| Phosphodiesterase-5 inhibitor in Eisenmenger syndrome: a preliminary observational study. | |
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MedLine Citation:
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PMID: 17030688 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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 > or = 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. |
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Authors:
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Saibal Mukhopadhyay; Manish Sharma; S Ramakrishnan; Jamal Yusuf; Mohit Dayal Gupta; Naveen Bhamri; Vijay Trehan; Sanjay Tyagi |
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Publication Detail:
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Type: Clinical Trial; Journal Article Date: 2006-10-09 |
Journal Detail:
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Title: Circulation Volume: 114 ISSN: 1524-4539 ISO Abbreviation: Circulation Publication Date: 2006 Oct |
Date Detail:
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Created Date: 2006-10-24 Completed Date: 2006-11-08 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 0147763 Medline TA: Circulation Country: United States |
Other Details:
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Languages: eng Pagination: 1807-10 Citation Subset: AIM; IM |
Affiliation:
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Department of Cardiology, GB Pant Hospital, New Delhi, India 110 002. saibalmukhopadhyay@yahoo.com |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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3',5'-Cyclic-GMP Phosphodiesterases
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antagonists & inhibitors* Adult Carbolines / administration & dosage, pharmacology, therapeutic use* Cyclic Nucleotide Phosphodiesterases, Type 5 Eisenmenger Complex / blood, drug therapy*, enzymology, physiopathology Exercise Tolerance / drug effects Female Humans Male Oxygen / blood Phosphodiesterase Inhibitors / administration & dosage, pharmacology, therapeutic use* Treatment Outcome Vascular Resistance / drug effects* Vasodilator Agents / administration & dosage, pharmacology, therapeutic use* |
| Chemical | |
Reg. No./Substance:
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0/Carbolines; 0/Phosphodiesterase Inhibitors; 0/Vasodilator Agents; 0/tadalafil; 7782-44-7/Oxygen; EC 3.1.4.35/3',5'-Cyclic-GMP Phosphodiesterases; EC 3.1.4.35/Cyclic Nucleotide Phosphodiesterases, Type 5; EC 3.1.4.35/PDE5A protein, human |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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