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Qsymia weight loss med now available

Robin Wulffson MD's picture
Qsymia, Vivus, weight loss, clinical trials, effective, obesity

Obesity is currently of epidemic proportions and now a new product is available to help individuals suffering from excess poundage. On September 18, the pharmaceutical manufacturer announced that Qsymia (pronounced Kyoo sim ee’ uh) is now available.

Qsymia is FDA-approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 or greater (obese), or 27 or greater (overweight) in the presence of at least one weight-related comorbidity, such as hypertension, type 2 diabetes mellitus or high cholesterol (dyslipidemia). Vivus notes that Qsymia is the first FDA-approved once daily combination therapy, as well as the first new medication available in 13 years, for the treatment of obesity.

Vivus notes that it is formally introducing Qsymia to medical professionals this week at The Obesity Society's Annual Scientific Meeting in San Antonio, Texas. “Vivus is proud to be leading the way in the treatment of obesity, a disease with very serious health consequences,” noted Peter Tam, President of VIVUS. He added, “Qsymia is the first-ever combination treatment made available, and today’s introduction marks a new beginning for many patients who struggle with obesity. We are excited about making this new treatment option available to patients because Qsymia is the first FDA-approved oral medication that has been shown to achieve an average weight loss of 10% in obese patients when used in conjunction with a lifestyle modification program.”

To help ensure healthcare providers and patients are properly educated, Vivus is emphasizing the Qsymia Risk Evaluation and Mitigation Strategy (REMS) program, which includes a Medication Guide, healthcare provider training, patient brochure and other education tools. As part of the REMS program, Qsymia is available only through certified mail order pharmacies that are part of the Qsymia Home Delivery Network including CVS Pharmacy and Walgreens.

Vivus notes that many factors contribute to excess weight gain. These include environmental factors, genetics, health conditions or certain medications, emotional factors and other behaviors.

All this contributes to more than 110 million Americans being obese or overweight with at least one weight-related comorbidity. Excess weight increases the risk of conditions including type 2 diabetes, high cholesterol, high blood pressure, heart disease, sleep apnea, stroke and osteoarthritis. According to the National Institutes of Health (NIH), losing just 10% of body weight may help obese patients reduce the risk of developing other medical conditions, while making a meaningful difference in health and well-being.

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On July 17, the US Food and Drug Administration (FDA) approved Qsymia (phentermine and topiramate extended-release) as a supplement to a reduced-calorie diet and exercise for chronic weight management. In clinical trials, Qsymia, was found to have the greatest weight loss of three drugs under consideration for FDA approval. However, as is the case with most pharmaceuticals, there is a down side.

Qsymia is a combination of two FDA-approved drugs, phentermine and topiramate, in an extended-release formulation. Phentermine is indicated for short-term weight loss in overweight or obese adults who are exercising and eating a reduced calorie diet. Topiramate is indicated to treat certain types of seizures in people who have epilepsy and to prevent migraine headaches. The safety and efficacy of Qsymia were evaluated in two randomized, placebo-controlled trials that included approximately 3,700 obese and overweight patients with and without significant weight-related conditions treated for one year. All patients received lifestyle modification that consisted of a reduced calorie diet and regular physical activity. Compared to the placebo, after one year of treatment with the recommended daily dose of Qsymia, patients had an average weight loss of 6.7%; those on the highest recommended percent experienced an 8.9% weight loss. Approximately 62% of patients on the recommended dose lost at least 5% of their body weight; 69% of patients on the highest recommended dose lost at least 5% of their body weight. In comparison, about 20% of patients treated with the placebo lost 5% of their body weight.

Now for the down-side: Qsymia carries a risk of birth defects if used by pregnant women and can cause elevated heart rates as well as cognitive problems. The medication should not be used during pregnancy because it can cause fetal harm. Studies have found that a fetus exposed to the Qsymia component topiramate in the first trimester of pregnancy (first three months) has an increased risk of oral clefts (cleft lip with or without cleft palate). Thus, the FDA cautions that women of reproductive potential must not be pregnant when starting Qsymia therapy or become pregnant while taking Qsymia. Females of reproductive potential should have a negative pregnancy test before starting Qsymia and every month while using the drug and should use effective contraception consistently while taking Qsymia.

Qsymia must not be used in patients with glaucoma or hyperthyroidism. Qsymia can increase heart rate. The FDA notes that the this drug’s effect on heart rate in patients at high risk for heart attack or stroke is not known; therefore, the use of Qsymia in patients with recent (within the last six months) or unstable heart disease or stroke is not recommended. Regular monitoring of heart rate is recommended for all patients taking Qsymia, especially when starting Qsymia or increasing the dose. The FDA provided no information regarding cognitive problems in its press release.

The FDA notes that the most common side effects of Qsymia are tingling of hands and feet (paresthesia), dizziness, altered taste sensation, insomnia, constipation, and dry mouth. The recommended daily dose of Qsymia contains 7.5 milligrams of phentermine and 46 mg of topiramate extended-release. Qsymia is also available at a higher dose (15 mg phentermine and 92 mg of topiramate extended-release) for select patients. Patients who did not lose at least 3% of their body weight by week 12 of treatment with Qsymia were unlikely to achieve and sustain weight loss with continued treatment at this dose. Therefore, the FDA recommends that the response to therapy with the recommended daily dose of Qsymia should be evaluated by 12 weeks to determine, based on the amount of weight loss, whether to discontinue Qsymia or increase to the higher dose. If after 12 weeks on the higher dose of Qsymia, a patient does not lose at least 5% of body weight, then Qsymia should be discontinued, as these patients are unlikely to achieve clinically meaningful weight loss with continued treatment.

Reference: Vivus

See also: Weight loss drug Qsymia found effective for slashing pounds