Fran Lowry

ORLANDO — KRAS tumor status has emerged as an important biomarker for the success or failure of therapies for metastatic colorectal cancer and should be assessed before starting treatment, researchers said at a meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.

“Clinicians should definitely start checking for KRAS status in their patients with advanced colorectal cancer. Such testing will become very easy to do in the next few months,” Dr. Josep Tabernero, head of the gastrointestinal tumors unit of Vall d'Hebron University Hospital, Barcelona, said at the meeting, which was also sponsored by the AGA Institute, the American Society for Therapeutic Radiology and Oncology, and the Society of Surgical Oncology.

In an open-label, phase I, multicenter study, Dr. Tabernero and colleagues evaluated the efficacy of cetuximab (Erbitux) given either once a week or once every 2 weeks, in 52 patients with epidermal growth factor receptor (EGF-R)-expressing metastatic colorectal cancer. Cetuximab was administered as a single agent over a 6-week period, and then FOLFIRI (irinotecan/5-fluorouracil [5-FU]/folinic acid [FA]) was added to the regimen.

The researchers also determined KRAS status in tumor samples from 48 of the patients, and correlated this status with overall response and progression-free survival.

The patients had had no prior exposure to EGF-R-targeting therapy, no previous chemotherapy (including adjuvant therapy) for metastatic colorectal cancer within 6 months of study entry, and no surgery or radiation treatment within 4 weeks of study entry.

The results showed that cetuximab 500 mg/m

The 29 patients with wild-type KRAS tumors had an overall response rate of 28%, compared with 0% for the 19 patients with mutant KRAS tumors when cetuximab was given as single agent. Once FOLFIRI was added to cetuximab, patients with wild-type KRAS tumors had an overall response rate of 55%, compared with 32% for those with mutant KRAS tumors.

The median progression-free survival for patients with wild-type KRAS tumors was 9 months, compared with 6 months for patients with mutant KRAS tumors (hazard ratio 0.47).

“This is the first time that the predictive value of the KRAS status has been demonstrated in patients treated with cetuximab and chemotherapy in the first-line setting of patients with advanced colorectal cancer,” Dr. Tabernero said.

In another study presented at the meeting, KRAS status influenced clinical response to treatment with panitumumab (Vectibix) in patients with chemotherapy-refractory metastatic colorectal cancer.

In a phase III trial that randomized 463 patients to panitumumab plus best supportive care (n = 231) or best supportive care alone (n = 232), the benefit of panitumumab was confined to patients with wild-type KRAS tumors. Patients with mutant KRAS tumors showed no benefit, said Dr. Rafael G. Amado at a press briefing. Dr. Amado works for Amgen Inc., which makes panitumumab.

The median progression-free survival for the 124 patients with wild-type KRAS who were treated with panitumumab was 12 weeks, compared with 7 weeks for the 84 patients who had mutant KRAS. The median progression-free survival for patients randomized to best supportive care only was 7 weeks, regardless of KRAS status.

The response rate for wild-type KRAS patients treated with panitumumab was 17%, and 34% had stable disease. In contrast, the response rate for mutant KRAS patients treated with panitumumab was 0%, and 12% had stable disease.

The median overall survival was longer in patients with wild-type KRAS than in those with mutant KRAS tumors, regardless of treatment arm. The median survival of patients with wild-type KRAS tumors receiving panitumumab was 8 months, versus 5 months for those in the mutant KRAS group. In the best-supportive-care arm, the median survival for patients with wild-type and mutant KRAS tumors was 8 months and 4 months, respectively.

“Over 75% of patients in the best-supportive-care arm in both KRAS groups went on to receive panitumumab in a crossover protocol, which likely confounded the survival results,” Dr. Amado noted.

In an interview, he commented on the significance of his study's results. “These findings are important because, by testing for KRAS mutations, physicians may now be able to identify patients who are more likely to respond to panitumumab treatment and avoid unnecessary side effects, as well as expense, to those who are unlikely to respond.”

He added that being able to pinpoint subgroups of patients according to KRAS status or other biomarkers will become increasingly important for directing cancer treatment.

“The field of oncology will continue to undergo further segmentation as diseases are catalogued according to molecular alterations, and drugs will be developed to specifically interdict pathways that are active for specific categories of tumors within the same type of cancer.”

To date in the United States, no tests have been approved by the Food and Drug Administration for testing KRAS in tumor samples. The test used in the panitumumab study, called the DxS KRAS, has a CE marking (a mandatory conformity marking in the European market). Amgen is currently collaborating with the maker of the test, DxS Ltd., to guide this test through the regulatory process of the FDA, Dr. Amado said.

Dr. Tabernero disclosed that he is a consultant to and receives honoraria from several pharmaceutical companies, including Merck KGaA, which sponsored his study. Dr. Amado is an employee of Amgen and owns stock in the company.

'Clinicians should definitely start checking for KRAS status in their patients with advanced colorectal cancer.' DR. TABERNERO

ORLANDO — KRAS tumor status has emerged as an important biomarker for the success or failure of therapies for metastatic colorectal cancer and should be assessed before starting treatment, researchers said at a meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.

“Clinicians should definitely start checking for KRAS status in their patients with advanced colorectal cancer. Such testing will become very easy to do in the next few months,” Dr. Josep Tabernero, head of the gastrointestinal tumors unit of Vall d'Hebron University Hospital, Barcelona, said at the meeting, which was also sponsored by the AGA Institute, the American Society for Therapeutic Radiology and Oncology, and the Society of Surgical Oncology.

In an open-label, phase I, multicenter study, Dr. Tabernero and colleagues evaluated the efficacy of cetuximab (Erbitux) given either once a week or once every 2 weeks, in 52 patients with epidermal growth factor receptor (EGF-R)-expressing metastatic colorectal cancer. Cetuximab was administered as a single agent over a 6-week period, and then FOLFIRI (irinotecan/5-fluorouracil [5-FU]/folinic acid [FA]) was added to the regimen.

The researchers also determined KRAS status in tumor samples from 48 of the patients, and correlated this status with overall response and progression-free survival.

The patients had had no prior exposure to EGF-R-targeting therapy, no previous chemotherapy (including adjuvant therapy) for metastatic colorectal cancer within 6 months of study entry, and no surgery or radiation treatment within 4 weeks of study entry.

The results showed that cetuximab 500 mg/m

The 29 patients with wild-type KRAS tumors had an overall response rate of 28%, compared with 0% for the 19 patients with mutant KRAS tumors when cetuximab was given as single agent. Once FOLFIRI was added to cetuximab, patients with wild-type KRAS tumors had an overall response rate of 55%, compared with 32% for those with mutant KRAS tumors.

The median progression-free survival for patients with wild-type KRAS tumors was 9 months, compared with 6 months for patients with mutant KRAS tumors (hazard ratio 0.47).

“This is the first time that the predictive value of the KRAS status has been demonstrated in patients treated with cetuximab and chemotherapy in the first-line setting of patients with advanced colorectal cancer,” Dr. Tabernero said.

In another study presented at the meeting, KRAS status influenced clinical response to treatment with panitumumab (Vectibix) in patients with chemotherapy-refractory metastatic colorectal cancer.

In a phase III trial that randomized 463 patients to panitumumab plus best supportive care (n = 231) or best supportive care alone (n = 232), the benefit of panitumumab was confined to patients with wild-type KRAS tumors. Patients with mutant KRAS tumors showed no benefit, said Dr. Rafael G. Amado at a press briefing. Dr. Amado works for Amgen Inc., which makes panitumumab.

The median progression-free survival for the 124 patients with wild-type KRAS who were treated with panitumumab was 12 weeks, compared with 7 weeks for the 84 patients who had mutant KRAS. The median progression-free survival for patients randomized to best supportive care only was 7 weeks, regardless of KRAS status.

The response rate for wild-type KRAS patients treated with panitumumab was 17%, and 34% had stable disease. In contrast, the response rate for mutant KRAS patients treated with panitumumab was 0%, and 12% had stable disease.

The median overall survival was longer in patients with wild-type KRAS than in those with mutant KRAS tumors, regardless of treatment arm. The median survival of patients with wild-type KRAS tumors receiving panitumumab was 8 months, versus 5 months for those in the mutant KRAS group. In the best-supportive-care arm, the median survival for patients with wild-type and mutant KRAS tumors was 8 months and 4 months, respectively.

“Over 75% of patients in the best-supportive-care arm in both KRAS groups went on to receive panitumumab in a crossover protocol, which likely confounded the survival results,” Dr. Amado noted.

In an interview, he commented on the significance of his study's results. “These findings are important because, by testing for KRAS mutations, physicians may now be able to identify patients who are more likely to respond to panitumumab treatment and avoid unnecessary side effects, as well as expense, to those who are unlikely to respond.”

He added that being able to pinpoint subgroups of patients according to KRAS status or other biomarkers will become increasingly important for directing cancer treatment.

“The field of oncology will continue to undergo further segmentation as diseases are catalogued according to molecular alterations, and drugs will be developed to specifically interdict pathways that are active for specific categories of tumors within the same type of cancer.”

To date in the United States, no tests have been approved by the Food and Drug Administration for testing KRAS in tumor samples. The test used in the panitumumab study, called the DxS KRAS, has a CE marking (a mandatory conformity marking in the European market). Amgen is currently collaborating with the maker of the test, DxS Ltd., to guide this test through the regulatory process of the FDA, Dr. Amado said.

Dr. Tabernero disclosed that he is a consultant to and receives honoraria from several pharmaceutical companies, including Merck KGaA, which sponsored his study. Dr. Amado is an employee of Amgen and owns stock in the company.

'Clinicians should definitely start checking for KRAS status in their patients with advanced colorectal cancer.' DR. TABERNERO

ORLANDO — KRAS tumor status has emerged as an important biomarker for the success or failure of therapies for metastatic colorectal cancer and should be assessed before starting treatment, researchers said at a meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.

“Clinicians should definitely start checking for KRAS status in their patients with advanced colorectal cancer. Such testing will become very easy to do in the next few months,” Dr. Josep Tabernero, head of the gastrointestinal tumors unit of Vall d'Hebron University Hospital, Barcelona, said at the meeting, which was also sponsored by the AGA Institute, the American Society for Therapeutic Radiology and Oncology, and the Society of Surgical Oncology.

