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'BelPhen' Passes Early Safety Test

Patients lost more weight combining lorcaserin (Belviq) with phentermine than taking lorcaserin alone, but there have been some potentially Instant Slim Tengda Diet Pills adverse variations in cardiac parameters, researchers reported here.

In a phase II study, patients lost a greater proportion of their bodyweight over 12 weeks when adding twice-daily phentermine for their lorcaserin prescription, compared with lorcaserin alone (8.7% versus 3.8%), according to Steven Smith, MD, of Florida Hospital in Orlando, and colleagues.

Although rates from the primary outcome of serotonergic-related adverse events were similar across groups, changes in blood pressure and pulse rate weren't as favorable for those who added phentermine to their regimens.

The findings were presented because the only "late-late-breaking abstract" during a poster session at the Obesity Week meeting here.

Smith told MedPage Today the lorcaserin half of the combination may have mitigated some of the cardiac effects of phentermine.

"We were amazed," he said. "We realize that both of these pathways we're touching in terms of control centers within the brain are related to and associated with one another. A number of them operate in a seesaw fashion -- you will find circuits that suppress, and circuits that activate. Here, the thing is reciprocal relationships instead of additivity."

Experts have long been asking whether combining lorcaserin with phentermine may be the next big diet drug craze, since the combination could be similar to the weight-loss blockbuster Fen-Phen, which was pulled from the market for adverse cardiovascular events.

The problems were chalked up to the fenfluramine (or dexfenfluramine) component, which targeted serotonin 5-HT2B receptors that are said to be expressed in heart muscle, among other tissues. Lorcaserin instead targets 5-HT2C receptors, which the company says are not expressed within the heart, negating concerns about cardiovascular risk.

The 238 overweight and obese patients in the 12-week study were randomized to one of three groups: lorcaserin alone (10 mg twice a day) or lorcaserin plus phentermine (15 mg), either a couple of times daily.

All patients received standardized weight-loss counseling during the trial.

The primary endpoint was the proportion of patients reporting a minumum of one of nine common potential serotonergic adverse events: headache, dizziness, nausea, fatigue, xerostomia, diarrhea, vomiting, insomnia, or anxiety.

Smith said the cardiac effects were not entirely unanticipated, but "when you appear at the magnitude, it seems to become less than we typically see with phentermine alone. We know there are positive blood pressure effects with lorcaserin. This really is one of those areas where you put these two together and you may tight on blood pressure and heart rate difficulties with phentermine than we'd have normally expected."

Adam Tsai, MD, of Kaiser Permanente Colorado in Denver, and chair of The Obesity Society's public affairs committee, said the issue will be if the weight-loss benefits of the combination will outweigh the increases in these cardiovascular risk markers.

"The differences in blood pressure level changes were small compared to the heart beat changes, and there happen to be plenty of studies that would say an increase in heart rate carries an increased chance of cardiovascular events," Tsai said.

But he explained he was not worried about the risk of valvulopathy since the drug works via a different mechanism than Fen-Phen.

The most common Green Lean Body Capsule
adverse events overall were xerostomia, headache, constipation, fatigue, and dizziness.



11月7日(金)19:20 | トラックバック(0) | コメント(0) | Music | 管理

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