Multicenter, Placebo-Controlled Trial of Lorcaserin for Weight Management

Smith, Steven R.; Weissman, Neil J.; Anderson, Christen M.; Sanchez, Matilde; Chuang, Emil; Stubbe, Scott; Bays, Harold; Shanahan, William R.

doi:10.1056/nejmoa0909809

Cited by 819 publications

(715 citation statements)

References 26 publications

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“…However, the expectation for weight loss effects in patients is often higher 11. Although weight‐loss drugs significantly improve cardiovascular risk factors such as insulin sensitivity, glycemic control, dyslipidemia, hypertension and chronic inflammation in patients with overweight or obesity 12, 13, 14, 15, 16, these health benefits may not be immediately obvious to patients. Also, no weight‐loss drug has been demonstrated to decrease cardiovascular morbidity or mortality 6.…”

Section: Discussionmentioning

confidence: 99%

Characteristics of patients potentially eligible for pharmacotherapy for weight loss in primary care practice in the United States

Zhang

Manne

Jiao

2016

Obesity Science & Practice

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SummaryObjectiveTo describe the characteristics of real‐world patients potentially eligible for adjunctive pharmacotherapy for weight loss.MethodsPatients from the GE Centricity electronic medical record database were selected if they had body mass index (BMI) ≥30 or ≥27 to <30 kg m−2 with ≥1 obesity‐associated comorbidity (hypertension, dyslipidemia, or type 2 diabetes) from 2002–2011; were aged ≥18 years and had ≥12 months of continuous enrollment before and after the date of first eligible BMI recorded (index date). Descriptive statistics and logistic regression were used for analysis.ResultsOf the 1,835,541 patients with overweight or obesity included, comorbidities were common (hypertension [55.4%], dyslipidemia [36.1%] and type 2 diabetes [13.4%]). The percentage of patients who received pharmacotherapy for weight loss was 0.7% within 12 months after the index date. Patients who received pharmacotherapy had higher BMI (median, 33.6 vs. 31.3 kg m−2), were younger (median, 42 vs. 52 years), primarily women (84.3 vs. 58.2%), commercially insured (70.1 vs. 50.4%) and had more frequent use of antidepressants (30.8 vs. 14.1%) and non‐steroidal anti‐inflammatory drugs (21.7 vs. 12.0%) than those who did not at baseline (all P values < 0.0001).ConclusionsFew eligible patients received pharmacotherapy for weight loss. Patients who received pharmacotherapy tended to be heavier, younger, female, commercially insured, and used more antidepressants and non‐steroidal anti‐inflammatory drugs.

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Section: Discussionmentioning

confidence: 99%

Characteristics of patients potentially eligible for pharmacotherapy for weight loss in primary care practice in the United States

Zhang

Manne

Jiao

2016

Obesity Science & Practice

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“…This retention programme was implemented proactively and was successful at improving upon the reported 53% 1‐year retention rate in the Rio‐North American study, which studied a similar weight loss drug in patients with similar BMI but without diabetes in the USA and Canada, also over a 1‐year time period 1, 19, and even improved upon the retention rate of Phase 3 trials conducted with more recently approved weight loss agents 2, 3, 4, 5.…”

Section: Discussionmentioning

confidence: 99%

“…On average, one‐third to one‐half of participants drops out of these large trials by 1 year 1, 2, 3, 4, 5. Such high‐attrition rates result in missing data that limit the interpretation and generalizability of findings 6.…”

Section: Introductionmentioning

confidence: 99%

Maximizing retention in long‐term clinical trials of a weight loss agent: use of a dietitian support team

Delahanty

Riggs

Klioze

et al. 2016

Obesity Science & Practice

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SummaryObjectiveHigh‐attrition rates have been observed in long‐term clinical trials of weight loss agents. We evaluated the impact of an innovative retention programme on 1‐year retention.MethodsThree Phase 3 global multicentre clinical trials evaluated the efficacy and safety of a CB1 receptor antagonist in subjects with BMI ≥ or = 27 kg/m2. The impact of a multifaceted retention programme including a dietitian screening interview, a comprehensive culturally adapted lifestyle modification programme, and a dietitian support system to maximize lifestyle adherence, was evaluated in 4,410 subjects from four subpopulations (non‐US English‐speaking, non‐English‐speaking, US‐without dietitian screening and US‐with dietitian screening) comprising 208 centres from 15 countries.ResultsThe median proportion retained over the first year among subjects in three protocols was 82%. Non‐English‐speaking countries showed higher retention rates (89%) compared with the USA (73%) and non‐US English‐speaking (81%) countries. Within the USA, behavioural screening was associated with 29% reduction in dropout rate; for every five monthly teleconferences attended above 11, there was a 32% decrease in dropout rate.ConclusionsThis novel retention programme greatly improved upon reported retention rates of studies conducted with other weight loss agents in long‐term clinical trials. Its effectiveness should be confirmed in future trials.

