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Cited by 94Pharmacology and Obesity TreatmentDiabetes Treatment and ManagementDiabetes, Cardiovascular Risks, and Lipoproteins

Effect of lorcaserin on prevention and remission of type 2 diabetes in overweight and obese patients (CAMELLIA-TIMI 61): a randomised, placebo-controlled trial

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Bohula, Erin A, Scirica, Benjamin M, Inzucchi, Silvio E, McGuire, Darren K, Keech, Anthony C, Smith, Steven R, Kanevsky, Estella, Murphy, Sabina A +567 more·2018·The Lancet
DOI 10.1016/s0140-6736(18)32328-6
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Abstract

Background There is a direct relationship between bodyweight and risk of diabetes. Lorcaserin, a selective serotonin 2C receptor agonist that suppresses appetite, has been shown to facilitate sustained weight loss in obese or overweight patients. We aimed to evaluate the long-term effects of lorcaserin on diabetes prevention and remission.Methods In this randomised, double-blind, placebo-controlled trial done in eight countries, we recruited overweight or obese patients (body-mass index ≥27 kg/m 2) with or at high risk for atherosclerotic vascular disease. Eligible patients were aged 40 years or older; patients at high risk for atherosclerotic vascular disease had to be aged 50 years or older with diabetes and at least one other risk factor. Patients were randomly assigned to receive either lorcaserin (10 mg twice daily) or matching placebo. Additionally, all patients had access to a standardised weight management programme based on lifestyle modification. The prespecified primary metabolic efficacy endpoint of time to incident diabetes was assessed in patients with prediabetes at baseline. The prespecified secondary outcomes for efficacy were incident diabetes in all patients without diabetes, achievement of normoglycaemia in patients with prediabetes, and change in glycated haemoglobin (HbA 1c) in patients with diabetes. Hypoglycaemia was a prespecified safety outcome. Analysis was by intention to treat, using Cox proportional hazard models for time-to-event analyses. This trial is registered with ClinicalTrials.gov, number NCT02019264.Findings Between Feb 7, 2014, and Nov 20, 2015, 12 000 patients were randomly assigned to lorcaserin or placebo (6000 patients in each group) and followed up for a median of 3·3 years (IQR 3·0-3·5). At baseline, 6816 patients (56·8%) had diabetes, 3991 (33·3%) prediabetes, and 1193 (9·9%) normoglycaemia. At 1 year, patients treated with lorcaserin had a net weight loss beyond placebo of 2·6 kg (95% CI 2·3-2·9) for those with diabetes, 2·8 kg (2·5-3·2) for those with prediabetes, and 3·3 kg (2·6-4·0) for those with normoglycaemia (p<0·0001 for all analyses). Lorcaserin reduced the risk of incident diabetes by 19% in patients with prediabetes (172 [8·5%] of 2015 vs 204 [10·3%] of 1976; hazard ratio 0·81, 95% CI 0·66-0·99; p=0·038) and by 23% in patients without diabetes (174 [6·7%] of 2615 vs 215 [8·4%] of 2569; 0·77, 0·63-0·94; p=0·012). Lorcaserin resulted in a non-significant increase in the rate of achievement of normoglycaemia in patients with prediabetes (185 [9·2%] vs 151 [7·6%]; 1·20, 0·97-1·49; p=0·093). In patients with diabetes, lorcaserin resulted in a reduction of 0·33% (95% CI 0·29-0·38; p<0·0001) in HbA 1c compared with placebo at 1 year from a mean baseline of 53 mmol/mol (7·0%). In patients with diabetes at baseline, severe hypoglycaemia with serious complications was rare, but more common with lorcaserin (12 [0·4%] vs four [0·1%] events; p=0·054).Interpretation Lorcaserin decreases risk for incident diabetes, induces remission of hyperglycaemia, and reduces the risk of microvascular complications in obese and overweight patients, supporting the role of lorcaserin as an adjunct to lifestyle modification for chronic management of weight and metabolic health.Funding Eisai.

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  • In CAMELLIA-TIMI 61, more lorcaserin-treated participants were diagnosed with cancer (n = 462; 7.7%) than placebo-treated participants (n = 423; 7.1%).

    “However, it was found that more participants (n = 462; 7.7%) treated with lorcaserin were diagnosed with cancer as compared to those treated with the placebo (n = 423; 7.1%).”

    From Long-Term Efficacy and Safety of Anti-Obesity Treatment: Where Do We Stand? (2021) · cites this paper as [24]

  • In CAMELLIA-TIMI 61, novel cancer diagnoses were similar in the lorcaserin (n = 76) and placebo (n = 77) groups within the first 180 days.

    “The number of participants diagnosed with a novel cancer was similar in both the lorcaserin (n = 76) and placebo (= 77) groups within the first 180 days.”

    From Long-Term Efficacy and Safety of Anti-Obesity Treatment: Where Do We Stand? (2021) · cites this paper as [24]

  • In CAMELLIA-TIMI 61, approximately 0.9% of lorcaserin-treated patients and 0.6% of placebo-treated patients died from cancer.

    “Approximately 0.9% and 0.6% of patients died from cancer in the lorcaserin and placebo group, respectively.”

