Cancer Risk Associated with Lorcaserin — The FDA’s Review of the CAMELLIA-TIMI 61 Trial

Sharretts, John M.; Galescu, Ovidiu; Gomatam, Shanti; Andraca‐Carrera, Eugenio; Hampp, Christian; Yanoff, Lisa B.

doi:10.1056/nejmp2003873

Cited by 105 publications

(68 citation statements)

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“…For most of these trials, we found that information in their ClinicalTrials.gov entries. The CAMELLIA‐TIMI 61 study was a particular case: The main article 7 reported 215 subjects with cancer in the lorcaserin group and 210 in the placebo group (relative risk [RR]: 1.02; 95% confidence interval [95% CI]: 0.85–1.23); by collecting data from ClinicalTrials.gov, we found 271 subjects with cancer in the active group and 248 in the control group (RR: 1.09; 95% CI: 0.92–1.29); in the FDA's review, 8,9 the agency reports that 462 subjects in the active group and 423 in the control group developed cancer (RR: 1.09; 95% CI: 0.96–1.24).…”

Section: Resultsmentioning

confidence: 99%

“…We examined the risk of the three types of cancer mentioned in the FDA's review as more frequent in the active group in the CAMELLIA‐TIMI 61 study: lung, colorectal and pancreatic 8,9 . We do not report results of meta‐analyses for these subtypes because of the extremely low number of events in the studies other than the CAMELLIA‐TIMI 61 trial.…”

Section: Resultsmentioning

confidence: 99%

“…However, the US Food and Drug Administration (FDA) issued a Drug Safety Communication in January 2020 reporting a possible increase in the risk of cancer (especially lung, colon, and pancreas) in the follow‐up of subjects treated with lorcaserin, and ultimately, the agency requested the withdrawal of the medication in February 8 . Detailed data from the FDA analysis have been recently published 9 …”

Section: Introductionmentioning

confidence: 99%

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Is lorcaserin really associated with increased risk of cancer? A systematic review and meta‐analysis

et al. 2020

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Summary The US Food and Drug Administration (FDA) reported in February 2020 an increased risk of cancer with lorcaserin in the follow‐up of the CAMELLIA‐TIMI 61 trial. This systematic review and meta‐analysis addresses whether lorcaserin is associated with higher incidence of cancer compared with other interventions or no treatment. We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) for randomized controlled trials that compared lorcaserin with other interventions or no treatment in adults. We performed descriptive synthesis of all included studies and conducted meta‐analysis of trials that reported new cases of cancer. From 11 trials, comprising 21,299 individuals, four studies were included in the meta‐analysis and reported 476 cases of cancer in 10,342 subjects in the lorcaserin group and 438 among 9429 individuals randomized to placebo (relative risk [RR]: 1.08; 95% confidence interval [95% CI]: 0.96–1.23). The result was heavily influenced by the CAMELLIA‐TIMI 61 trial. In this study, the lorcaserin group had a higher risk of lung and pancreatic but not colon cancer. Overall risk of bias was low, and quality of evidence was moderate. The current evidence does not confirm the increased risk of cancer with lorcaserin but suggests a trend in this direction, with a greater incidence of some subtypes such as lung and pancreas.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Is lorcaserin really associated with increased risk of cancer? A systematic review and meta‐analysis

et al. 2020

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“…When considering the use of lorcaserin for smoking cessation therapy, one should consider its narrow therapeutic window and potential carcinogenicity [ 9 ]. Taking into account the carcinogenicity studies in rats showing that lorcaserin at clinical (10 mg/kg) or higher doses was associated with an increased incidence of cancer [ 67 ], the risk of tumor following administration of much lower 0.1-mg/kg dose of lorcaserin as in the present study seems to be rather low.…”

Section: Discussionmentioning

confidence: 99%

“…Preliminary clinical studies have shown that a selective 5-HT 2C receptor agonist named lorcaserin (K i = 29 nM; [ 6 ]), which in 2012 was approved by the US Food and Drug Administration for treating obesity [ 5 ], exhibits positive effects in people addicted to tobacco (such as an increase in smoking abstinence and decrease in associated weight gain) [ 7 , 8 ]. Although more recently the drug was withdrawn from the market due to an increased occurrence of cancer in lorcaserin-treated (10 mg, twice daily) group of patients [ 9 ], the effect of a centrally acting agent on the increased incidence of tumors is hard to explain [ 10 ].…”

Section: Introductionmentioning

confidence: 99%

Chronic Lorcaserin Treatment Reverses the Nicotine Withdrawal-Induced Disruptions to Behavior and Maturation in Developing Neurons in the Hippocampus of Rats

Zaniewska

Nikiforuk

Głowacka

et al. 2021

IJMS

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Preclinical data have shown that treatment with serotonin (5-HT)2C receptor agonists inhibits the behavioral effects of nicotine, including self-administration, reinstatement, and locomotor responses to nicotine. Since the data on the effects of 5-HT2C receptor agonism on nicotine withdrawal signs are limited, we aimed to investigate whether 5-HT2C receptor agonism alleviated the behavioral and neurobiochemical (hippocampal neurogenesis) consequences of nicotine withdrawal in Sprague-Dawley rats. Our data indicate that withdrawal from nicotine self-administration induced locomotor hyperactivity, lengthened immobility time (the forced swim test), induced ‘drug-seeking’ behavior and deficits in cognition-like behavior (the novel object recognition task). A two-week exposure to the 5-HT2C receptor agonist lorcaserin attenuated locomotor hyperactivity and induced recovery from depression-like behavior. Analyses of brain slices from nicotine-withdrawn animals revealed that lorcaserin treatment recovered the reduced number of doublecortin (DCX)-positive cells, but it did not affect the number of Ki-67- or 5-bromo-2’-deoxyuridine (BrdU)-positive cells or the maturation of proliferating neurons in drug-weaned rats. To summarize, we show that lorcaserin alleviated locomotor responses and depression-like state during nicotine withdrawal. We propose that the modulatory effect of lorcaserin on the ‘affective’ aspects of nicotine cessation may be linked to the positive changes caused by the compound in hippocampal neurogenesis during nicotine withdrawal.

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Obesity and Diabetes

Finer

2024

Textbook of Diabetes

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Cancer Risk Associated with Lorcaserin — The FDA’s Review of the CAMELLIA-TIMI 61 Trial

Cited by 105 publications

References 3 publications

Is lorcaserin really associated with increased risk of cancer? A systematic review and meta‐analysis

Is lorcaserin really associated with increased risk of cancer? A systematic review and meta‐analysis

Chronic Lorcaserin Treatment Reverses the Nicotine Withdrawal-Induced Disruptions to Behavior and Maturation in Developing Neurons in the Hippocampus of Rats

Obesity and Diabetes

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