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“…29,30 At 2-year follow-up of SEQUEL, phentermine plus topiramate reduced HbA 1c in patients with DM at baseline and reduced -34 In BLOOM, patients who continued therapy for a second year maintained most of their weight loss, but those who switched to placebo at 1 year regressed to the weight of the original placebo group. 34 In BLOOM, patients receiving lorcaserin had lower SBP and DBP, pulse rate, LDL-C and total cholesterol levels, insulin resistance, and C-reactive protein levels than those receiving placebo. 34 The BLOSSOM results were consistent with BLOOM and also showed an increase in HDL-C and a decrease in apolipoprotein B level.…”

Section: Potential Benefits Of Modern Pharmacotherapy For Obesity Phementioning

confidence: 99%

Modern Obesity Pharmacotherapy: Weighing Cardiovascular Risk and Benefit

Cunningham

Wiviott

2014

Clinical Cardiology

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Obesity is a major correlate of cardiovascular disease. Weight loss improves cardiovascular risk factors and has the potential to improve outcomes. Two drugs, phentermine plus topiramate and lorcaserin, have recently been approved by the US Food and Drug Administration for the indication of obesity; a third, bupropion plus naltrexone, is under consideration for approval. In clinical trials, these drugs cause weight loss and improve glucose tolerance, lipid profile, and, with the exception of bupropion plus naltrexone, blood pressure. However, their effect on cardiovascular outcomes is unknown. In defining appropriate roles for these drugs in preventive cardiology, it is important to remember the checkered history of drugs for obesity. New weight-loss drugs share the serotonergic and sympathomimetic mechanisms that proved harmful in the cases of Fen-Phen and sibutramine, respectively, albeit with significant differences. Given these risks, randomized cardiovascular outcomes trials are needed to establish the safety, and potential benefit, of these drugs. This review will discuss the history of pharmacotherapy for obesity, existing efficacy and safety data for the novel weight-loss drugs, and issues in the design of postapproval clinical trials. IntroductionAdvances in prevention-smoking-cessation campaigns, statin therapy, and tight blood pressure (BP) control, among others-have contributed to decreases in the burden of coronary artery disease over the past several decades. However, the increasing prevalence of obesity and obesityassociated diseases like type 2 diabetes mellitus (T2DM) have tempered these gains. 1 Despite recent data suggesting a plateau, rates of obesity remain substantially higher than a few decades ago. 2 Intensive lifestyle interventions have produced clinically relevant weight loss, 3 but modest interventions that are feasible in the primary-care setting are less successful. 4 Many efforts to develop an effective and safe weight-loss pill have failed. In fact, the history of obesity pharmacotherapy has been notable for cardiovascular side effects, not benefits. In 2012, the US Food and Drug Administration (FDA) approved 2 medications for weight loss, the selective 5-HT 2C agonist lorcaserin and the combination pill phentermine plus topiramate; a third, bupropion plus naltrexone, is under consideration for approval at the time of this writing. 5 The mechanisms of

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Multicenter, Placebo-Controlled Trial of Lorcaserin for Weight Management

Abstract: In conjunction with behavioral modification, lorcaserin was associated with significant weight loss and improved maintenance of weight loss, as compared with placebo. (Funded by Arena Pharmaceuticals; ClinicalTrials.gov number, NCT00395135.)

Cited by 819 publications

References 26 publications

Characteristics of patients potentially eligible for pharmacotherapy for weight loss in primary care practice in the United States

Characteristics of patients potentially eligible for pharmacotherapy for weight loss in primary care practice in the United States

Maximizing retention in long‐term clinical trials of a weight loss agent: use of a dietitian support team

Modern Obesity Pharmacotherapy: Weighing Cardiovascular Risk and Benefit

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