Efficacy and safety of PDE-5 inhibitor tadalafil in pulmonary arterial hypertension.

dc.contributor.authorBharani, Anilen_US
dc.contributor.authorPatel, Ashishen_US
dc.contributor.authorSaraf, Jitendraen_US
dc.contributor.authorJain, Akhleshen_US
dc.contributor.authorMehrotra, Shubhaen_US
dc.contributor.authorLunia, Basanten_US
dc.date.accessioned2007-07-08en_US
dc.date.accessioned2009-05-27T04:18:19Z
dc.date.available2007-07-08en_US
dc.date.available2009-05-27T04:18:19Z
dc.date.issued2007-07-08en_US
dc.description.abstractBACKGROUND: Pulmonary arterial hypertension (PAH) is a life threatening disease for which phosphodiesterase-5 inhibitor sildenafil is recently approved. We aimed to evaluate the efficacy and safety of tadalafil, a long acting congener of sildenafil, in treatment of PAH related to previous left to right shunt lesions. METHODS: In this blinded, cross over study, 11 patients with severe PAH related to congenital left to right shunt lesions (Eisenmenger syndrome) were randomly assigned to tadalafil (20 mg daily) or placebo for 4 weeks period, separated by a wash out period of at least 2 weeks. They were symptomatic with a six minute walk distance (6MWD)>or=50 m. The change in 6MWD, echo-Doppler determined pulmonary artery systolic pressure (PASP), WHO Class and modified Borg Dyspnea Index (BDI) were assessed after each therapy. RESULTS: Eight patients who completed the study protocol were analyzed. Tadalafil was associated with a significant increase in 6MWD (mean 409.25 SD 40.25 m vs 319.37 SD 42.39 m, p<0.0001), reduction in PASP (88.75 SD 23.26 mmHg vs 109.5 SD 23.78 mmHg, p<0.0001), improvement in BDI (4.62 SD 2.56 vs 6.37 SD 2.61, p=0.021) and WHO Class (6 patients vs 2 patients), compared to placebo. Tadalafil was well tolerated with no significant untoward effects. CONCLUSIONS: Tadalafil, in patients with PAH related to previous congenital left to right shunt lesions, lead to a significant improvement in exercise capacity (6MWD), PASP and WHO Class with reduced perceived exertion and was well tolerated.en_US
dc.description.affiliationDivision of Cardiology, Department of Medicine, M.G.M. Medical College and M.Y. Hospital, Indore, India. anilbharani@gmail.comen_US
dc.identifier.citationBharani A, Patel A, Saraf J, Jain A, Mehrotra S, Lunia B. Efficacy and safety of PDE-5 inhibitor tadalafil in pulmonary arterial hypertension. Indian Heart Journal. 2007 Jul-Aug; 59(4): 323-8en_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/3116
dc.language.isoengen_US
dc.source.urihttps://indianheartjournal.comen_US
dc.subject.meshAdolescenten_US
dc.subject.meshAdulten_US
dc.subject.meshAnalysis of Varianceen_US
dc.subject.meshCarbolines --therapeutic useen_US
dc.subject.meshChilden_US
dc.subject.meshCross-Over Studiesen_US
dc.subject.meshDouble-Blind Methoden_US
dc.subject.meshDyspneaen_US
dc.subject.meshFemaleen_US
dc.subject.meshHumansen_US
dc.subject.meshHypertension, Pulmonary --drug therapyen_US
dc.subject.meshMaleen_US
dc.subject.meshPhosphodiesterase Inhibitors --therapeutic useen_US
dc.subject.meshTreatment Outcomeen_US
dc.subject.meshWalking --physiologyen_US
dc.titleEfficacy and safety of PDE-5 inhibitor tadalafil in pulmonary arterial hypertension.en_US
dc.typeJournal Articleen_US
dc.typeRandomized Controlled Trialen_US
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