Fran Lowry

NEW ORLEANS — Overweight and obese adults who supplemented their meals with oligofructose—a type of soluble dietary fiber derived from chicory root—lost about 1 kg of body fat over a 12-week period in the absence of dieting and exercise.

In the placebo-controlled study, the 21 participants who used the supplement also decreased by twofold their blood levels of the appetite-inducing hormone ghrelin over a 6-hour meal test. No reduction was seen in the 18 subjects taking a placebo, Canadian investigators reported in a poster presentation at the annual meeting of NAASO, the Obesity Society.

Lead investigator Jill Parnell, a Ph.D. candidate at the University of Calgary (Alta.), and her associates have shown in animal studies that oligofructose modulates satiety-hormone secretion and, as a result, decreases energy intake. It also improves lipid profiles and blood glucose levels.

To see if oligofructose would have similar effects in a clinical trial, the investigators randomized participants (32 women and 7 men) to receive 21 g of oligofructose or an equicaloric amount of maltodextrin as placebo. Both substances were given as a white powder stirred into a beverage of the subjects' choice before their breakfast, lunch, and dinner.

The average body mass index (BMI) for individuals in both groups was 30 kg/m

Those in the supplement group had lost an average of 1 kg of body fat without losing muscle mass. “We used a DXA [dual-energy x-ray absorptiometry] scan to look at body composition, and we could see that all of the reduction was coming from fat mass,” Ms. Parnell said.

Placebo group members gained weight (0.5 kg on average), according to findings of the study, which was sponsored by the Canadian Institute of Health Research.

NEW ORLEANS — Overweight and obese adults who supplemented their meals with oligofructose—a type of soluble dietary fiber derived from chicory root—lost about 1 kg of body fat over a 12-week period in the absence of dieting and exercise.

In the placebo-controlled study, the 21 participants who used the supplement also decreased by twofold their blood levels of the appetite-inducing hormone ghrelin over a 6-hour meal test. No reduction was seen in the 18 subjects taking a placebo, Canadian investigators reported in a poster presentation at the annual meeting of NAASO, the Obesity Society.

Lead investigator Jill Parnell, a Ph.D. candidate at the University of Calgary (Alta.), and her associates have shown in animal studies that oligofructose modulates satiety-hormone secretion and, as a result, decreases energy intake. It also improves lipid profiles and blood glucose levels.

To see if oligofructose would have similar effects in a clinical trial, the investigators randomized participants (32 women and 7 men) to receive 21 g of oligofructose or an equicaloric amount of maltodextrin as placebo. Both substances were given as a white powder stirred into a beverage of the subjects' choice before their breakfast, lunch, and dinner.

The average body mass index (BMI) for individuals in both groups was 30 kg/m

Those in the supplement group had lost an average of 1 kg of body fat without losing muscle mass. “We used a DXA [dual-energy x-ray absorptiometry] scan to look at body composition, and we could see that all of the reduction was coming from fat mass,” Ms. Parnell said.

Placebo group members gained weight (0.5 kg on average), according to findings of the study, which was sponsored by the Canadian Institute of Health Research.

NEW ORLEANS — Overweight and obese adults who supplemented their meals with oligofructose—a type of soluble dietary fiber derived from chicory root—lost about 1 kg of body fat over a 12-week period in the absence of dieting and exercise.

In the placebo-controlled study, the 21 participants who used the supplement also decreased by twofold their blood levels of the appetite-inducing hormone ghrelin over a 6-hour meal test. No reduction was seen in the 18 subjects taking a placebo, Canadian investigators reported in a poster presentation at the annual meeting of NAASO, the Obesity Society.

Lead investigator Jill Parnell, a Ph.D. candidate at the University of Calgary (Alta.), and her associates have shown in animal studies that oligofructose modulates satiety-hormone secretion and, as a result, decreases energy intake. It also improves lipid profiles and blood glucose levels.

To see if oligofructose would have similar effects in a clinical trial, the investigators randomized participants (32 women and 7 men) to receive 21 g of oligofructose or an equicaloric amount of maltodextrin as placebo. Both substances were given as a white powder stirred into a beverage of the subjects' choice before their breakfast, lunch, and dinner.

The average body mass index (BMI) for individuals in both groups was 30 kg/m

Those in the supplement group had lost an average of 1 kg of body fat without losing muscle mass. “We used a DXA [dual-energy x-ray absorptiometry] scan to look at body composition, and we could see that all of the reduction was coming from fat mass,” Ms. Parnell said.

Placebo group members gained weight (0.5 kg on average), according to findings of the study, which was sponsored by the Canadian Institute of Health Research.

NEW ORLEANS — An oral device that fits in the mouth much like a retainer could help overweight individuals eat more slowly and, in the process, eat less and lose weight, according to a poster presented at the annual meeting of NAASO, the Obesity Society.

Almost half of those who ate with the device in their mouths lost at least 5% of their body weight at the end of a 20-week, open-label, randomized study, said Dr. Mitchell Roslin, chief of the bariatric surgery program at Lenox Hill Hospital in New York City.

The study, which was carried out at four centers in the United States, randomized 108 adults aged 18–49 years who had a body mass index (BMI) of between 26 kg/m

The subjects in both groups were demographically similar. They were weighed at baseline and at the end of the study, and palatal impressions were taken for those who were randomized to receive the oral device to optimize its comfort and fit, Dr. Roslin said.

After 20 weeks, nearly half of those in the experimental group (20 subjects) had lost at least 5% of their body weight, compared with almost 5% (3 subjects) in the control group, he reported.

Those who wore the oral device while they ate two of their daily meals had the greatest weight loss, an average of 13.7 pounds. Those who wore it for one meal a day lost an average of 8.0 pounds. Weight loss for the control subjects averaged 0.6 pounds, Dr. Roslin reported.

The device contained a chip, or sensor, to let providers know how often it was used. “If you … tell me you haven't lost any weight, I can plug in the device and see how many times you have actually worn it. If you've only worn it once, how can it help you?” Dr. Roslin said.

The device works best if patients are motivated, he added.

“Obesity comes from a caloric imbalance and the only way to maintain weight loss is through behavioral change. This device helps with behavioral change. Whether you use [it] to stop you from wolfing down your food, or whether you have an operation, the results you obtain are ultimately up to you. This device is tolerable for motivated patients, but it's not going to overwhelm a person who is not motivated to change his or her behavior. It's a tool, and like any other tool, it has to be used effectively.”

