Phase 3
Completed N=9,804
A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients
Source: ClinicalTrials.gov NCT00234832 ↗Enrolled (actual)
9,804
Serious AEs
21.8%
Results posted
Apr 2010
Primary outcomePrimary: Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death) — 561; 490; 79; 77 Participants — p=0.015
Summary
The purpose of the study was to determine the long-term effect of sibutramine treatment on cardiovascular outcomes in overweight and obese patients at risk of a cardiovascular event.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death) |
561; 490; 79; 77; 77; 66 | 0.015 sig |
| SECONDARY Risk of Death From Any Cause (All-cause Mortality) |
418; 404 | 0.543 |
| SECONDARY Risk of Experiencing a POE or a Revascularization Procedure |
927; 856 | 0.051 |
| SECONDARY Risk of Experiencing a Nonfatal MI Included in the POE |
200; 159 | 0.022 sig |
| SECONDARY Risk of Experiencing a Nonfatal Stroke Included in the POE |
127; 95 | 0.025 sig |
| SECONDARY Risk of Experiencing a Resuscitated Cardiac Arrest Included in the POE |
11; 7 | 0.343 |
| SECONDARY Risk of Experiencing Cardiovascular Death Included in the POE |
223; 229 | 0.899 |
Eligibility Criteria
Inclusion Criteria
- Subject's body mass index (BMI) was >= 27 kg/m(2) and = 25 kg/m(2) and = 102 cm in males or >= 88 cm in females.
- Medical history positive for:
- Preexisting cardiovascular disease (i.e., coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease) and/or
- Type 2 diabetes mellitus with at least 1 other risk factor (i.e., dyslipidemia, controlled hypertension, current smoker, or diabetic nephropathy with evidence of microalbuminuria)
Exclusion Criteria
- History of recent myocardial infarction.
- Heart failure symptoms greater than New York Heart Association Functional Class II.
- Hemodynamically significant valvular or left ventricular (LV) tract obstruction.
- Subjects without a pacemaker and with any of the following:
- Sinus bradycardia ( 160 mmHg. Mean sitting diastolic blood pressure (DBP) > 100 mmHg. Mean sitting heart rate (HR) > 100 bpm.
- Syncopal episodes presumed to be due to uncontrolled life-threatening arrhythmias.
- Planned cardiac surgery or coronary angioplasty within 6 months of screening.
- History of recent non-hemorrhagic stroke or transient ischemic attack (TIA), history of hemorrhagic stroke.
- Hyperthyroidism.
- Known chronic liver disease or endstage renal disease.
- Severe, symptomatic benign prostatic hyperplasia which may require surgery.
- Known pheochromocytoma, history of narrow angle glaucoma, Gilles de la Tourette syndrome, history of seizures, history of bariatric or abdominal obesity surgery (excluding liposuction).
- Concomitant use of monoamine oxidase inhibitors or drugs that increase levels of serotonin in the brain.
- Treated hypertension stabilized for less than 3 months.
- Inability to perform regular physical activity.
Data sourced from ClinicalTrials.gov (NCT00234832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.