PMID- 19057523 OWN - NLM STAT- MEDLINE DCOM- 20090604 LR - 20220408 IS - 1930-7381 (Print) IS - 1930-7381 (Linking) VI - 17 IP - 3 DP - 2009 Mar TI - Lorcaserin (APD356), a selective 5-HT(2C) agonist, reduces body weight in obese men and women. PG - 494-503 LID - 10.1038/oby.2008.537 [doi] AB - Lorcaserin (APD356) is a potent, selective 5-HT(2C) agonist with ~15-fold and 100-fold selectivity vs. 5-HT(2A) and 5-HT(2B) receptors, respectively. This study evaluated the safety and efficacy of lorcaserin for weight reduction in obese patients during a 12-week period. The randomized, double-blind, placebo-controlled, parallel-arm study enrolled 469 men and women between ages 18 and 65 and with BMI 30-45 kg/m(2). Patients received placebo, lorcaserin 10 mg q.d., lorcaserin 15 mg q.d., or lorcaserin 10 mg b.i.d. for 12 weeks, and were counseled to maintain their usual diet and activity. The primary end point was change in weight from baseline to day 85 by completer analysis. Safety analyses included echocardiograms at Screening and day 85/study exit. Lorcaserin was associated with progressive weight loss of 1.8 kg, 2.6 kg, and 3.6 kg at 10 mg q.d., 15 mg q.d., and 10 mg b.i.d., respectively, compared to placebo weight loss of 0.3 kg (P < 0.001 for each group). Similar results were seen by intent-to-treat last observation-carried forward (ITT-LOCF) analysis. The proportions of completers achieving > or =5% of initial body weight were 12.8, 19.5, 31.2, and 2.3% in the 10 mg q.d., 15 mg q.d., 10 mg b.i.d., and placebo groups, respectively. The most frequent adverse events (AEs) were transient headache, nausea, and dizziness. Echocardiograms showed no apparent drug-related effects on heart valves or pulmonary artery pressure (PAP). Lorcaserin was well tolerated and efficacious for weight reduction in this 12-week study. Longer-term trials employing behavior modification will be needed to more fully assess its safety and efficacy. FAU - Smith, Steven R AU - Smith SR AD - Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, Louisiana, USA. FAU - Prosser, Warren A AU - Prosser WA FAU - Donahue, David J AU - Donahue DJ FAU - Morgan, Michael E AU - Morgan ME FAU - Anderson, Christen M AU - Anderson CM FAU - Shanahan, William R AU - Shanahan WR CN - APD356-004 Study Group LA - eng SI - ClinicalTrials.gov/NCT00116740 PT - Journal Article PT - Randomized Controlled Trial DEP - 20081204 PL - United States TA - Obesity (Silver Spring) JT - Obesity (Silver Spring, Md.) JID - 101264860 RN - 0 (Benzazepines) RN - 0 (Serotonin 5-HT2 Receptor Agonists) RN - 637E494O0Z (lorcaserin) SB - IM MH - Adult MH - Benzazepines/adverse effects/*therapeutic use MH - Blood Pressure/drug effects MH - Body Weight/*drug effects MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Echocardiography MH - Female MH - Humans MH - Male MH - Middle Aged MH - Obesity/*drug therapy MH - *Serotonin 5-HT2 Receptor Agonists FIR - Adelglass, Jeffrey M IR - Adelglass JM FIR - Geohas, Jeffery G IR - Geohas JG FIR - McKenney, James M IR - McKenney JM FIR - Agaiby, John M IR - Agaiby JM FIR - Gilderman, Larry I IR - Gilderman LI FIR - Noss, Michael J IR - Noss MJ FIR - Ahmann, Andrew J IR - Ahmann AJ FIR - Hakkarainen, Gloria C IR - Hakkarainen GC FIR - Pierson, Monica R IR - Pierson MR FIR - Anderson, James W IR - Anderson JW FIR - Halpern, Stephen W IR - Halpern SW FIR - Pogue, Bryan C IR - Pogue BC FIR - Bays, Harold IR - Bays H FIR - Headapohl, Dana IR - Headapohl D FIR - Pudi, Krishna K IR - Pudi KK FIR - Berwald, Bruce IR - Berwald B FIR - Horn, Curtis Scott IR - Horn CS FIR - Reynolds, Michele D IR - Reynolds MD FIR - Call, Robert S IR - Call RS FIR - Jones, Spencer B IR - Jones SB FIR - Saparano, Joseph IR - Saparano J FIR - Caos, Antonio IR - Caos A FIR - Fujioka, Ken IR - Fujioka K FIR - Schumacher, Douglas R IR - Schumacher DR FIR - Carfagno, David G IR - Carfagno DG FIR - Kaplan, Roy A IR - Kaplan RA FIR - Severance, Randall J IR - Severance RJ FIR - Connor, Gordon T IR - Connor GT FIR - Kipnes, Mark S IR - Kipnes MS FIR - Sherman, Lawrence IR - Sherman L FIR - Ellison, William T IR - Ellison WT FIR - Krieger, Diane R IR - Krieger DR FIR - Simon, Stuart J IR - Simon SJ FIR - Emkey, Ronald D IR - Emkey RD FIR - Magnuson, Sharyl IR - Magnuson S FIR - Smith, Steven R IR - Smith SR FIR - Fleischmann, Roy M IR - Fleischmann RM FIR - Marbury, Thomas C IR - Marbury TC FIR - Warren, Michael W IR - Warren MW FIR - Frank, Arthur IR - Frank A FIR - Timm McCarty, F IR - Timm McCarty F FIR - Zavoral, James H IR - Zavoral JH EDAT- 2008/12/06 09:00 MHDA- 2009/06/06 09:00 CRDT- 2008/12/06 09:00 PHST- 2008/12/06 09:00 [pubmed] PHST- 2009/06/06 09:00 [medline] PHST- 2008/12/06 09:00 [entrez] AID - oby2008537 [pii] AID - 10.1038/oby.2008.537 [doi] PST - ppublish SO - Obesity (Silver Spring). 2009 Mar;17(3):494-503. doi: 10.1038/oby.2008.537. Epub 2008 Dec 4.