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J Am Coll Cardiol, 2004; 43:1149-1153, doi:10.1016/j.jacc.2003.10.056
© 2004 by the American College of Cardiology Foundation
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CLINICAL RESEARCH: CLINICAL TRIAL

Clinical efficacy of sildenafil in primary pulmonary hypertension

A randomized, placebo-controlled, double-blind, crossover study

B. K. S. Sastry, DM*,*, C. Narasimhan, DM*, N. Krishna Reddy, DM* and B. Soma Raju, DM*

* Department of Cardiology, CARE Hospital, Hyderabad, India

Manuscript received July 27, 2003; revised manuscript received September 25, 2003, accepted October 19, 2003.

* Reprint requests and correspondence: Dr. B. K. S. Sastry, Cardiologist, CARE Hospital, Exhibition Road, Nampally, Hyderabad. AP, India 500 001.
bkssastry{at}hotmail.com

OBJECTIVES: In a randomized, double-blind, crossover design, we compared the efficacy of sildenafil with placebo in patients with primary pulmonary hypertension (PPH). The primary end point was the change in exercise time on treadmill using the Naughton protocol. Secondary end points were change in cardiac index and pulmonary artery systolic pressure as assessed by Doppler echocardiography and quality of life (QOL) as assessed by a questionnaire.

BACKGROUND: Primary pulmonary hypertension is a disorder with limited treatment options. Uncontrolled studies had shown sildenafil to be beneficial in the treatment of PPH.

METHODS: After initial clinical evaluation, including Doppler echocardiography and treadmill exercise test, patients were randomized to placebo or sildenafil with dosages ranging from 25 to 100 mg thrice daily on the basis of body weight. The evaluation was repeated after six weeks. Then patients were crossed over to alternate therapy. Final evaluation was performed after another six weeks of treatment.

RESULTS: Twenty-two patients completed the study. Exercise time increased by 44% from 475 ± 168 s at the end of placebo phase to 686 ± 224 s at the end of sildenafil phase (p < 0.0001). With sildenafil, cardiac index improved from 2.80 ± 0.9 l/m2 to 3.45 ± 1.1 l/m2 (p < 0.0001), whereas pulmonary artery systolic pressure decreased insignificantly from 105.23 ± 17.82 mm Hg to 98.50 ± 24.38 mm Hg. There was significant improvement in the dyspnea and fatigue components of the QOL questionnaire. During the placebo phase, one patient died and another had syncope. There were no serious side effects with sildenafil.

CONCLUSIONS: Sildenafil significantly improves exercise tolerance, cardiac index, and QOL in patients with PPH.

Abbreviations and Acronyms
  NYHA = New York Heart Association
  PPH = primary pulmonary hypertension
  QOL = quality of life




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