In an open-label, phase I, multicenter study, Dr. Tabernero and colleagues evaluated the efficacy of cetuximab (Erbitux) given either once a week or once every 2 weeks, in 52 patients with epidermal growth factor receptor (EGF-R)-expressing metastatic colorectal cancer. Cetuximab was administered as a single agent over a 6-week period, and then FOLFIRI (irinotecan/5-fluorouracil [5-FU]/folinic acid [FA]) was added to the regimen.

The researchers also determined KRAS status in tumor samples from 48 of the patients, and correlated this status with overall response and progression-free survival.

The patients had had no prior exposure to EGF-R-targeting therapy, no previous chemotherapy (including adjuvant therapy) for metastatic colorectal cancer within 6 months of study entry, and no surgery or radiation treatment within 4 weeks of study entry.

The results showed that cetuximab 500 mg/m

The 29 patients with wild-type KRAS tumors had an overall response rate of 28%, compared with 0% for the 19 patients with mutant KRAS tumors when cetuximab was given as single agent. Once FOLFIRI was added to cetuximab, patients with wild-type KRAS tumors had an overall response rate of 55%, compared with 32% for those with mutant KRAS tumors.

The median progression-free survival for patients with wild-type KRAS tumors was 9 months, compared with 6 months for patients with mutant KRAS tumors (hazard ratio 0.47).

“This is the first time that the predictive value of the KRAS status has been demonstrated in patients treated with cetuximab and chemotherapy in the first-line setting of patients with advanced colorectal cancer,” Dr. Tabernero said.

In another study presented at the meeting, KRAS status influenced clinical response to treatment with panitumumab (Vectibix) in patients with chemotherapy-refractory metastatic colorectal cancer.

In a phase III trial that randomized 463 patients to panitumumab plus best supportive care (n = 231) or best supportive care alone (n = 232), the benefit of panitumumab was confined to patients with wild-type KRAS tumors. Patients with mutant KRAS tumors showed no benefit, said Dr. Rafael G. Amado at a press briefing. Dr. Amado works for Amgen Inc., which makes panitumumab.

The median progression-free survival for the 124 patients with wild-type KRAS who were treated with panitumumab was 12 weeks, compared with 7 weeks for the 84 patients who had mutant KRAS. The median progression-free survival for patients randomized to best supportive care only was 7 weeks, regardless of KRAS status.

The response rate for wild-type KRAS patients treated with panitumumab was 17%, and 34% had stable disease. In contrast, the response rate for mutant KRAS patients treated with panitumumab was 0%, and 12% had stable disease.

The median overall survival was longer in patients with wild-type KRAS than in those with mutant KRAS tumors, regardless of treatment arm. The median survival of patients with wild-type KRAS tumors receiving panitumumab was 8 months, versus 5 months for those in the mutant KRAS group. In the best-supportive-care arm, the median survival for patients with wild-type and mutant KRAS tumors was 8 months and 4 months, respectively.

“Over 75% of patients in the best-supportive-care arm in both KRAS groups went on to receive panitumumab in a crossover protocol, which likely confounded the survival results,” Dr. Amado noted.

In an interview, he commented on the significance of his study's results. “These findings are important because, by testing for KRAS mutations, physicians may now be able to identify patients who are more likely to respond to panitumumab treatment and avoid unnecessary side effects, as well as expense, to those who are unlikely to respond.”

He added that being able to pinpoint subgroups of patients according to KRAS status or other biomarkers will become increasingly important for directing cancer treatment.

“The field of oncology will continue to undergo further segmentation as diseases are catalogued according to molecular alterations, and drugs will be developed to specifically interdict pathways that are active for specific categories of tumors within the same type of cancer.”

To date in the United States, no tests have been approved by the Food and Drug Administration for testing KRAS in tumor samples. The test used in the panitumumab study, called the DxS KRAS, has a CE marking (a mandatory conformity marking in the European market). Amgen is currently collaborating with the maker of the test, DxS Ltd., to guide this test through the regulatory process of the FDA, Dr. Amado said.

Dr. Tabernero disclosed that he is a consultant to and receives honoraria from several pharmaceutical companies, including Merck KGaA, which sponsored his study. Dr. Amado is an employee of Amgen and owns stock in the company.

'Clinicians should definitely start checking for KRAS status in their patients with advanced colorectal cancer.' DR. TABERNERO

ORLANDO — Colorectal cancer screening plays an important role in cancer prevention and detection, not just in the “young-old,” but also in the “old-old”—people in their eighties and beyond.

And if a cancer is found, the elderly can also derive considerable benefit from treatments including surgery and chemotherapy, two presenters said at a meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.

A retrospective review of 1,390 patients aged 80 years and older who were screened with colonoscopy at Mount Sinai Medical Center in Miami Beach during the last 26 years showed that the majority of cancers (74%) were caught at an early stage when they were treatable by surgery alone, Dr. Heloisa P. Soares said at the symposium, also sponsored by the AGA Institute, the American Society for Therapeutic Radiology and Oncology, and the Society of Surgical Oncology.

Treatment with chemotherapy for more advanced colon cancer was also beneficial in this elderly population, whose mean age at diagnosis was 85 years, Dr. Soares said.

In all, 98 patients received chemotherapy as part of their treatment. In patients with stage II colon cancer, chemotherapy resulted in a median overall survival of 75 months, compared with 46 months for patients treated with surgery alone. In stage III colon cancer, chemotherapy likewise improved survival, to 49 months vs. 25 months for surgery alone. However, in stage IV colon cancer, survival was similar: 9 months with and 8 months without chemotherapy.

“More than 70% of newly diagnosed colon cancer cases are in people older than 70 years. Screening in this population pays off, and so does chemotherapy, especially in the early stages,” Dr. Soares said.

In another study presented at the meeting, 161 metastatic colorectal cancer patients aged 80 years or older who were treated with bevacizumab (Avastin) and standard chemotherapy tolerated the regimen as well as their younger counterparts aged 65–79 years, and also had the same progression-free survival. After a median follow-up of 21 months, the median progression-free survival was 10 months for all patients, regardless of their age.

The only risk factors for poor outcome were poor performance status (defined as ECOG [Eastern Cooperative Oncology Group] performance status of grade 2 or greater) and a history of arterial thrombotic events.

These results, from the BRITE (Bevacizumab Regimens Investigation of Treatment Effects and Safety) prospective cohort study, show that advanced age in itself should not be considered a deterrent to treating patients, said Dr. Mark Kozloff of Ingalls Memorial Hospital, Harvey, Ill., and the University of Chicago.

BRITE's large cohort of elderly metastatic colorectal cancer patients offers a unique opportunity to analyze bevacizumab and chemotherapy treatment outcomes in a population that is poorly represented in clinical trials, he said in an interview.

“These were basically all comers, unselected patients with metastatic colorectal cancer who are age 65 and older, and just those patients that we encounter most often in our real-world clinical practices. So these data are reassuring,” he said.

Bevacizumab has been shown to prolong overall survival and progression-free survival when added to chemotherapy for metastatic colorectal cancer, but it is associated with an increase in arterial thromboembolic events.

Of 1,953 patients in the observational cohort, 896 patients were aged 65–74 years, 533 were aged 75–79 years, and the rest were aged 80 years or older.

There was a lower median overall survival for patients aged 80 years and older (16 months vs. 21 months for patients aged 65–74, and 20 months for patients aged 75–79) but this might be because of less aggressive treatment in this older cohort, Dr. Kozloff said.

Side effects with bevacizumab—such as gastrointestinal perforations, postoperative bleeding, delayed wound healing, and hypertension—were similar across all age groups.

Dr. Soares disclosed no conflicts of interest. Dr. Kozloff disclosed that he receives research funding from Genentech Inc. The BRITE study was sponsored by Genentech, which developed Avastin.

'Screening in this population pays off, and so does chemotherapy, especially in the early stages.' DR. SOARES

ORLANDO — Colorectal cancer screening plays an important role in cancer prevention and detection, not just in the “young-old,” but also in the “old-old”—people in their eighties and beyond.

And if a cancer is found, the elderly can also derive considerable benefit from treatments including surgery and chemotherapy, two presenters said at a meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.

A retrospective review of 1,390 patients aged 80 years and older who were screened with colonoscopy at Mount Sinai Medical Center in Miami Beach during the last 26 years showed that the majority of cancers (74%) were caught at an early stage when they were treatable by surgery alone, Dr. Heloisa P. Soares said at the symposium, also sponsored by the AGA Institute, the American Society for Therapeutic Radiology and Oncology, and the Society of Surgical Oncology.

Treatment with chemotherapy for more advanced colon cancer was also beneficial in this elderly population, whose mean age at diagnosis was 85 years, Dr. Soares said.

In all, 98 patients received chemotherapy as part of their treatment. In patients with stage II colon cancer, chemotherapy resulted in a median overall survival of 75 months, compared with 46 months for patients treated with surgery alone. In stage III colon cancer, chemotherapy likewise improved survival, to 49 months vs. 25 months for surgery alone. However, in stage IV colon cancer, survival was similar: 9 months with and 8 months without chemotherapy.

“More than 70% of newly diagnosed colon cancer cases are in people older than 70 years. Screening in this population pays off, and so does chemotherapy, especially in the early stages,” Dr. Soares said.

In another study presented at the meeting, 161 metastatic colorectal cancer patients aged 80 years or older who were treated with bevacizumab (Avastin) and standard chemotherapy tolerated the regimen as well as their younger counterparts aged 65–79 years, and also had the same progression-free survival. After a median follow-up of 21 months, the median progression-free survival was 10 months for all patients, regardless of their age.

The only risk factors for poor outcome were poor performance status (defined as ECOG [Eastern Cooperative Oncology Group] performance status of grade 2 or greater) and a history of arterial thrombotic events.

These results, from the BRITE (Bevacizumab Regimens Investigation of Treatment Effects and Safety) prospective cohort study, show that advanced age in itself should not be considered a deterrent to treating patients, said Dr. Mark Kozloff of Ingalls Memorial Hospital, Harvey, Ill., and the University of Chicago.

BRITE's large cohort of elderly metastatic colorectal cancer patients offers a unique opportunity to analyze bevacizumab and chemotherapy treatment outcomes in a population that is poorly represented in clinical trials, he said in an interview.

