VIVUS LLC announced the United States Food and Drug Administration (FDA) approved a labeling update for QSYMIA® (phentermine and topiramate extended-release capsules CIV). This update removed specific body mass index (BMI) requirements and warnings or precautions regarding increase in heart rate, risk of hypoglycemia in people with type 2 diabetes taking anti-diabetic therapy, and risk of hypotension in people taking antihypertensive medication. The revised QSYMIA label includes data from the first head-to-head, randomized, double-blind clinical trial of phentermine.
The post-marketing study assessed ambulatory blood pressure (ABPM) for eight weeks in patients with overweight or obesity who also had at least one weight-related comorbidity (i.e., hypertension, dyslipidemia, impaired fasting glucose or glucose tolerance, type 2 diabetes mellitus, or obstructive sleep apnea). Key findings from this study include: The placebo-adjusted difference in systolic blood pressure was ?3.2 mmHg for QSYMIA and +1.5 mmHg for phentermine, corresponding to a mean treatment difference of ?4.7 mmHg for QSYMIA. The placebo-adjusted difference in diastolic blood pressure was +1.2 mmHg for QSYMIA and +2.7 mmHg for phentermine, corresponding to a mean treatment difference of ?1.5 mmHg for QSYMIA.
The placebo-adjusted difference in heart rate was +3.6 beats per minute (bpm) for QSYMIA and +7.2 bpm for phentermine, corresponding to a mean treatment difference of ?3.6 bpm for QSYMIA. Obesity is linked to major causes of death, including heart disease, stroke, and diabetes. With an estimated one billion people worldwide to be affected by obesity by 2030, an almost two-fold increase from its 2020 prevalence of approximately 511 million, medical communities and health care providers are adopting evolving perspectives on defining how to qualify patients with overweight or obesity.
While BMI remained a key benchmark for developing weight management plans, it did not always account for patients with weight-related comorbidities nor allow for providers to optimize results based on a number of success indicators. BMI can vary significantly across different populations due to a range of factors, including genetics, cultural dietary habits, socioeconomic conditions, and lifestyle behaviors. For example, the World Health Organization (WHO) has shared scientific evidence that suggests Asian populations have different associations between BMI, percentage of body fat, and health risks than European populations.
One expert consultation concluded that the proportion of Asian people with a high risk of type 2 diabetes and cardiovascular disease is substantial at BMIs lower than the existing WHO cut-off point for overweight (> or =25 kg/m2). QSYMIA is the leading non-injectable branded weight loss medication in the U.S. for adults. QSYMIA is a combination of phentermine, a sympathomimetic amine anorectic, and topiramate, indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight in some adults and certain pediatric patients aged 12 years and older.
The once-daily pill is currently covered by 81% of commercial healthcare plans and is indicated for long-term use. QSYMIA is designed to help patients manage hunger and reduce cravings throughout the day and, combined with a healthy diet and exercise, has been proven to help patients lose, and maintain, weight loss.
