I guessed I missed the fanfare when the FDA approved a new diet pill. http://www.webmd.com/diet/news/20120627/fda-approves-diet-pill-belviq
So, I really want to know why, if it solves the weight loss problem, not everyone is on it? So I went looking.
Turns out that Belviq is an “appetite suppressant.” It is also a serotonin receptor agonist that got me thinking. I remember studies on 5HTP (5-hydroxytryptophan) which is an over-the-counter supplement used for depression. In higher doses, 5HTP suppresses the appetite. Maybe this is one of the reasons we all get so full so fast on Thanksgiving. (Turkey is very high in tryptophan, the raw material for 5HTP.
So now here comes a drug that does the same thing, and it is effective. As long as you are dieting, taking Belviq seems to make you less hungry and more able to lose weight. But there’s a catch. The studies only followed patients for one year, and higher doses seemed to have less effect than a lower dose of the drug.
For those in the know about dieting, the golden rule is that no diet regime is effective over five years. Almost anything works short term (my favorite is the chocolate cheesecake diet) but by the end of five years nothing has effectively kept the weight off because most people haven’t stayed on the diet for all that time.
So will Belviq help lose weight? Yes. Will it keep it off? Probably not. It is only a little annoying that the weight loss properties of the supplement were ignored until we came out with a patented drug.
But if you aren’t concerned about long-term weight loss, Belviq may help you shed a few pounds. If not enough people take them up on it, Belviq’s manufacturers are already working on other uses. Turns out it might also be helpful with Schizophrenia. http://www.ncbi.nlm.nih.gov/pubmed/23027415
Randomized placebo-controlled clinical trial of lorcaserin for weight loss in type 2 diabetes mellitus: the BLOOM-DM study.
The BLOOM-DM (Behavioral Modification and Lorcaserin for Obesity and Overweight Management in Diabetes Mellitus) study evaluated efficacy and safety of lorcaserin for weight loss in patients with type 2 diabetes. Secondary objectives included evaluations of glycemic control, lipids, blood pressure, and quality of life. This 1-year, randomized, placebo-controlled trial enrolled 604 patients 1:1:1 to placebo, lorcaserin 10 mg once daily (QD) or lorcaserin 10 mg twice daily (BID). Patients were treated with metformin, a sulfonylurea (SFU) or both; had glycated hemoglobin (HbA(1c)) 7-10%; were 18-65 years old; and had BMI 27-45 kg/m(2). Patients received diet and exercise counseling. Safety monitoring included serial echocardiograms. Mean (± SD) age was 52.7 ± 8.7; 54.2% were women; 60.5% were white, 20.9% were African American, and 13.8% were Hispanic. Mean (± SD) weight was 103.6 ± 17.8 kg; BMI was 36.0 ± 4.5 kg/m(2). Most patients (91.7%) took metformin; 50.2% took a SFU. More patients lost ≥5% body weight with lorcaserin BID (37.5%; P < 0.001) or lorcaserin QD (44.7%; P < 0.001) vs. placebo (16.1%; modified intent to treat (MITT)/last observation carried forward (LOCF)). Least square mean (± SEM) weight change was -4.5 ± 0.35% with lorcaserin BID and -5.0 ± 0.5% with lorcaserin QD vs. -1.5 ± 0.36% with placebo (P < 0.001 for each). HbA(1c) decreased 0.9 ± 0.06 with lorcaserin BID, 1.0 ± 0.09 with lorcaserin QD, and 0.4 ± 0.06 with placebo (P < 0.001 for each); fasting glucose decreased 27.4 ± 2.5 mg/dl, -28.4 ± 3.8 mg/dl, and 11.9 ± 2.5 mg/dl, respectively (P < 0.001 for each). Symptomatic hypoglycemia occurred in 7.4% of patients on lorcaserin BID, 10.5% on lorcaserin QD, and 6.3% on placebo. Common adverse events were headache, back pain, nasopharyngitis, and nausea. Lorcaserin was associated with significant weight loss and improvement in glycemic control in patients with type 2 diabetes.
- PMID: 22421927
A one-year randomized trial of lorcaserin for weight loss in obese and overweight adults: the BLOSSOM trial.
