Influence of Sibutramine on blood pressure: evidence from placebo-controlled trials

Jordan, Jens; Scholze, J.; Matiba, Bernd; Wirth, Alfred; Hauner, Hans; Sharma, Arya M.

doi:10.1038/sj.ijo.0802887

Cited by 82 publications

(57 citation statements)

References 33 publications

(37 reference statements)

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…47 However, the authors of a publication that presented the findings from a new metaanalysis of two 12-month sibutramine studies have described a similar small reduction in heart rate in both sibutramine and placebo patients in the subgroups with baseline heart rate X80 bpm. 50 It is interesting to note that the mean baseline heart rate in our study was 79.079.0 bpm. The current Summary of Product Characteristics (SmPC) 14 does not contraindicate the use of sibutramine in patients with well-controlled hypertension, and several studies conducted over the dose range 10-20 mg for periods of upto 12 months have indicated that sibutramine is safe and effective in these patients.…”

Section: Discussionmentioning

confidence: 59%

Efficacy and safety of sibutramine in 2225 subjects with cardiovascular risk factors: short-term, open-label, observational study

Gaciong

Placha

2005

J Hum Hypertens

View full text Add to dashboard Cite

This study aims to determine the efficacy and tolerability of sibutramine hydrochloride in overweight and obese patients with cardiovascular risk factors. This was a 12-week, open-label, observational trial carried out in primary care settings. Patients' data were obtained from questionnaires received from 153 physicians. A total of 2225 overweight and obese (BMIX27 kg/m 2 ) patients received sibutramine in single daily doses of 10 and/or 15 mg. The study population included patients in general good health and with controlled hypertension (41.2%), type II diabetes mellitus (15.6%), hyperlipidaemia (45.5%), and who were chronic tobacco users (smokers) (37.0%). The main outcome measures were changes in body weight, blood pressure and heart rate, and evaluation of reported adverse events. Reduction of body weight of at least 45% from baseline to week 12 was achieved in 2030 (91%) patients and 410% was achieved in 987 (44%) patients. Baseline differences in the percentages of male and female patients, presence or absence of hyperlipidaemia or smoking status did not appear to affect the rate of weight change. Weight loss was less in patients with type II diabetes mellitus and/or controlled systolic hypertension at baseline compared to those patients without these conditions. Mean systolic and diastolic blood pressure and heart rate decreased from baseline to week 12. Overall, sibutramine was well tolerated. In conclusions, treatment with sibutramine resulted in clinically significant weight loss during short-term therapy in obese adults with a range of cardiovascular risk factors.

show abstract

Section: Discussionmentioning

confidence: 59%

Efficacy and safety of sibutramine in 2225 subjects with cardiovascular risk factors: short-term, open-label, observational study

Gaciong

Placha

2005

J Hum Hypertens

View full text Add to dashboard Cite

show abstract

“…35,36 In contrast to blood pressure however, the overall changes in heart rate seen in the study were approximately twice those reported in other placebo-controlled trials. 21 This difference may relate to gender bias (all subjects in the current study were male) or enhanced sympathetic activity secondary to the combined effects of moderate-severe sleep apnoea 37 and sibutramine. However, the clinical significance of the small heart rate rise observed in this study is not clear despite the known cardiovascular risk associated with an elevated resting heart rate.…”

Section: Discussionmentioning

confidence: 86%

“…While dietinduced weight loss is associated with a fall in blood pressure, 19 the effects from sibutramine are less clear. 20,21 Given that OSA is a risk factor for hypertension 22 and difficult to control blood pressure, 11 there may be specific concerns in using sibutramine in obese patients with OSA. It is possible that sibutramine may initially increase blood pressure in subjects with OSA at least in the early stages of use before weight loss occurs.…”

