A five-year cardiovascular outcomes study is among the postmarketing requirements the Food and Drug ...

1. Weight-loss drug approved, with stipulations.
A five-year cardiovascular outcomes study is among the postmarketing requirements the Food and
Drug Administration is imposing on the manufacturer of the phentermine-topiramate combination
product that was approved as a weight-loss treatment.
The combination of an immediate-release formulation of phentermine
phentermine /phen·ter·mine/ (fen´ter-men) a sympathomimetic amine related to amphetamine,
used as an anorectic either as the hydrochloride salt or as the base complexed with an ion exchange
resin. Â and a controlled-release formulation topiramate was approved for the treatment of adults
with a body mass index of at least 30 kg/[m.sup.2], or those with a BMI BMIÂ body mass index.
BMI
abbr.
body mass indexBody mass index (BMI)
A measurement that has replaced weight as the preferred determinant of obesity. Â of at least 27
who also have weight-related comorbidities, in combination with diet and exercise. Phentermine, a
sympathomimetic amine sympathomimetic amine
n.
An agent that elicits physiological responses similar to those produced during adrenergic nerve
activity. Also called adrenergic amine, adrenomimetic amine, sympathetic amine. Â approved for
short-term weight loss, has been marketed in the United States since 1959; topiramate, an
antiseizure medication, was approved for treating adult epilepsy in 1996, migraine prophylaxis in
2004, and pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children.
pe·di·at·ric
adj.
Of or relating to pediatrics. Â epilepsy in 2011.
It was approved with a risk evaluation and mitigation strategy (REMS) that addresses the
teratogenicity ter·a·to·ge·nic·i·ty
n.
The capability of producing fetal malformation.
teratogenicity, (ter'·  of topiramate, which is known to increase the risk of oral clefts at the higher
doses used for treating epilepsy, and the possible adverse cardiac effects of phentermine, which
increases the pulse rate pulse rate

2. n.
The rate of the pulse as observed in an artery, expressed as beats per minute. . The REMS includes a
patient medication guide that is provided with each filled prescription, health care provider training,
and distribution of the product through certified pharmacies.
It will be marketed by Vivus as Qsymia. After a starting dose of 3.75 mg/23 mg of
phentermine/topiramate daily for 2 weeks, the recommended dose is 7.5 mg of phentermine with 46
mg of extended-release topiramate. A higher dose (15 mg/92 mg) is available for select patients who
do not reach their weight-loss goal.
In the approval letter for Qsymia, the FDA stated that because there have been signals of a serious
risk of major adverse cardiovascular events with some medications developed for treating obesity,
and available data "have not definitively excluded the potential for this serious risk" with the
phentermine-topiramate combination, only a clinical trial will be "sufficient to assess a signal of a
serious risk of major adverse cardiovascular events with anti-obesity medications, including
Qsymia."
The study, to be completed in June 2017, will be a randomized, double-blind, placebo-controlled trial
that will evaluate the effect of long-term treatment with Qsymia on the incidence of major adverse
cardiovascular events (nonfatal myocardial infarction myocardial infarction:Â see under infarction. ,
nonfatal stroke, and cardiovascular death) in obese and overweight people with cardiovascular
disease or multiple cardiovascular risk factors.
Approval was based on the results of two 1-year studies involving nearly 4,000 obese and overweight
people, mostly white women, with and without significant comorbidities, comparing phentermine-topiramate
to placebo. Patients on the recommended and the higher doses of phentermine-topiramate
lost an average of 6.7% and 8.9% of their weight, respectively, over those on placebo.
One of the two FDA advisory panelists voting against approval at a February meeting was Dr.
Michael Lauer, director of the division of cardiovascular sciences at the National Heart, Lung, and
Blood Institute in Bethesda, Md. Explaining his vote at the meeting, he said that based on the data
available, "there's a real possibility that this agent ... may help people lose weight, it may make the
chemistry tests look better, and yet it may wind up causing heart attacks, strokes, and higher death
rates."
Qsymia is the second drug product approved for weight loss in 13 years.
The prescribing information is available at vivus.com/docs/QsymiaPI.pdf.
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