“These were basically all comers, unselected patients with metastatic colorectal cancer who are age 65 and older, and just those patients that we encounter most often in our real-world clinical practices. So these data are reassuring,” he said.

Bevacizumab has been shown to prolong overall survival and progression-free survival when added to chemotherapy for metastatic colorectal cancer, but it is associated with an increase in arterial thromboembolic events.

Of 1,953 patients in the observational cohort, 896 patients were aged 65–74 years, 533 were aged 75–79 years, and the rest were aged 80 years or older.

There was a lower median overall survival for patients aged 80 years and older (16 months vs. 21 months for patients aged 65–74, and 20 months for patients aged 75–79) but this might be because of less aggressive treatment in this older cohort, Dr. Kozloff said.

Side effects with bevacizumab—such as gastrointestinal perforations, postoperative bleeding, delayed wound healing, and hypertension—were similar across all age groups.

Dr. Soares disclosed no conflicts of interest. Dr. Kozloff disclosed that he receives research funding from Genentech Inc. The BRITE study was sponsored by Genentech, which developed Avastin.

'Screening in this population pays off, and so does chemotherapy, especially in the early stages.' DR. SOARES

ORLANDO — Colorectal cancer screening plays an important role in cancer prevention and detection, not just in the “young-old,” but also in the “old-old”—people in their eighties and beyond.

And if a cancer is found, the elderly can also derive considerable benefit from treatments including surgery and chemotherapy, two presenters said at a meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.

A retrospective review of 1,390 patients aged 80 years and older who were screened with colonoscopy at Mount Sinai Medical Center in Miami Beach during the last 26 years showed that the majority of cancers (74%) were caught at an early stage when they were treatable by surgery alone, Dr. Heloisa P. Soares said at the symposium, also sponsored by the AGA Institute, the American Society for Therapeutic Radiology and Oncology, and the Society of Surgical Oncology.

Treatment with chemotherapy for more advanced colon cancer was also beneficial in this elderly population, whose mean age at diagnosis was 85 years, Dr. Soares said.

In all, 98 patients received chemotherapy as part of their treatment. In patients with stage II colon cancer, chemotherapy resulted in a median overall survival of 75 months, compared with 46 months for patients treated with surgery alone. In stage III colon cancer, chemotherapy likewise improved survival, to 49 months vs. 25 months for surgery alone. However, in stage IV colon cancer, survival was similar: 9 months with and 8 months without chemotherapy.

“More than 70% of newly diagnosed colon cancer cases are in people older than 70 years. Screening in this population pays off, and so does chemotherapy, especially in the early stages,” Dr. Soares said.

In another study presented at the meeting, 161 metastatic colorectal cancer patients aged 80 years or older who were treated with bevacizumab (Avastin) and standard chemotherapy tolerated the regimen as well as their younger counterparts aged 65–79 years, and also had the same progression-free survival. After a median follow-up of 21 months, the median progression-free survival was 10 months for all patients, regardless of their age.

The only risk factors for poor outcome were poor performance status (defined as ECOG [Eastern Cooperative Oncology Group] performance status of grade 2 or greater) and a history of arterial thrombotic events.

These results, from the BRITE (Bevacizumab Regimens Investigation of Treatment Effects and Safety) prospective cohort study, show that advanced age in itself should not be considered a deterrent to treating patients, said Dr. Mark Kozloff of Ingalls Memorial Hospital, Harvey, Ill., and the University of Chicago.

BRITE's large cohort of elderly metastatic colorectal cancer patients offers a unique opportunity to analyze bevacizumab and chemotherapy treatment outcomes in a population that is poorly represented in clinical trials, he said in an interview.

“These were basically all comers, unselected patients with metastatic colorectal cancer who are age 65 and older, and just those patients that we encounter most often in our real-world clinical practices. So these data are reassuring,” he said.

Bevacizumab has been shown to prolong overall survival and progression-free survival when added to chemotherapy for metastatic colorectal cancer, but it is associated with an increase in arterial thromboembolic events.

Of 1,953 patients in the observational cohort, 896 patients were aged 65–74 years, 533 were aged 75–79 years, and the rest were aged 80 years or older.

There was a lower median overall survival for patients aged 80 years and older (16 months vs. 21 months for patients aged 65–74, and 20 months for patients aged 75–79) but this might be because of less aggressive treatment in this older cohort, Dr. Kozloff said.

Side effects with bevacizumab—such as gastrointestinal perforations, postoperative bleeding, delayed wound healing, and hypertension—were similar across all age groups.

Dr. Soares disclosed no conflicts of interest. Dr. Kozloff disclosed that he receives research funding from Genentech Inc. The BRITE study was sponsored by Genentech, which developed Avastin.

'Screening in this population pays off, and so does chemotherapy, especially in the early stages.' DR. SOARES

Treatment with desvenlafaxine succinate, an experimental nonhormonal therapy, continues to reduce the frequency and severity of moderate to severe hot flashes out to 26 weeks.

The drug, a selective serotonin norepinephrine reuptake inhibitor (SNRI), has already been shown to be effective in relieving this bothersome menopausal symptom in a 12-week trial, which was reported last year.

The current findings, from an extension of that trial, show that desvenlafaxine continues to be effective for more than 6 months, said Dr. Risa Kagan, professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, and a consultant for Wyeth, which developed the drug.

“This is good news for the many women who are bothered [by hot flashes] and who are looking for alternatives to estrogen or hormone replacement therapy,” she said in an interview.

In the continuation of the multicenter, randomized, double-blind, placebo-controlled trial, 541 women who had at least 50 moderate to severe hot flashes per week and who received 150 mg/day of desvenlafaxine maintained the significant reduction in the number of hot flashes they had achieved by week 12 of the trial (from 10 per day to 2 per day) for the duration of the 26-week study, she said at the annual meeting of the North American Menopause Society.

The improvement in hot flash frequency and severity was dose dependent. The 118 women who were randomized to desvenlafaxine 100 mg/day had a less robust decrease in hot flash frequency, and went from an average of 10 to 4 hot flashes per day by week 26. The 138 women who were randomized to placebo also saw a reduction in their hot flashes from baseline, from an average of 10 to 6 per day.

The women recorded their hot flash episodes in diaries and were assessed weekly for the first 12 months, and then every 3 weeks thereafter.

The reductions from baseline in the frequency of moderate to severe hot flashes “were significantly greater, compared with placebo, at all time points with desvenlafaxine 150 mg and at most time points with desvenlafaxine 100 mg throughout the 26 weeks of the study,” Dr. Kagan said.

The most common adverse event was nausea, which was mild to moderate and improved with time. “Nausea is not unique to this agent, and is something that is associated with many of this category of drugs. However, it was responsible for about 12.7% of the desvenlafaxine subjects' withdrawing from the study,” she said.

Fluctuations and the eventual decline in estrogen levels during menopause may cause alterations in brain serotonin and norepinephrine transmitter levels, which may in turn produce instability in thermoregulatory function and, as a result, hot flashes, Dr. Kagan explained. “The hope is that drugs like desvenlafaxine, which act on these transmitters, may provide nonhormonal relief of menopausal vasomotor symptoms.”

Treatment with desvenlafaxine succinate, an experimental nonhormonal therapy, continues to reduce the frequency and severity of moderate to severe hot flashes out to 26 weeks.

The drug, a selective serotonin norepinephrine reuptake inhibitor (SNRI), has already been shown to be effective in relieving this bothersome menopausal symptom in a 12-week trial, which was reported last year.

The current findings, from an extension of that trial, show that desvenlafaxine continues to be effective for more than 6 months, said Dr. Risa Kagan, professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, and a consultant for Wyeth, which developed the drug.

“This is good news for the many women who are bothered [by hot flashes] and who are looking for alternatives to estrogen or hormone replacement therapy,” she said in an interview.

In the continuation of the multicenter, randomized, double-blind, placebo-controlled trial, 541 women who had at least 50 moderate to severe hot flashes per week and who received 150 mg/day of desvenlafaxine maintained the significant reduction in the number of hot flashes they had achieved by week 12 of the trial (from 10 per day to 2 per day) for the duration of the 26-week study, she said at the annual meeting of the North American Menopause Society.

The improvement in hot flash frequency and severity was dose dependent. The 118 women who were randomized to desvenlafaxine 100 mg/day had a less robust decrease in hot flash frequency, and went from an average of 10 to 4 hot flashes per day by week 26. The 138 women who were randomized to placebo also saw a reduction in their hot flashes from baseline, from an average of 10 to 6 per day.

The women recorded their hot flash episodes in diaries and were assessed weekly for the first 12 months, and then every 3 weeks thereafter.

The reductions from baseline in the frequency of moderate to severe hot flashes “were significantly greater, compared with placebo, at all time points with desvenlafaxine 150 mg and at most time points with desvenlafaxine 100 mg throughout the 26 weeks of the study,” Dr. Kagan said.

The most common adverse event was nausea, which was mild to moderate and improved with time. “Nausea is not unique to this agent, and is something that is associated with many of this category of drugs. However, it was responsible for about 12.7% of the desvenlafaxine subjects' withdrawing from the study,” she said.

Fluctuations and the eventual decline in estrogen levels during menopause may cause alterations in brain serotonin and norepinephrine transmitter levels, which may in turn produce instability in thermoregulatory function and, as a result, hot flashes, Dr. Kagan explained. “The hope is that drugs like desvenlafaxine, which act on these transmitters, may provide nonhormonal relief of menopausal vasomotor symptoms.”

Treatment with desvenlafaxine succinate, an experimental nonhormonal therapy, continues to reduce the frequency and severity of moderate to severe hot flashes out to 26 weeks.

The drug, a selective serotonin norepinephrine reuptake inhibitor (SNRI), has already been shown to be effective in relieving this bothersome menopausal symptom in a 12-week trial, which was reported last year.

The current findings, from an extension of that trial, show that desvenlafaxine continues to be effective for more than 6 months, said Dr. Risa Kagan, professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, and a consultant for Wyeth, which developed the drug.

“This is good news for the many women who are bothered [by hot flashes] and who are looking for alternatives to estrogen or hormone replacement therapy,” she said in an interview.

