Weight loss surgery tied to increase in drinking

People who had weight loss surgery reported greater alcohol use two years after their procedures than in the weeks beforehand, in a new study.

"This is perhaps a risk. I don't think it should deter people from having surgery, but you should be cautious to monitor (alcohol use) after surgery," Alexis Conason, who worked on the study at the New York Obesity Nutrition Research Center at St. Luke's-Roosevelt Hospital Center, told Reuters Health.

Researchers said it's possible some patients may turn to drinking if surgery successfully stops their ability to overeat without addressing their underlying issues. Or, the effects of certain types of stomach-shrinking procedures on alcohol tolerance may influence drinking habits.

Still, the new study can't show whether people were drinking in a dangerous way - and there was no clear increase in drug use or smoking after surgery.

"This does not mean that everyone who has gastric bypass surgery has problems with alcohol or becomes an alcoholic," said Conason.

Her team's study involved 155 people getting gastric bypass or gastric banding surgery, mostly women. Participants started the study with an average body mass index, or BMI, of 46 - equivalent to a five-foot, six-inch person who weighs 285 pounds.

Surgery is typically recommended for people with a BMI of at least 40, or at least 35 if they also have health problems such as diabetes or severe sleep apnea.

Alcohol use dropped immediately following surgery, from 61 percent of people who initially reported drinking to 20 percent at one month post-surgery.

But by three months, drinking rates had started to creep back up. And at two years out, people were drinking significantly more often than before their procedures, according to findings published Monday in the Archives of Surgery.

That was primarily the case for those who had gastric bypass surgery, not banding. On a scale from 0 to 10 of drinking frequency, where 0 represented never, 5 was sometimes and 10 always, gastric bypass patients reported an increase from 1.86 before surgery to 3.08 two years later.

CHANGES IN TOLERANCE
Conason said gastric bypass, in particular, has been shown to drastically lower alcohol tolerance - to the point that some post-surgery patients have a blood alcohol content above the legal driving limit after just one drink. For some, that could make drinking more appealing, she added.
The new findings are "proving more support for the idea that we really need to talk to patients about alcohol use, especially those undergoing (gastric bypass)," said Wendy King, an epidemiologist and weight loss surgery researcher at the University of Pittsburgh, who wasn't part of the study team.

According to the American Society for Metabolic and Bariatric Surgery, about 200,000 people have weight loss surgery every year. The procedures cost about $20,000 each.

Although some researchers have questioned the long-term benefits of surgery, one recent study found three-quarters of people who'd undergone gastric bypass had lost and kept off at least 20 percent of their initial pre-surgery weight six years later (see Reuters Health story of September 18, 2012).

One limitation of the new study is that only one-quarter of the initial participants were still in touch to report their current alcohol and drug use at the two-year mark - so the researchers don't know how everyone else fared.

Psychiatrist Dr. James Mitchell, who has studied alcohol use after weight loss surgery at the University of North Dakota School of Medicine and Health Sciences in Grand Forks, said there's also a need for research going out more than two years - to see if alcohol use keeps increasing.

Researchers said people who've had weight loss surgery should talk with their doctors soon if they notice themselves wanting to drink more.

"The health risks of obesity are such that people with severe obesity should not forgo bariatric surgery because of this," Mitchell, who was not involved in the new study, told Reuters Health.

But he said everyone should be warned about this possibility - and people with a history of alcohol abuse should be particularly careful.

"I don't have the impression (doctors) are talking a tremendous amount about these things," Conason said. "I think we should be. I think we should be educating patients about all the potential risks and benefits."

NEW CLASS OF DRUGS FOR OSTEOPOROSIS-CATHEPSIN K INHIBITORS

The investigational agent odanacatib appears to be an effective treatment for postmenopausal osteoporosis that persists after 3 years of alendronate therapy, according to a phase 3 trial presented here at ACR 2012.

Treatment with odanacatib significantly improved bone mineral density (BMD) at the femoral neck, hip, trochanter, and lumbar spine, compared with placebo, in postmenopausal women previously treated with alendronate. In addition, the novel agent was generally safe and tolerable.

The phase 3 trial was stopped early after an independent data and safety monitoring committee determined that odanacatib had a favorable risk/benefit profile.

"Odanacatib is a cathepsin K inhibitor that inhibits bone resorption while maintaining bone formation, whereas bisphosphonates reduce bone resorption and bone formation," said lead author Roland Chapurlat, MD, from Hôpital Edouard Herriot in Lyon, France.

"In this study of women with low bone mass after alendronate treatment, we saw no issues of excess bone formation or abnormal stress fractures," he explained.

Dr. Chapurlat noted that most studies of women with osteoporosis do not enroll previously treated women, but this study sought to determine if the drug had a benefit in previously treated patients.

The randomized double-blind placebo-controlled 24-month trial was conducted at 42 sites in 12 countries. Investigators enrolled 246 women 60 years or older with osteoporosis, and randomly assigned them to receive odanacatib 50 mg once weekly or placebo. All patients received vitamin D and calcium supplementation.

The mean age of the participants was 71.3 years, most were white, 73.7% had a history of any fracture, and 68.3% had a fracture history after menopause. The mean duration of previous alendronate therapy was 5.5 years; 55% had taken alendronate for 3 to 5 years.

