Artikel
Better efficacy of initial low dose combination therapy with Preterax(R) vs. other strategies in hypertension (STRATHE)
Höhere Effektivität der initial niedrig-dosierten Fixkombination Preterax(R) vs. anderer Behandlungsstrategien in der Hypertonie
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Autoren
Veröffentlicht: | 11. November 2004 |
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Gliederung
Text
Objective
To compare 3 different currently recommended antihypertensive strategies (STRATHE: STRAtegies of Treatment in Hypertension Evaluation): Initial Low Dose Perindopril/Indapamide (Per/Ind) Combination (PreteraxÒ) strategy versus Sequential versus Step by Step strategies.
Methods
A 6- to 9-months, randomised, double-blind, controlled study. 533 Patients (160 £ SBP < 210mmHg and 95 £ DBP < 115mmHg) were randomised to
a) Initial Low Dose Combination Per/Ind strategy (Per 2mg/Ind 0.625mg to Per 4mg/Ind 1.25mg),
b) Sequential strategy (Atenolol 50mg, Losartan 50mg, Amlodipine 5mg), or
c) Step by step strategy (Valsartan 40mg, Valsartan 80mg, Valsartan 80mg/HCTZ 12.5mg).
Treatment could be adapted at M3 or M6 according to BP level. The main analysis criteria was based on the comparison of a predefined composite efficacy/safety ratio (=BP normalization without adverse events).
Results
The initial Low Dose Combination strategy with Per/Ind showed a significant better efficacy/safety ratio compared with Sequential strategy (p=0.0015) and with Step by Step strategy (p=0.0042) (ITT, Intention-to-treat analysis). Systolic BP decrease was significantly superior in the Per/Ind group compared with Sequential and Step by Step strategies. BP normalisation rate (BP<140/90mmHg)in the Per/Ind group was significantly superior to the two other strategies [Tab. 1]. Tolerability was equivalent in the 3 groups with a tendency to a lower incidence of adverse events in Per/Ind group (Severe adverse events: 2.2% in Per/Ind vs. 5.5% in Sequential, 4.4% in Step by Step)
Conclusion
The new treatment strategy of initial Low Dose Combination therapy Per/ Ind recommended by ESH/ ESC resulted in a significant higher BP normalization rate and SBP decrease. Furthermore it showed a superior efficacy/ safety ratio than sequential or step by step strategies.