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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).
Diabetes Obes Metab 2009; 11(3):239-50DO

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+Show Affiliations

Royal Alexandra Hospital, University of Alberta, Alberta, Canada. sharma@obesitynetwork.caNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18671798

Citation

Sharma, A M., et al. "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)." Diabetes, Obesity & Metabolism, vol. 11, no. 3, 2009, pp. 239-50.
Sharma AM, Caterson ID, Coutinho W, et al. 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). Diabetes Obes Metab. 2009;11(3):239-50.
Sharma, A. M., Caterson, I. D., Coutinho, W., Finer, N., Van Gaal, L., Maggioni, A. P., ... James, W. P. (2009). 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). Diabetes, Obesity & Metabolism, 11(3), pp. 239-50. doi:10.1111/j.1463-1326.2008.00930.x.
Sharma AM, et al. 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). Diabetes Obes Metab. 2009;11(3):239-50. PubMed PMID: 18671798.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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). AU - Sharma,A M, AU - Caterson,I D, AU - Coutinho,W, AU - Finer,N, AU - Van Gaal,L, AU - Maggioni,A P, AU - Torp-Pedersen,C, AU - Bacher,H P, AU - Shepherd,G M, AU - James,W P T, AU - ,, Y1 - 2008/07/29/ PY - 2008/8/2/pubmed PY - 2009/11/3/medline PY - 2008/8/2/entrez SP - 239 EP - 50 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 11 IS - 3 N2 - 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. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/18671798/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__ L2 - https://doi.org/10.1111/j.1463-1326.2008.00930.x DB - PRIME DP - Unbound Medicine ER -