A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients (SCOUT)

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00234832
First received: September 13, 2005
Last updated: May 6, 2010
Last verified: May 2010
Results First Received: March 26, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Obesity
Interventions: Drug: Sibutramine hydrochloride
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 10777 subjects enrolled into the study, 33 were not treated with Lead-in Period sibutramine. Of the 10744 subjects who took at least 1 dose of Lead-in Period sibutramine, 939 were not randomized. One of the remaining 9805 subjects was not dispensed randomized study drug and was not included in the intent-to-treat population (N = 9804).

Reporting Groups
  Description
Randomized Sibutramine Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
Randomized Placebo Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.

Participant Flow:   Overall Study
    Randomized Sibutramine     Randomized Placebo  
STARTED     4906 [1]   4898 [1]
COMPLETED     3890 [2]   3902 [2]
NOT COMPLETED     1016     996  
[1] Subjects completed the 6-week Lead-in Period and were dispensed randomized study drug.
[2] Subjects completed the Randomization Phase.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Randomized Sibutramine Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
Randomized Placebo Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
Total Total of all reporting groups

Baseline Measures
    Randomized Sibutramine     Randomized Placebo     Total  
Number of Participants  
[units: participants]
  4906     4898     9804  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     3040     2997     6037  
>=65 years     1866     1901     3767  
Age  
[units: years]
Mean ± Standard Deviation
  63.2  ± 6.09     63.3  ± 6.15     63.2  ± 6.12  
Gender  
[units: participants]
     
Female     2099     2055     4154  
Male     2807     2843     5650  
Region of Enrollment  
[units: participants]
     
Europe     4160     4150     8310  
Australia     384     385     769  
Brazil     233     234     467  
Mexico     129     129     258  
Cardiovascular (CV) risk group status [1]
[units: Participants]
     
DM only     1207     1178     2385  
CV only     759     793     1552  
CV + DM     2906     2901     5807  
Unknown CV risk group status     34     26     60  
[1] Subjects were categorized at study entry into 1 of 3 prespecified CV risk groups: 1) diabetes mellitus (DM) only = history of type 2 DM with at least one other risk factor but no history of CV disease, 2) CV only = history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor, and 3) CV + DM = history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and a history of type 2 DM with at least one other risk factor.



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death)   [ Time Frame: From randomization up to 6 years ]

Measure Type Primary
Measure Title Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death)
Measure Description 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.
Time Frame From randomization up to 6 years  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis based on intent-to-treat (ITT) population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized. Subjects were also categorized into 1 of 3 prespecified CV risk groups: diabetes mellitus (DM) only, CV only, and CV + DM.

Reporting Groups
  Description
Randomized Sibutramine Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
Randomized Placebo Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
DM Only Randomized to Sibutramine Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.
DM Only Randomized to Placebo Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
CV Only Randomized to Sibutramine Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.
CV Only Randomized to Placebo Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
CV + DM Randomized to Sibutramine Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.
CV + DM Randomized to Placebo Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.

Measured Values
    Randomized Sibutramine     Randomized Placebo     DM Only Randomized to Sibutramine     DM Only Randomized to Placebo     CV Only Randomized to Sibutramine     CV Only Randomized to Placebo     CV + DM Randomized to Sibutramine     CV + DM Randomized to Placebo  
Number of Participants Analyzed  
[units: participants]
  4906     4898     1207     1178     759     793     2906     2901  
Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death)  
[units: Participants]
               
Intent-to-treat population     561     490     79     77     77     66     403     346  


Statistical Analysis 1 for Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death)
Groups [1] Randomized Sibutramine vs. Randomized Placebo
Method [2] Log Rank
P Value [3] 0.015
Cox Proportional Hazard [4] 1.162
95% Confidence Interval ( 1.029 to 1.311 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  For the sample size calculation, a two-tailed alpha level of 0.05 was used along with power of 90%. The annual composite event rate in the placebo arm was assumed to be 7.0%. A sample of 3983 subjects in each of the 2 groups, corrected for a 30% noncompliance rate (15% in Year 1 and 6.3% in each year, Years 2 to 4), followed for at least 3 years was expected to have 90% power to detect a relative risk reduction of 15% with sibutramine relative to placebo.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No adjustment for multiple testing or interim analysis was performed. The primary outcome was tested at a 2-sided alpha level of 0.05.
[4] Other relevant estimation information:
  The Cox model included factors for treatment, country, gender, and age (continuous) at Lead-in Period baseline. For the calculation of risk, the sibutramine arm is the numerator and the placebo arm is the denominator.

Statistical Analysis 2 for Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death)
Groups [1] DM Only Randomized to Sibutramine vs. DM Only Randomized to Placebo
Method [2] Log Rank
P Value [3] 0.948
Cox Proportional Hazard [4] 1.010
95% Confidence Interval ( 0.738 to 1.384 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This analysis included only subjects with DM only in a comparison of sibutramine and placebo.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death)
Groups [1] CV Only Randomized to Sibutramine vs. CV Only Randomized to Placebo
Method [2] Log Rank
P Value [3] 0.149
Cox Proportional Hazard [4] 1.276
95% Confidence Interval ( 0.916 to 1.776 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This analysis included only subjects with CV only in a comparison of sibutramine and placebo.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death)
Groups [1] CV + DM Randomized to Sibutramine vs. CV + DM Randomized to Placebo
Method [2] Log Rank
P Value [3] 0.022
Cox Proportional Hazard [4] 1.182
95% Confidence Interval ( 1.024 to 1.365 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This analysis included only subjects with CV + DM in a comparison of sibutramine and placebo.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



2.  Secondary:   Risk of Death From Any Cause (All-cause Mortality)   [ Time Frame: From randomization up to 6 years ]

Measure Type Secondary
Measure Title Risk of Death From Any Cause (All-cause Mortality)
Measure Description For each subject who died, the time to death was evaluated using time-to-event analysis.
Time Frame From randomization up to 6 years  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.