In the continuation of the multicenter, randomized, double-blind, placebo-controlled trial, 541 women who had at least 50 moderate to severe hot flashes per week and who received 150 mg/day of desvenlafaxine maintained the significant reduction in the number of hot flashes they had achieved by week 12 of the trial (from 10 per day to 2 per day) for the duration of the 26-week study, she said at the annual meeting of the North American Menopause Society.

The improvement in hot flash frequency and severity was dose dependent. The 118 women who were randomized to desvenlafaxine 100 mg/day had a less robust decrease in hot flash frequency, and went from an average of 10 to 4 hot flashes per day by week 26. The 138 women who were randomized to placebo also saw a reduction in their hot flashes from baseline, from an average of 10 to 6 per day.

The women recorded their hot flash episodes in diaries and were assessed weekly for the first 12 months, and then every 3 weeks thereafter.

The reductions from baseline in the frequency of moderate to severe hot flashes “were significantly greater, compared with placebo, at all time points with desvenlafaxine 150 mg and at most time points with desvenlafaxine 100 mg throughout the 26 weeks of the study,” Dr. Kagan said.

The most common adverse event was nausea, which was mild to moderate and improved with time. “Nausea is not unique to this agent, and is something that is associated with many of this category of drugs. However, it was responsible for about 12.7% of the desvenlafaxine subjects' withdrawing from the study,” she said.

Fluctuations and the eventual decline in estrogen levels during menopause may cause alterations in brain serotonin and norepinephrine transmitter levels, which may in turn produce instability in thermoregulatory function and, as a result, hot flashes, Dr. Kagan explained. “The hope is that drugs like desvenlafaxine, which act on these transmitters, may provide nonhormonal relief of menopausal vasomotor symptoms.”

Severely obese individuals who opt to have gastric bypass surgery not only reduce their waistlines, they reduce their long-term total mortality as well, Utah researchers have reported.

Rates of death from diabetes, coronary artery disease, and cancer were all significantly lower in 7,925 patients who underwent gastric bypass between 1984 and 2002, Ted D. Adams, Ph.D., and his associates wrote.

Compared with a group of similarly obese control subjects who did not have the surgery, the gastric bypass group had a statistically significant, 40% decrease in adjusted long-term mortality from any cause during the mean follow-up of 7.1 years (37.6 vs. 57.1 deaths/10,000 person-years, P less than .001).

Deaths from coronary artery disease decreased by 56% (2.6 vs. 5.9/10,000 person-years, P = .006); deaths from diabetes were reduced by 92% (0.4 vs. 3.4/10,000 person-years, P = .005), and deaths from cancer dropped by 60% (5.5 vs. 13.3/10,000 person-years, P less than .001).

However, the rate of death from all nondisease causes, such as accidents and suicides, was 58% higher in the surgery group than in the control group, wrote Dr. Adams, professor in the division of cardiovascular genetics at the University of Utah, Salt Lake City, and his associates (N. Engl. J. Med. 2007;357:753–61).

The retrospective cohort study compared long-term mortality among severely obese men and women who had chosen gastric bypass surgery with that of an equal number (7,925) of severely obese persons who had applied for driver's licenses in the state of Utah. The two groups were matched for age, gender, and body mass index. The rates of death from any cause and from specific causes were determined with the use of the National Death Index.

Dr. Adams said that the reduced mortality from disease likely is related to the improvements in health that follow significant weight loss, such as reduced blood pressure, lower diabetes and coronary artery disease risk, and reduced sleep apnea. Dr. Adams also is a program director at the Health and Fitness Institute at Latter Day Saints Hospital, Salt Lake City.

When asked what he thought might be the reason for the higher rate of nondisease deaths in the bariatric surgery group, he commented that it was difficult to know. “We don't have any information about patients' psychosocial makeup or anything like that. There have been suggestions that some individuals who have undergone gastric bypass surgery may go on to increase their intake of alcohol.”

He also suggested that the significant weight loss associated with bariatric surgery may lead patients to become more physically active, and thus at greater exposure to accidents. “Patients lose, on average, more than 100 pounds.”

The finding that cancer deaths were lower after bypass surgery was a surprise, especially because this occurred within the relatively short time frame of 7.1 years, Dr. Adams said.

“This reduction persisted even after we excluded prevalent cancers and deaths from cancer occurring within 5 years after baseline. It really interested us that in such a short period of time we would see such a dramatic reduction in cancer.”

ELSEVIER GLOBAL MEDICAL NEWS

Severely obese individuals who opt to have gastric bypass surgery not only reduce their waistlines, they reduce their long-term total mortality as well, Utah researchers have reported.

Rates of death from diabetes, coronary artery disease, and cancer were all significantly lower in 7,925 patients who underwent gastric bypass between 1984 and 2002, Ted D. Adams, Ph.D., and his associates wrote.

Compared with a group of similarly obese control subjects who did not have the surgery, the gastric bypass group had a statistically significant, 40% decrease in adjusted long-term mortality from any cause during the mean follow-up of 7.1 years (37.6 vs. 57.1 deaths/10,000 person-years, P less than .001).

Deaths from coronary artery disease decreased by 56% (2.6 vs. 5.9/10,000 person-years, P = .006); deaths from diabetes were reduced by 92% (0.4 vs. 3.4/10,000 person-years, P = .005), and deaths from cancer dropped by 60% (5.5 vs. 13.3/10,000 person-years, P less than .001).

However, the rate of death from all nondisease causes, such as accidents and suicides, was 58% higher in the surgery group than in the control group, wrote Dr. Adams, professor in the division of cardiovascular genetics at the University of Utah, Salt Lake City, and his associates (N. Engl. J. Med. 2007;357:753–61).

The retrospective cohort study compared long-term mortality among severely obese men and women who had chosen gastric bypass surgery with that of an equal number (7,925) of severely obese persons who had applied for driver's licenses in the state of Utah. The two groups were matched for age, gender, and body mass index. The rates of death from any cause and from specific causes were determined with the use of the National Death Index.

Dr. Adams said that the reduced mortality from disease likely is related to the improvements in health that follow significant weight loss, such as reduced blood pressure, lower diabetes and coronary artery disease risk, and reduced sleep apnea. Dr. Adams also is a program director at the Health and Fitness Institute at Latter Day Saints Hospital, Salt Lake City.

When asked what he thought might be the reason for the higher rate of nondisease deaths in the bariatric surgery group, he commented that it was difficult to know. “We don't have any information about patients' psychosocial makeup or anything like that. There have been suggestions that some individuals who have undergone gastric bypass surgery may go on to increase their intake of alcohol.”

He also suggested that the significant weight loss associated with bariatric surgery may lead patients to become more physically active, and thus at greater exposure to accidents. “Patients lose, on average, more than 100 pounds.”

The finding that cancer deaths were lower after bypass surgery was a surprise, especially because this occurred within the relatively short time frame of 7.1 years, Dr. Adams said.

“This reduction persisted even after we excluded prevalent cancers and deaths from cancer occurring within 5 years after baseline. It really interested us that in such a short period of time we would see such a dramatic reduction in cancer.”

ELSEVIER GLOBAL MEDICAL NEWS

Severely obese individuals who opt to have gastric bypass surgery not only reduce their waistlines, they reduce their long-term total mortality as well, Utah researchers have reported.

Rates of death from diabetes, coronary artery disease, and cancer were all significantly lower in 7,925 patients who underwent gastric bypass between 1984 and 2002, Ted D. Adams, Ph.D., and his associates wrote.

Compared with a group of similarly obese control subjects who did not have the surgery, the gastric bypass group had a statistically significant, 40% decrease in adjusted long-term mortality from any cause during the mean follow-up of 7.1 years (37.6 vs. 57.1 deaths/10,000 person-years, P less than .001).

Deaths from coronary artery disease decreased by 56% (2.6 vs. 5.9/10,000 person-years, P = .006); deaths from diabetes were reduced by 92% (0.4 vs. 3.4/10,000 person-years, P = .005), and deaths from cancer dropped by 60% (5.5 vs. 13.3/10,000 person-years, P less than .001).

However, the rate of death from all nondisease causes, such as accidents and suicides, was 58% higher in the surgery group than in the control group, wrote Dr. Adams, professor in the division of cardiovascular genetics at the University of Utah, Salt Lake City, and his associates (N. Engl. J. Med. 2007;357:753–61).

The retrospective cohort study compared long-term mortality among severely obese men and women who had chosen gastric bypass surgery with that of an equal number (7,925) of severely obese persons who had applied for driver's licenses in the state of Utah. The two groups were matched for age, gender, and body mass index. The rates of death from any cause and from specific causes were determined with the use of the National Death Index.

Dr. Adams said that the reduced mortality from disease likely is related to the improvements in health that follow significant weight loss, such as reduced blood pressure, lower diabetes and coronary artery disease risk, and reduced sleep apnea. Dr. Adams also is a program director at the Health and Fitness Institute at Latter Day Saints Hospital, Salt Lake City.

When asked what he thought might be the reason for the higher rate of nondisease deaths in the bariatric surgery group, he commented that it was difficult to know. “We don't have any information about patients' psychosocial makeup or anything like that. There have been suggestions that some individuals who have undergone gastric bypass surgery may go on to increase their intake of alcohol.”

He also suggested that the significant weight loss associated with bariatric surgery may lead patients to become more physically active, and thus at greater exposure to accidents. “Patients lose, on average, more than 100 pounds.”

The finding that cancer deaths were lower after bypass surgery was a surprise, especially because this occurred within the relatively short time frame of 7.1 years, Dr. Adams said.

“This reduction persisted even after we excluded prevalent cancers and deaths from cancer occurring within 5 years after baseline. It really interested us that in such a short period of time we would see such a dramatic reduction in cancer.”

ELSEVIER GLOBAL MEDICAL NEWS

An extract derived from the roots of the rhubarb plant has been shown in a randomized, placebo-controlled trial to provide relief of vasomotor symptoms in peri- and postmenopausal women, Dr. David S. Riley said at the annual meeting of the North American Menopause Society.

The trial, which was conducted at University Hospital, Frankfurt, Germany, showed that women who consumed one tablet containing 4 mg of the extract Rheum rhaponticum, or ERr 731, every day for 12 weeks had a significant reduction in the number and severity of hot flashes, compared with women who took placebo.

Although ERr 731 has been available in Germany for several years, it is still relatively unknown on this side of the Atlantic, Dr. Riley of the University of New Mexico, Albuquerque, explained in a telephone interview.

