Issue 45 July 2012
8. Diabetes Medicine Updates

FDA Approves New Weight-Loss Drug Lorcaserin

FDA gave the green light to Arena Pharmaceuticals to sell Belviq, or Lorcaserin generically, a twice-a-day pill that suppresses appetite and appears to affect metabolism by influencing levels of the brain chemical serotonin.

The drug was approved for obese people (those with a body mass index of 30 or more) and overweight people with a BMI of 27 or more who also have at least one weight-related health condition, such as high blood pressure, type 2 diabetes or high cholesterol. Arena will be required to conduct six additional studies to monitor the drug's safety, including one specifically designed to examine cardiovascular risks, the FDA said.

The weight-loss benefits are extremely modest. Compared to placebo, over the course of a year of dieting and exercise, patients taking Belviq lost an average of 3 to 3.7 % of their initial body weight but would have to keep taking the drug for the rest of life to keep it off. The manufacturers of Belviq recommend that patients stop taking the drug if they don’t lose at least 5 percent of their body weight in the first 12 weeks.
SGLT-2 Inhibitor (Empagliflozin) safe and effective as monotherapy

A phase 2b open-label extension study shows that Empagliflozin reduces HbA1c, fasting plasma glucose and body weight when administered alone or as an add-on to metformin in patients with type 2 diabetes.

Adults with type 2 diabetes who had participated in one of two 12-week studies of empagliflozin (Boehringer Ingelheim, Eli Lilly) were treated for an additional 78 weeks with empagliflozin. Those treated with empagliflozin 1 mg, 5 mg or 50 mg or placebo in the first trial, were randomly assigned to empagliflozin at 10 mg or 25 mg alone or as an add-on to metformin. Patients treated with empagliflozin 10 mg or 25 mg, metformin alone or sitagliptin as an add-on to metformin continued the same treatment course.

The rate of hypoglycemic events was lower with empagliflozin (between 0.9% and 3.6%) compared with metformin alone (7.1%) and sitagliptin (5.4%). The rate of adverse events associated with urinary tract infections was similar among groups: 3.8% to 12.7% for empagliflozin; 3.6% for metformin alone and 12.5% for sitagliptin.

Adverse events associated with genital infections occurred in 3% to 5.5% of those on empagliflozin; 1.8% of those on metformin alone and none of the patients on sitagliptin.
 
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