Dr. Roslin said he also believes that the oral device, which does not yet have a name, will help people achieve better weight loss than any of the currently available pharmaceuticals—without side effects.

The manufacturer of the device, Atlanta-based Scientific Intake, plans to make a submission to the Food and Drug Administration for approval to market it as a low-risk device.

“It makes intuitive sense that if you place a speed bump in the mouth, you are going to make people more conscious of their eating behavior. This is what behavior modification is all about. It is making people think about what they are doing so that they can reflect,” Dr. Roslin said. “If you can break the fast-eating habit, you can make people eat less, and this is what we have seen in our study.”

Dr. Roslin disclosed that has received shares in Scientific Intake for his advisory role as medical officer to the company.

ELSEVIER GLOBAL MEDICAL NEWS

NEW ORLEANS — An oral device that fits in the mouth much like a retainer could help overweight individuals eat more slowly and, in the process, eat less and lose weight, according to a poster presented at the annual meeting of NAASO, the Obesity Society.

Almost half of those who ate with the device in their mouths lost at least 5% of their body weight at the end of a 20-week, open-label, randomized study, said Dr. Mitchell Roslin, chief of the bariatric surgery program at Lenox Hill Hospital in New York City.

The study, which was carried out at four centers in the United States, randomized 108 adults aged 18–49 years who had a body mass index (BMI) of between 26 kg/m

The subjects in both groups were demographically similar. They were weighed at baseline and at the end of the study, and palatal impressions were taken for those who were randomized to receive the oral device to optimize its comfort and fit, Dr. Roslin said.

After 20 weeks, nearly half of those in the experimental group (20 subjects) had lost at least 5% of their body weight, compared with almost 5% (3 subjects) in the control group, he reported.

Those who wore the oral device while they ate two of their daily meals had the greatest weight loss, an average of 13.7 pounds. Those who wore it for one meal a day lost an average of 8.0 pounds. Weight loss for the control subjects averaged 0.6 pounds, Dr. Roslin reported.

The device contained a chip, or sensor, to let providers know how often it was used. “If you … tell me you haven't lost any weight, I can plug in the device and see how many times you have actually worn it. If you've only worn it once, how can it help you?” Dr. Roslin said.

The device works best if patients are motivated, he added.

“Obesity comes from a caloric imbalance and the only way to maintain weight loss is through behavioral change. This device helps with behavioral change. Whether you use [it] to stop you from wolfing down your food, or whether you have an operation, the results you obtain are ultimately up to you. This device is tolerable for motivated patients, but it's not going to overwhelm a person who is not motivated to change his or her behavior. It's a tool, and like any other tool, it has to be used effectively.”

Dr. Roslin said he also believes that the oral device, which does not yet have a name, will help people achieve better weight loss than any of the currently available pharmaceuticals—without side effects.

The manufacturer of the device, Atlanta-based Scientific Intake, plans to make a submission to the Food and Drug Administration for approval to market it as a low-risk device.

“It makes intuitive sense that if you place a speed bump in the mouth, you are going to make people more conscious of their eating behavior. This is what behavior modification is all about. It is making people think about what they are doing so that they can reflect,” Dr. Roslin said. “If you can break the fast-eating habit, you can make people eat less, and this is what we have seen in our study.”

Dr. Roslin disclosed that has received shares in Scientific Intake for his advisory role as medical officer to the company.

ELSEVIER GLOBAL MEDICAL NEWS

NEW ORLEANS — An oral device that fits in the mouth much like a retainer could help overweight individuals eat more slowly and, in the process, eat less and lose weight, according to a poster presented at the annual meeting of NAASO, the Obesity Society.

Almost half of those who ate with the device in their mouths lost at least 5% of their body weight at the end of a 20-week, open-label, randomized study, said Dr. Mitchell Roslin, chief of the bariatric surgery program at Lenox Hill Hospital in New York City.

The study, which was carried out at four centers in the United States, randomized 108 adults aged 18–49 years who had a body mass index (BMI) of between 26 kg/m

The subjects in both groups were demographically similar. They were weighed at baseline and at the end of the study, and palatal impressions were taken for those who were randomized to receive the oral device to optimize its comfort and fit, Dr. Roslin said.

After 20 weeks, nearly half of those in the experimental group (20 subjects) had lost at least 5% of their body weight, compared with almost 5% (3 subjects) in the control group, he reported.

Those who wore the oral device while they ate two of their daily meals had the greatest weight loss, an average of 13.7 pounds. Those who wore it for one meal a day lost an average of 8.0 pounds. Weight loss for the control subjects averaged 0.6 pounds, Dr. Roslin reported.

The device contained a chip, or sensor, to let providers know how often it was used. “If you … tell me you haven't lost any weight, I can plug in the device and see how many times you have actually worn it. If you've only worn it once, how can it help you?” Dr. Roslin said.

The device works best if patients are motivated, he added.

“Obesity comes from a caloric imbalance and the only way to maintain weight loss is through behavioral change. This device helps with behavioral change. Whether you use [it] to stop you from wolfing down your food, or whether you have an operation, the results you obtain are ultimately up to you. This device is tolerable for motivated patients, but it's not going to overwhelm a person who is not motivated to change his or her behavior. It's a tool, and like any other tool, it has to be used effectively.”

Dr. Roslin said he also believes that the oral device, which does not yet have a name, will help people achieve better weight loss than any of the currently available pharmaceuticals—without side effects.

The manufacturer of the device, Atlanta-based Scientific Intake, plans to make a submission to the Food and Drug Administration for approval to market it as a low-risk device.

“It makes intuitive sense that if you place a speed bump in the mouth, you are going to make people more conscious of their eating behavior. This is what behavior modification is all about. It is making people think about what they are doing so that they can reflect,” Dr. Roslin said. “If you can break the fast-eating habit, you can make people eat less, and this is what we have seen in our study.”

Dr. Roslin disclosed that has received shares in Scientific Intake for his advisory role as medical officer to the company.

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 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).

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

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 findings should help clinicians and their patients weigh the risks and benefits of gastric bypass, Dr. Adams commented in an interview.

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 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.

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, said Dr. Adams, who is also a program director at the Health and Fitness Institute at Latter Day Saints Hospital, Salt Lake City.

When asked the reason for the higher rate of nondisease deaths in the bariatric surgery group, he said it was difficult to know. “There have been suggestions that some individuals who have undergone gastric bypass surgery may go on to increase their intake of alcohol. There is the thought that perhaps the addictive behaviors related to some obesity may be continued with substance abuse.”