As a consultant to the German researchers, he said he thought it would be interesting to present their data to clinicians in the United States.

“This is a substance that has been on the market in Germany since 1993, and the research was done in order to reregister it as an herbal medication,” said Dr. Riley, who also is editor in chief of Explore, The Journal of Science and Healing.

Hormone therapy, the standard for relieving vasomotor symptoms of menopause, can have unwanted side effects; other therapies, which do not have troublesome side effects, are of questionable efficacy, he said.

In this study, 112 perimenopausal women were randomized to 4 mg/day of ERr 731 or to placebo for 12 weeks.

At the beginning of the trial, all of the women had a menopause rating scale (MRS) score of at least 18, which meant that their menopausal symptoms were moderate to severe.

Factors that were rated in the MRS score included hot flashes and sweating, heart complaints, sleep disturbances, depressive mood, irritability, anxiety, physical and mental exhaustion, sexual problems, urinary tract complaints, vaginal dryness, and joint and muscle complaints.

The women rated their symptoms on a scale from 0 (no symptoms) to 4 (very severe symptoms). The maximum obtainable MRS score was 44 points, Dr. Riley explained.

After 12 weeks of treatment, there was a significant reduction in MRS score in the women taking the extract; 46 of the 56 (82%) women randomized to ERr 731 had a decrease of at least 10 points in their MRS score, compared with 2 (4%) of the women randomized to placebo.

Taking ERr 731 was associated with a significant reduction in hot flashes, compared with placebo, from 11 per day at baseline, to 4 per day at 12 weeks, Dr. Riley said.

The compound was safe and was associated with no breast tenderness or increase in endometrial thickness as assessed on ultrasound and biopsies, no changes in liver enzymes, no changes in blood pressure, no changes in weight, no increase in estradiol or progesterone, and no enhanced bone turnover, Dr. Riley added.

“Women are looking for safe and natural alternatives to hormones to relieve their menopausal symptoms, especially hot flashes, which appear to be the most annoying. This compound is exciting and shows promise, and hopefully we can generate some interest on this side of the Atlantic,” he said.

An extract derived from the roots of the Rheum rhaponticum, shown here, has been on the market in Europe since 1993 but is not well known in the U.S. Courtesy Mueller-Goeppingen

An extract derived from the roots of the rhubarb plant has been shown in a randomized, placebo-controlled trial to provide relief of vasomotor symptoms in peri- and postmenopausal women, Dr. David S. Riley said at the annual meeting of the North American Menopause Society.

The trial, which was conducted at University Hospital, Frankfurt, Germany, showed that women who consumed one tablet containing 4 mg of the extract Rheum rhaponticum, or ERr 731, every day for 12 weeks had a significant reduction in the number and severity of hot flashes, compared with women who took placebo.

Although ERr 731 has been available in Germany for several years, it is still relatively unknown on this side of the Atlantic, Dr. Riley of the University of New Mexico, Albuquerque, explained in a telephone interview.

As a consultant to the German researchers, he said he thought it would be interesting to present their data to clinicians in the United States.

“This is a substance that has been on the market in Germany since 1993, and the research was done in order to reregister it as an herbal medication,” said Dr. Riley, who also is editor in chief of Explore, The Journal of Science and Healing.

Hormone therapy, the standard for relieving vasomotor symptoms of menopause, can have unwanted side effects; other therapies, which do not have troublesome side effects, are of questionable efficacy, he said.

In this study, 112 perimenopausal women were randomized to 4 mg/day of ERr 731 or to placebo for 12 weeks.

At the beginning of the trial, all of the women had a menopause rating scale (MRS) score of at least 18, which meant that their menopausal symptoms were moderate to severe.

Factors that were rated in the MRS score included hot flashes and sweating, heart complaints, sleep disturbances, depressive mood, irritability, anxiety, physical and mental exhaustion, sexual problems, urinary tract complaints, vaginal dryness, and joint and muscle complaints.

The women rated their symptoms on a scale from 0 (no symptoms) to 4 (very severe symptoms). The maximum obtainable MRS score was 44 points, Dr. Riley explained.

After 12 weeks of treatment, there was a significant reduction in MRS score in the women taking the extract; 46 of the 56 (82%) women randomized to ERr 731 had a decrease of at least 10 points in their MRS score, compared with 2 (4%) of the women randomized to placebo.

Taking ERr 731 was associated with a significant reduction in hot flashes, compared with placebo, from 11 per day at baseline, to 4 per day at 12 weeks, Dr. Riley said.

The compound was safe and was associated with no breast tenderness or increase in endometrial thickness as assessed on ultrasound and biopsies, no changes in liver enzymes, no changes in blood pressure, no changes in weight, no increase in estradiol or progesterone, and no enhanced bone turnover, Dr. Riley added.

“Women are looking for safe and natural alternatives to hormones to relieve their menopausal symptoms, especially hot flashes, which appear to be the most annoying. This compound is exciting and shows promise, and hopefully we can generate some interest on this side of the Atlantic,” he said.

An extract derived from the roots of the Rheum rhaponticum, shown here, has been on the market in Europe since 1993 but is not well known in the U.S. Courtesy Mueller-Goeppingen

An extract derived from the roots of the rhubarb plant has been shown in a randomized, placebo-controlled trial to provide relief of vasomotor symptoms in peri- and postmenopausal women, Dr. David S. Riley said at the annual meeting of the North American Menopause Society.

The trial, which was conducted at University Hospital, Frankfurt, Germany, showed that women who consumed one tablet containing 4 mg of the extract Rheum rhaponticum, or ERr 731, every day for 12 weeks had a significant reduction in the number and severity of hot flashes, compared with women who took placebo.

Although ERr 731 has been available in Germany for several years, it is still relatively unknown on this side of the Atlantic, Dr. Riley of the University of New Mexico, Albuquerque, explained in a telephone interview.

As a consultant to the German researchers, he said he thought it would be interesting to present their data to clinicians in the United States.

“This is a substance that has been on the market in Germany since 1993, and the research was done in order to reregister it as an herbal medication,” said Dr. Riley, who also is editor in chief of Explore, The Journal of Science and Healing.

Hormone therapy, the standard for relieving vasomotor symptoms of menopause, can have unwanted side effects; other therapies, which do not have troublesome side effects, are of questionable efficacy, he said.

In this study, 112 perimenopausal women were randomized to 4 mg/day of ERr 731 or to placebo for 12 weeks.

At the beginning of the trial, all of the women had a menopause rating scale (MRS) score of at least 18, which meant that their menopausal symptoms were moderate to severe.

Factors that were rated in the MRS score included hot flashes and sweating, heart complaints, sleep disturbances, depressive mood, irritability, anxiety, physical and mental exhaustion, sexual problems, urinary tract complaints, vaginal dryness, and joint and muscle complaints.

The women rated their symptoms on a scale from 0 (no symptoms) to 4 (very severe symptoms). The maximum obtainable MRS score was 44 points, Dr. Riley explained.

After 12 weeks of treatment, there was a significant reduction in MRS score in the women taking the extract; 46 of the 56 (82%) women randomized to ERr 731 had a decrease of at least 10 points in their MRS score, compared with 2 (4%) of the women randomized to placebo.

Taking ERr 731 was associated with a significant reduction in hot flashes, compared with placebo, from 11 per day at baseline, to 4 per day at 12 weeks, Dr. Riley said.

The compound was safe and was associated with no breast tenderness or increase in endometrial thickness as assessed on ultrasound and biopsies, no changes in liver enzymes, no changes in blood pressure, no changes in weight, no increase in estradiol or progesterone, and no enhanced bone turnover, Dr. Riley added.

“Women are looking for safe and natural alternatives to hormones to relieve their menopausal symptoms, especially hot flashes, which appear to be the most annoying. This compound is exciting and shows promise, and hopefully we can generate some interest on this side of the Atlantic,” he said.

An extract derived from the roots of the Rheum rhaponticum, shown here, has been on the market in Europe since 1993 but is not well known in the U.S. Courtesy Mueller-Goeppingen

NEW ORLEANS — In a patient with a body mass index of 40 kg/m

In fact, said Dr. Nana Gletsu Miller, measuring waist circumference in such individuals is difficult, impractical, and does not provide a good measure of intra-abdominal fat stores, which is the fat that is more detrimental to health.

Dr. Gletsu Miller, of Emory University, Atlanta, showed measuring sagittal abdominal diameter while patients were in a supine position provided information that was more predictive of changes in insulin resistance and other cardiometabolic risk factors during weight loss than did waist circumference measured when the patient was standing up.

The 30 severely obese female patients were assessed at baseline, 1 month, and 6 months after Roux-en-Y gastric bypass or adjustable banding surgery for weight loss. Fifteen of the women also were assessed at 24 months postsurgery.

Visceral and subcutaneous adipose tissue volumes were determined using computed tomography. The height of the abdominal region was measured with a sliding-beam caliper, and waist circumference was measured at the iliac crest with a tape measure.

Other measures included hepatic insulin sensitivity, which was determined using the homeostatic model assessment of insulin resistance index that measures fasting glucose and insulin concentrations, along with the following indicators of cardiometabolic risk: systolic blood pressure, fasting LDL cholesterol, triglycerides, and high-sensitivity C-reactive protein.

All of the subjects exhibited significant decreases in general and abdominal adiposity, sagittal abdominal diameter, waist circumference, and visceral and subcutaneous fat volumes. They also improved measures of cardiometabolic risk, Dr. Gletsu Miller said.

However, as the severely obese subjects experienced weight loss over 6 months, changes in saggital abdominal diameter accounted for 15% of the changes in intra-abdominal fat volumes, whereas changes in waist circumference did not significantly explain these changes, she said.

Dr. Gletsu Miller said more studies need to be done to determine a cutoff value that will best predict insulin resistance and other risk factors in severely obese patients.

NEW ORLEANS — In a patient with a body mass index of 40 kg/m

In fact, said Dr. Nana Gletsu Miller, measuring waist circumference in such individuals is difficult, impractical, and does not provide a good measure of intra-abdominal fat stores, which is the fat that is more detrimental to health.

Dr. Gletsu Miller, of Emory University, Atlanta, showed measuring sagittal abdominal diameter while patients were in a supine position provided information that was more predictive of changes in insulin resistance and other cardiometabolic risk factors during weight loss than did waist circumference measured when the patient was standing up.

