PMID- 28440045 OWN - NLM STAT- MEDLINE DCOM- 20171116 LR - 20220214 IS - 1930-739X (Electronic) IS - 1930-7381 (Print) IS - 1930-7381 (Linking) VI - 25 IP - 5 DP - 2017 May TI - Coadministration of lorcaserin and phentermine for weight management: A 12-week, randomized, pilot safety study. PG - 857-865 LID - 10.1002/oby.21811 [doi] AB - OBJECTIVE: To assess the short-term tolerability of lorcaserin alone or with two dose regimens of phentermine. METHODS: This was a 12-week, randomized, double-blind, pilot safety study of N = 238 nondiabetic patients with obesity or overweight with >/=1 comorbidity randomized to lorcaserin 10 mg twice daily (BID; LOR BID) alone or with phentermine 15 mg once daily (QD; LOR BID+PHEN QD) or 15 mg twice daily (LOR BID+PHEN BID). Patients reporting >/= 1 of 9 potentially serotonergic adverse events (AEs), mean weight loss (WL), and >/=5% WL are reported. RESULTS: N = 238 were randomized, and N = 235 were treated. N = 94 reported potentially serotonergic AEs: 37.2% LOR BID, 42.3% LOR BID+PHEN QD, and 40.5% LOR BID+PHEN BID. AEs leading to discontinuation were reported approximately twice as often in the LOR BID+PHEN BID group versus the LOR BID group. Mean WL was 3.5 kg/3.3%, 7.0 kg/6.7%, and 7.6 kg/7.2% for LOR BID, LOR BID+PHEN QD, and LOR BID+PHEN BID, respectively. At least 5% WL was achieved by 28.2% LOR BID, 59.0% LOR BID+PHEN QD (P = 0.0002 vs. LOR BID), and 70.9% LOR BID+PHEN BID (P < 0.0001 vs. LOR BID) patients. CONCLUSIONS: Phentermine added to lorcaserin enhanced short-term weight loss but did not increase incidence of potentially serotonergic AEs; however, phentermine twice daily increased discontinuation compared to both lorcaserin alone and lorcaserin plus phentermine once daily. CI - (c) 2017 The Authors. Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS). FAU - Smith, Steven R AU - Smith SR AD - Center for the Metabolic Origins of Disease, Sanford Burnham Prebys Medical Discovery Institute, Orlando, Florida, USA. AD - Translational Research Institute for Metabolism and Diabetes, Florida Hospital, Orlando, Florida, USA. FAU - Garvey, W Timothy AU - Garvey WT AD - Department of Nutrition Sciences, University of Alabama at Birmingham, and the Birmingham VA Medical Center, Birmingham, Alabama, USA. FAU - Greenway, Frank L AU - Greenway FL AD - Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, Louisiana, USA. FAU - Zhou, Sharon AU - Zhou S AD - Eisai Medical and Scientific Affairs, Eisai Inc., Woodcliff Lake, New Jersey, USA. FAU - Fain, Randi AU - Fain R AD - Formerly Eisai Inc., Woodcliff Lake, New Jersey, USA. FAU - Pilson, Robert AU - Pilson R AD - Formerly Eisai Inc., Woodcliff Lake, New Jersey, USA. FAU - Fujioka, Ken AU - Fujioka K AD - Department of Diabetes and Endocrinology, Scripps Clinic, La Jolla, California, USA. FAU - Aronne, Louis J AU - Aronne LJ AD - Department of Medicine, Weill Cornell Medical College, New York, New York, USA. LA - eng SI - ClinicalTrials.gov/NCT01987427 GR - P30 DK079626/DK/NIDDK NIH HHS/United States PT - Journal Article PT - Randomized Controlled Trial PL - United States TA - Obesity (Silver Spring) JT - Obesity (Silver Spring, Md.) JID - 101264860 RN - 0 (Anti-Obesity Agents) RN - 0 (Benzazepines) RN - 637E494O0Z (lorcaserin) RN - C045TQL4WP (Phentermine) SB - IM MH - Adolescent MH - Adult MH - Anti-Obesity Agents/administration & dosage/pharmacology/*therapeutic use MH - Benzazepines/administration & dosage/pharmacology/*therapeutic use MH - Double-Blind Method MH - Female MH - Humans MH - Male MH - Middle Aged MH - Phentermine/administration & dosage/pharmacology/*therapeutic use MH - Pilot Projects MH - Weight Loss/*drug effects MH - Young Adult PMC - PMC5518190 EDAT- 2017/04/26 06:00 MHDA- 2017/11/29 06:00 PMCR- 2017/07/20 CRDT- 2017/04/26 06:00 PHST- 2015/10/30 00:00 [received] PHST- 2017/01/07 00:00 [revised] PHST- 2017/01/30 00:00 [accepted] PHST- 2017/04/26 06:00 [entrez] PHST- 2017/04/26 06:00 [pubmed] PHST- 2017/11/29 06:00 [medline] PHST- 2017/07/20 00:00 [pmc-release] AID - OBY21811 [pii] AID - 10.1002/oby.21811 [doi] PST - ppublish SO - Obesity (Silver Spring). 2017 May;25(5):857-865. doi: 10.1002/oby.21811.