He also suggested that the significant weight loss may lead patients to become more physically active, and thus at greater exposure to accidents.

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.”

The finding has prompted the investigators to do additional research on cancer types and staging after gastric bypass. The investigators also are studying morbidity after gastric bypass; results of that trial, which has been ongoing for the last 5 years, are expected soon, Dr. Adams said.

He emphasized that individuals should take the time to consider the pros and cons of gastric bypass surgery, especially in light of his study's results. “This surgery, which has been shown to be effective for long-term weight loss, also provides a reduction in long-term mortality. But even in light of this research, we would never want individuals to lose track of the very important step they should take to weigh the benefits of the surgery with the risks.”

'It really interested us that in such a short period of time we would see such a dramatic reduction in cancer.' DR. ADAMS

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 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).

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

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 findings should help clinicians and their patients weigh the risks and benefits of gastric bypass, Dr. Adams commented in an interview.

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 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.

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, said Dr. Adams, who is also a program director at the Health and Fitness Institute at Latter Day Saints Hospital, Salt Lake City.

When asked the reason for the higher rate of nondisease deaths in the bariatric surgery group, he said it was difficult to know. “There have been suggestions that some individuals who have undergone gastric bypass surgery may go on to increase their intake of alcohol. There is the thought that perhaps the addictive behaviors related to some obesity may be continued with substance abuse.”

He also suggested that the significant weight loss may lead patients to become more physically active, and thus at greater exposure to accidents.

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.”

The finding has prompted the investigators to do additional research on cancer types and staging after gastric bypass. The investigators also are studying morbidity after gastric bypass; results of that trial, which has been ongoing for the last 5 years, are expected soon, Dr. Adams said.

He emphasized that individuals should take the time to consider the pros and cons of gastric bypass surgery, especially in light of his study's results. “This surgery, which has been shown to be effective for long-term weight loss, also provides a reduction in long-term mortality. But even in light of this research, we would never want individuals to lose track of the very important step they should take to weigh the benefits of the surgery with the risks.”

'It really interested us that in such a short period of time we would see such a dramatic reduction in cancer.' DR. ADAMS

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 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).

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

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 findings should help clinicians and their patients weigh the risks and benefits of gastric bypass, Dr. Adams commented in an interview.

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 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.

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, said Dr. Adams, who is also a program director at the Health and Fitness Institute at Latter Day Saints Hospital, Salt Lake City.

When asked the reason for the higher rate of nondisease deaths in the bariatric surgery group, he said it was difficult to know. “There have been suggestions that some individuals who have undergone gastric bypass surgery may go on to increase their intake of alcohol. There is the thought that perhaps the addictive behaviors related to some obesity may be continued with substance abuse.”

He also suggested that the significant weight loss may lead patients to become more physically active, and thus at greater exposure to accidents.

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.”

The finding has prompted the investigators to do additional research on cancer types and staging after gastric bypass. The investigators also are studying morbidity after gastric bypass; results of that trial, which has been ongoing for the last 5 years, are expected soon, Dr. Adams said.

He emphasized that individuals should take the time to consider the pros and cons of gastric bypass surgery, especially in light of his study's results. “This surgery, which has been shown to be effective for long-term weight loss, also provides a reduction in long-term mortality. But even in light of this research, we would never want individuals to lose track of the very important step they should take to weigh the benefits of the surgery with the risks.”

'It really interested us that in such a short period of time we would see such a dramatic reduction in cancer.' DR. ADAMS

ELSEVIER GLOBAL MEDICAL NEWS

Hypothyroid postmenopausal women appear to be at significantly higher risk of developing breast cancer, Argentinian researchers reported in a poster presentation at the annual meeting of the North American Menopause Society.

In the prospective study, Dr. Maria Franchina and her colleagues of the Preventive Medical Center in Buenos Aires found a high incidence of breast cancer among postmenopausal women who were newly diagnosed with autoimmune hypothyroidism or whose hypothyroidism was poorly controlled because they had stopped taking their thyroid medication.

Among a total of 180 hypothyroid women attending their clinic between January 2006 and June 2007, 33 (18%) had breast cancer, compared with 15 (5%) of 300 euthyroid women, the investigators reported.

The median age of the women was 52.9 years, and all were within 1 year of their last menstrual period.

The researchers also compared the prevalence of endometrial, thyroid, and ovarian cancers between the two groups, but did not find any significant differences in those measures.

More hypothyroid than euthyroid women had thyroid cancer, 8% vs. 1%, but this difference was not statistically significant, Dr. Franchina said. (See accompanying graphic.)

“Growing breasts require several hormones, such as prolactin, estrogen, progesterone, adrenal steroids, insulin, growth hormone, and thyroid hormones, so there could well be an association between low thyroid hormone and breast cancer,” she said in a telephone interview.

But she added that such an association is controversial.

“There have been many discrepant results reported in the literature, with some researchers reporting that thyroid diseases are common in women with breast cancer, and others reporting just the opposite.”

In truth, whether thyroid autoimmune diseases actually increase a woman's risk for developing cancer is still not known, Dr. Franchina concluded.

The study generated a lot of interest among North American Menopause Society delegates, Dr. Franchina said.

She and her associates are planning a correlative study to further investigate this finding.

There could well be an association between the two phenomena, but such a finding is controversial. DR. FRANCHINA

ELSEVIER GLOBAL MEDICAL NEWS

Hypothyroid postmenopausal women appear to be at significantly higher risk of developing breast cancer, Argentinian researchers reported in a poster presentation at the annual meeting of the North American Menopause Society.

In the prospective study, Dr. Maria Franchina and her colleagues of the Preventive Medical Center in Buenos Aires found a high incidence of breast cancer among postmenopausal women who were newly diagnosed with autoimmune hypothyroidism or whose hypothyroidism was poorly controlled because they had stopped taking their thyroid medication.

Among a total of 180 hypothyroid women attending their clinic between January 2006 and June 2007, 33 (18%) had breast cancer, compared with 15 (5%) of 300 euthyroid women, the investigators reported.

The median age of the women was 52.9 years, and all were within 1 year of their last menstrual period.

The researchers also compared the prevalence of endometrial, thyroid, and ovarian cancers between the two groups, but did not find any significant differences in those measures.

