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Arch Mal Coeur Vaiss. 2002 Jul-Aug;95(7-8):738-42.

[Evaluation of blood pressure self-monitoring of the residual efficacy of telmisartan compared to perindopril. The EVERESTE study].

[Article in French]

Author information

1
Laboratoire GlaxoSmithKline, 100, route de Versailles, 78 163 Marly-le-Roi.

Abstract

The aim of this multicentre, prospective, randomised, open study was to compare the trough effect of telmisartan (T) and perindopril (P) on diastolic blood pressure (DBP) after a 12-week treatment, using self blood pressure measurement (SBPM).

METHODS:

To enter the study, patients had to be 18 years of age or older and were required to suffer from mild to moderate hypertension (90 < or = PAD < 110 mmHg and/or PAS < 180 mmHg). At the end of a 3-week run-in placebo period, patients were allocated to receive either T (40 mg) or P (4 mg) once daily for a period of 12 weeks. Patients whose clinic DBP remained higher than or equal to 90 mmHg at the end of the sixth week, were given a double dose regimen. SBPM was performed over 7 consecutive days at 3 different times: at the end of the washout period (W0), at week 6 (W6) and week 12 (W12). A clinic determination of blood pressure (BP) was also performed at each visit, using the same automatic device as that used for SBPM.

RESULTS:

671 patients were selected and 441 were randomised (age: 55 +/- 12 years: 240 men and 201 women). Study populations were the following: the safety population (n = 441, T = 220; P = 221), the intent-to-treat (ITT) population (n = 435, T = 217 and P = 218), and the per protocol population (n = 368, T = 188; P = 180). ITT analysis showed a greater diminution of trough DBP from W0 to W12 with T than with P (T: -6.6 +/- 6.7 mmHg and P: -5.1 +/- 7.0 mmHg; p = 0.018 according to ANOVA for repeated measures). Regarding clinic BP, the same results were observed. Likewise, the per-protocol analysis provided similar findings. Doubling dose was significantly less frequent with T (41%; n = 85) than with P (55%; n = 115; p = 0.005). The overall frequency of adverse events was similar in both treatment groups: T = 34% (n = 74) vs p = 32% (n = 70). Most of them were of mild to moderate intensity and transient. As expected, the occurrence of cough was more frequent with P [5% (n = 12), T < 1% (n = 2), p = 0.007].

CONCLUSION:

The trough effect on DBP was statistically higher with T (40 mg) than with P (4 mg), using SBPM as well as automatic clinic BP measurement.

PMID:
12365090
[Indexed for MEDLINE]

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