh-Hain came from 2,221 patients hospitalized and treated with radical hysterectomy and pelvic lymph node dissection at a U.S. center during 2010-2012 for either stage 1A2 or 1B1 cervical cancer. Among these patients, 47.5% underwent MIS, with 79% of those procedures done with robotic assistance, while the other 52.5% underwent open laparotomy, Dr. Rauh-Hain reported. Additional analysis of data from this database by the researchers showed that, although the first report of MIS for radical hysterectomy appeared in 1992, the approach remained largely unused in U.S. practice until 2007, when use of MIS began to sharply rise. By 2010, about a third of radical hysterectomies for cervical cancer involved MIS, and usage increased still further during 2011 and 2012 to produce a nearly 48% rate during the 3-year study period.
The primary endpoint of Dr. Rauh-Hain’s analysis was overall survival following propensity-score matching of the MIS and laparotomy patients using 13 demographic and clinical criteria. The analysis showed 4-year mortality rates of 5.8% among the laparotomy patients and 8.4% among the MIS patients, which calculated to a relatively increased mortality hazard from MIS of 48% (P = .02).
Dr. Rauh-Hain also reported results from an interrupted time series analysis using data from the Surveillance, Epidemiology, and End Results database of the National Cancer Institute. This analysis compared annual 4-year relative survival rates among women undergoing radical hysterectomy for cervical cancer and found that, after survival rates showed a gradual, steady rise during the years culminating in 2006, once MIS began being more widely used in 2007 survival rates began to drop, with a statistically significant annualized decline of 1% through 2010.
Based on the results from both studies, “at MD Anderson we discuss the results with patients,” with the consequence that the percentage of patients treated with laparotomy is now increasing, Dr. Rauh-Hain said. The results from both studies “are concerning,” he explained.
SOURCE: Ramirez PT and Rauh-Hain JA. SGO 2018, Late-Breaking Abstracts 1 and 2.
NEW ORLEANS – Use of minimally invasive radical hysterectomy to treat early-stage cervical cancer has grown over the past decade, and in current U.S. practice, roughly half of these cases are done with a minimally-invasive approach, with the rest done by conventional laparotomy. But the first data ever reported from a large, prospective trial that compared the efficacy of both methods for cervical cancer had the unexpected finding that disease-free survival following minimally invasive procedures significantly lagged behind radical hysterectomies done by open laparotomy, Pedro T. Ramirez, MD, said at the annual meeting of the Society of Gynecologic Oncology.
Just after this report came results from a second study that used propensity score–adjusted observational data from the National Cancer Database and found significantly worse overall survival following minimally invasive radical hysterectomy for early-stage cervical cancer, compared with laparotomy, said J. Alejandro Rauh-Hain, MD, a gynecologic oncologist at the University of Texas MD Anderson Cancer Center in Houston.
Both findings were “very surprising,” said Dr. Rauh-Hain in a video interview. “I was pretty sure we’d see no difference” in outcomes between minimally invasive radical hysterectomies and the same surgery either done by laparoscope or robotically assisted.
Prior prospective comparisons of minimally invasive and open surgical methods for other cancer types, including endometrial, gastric, and ovarian, showed no differences in cancer recurrences and survival, which led to widening use of minimally invasive surgery (MIS) for cervical cancer despite no direct evidence supporting equivalence, Dr. Rauh-Hain noted. “We adopted it with no data. It made sense that cervical cancer would be the same as endometrial cancer,” he explained.
The Laparoscopic Approach to Cervical Cancer (LACC) trial ran at 33 centers in 12 countries, including six U.S. centers. The study randomized women during 2008-2017 who had stage 1A1, 1A2, or 1B1 cervical cancer to either MIS or open surgery for a radical hysterectomy. Each participating center had to submit to a trial review committee full case records for 10 patients and unedited surgical videos of two patients who had previously undergone a minimally invasive radical hysterectomy at the center to document local prowess with MIS.
Dr. Ramirez and his colleagues designed LACC to prove the noninferiority of MIS and calculated an expected enrollment of 740 patients based on statistical expectations, but the study stopped early after enrolling 631 patients because of the adverse outcomes identified in the MIS patients, with a median follow-up of 2.5 years instead of the planned follow-up of 4.5 years. The study reached the 4.5-year follow-up in about 39% of patients. Of the 312 patients randomized to undergo laparotomy, 88% actually underwent the surgery; of the 319 patients randomized to MIS, 91% received this surgery, with 16% of the MIS procedures done using robotic assistance.