More hypothyroid than euthyroid women had thyroid cancer, 8% vs. 1%, but this difference was not statistically significant, Dr. Franchina said. (See accompanying graphic.)

“Growing breasts require several hormones, such as prolactin, estrogen, progesterone, adrenal steroids, insulin, growth hormone, and thyroid hormones, so there could well be an association between low thyroid hormone and breast cancer,” she said in a telephone interview.

But she added that such an association is controversial.

“There have been many discrepant results reported in the literature, with some researchers reporting that thyroid diseases are common in women with breast cancer, and others reporting just the opposite.”

In truth, whether thyroid autoimmune diseases actually increase a woman's risk for developing cancer is still not known, Dr. Franchina concluded.

The study generated a lot of interest among North American Menopause Society delegates, Dr. Franchina said.

She and her associates are planning a correlative study to further investigate this finding.

There could well be an association between the two phenomena, but such a finding is controversial. DR. FRANCHINA

ELSEVIER GLOBAL MEDICAL NEWS

Hypothyroid postmenopausal women appear to be at significantly higher risk of developing breast cancer, Argentinian researchers reported in a poster presentation at the annual meeting of the North American Menopause Society.

In the prospective study, Dr. Maria Franchina and her colleagues of the Preventive Medical Center in Buenos Aires found a high incidence of breast cancer among postmenopausal women who were newly diagnosed with autoimmune hypothyroidism or whose hypothyroidism was poorly controlled because they had stopped taking their thyroid medication.

Among a total of 180 hypothyroid women attending their clinic between January 2006 and June 2007, 33 (18%) had breast cancer, compared with 15 (5%) of 300 euthyroid women, the investigators reported.

The median age of the women was 52.9 years, and all were within 1 year of their last menstrual period.

The researchers also compared the prevalence of endometrial, thyroid, and ovarian cancers between the two groups, but did not find any significant differences in those measures.

More hypothyroid than euthyroid women had thyroid cancer, 8% vs. 1%, but this difference was not statistically significant, Dr. Franchina said. (See accompanying graphic.)

“Growing breasts require several hormones, such as prolactin, estrogen, progesterone, adrenal steroids, insulin, growth hormone, and thyroid hormones, so there could well be an association between low thyroid hormone and breast cancer,” she said in a telephone interview.

But she added that such an association is controversial.

“There have been many discrepant results reported in the literature, with some researchers reporting that thyroid diseases are common in women with breast cancer, and others reporting just the opposite.”

In truth, whether thyroid autoimmune diseases actually increase a woman's risk for developing cancer is still not known, Dr. Franchina concluded.

The study generated a lot of interest among North American Menopause Society delegates, Dr. Franchina said.

She and her associates are planning a correlative study to further investigate this finding.

There could well be an association between the two phenomena, but such a finding is controversial. DR. FRANCHINA

ELSEVIER GLOBAL MEDICAL NEWS

NEW ORLEANS — Women who put on more than the recommended weight during pregnancy increase the chances that their offspring will be overweight before they reach their 10th birthday, according to findings from a retrospective cohort study of 7,674 women.

The findings from this study, which is the largest to date on the subject, have important implications for counseling pregnant women, Brian Wrotniak, Ph.D., said at the annual meeting of NAASO, the Obesity Society.

Mothers-to-be who gained more than the weight recommended by the Institute of Medicine had a 44% greater likelihood of having offspring who were overweight at 7 years of age than did women who did not exceed the weight-gain recommendations during their pregnancy.

Study investigators reviewed data from the Collaborative Perinatal Project, a multicenter, multiethnic study that was initiated in 1959 to investigate risk factors for cerebral palsy in children, said Dr. Wrotniak of Children's Hospital of Philadelphia.

The association between excess weight gain during pregnancy and an overweight child by age 7 years was even stronger for women who were underweight at the time they became pregnant, he said.

The link between the mother's weight gain during pregnancy and her child's excess weight in later years remained significant after adjustment for the gender of the child, gestational age, infant birth weight, first-born status, mother's race, maternal age, maternal body mass index, smoking, and study site, the researchers reported.

“How much weight to gain depends on the mother's prepregnancy BMI. For women of normal weight, the recommendations for weight gain during [a singleton] pregnancy are 12.5–18 kg, but for women who are overweight, 7–11.5 kg is the recommended range,” Dr. Wrotniak said.

The Collaborative Perinatal Project data were collected in the 1960s. At that time, 11% of the cohort exceeded pregnancy weight-gain recommendations. Today, almost half—46% of expectant mothers—are gaining more weight than they should during their pregnancies, Dr. Wrotniak said.

“From a public health standpoint, helping women to develop healthy eating and physical activity habits and to achieve a healthier weight before becoming pregnant, and to adhere to weight gain recommendations during pregnancy, may be an effective way to help prevent childhood obesity.

“With almost half of women exceeding the recommendations, such counseling could have a sizeable impact on future obesity in children,” the study authors concluded.

NEW ORLEANS — Women who put on more than the recommended weight during pregnancy increase the chances that their offspring will be overweight before they reach their 10th birthday, according to findings from a retrospective cohort study of 7,674 women.

The findings from this study, which is the largest to date on the subject, have important implications for counseling pregnant women, Brian Wrotniak, Ph.D., said at the annual meeting of NAASO, the Obesity Society.

Mothers-to-be who gained more than the weight recommended by the Institute of Medicine had a 44% greater likelihood of having offspring who were overweight at 7 years of age than did women who did not exceed the weight-gain recommendations during their pregnancy.

Study investigators reviewed data from the Collaborative Perinatal Project, a multicenter, multiethnic study that was initiated in 1959 to investigate risk factors for cerebral palsy in children, said Dr. Wrotniak of Children's Hospital of Philadelphia.

The association between excess weight gain during pregnancy and an overweight child by age 7 years was even stronger for women who were underweight at the time they became pregnant, he said.

The link between the mother's weight gain during pregnancy and her child's excess weight in later years remained significant after adjustment for the gender of the child, gestational age, infant birth weight, first-born status, mother's race, maternal age, maternal body mass index, smoking, and study site, the researchers reported.

“How much weight to gain depends on the mother's prepregnancy BMI. For women of normal weight, the recommendations for weight gain during [a singleton] pregnancy are 12.5–18 kg, but for women who are overweight, 7–11.5 kg is the recommended range,” Dr. Wrotniak said.

