Published Online
on October 9, 2006

A more recent version of this article appeared on October 24, 2006

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Submitted on November 22, 2005
Revised on August 19, 2006
Accepted on August 21, 2006

Phosphodiesterase-5 Inhibitor in Eisenmenger Syndrome. A Preliminary Observational Study

Saibal Mukhopadhyay MD, DM^*, Manish Sharma MD, DM, S. Ramakrishnan MD, DM, Jamal Yusuf MD, DM, Mohit Dayal Gupta MD, DM, Naveen Bhamri MD, Vijay Trehan MD, DM, and Sanjay Tyagi MD, DM

From the Department of Cardiology, GB Pant Hospital and Maulana Azad Medical College, New Delhi, India.

^* To whom correspondence should be addressed. E-mail: saibalmukhopadhyay{at}yahoo.com.

Background--Phosphodiesterase-5 inhibitors produce a significant decrease in pulmonary vascular resistance in patients with idiopathic pulmonary arterial hypertension. We studied the effects of tadalafil, a phosphodiesterase-5 inhibitor, on short-term hemodynamics, tolerability, and efficacy over a 12-week period in patients of Eisenmenger syndrome having a pulmonary vascular pathology similar to idiopathic pulmonary arterial hypertension.

Methods and Results--Sixteen symptomatic Eisenmenger syndrome patients (mean age, 25±8.9 years) were assessed hemodynamically at baseline and 90 minutes after a single dose of tadalafil (1 mg/kg body weight up to a maximum of 40 mg). The same dose was then continued daily for 12 weeks, and the patients were restudied. There was a significant decrease in mean pulmonary vascular resistance immediately (24.75±8.49 to 19.22±8.23 Woods units; P<0.005) and at 12 weeks (19.22±8.23 to 17.02±6.19 Woods units; P=0.03 versus 90 minutes). Thirteen of 16 patients (81.25%) showed a 20% decrease in pulmonary vascular resistance and were defined as responders. The mean systemic oxygen saturation improved significantly both immediately (84.34±5.47% to 87.39±4.34%; P<0.005) and at 12 weeks (87.39±4.34% to 89.16±3.8%; P<0.02 versus 90 minutes) without a significant change in systemic vascular resistance. None of the patients had a fall in systemic arterial pressure, worsening of systemic oxygen saturation, or any adverse reactions to the drug. The mean World Health Organization functional class improved from 2.31±0.47 to 1.25±0.44 (P<0.0001), and the 6-minute walk distance improved from 344.56±119.06 to 387.56±117.18 m (P<0.001).

Conclusions--Preliminary evaluation of tadalafil has shown efficacy and safety in selected patients with Eisenmenger syndrome, warranting further investigation in this subgroup of patients.

Key words: hypertension, pulmonary • Eisenmenger Complex • phosphodiesterase inhibitors • pulmonary heart disease • tadalafil

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