    From Long-Term Efficacy and Safety of Anti-Obesity Treatment: Where Do We Stand? (2021) · cites this paper as [24]

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Bohula, E. A., Scirica, B. M., Inzucchi, S. E., McGuire, D. K., Keech, A. C., Smith, S. R., Kanevsky, E., Murphy, S. A., Leiter, L. A., Dwyer, J. P., Corbalan, R., Hamm, C., Kaplan, L., Nicolau, J. C., Ophuis, T. O., Ray, K. K., Ruda, M., Spinar, J., Patel, T., Miao, W., Perdomo, C., Francis, B., Dhadda, S., Bonaca, M. P., Ruff, C. T., Sabatine, M. S., Wiviott, S. D., Sabatine, M. S., Wiviott, S. D., Scirica, B. M., Inzucchi, S., Keech, A., McGuire, D. K., Smith, S. R., Satlin, A., Brown, C., Budaj, A., Corbalan, R., Dwyer, J., Garcia-Castillo, A., Gupta, M., Hamm, C., Kaplan, L., Keech, A., Leiter, L. A., Nicolau, J. C., Oude Ophuis, T., Ray, K., Ruda, M., Scirica, B. M., Spinar, J., Weissman, N., White, H. D., Wiviott, S. 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Salacata, A., Blevins, T., Benjamin, S., Diener, J., George, W., Barker, B., Richwine, R., Baldari, D., Alfieri, A., Barreto, A., Zhang, L., Shah, R., Hendrix, E., Subramaniyam, V, Hurley, S., Lillestol, M., O'Donoghue, M., Shayani, S., Ryan, E., Call, R., Zemel, L., Chang, A., Kivitz, A., Freyne, B., Bland, V, Shore, K., Mostel, E., Uzoaga, E., Andrawis, N., Gabra, N., Ghitis, A., Sabatino, K., Browder, D., Varma, S., Smith, S., Fink, R., Aycock, G., Doty, W., Alfonso, T., Eshaghian, S., Karlsberg, R., Zarich, S., Landau, C., McKenzie, M., Krause, R., Davis, W., Haddad, T., Voyce, S., Alford, C., LeDoux, J., O'Dea, D., McKenzie, M., Park, J., Aroda, V, Getaneh, A., Graham, B., Bhagwat, R., Korn, D., Ruoff, G., Wiseman, A., Lieber, I., Fialkow, J., Gonzalez-Campoy, J., Bayron, C., Bertolet, B., Lash, J., Gerrish, C., Robertson, D., Rosenfeld, J., Seidner, M., Agaiby, J., Silverfield, J., Sugimoto, D., Lubin, B., Alhaddad, M., Lui, H., Lakin, G., Chokshi, S., Donovan, D., Felten, W., 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Dor, I., Duffy, B., Rubin, P., Lewis, D., Kaye, W., Benton, R., Burbano, J., Hotchkiss, D., Magno, A., Alberton, A., Collins, J., Alvarado, O., Stich, M., Mahal, S., Liu, J., Hong, M., Dy, J., Block, B., Lamantia, J., Pritchard, J., Davis, M., Srivastava, S., Bilazarian, S., Rosario, R., McCartney, M., Blumberg, V, Rajan, R., Martin, E., Wright, S., White, A., Levinson, L., Brinson, C., Johnston, J., Wilson, S., Graves, M., Dominguez, M., McKenzie, W., Abadier, R., Tran, C., Castello, R., Morawski, E., White, J., Morris, F., Perez, A., Trueba, P., Sanchez, M., Andersen, J., Kastelic, R., Khan, J., Rodriguez, H., Izquierdo, W., Matias, A., Essandoh, L., & Ince, C.
Affiliations
  • Brigham and Women's Hospital (US)
  • Imperial College London (GB)
  • Eisai (United States) (US)
  • University Hospital Brno (CZ)
  • Massachusetts General Hospital (US)
  • St. Michael's Hospital (CA)
  • Yale University (US)
Corresponding author
Bohula, Erin A
ORCID
Venue
The Lancet
Publisher
Elsevier BV
Published
2018-11
Volume
392
Issue
10161
Pages
2269-2279
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
DOI
10.1016/s0140-6736(18)32328-6
OpenAlex
W2895448784
Cited by
94
References
32
Citations by year
2026: 2 · 2025: 3 · 2024: 7 · 2023: 8 · 2022: 8 · 2021: 27 · 2020: 16 · 2019: 19 · 2018: 4
FWCI
10.65
Type
journal article
Language
en
Open access
Licence
Locations
  • The Lancet (publishedVersion)
  • PubMed (publishedVersion)
  • Deakin Research Online (Deakin University) (submittedVersion)
  • Figshare (submittedVersion, cc-by)
  • Spiral (Imperial College London) (submittedVersion, cc-by-nc-nd)
Topics
  • Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
Keywords
lorcaserin, type 2 diabetes prevention, diabetes remission, obesity, overweight, appetite suppression, weight loss, hypoglycemia, microvascular complications, hyperglycemia
MeSH terms
Aged, Appetite Depressants, Benzazepines, Body Weight, Diabetes Mellitus, Type 2, Double-Blind Method, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Male, Middle Aged, Obesity, Prediabetic State, Remission Induction, Weight Loss, Overweight, Atherosclerosis

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