Arena: compliant trial patients lost more weight
LOS ANGELES (Reuters) – 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.
Arena had announced in March that for the overall trial, the average weight loss of lorcaserin patients was 5.8 percent, or 12.7 pounds, while placebo patients lost 2.2 percent, or 4.7 pounds — a percentage point difference of 3.6 percent.
That news was a disappointment for Wall Street, since one of the U.S. Food and Drug Administration’s guidelines for a weight loss drug is that there be a 5 percentage point difference in weight loss between the test drug and placebo.
Looking only at patients who complied with treatment, the spread between the two groups was 4.9 points at one year, Arena said on Saturday at a meeting of the American Diabetes Association.
The company also said treatment with lorcaserin resulted in “highly significant” improvements in cardiovascular risk factors such as blood pressure and cholesterol levels.
The U.S. study showed no signs that the drug, over a two-year treatment period, increased risk of depression or heart valve damage, the problem that forced Wyeth to recall its blockbuster “fen-phen” diet drugs in 1997. The recall cost Wyeth more than $21 billion of damages and legal expenses and has long cast a shadow over obesity treatments.
Like drugs used in fen-phen, Lorcaserin affects a messenger chemical called serotonin, but is designed to selectively target only one variety of the chemical — and thereby sidestep heart-related side effects seen with Wyeth’s withdrawn pills.
Arena expects to announce in September results from a second pivotal trial of lorcaserin and said it remains focused on partnering efforts.
Source : http://news.yahoo.com/health
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