The 30 severely obese female patients were assessed at baseline, 1 month, and 6 months after Roux-en-Y gastric bypass or adjustable banding surgery for weight loss. Fifteen of the women also were assessed at 24 months postsurgery.

Visceral and subcutaneous adipose tissue volumes were determined using computed tomography. The height of the abdominal region was measured with a sliding-beam caliper, and waist circumference was measured at the iliac crest with a tape measure.

Other measures included hepatic insulin sensitivity, which was determined using the homeostatic model assessment of insulin resistance index that measures fasting glucose and insulin concentrations, along with the following indicators of cardiometabolic risk: systolic blood pressure, fasting LDL cholesterol, triglycerides, and high-sensitivity C-reactive protein.

All of the subjects exhibited significant decreases in general and abdominal adiposity, sagittal abdominal diameter, waist circumference, and visceral and subcutaneous fat volumes. They also improved measures of cardiometabolic risk, Dr. Gletsu Miller said.

However, as the severely obese subjects experienced weight loss over 6 months, changes in saggital abdominal diameter accounted for 15% of the changes in intra-abdominal fat volumes, whereas changes in waist circumference did not significantly explain these changes, she said.

Dr. Gletsu Miller said more studies need to be done to determine a cutoff value that will best predict insulin resistance and other risk factors in severely obese patients.

NEW ORLEANS — In a patient with a body mass index of 40 kg/m

In fact, said Dr. Nana Gletsu Miller, measuring waist circumference in such individuals is difficult, impractical, and does not provide a good measure of intra-abdominal fat stores, which is the fat that is more detrimental to health.

Dr. Gletsu Miller, of Emory University, Atlanta, showed measuring sagittal abdominal diameter while patients were in a supine position provided information that was more predictive of changes in insulin resistance and other cardiometabolic risk factors during weight loss than did waist circumference measured when the patient was standing up.

The 30 severely obese female patients were assessed at baseline, 1 month, and 6 months after Roux-en-Y gastric bypass or adjustable banding surgery for weight loss. Fifteen of the women also were assessed at 24 months postsurgery.

Visceral and subcutaneous adipose tissue volumes were determined using computed tomography. The height of the abdominal region was measured with a sliding-beam caliper, and waist circumference was measured at the iliac crest with a tape measure.

Other measures included hepatic insulin sensitivity, which was determined using the homeostatic model assessment of insulin resistance index that measures fasting glucose and insulin concentrations, along with the following indicators of cardiometabolic risk: systolic blood pressure, fasting LDL cholesterol, triglycerides, and high-sensitivity C-reactive protein.

All of the subjects exhibited significant decreases in general and abdominal adiposity, sagittal abdominal diameter, waist circumference, and visceral and subcutaneous fat volumes. They also improved measures of cardiometabolic risk, Dr. Gletsu Miller said.

However, as the severely obese subjects experienced weight loss over 6 months, changes in saggital abdominal diameter accounted for 15% of the changes in intra-abdominal fat volumes, whereas changes in waist circumference did not significantly explain these changes, she said.

Dr. Gletsu Miller said more studies need to be done to determine a cutoff value that will best predict insulin resistance and other risk factors in severely obese patients.

NEW ORLEANS — Extremely obese individuals who lost weight and kept it off for at least 1 year significantly improved their vascular endothelial function, Dr. Noyan Gokce reported in a poster at the annual meeting of NAASO, the Obesity Society.

Arterial flow-mediated dilation rose by 3.2% in those who lost weight, but deteriorated by 1.1% in those whose weight increased or stayed the same, Dr. Gokce, a cardiologist at Boston Medical Center, said in an interview. Patients who lost weight also reduced their cholesterol and glucose levels.

Dr. Gokce and a colleague, recruited 39 consecutive subjects aged 34–58 years with a body mass index range of 36 kg/m

They measured the patients' arterial function, blood glucose, and cholesterol levels at baseline and at 12 months, and compared the results of those who lost weight with the results of those who gained weight or whose weight stayed the same. Of the total, 27 achieved successful weight loss, defined as a loss of at least 10% of body weight from baseline to 12-month follow-up, and 12 lost no weight or gained weight during the same period.

The weight-loss group showed a significant increase in flow-mediated dilation. At baseline, the mean flow-mediated dilation was impaired at 6.9% and 6.4% in weight-loss and no-weight-loss/weight-gain subjects, respectively. At 12 months, the mean flow-mediated dilation increased to 10.1% in weight-loss subjects and decreased slightly, to 5.3%, in the other group.

In addition, in those who lost weight, mean blood glucose decreased by 27 mg/dL, total cholesterol fell by 13 mg/dL, and mean triglyceride levels fell by 32 mg/dL. In those who gained or maintained their weight, mean blood glucose increased by 15 mg/dL, total cholesterol increased by 29 mg/dL, and mean triglyceride levels rose by 10 mg/dL.

NEW ORLEANS — Extremely obese individuals who lost weight and kept it off for at least 1 year significantly improved their vascular endothelial function, Dr. Noyan Gokce reported in a poster at the annual meeting of NAASO, the Obesity Society.

Arterial flow-mediated dilation rose by 3.2% in those who lost weight, but deteriorated by 1.1% in those whose weight increased or stayed the same, Dr. Gokce, a cardiologist at Boston Medical Center, said in an interview. Patients who lost weight also reduced their cholesterol and glucose levels.

Dr. Gokce and a colleague, recruited 39 consecutive subjects aged 34–58 years with a body mass index range of 36 kg/m

They measured the patients' arterial function, blood glucose, and cholesterol levels at baseline and at 12 months, and compared the results of those who lost weight with the results of those who gained weight or whose weight stayed the same. Of the total, 27 achieved successful weight loss, defined as a loss of at least 10% of body weight from baseline to 12-month follow-up, and 12 lost no weight or gained weight during the same period.

The weight-loss group showed a significant increase in flow-mediated dilation. At baseline, the mean flow-mediated dilation was impaired at 6.9% and 6.4% in weight-loss and no-weight-loss/weight-gain subjects, respectively. At 12 months, the mean flow-mediated dilation increased to 10.1% in weight-loss subjects and decreased slightly, to 5.3%, in the other group.

In addition, in those who lost weight, mean blood glucose decreased by 27 mg/dL, total cholesterol fell by 13 mg/dL, and mean triglyceride levels fell by 32 mg/dL. In those who gained or maintained their weight, mean blood glucose increased by 15 mg/dL, total cholesterol increased by 29 mg/dL, and mean triglyceride levels rose by 10 mg/dL.

NEW ORLEANS — Extremely obese individuals who lost weight and kept it off for at least 1 year significantly improved their vascular endothelial function, Dr. Noyan Gokce reported in a poster at the annual meeting of NAASO, the Obesity Society.

Arterial flow-mediated dilation rose by 3.2% in those who lost weight, but deteriorated by 1.1% in those whose weight increased or stayed the same, Dr. Gokce, a cardiologist at Boston Medical Center, said in an interview. Patients who lost weight also reduced their cholesterol and glucose levels.

Dr. Gokce and a colleague, recruited 39 consecutive subjects aged 34–58 years with a body mass index range of 36 kg/m

They measured the patients' arterial function, blood glucose, and cholesterol levels at baseline and at 12 months, and compared the results of those who lost weight with the results of those who gained weight or whose weight stayed the same. Of the total, 27 achieved successful weight loss, defined as a loss of at least 10% of body weight from baseline to 12-month follow-up, and 12 lost no weight or gained weight during the same period.

The weight-loss group showed a significant increase in flow-mediated dilation. At baseline, the mean flow-mediated dilation was impaired at 6.9% and 6.4% in weight-loss and no-weight-loss/weight-gain subjects, respectively. At 12 months, the mean flow-mediated dilation increased to 10.1% in weight-loss subjects and decreased slightly, to 5.3%, in the other group.

In addition, in those who lost weight, mean blood glucose decreased by 27 mg/dL, total cholesterol fell by 13 mg/dL, and mean triglyceride levels fell by 32 mg/dL. In those who gained or maintained their weight, mean blood glucose increased by 15 mg/dL, total cholesterol increased by 29 mg/dL, and mean triglyceride levels rose by 10 mg/dL.

NEW ORLEANS — The fat that surrounds the heart is associated with cardiac abnormalities, including low stroke volume and cardiac output, that are independent of body mass index, a study has found.

The finding casts doubt on the widespread practice of using body mass index (BMI) as an indicator of cardiovascular disease risk, Dr. Zhongjing Chen, of Boston University, said at the annual meeting of NAASO, the Obesity Society.

Dr. Chen and colleagues assessed 13 obese women (average age 47 years) with metabolic syndrome—but no recognized atherosclerosis—using MRI.

The women had a BMI of 30 kg/m

“The limit for weight was 275 pounds, and for waist circumference 50 inches, because of the table weight and size limits of our scanner,” Dr. Chen said.

The researchers used special software developed by Boston University's Center for Biomedical Imaging to calculate epicardial and periaortic fat and then analyzed stroke volume, end diastolic wall mass, and ejection fraction, as well as flow volume and peak blood velocity.

Both stroke volume and cardiac output were negatively correlated with epicardial and periaortic fat, and this negative correlation was statistically significant. Ascending aorta compliance also worsened in the presence of epicardial and periaortic fat.

However, there were no correlations between stroke volume, cardiac output, or ascending aorta compliance and the subjects' BMI, Dr. Chen said.

“The major morbidities associated with metabolic syndrome are myocardial infarction and stroke. People have been correlating body mass index with these risks, but our results indicate that it's the fat stores around the heart that are important risk factors,” she said in an interview.

Dr. Chen added that MRI is noninvasive and therefore provides an excellent way of measuring epicardial fat and cardiovascular disease risk. “Epicardial and periaortic fat can be directly detected and quantified with MRI to give us a good reading of cardiac function and vessel wall properties. We would like to see whether reducing those fat depots is associated with improvements in cardiac or vascular function. More studies are needed,” she said.

Epicardial fat tissues appear bright on MRI of woman with a BMI of 44 kg/m

Despite her lower BMI of 34 kg/m

NEW ORLEANS — The fat that surrounds the heart is associated with cardiac abnormalities, including low stroke volume and cardiac output, that are independent of body mass index, a study has found.

