World News: 12:30 GMT Monday 14th January 2019. [VIVUS, Inc. via Globe Newswire via SPi World News]
CAMPBELL, Calif., Jan. 14, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq: VVUS; the “Company”), a biopharmaceutical company, today announced that results from a new study evaluating the cardiovascular safety of Qsymia (phentermine and topiramate extended-release) capsules CIV will be published in the February 1, 2019 issue of and are currently available . This retrospective study, conducted using medical claims databases, was prompted by the observation in clinical trials that participants taking Qsymia had higher heart rates than those taking placebo. The new findings indicate that the combined risk of major adverse cardiovascular events (MACE) was not elevated in patients currently taking Qsymia, or concurrently taking both phentermine and topiramate, compared with former users of these medications. The number of MACE events (3 events during 3,245 person-years of follow-up) was too few to draw a definitive conclusion from the data. Results from the study were previously presented in a poster at the 34 International Conference on Pharmacoepidemiology & Therapeutic Risk Management in August 2018.
“The results of this study provide some assurance that, despite the increase in heart rate seen in the clinical trials, current use of phentermine in combination with topiramate did not appear to be associated with a higher cardiovascular risk. We note that the confidence intervals for this observation were broad, indicating that the data were imprecise and compatible with a considerable range of possible effects,” said Peter R. Kowey, MD, Emeritus Chief, Cardiology at Lankenau Heart Institute, Professor of Medicine and Pharmacology at Jefferson Medical College in Philadelphia, and an author on the publication.
“Obesity is a significant and growing problem in the United States. Safe and effective tools for managing body weight and body mass index are critical for helping patients reduce the risks of overall cardiovascular and diabetes-related mortality, which are increased in obese individuals. Qsymia provides a safe and efficacious option for patients seeking to manage body weight and body mass index,” said Santosh T. Varghese, MD, Chief Medical Officer at VIVUS.
More than 500,000 patients were included in this retrospective study, which evaluated risk of MACE among current users of Qsymia, phentermine and topiramate in combination (PHEN/TPM), phentermine (PHEN), and topiramate (TPM), compared to the risk among patients who were former users who had discontinued these medications. MACE was defined as hospitalization for acute myocardial infarction (AMI) or stroke or in-hospital cardiovascular-related death, as determined via discharge status and ICD-9-CM diagnoses.
“Qsymia is an effective tool as a component of body mass index management regimens. These study results provide additional evidence that its use does not increase MACE risk,” said John Amos, Chief Executive Officer at VIVUS. “We intend to include these findings in our ongoing discussions with the U.S. Food and Drug Administration related to our requested label modification for Qsymia. The requested modification would allow for the safe and effective short-term use of Qsymia and could potentially reduce or modify the need for a cardiovascular outcomes study.”
The efficacy and safety of Qsymia have been demonstrated in multiple clinical trials and peer-reviewed publications, including:
Qsymia is approved in the United States and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m or greater (obese) or 27 kg/m or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol.
The effect of Qsymia on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established.
Qsymia (phentermine and topiramate extended-release) capsules CIV is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors; or in patients with hypersensitivity to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.
Qsymia can cause fetal harm. Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy. If a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus.
The most commonly observed side effects in controlled clinical studies, 5% or greater and at least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.
VIVUS is a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs. For more information about the Company, please visit .
___________________________ Ritchey ME, Harding A, Hunter S, Peterson C, Sager PT, Kowey PR, et al. Cardiovascular safety during and after use of phentermine and topiramate. J Clin Endocrinol Metab 2019;104(2):513-522. Allison DB, Gadde KM, Garvey WT, Peterson CA, Schwiers ML, Najarian T, et al. Controlled-release phentermine/topiramate in severely obese adults: a randomized controlled trial (EQUIP). Obesity 2012;20(2):330-42. Gadde KM, Allison DB, Ryan DH, Peterson CA, Troupin B, Schwiers, et al. Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial. Lancet 2011;37(9774):1341-52. Garvey TW, Ryan DH, Look M, Gadde KM, Allison DB, Peterson CA, Schwiers M, et al. Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study. Am J Clin Nutr 2012; 95(2):297-308. Garvey TW, Ryan DH, Henry R, Bohannon NJV, Toplak H, Schwiers M, et al. Prevention of Type 2 diabetes in subjects with prediabetes and metabolic syndrome treated with phentermine and topiramate extended release. Diabetes Care 2014;37(4):912-21. Winslow DH, Bowden CH, DiDonato KP and McCullough PA. A randomized, double-blind, placebo-controlled study of an oral, extended-release formulation of phentermine/topiramate for the treatment of obstructive sleep apnea in obese adults. Sleep 2012;35(11):1529-39.
Globe Newswire: 12:30 GMT Monday 14th January 2019
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