Magazine article Drug Topics

A Near-Empty Diet Market Welcomes New Antiobesity Drug

Magazine article Drug Topics

A Near-Empty Diet Market Welcomes New Antiobesity Drug

Article excerpt

In the lingering aftermath of the recent withdrawal of two leading diet drugs, Meridia (sibutramine HCI monohydrate) enters with caution what now appears to be a virtually deserted and uncertain antiobesity market.

Although labeling warns that it is not yet known whether or not sibutramine (a norepinephrine, serotonin, and dopamine reuptake inhibitor) may cause primary pulmonary hypertension (PPH), the drug has not been associated with the potentially fatal complication or with cardiac valve dysfunction during clinical trials. Jack Rosenberg, Pharm.D., Ph.D., Arnold & Marie Schwartz College of Pharmacy & Health Sciences, Long Island University, does not anticipate appearance of those adverse effects but still cautions that long-term data have yet to confirm clinical trial findings. The observed absence of PPH is attributed to the fact that, unlike other agents, sibutramine is not known to cause release of serotonin from nerve terminals. Although it is not yet certain, experts believe that the withdrawn antiobesity drugs may have been associated with PPH and valvular disorders because of their ability to release serotonin into the circulation.

But no matter how clear the waters look this time, no one seems to be taking any chances. The drug's manufacturer, Knoll Pharmaceuticals, recently held a teleconference to announce its plans to provide physicians, allied health professionals, state medical boards, and weight-loss centers with guidelines regarding the proper use of the product. One important consideration is identifying appropriate individuals for therapy. Sibutramine is recommended only for obese patients with an initial body mass index (BMI) greater or equal to 30 kg/m2 or a BMI greater or equal to 27 kg/m2 in the presence of other risk factors, such as diabetes or dyslipidemia. In addition, "patients receiving sibutramine should be regularly monitored and comply with behavior and lifestyle modifications, which include a reduced-calorie diet and increased physical activity," said Knoll president Carter Eckert. The company is currently developing an integrated weight-management program for those who will be placed on sibutramine.

So how much weight loss can individuals expect from the new agent? Clinical trial results indicate that, on average, patients receiving various dosage levels of sibutramine, in combination with lifestyle modifications, experienced a 5% to 10% reduction in weight from baseline. Maximal weight loss was achieved by six months and maintained over 12 months.

Rosenberg feels that although sibutramine's efficacy profile is "modest," the drug's sustained actions are advantageous since obesity tends to be a chronic condition. …

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