VIVUS says study shows addition of Qsymia to LSG surgery improved weight loss
VIVUS announced the results of a pilot clinical study demonstrating that patients receiving Qsymia capsules CIV before and after laparoscopic sleeve gastrectomy surgery lost more weight and had a greater probability of achieving a body mass index of less than 40 compared with patients undergoing surgery alone without anti-obesity medication. The study was conducted at the Wake Forest School of Medicine and the results appear in the current issue of Surgery for Obesity and Related Diseases. In addition to increased surgical risk, patients with a BMI of 50 or greater are likely to have a BMI of 40 or greater even after successful surgery. Physicians often address this issue by offering patients a two-stage weight loss process that involves an initial LSG followed by a second surgical procedure after initial post-LSG weight loss. Treatments that allow patients to achieve BMI of less than 40 after the initial LSG could reduce the need for a second surgical procedure, decreasing health risks and costs. The pilot study recruited 25 participants with a BMI of 50 or more who were planning to undergo LSG. Patients in the control group had a BMI of 50 or more and underwent LSG in the same timeframe but were not included in the study protocol. Patients in the experimental arm received Qsymia at a dose of 3.75/23 mg once daily for two weeks, which was then increased to 7.5/46 mg or 15/92 mg daily in order to achieve the greatest weight loss with the fewest side effects. Patients tapered off the medication beginning two weeks prior to surgery in order to avoid potential interactions between phentermine and anesthesia and resumed dosing at 7.5/46 mg daily one month following LSG, with dose adjustments made monthly over the next two months. Patients then continued to utilize Qsymia for a 24-month period. Key findings from the study include: The experimental group had a baseline BMI of 61.2 +/- 7.1 kg/m2 compared with 57.0 +/- 5.6 kg/m2 for control participants. At 24 months, the mean BMI was 33.8 kg/m2 for the experimental group vs. 42 kg/m2 for control participants. Of the 25 patients recruited, 13 completed LSG. Patients who did not complete LSG were due to: medical complications unrelated to Qsymia, decision not to pursue surgery, Qsymia-related adverse events, because they were lost to follow-up and withdrawn from the study or opted to undergo a surgical procedure other than LSG. Patients in the experimental arm lost more than twice the weight with an average of 28.1 kg during the pre-operative period compared with an average of 12.3 kg for those in the control group. At two years post-LSG, the experimental group lost 11.2% more of initial body weight compared with controls, which translates to a -18.2% difference in percent excess weight loss (%EWL) of favoring the experimental group. A higher proportion of patients in the experimental group compared with controls achieved a BMI less than 40 at 3, 6, 12 and 24 months post-LSG. There was a significant increase in the odds of achieving BMI less than 40 for the experimental group compared with controls at 6 months post-LSG; at 24 months the odds ratio remained 4.1 but was no longer statistically significant. The study authors conclude that for patients with a BMI of 50 or more the combination of LSG and phentermine/topiramate ER had a robust impact on patients both before and for up to two years after LSG surgery.