Page last updated: 2024-11-04

sibutramine and Stroke

sibutramine has been researched along with Stroke in 5 studies

sibutramine: serotonin and norepinephrine transporter inhibitor; Meridia is tradename for sibutramine hydrochloride

Stroke: A group of pathological conditions characterized by sudden, non-convulsive loss of neurological function due to BRAIN ISCHEMIA or INTRACRANIAL HEMORRHAGES. Stroke is classified by the type of tissue NECROSIS, such as the anatomic location, vasculature involved, etiology, age of the affected individual, and hemorrhagic vs. non-hemorrhagic nature. (From Adams et al., Principles of Neurology, 6th ed, pp777-810)

Research Excerpts

ExcerptRelevanceReference
"The Sibutramine Cardiovascular OUTcomes trial showed that sibutramine produced greater mean weight loss than placebo but increased cardiovascular morbidity but not mortality."9.16Maintained intentional weight loss reduces cardiovascular outcomes: results from the Sibutramine Cardiovascular OUTcomes (SCOUT) trial. ( Caterson, ID; Coutinho, W; Finer, N; James, WP; Legler, UF; Maggioni, AP; Perdok, RJ; Renz, CL; Rode, RA; Sharma, AM; Shepherd, GM; Torp-Pedersen, C; Van Gaal, LF, 2012)
"We enrolled in our study 10,744 overweight or obese subjects, 55 years of age or older, with preexisting cardiovascular disease, type 2 diabetes mellitus, or both to assess the cardiovascular consequences of weight management with and without sibutramine in subjects at high risk for cardiovascular events."9.14Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. ( Caterson, ID; Coutinho, W; Finer, N; James, WP; Maggioni, AP; Renz, CL; Rode, RA; Sharma, AM; Shepherd, GM; Torp-Pedersen, C; Van Gaal, LF, 2010)
"The risk of AMI, stroke and either AMI or stroke was not higher among sibutramine users than comparable non-users of sibutramine in both Germany and the UK [Germany: HR 0."7.78Safety assessment of an anti-obesity drug (sibutramine): a retrospective cohort study. ( Ferrufino, CP; Klingman, D; Lee, WC; Oleske, DM; Tyczynski, JE, 2012)
"This analysis included 8,192 overweight patients with type 2 diabetes from the Sibutramine Cardiovascular Outcomes (SCOUT) trial randomized to lifestyle intervention with or without sibutramine for up to 6 years."5.17Association of hypoglycemic treatment regimens with cardiovascular outcomes in overweight and obese subjects with type 2 diabetes: a substudy of the SCOUT trial. ( Andersson, C; Caterson, I; Coutinho, W; Finer, N; Ghotbi, AA; James, WP; Køber, L; Sharma, AM; Torp-Pedersen, C; Van Gaal, LF, 2013)
"The Sibutramine Cardiovascular OUTcomes trial showed that sibutramine produced greater mean weight loss than placebo but increased cardiovascular morbidity but not mortality."5.16Maintained intentional weight loss reduces cardiovascular outcomes: results from the Sibutramine Cardiovascular OUTcomes (SCOUT) trial. ( Caterson, ID; Coutinho, W; Finer, N; James, WP; Legler, UF; Maggioni, AP; Perdok, RJ; Renz, CL; Rode, RA; Sharma, AM; Shepherd, GM; Torp-Pedersen, C; Van Gaal, LF, 2012)
"We enrolled in our study 10,744 overweight or obese subjects, 55 years of age or older, with preexisting cardiovascular disease, type 2 diabetes mellitus, or both to assess the cardiovascular consequences of weight management with and without sibutramine in subjects at high risk for cardiovascular events."5.14Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. ( Caterson, ID; Coutinho, W; Finer, N; James, WP; Maggioni, AP; Renz, CL; Rode, RA; Sharma, AM; Shepherd, GM; Torp-Pedersen, C; Van Gaal, LF, 2010)
"The marketing authorization for the weight loss drug sibutramine was suspended in 2010 following a major trial that showed increased rates of non-fatal myocardial infarction and cerebrovascular events in patients with pre-existing cardiovascular disease."3.81The effect of sibutramine prescribing in routine clinical practice on cardiovascular outcomes: a cohort study in the United Kingdom. ( Batterham, R; Bhaskaran, K; Douglas, I; Hayes, JF; Smeeth, L, 2015)
"The risk of AMI, stroke and either AMI or stroke was not higher among sibutramine users than comparable non-users of sibutramine in both Germany and the UK [Germany: HR 0."3.78Safety assessment of an anti-obesity drug (sibutramine): a retrospective cohort study. ( Ferrufino, CP; Klingman, D; Lee, WC; Oleske, DM; Tyczynski, JE, 2012)