Reporting Groups
  Description
Randomized Sibutramine Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
Randomized Placebo Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.

Measured Values
    Randomized Sibutramine     Randomized Placebo  
Number of Participants Analyzed  
[units: participants]
  4906     4898  
Risk of Death From Any Cause (All-cause Mortality)  
[units: Participants]
  418     404  


Statistical Analysis 1 for Risk of Death From Any Cause (All-cause Mortality)
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.543
Cox Proportional Hazard [4] 1.043
95% Confidence Interval ( 0.910 to 1.196 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



3.  Secondary:   Risk of Experiencing a POE or a Revascularization Procedure   [ Time Frame: From randomization up to 6 years ]

Measure Type Secondary
Measure Title Risk of Experiencing a POE or a Revascularization Procedure
Measure Description 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.
Time Frame From randomization up to 6 years  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.

Reporting Groups
  Description
Randomized Sibutramine Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
Randomized Placebo Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.

Measured Values
    Randomized Sibutramine     Randomized Placebo  
Number of Participants Analyzed  
[units: participants]
  4906     4898  
Risk of Experiencing a POE or a Revascularization Procedure  
[units: Participants]
  927     856  


Statistical Analysis 1 for Risk of Experiencing a POE or a Revascularization Procedure
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.051
Cox Proportional Hazard [4] 1.097
95% Confidence Interval ( 0.999 to 1.204 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



4.  Secondary:   Risk of Experiencing a Nonfatal MI Included in the POE   [ Time Frame: From randomization up to 6 years ]

Measure Type Secondary
Measure Title Risk of Experiencing a Nonfatal MI Included in the POE
Measure Description For each subject, the first occurrence of a nonfatal MI included in the POE was evaluated using time-to-event analysis.
Time Frame From randomization up to 6 years  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.

Reporting Groups
  Description
Randomized Sibutramine Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
Randomized Placebo Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.

Measured Values
    Randomized Sibutramine     Randomized Placebo  
Number of Participants Analyzed  
[units: participants]
  4906     4898  
Risk of Experiencing a Nonfatal MI Included in the POE  
[units: Participants]
  200     159  


Statistical Analysis 1 for Risk of Experiencing a Nonfatal MI Included in the POE
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.022
Cox Proportional Hazard [4] 1.276
95% Confidence Interval ( 1.036 to 1.571 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



5.  Secondary:   Risk of Experiencing a Nonfatal Stroke Included in the POE   [ Time Frame: From randomization up to 6 years ]

Measure Type Secondary
Measure Title Risk of Experiencing a Nonfatal Stroke Included in the POE
Measure Description For each subject, the time to first occurrence of a nonfatal stroke included in the POE was evaluated using time-to-event analysis.
Time Frame From randomization up to 6 years  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.

Reporting Groups
  Description
Randomized Sibutramine Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
Randomized Placebo Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.

Measured Values
    Randomized Sibutramine     Randomized Placebo  
Number of Participants Analyzed  
[units: participants]
  4906     4898  
Risk of Experiencing a Nonfatal Stroke Included in the POE  
[units: Participants]
  127     95  


Statistical Analysis 1 for Risk of Experiencing a Nonfatal Stroke Included in the POE
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.025
Cox Proportional Hazard [4] 1.355
95% Confidence Interval ( 1.038 to 1.767 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



6.  Secondary:   Risk of Experiencing a Resuscitated Cardiac Arrest Included in the POE   [ Time Frame: From randomization up to 6 years ]

Measure Type Secondary
Measure Title Risk of Experiencing a Resuscitated Cardiac Arrest Included in the POE
Measure Description For each subject, the time to first occurrence of a resuscitated cardiac arrest included in the POE was evaluated using time-to-event analysis.
Time Frame From randomization up to 6 years  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.

Reporting Groups
  Description
Randomized Sibutramine Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
Randomized Placebo Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.

Measured Values
    Randomized Sibutramine     Randomized Placebo  
Number of Participants Analyzed  
[units: participants]
  4906     4898  
Risk of Experiencing a Resuscitated Cardiac Arrest Included in the POE  
[units: Participants]
  11     7  


Statistical Analysis 1 for Risk of Experiencing a Resuscitated Cardiac Arrest Included in the POE
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.343
Cox Proportional Hazard [4] 1.582
95% Confidence Interval ( 0.613 to 4.081 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



7.  Secondary:   Risk of Experiencing Cardiovascular Death Included in the POE   [ Time Frame: From randomization up to 6 years ]

Measure Type Secondary
Measure Title Risk of Experiencing Cardiovascular Death Included in the POE
Measure Description For each subject, the time to cardiovascular death included in the POE was evaluated using time-to-event analysis.
Time Frame From randomization up to 6 years  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.

Reporting Groups
  Description
Randomized Sibutramine Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
Randomized Placebo Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.

Measured Values
    Randomized Sibutramine     Randomized Placebo  
Number of Participants Analyzed  
[units: participants]
  4906     4898  
Risk of Experiencing Cardiovascular Death Included in the POE  
[units: Participants]
  223     229  


Statistical Analysis 1 for Risk of Experiencing Cardiovascular Death Included in the POE
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.899
Cox Proportional Hazard [4] 0.988
95% Confidence Interval ( 0.822 to 1.188 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Most subjects not indicated for sibutramine (sbt) due to CV disease. Long-term sbt use (6 yrs) regardless of weight loss, is inconsistent with label (limits use to 1-2 yrs & 5% weight loss). Trial lacked true placebo; all received Lead-in Period sbt.


  More Information