The finding casts doubt on the widespread practice of using body mass index (BMI) as an indicator of cardiovascular disease risk, Dr. Zhongjing Chen, of Boston University, said at the annual meeting of NAASO, the Obesity Society.

Dr. Chen and colleagues assessed 13 obese women (average age 47 years) with metabolic syndrome—but no recognized atherosclerosis—using MRI.

The women had a BMI of 30 kg/m

“The limit for weight was 275 pounds, and for waist circumference 50 inches, because of the table weight and size limits of our scanner,” Dr. Chen said.

The researchers used special software developed by Boston University's Center for Biomedical Imaging to calculate epicardial and periaortic fat and then analyzed stroke volume, end diastolic wall mass, and ejection fraction, as well as flow volume and peak blood velocity.

Both stroke volume and cardiac output were negatively correlated with epicardial and periaortic fat, and this negative correlation was statistically significant. Ascending aorta compliance also worsened in the presence of epicardial and periaortic fat.

However, there were no correlations between stroke volume, cardiac output, or ascending aorta compliance and the subjects' BMI, Dr. Chen said.

“The major morbidities associated with metabolic syndrome are myocardial infarction and stroke. People have been correlating body mass index with these risks, but our results indicate that it's the fat stores around the heart that are important risk factors,” she said in an interview.

Dr. Chen added that MRI is noninvasive and therefore provides an excellent way of measuring epicardial fat and cardiovascular disease risk. “Epicardial and periaortic fat can be directly detected and quantified with MRI to give us a good reading of cardiac function and vessel wall properties. We would like to see whether reducing those fat depots is associated with improvements in cardiac or vascular function. More studies are needed,” she said.

Epicardial fat tissues appear bright on MRI of woman with a BMI of 44 kg/m

Despite her lower BMI of 34 kg/m

NEW ORLEANS — The fat that surrounds the heart is associated with cardiac abnormalities, including low stroke volume and cardiac output, that are independent of body mass index, a study has found.

The finding casts doubt on the widespread practice of using body mass index (BMI) as an indicator of cardiovascular disease risk, Dr. Zhongjing Chen, of Boston University, said at the annual meeting of NAASO, the Obesity Society.

Dr. Chen and colleagues assessed 13 obese women (average age 47 years) with metabolic syndrome—but no recognized atherosclerosis—using MRI.

The women had a BMI of 30 kg/m

“The limit for weight was 275 pounds, and for waist circumference 50 inches, because of the table weight and size limits of our scanner,” Dr. Chen said.

The researchers used special software developed by Boston University's Center for Biomedical Imaging to calculate epicardial and periaortic fat and then analyzed stroke volume, end diastolic wall mass, and ejection fraction, as well as flow volume and peak blood velocity.

Both stroke volume and cardiac output were negatively correlated with epicardial and periaortic fat, and this negative correlation was statistically significant. Ascending aorta compliance also worsened in the presence of epicardial and periaortic fat.

However, there were no correlations between stroke volume, cardiac output, or ascending aorta compliance and the subjects' BMI, Dr. Chen said.

“The major morbidities associated with metabolic syndrome are myocardial infarction and stroke. People have been correlating body mass index with these risks, but our results indicate that it's the fat stores around the heart that are important risk factors,” she said in an interview.

Dr. Chen added that MRI is noninvasive and therefore provides an excellent way of measuring epicardial fat and cardiovascular disease risk. “Epicardial and periaortic fat can be directly detected and quantified with MRI to give us a good reading of cardiac function and vessel wall properties. We would like to see whether reducing those fat depots is associated with improvements in cardiac or vascular function. More studies are needed,” she said.

Epicardial fat tissues appear bright on MRI of woman with a BMI of 44 kg/m

Despite her lower BMI of 34 kg/m

NEW ORLEANS — Gastric bypass surgery resulted in more rapid and greater weight loss over a 2-year period than did gastric band surgery, according to a retrospective analysis of both procedures presented at the annual meeting of NAASO, the Obesity Society.

At 24 months after the procedures, patients who had gastric bypass had a mean excess weight loss of 68%, compared with 37% for those who had gastric band surgery, said Dr. Nancy Puzziferri of the University of Texas Southwestern Medical Center, Dallas. Both types of surgery were nevertheless associated with a significant and sustained excess weight loss benefit, she noted.

Data are scant regarding the relative benefits of both procedures, even though they are the most common operations for obesity in the United States, so Dr. Puzziferri and her colleagues analyzed the outcomes in 1,518 patients aged 18–65 years, of whom 958 underwent gastric bypass and 560 had gastric band surgery between March 1997 and November 2006.

All of the patients met National Institutes of Health eligibility criteria for obesity surgery, which included the following:

▸ A body mass index (BMI) of 35 kg/m

▸ A BMI of 40 or greater.

▸ A history of failed dietary or lifestyle interventions for weight loss.

All of the procedures were done by bariatric surgeons at Southwestern Medical Center.

The patients were seen at 6, 12, 18, and 24 months postoperatively, and once a year thereafter. Their excess weight loss (EWL) was assessed at each visit; successful weight loss was defined as at least 40% EWL at each measurement. Patients with less than 40% EWL were considered to be unsuccessful, Dr. Puzziferri said.

The average preoperative weight for all patients was 311 pounds (range, 167–825 pounds), and the average BMI was 50 (range, 28–115).

At each measurement period, EWL was significantly greater in the bypass patients than it was in the band patients. Bypass patients also lost weight more rapidly than did band patients, Dr. Puzziferri said. (See box.)

Fewer gastric band patients experienced successful weight loss by 2 years. Early success was a predictor of successful weight loss at 24 months for both procedures. However, lack of early success with gastric band did not automatically predict failure at 2 years, Dr. Puzziferri said.

“The weight loss following gastric bypass most likely results from anatomical changes, which confer hormonal and malabsorptive weight loss advantages in addition to restriction, whereas the gradual weight loss with gastric band mimics weight loss resulting from low-fat, low-calorie dietary interventions,” she said.

She added that gastric band patients may need more support to help them make dietary and lifestyle changes so that they can continue to lose weight. “Behavioral practices may be more critical for weight loss success in gastric band patients than in gastric bypass patients, because the band patients lack the changed physiology which promotes weight loss,” she explained.

Dr. Puzziferri cautioned that the study had limitations, including lack of randomization and a relatively short follow-up time. “It is possible that gastric band patients may catch up with the bypass patients with additional time. And bypass patients may regain the weight they have lost. We don't know at this time.”

ELSEVIER GLOBAL MEDICAL NEWS

NEW ORLEANS — Gastric bypass surgery resulted in more rapid and greater weight loss over a 2-year period than did gastric band surgery, according to a retrospective analysis of both procedures presented at the annual meeting of NAASO, the Obesity Society.

At 24 months after the procedures, patients who had gastric bypass had a mean excess weight loss of 68%, compared with 37% for those who had gastric band surgery, said Dr. Nancy Puzziferri of the University of Texas Southwestern Medical Center, Dallas. Both types of surgery were nevertheless associated with a significant and sustained excess weight loss benefit, she noted.

Data are scant regarding the relative benefits of both procedures, even though they are the most common operations for obesity in the United States, so Dr. Puzziferri and her colleagues analyzed the outcomes in 1,518 patients aged 18–65 years, of whom 958 underwent gastric bypass and 560 had gastric band surgery between March 1997 and November 2006.

All of the patients met National Institutes of Health eligibility criteria for obesity surgery, which included the following:

▸ A body mass index (BMI) of 35 kg/m

▸ A BMI of 40 or greater.

▸ A history of failed dietary or lifestyle interventions for weight loss.

All of the procedures were done by bariatric surgeons at Southwestern Medical Center.

The patients were seen at 6, 12, 18, and 24 months postoperatively, and once a year thereafter. Their excess weight loss (EWL) was assessed at each visit; successful weight loss was defined as at least 40% EWL at each measurement. Patients with less than 40% EWL were considered to be unsuccessful, Dr. Puzziferri said.

The average preoperative weight for all patients was 311 pounds (range, 167–825 pounds), and the average BMI was 50 (range, 28–115).

At each measurement period, EWL was significantly greater in the bypass patients than it was in the band patients. Bypass patients also lost weight more rapidly than did band patients, Dr. Puzziferri said. (See box.)

Fewer gastric band patients experienced successful weight loss by 2 years. Early success was a predictor of successful weight loss at 24 months for both procedures. However, lack of early success with gastric band did not automatically predict failure at 2 years, Dr. Puzziferri said.

“The weight loss following gastric bypass most likely results from anatomical changes, which confer hormonal and malabsorptive weight loss advantages in addition to restriction, whereas the gradual weight loss with gastric band mimics weight loss resulting from low-fat, low-calorie dietary interventions,” she said.

She added that gastric band patients may need more support to help them make dietary and lifestyle changes so that they can continue to lose weight. “Behavioral practices may be more critical for weight loss success in gastric band patients than in gastric bypass patients, because the band patients lack the changed physiology which promotes weight loss,” she explained.

Dr. Puzziferri cautioned that the study had limitations, including lack of randomization and a relatively short follow-up time. “It is possible that gastric band patients may catch up with the bypass patients with additional time. And bypass patients may regain the weight they have lost. We don't know at this time.”

ELSEVIER GLOBAL MEDICAL NEWS

NEW ORLEANS — Gastric bypass surgery resulted in more rapid and greater weight loss over a 2-year period than did gastric band surgery, according to a retrospective analysis of both procedures presented at the annual meeting of NAASO, the Obesity Society.

At 24 months after the procedures, patients who had gastric bypass had a mean excess weight loss of 68%, compared with 37% for those who had gastric band surgery, said Dr. Nancy Puzziferri of the University of Texas Southwestern Medical Center, Dallas. Both types of surgery were nevertheless associated with a significant and sustained excess weight loss benefit, she noted.

Data are scant regarding the relative benefits of both procedures, even though they are the most common operations for obesity in the United States, so Dr. Puzziferri and her colleagues analyzed the outcomes in 1,518 patients aged 18–65 years, of whom 958 underwent gastric bypass and 560 had gastric band surgery between March 1997 and November 2006.

All of the patients met National Institutes of Health eligibility criteria for obesity surgery, which included the following:

▸ A body mass index (BMI) of 35 kg/m

▸ A BMI of 40 or greater.