Research

Studies (5)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's5 (100.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Ghotbi, AA1
Køber, L1
Finer, N3
James, WP3
Sharma, AM3
Caterson, I1
Coutinho, W3
Van Gaal, LF3
Torp-Pedersen, C3
Andersson, C1
Hayes, JF1
Bhaskaran, K1
Batterham, R1
Smeeth, L1
Douglas, I1
Caterson, ID2
Maggioni, AP2
Shepherd, GM2
Rode, RA2
Renz, CL2
Legler, UF1
Perdok, RJ1
Tyczynski, JE1
Oleske, DM1
Klingman, D1
Ferrufino, CP1
Lee, WC1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Sibutramine Cardiovascular Morbidity/Mortality Outcomes Study in Overweight or Obese Subjects at Risk of a Cardiovascular Event[NCT00234832]Phase 310,777 participants (Actual)Interventional2003-01-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Risk of Death From Any Cause (All-cause Mortality)

For each subject who died, the time to death was evaluated using time-to-event analysis. (NCT00234832)
Timeframe: From randomization up to 6 years

InterventionParticipants (Number)
Randomized Sibutramine418
Randomized Placebo404

Risk of Experiencing a Nonfatal MI Included in the POE

For each subject, the first occurrence of a nonfatal MI included in the POE was evaluated using time-to-event analysis. (NCT00234832)
Timeframe: From randomization up to 6 years

InterventionParticipants (Number)
Randomized Sibutramine200
Randomized Placebo159

Risk of Experiencing a Nonfatal Stroke Included in the POE

For each subject, the time to first occurrence of a nonfatal stroke included in the POE was evaluated using time-to-event analysis. (NCT00234832)
Timeframe: From randomization up to 6 years

InterventionParticipants (Number)
Randomized Sibutramine127
Randomized Placebo95

Risk of Experiencing a POE or a Revascularization Procedure

This outcome includes nonfatal MI, nonfatal stroke, resuscitated cardiac arrest, CV death (including events such as fatal MI and fatal stroke), and any of the following revascularization procedures: percutaneous transluminal coronary angioplasty, coronary artery bypass graft, coronary artery stent placement, cardiac transplant, peripheral vascular bypass or angioplasty, and carotid endarterectomy. For each subject, the POE or revascularization status (yes/no) and time to first occurrence of an event using time-to-event analysis were evaluated. (NCT00234832)
Timeframe: From randomization up to 6 years

InterventionParticipants (Number)
Randomized Sibutramine927
Randomized Placebo856

Risk of Experiencing a Resuscitated Cardiac Arrest Included in the POE

For each subject, the time to first occurrence of a resuscitated cardiac arrest included in the POE was evaluated using time-to-event analysis. (NCT00234832)
Timeframe: From randomization up to 6 years

InterventionParticipants (Number)
Randomized Sibutramine11
Randomized Placebo7

Risk of Experiencing Cardiovascular Death Included in the POE

For each subject, the time to cardiovascular death included in the POE was evaluated using time-to-event analysis. (NCT00234832)
Timeframe: From randomization up to 6 years

InterventionParticipants (Number)
Randomized Sibutramine223
Randomized Placebo229

Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death)

For each subject, POE status (with/without an event) and time to first occurrence of a POE using time-to-event analysis were evaluated. All POE confirmed by an independent adjudication committee were included in the analysis. (NCT00234832)
Timeframe: From randomization up to 6 years

,,,,,,,
InterventionParticipants (Number)
Intent-to-treat population
CV + DM Randomized to Placebo346
CV + DM Randomized to Sibutramine403
CV Only Randomized to Placebo66
CV Only Randomized to Sibutramine77
DM Only Randomized to Placebo77
DM Only Randomized to Sibutramine79
Randomized Placebo490
Randomized Sibutramine561

Trials

3 trials available for sibutramine and Stroke

ArticleYear
Association of hypoglycemic treatment regimens with cardiovascular outcomes in overweight and obese subjects with type 2 diabetes: a substudy of the SCOUT trial.
    Diabetes care, 2013, Volume: 36, Issue:11

    Topics: Aged; Cardiovascular Diseases; Clinical Protocols; Cyclobutanes; Diabetes Mellitus, Type 2; Female;

2013
Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects.
    The New England journal of medicine, 2010, Sep-02, Volume: 363, Issue:10

    Topics: Aged; Appetite Depressants; Blood Pressure; Cardiovascular Diseases; Cyclobutanes; Diabetes Mellitus

2010
Maintained intentional weight loss reduces cardiovascular outcomes: results from the Sibutramine Cardiovascular OUTcomes (SCOUT) trial.
    Diabetes, obesity & metabolism, 2012, Volume: 14, Issue:6

    Topics: Appetite Depressants; Cardiovascular Diseases; Cyclobutanes; Diabetes Mellitus, Type 2; Double-Blind

2012

Other Studies

2 other studies available for sibutramine and Stroke

ArticleYear
The effect of sibutramine prescribing in routine clinical practice on cardiovascular outcomes: a cohort study in the United Kingdom.
    International journal of obesity (2005), 2015, Volume: 39, Issue:9

    Topics: Anti-Obesity Agents; Appetite Depressants; Cohort Studies; Contraindications; Cyclobutanes; Female;

2015
Safety assessment of an anti-obesity drug (sibutramine): a retrospective cohort study.
    Drug safety, 2012, Aug-01, Volume: 35, Issue:8

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Obesity Agents; Child; Child, Preschool; Cohort Stu

2012