Section: Introductionmentioning

confidence: 99%

The effect of sibutramine-assisted weight loss in men with obstructive sleep apnoea

et al. 2006

View full text Add to dashboard Cite

Objective: Obstructive sleep apnoea (OSA) occurs frequently in obese patients and may be reversible with weight loss. Obstructive sleep apnoea and obesity are both independent risk factors for hypertension and increased sympathetic activity. Sibutramine has been increasingly used in the management of obesity, but is relatively contraindicated in patients with hypertension. No studies have investigated the effect of sibutramine on OSA, blood pressure and heart rate. We aimed to assess the changes in OSA and cardiovascular parameters in obese men with OSA enrolled in a sibutramine-assisted weight loss programme (SIB-WL). Design: Open uncontrolled cohort study of obese male subjects with OSA in an SIB-WL. Subjects: Eighty-seven obese (body mass index ¼ 34.272.8 kg/m 2 ) middle-aged (46.379.3 years) male subjects with symptomatic OSA (Epworth score 13.473.6; respiratory disturbance index (RDI) 46.0723.1 events/h) completed the study. Results: At 6 months, there was significant weight loss (8.374.7 kg, Po0.0001), as well as a reduction in waist and neck circumference and sagittal height (all Po0.0001). These changes were accompanied by a reduction in OSA severity (RDI fell by 16.3719.4 events/h and Epworth score by 4.574.6), both Po0.0001). There was no significant change to systolic (P ¼ 0.07) or diastolic blood pressure (P ¼ 0.87); however, there was a mild rise in resting heart rate (Po0.0001). Conclusion: Moderate (B10%) weight loss with SIB-WL results in improvement in OSA severity without increase in blood pressure in closely monitored OSA subjects.

show abstract

“…Sibutramine increases systolic and diastolic blood pressure by 2-3 and 1-2 mmHg, respectively, and medium heart rate augments by 4-5 beats per minute 17,18 . Anyway, the potential benefits of weight loss outweighed the small increases in heart rate and blood pressure, as shown in the largest study that included 2225 subjects with cardiovascular risk factors, from a primary care setting 19 .…”

Section: Safety and Adverse Eventsmentioning

confidence: 99%

Drugs in the treatment of obesity: sibutramine, orlistat and rimonabant

Rubio

Gargallo²,

Millán

et al. 2007

Public Health Nutr.

View full text Add to dashboard Cite

Background: Modification of lifestyle is the main therapeutical approach in the treatment of obesity, but use to fail on long terms of time. Addition of anti-obesity drugs allows keeping the weight loss during years and improving obesity-related comorbidities. Methods: This review is an actualisation on efficacy, safety and tolerability of the approved drugs on the long-term treatment of obesity (orlistat and sibutramine). New indications and effects of their use far beyond the weight loss are as well commented. Finally, potential benefits of the administration of CB1 antagonist rimonabant on the weight loss and cardiometabolic risk factors are analysed in detail. Discussion: A decade of experience on the use of orlistat and sibutramine has demonstrated their higher efficacy on the weight loss when compared to placebo either on adult or teenage population as well as safety and tolerability on longterm administration. Beneficial effects on the lipid profile, glycosilated haemoglobin on diabetic patients, blood pressure and levels of inflammatory cytokines, contribute to decrease the cardiovascular risk on obese patients. Phase III clinical trials using rimonabant show additional benefits to the expected weight loss, mainly reducing visceral fat and cardiometabolic risk factors. Conclusion: Pharmacological treatment of obesity must be considered as a therapeutical tool that has to be used together with long-term lifestyle changes, contributing to the body weight reduction as well as to the improvement of the cardiometabolic risk related to obesity.

show abstract

Influence of Sibutramine on blood pressure: evidence from placebo-controlled trials

Cited by 82 publications

References 33 publications

Efficacy and safety of sibutramine in 2225 subjects with cardiovascular risk factors: short-term, open-label, observational study

Efficacy and safety of sibutramine in 2225 subjects with cardiovascular risk factors: short-term, open-label, observational study

The effect of sibutramine-assisted weight loss in men with obstructive sleep apnoea

Drugs in the treatment of obesity: sibutramine, orlistat and rimonabant

Contact Info

Product

Resources

About