Authors: Patterson, Dean; McInnes, Gordon T.¹; Webster, John²; Mitchell, Malcolm M.³; MacDonald, Thomas M.⁴

Source: British Journal of Clinical Pharmacology, Volume 62, Number 3, September 2006 , pp. 280-287(8)

Publisher: Wiley-Blackwell

Abstract:

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.

Keywords: ambulatory blood pressure; hypertension; phosphodiesterase-5 inhibitor

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1365-2125.2006.02658.x

Affiliations: 1: Division of Cardiovascular and Medical Sciences, Western Infirmary, Glasgow, 2: Clinical Pharmacology Unit, Aberdeen Royal Infirmary, Aberdeen and 3: Eli-Lilly, Windlesham, UK 4: Department of Medicine, Clinical Pharmacology and Therapeutics, Ninewells Hospital and Medical School, Dundee, UK,

Publication date: 2006-09-01

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