(Reuters) – Vivus Inc said it expects a European committee to recommend against the approval of its obesity drug Qsiva, based on preliminary feedback from the committee.

The formal decision from the European Medicines Agency‘s Committee for Medicinal Products for Human Use is expected following their October meeting.

If a negative recommendation is issued in October and depending upon issues raised, Vivus will either resubmit the marketing application at a later date or appeal the decision and request a re-examination.

“We await the official decision and the formal report which should provide us specifics on any additional requirements leading to the approval of Qsiva in Europe,” Vivus President Peter Tam said in a statement.

Qsiva was approved by the U.S. health regulators in July and was recently launched in the United States under the trade name Qsymia.

(Reporting by Esha Dey in Bangalore; Editing by Roshni Menon)

Main Category: Obesity / Weight Loss / Fitness
Also Included In: Diabetes
Article Date: 20 Sep 2012 – 1:00 PDT

Current ratings for:
Risk Of Diabetes Substantially Reduced By Bariatric Surgery

Patient / Public:
Healthcare Prof:		4 (1 votes)

Bariatric surgery reduces the long-term risk of developing diabetes by over 80 % among people with obesity. The New England Journal of Medicine (NEJM) has published the results of a study conducted at Sahlgrenska Academy, University of Gothenburg, Sweden.

A study conducted by Professor Lars Sjöström, Professor Lena Carlsson and their team at Sahlgrenska Academy, University of Gothenburg, has found that bariatric surgery is considerably more effective than traditional care and lifestyle changes in preventing diabetes among people with obesity.

The treatment group consisted of 1,658 subjects who had undergone bariatric surgery, while the control group consisted of 1,771 equally obese people who had received traditional care. During 15-year follow-up, 392 people in the control group and only 110 people in the treatment group developed diabetes.

“Our results show that bariatric surgery can reduce the risk of developing diabetes by more than 80 %”, Professor Sjöström says. “This is an extremely high figure.”

The study is based on an extensive study entitled Swedish Obese Subjects (SOS), which has given rise to more than 90 scientific articles and demonstrated that bariatric surgery is also highly beneficial when it comes to cancer, cardiovascular disease, total mortality and health-related quality of life.

“Both women and men benefited in terms of diabetes”, Professor Sjöström says, “but the degree of obesity at baseline did not affect the results.”

• Additional
• References
• Citations

ATLANTA (AP) — A new report forecasts a sharp rise in obesity in every American state over the next 20 years, though Georgia is projected to remain in the middle of the pack.

The research by Trust for America’s Health and the Robert Wood Johnson Foundation estimates that if current trends continue, 13 states would have obesity rates higher than 60 percent by 2030; 39 states would have rates topping 50 percent; and every state would exceed 40 percent.

In Georgia, the analysis found that 53.9 percent of adults would be obese, up from 28 percent now. Mississippi would remain the fattest state, with two-thirds of adults being obese. Colorado would be thinnest at 44 percent.

State rates in 2011 ranged from 20.7 percent in Colorado to 34.9 percent in Mississippi.

Action Points

Obese patients who underwent bariatric surgery had greater healthcare utilization during the first years after the procedure, but this leveled off over time and medication costs eventually were significantly lower than for patients who had not had the surgery, a Swedish study found.

During the first 6 years postsurgery, patients spent an annual mean of 1.7 days in the hospital compared with 1.2 days among controls, for an adjusted difference of 0.5 (95% CI 0.2 to 0.7, P<0.001) days, according to Martin Neovius, PhD, of the Karolinska Institute in Stockholm, and colleagues.

However, between years 7 and 20, surgery patients and controls both had an annual 1.8 in-hospital days (P=0.95), the researchers reported in the Sept. 19 Journal of the American Medical Association.

Drug costs were lower among the surgery group during this same period, however. Between years 7 and 20, the mean annual drug price tag for the surgery patients was $930, compared with $1,123 for controls (adjusted difference ?$228, 95% CI ?335 to ?121, P<0.001).

In particular, drug costs were lower for cardiovascular and diabetes treatments, “reflecting the effects of bariatric surgery on diabetes remission, diabetes prevention, and cardiovascular disease events,” the researchers noted.

Many benefits have been established for bariatric surgery among obese individuals, including reductions in rates of cardiovascular disease and diabetes, as well as decreased mortality.

Nonetheless, the long-term effects on healthcare utilization have not been established, so Neovius and colleagues examined data from the Swedish Obese Subjects study, which included 2,010 patients who had bariatric surgery and 2,037 matched controls who were given interventions such as behavior modification and lifestyle guidance.

Available data included hospitalizations beginning 4 years before the surgery through 20 years postsurgery, outpatient visits (other than primary care) between postsurgery years 2 through 20, and drug expenditures between years 7 and 20.

At baseline, patients who had the surgery were heavier and younger and more likely to smoke and have diabetes.

In almost 70% of the surgical patients, the procedure used was vertical-banded gastroplasty.

After 10 years, those who had surgery had lost 17% of their body weight. At years 15 and 20, their weight loss was maintained at 16% and 18%, respectively.

In contrast, controls gained 1% of their body weight by year 10, and lost 1% at years 15 and 20.

During the overall 20-year follow-up, the surgery group accrued 54 total hospital days compared with 40 days among controls, for an adjusted difference of 15 days (95% CI 2 to 27, P=0.03).

A year-by-year analysis determined that the greatest difference in days spent in the hospital among surgery patients was during the first year, at 9.4 versus 0.9 for controls, giving an adjusted difference of 8.4 (95% CI 7.8 to 9.1, P<0.001) days, the researchers reported.

However, the differences declined in the subsequent years, though remaining significant, to 1 (95% CI 0.6 to 1.4, P<0.001) during the second year, 0.4 (95% CI 0.1 to 0.7, P=0.02) during the third year, and 0.5 (95% CI 0.1 to 0.9, P=0.02) in the fourth year.

By the fifth year, differences in in-hospital days no longer were seen.

These increased hospitalizations in the surgery group most likely related to the need for surgical revisions and management of complications, as well as for gallstones and anemia, according to the researchers.

For nonprimary care outpatient visits, the surgery group again had more usage between years 2 and 6, with an adjusted mean difference of 0.3 (95% CI 0.1 to 0.4, P=0.003) visits.

Beginning in year 7, however, no differences were seen (adjusted mean difference ?0.2, 95% CI ?0.4 to 0.1, P=0.12).

The researchers conceded that an overall reduction in healthcare usage was not seen in the study.

Despite the benefits of surgery on chronic disease, “translating these benefits into reduced healthcare resource use may not be evident for many years because these diseases take many years before they become problematic,” they explained.

Limitations of the study included a lack of randomization, no information on primary care outpatient visits, and changes in surgical procedures since the early years of enrollment in the cohort.

From the American Heart Association:

• Bariatric Surgery and Cardiovascular Risk Factors

ADVERTISEMENT

ADVERTISEMENT