What you need to know about new weight loss medication Belviq

After a long gap of over 13 years, the FDA started approving new weight loss medications beginning with Belviq approved in June of 2012 and Qsymia approved in July 2012. After a gap of another 2 years, the FDA approved two new weight loss medications in late 2014 with Contrave approved in September and Saxenda in December. Let us review these 4 new weight loss medications and compare their relative utility in helping one lose weight!

First new weight loss drug - Belviq 

Of the four new weight loss drugs, Belviq is probably one of the safest albeit not the most potent! Since it is not a stimulant type medication, it can safely be used even in those that have had a prior history of certain cardiovascular problems in the remote past including coronary artery disease.


When was Belviq approved for weight loss?

The U.S. approved Belviq (lorcaserin hydrochloride), in June of 2012 in addition to a reduced-calorie diet and exercise, for chronic weight management.


What are the indications for Belviq?

• Belviq is approved for use in adults with a body mass index (BMI) of 30 or greater (obese)
• Adults with a BMI of 27 or greater (overweight) and who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, sleep apnea or high cholesterol (dyslipidemia).

What is BMI?

• Commonly shortened to BMI,  body mass index measures body fat based on an individual’s weight and height, is used to define the obesity and overweight categories. 
• According to the CDC(Centers for Disease Control and Prevention), more than one-third of adults in the United States are obese and another more than a third are overweight.

FDA statement on Belviq

According to Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research:

“Obesity threatens the overall well being of patients and is a major public health concern and the approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition.”

How does Belviq work?
Belviq activates the serotonin 2C receptor in the brain. Activation of serotonin 2C receptor may help a person eat less and feel full after eating smaller amounts of food.

Studies supporting use and safety of Belviq

There were about three randomized, placebo-controlled trials done on Belviq with 8,000 obese and overweight patients, with and without type 2 diabetes, treated for 52 to 104 weeks where all subjects also received lifestyle modification that consisted of a reduced calorie diet and exercise counseling.


Results of Belviq weight loss studies
Compared with placebo, treatment with Belviq for up to one year was associated with average weight loss ranging from 3 percent to 3.7 percent.


Better results in those without diabetes with Belviq

• Similar to most other weight loss medications, about 47 percent of patients without type 2 diabetes lost at least 5 percent of their body weight compared with about 23 percent of patients treated with placebo. 
• In thos with type 2 diabetes, about 38 percent of patients treated with Belviq and 16 percent treated with placebo lost at least 5 percent of their body weight. 
• Belviq treatment was associated with favorable changes in glycemic control in those with type 2 diabetes. 
• The labeling for Belviq recommends that the drug be discontinued in patients who fail to lose 5 percent of their body weight after 12 weeks of treatment, as these patients are unlikely to achieve clinically meaningful weight loss with continued treatment.

Contraindications of Belviq
Belviq should not be used during pregnancy.

Side effects of Belviq
Side effects of belviq include serotonin syndrome, particularly when taken with certain medicines that increase serotonin levels or activate serotonin receptors such as drugs commonly used to treat depression and migraine.
Belviq may cause disturbances in attention or memory.

Belviq and cardiovascular safety

• In 1997, the weight-loss drugs fenfluramine and dexfenfluramine were withdrawn from the market after evidence emerged that they caused heart valve damage. This effect is assumed to be related to activation of the serotonin 2B receptor on heart tissue. 
• When used at the approved dose of 10 milligrams twice a day, Belviq does not appear to activate the serotonin 2B receptor.
• Heart valve function was assessed by echocardiography in nearly 8,000 patients in the Belviq development program. 
• There was no statistically significant difference in the development of FDA-defined valve abnormalities between Belviq and placebo-treated patients. 
• Because preliminary data suggest that the number of serotonin 2B receptors may be increased in patients with congestive heart failure, 
• Belviq should be used with caution in patients with this condition. 
• Belviq has not been studied in patients with serious valvular heart disease.

Other side effects of Belviq 
The most common side effects of Belviq in patients without diabetes include headache, dizziness, fatigue, nausea, dry mouth, and constipation, and in diabetic patients are low blood sugar (hypoglycemia), headache, back pain, cough, and fatigue.

Who makes Belviq?
Belviq is manufactured by Arena Pharmaceuticals GmbH of Zofingen, Switzerland, and distributed by Eisai Inc. of Woodcliff Lake, N.J.