Agaiby J, Arguello F, Aronne L, Bays H, Berwald B, Bleser SD, Burch F, Butler C, Call R, Carter JZ, Cheung D, Beach L, Church T, Cohen J, Cohen S, Connor G, Conway M, Cuevas E, Davis M, Denham D, DePriest M, Travis Ellison W, Fagan T, Farmer M, David Ferrera R, Fitz-Patrick D, Geohas J, Sekhar Ghosh C, Gilderman LI, Gonte W, Halpern S, Harper W, Hartman I, Herring C, Herzog W, Huffman C, Hull S, Hutchins R, Jackson RE, Jacobs M, Jennings W, Johnson GE, Kaplan L, Kaplan R, Kapoor S, Kempf K, Kereiakes D, Kipnes M, Klatt K, Klein TR, Knutson T, Krause R, Krieger D, Larson W, Lefebvre GC, James Lenhard M, Levine S, Littlejohn TW 3rd, Lubin BC, Marbury T, Timm McCarty F, McCluskey D, McKenney J, Mehrtash AO, Mohaupt SM, Moldauer L, Mollen M, Morcos NC, Morin D, Mudaliar S, Noss M, O’Neil P, Pate D, Petit CA, Pipek R, Pi-Sunyer X, Powell S, Pudi K, Pullman J, Radin D, Reynolds M, Richter RW, Robertson DG, Rodstein S, Rubino D, Rubino J, Ryan E, Schumacher D, Seiden DJ, Seiler J, Self KS, Sellers DM, Simon S, Streja D, Strout C, Taber LA, Throne M, Tobin T, Varano S, Vine D, Weiss R, Wynstock L.
Arena Pharmaceuticals San Diego, California 92121, USA.
Lorcaserin is a novel selective agonist of the serotonin 2C receptor.
Our objective was to evaluate the effects of lorcaserin on body weight, cardiovascular risk factors, and safety in obese and overweight patients.
DESIGN AND SETTING:
This randomized, placebo-controlled, double-blind, parallel arm trial took place at 97 U.S. research centers.
Patients included 4008 patients, aged 18-65 yr, with a body mass index between 30 and 45 kg/m(2) or between 27 and 29.9 kg/m(2) with an obesity-related comorbid condition.
Patients were randomly assigned in a 2:1:2 ratio to receive lorcaserin 10 mg twice daily (BID), lorcaserin 10 mg once daily (QD), or placebo. All patients received diet and exercise counseling.
MAIN OUTCOME MEASURES:
The ordered primary endpoints were proportion of patients achieving at least 5% reduction in body weight, mean change in body weight, and proportion of patients achieving at least 10% reduction in body weight at 1 yr. Serial echocardiograms monitored heart valve function.
Significantly more patients treated with lorcaserin 10 mg BID and QD lost at least 5% of baseline body weight (47.2 and 40.2%, respectively) as compared with placebo (25.0%, P < 0.001 vs. lorcaserin BID). Least squares mean (95% confidence interval) weight loss with lorcaserin BID and QD was 5.8% (5.5-6.2%) and 4.7% (4.3-5.2%), respectively, compared with 2.8% (2.5-3.2%) with placebo (P < 0.001 vs. lorcaserin BID; least squares mean difference, 3.0%). Weight loss of at least 10% was achieved by 22.6 and 17.4% of patients receiving lorcaserin 10 mg BID and QD, respectively, and 9.7% of patients in the placebo group (P < 0.001 vs. lorcaserin BID). Headache, nausea, and dizziness were the most common lorcaserin-related adverse events. U.S. Food and Drug Administration-defined echocardiographic valvulopathy occurred in 2.0% of patients on placebo and 2.0% on lorcaserin 10 mg BID.
Lorcaserin administered in conjunction with a lifestyle modification program was associated with dose-dependent weight loss that was significantly greater than with placebo.
- Long-Term Weight Control (healthcaredocs.wordpress.com)
- FDA approves Belviq to treat some overweight or obese adults (gloucestercitynews.net)
- Epilepsy Drug Shows Promise as Weight-Loss Aid, Study Says (nlm.nih.gov)
- My Take on the New Diet Pills Approved by the FDA (Do You Really Need to Ask!) (paleolithicmd.com)
- Weight loss alone `doesn’t lower heart disease risk in diabetics` – Zee News (zeenews.india.com)
- NIH Trial Of Lifestyle Intervention For Type 2 Diabetes Stopped For Futility After 11 Years (forbes.com)
- Two New Drugs May Help In Fight Against Obesity (wnyc.org)
- Study Finds Weight Loss Doesn’t Lower Heart Risks For Diabetics (badgleyandassociates.wordpress.com)
- Weight loss does not lower heart disease risk from type 2 diabetes (eurekalert.org)
- Vitamin D may help prevent diabetes mellitus – study (foodconsumer.org)