In studies with BELVIQ® 10 mg twice daily
Patients taking BELVIQ® showed improvement
in MULTIPLE CARDIOMETABOLIC PARAMETERS
‡Statistically significant vs placebo.
Pooled BLOOM/BLOSSOM: BELVIQ®, N=3096; placebo, N=3039. BLOOM-DM: BELVIQ®, N=256; placebo, N=252.
- In the BLOOM-DM trial, statistical testing was not performed as specified by the multiplicity testing rule for TC, LDL, HDL, TG, SBP, DBP. In the BLOSSOM trial, fasting plasma glucose was not controlled for type I error.
- All patients received lifestyle modification counseling
- Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus who are being treated with antidiabetic medications, so measurement of blood sugar levels before and during treatment with BELVIQ is recommended. Decreases in doses of antidiabetic medications or changes in medication regimen should be considered
- The effect of BELVIQ® on cardiovascular morbidity and mortality has not been established
- BELVIQ® is not indicated for the treatment of blood pressure, heart rate, cholesterol, or type 2 diabetes
DBP=diastolic blood pressure; HDL=high-density lipoprotein; LDL=low-density lipoprotein;
SBP=systolic blood pressure; TC=total cholesterol; TG=triglycerides.
* MITT using LOCF method; all patients who received study medication and had a postbaseline body weight measurement. Pooled BLOOM/BLOSSOM trials: 44% of patients receiving BELVIQ® and 51% of patients receiving placebo withdrew prior to Week 52. BLOOM-DM: 34% of patients receiving BELVIQ® and 38% receiving placebo withdrew prior to Week 52.
†In BLOOM-DM trial at baseline, 91.5% of patients took metformin, 50.4% took a sulfonylurea (SFU), and 41.9% took both.4
§Measured in BLOOM only (BELVIQ®, n=1538; placebo, n=1499).2