▸ A history of failed dietary or lifestyle interventions for weight loss.

All of the procedures were done by bariatric surgeons at Southwestern Medical Center.

The patients were seen at 6, 12, 18, and 24 months postoperatively, and once a year thereafter. Their excess weight loss (EWL) was assessed at each visit; successful weight loss was defined as at least 40% EWL at each measurement. Patients with less than 40% EWL were considered to be unsuccessful, Dr. Puzziferri said.

The average preoperative weight for all patients was 311 pounds (range, 167–825 pounds), and the average BMI was 50 (range, 28–115).

At each measurement period, EWL was significantly greater in the bypass patients than it was in the band patients. Bypass patients also lost weight more rapidly than did band patients, Dr. Puzziferri said. (See box.)

Fewer gastric band patients experienced successful weight loss by 2 years. Early success was a predictor of successful weight loss at 24 months for both procedures. However, lack of early success with gastric band did not automatically predict failure at 2 years, Dr. Puzziferri said.

“The weight loss following gastric bypass most likely results from anatomical changes, which confer hormonal and malabsorptive weight loss advantages in addition to restriction, whereas the gradual weight loss with gastric band mimics weight loss resulting from low-fat, low-calorie dietary interventions,” she said.

She added that gastric band patients may need more support to help them make dietary and lifestyle changes so that they can continue to lose weight. “Behavioral practices may be more critical for weight loss success in gastric band patients than in gastric bypass patients, because the band patients lack the changed physiology which promotes weight loss,” she explained.

Dr. Puzziferri cautioned that the study had limitations, including lack of randomization and a relatively short follow-up time. “It is possible that gastric band patients may catch up with the bypass patients with additional time. And bypass patients may regain the weight they have lost. We don't know at this time.”

ELSEVIER GLOBAL MEDICAL NEWS

An extract derived from the roots of the rhubarb plant has been shown in a randomized, placebo-controlled trial to provide relief of vasomotor symptoms in peri- and postmenopausal women, Dr. David S. Riley said at the annual meeting of the North American Menopause Society.

The trial, which was conducted at University Hospital, Frankfurt, Germany, showed that women who consumed one tablet containing 4 mg of the extract Rheum rhaponticum, or ERr 731, every day for 12 weeks had a significant reduction in the number and severity of hot flashes, compared with women who took placebo.

Although ERr 731 has been available in Germany for several years, it is still relatively unknown on this side of the Atlantic, Dr. Riley of the University of New Mexico, Albuquerque, explained in a telephone interview. As a consultant to the German researchers, he thought it would be interesting to present their data to clinicians in the United States.

“This is a substance that has been on the market in Germany since 1993, and the research was done in order to reregister it as an herbal medication,” said Dr. Riley, also editor-in-chief of Explore, The Journal of Science and Healing.

Hormone therapy, the standard for relieving vasomotor symptoms of menopause, can have unwanted side effects; other therapies, which do not have troublesome side effects, are of questionable efficacy, he said.

In this study, 112 perimenopausal women were randomized to 4 mg per day of ERr 731 or to placebo for 12 weeks. At the beginning of the trial, all of the women had a menopause rating scale (MRS) score of at least 18, which meant that their menopausal symptoms were moderate to severe.

Factors rated in the MRS score included hot flashes and sweating, heart complaints, sleep disturbances, depressive mood, irritability, anxiety, physical and mental exhaustion, sexual problems, urinary tract complaints, vaginal dryness, and joint and muscle complaints.

The women rated their symptoms on a scale from 0 (no symptoms) to 4 (very severe symptoms). The maximum attainable MRS score was 44 points, Dr. Riley explained.

After 12 weeks of treatment, there was a significant reduction in MRS score in the women taking the extract; 46 of the 56 (82%) women randomized to ERr 731 had a decrease of at least 10 points in their MRS score, compared with 2 (4%) of the women randomized to placebo.

ERr 731 was associated with a significant reduction in hot flashes, compared with placebo, from 11 per day at baseline, to 4 per day at 12 weeks, Dr. Riley said.

The compound was safe and was associated with no breast tenderness or increase in endometrial thickness as assessed on ultrasound and biopsies, no changes in liver enzymes, no changes in blood pressure, no changes in weight, no increase in estradiol or progesterone, and no enhanced bone turnover, he added.

“Women are looking for safe and natural alternatives to hormones to relieve their menopausal symptoms, especially hot flashes, which appear to be the most annoying. This compound is exciting and shows promise, and hopefully we can generate some interest on this side of the Atlantic,” he said.

An extract derived from the roots of Rheum rhaponticum, shown here, has been on the market in Europe since 1993. Courtesy Mueller-Goeppingen

An extract derived from the roots of the rhubarb plant has been shown in a randomized, placebo-controlled trial to provide relief of vasomotor symptoms in peri- and postmenopausal women, Dr. David S. Riley said at the annual meeting of the North American Menopause Society.

The trial, which was conducted at University Hospital, Frankfurt, Germany, showed that women who consumed one tablet containing 4 mg of the extract Rheum rhaponticum, or ERr 731, every day for 12 weeks had a significant reduction in the number and severity of hot flashes, compared with women who took placebo.

Although ERr 731 has been available in Germany for several years, it is still relatively unknown on this side of the Atlantic, Dr. Riley of the University of New Mexico, Albuquerque, explained in a telephone interview. As a consultant to the German researchers, he thought it would be interesting to present their data to clinicians in the United States.

“This is a substance that has been on the market in Germany since 1993, and the research was done in order to reregister it as an herbal medication,” said Dr. Riley, also editor-in-chief of Explore, The Journal of Science and Healing.

Hormone therapy, the standard for relieving vasomotor symptoms of menopause, can have unwanted side effects; other therapies, which do not have troublesome side effects, are of questionable efficacy, he said.

In this study, 112 perimenopausal women were randomized to 4 mg per day of ERr 731 or to placebo for 12 weeks. At the beginning of the trial, all of the women had a menopause rating scale (MRS) score of at least 18, which meant that their menopausal symptoms were moderate to severe.

Factors rated in the MRS score included hot flashes and sweating, heart complaints, sleep disturbances, depressive mood, irritability, anxiety, physical and mental exhaustion, sexual problems, urinary tract complaints, vaginal dryness, and joint and muscle complaints.

The women rated their symptoms on a scale from 0 (no symptoms) to 4 (very severe symptoms). The maximum attainable MRS score was 44 points, Dr. Riley explained.

After 12 weeks of treatment, there was a significant reduction in MRS score in the women taking the extract; 46 of the 56 (82%) women randomized to ERr 731 had a decrease of at least 10 points in their MRS score, compared with 2 (4%) of the women randomized to placebo.

ERr 731 was associated with a significant reduction in hot flashes, compared with placebo, from 11 per day at baseline, to 4 per day at 12 weeks, Dr. Riley said.

The compound was safe and was associated with no breast tenderness or increase in endometrial thickness as assessed on ultrasound and biopsies, no changes in liver enzymes, no changes in blood pressure, no changes in weight, no increase in estradiol or progesterone, and no enhanced bone turnover, he added.

“Women are looking for safe and natural alternatives to hormones to relieve their menopausal symptoms, especially hot flashes, which appear to be the most annoying. This compound is exciting and shows promise, and hopefully we can generate some interest on this side of the Atlantic,” he said.

An extract derived from the roots of Rheum rhaponticum, shown here, has been on the market in Europe since 1993. Courtesy Mueller-Goeppingen

An extract derived from the roots of the rhubarb plant has been shown in a randomized, placebo-controlled trial to provide relief of vasomotor symptoms in peri- and postmenopausal women, Dr. David S. Riley said at the annual meeting of the North American Menopause Society.

The trial, which was conducted at University Hospital, Frankfurt, Germany, showed that women who consumed one tablet containing 4 mg of the extract Rheum rhaponticum, or ERr 731, every day for 12 weeks had a significant reduction in the number and severity of hot flashes, compared with women who took placebo.

Although ERr 731 has been available in Germany for several years, it is still relatively unknown on this side of the Atlantic, Dr. Riley of the University of New Mexico, Albuquerque, explained in a telephone interview. As a consultant to the German researchers, he thought it would be interesting to present their data to clinicians in the United States.

“This is a substance that has been on the market in Germany since 1993, and the research was done in order to reregister it as an herbal medication,” said Dr. Riley, also editor-in-chief of Explore, The Journal of Science and Healing.

Hormone therapy, the standard for relieving vasomotor symptoms of menopause, can have unwanted side effects; other therapies, which do not have troublesome side effects, are of questionable efficacy, he said.

In this study, 112 perimenopausal women were randomized to 4 mg per day of ERr 731 or to placebo for 12 weeks. At the beginning of the trial, all of the women had a menopause rating scale (MRS) score of at least 18, which meant that their menopausal symptoms were moderate to severe.

Factors rated in the MRS score included hot flashes and sweating, heart complaints, sleep disturbances, depressive mood, irritability, anxiety, physical and mental exhaustion, sexual problems, urinary tract complaints, vaginal dryness, and joint and muscle complaints.

The women rated their symptoms on a scale from 0 (no symptoms) to 4 (very severe symptoms). The maximum attainable MRS score was 44 points, Dr. Riley explained.

After 12 weeks of treatment, there was a significant reduction in MRS score in the women taking the extract; 46 of the 56 (82%) women randomized to ERr 731 had a decrease of at least 10 points in their MRS score, compared with 2 (4%) of the women randomized to placebo.

ERr 731 was associated with a significant reduction in hot flashes, compared with placebo, from 11 per day at baseline, to 4 per day at 12 weeks, Dr. Riley said.

The compound was safe and was associated with no breast tenderness or increase in endometrial thickness as assessed on ultrasound and biopsies, no changes in liver enzymes, no changes in blood pressure, no changes in weight, no increase in estradiol or progesterone, and no enhanced bone turnover, he added.

“Women are looking for safe and natural alternatives to hormones to relieve their menopausal symptoms, especially hot flashes, which appear to be the most annoying. This compound is exciting and shows promise, and hopefully we can generate some interest on this side of the Atlantic,” he said.

An extract derived from the roots of Rheum rhaponticum, shown here, has been on the market in Europe since 1993. Courtesy Mueller-Goeppingen