Evidence map›Paper›PMID 30145941›Full record

Trial reportThe New England journal of medicine2018

Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients.

Erin A Bohula, Stephen D Wiviott, Darren K McGuire, Silvio E Inzucchi, Julia Kuder, KyungAh Im, Christina L Fanola, Arman Qamar, Conville Brown, Andrzej Budaj and 17 more

3 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 107 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
107citing papers in PubMed, 6 pooled it
26.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02019264 phase4completednot on this map

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors

TypeinterventionalSponsorEisai Inc.Ran2014 to 2018Enrolled14,673ConditionsCardiovascular Disease, High Cardiovascular Risk, Obesity, OverweightArmsLorcaserin hydrochloride, Placebo
NCT03192995 phase2terminatednot on this map

Treatment With Lorcaserin for Cocaine Use: The TLC Study

TypeinterventionalSponsorGlenn-Milo SantosRan2018 to 2020Enrolled22ConditionsCocaine Use DisorderArmslorcaserin, Placebo Oral Tablet, Substance use counseling, ACASI, Cocaine metabolites
NCT06455878 narecruitingnot on this mapstarted 2024, after this paper: background citation

The Impact of Dietary Management Applet for Weight Reduction in Obese Heart Failure Patients: a Multicenter, Single-blind Randomized Controlled Trial

TypeinterventionalSponsorHeart Health Research CenterRan2024 to 2026Enrolled830ConditionsHeart Failure, Overweight and Obesity, Weight Loss, Heart Failure With Reduced Ejection FractionArmsFull usage of diet management app group and with the full usage of an intelligent weight scale, Limited usage of diet management app group and with the limited usage of an intelligent weight scale
3 · Its place in the literature

Who cites it

107 citing papers in PubMed, 6 syntheses or guidelines pooled it, 261 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Long-term effects of weight-reducing drugs in people with hypertension.The Cochrane database of systematic reviews · 2021
    Pooled it
  5. Guideline
  6. Pooled it
  7. Defining Predictors of Weight Loss Response to Lorcaserin.The Journal of clinical endocrinology and metabolism · 2023
    Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Article
  15. Review
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  19. Review
  20. 5-HTGeroScience · 2025
    Article

47 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 10 institutions in 6 countries.

Erin A BohulaFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Stephen D WiviottFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Darren K McGuireFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Silvio E InzucchiFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Julia KuderFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
KyungAh ImFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Christina L FanolaFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Arman QamarFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Conville BrownFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Andrzej BudajFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Armando Garcia-CastilloFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Milan GuptaFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Lawrence A LeiterFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Neil J WeissmanFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Harvey D WhiteFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Tushar PatelFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Bruce FrancisFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Wenfeng MiaoFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Carlos PerdomoFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Shobha DhaddaFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Marc P BonacaFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Christian T RuffFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Anthony C KeechFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Steven R SmithFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Marc S SabatineFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
Benjamin M SciricaFrom the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston (E.A.B., S.D.W., J.K., K.I., A.Q., M.P.B., C.T.R., M.S.S., B.M.S.); the Cardiovascular Division, University of Texas Southwestern Medical Center, Dallas (D.K.M.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); the Department of Medicine, University of Minnesota, Minneapolis (C.L.F.); the Partners Clinical Research Centre, Nassau, Bahamas (C.B.); the Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); Cardiolink Clinical Trials, Monterrey, Mexico (A.G.-C.); McMaster University, Brampton, ON (M.G.), and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; MedStar Health Research Institute, Hyattsville, MD (N.J.W.); the Cardiology Department, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Eisai, Woodcliff Lake, NJ (T.P., B.F., W.M., C.P., S.D.); National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (A.C.K.); and the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park (S.R.S.).
CAMELLIA–TIMI 61 Steering Committee and Investigators
Brigham and Women's Hospital · USEisai (United States) · USThrombolysis in Myocardial Infarction Study Group · USAuckland City Hospital · NZGrochowski Hospital · PLSanford Burnham Prebys Medical Discovery Institute · USSt. Michael's Hospital · CAThe University of Sydney · AUUniversity of Minnesota · USYale University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLorcaserin, a selective serotonin 2C receptor agonist that modulates appetite, has proven efficacy for weight management in overweight or obese patients. The cardiovascular safety and efficacy of lorcaserin are undefined.

methodsWe randomly assigned 12,000 overweight or obese patients with atherosclerotic cardiovascular disease or multiple cardiovascular risk factors to receive either lorcaserin (10 mg twice daily) or placebo. The primary safety outcome of major cardiovascular events (a composite of cardiovascular death, myocardial infarction, or stroke) was assessed at an interim analysis to exclude a noninferiority boundary of 1.4. If noninferiority was met, the primary cardiovascular efficacy outcome (a composite of major cardiovascular events, heart failure, hospitalization for unstable angina, or coronary revascularization [extended major cardiovascular events]) was assessed for superiority at the end of the trial.

resultsAt 1 year, weight loss of at least 5% had occurred in 1986 of 5135 patients (38.7%) in the lorcaserin group and in 883 of 5083 (17.4%) in the placebo group (odds ratio, 3.01; 95% confidence interval [CI], 2.74 to 3.30; P<0.001). Patients in the lorcaserin group had slightly better values with respect to cardiac risk factors (including blood pressure, heart rate, glycemic control, and lipids) than those in the placebo group. During a median follow-up of 3.3 years, the rate of the primary safety outcome was 2.0% per year in the lorcaserin group and 2.1% per year in the placebo group (hazard ratio, 0.99; 95% CI, 0.85 to 1.14; P<0.001 for noninferiority); the rate of extended major cardiovascular events was 4.1% per year and 4.2% per year, respectively (hazard ratio, 0.97; 95% CI, 0.87 to 1.07; P=0.55). Adverse events of special interest were uncommon, and the rates were generally similar in the two groups, except for a higher number of patients with serious hypoglycemia in the lorcaserin group (13 vs. 4, P=0.04).

conclusionsIn a high-risk population of overweight or obese patients, lorcaserin facilitated sustained weight loss without a higher rate of major cardiovascular events than that with placebo. (Funded by Eisai; CAMELLIA-TIMI 61 ClinicalTrials.gov number, NCT02019264 .).

Indexed as

AgedAnti-Obesity AgentsAortic Valve InsufficiencyBenzazepinesCardiovascular DiseasesDiabetes Mellitus, Type 2Double-Blind MethodFemaleFollow-Up StudiesHumansHypertension, PulmonaryHypoglycemiaMaleMiddle AgedObesityOverweightAnti-Obesity AgentsBenzazepineslorcaserin

Identifiers

PMID30145941
OpenAlexW2888628330

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.