The study’s primary endpoint was disease-free survival at 4.5 years, which occurred in 86% of the MIS patients and in 96.5% of the laparotomy patients, a difference that failed to meet the study’s prespecified definition of noninferiority for MIS, reported Dr. Ramirez, a professor of gynecologic oncology and director of Minimally Invasive Surgery Research and Education at the MD Anderson Cancer Center. In addition, several secondary analyses of the data all showed starkly superior outcomes in the laparotomy subgroup.
Disease-free survival among all patients regardless of follow-up duration occurred in 98% of laparotomy patients and 92% of MIS patients, which translated into a 3.74 hazard ratio (P = .002) for disease recurrence or death among the MIS patients when compared with laparotomy patients. The all-cause mortality rates were 1% in the laparotomy patients and 6% among the MIS patients, a hazard ratio of 6.00 (P = .004). The risk of local or regional recurrences was more than fourfold higher in the MIS patients. A blinded, central panel adjudicated all recurrences identified during the study.
The LACC results “should be discussed with patients scheduled to undergo radical hysterectomy” for cervical cancer, Dr. Ramirez concluded.
The observational data from the National Cancer Database used in the analysis led by Dr. Rauh-Hain came from 2,221 patients hospitalized and treated with radical hysterectomy and pelvic lymph node dissection at a U.S. center during 2010-2012 for either stage 1A2 or 1B1 cervical cancer. Among these patients, 47.5% underwent MIS, with 79% of those procedures done with robotic assistance, while the other 52.5% underwent open laparotomy, Dr. Rauh-Hain reported. Additional analysis of data from this database by the researchers showed that, although the first report of MIS for radical hysterectomy appeared in 1992, the approach remained largely unused in U.S. practice until 2007, when use of MIS began to sharply rise. By 2010, about a third of radical hysterectomies for cervical cancer involved MIS, and usage increased still further during 2011 and 2012 to produce a nearly 48% rate during the 3-year study period.
The primary endpoint of Dr. Rauh-Hain’s analysis was overall survival following propensity-score matching of the MIS and laparotomy patients using 13 demographic and clinical criteria. The analysis showed 4-year mortality rates of 5.8% among the laparotomy patients and 8.4% among the MIS patients, which calculated to a relatively increased mortality hazard from MIS of 48% (P = .02).
Dr. Rauh-Hain also reported results from an interrupted time series analysis using data from the Surveillance, Epidemiology, and End Results database of the National Cancer Institute. This analysis compared annual 4-year relative survival rates among women undergoing radical hysterectomy for cervical cancer and found that, after survival rates showed a gradual, steady rise during the years culminating in 2006, once MIS began being more widely used in 2007 survival rates began to drop, with a statistically significant annualized decline of 1% through 2010.
Based on the results from both studies, “at MD Anderson we discuss the results with patients,” with the consequence that the percentage of patients treated with laparotomy is now increasing, Dr. Rauh-Hain said. The results from both studies “are concerning,” he explained.
SOURCE: Ramirez PT and Rauh-Hain JA. SGO 2018, Late-Breaking Abstracts 1 and 2.
REPORTING FROM SGO 2018
Key clinical point: Laparotomy produced better survival than did minimally invasive surgery for cervical cancer.
Major finding: Disease-free survival after 4.5 years was 96.5% with laparotomy and 86.0% with minimally invasive surgery.
Study details: LACC was a multicenter, randomized trial with 631 patients. The observational study included 2,221 patients from the National Cancer Database during 2010-2012.
Disclosures: Dr. Ramirez and Dr. Rauh-Hain had no disclosures.
Source: Ramirez PT and Rauh-Hain JA. SGO 2018, Late-Breaking Abstracts 1 and 2.
Ari Green, MD
VIDEO: Poorer cardiometabolic health seen in men with low sperm count
CHICAGO – Low testosterone levels alone didn’t account for the finding, said Alberto Ferlin, MD, PhD, professor of reproductive endocrinology at the University of Brescia, Italy.
“So at the end, we showed that, independent of testosterone, low sperm count could be a marker of general male health, in particular for cardiovascular risk factors or metabolic derangement,” said Dr. Ferlin in an interview following a press conference at the annual meeting of the Endocrine Society.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The Italian study, which Dr. Ferlin said was the largest of its kind to date, studied 5,177 males who were part of an infertile couple, comparing men with low sperm count (less than 39 million sperm per ejaculate) with those with normal sperm count (at least 39 million sperm per ejaculate). In all, 2,583 of the participants had low sperm counts.
