A consultant to Mountain View, California-based Vivus Inc said three separate studies showed patients lost more weight when they took the highest doses of Qnexa, which is up for Food and Drug Administration approval in July.

Shares in Vivus soared 13.6 percent to $11.73 a share in early afternoon trading.

Drops in blood pressure were small but clear and equated with the weight loss, said Dr. Suzanne Oparil of the University of Alabama at Birmingham.

“The weight loss is very impressive, and it is good that there is concomitant reduction in blood pressure,” Oparil said in a telephone interview from a meeting of the American Society of Hypertension in New York.

Oparil, a past president of the American Heart Association, pooled and analyzed the results of three separate studies of Qnexa in nearly 8,000 overweight and obese patients.

“At week 58 there is a nice weight reduction,” she said. The higher the dose, the more weight loss and the more blood pressure went down, she said.

The patients who got the highest dose along with diet and exercise advice lost about 10 percent of their body weight on average, she said.

Vivus is trying to improve on the notorious “fen-phen” combination pulled off the market in 1997 after it was found to damage the heart and cause sometimes fatal cases of pulmonary hypertension.

IMPROVING HEALTH

Fen-phen combined fenfluramine and phentermine. Phentermine, a stimulant now available generically, appears safe and is used at low doses in Qnexa along with the epilepsy drug topiramate, available generically and sold by Johnson & Johnson’s Ortho-McNeil unit as Topamax.

Losing just 10 percent of body weight is enough to lower cholesterol and blood pressure, reduce the risk of diabetes and early death. About 68 percent of U.S. adults are overweight or obese.

In the three studies that Oparil analyzed, about 80 percent of the patients were women, most morbidly obese with weights of 220 to 260 pounds (100 to 118 kg).

Most did not have high blood pressure but among those who did and who took the highest Qnexa dose, the systolic or top number in the blood pressure reading went down an average of 9 points, compared to 4 points for the women who got placebos.

Oparil said the most common side effects were tingling and dry mouth, each seen in 19 percent of the patients who took the highest dosages.

Topiramate acts on the nervous system and tends to act as a sedative, said Oparil. This can reduce appetite. In addition, patients said the drug made carbonated drinks taste metallic and that may have helped patients avoid sugary soft drinks.

Doses of both drugs are far lower than those usually used — when phentermine is used alone to treat obesity, for example, or when topiramate is used for epilepsy, she said.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee is tentatively scheduled to review Vivus’ Qnexa on July 15, the company said.

Thomson Pharma has forecast 2013 sales of $357 million for Qnexa. Vivus reported its first quarter 2010 results on Monday with a net loss of $18.8 million, or $0.23 per share.

Technorati Tags: blood pressure, experimental weight loss drug, lower cholesterol, phentermine, Qnexa, Topiramate, treat obesity, weight loss

As reported in The Cochrane Library, Dr. Jill L. Colquitt and colleagues, from the University of Southampton, UK, searched various electronic databases and identified 26 studies that compared weight loss surgical procedures (also called bariatric surgery) with each other or with non-surgical treatments for obesity such as drugs, diets and exercise.

The studies included three randomized trials and three prospective studies that compared surgical with non-surgical treatments. The remaining 20 studies were trials that compared various types of bariatric operations.

Overall, the authors found that surgery provided greater weight loss for any degree of obesity compared with non-surgical treatments. Surgery was also associated with reductions in diabetes, hypertension, and other co-existing conditions. Improvements in health-related quality of life were noted after 2 years, but their long-term persistence was unclear.

The bariatric operations were not free from complications, including serious ones such as pulmonary embolism and even postoperative death, the report indicates.

In the studies that compared different bariatric procedures, there was some evidence that gastric bypass provided greater weight loss than did vertical banded gastroplasty or adjustable gastric banding.

Isolated sleeve gastrectomy and banded gastric bypass both produced weight losses comparable to that seen with gastric bypass.

No statistically significant differences in weight loss or quality of life were seen between procedures performed using conventional open surgery and those using laparoscopic bariatric procedures.

Due to limited data, the authors were unable to reach firm conclusions regarding the relative safety of each bariatric operation.

While surgery produces greater weight loss than conventional obesity treatments, and exactly which procedure provides the best mix of effectiveness and safety is unclear, they note.

SOURCE: Cochrane Database System Review 2009.

Technorati Tags: obese, obese patients, obesity, obesity surgery, obesity treatments, severe obesity, weight loss, weight losses