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Influence of a single dose of 20 mg tadalafil, a phosphodiesterase 5 inhibitor, on ambulatory blood pressure in subjects with hypertension
Author(s) -
Patterson Dean,
McInnes Gordon T.,
Webster John,
Mitchell Malcolm M.,
MacDonald Thomas M.
Publication year - 2006
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/j.1365-2125.2006.02658.x
Subject(s) - ambulatory blood pressure , blood pressure , medicine , tadalafil , ambulatory , placebo , crossover study , diastole , confidence interval , essential hypertension , anesthesia , cardiology , urology , erectile dysfunction , alternative medicine , pathology
Aims To test the non‐inferiority of a single dose of tadalafil 20 mg compared with placebo with respect to 26‐h mean ambulatory systolic and diastolic blood pressure in treated and untreated hypertensive subjects. Methods A multicentre, randomized, double‐blind, placebo‐controlled crossover study in 114 subjects with hypertension (36 subjects on no therapy with daytime mean ambulatory blood pressure ≥ 140/85 mmHg; 38 subjects on two to four classes of antihypertensive agents with daytime mean ambulatory blood pressure ≥140/85 mmHg and 40 subjects on two to four classes of antihypertensive agents with ambulatory blood pressure < 140/85 mmHg). Results Overall tadalafil reduced mean ambulatory blood pressure monitor systolic and diastolic blood pressure by 4.8 mmHg [95% confidence interval (Cl) 3.7, 5.9; P < 0.01] and 2.9 mmHg (95% CI 1.9, 3.6; P < 0.01), respectively, compared with placebo. In hypertensive subjects with uncontrolled blood pressure on two to four classes of antihypertensive agents ( n = 36) tadalafil reduced mean ABPM systolic and diastolic blood pressure by 7.5 mmHg (95% CI 5.4, 9.6; P < 0.01) and 4.3 mmHg (95% CI 6.1, 8.9; P < 0.01) compared with placebo. Conclusions In patients with uncontrolled hypertension on multiple agents the addition of tadalafil 20 mg lowered mean 26‐h blood pressure.