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Compliant patients in drug trials lose more weight: firm

LOS ANGELES -- Arena Pharmaceuticals Inc. on Saturday said patients who complied with treatment during a recent pivotal trial of its experimental obesity drug lost more weight than was seen in the overall trial.

Looking only at compliant trial participants, two-thirds of patients treated for a year with the drug, lorcaserin, lost at least 5 percent of their weight, compared with 32 percent of placebo patients, the company said.

In addition, 36 percent of compliant lorcaserin patients lost at least 10 percent of their weight compared with 13.6 percent for placebo.

Of the 3,182 obese patients enrolled in the trial, 55 percent of the lorcaserin group and 45 percent of the placebo group remained after one year, according to Christy Anderson, head of clinical development at Arena.

About 7 percent of each group dropped out due to side effects, of which the most frequent was headache, according to Arena.

"We think this speaks to a very well-tolerated profile for lorcaserin," said Dominic Behan, Arena's chief scientific officer. "Patients are not dropping out due to adverse events."

Arena also said the amount of weight loss maintained by patients randomized to remain on lorcaserin for a second year was significant compared with patients switched to placebo.

Clinical trial results are typically reported on an "intent to treat," basis, meaning results from all patients, even those who do not follow through with the therapy.

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