The Collaborative Perinatal Project data were collected in the 1960s. At that time, 11% of the cohort exceeded pregnancy weight-gain recommendations. Today, almost half—46% of expectant mothers—are gaining more weight than they should during their pregnancies, Dr. Wrotniak said.

“From a public health standpoint, helping women to develop healthy eating and physical activity habits and to achieve a healthier weight before becoming pregnant, and to adhere to weight gain recommendations during pregnancy, may be an effective way to help prevent childhood obesity.

“With almost half of women exceeding the recommendations, such counseling could have a sizeable impact on future obesity in children,” the study authors concluded.

NEW ORLEANS — Women who put on more than the recommended weight during pregnancy increase the chances that their offspring will be overweight before they reach their 10th birthday, according to findings from a retrospective cohort study of 7,674 women.

The findings from this study, which is the largest to date on the subject, have important implications for counseling pregnant women, Brian Wrotniak, Ph.D., said at the annual meeting of NAASO, the Obesity Society.

Mothers-to-be who gained more than the weight recommended by the Institute of Medicine had a 44% greater likelihood of having offspring who were overweight at 7 years of age than did women who did not exceed the weight-gain recommendations during their pregnancy.

Study investigators reviewed data from the Collaborative Perinatal Project, a multicenter, multiethnic study that was initiated in 1959 to investigate risk factors for cerebral palsy in children, said Dr. Wrotniak of Children's Hospital of Philadelphia.

The association between excess weight gain during pregnancy and an overweight child by age 7 years was even stronger for women who were underweight at the time they became pregnant, he said.

The link between the mother's weight gain during pregnancy and her child's excess weight in later years remained significant after adjustment for the gender of the child, gestational age, infant birth weight, first-born status, mother's race, maternal age, maternal body mass index, smoking, and study site, the researchers reported.

“How much weight to gain depends on the mother's prepregnancy BMI. For women of normal weight, the recommendations for weight gain during [a singleton] pregnancy are 12.5–18 kg, but for women who are overweight, 7–11.5 kg is the recommended range,” Dr. Wrotniak said.

The Collaborative Perinatal Project data were collected in the 1960s. At that time, 11% of the cohort exceeded pregnancy weight-gain recommendations. Today, almost half—46% of expectant mothers—are gaining more weight than they should during their pregnancies, Dr. Wrotniak said.

“From a public health standpoint, helping women to develop healthy eating and physical activity habits and to achieve a healthier weight before becoming pregnant, and to adhere to weight gain recommendations during pregnancy, may be an effective way to help prevent childhood obesity.

“With almost half of women exceeding the recommendations, such counseling could have a sizeable impact on future obesity in children,” the study authors concluded.

Bazedoxifene, a novel selective estrogen-receptor modulator, is as safe as placebo in terms effects on the endometrium and will be a new therapy for preventing and treating postmenopausal osteoporosis, according to data presented at the annual meeting of the North American Menopause Society.

Dr. David F. Archer, professor of obstetrics and gynecology at Eastern Virginia Medical School, Norfolk, and a consultant for Wyeth Pharmaceuticals (the study's sponsor), presented data on endometrial safety in a subset of women in a large phase III trial comparing the efficacy of bazedoxifene, raloxifene, and placebo in reducing the relative risk of new vertebral fractures.

The results of that trial found bazedoxifene at 20 mg or 40 mg per day significantly reduced new vertebral fractures, versus placebo. Similar results were obtained with raloxifene 60 mg per day.

However, in the subanalysis raloxifene was linked to more endometrial hyperplasia, Dr. Archer said.

“Importantly, bazedoxifene exerted its beneficial effect on bone without increasing endometrial thickness or causing endometrial bleeding,” Dr. Archer added in an interview.

The endometrial safety substudy focused on 643 women who had transvaginal ultrasonography at baseline and at month 24. Endometrial biopsies also were performed at these two time points.

Endometrial thickness between baseline and 24 months increased by 0.1 mm with both doses of bazedoxifene and placebo, compared with an increase of 0.3 mm with raloxifene, Dr. Archer said.

About five women in each of the four treatment arms had 4 mm or more growth in endometrial thickness, but when they were biopsied, no evidence of hyperplasia was detected.

“We are not sure what the exact cause of this increase in endometrial thickness is, but it does not appear to be mycotic,” he commented.

Food and Drug Administration approval of bazedoxifene is pending, and Wyeth, the drug's developer, expects the FDA to approve it for the treatment of postmenopausal osteoporosis by the end of 2007, Dr. Archer said.

Bazedoxifene, a novel selective estrogen-receptor modulator, is as safe as placebo in terms effects on the endometrium and will be a new therapy for preventing and treating postmenopausal osteoporosis, according to data presented at the annual meeting of the North American Menopause Society.

Dr. David F. Archer, professor of obstetrics and gynecology at Eastern Virginia Medical School, Norfolk, and a consultant for Wyeth Pharmaceuticals (the study's sponsor), presented data on endometrial safety in a subset of women in a large phase III trial comparing the efficacy of bazedoxifene, raloxifene, and placebo in reducing the relative risk of new vertebral fractures.

The results of that trial found bazedoxifene at 20 mg or 40 mg per day significantly reduced new vertebral fractures, versus placebo. Similar results were obtained with raloxifene 60 mg per day.

However, in the subanalysis raloxifene was linked to more endometrial hyperplasia, Dr. Archer said.

“Importantly, bazedoxifene exerted its beneficial effect on bone without increasing endometrial thickness or causing endometrial bleeding,” Dr. Archer added in an interview.

The endometrial safety substudy focused on 643 women who had transvaginal ultrasonography at baseline and at month 24. Endometrial biopsies also were performed at these two time points.

Endometrial thickness between baseline and 24 months increased by 0.1 mm with both doses of bazedoxifene and placebo, compared with an increase of 0.3 mm with raloxifene, Dr. Archer said.

About five women in each of the four treatment arms had 4 mm or more growth in endometrial thickness, but when they were biopsied, no evidence of hyperplasia was detected.

“We are not sure what the exact cause of this increase in endometrial thickness is, but it does not appear to be mycotic,” he commented.

Food and Drug Administration approval of bazedoxifene is pending, and Wyeth, the drug's developer, expects the FDA to approve it for the treatment of postmenopausal osteoporosis by the end of 2007, Dr. Archer said.

Bazedoxifene, a novel selective estrogen-receptor modulator, is as safe as placebo in terms effects on the endometrium and will be a new therapy for preventing and treating postmenopausal osteoporosis, according to data presented at the annual meeting of the North American Menopause Society.

