20881
document
Effectiveness of once-daily monotherapy with a new nifedipine sustained release calcium antagonist . Data from 2 separate multicenter , double-blind clinical studies following the same protocol , except for the selection of doses , were pooled to evaluate the efficacy and tolerability of fixed doses of a new sustained-release ( SR ) formulation of nifedipine compared with placebo in 388 patients with mild to moderate uncomplicated essential hypertension . After a 3-6 week placebo washout period , the patients were randomized to receive either placebo or nifedipine SR-20 mg ( study I only ) , 50 mg , 100 mg , or 150 mg ( study II only ) . Among the 278 patients who completed 6 weeks of active therapy , mean supine diastolic blood pressure reductions from pretreatment baseline were 5.9 , 9.3 , 9.2 , 11.1 , and 13.2 mm Hg in the placebo , 20- , 50- , 100- , and 150-mg groups , respectively . The reductions achieved in each of the nifedipine SR groups were statistically significant versus baseline values ( p less than 0.001 ) . All nifedipine-SR doses reduced supine systolic blood pressure significantly more than placebo ( p less than 0.001 ) . In addition , there was a significant linear relationship between the log of the dose and the blood pressure reduction ( p less than 0.05 ) . Automated ambulatory blood pressure recordings performed in 221 of the patients showed that the blood pressure was lowered evenly through the entire 24-hour dosing period . The doses that were effective and associated with the fewest adverse reactions were 20 mg and 50 mg once daily .
20882
Intervention_Pharmacological
once-daily monotherapy
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Intervention_Pharmacological
new sustained-release ( SR ) formulation of nifedipine
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Intervention_Control
placebo
20885
Intervention_Pharmacological
placebo or nifedipine
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Intervention_Pharmacological
nifedipine
20887
Intervention_Control
placebo
20888
Outcome_Other
Effectiveness
20889
Outcome_Other
efficacy and tolerability
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Outcome_Physical
mean supine diastolic blood pressure reductions
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Outcome_Physical
reduced supine systolic blood pressure
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Outcome_Physical
log of the dose
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Outcome_Physical
blood pressure reduction
20894
Outcome_Physical
Automated ambulatory blood pressure recordings
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Outcome_Physical
blood pressure
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Participant_Condition
2 separate multicenter