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document
Safety of nifedipine in patients with hypertension : a meta-analysis . Our objective was to compare cardiovascular event rates in patients with mild or moderate hypertension who received nifedipine with active drug controls . We performed a MEDLARS search using the MeSH heading " hypertension " and the text word " nifedipine " to identify all articles that were published between 1966 and August 1995 in English , French , German , Italian , and Spanish languages and that involved human subjects . The computerized search was supplemented by a manual search of article bibliographies . Review of 1880 citations revealed 98 randomized controlled clinical trials that met protocol criteria . Articles were extracted independently by two doctors who were blinded for author , institution , and treatment regimen , using a structured , pretested extraction form . Differences of opinion were resolved by consensus . Fourteen events occurred in 5198 exposures ( 0.27 % ) to nifedipine and 24 events in 5402 exposures ( 0.44 % ) to other active drug controls . Unadjusted odds ratios for nifedipine versus controls were 0.49 ( 95 % confidence interval [ CI ] , 0.22-1.09 ) for definitive events ( death , nonfatal myocardial infarction or stroke , revascularization procedure ) and 0.61 ( 95 % CI , 0.31-1.17 ) for all events ( definitive plus increased angina ) . The odds ratio for nifedipine monotherapy ( sustained- or extended-release in 91 % of exposures ) was nonsignificantly higher for definitive and all events ( odds ratio , 1.40 ; 95 % CI , 0.49-4.03 and odds ratio , 1.39 ; 95 % CI , 0.59-3.32 , respectively ) . The odds ratio for nifedipine in combination with another drug was significantly lower for definitive and all events ( odds ratio , 0.09 ; 95 % CI , 0.01-0.66 and odds ratio , 0.15 ; 95 % CI , 0.03-0.65 , respectively ) . Differences in odds ratio for nifedipine monotherapy and combined therapy were statistically significant ( P=.02 for definitive events and P=.001 for all events ) . Results support the safety of sustained- and extended-release nifedipine in the treatment of mild or moderate hypertension when it is used in combination with other drugs .
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Intervention_Pharmacological
nifedipine
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Intervention_Pharmacological
nifedipine
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Intervention_Control
active drug controls
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Intervention_Pharmacological
nifedipine
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Intervention_Pharmacological
nifedipine
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Intervention_Pharmacological
nifedipine
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Intervention_Pharmacological
nifedipine
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Intervention_Pharmacological
nifedipine
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Intervention_Pharmacological
nifedipine
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Outcome_Other
Safety
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Outcome_Physical
cardiovascular event rates
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Outcome_Other
Unadjusted odds ratios
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Outcome_Mortality
death
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Outcome_Adverse-effects
nonfatal myocardial infarction or stroke , revascularization procedure
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Outcome_Adverse-effects
all events ( definitive plus increased angina ) .
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Outcome_Other
odds ratio for nifedipine monotherapy
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Outcome_Other
odds ratio for nifedipine in combination with another drug
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Outcome_Other
Differences in odds ratio for nifedipine monotherapy and combined therapy
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Outcome_Other
safety of sustained- and extended-release nifedipine
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Participant_Condition
hypertension
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Participant_Condition
mild or moderate hypertension