Dr. David F. Archer, professor of obstetrics and gynecology at Eastern Virginia Medical School, Norfolk, and a consultant for Wyeth Pharmaceuticals (the study's sponsor), presented data on endometrial safety in a subset of women in a large phase III trial comparing the efficacy of bazedoxifene, raloxifene, and placebo in reducing the relative risk of new vertebral fractures.

The results of that trial found bazedoxifene at 20 mg or 40 mg per day significantly reduced new vertebral fractures, versus placebo. Similar results were obtained with raloxifene 60 mg per day.

However, in the subanalysis raloxifene was linked to more endometrial hyperplasia, Dr. Archer said.

“Importantly, bazedoxifene exerted its beneficial effect on bone without increasing endometrial thickness or causing endometrial bleeding,” Dr. Archer added in an interview.

The endometrial safety substudy focused on 643 women who had transvaginal ultrasonography at baseline and at month 24. Endometrial biopsies also were performed at these two time points.

Endometrial thickness between baseline and 24 months increased by 0.1 mm with both doses of bazedoxifene and placebo, compared with an increase of 0.3 mm with raloxifene, Dr. Archer said.

About five women in each of the four treatment arms had 4 mm or more growth in endometrial thickness, but when they were biopsied, no evidence of hyperplasia was detected.

“We are not sure what the exact cause of this increase in endometrial thickness is, but it does not appear to be mycotic,” he commented.

Food and Drug Administration approval of bazedoxifene is pending, and Wyeth, the drug's developer, expects the FDA to approve it for the treatment of postmenopausal osteoporosis by the end of 2007, Dr. Archer said.

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 with metabolic syndrome—but no recognized atherosclerosis—using magnetic resonance imaging. The patients' average age was 47 years (range 30–59).

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 to answer this question,” she said.

MRI images show epicardial fat (bright ring) in a woman with a BMI of 44 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 with metabolic syndrome—but no recognized atherosclerosis—using magnetic resonance imaging. The patients' average age was 47 years (range 30–59).

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 to answer this question,” she said.

MRI images show epicardial fat (bright ring) in a woman with a BMI of 44 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 with metabolic syndrome—but no recognized atherosclerosis—using magnetic resonance imaging. The patients' average age was 47 years (range 30–59).

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 to answer this question,” she said.

MRI images show epicardial fat (bright ring) in a woman with a BMI of 44 kg/m

NEW ORLEANS —A low-carbohydrate diet, which used to be the only treatment for diabetes before the advent of insulin, may turn out to be the preferred diet for overweight individuals with type 2 diabetes, researchers said at the annual meeting of NAASO, the Obesity Society.

In a poster, preliminary results from a randomized trial of two dietary regimens for weight loss—a low-carbohydrate, ketogenic diet alone, or a low-fat, energy-restricted diet plus drug therapy with orlistat (Xenical) —showed that the low-carb regimen produced more favorable changes in hemoglobin A_1c (HbA_1c) in a subset of diabetic patients. The diet also reduced or eliminated their need for insulin or other diabetes medications, more so than the orlistat diet, said Jennifer R. McDuffie, Ph.D., of Duke University, Durham, N.C.

In the 6 months that the trial has been ongoing, weight loss with both regimens has been similar (10–12 kg) and so has the reduction in waist circumference. “Because the weight loss has been the same in both groups, we think that the low-carbohydrate ketogenic diet may be exerting its good effects on HbA_1c because of its low carbohydrate content,” Dr. McDuffie said in an interview.

The study, which is planned to last 48 weeks, includes 146 outpatients from the Durham Veterans Affairs Medical Center. All have a body mass index 27 kg/m

After 24 weeks, the mean HbA_1c among the 22 type 2 diabetes patients in the low- carb arm dropped from 7.5% to 6.8%, a significant reduction. The HbA_1c in the 24 type 2 diabetes patients in the orlistat arm went from 7.6 to 7.4, and did not fall significantly from baseline, Dr. McDuffie said.

The need for metformin was decreased or eliminated in 15 (68%) of the 22 patients on the low-carbohydrate ketogenic diet, compared with 7 (29%) of the 24 patients on the orlistat low-fat diet. The low-carbohydrate ketogenic diet also had a favorable effect on HDL-cholesterol levels in all patients, regardless of their type 2 diabetes status. The mean increase in HDL cholesterol was 4 mg/dL in the low-carb group, compared with 0.4 mg/dL in the orlistat group.

Dr. McDuffie stressed that these results are preliminary, and that further analysis of factors such as adherence, physical activity, and adverse events is needed.

NEW ORLEANS —A low-carbohydrate diet, which used to be the only treatment for diabetes before the advent of insulin, may turn out to be the preferred diet for overweight individuals with type 2 diabetes, researchers said at the annual meeting of NAASO, the Obesity Society.

In a poster, preliminary results from a randomized trial of two dietary regimens for weight loss—a low-carbohydrate, ketogenic diet alone, or a low-fat, energy-restricted diet plus drug therapy with orlistat (Xenical) —showed that the low-carb regimen produced more favorable changes in hemoglobin A_1c (HbA_1c) in a subset of diabetic patients. The diet also reduced or eliminated their need for insulin or other diabetes medications, more so than the orlistat diet, said Jennifer R. McDuffie, Ph.D., of Duke University, Durham, N.C.

In the 6 months that the trial has been ongoing, weight loss with both regimens has been similar (10–12 kg) and so has the reduction in waist circumference. “Because the weight loss has been the same in both groups, we think that the low-carbohydrate ketogenic diet may be exerting its good effects on HbA_1c because of its low carbohydrate content,” Dr. McDuffie said in an interview.

The study, which is planned to last 48 weeks, includes 146 outpatients from the Durham Veterans Affairs Medical Center. All have a body mass index 27 kg/m

After 24 weeks, the mean HbA_1c among the 22 type 2 diabetes patients in the low- carb arm dropped from 7.5% to 6.8%, a significant reduction. The HbA_1c in the 24 type 2 diabetes patients in the orlistat arm went from 7.6 to 7.4, and did not fall significantly from baseline, Dr. McDuffie said.

