Lorcaserin treatment allows for decreased number needed to treat for weight and glycemic parameters in week 12 responders with ≥5% weight loss

ABSTRACT

Objectives: Lorcaserin is a serotonin 2C receptor agonist approved for chronic weight management. This analysis explores the number of patients needed to be treated (NNT) with lorcaserin for one more patient to achieve weight loss and glycemic goals.

Methods: This is a post hoc analysis of three Phase 3 studies in adults with and without type 2 diabetes mellitus (T2DM) treated with lorcaserin 10 mg BID or placebo. NNT is reported for patients achieving ≥5% or ≥10% weight loss, achievement of either HbA1c <5.7% or FPG <100 mg/dL in patients with prediabetes, and reduction of HbA1c to <7% in patients with T2DM at Week 52.

Results: In the modified intention-to-treat (MITT) population, NNTs for ≥5% and ≥10% weight loss were 3.6 and 6.2 (without T2DM) and 4.3 and 7.5 (with T2DM); in Week 12 responders (≥5% weight loss at Week 12), NNTs were 1.7 and 2.6 (without T2DM) and 1.9 and 3.2 (with T2DM). In patients with prediabetes, NNTs to achieve HbA1c <5.7% were 9.9 (MITT) and 5.2 (Week 12 responders). In patients with T2DM, NNTs to achieve HbA1c <7% were 4.2 (MITT) and 2.3 (Week 12 responders).

Conclusion: In addition to weight management, lorcaserin improved glycemic control in patients with prediabetes and facilitated targeted HbA1c reduction in patients with T2DM, especially for those who achieved ≥5% weight loss by Week 12. Assessment of treatment response at Week 12 is a valuable tool to achieve efficient use of healthcare resources.

Clinical trial registration: www.clinicaltrials.gov identifiers are NCT00395135, NCT00603291, and NCT00603902

KEYWORDS:

• Lorcaserin
• number needed to treat
• glycemic benefits
• weight management

Acknowledgments

We gratefully acknowledge the scientific guidance of William Soliman, Alan Glicklich, and Yuhan Li.

Declaration of interest

Editorial support was provided by Imprint Publication Science (New York, NY, USA) and was funded by Eisai Inc. Y Handelsman has received research grants, consultation fees, and speaker honoraria from Amarin, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eisai Inc., Esperion, GlaxoSmithKline, Grifols, Hanmi, Intarcia, Janssen, Lexicon, Lilly, Merck, Novo Nordisk, Pfizer, Regeneron, Sanofi, Takeda, and Vivus; and is Associate Editor of Journal of Diabetes. R Fain is a former employee of Eisai Inc. Z Wang and X Li are employees of Eisai Inc. K Fujioka has received research grants through his employer from Eisai Inc., EnteroMedics, Novo Nordisk, Orexigen Therapeutics, Shire, and Weight Watchers; has consulted for Eisai Inc., EnteroMedics, Isis Pharmaceuticals, NaZura BioHealth, Novo Nordisk, Takeda, and Zafgen; and is on the speaker bureaus of Abbott, Eisai Inc., Novo Nordisk, NPS, and Takeda. W Shanahan is a former employee of Arena Pharmaceuticals, Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

Arena Pharmaceuticals, Inc., funded the Phase 3 studies (BLOOM, BLOSSSOM, and BLOOM-DM) and participated in data analysis and interpretation for the primary publications. This post hoc analysis was funded by Eisai Inc., and the participating author contributions are listed in this manuscript.