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Changes in body weight and blood pressure : paradoxical outcome events in overweight and obese subjects with cardiovascular disease . BACKGROUND/OBJECTIVES The Sibutramine Cardiovascular OUTcomes ( SCOUT ) trial showed a significantly increased relative risk of nonfatal cardiovascular events , but not mortality , in overweight and obese subjects receiving long-term sibutramine treatment with diet and exercise . We examined the relationship between early changes ( both increases and decreases ) in body weight and blood pressure , and the impact of these changes on subsequent cardiovascular outcome events . SUBJECTS/METHODS A total of 9804 male and female subjects , aged 55 years or older , with a body mass index of 27-45 kg m ( -2 ) were included in this current subanalysis of the SCOUT trial . Subjects were required to have a history of cardiovascular disease and/or type 2 diabetes mellitus with at least one cardiovascular risk factor ( hypertension , dyslipidemia , current smoking or diabetic nephropathy ) to assess cardiovascular outcomes . Post hoc subgroup analyses of weight change ( categories ) and blood pressure were performed overall and by treatment group ( 6-week sibutramine followed by randomized placebo or continued sibutramine ) . The primary outcome event ( POE ) was a composite of nonfatal myocardial infarction , nonfatal stroke , resuscitated cardiac arrest or cardiovascular death . Time-to-event analyses of the POE were performed using Cox regression models with factors for treatment , subgroups and interactions . RESULTS During the initial 6-week sibutramine treatment period , systolic blood pressure decreased progressively with increasing weight loss in hypertensive subjects ( -8.1±10.5 mm Hg with < 5 kg weight loss to -10.8±11.0 mm Hg with ⩾5 kg weight loss ) . The highest POE incidence occurred mainly in groups with increases in both weight and blood pressure . However , with long-term sibutramine treatment , a markedly lower blood pressure tended to increase POEs . CONCLUSION Modest weight loss and modest lower blood pressure each reduced the incidence of cardiovascular events , as expected . However , the combination of early marked weight loss and rapid blood pressure reduction seems to be harmful in this obese elderly cardiovascular diseased population .
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Intervention_Pharmacological
long-term sibutramine treatment with diet and exercise
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Outcome_Physical
body weight
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Outcome_Physical
blood pressure
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Outcome_Physical
nonfatal cardiovascular events
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Outcome_Mortality
mortality
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Outcome_Physical
body weight
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Outcome_Physical
blood pressure
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Outcome_Physical
cardiovascular outcome events .
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Outcome_Physical
analyses of weight change
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Outcome_Physical
and blood pressure
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Outcome_Physical
The primary outcome event ( POE ) was a composite of nonfatal myocardial infarction , nonfatal stroke , resuscitated cardiac arrest or cardiovascular death
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Outcome_Physical
systolic blood pressure
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Outcome_Physical
weight loss
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Outcome_Physical
weight loss ) .
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Outcome_Physical
weight
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Outcome_Physical
pressure
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Outcome_Physical
loss
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Outcome_Physical
weight loss
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Outcome_Physical
blood
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Participant_Condition
overweight and obese subjects with cardiovascular disease
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Participant_Condition
overweight and obese subjects receiving long-term sibutramine treatment with diet and exercise
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Participant_Sample-size
9804
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Participant_Sex
male
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Participant_Sex
female
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Participant_Age
aged 55 years or older
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Participant_Condition
cardiovascular disease
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Participant_Condition
type 2 diabetes mellitus
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Participant_Condition
hypertension
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Participant_Condition
dyslipidemia
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Participant_Condition
harmful in this obese elderly cardiovascular