“Our main aim was to understand if semen analysis and, in general, the reproductive function of a man, could be a marker of his general cardiovascular and metabolic health,” said Dr. Ferlin.
Only men with a comprehensive work-up were included, so all participants had a medical history and physical exam, and semen analysis and culture. Additional components of the evaluation included blood lipid and glucose metabolism testing, reproductive hormone levels, ultrasound of the testes and, for men diagnosed with hypogonadism, bone densitometry.
The study, said Dr. Ferlin, found that among men with a low total sperm count, there was a high prevalence of hypogonadism, defined as both low testosterone and elevated levels of luteinizing hormone. Additionally, these men had a high prevalence of elevated luteinizing hormones with normal testosterone – “so-called subclinical hypogonadism,” said Dr. Ferlin.
In men with a low sperm count – defined as fewer than 39 million sperm per ejaculate – the prevalence of biochemical hypogonadism was about 45%, compared with just 6% in men with normal sperm counts, said Dr. Ferlin. Men with infertility had an odds ratio for hypogonadism of 12.2, said Dr. Ferlin (95% confidence interval, 10.2-14.6).
Additionally, Dr. Ferlin reported that 35% of men with hypogonadism had osteopenia, and 17% met criteria for osteoporosis. The numbers surprised the investigators. “These are very young men – about 30 years old,” said Dr. Ferlin.
Dr. Ferlin and his collaborators also looked at the subset of eugonadal men in the study, comparing those with normal sperm counts (n = 2,431) to those who had low sperm counts, (n = 1,423). They found that men with low sperm counts had significantly higher body mass index, waist circumference, systolic blood pressure, hemoglobin A1c, and homeostatic model assessment of insulin resistance (HOMA-IR) levels (P less than .001 for all).
High density lipoprotein (HDL) cholesterol, testosterone, and follicle stimulating hormone levels were also significantly lower for men with low sperm count. “Men with oligozoospermia … have an increased risk of metabolic derangement – so, altered lipid profile with higher LDL cholesterol and lower HDL [cholesterol], higher triglycerides, higher insulin resistance,” said Dr. Ferlin.
The findings have implications for reproductive endocrinologists caring for couples with infertility, said Dr. Ferlin. “Infertile men should be studied comprehensively, and the diagnosis cannot be limited to just one semen analysis,” given the study’s findings, he said. “All these men should be counseled, should be treated … for worsening of these cardiovascular and metabolic risk factors that are present in such frequency in oligozoospermic men.”
Dr. Ferlin reported no conflicts of interest.
CHICAGO – Low testosterone levels alone didn’t account for the finding, said Alberto Ferlin, MD, PhD, professor of reproductive endocrinology at the University of Brescia, Italy.
“So at the end, we showed that, independent of testosterone, low sperm count could be a marker of general male health, in particular for cardiovascular risk factors or metabolic derangement,” said Dr. Ferlin in an interview following a press conference at the annual meeting of the Endocrine Society.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The Italian study, which Dr. Ferlin said was the largest of its kind to date, studied 5,177 males who were part of an infertile couple, comparing men with low sperm count (less than 39 million sperm per ejaculate) with those with normal sperm count (at least 39 million sperm per ejaculate). In all, 2,583 of the participants had low sperm counts.
“Our main aim was to understand if semen analysis and, in general, the reproductive function of a man, could be a marker of his general cardiovascular and metabolic health,” said Dr. Ferlin.
Only men with a comprehensive work-up were included, so all participants had a medical history and physical exam, and semen analysis and culture. Additional components of the evaluation included blood lipid and glucose metabolism testing, reproductive hormone levels, ultrasound of the testes and, for men diagnosed with hypogonadism, bone densitometry.
The study, said Dr. Ferlin, found that among men with a low total sperm count, there was a high prevalence of hypogonadism, defined as both low testosterone and elevated levels of luteinizing hormone. Additionally, these men had a high prevalence of elevated luteinizing hormones with normal testosterone – “so-called subclinical hypogonadism,” said Dr. Ferlin.
In men with a low sperm count – defined as fewer than 39 million sperm per ejaculate – the prevalence of biochemical hypogonadism was about 45%, compared with just 6% in men with normal sperm counts, said Dr. Ferlin. Men with infertility had an odds ratio for hypogonadism of 12.2, said Dr. Ferlin (95% confidence interval, 10.2-14.6).
Additionally, Dr. Ferlin reported that 35% of men with hypogonadism had osteopenia, and 17% met criteria for osteoporosis. The numbers surprised the investigators. “These are very young men – about 30 years old,” said Dr. Ferlin.
