Efficacy and safety of Sildenafil added to Treprostinil in pulmonary hypertension

Mardi Gomberg-Maitland*, Vallerie McLaughlin, Martha Gulati, Stuart Rich

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

80 Scopus citations


Pulmonary arterial hypertension (PAH) is characterized by abnormalities in endothelial and smooth muscle cell function. Prostacyclin released by endothelial cells is a potent vasodilator by increasing cyclic adenosine monophosphate. Sildenafil, an inhibitor of phosphodiesterase-5, increases cyclic guanosine monophosphate in the lungs, producing vasodilation. To test for a therapeutic benefit of the combination of a prostacyclin analogue, subcutaneous treprostinil, and sildenafil, a proof-of-concept, open-label investigational trial was initiated. Subjects with PAH in World Health Organization (WHO) functional classes II to IV receiving subcutaneous treprostinil for <6 months were evaluated with an exercise treadmill test using the Naughton-Balke protocol at baseline and after 12 weeks. Sildenafil 50 mg 3 times daily was added to the treprostinil. Mean treadmill times in seconds were compared before and after 12 weeks of therapy. Nine subjects enrolled in the trial; 7 were women (mean age 35 years). At baseline, 3 subjects were in WHO functional class II and 6 subjects were in WHO functional class III. The mean treadmill time at baseline was 465 ± 167 seconds and at 12 weeks was 656 ± 205 seconds (42% improvement, p = 0.049). All patients had symptomatic improvement. In conclusion, this pilot study of subcutaneous treprostinil with sildenafil for PAH suggests additive beneficial effects.

Original languageEnglish (US)
Pages (from-to)1334-1336
Number of pages3
JournalAmerican Journal of Cardiology
Issue number9
StatePublished - Nov 1 2005

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine


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