The need for metformin was decreased or eliminated in 15 (68%) of the 22 patients on the low-carbohydrate ketogenic diet, compared with 7 (29%) of the 24 patients on the orlistat low-fat diet. The low-carbohydrate ketogenic diet also had a favorable effect on HDL-cholesterol levels in all patients, regardless of their type 2 diabetes status. The mean increase in HDL cholesterol was 4 mg/dL in the low-carb group, compared with 0.4 mg/dL in the orlistat group.

Dr. McDuffie stressed that these results are preliminary, and that further analysis of factors such as adherence, physical activity, and adverse events is needed.

NEW ORLEANS —A low-carbohydrate diet, which used to be the only treatment for diabetes before the advent of insulin, may turn out to be the preferred diet for overweight individuals with type 2 diabetes, researchers said at the annual meeting of NAASO, the Obesity Society.

In a poster, preliminary results from a randomized trial of two dietary regimens for weight loss—a low-carbohydrate, ketogenic diet alone, or a low-fat, energy-restricted diet plus drug therapy with orlistat (Xenical) —showed that the low-carb regimen produced more favorable changes in hemoglobin A_1c (HbA_1c) in a subset of diabetic patients. The diet also reduced or eliminated their need for insulin or other diabetes medications, more so than the orlistat diet, said Jennifer R. McDuffie, Ph.D., of Duke University, Durham, N.C.

In the 6 months that the trial has been ongoing, weight loss with both regimens has been similar (10–12 kg) and so has the reduction in waist circumference. “Because the weight loss has been the same in both groups, we think that the low-carbohydrate ketogenic diet may be exerting its good effects on HbA_1c because of its low carbohydrate content,” Dr. McDuffie said in an interview.

The study, which is planned to last 48 weeks, includes 146 outpatients from the Durham Veterans Affairs Medical Center. All have a body mass index 27 kg/m

After 24 weeks, the mean HbA_1c among the 22 type 2 diabetes patients in the low- carb arm dropped from 7.5% to 6.8%, a significant reduction. The HbA_1c in the 24 type 2 diabetes patients in the orlistat arm went from 7.6 to 7.4, and did not fall significantly from baseline, Dr. McDuffie said.

The need for metformin was decreased or eliminated in 15 (68%) of the 22 patients on the low-carbohydrate ketogenic diet, compared with 7 (29%) of the 24 patients on the orlistat low-fat diet. The low-carbohydrate ketogenic diet also had a favorable effect on HDL-cholesterol levels in all patients, regardless of their type 2 diabetes status. The mean increase in HDL cholesterol was 4 mg/dL in the low-carb group, compared with 0.4 mg/dL in the orlistat group.

Dr. McDuffie stressed that these results are preliminary, and that further analysis of factors such as adherence, physical activity, and adverse events is needed.

Bazedoxifene, a novel selective estrogen-receptor modulator, is as safe as placebo in terms of effects on the endometrium and promises to be an excellent new therapy for the prevention and treatment of postmenopausal osteoporosis, Dr. David F. Archer said at the annual meeting of the North American Menopause Society. Dr. Archer, professor of obstetrics and gynecology at Eastern Virginia Medical School, Norfolk, and a consultant for Wyeth Pharmaceuticals, the sponsor of the study, presented data on endometrial safety in a subset of women who were participants in a large phase III trial comparing the efficacy of bazedoxifene, raloxifene, and placebo in reducing the relative risk of new vertebral fractures in 7,492 subjects.

The results of that trial, presented at the annual meeting of the American Society for Bone and Mineral Research, found bazedoxifene at 20 mg or 40 mg per day significantly reduced new vertebral fractures, compared with placebo. Similar results also were obtained with raloxifene 60 mg per day. However, in the subanalysis raloxifene was linked to more endometrial hyperplasia, Dr. Archer said.

The endometrial safety substudy focused on 643 women who had transvaginal ultrasonography at baseline and at month 24. Endometrial biopsies also were performed at these two time points.

Endometrial thickness between baseline and 24 months increased by 0.1 mm with both doses of bazedoxifene and placebo, compared with an increase of 0.3 mm with raloxifene, Dr. Archer said.

About five women in each of the four treatment arms had 4 mm or more growth in endometrial thickness, but when they were biopsied, no evidence of hyperplasia was detected.

Food and Drug Administration approval of bazedoxifene is pending.

Bazedoxifene, a novel selective estrogen-receptor modulator, is as safe as placebo in terms of effects on the endometrium and promises to be an excellent new therapy for the prevention and treatment of postmenopausal osteoporosis, Dr. David F. Archer said at the annual meeting of the North American Menopause Society. Dr. Archer, professor of obstetrics and gynecology at Eastern Virginia Medical School, Norfolk, and a consultant for Wyeth Pharmaceuticals, the sponsor of the study, presented data on endometrial safety in a subset of women who were participants in a large phase III trial comparing the efficacy of bazedoxifene, raloxifene, and placebo in reducing the relative risk of new vertebral fractures in 7,492 subjects.

The results of that trial, presented at the annual meeting of the American Society for Bone and Mineral Research, found bazedoxifene at 20 mg or 40 mg per day significantly reduced new vertebral fractures, compared with placebo. Similar results also were obtained with raloxifene 60 mg per day. However, in the subanalysis raloxifene was linked to more endometrial hyperplasia, Dr. Archer said.

The endometrial safety substudy focused on 643 women who had transvaginal ultrasonography at baseline and at month 24. Endometrial biopsies also were performed at these two time points.

Endometrial thickness between baseline and 24 months increased by 0.1 mm with both doses of bazedoxifene and placebo, compared with an increase of 0.3 mm with raloxifene, Dr. Archer said.

About five women in each of the four treatment arms had 4 mm or more growth in endometrial thickness, but when they were biopsied, no evidence of hyperplasia was detected.

Food and Drug Administration approval of bazedoxifene is pending.

Bazedoxifene, a novel selective estrogen-receptor modulator, is as safe as placebo in terms of effects on the endometrium and promises to be an excellent new therapy for the prevention and treatment of postmenopausal osteoporosis, Dr. David F. Archer said at the annual meeting of the North American Menopause Society. Dr. Archer, professor of obstetrics and gynecology at Eastern Virginia Medical School, Norfolk, and a consultant for Wyeth Pharmaceuticals, the sponsor of the study, presented data on endometrial safety in a subset of women who were participants in a large phase III trial comparing the efficacy of bazedoxifene, raloxifene, and placebo in reducing the relative risk of new vertebral fractures in 7,492 subjects.