Dr. Ferlin and his collaborators also looked at the subset of eugonadal men in the study, comparing those with normal sperm counts (n = 2,431) to those who had low sperm counts, (n = 1,423). They found that men with low sperm counts had significantly higher body mass index, waist circumference, systolic blood pressure, hemoglobin A1c, and homeostatic model assessment of insulin resistance (HOMA-IR) levels (P less than .001 for all).
High density lipoprotein (HDL) cholesterol, testosterone, and follicle stimulating hormone levels were also significantly lower for men with low sperm count. “Men with oligozoospermia … have an increased risk of metabolic derangement – so, altered lipid profile with higher LDL cholesterol and lower HDL [cholesterol], higher triglycerides, higher insulin resistance,” said Dr. Ferlin.
The findings have implications for reproductive endocrinologists caring for couples with infertility, said Dr. Ferlin. “Infertile men should be studied comprehensively, and the diagnosis cannot be limited to just one semen analysis,” given the study’s findings, he said. “All these men should be counseled, should be treated … for worsening of these cardiovascular and metabolic risk factors that are present in such frequency in oligozoospermic men.”
Dr. Ferlin reported no conflicts of interest.
CHICAGO – Low testosterone levels alone didn’t account for the finding, said Alberto Ferlin, MD, PhD, professor of reproductive endocrinology at the University of Brescia, Italy.
“So at the end, we showed that, independent of testosterone, low sperm count could be a marker of general male health, in particular for cardiovascular risk factors or metabolic derangement,” said Dr. Ferlin in an interview following a press conference at the annual meeting of the Endocrine Society.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The Italian study, which Dr. Ferlin said was the largest of its kind to date, studied 5,177 males who were part of an infertile couple, comparing men with low sperm count (less than 39 million sperm per ejaculate) with those with normal sperm count (at least 39 million sperm per ejaculate). In all, 2,583 of the participants had low sperm counts.
“Our main aim was to understand if semen analysis and, in general, the reproductive function of a man, could be a marker of his general cardiovascular and metabolic health,” said Dr. Ferlin.
Only men with a comprehensive work-up were included, so all participants had a medical history and physical exam, and semen analysis and culture. Additional components of the evaluation included blood lipid and glucose metabolism testing, reproductive hormone levels, ultrasound of the testes and, for men diagnosed with hypogonadism, bone densitometry.
The study, said Dr. Ferlin, found that among men with a low total sperm count, there was a high prevalence of hypogonadism, defined as both low testosterone and elevated levels of luteinizing hormone. Additionally, these men had a high prevalence of elevated luteinizing hormones with normal testosterone – “so-called subclinical hypogonadism,” said Dr. Ferlin.
In men with a low sperm count – defined as fewer than 39 million sperm per ejaculate – the prevalence of biochemical hypogonadism was about 45%, compared with just 6% in men with normal sperm counts, said Dr. Ferlin. Men with infertility had an odds ratio for hypogonadism of 12.2, said Dr. Ferlin (95% confidence interval, 10.2-14.6).
Additionally, Dr. Ferlin reported that 35% of men with hypogonadism had osteopenia, and 17% met criteria for osteoporosis. The numbers surprised the investigators. “These are very young men – about 30 years old,” said Dr. Ferlin.
Dr. Ferlin and his collaborators also looked at the subset of eugonadal men in the study, comparing those with normal sperm counts (n = 2,431) to those who had low sperm counts, (n = 1,423). They found that men with low sperm counts had significantly higher body mass index, waist circumference, systolic blood pressure, hemoglobin A1c, and homeostatic model assessment of insulin resistance (HOMA-IR) levels (P less than .001 for all).
High density lipoprotein (HDL) cholesterol, testosterone, and follicle stimulating hormone levels were also significantly lower for men with low sperm count. “Men with oligozoospermia … have an increased risk of metabolic derangement – so, altered lipid profile with higher LDL cholesterol and lower HDL [cholesterol], higher triglycerides, higher insulin resistance,” said Dr. Ferlin.
The findings have implications for reproductive endocrinologists caring for couples with infertility, said Dr. Ferlin. “Infertile men should be studied comprehensively, and the diagnosis cannot be limited to just one semen analysis,” given the study’s findings, he said. “All these men should be counseled, should be treated … for worsening of these cardiovascular and metabolic risk factors that are present in such frequency in oligozoospermic men.”
Dr. Ferlin reported no conflicts of interest.
REPORTING FROM ENDO 2018
