Abstract | BACKGROUND: OBJECTIVE: DESIGN: Prospective, open-label, multicentre study. SETTING: PATIENTS: INTERVENTIONS: OUTCOME MEASURES: 6-min walk distance (6MWD) test, resting systemic arterial blood oxygen saturation (SaO(2)) in room air, haemodynamic parameters assessed by right heart catheterisation, safety and tolerability. RESULTS: The overall treatment effects at 12 months versus baseline (mean changes with 95% CIs) were 56 m increase (42 to 69, p<0.0001) in 6MWD, and 2.4% increase (1.8% to 2.9%, p<0.0001) in resting room air SaO(2). Improvements were also seen in mean pulmonary arterial pressure and pulmonary vascular resistance index (-4.7 mm Hg (-7.5 to -1.9), p=0.001; and -474 dyn×s×cm(-5)×m(2) (-634 to -314), p<0.0001, respectively). Sildenafil was well tolerated. Most adverse events were mild and transient, and occurred in the first 2 weeks of treatment. CONCLUSIONS: Twelve months of oral sildenafil treatment was well tolerated and appeared to improve exercise capacity, systemic arterial oxygen saturation and haemodynamic parameters in patients with Eisenmenger syndrome.
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Authors | Zhen-Ning Zhang, Xin Jiang, Rui Zhang, Xin-Li Li, Bing-Xiang Wu, Qin-Hua Zhao, Yong Wang, Li-Zhi Dai, Lei Pan, Mardi Gomberg-Maitland, Zhi-Cheng Jing |
Journal | Heart (British Cardiac Society)
(Heart)
Vol. 97
Issue 22
Pg. 1876-81
(Nov 2011)
ISSN: 1468-201X [Electronic] England |
PMID | 21948962
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Piperazines
- Purines
- Sulfones
- Vasodilator Agents
- Sildenafil Citrate
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Topics |
- Administration, Oral
- Adolescent
- Adult
- China
- Drug Administration Schedule
- Eisenmenger Complex
(diagnosis, drug therapy)
- Exercise Tolerance
- Female
- Humans
- Male
- Middle Aged
- Piperazines
(administration & dosage, pharmacology, therapeutic use)
- Prospective Studies
- Purines
(administration & dosage, pharmacology, therapeutic use)
- Severity of Illness Index
- Sildenafil Citrate
- Sulfones
(administration & dosage, pharmacology, therapeutic use)
- Treatment Outcome
- Vasodilator Agents
(administration & dosage, pharmacology, therapeutic use)
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