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Wiley InterScience

British Journal of Clinical Pharmacology

British Journal of Clinical Pharmacology

Volume 62 Issue 3, Pages 280 - 287

Published Online: 21 Apr 2006

Journal compilation © 2010 The British Pharmacological Society



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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
Dean Patterson 1 , Gordon T. McInnes 2 , John Webster 3 , Malcolm M. Mitchell 4 & Thomas M. MacDonald 1
  1 Department of Medicine, Clinical Pharmacology and Therapeutics, Ninewells Hospital and Medical School, Dundee, UK,   2 Division of Cardiovascular and Medical Sciences, Western Infirmary, Glasgow,   3 Clinical Pharmacology Unit, Aberdeen Royal Infirmary, Aberdeen and   4 Eli-Lilly, Windlesham, UK
Correspondence to  Dean Patterson, Clinical Lecturer, Department of Medicine and Therapeutics, Ninewells Hospital and Medical School, Dundee DD1 9SY, UK. Tel: + 013 8266 0111, ext 33531, pager 4100 Fax: + 013 8263 2333 E-mail: d.patterson@dundee.ac.uk
Copyright 2006 Blackwell Publishing Ltd
KEYWORDS
ambulatory blood pressure • hypertension • phosphodiesterase-5 inhibitor

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.


Received
25 August 2005
Accepted
9 February 2006
Published OnlineEarly
21 April 2006

DIGITAL OBJECT IDENTIFIER (DOI)
10.1111/j.1365-2125.2006.02658.x About DOI

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