Blood pressure changes associated with sibutramine and weight management - an analysis from the 6-week lead-in period of the sibutramine cardiovascular outcomes trial (SCOUT).

Abstract

OBJECTIVE:

To explore vital sign changes among patient subgroups during the 6-week lead-in period of the sibutramine cardiovascular outcomes (SCOUT) trial.

METHODS:

SCOUT is an ongoing, double-blind, randomized, placebo-controlled outcome trial in overweight/obese patients at high risk of a cardiovascular event. During the 6-week lead-in period, 10,742 patients received sibutramine and weight management. Vital sign changes were assessed post hoc by initial blood pressure (mmHg) categorized as normal (<130/<85), high-normal (130 to <140/85 to <90) or hypertensive (>or=140/>or=90); weight change categories (weight gain/no weight change, >0 to 2.5% weight loss, >2.5 to 5% weight loss and >5% weight loss) and current antihypertensive medication class use (none, one, or two or more). To assess the impact of sibutramine on blood pressure and pulse rate, only patients (N = 10,025) who reported no change in the class of antihypertensive medication used and who did not report an increase in antihypertensive medication use were analysed.

RESULTS:

At entry, approximately 50% of patients were hypertensive and 26% were high-normal. In hypertensive patients, blood pressure changes (mmHg) decreased by median [5th, 95th percentile] of -6.5 systolic [-27.0, 8.0] and -2.0 diastolic [-15.0, 8.0] (p < 0.001). Hypertensive patients with no weight loss or with weight gain had median decreases of -3.5 systolic [-26.0, 10.0] and -1.5 diastolic [-16.0, 9.0] (p < 0.001). Normotensive patients had median increases of 1.5 systolic [-15.0, 19.5] and 1.0 diastolic [-10.5, 13.0] (p < 0.001) attenuated with increasing weight loss. Approximately 43% of patients initially categorized as hypertensive had a lower blood pressure category at end-point. Concomitant antihypertensive medication classes did not affect blood pressure reductions. Pulse rates were uniformly elevated (median 1-4 bpm, p < 0.001) across blood pressure and weight change categories.

CONCLUSIONS:

In hypertensive patients (>or=140/>or=90), blood pressure decreases were observed during 6-week treatment with sibutramine even when body weight was unchanged. In patients with normal blood pressure (<130/<85), weight loss of >5% induced decreases in systolic blood pressure; otherwise, small increases were observed. Small pulse rate increases were observed regardless of blood pressure or weight change status.

• Authors: A M Sharma, I D Caterson, W Coutinho, N Finer, L Van Gaal, A P Maggioni, C Torp-Pedersen, H P Bacher, G M Shepherd, W P T James, SCOUT Investigators
• Journal: Diabetes, obesity & metabolism (Diabetes Obes Metab) Vol. 11 Issue 3 Pg. 239-50 (Mar 2009) ISSN: 1463-1326 [Electronic] England
• PMID: 18671798 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Appetite Depressants
• Cyclobutanes
• sibutramine

Topics

• Appetite Depressants (therapeutic use)
• Blood Pressure (drug effects)
• Cyclobutanes (therapeutic use)
• Diabetes Mellitus, Type 2 (drug therapy, physiopathology)
• Diabetic Angiopathies (drug therapy, physiopathology)
• Double-Blind Method
• Female
• Humans
• Hypertension (drug therapy, physiopathology)
• Male
• Middle Aged
• Obesity (drug therapy, physiopathology)
• Weight Loss (drug effects, physiology)