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document
Efficacy and safety of a fixed low-dose perindopril/indapamide combination in essential hypertension . A randomised controlled study . This multicenter , double-blind , parallel-group study was designed to assess the efficacy and the safety of fixed low dose combination perindopril 2 mg/indapamide 0.625 mg ( Per/Ind ) versus atenolol 50 mg ( Ate ) . After a 4-week placebo run-in , 446 hypertensive patients ( mean age : 55.8 +/- 11.0 years ) were randomised to receive Per/Ind or Ate for 12 weeks . The primary outcome measures were the changes in trough supine systolic and diastolic blood pressure ( sSBP , sDBP ) between baseline and the last observation . Equivalence was assessed in an intention-to-treat analysis using a two one-sided tests procedure . Per/Ind and Ate decreased sSBP by -20.5 mmHg and -20.1 mmHg , respectively ; the 90 % confidence interval [ -2.3 ; 1.5 ] of the intertreatment difference ( -0.4 mmHg ) fell within the predefined equivalence interval [ -8 ; +8 mmHg ] . Similarly , the sDBP decreased by -15.1 mmHg ( Per/Ind ) and -16.2 mmHg ( Ate ) with an intertreatment difference of 1.1 mmHg whose 90 % confidence interval [ -0.1 ; 2.2 mmHg ] fell within the predefined equivalence interval [ -4 ; +4 mmHg ] ; thus antihypertensive efficacy of Per/Ind and Ate were equivalent ( P < 0.001 ) . In patients older than 65 , Per/Ind induces a statistically greater decrease in sSBP than Ate ( P < 0.05 ) . Per/Ind was well tolerated . Further controlled studies are needed to confirm these results on a long-term period .
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Intervention_Pharmacological
perindopril/indapamide combination
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Intervention_Pharmacological
low dose combination perindopril 2 mg/indapamide
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Intervention_Pharmacological
atenolol
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Intervention_Pharmacological
Per/Ind
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Intervention_Pharmacological
Ate
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Outcome_Other
Efficacy
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Outcome_Other
safety
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Outcome_Other
efficacy
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Outcome_Other
safety
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Outcome_Physical
changes in trough supine systolic and diastolic blood pressure ( sSBP , sDBP )
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Outcome_Physical
Equivalence
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Outcome_Physical
sSBP
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Outcome_Physical
confidence interval
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Outcome_Physical
sDBP decreased
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Outcome_Physical
equivalence interval
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Outcome_Other
antihypertensive efficacy
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Outcome_Physical
sSBP
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Outcome_Other
tolerated
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Participant_Condition
essential hypertension
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Participant_Sample-size
446
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Participant_Condition
hypertensive
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Participant_Age
mean age : 55.8 +/- 11.0 years