Vivus says obesity drug may fail EU test, shares fall

(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)

Vivus: EU to recommend against its obesity drug

MOUNTAIN VIEW, Calif. (AP) — Vivus Inc. said Friday it believes a panel of advisers to the European Union‘s health agency will recommend against approving its weight loss drug Qsymia.

Vivus said its opinion is based on “preliminary feedback” from the Committee for Medicinal Products for Human Use. The panel is expected to make a recommendation in October. After that the European Medicines Agency will make a ruling on the marketing of Qsymia.

If the drug is not approved, Vivus said it will file a new marketing application or appeal the agency’s decision. Vivus wants to market the drug in Europe under the name Qsiva. The drug received U.S. approval in July, and it is Vivus’ only marketed product.

Shares of Vivus fell $2.54, or 10.7 percent, to $21.18 in morning trading, but for the year to date, shares have more than doubled.

Vivus announced Monday that Qsymia is now available in the U.S., making it the first long-term prescription weight loss drug to reach the market since 1999. The Food and Drug Administration approved the drug in July for adults who are obese or overweight and have at least one weight-related condition such as high blood pressure, diabetes or high cholesterol.

The FDA also approved Arena Pharmaceuticals Inc.‘s drug Belviq in June, and Belviq is expected to go on sale in early 2013. Qsymia is generally seen as the more effective of the two drugs.

Cowen & Co. analyst Simos Simeonidis said Vivus may have trouble getting Qsiva approved because European regulators are concerned about the effects of phentermine, one of the drug’s two main ingredients. Phentermine is a stimulant that suppresses the appetite, and it was part of the fen-phen diet drug cocktail, which became a popular weight-loss prescription in the 1990s.

However fen-phen was linked to heart valve damage and the other ingredient, fenfluramine, was withdrawn from the market.

Simeonidis said that if Qsiva is not approved, it hurts Vivus’ chances of being acquired more than it would hurt the company’s revenue. He expects sales of the drug in Europe to reach about $700 million a year in 2019, and said Vivus would probably market Qsiva through a partnership that would give it around $150 million of that amount. He expects U.S. sales of Qsymia to reach $1.6 billion that year.

The analyst reiterated a “Neutral” rating on the stock.

Risk Of Diabetes Substantially Reduced By Bariatric Surgery

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

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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.”

Article adapted by Medical News Today from original press release. Click ‘references’ tab above for source.
Visit our obesity / weight loss / fitness section for the latest news on this subject.
The article, “Bariatric Surgery and Prevention of Type 2 Diabetes in Swedish Obese Persons” was published in the August 23 issue of NEJM.
FACTS ABOUT THE SOS STUDY
Swedish Obese Subjects (SOS) is one of the largest studies ever conducted on obesity treatment. The results of the study helped raise the number of bariatric operations in Sweden from a few hundred in 1987 to almost 10,000 in 2011.
University of Gothenburg
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More NJ Adults Will Be Obese By 2030, Report Finds

Americans are getting fatter.  Over the next 20 years, nine states could see their obesity-related health care costs climb more than twenty-percent.

“New Jersey is unfortunately on track to see the biggest increase of obesity related health care costs at 34 percent” said Albert Lang, of Trust For America’s Health and co-author of the report released today.

If states’ obesity rates continue on their current trajectories, the number of new cases of type 2 diabetes, coronary heart disease and stroke, hypertension and arthritis could increase 10 times between 2010 and 2020—and double again by 2030. Read more

Georgia obesity rates projected to rise

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.

Bariatric surgery substantially reduces the risk of diabetes (AlphaGalileo, 18 September 2012)

19 Sep 2012

Bariatric surgery substantially reduces the risk of diabetes (AlphaGalileo, 18 September 2012)

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Further results from the Swedish Obese Subjects study published in The New England Journal of Medicine demonstrate rates of diabetes in a 15-year follow-up of obese people undergoing bariatric surgery vs. those undergoing traditional care and lifestyle changes.

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Obesity Surgery Cuts Drug Costs (CME/CE)

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By Nancy Walsh, Staff Writer, MedPage Today

Published: September 18, 2012

Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston and Dorothy Caputo, MA, BSN, RN, Nurse Planner

Action Points

  • Explain that a long-running Swedish study found that overall hospitalizations did not decrease in patients undergoing bariatric surgery compared with controls, primarily because of increased hospital use during the first 6 years after the procedure.
  • Note, however, that drug use, especially for diabetes and cardiovascular disease, decreased for those who had the surgery compared with controls, and weight loss was sustained over the 20-year follow-up period.

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.

Support for this study and for the Swedish Obese Subjects study was provided by the Swedish Medical Research Council, the Swedish Research Council, the Swedish Foundation for Strategic Research, the Swedish government, and from Hoffmann-La Roche, AstraZeneca, Cederroth, sanofi-aventis, and Johnson & Johnson.

Several of the authors reported receiving support from companies including sanofi-aventis, Johnson & Johnson, Merck, Novo Nordisk, Hoffmann-LaRoche, Abbott, and Allergan.

From the American Heart Association:

Primary source: Journal of the American Medical Association
Source reference:
Neovius M, et al “Health care use during 20 years following bariatric surgery” JAMA 2012; 308: 1132-1141.

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Outcomes of Revisional Procedures for Insufficient Weight Loss or Weight Regain After Roux-En-Y Gastric Bypass

Background  

The Roux-en-Y gastric bypass (RYGB) performed laparoscopically (LRYGB) is the most frequently performed bariatric procedure in Belgium. However, late results in terms of weight loss or weight regain are inconsistent and may warrant a second procedure. This retrospective study analyzes the laparoscopic options for revisional surgery after LRYGB.

Methods  

Between January 1, 2001 and December 31, 2009, 70 patients underwent a new laparoscopic procedure for poor weight loss or weight regain after LRYGB. The revisional procedure was performed a median of 2.6 years after the initial bypass operation. Fifty-eight patients were available for follow-up (82.9 %); 19 underwent distalization; and 39 a new restrictive procedure.

Results  

The mean mass index (BMI) before the revisional procedure was 39.1?+?11.3 kg/m2 (30.8–51.8), down from 42.7?+?19.7 kg/m2 (33.0–56.6) initially, which corresponded to a percentage of excess weight loss (EWL) of 12.4?+?9.3 % (?1.0–29.1). After the corrective procedure, with a follow-up of approximately 4 years, mean BMI was 29.6?+?12.4 kg/m2 (18.0–45.5), for a significant additional percentage of EWL of 53.7?+?9.8 % (2.0–65.8). The overall complication rate was 20.7 %, and the reoperation rate was 7.3 %. The overall leak rate was 12.1 %. Patients suffering from leaks could consistently be treated conservatively or by stent placement. Two patients needed reconversion after distal bypass. The satisfaction index was good in just over 50 % of the patients.

Conclusion  

Revisional laparoscopic surgery after RYGB performed for weight issues provides good additional weight loss but carries significant morbidity. Leaks can usually be handled non-surgically. Patient satisfaction is only fair.

Keywords  Laparoscopic Roux-en-Y gastric bypass – Revisional surgery – Weight regain – Insufficient weight loss – Complications

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