"Long-term alendronate [treatment] results in persistent suppression of bone turnover, and there is a residual effect even after stopping," Dr. Chapurlat said.

For the primary end point of femoral neck BMD at 24 months, there was a 2.67% difference favoring odanacatib ( P < .001), and for total hip BMD, there was a 2.7% difference favoring odanacatib ( P < .001). For both these end points, the effect of odanacatib was seen after 6 months because of the residual effect of alendronate, Dr. Chapurlat reported.

A 3.18% difference in BMD at the trochanter and a 2.57% difference in BMD at the lumbar spine also favored odanacatib at 24 months ( P < .001 for both, compared with placebo).

At 24 months, odanacatib significantly reduced markers of bone resorption ( P < .001) and significantly increased markers of bone formation ( P = .011).

There were no significant differences in adverse events in the 2 treatment groups, although the rate of discontinuations related to adverse events was higher in the odanacatib group than in the placebo group (9% vs 3%).

The rate of fracture was lower in the odanacatib group than in the placebo group (4.9% vs 13.2%). "The study was not designed to look at fracture efficacy," Dr. Chapurlat stated.

An ongoing phase 3 trial of 16,000 women will show fracture rate; those results are expected next year, he said.

In contrast to bisphosphonates, odanacatib and denosumab are not deposited in the bone, so they should not have a long-term effect on bone turnover after drug discontinuation.

"They block osteoclasts and don't reside in the bone," said Stanley Cohen, MD, medical director of the rheumatology training program, clinical professor of internal medicine at the University of Texas Southwestern Medical School in Dallas, and past president of the ACR.

"What happens to patients who were taking alendronate and still have low bone mass? Will they respond with improvement in bone density? The answer is yes," Dr. Cohen stated.

Dr. Cohen doubts that odanacatib will replace bisphosphonates "because they cost pennies and their benefits are outstanding. But we need to define better which patients should be treated and for how long, in light of the rare cases of atypical fracture reported with long-term treatment," he said.

If long-term follow-up shows that odanacatib does reduce bone resorption and allows new bone formation to continue, this drug is likely to play a role in the treatment of osteoporosis, Dr. Cohen said.

Abbott hepatitis C drugs bring high cure rates in trial

 A trio of oral medicines from Abbott Laboratories Inc to treat hepatitis C produced unprecedented cure rates in patients who had failed to benefit from standard treatment, as well as very high cure rates for newly treated patients, Abbott said on Saturday.
Detailed data from the mid-stage trial, called Aviator, were released Saturday at the annual meeting of the American Association for the Study of Liver Disease (AASLD) in Boston.
Investors and patients have very high hopes for the Abbott drugs - a protease inhibitor called ABT-450, a polymerase inhibitor ABT-333 and ABT-267 from a class known as NS5A inhibitors. They are used without interferon, an injectable standard treatment that causes flu-like symptoms.
Abbott said it plans to move ahead with large Phase III studies of the three drugs, used either with or without the standard antiviral pill ribavirin, based on favorable results seen in patients treated for eight weeks or twelve weeks in the Aviator study. Patients in the study had the most common, and hardest-to-treat, strain of hepatitis C known as Genotype 1.
Some 93 percent of patients who failed prior therapy had a sustained virologic response (SVR), meaning they were considered cured, after 12 weeks of taking the trio of new drugs, plus ribavirin.
"Nobody anywhere has broken the 50 percent mark in (cure rates) for this population," Scott Brun, a senior Abbott research executive said in an interview. "These are robust results."
Abbott said it aims to be the first company to market an interferon-free regimen to patients with Genotype 1 infections.
Four of 448 patients in the study discontinued treatment due to adverse events, a dropout rate that Abbott said suggested the medicines were very well tolerated.
About 97 percent of previously untreated patients were considered cured after 12 weeks of treatment with the three Abbott drugs, plus ribavirin. Moreover, similarly impressive cure rates were seen among patients taking the three drugs, plus ribavirin, for 8 weeks.
Without ribavirin, 87 percent of previously untreated patients were considered cured after 12 weeks on Abbott's three drugs, Abbott said.
Rival drugmaker Gilead Sciences Inc stole a bit of Abbott's thunder on Saturday by releasing data showing a 100 percent cure rate among previously untreated genotype 1 patients who took only two of its oral treatments, plus ribavirin, for 12 weeks.
A pair of new hepatitis C drugs approved last year, Vertex Pharmaceuticals Inc's Incivek and Merck & Co's Victrelis, significantly boosted cure rates and cut treatment duration to as low as 24 weeks for some patients. But the protease inhibitors must still be taken with interferon, an injected drug that often causes severe flu-like symptoms that lead many hepatitis patients to delay or discontinue treatment.
Gilead, Bristol-Myers Squibb Co and Vertex are racing to develop interferon-free treatment regimens. They are expected to become blockbuster products, if approved, because of their far shorter treatment times and better cure rates, compared with existing drug regimens.
Many analysts view Gilead as current leader both on timing and perceived advantages of its experimental hepatitis C program.
An estimated 3 million Americans are believed infected with the virus, which quietly damages the liver over years or decades and is the biggest reason for liver transplants in the United States. Abbott said as many as 170 million people worldwide are infected.