The results of that trial, presented at the annual meeting of the American Society for Bone and Mineral Research, found bazedoxifene at 20 mg or 40 mg per day significantly reduced new vertebral fractures, compared with placebo. Similar results also were obtained with raloxifene 60 mg per day. However, in the subanalysis raloxifene was linked to more endometrial hyperplasia, Dr. Archer said.

The endometrial safety substudy focused on 643 women who had transvaginal ultrasonography at baseline and at month 24. Endometrial biopsies also were performed at these two time points.

Endometrial thickness between baseline and 24 months increased by 0.1 mm with both doses of bazedoxifene and placebo, compared with an increase of 0.3 mm with raloxifene, Dr. Archer said.

About five women in each of the four treatment arms had 4 mm or more growth in endometrial thickness, but when they were biopsied, no evidence of hyperplasia was detected.

Food and Drug Administration approval of bazedoxifene is pending.

TORONTO — Ulceration and depth of invasion should be included in the staging of Merkel cell cancers, as they are for the staging of melanoma, because of the strong similarities between the two types of neoplasm, Dr. Ralph L. George and Dr. A. McGuire said in a poster presented at the annual meeting of the Canadian Association of Thoracic Surgeons.

As with melanoma, ulceration in a primary Merkel cell cancer appears to be an indication that the tumor has spread.

An analysis of 14 Merkel cell cancer cases found that ulceration was significantly associated with metastatic disease. Depth of invasion was also a sign of advanced disease that "approached but did not achieve statistical significance," Dr. George said in an interview.

Merkel cell cancer is a rare form of cutaneous neuroendocrine neoplasm that is known to have a poor prognosis, but there is limited information on staging Merkel cell cancer and no data on the prognostic significance of ulceration, wrote Dr. George and Dr. McGuire of Kingston (Ont.) Regional Cancer Centre, Queen's University.

After noticing that patients coming to their clinic with either of the cancers had the same risk factors, the physicians decided to compare the prognostic and etiologic characteristics of 232 melanoma cases with those of the Merkel cases.

They documented several important similarities. Like melanoma, Merkel cell cancer was most common in type I, II, and III skin and on sun-exposed areas of the body. In fact, Merkel cell cancer's relationship with sun exposure was "even stronger than that of the melanomas, with a P value equal to .026 for the comparison," Dr. George said.

Like melanoma, Merkel cell cancer occurred more in older patients and showed a propensity for full-thickness skin invasion, metastases to regional lymph nodes, and systemic failure.

These data are preliminary and need to be confirmed in a larger study. "Knowing about the staging [may] lead to better treatment. We have systemic treatment for melanoma but we do not have … an effective systemic treatment for Merkel at this time. If we can predict a group who are likely to fail, we can perhaps target them with adjuvant therapy," Dr. George said.

TORONTO — Ulceration and depth of invasion should be included in the staging of Merkel cell cancers, as they are for the staging of melanoma, because of the strong similarities between the two types of neoplasm, Dr. Ralph L. George and Dr. A. McGuire said in a poster presented at the annual meeting of the Canadian Association of Thoracic Surgeons.

As with melanoma, ulceration in a primary Merkel cell cancer appears to be an indication that the tumor has spread.

An analysis of 14 Merkel cell cancer cases found that ulceration was significantly associated with metastatic disease. Depth of invasion was also a sign of advanced disease that "approached but did not achieve statistical significance," Dr. George said in an interview.

Merkel cell cancer is a rare form of cutaneous neuroendocrine neoplasm that is known to have a poor prognosis, but there is limited information on staging Merkel cell cancer and no data on the prognostic significance of ulceration, wrote Dr. George and Dr. McGuire of Kingston (Ont.) Regional Cancer Centre, Queen's University.

After noticing that patients coming to their clinic with either of the cancers had the same risk factors, the physicians decided to compare the prognostic and etiologic characteristics of 232 melanoma cases with those of the Merkel cases.

They documented several important similarities. Like melanoma, Merkel cell cancer was most common in type I, II, and III skin and on sun-exposed areas of the body. In fact, Merkel cell cancer's relationship with sun exposure was "even stronger than that of the melanomas, with a P value equal to .026 for the comparison," Dr. George said.

Like melanoma, Merkel cell cancer occurred more in older patients and showed a propensity for full-thickness skin invasion, metastases to regional lymph nodes, and systemic failure.

These data are preliminary and need to be confirmed in a larger study. "Knowing about the staging [may] lead to better treatment. We have systemic treatment for melanoma but we do not have … an effective systemic treatment for Merkel at this time. If we can predict a group who are likely to fail, we can perhaps target them with adjuvant therapy," Dr. George said.

TORONTO — Ulceration and depth of invasion should be included in the staging of Merkel cell cancers, as they are for the staging of melanoma, because of the strong similarities between the two types of neoplasm, Dr. Ralph L. George and Dr. A. McGuire said in a poster presented at the annual meeting of the Canadian Association of Thoracic Surgeons.

As with melanoma, ulceration in a primary Merkel cell cancer appears to be an indication that the tumor has spread.

An analysis of 14 Merkel cell cancer cases found that ulceration was significantly associated with metastatic disease. Depth of invasion was also a sign of advanced disease that "approached but did not achieve statistical significance," Dr. George said in an interview.

Merkel cell cancer is a rare form of cutaneous neuroendocrine neoplasm that is known to have a poor prognosis, but there is limited information on staging Merkel cell cancer and no data on the prognostic significance of ulceration, wrote Dr. George and Dr. McGuire of Kingston (Ont.) Regional Cancer Centre, Queen's University.

After noticing that patients coming to their clinic with either of the cancers had the same risk factors, the physicians decided to compare the prognostic and etiologic characteristics of 232 melanoma cases with those of the Merkel cases.

They documented several important similarities. Like melanoma, Merkel cell cancer was most common in type I, II, and III skin and on sun-exposed areas of the body. In fact, Merkel cell cancer's relationship with sun exposure was "even stronger than that of the melanomas, with a P value equal to .026 for the comparison," Dr. George said.

Like melanoma, Merkel cell cancer occurred more in older patients and showed a propensity for full-thickness skin invasion, metastases to regional lymph nodes, and systemic failure.

These data are preliminary and need to be confirmed in a larger study. "Knowing about the staging [may] lead to better treatment. We have systemic treatment for melanoma but we do not have … an effective systemic treatment for Merkel at this time. If we can predict a group who are likely to fail, we can perhaps target them with adjuvant therapy," Dr. George said.