Abstract | BACKGROUND: 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.
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Authors | Anil Bharani, Ashish Patel, Jitendra Saraf, Akhlesh Jain, Shubha Mehrotra, Basant Lunia |
Journal | Indian heart journal
(Indian Heart J)
2007 Jul-Aug
Vol. 59
Issue 4
Pg. 323-8
ISSN: 0019-4832 [Print] India |
PMID | 19126937
(Publication Type: Journal Article, Randomized Controlled Trial)
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Chemical References |
- Carbolines
- Phosphodiesterase Inhibitors
- Tadalafil
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Topics |
- Adolescent
- Adult
- Analysis of Variance
- Carbolines
(therapeutic use)
- Child
- Cross-Over Studies
- Double-Blind Method
- Dyspnea
- Female
- Humans
- Hypertension, Pulmonary
(drug therapy, physiopathology)
- Male
- Phosphodiesterase Inhibitors
(therapeutic use)
- Tadalafil
- Treatment Outcome
- Walking
(physiology)
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