Key result
A single 20 mg dose of tadalafil reduced 26-hour mean ambulatory systolic blood pressure by 4.8 mmHg (95% CI 3.7-5.9; P<0.01) compared with placebo in subjects with hypertension.
Why the study?
Does a single dose of tadalafil 20 mg reduce 26-h mean ambulatory blood pressure in treated and untreated hypertensive subjects?
RCT (n=114)
double-blind
randomized
Yes
Does a single dose of tadalafil 20 mg reduce 26-h mean ambulatory blood pressure in treated and untreated hypertensive subjects?
Mean Difference: -4.8 (95% CI -5.9–-3.7)
p-value: p=< 0.01
A single 20 mg dose of tadalafil significantly lowers 26-hour ambulatory blood pressure in hypertensive patients, including those with uncontrolled hypertension on multiple agents.
Clinicians should note tadalafil's BP-lowering action in hypertensives; confirms ambulatory SBP reduction in this RCT.
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.
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Patterson et al. (2006) conducted an RCT in hypertension (n=114). tadalafil vs. placebo was evaluated on 26-h mean ambulatory systolic and diastolic blood pressure (4.8 mmHg reduction in systolic BP, 95% CI 3.7-5.9, p=< 0.01). A single 20 mg dose of tadalafil reduced 26-hour mean ambulatory systolic blood pressure by 4.8 mmHg (95% CI 3.7-5.9; P<0.01) compared with placebo in subjects with hypertension.
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