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Original article
Pulmonary hypertension
Vardenafil treatment for patients with pulmonary arterial hypertension: a multicentre, open-label study
  1. Z-C Jing1,
  2. X Jiang1,
  3. B-X Wu2,
  4. X-Q Xu3,
  5. Y Wu4,
  6. C-R Ma1,
  7. Y Wang5,
  8. Y-J Yang4,
  9. J-L Pu4,
  10. W Gao6
  1. 1
    Department of Pulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China
  2. 2
    Department of Cardiology, First Affiliated Hospital, Haerbin Medical University, Haerbin, China
  3. 3
    Department of Internal Medicine, Aviation Industry Central Hospital, Beijing, China
  4. 4
    Department of Cardiovascular Medicine, Cardiovascular Institute and Fu Wai Hospital, Peking Union Medical College, Beijing, China
  5. 5
    Department of Respiratory Medicine, Beijing Shijitan Hospital, Peking University, Beijing, China
  6. 6
    Department of Thoracic Surgery, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China
  1. Correspondence to Professor Z-C Jing, Department of Pulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University School of Medicine, 507 Zhengmin Road, Shanghai 200433, China; jingzhicheng{at}gmail.com

Abstract

Background: Vardenafil is a new phosphodiesterase-5 inhibitor that has shown some efficacy in the treatment of pulmonary arterial hypertension (PAH).

Objective: To examine the long-term effects of vardenafil in patients with PAH.

Methods: A multicentre, open-label study of 1-year’s duration was undertaken in 45 patients with PAH to determine the long-term safety and efficacy of vardenafil (5 mg once daily for the first 4 weeks, then 5 mg twice daily) and make a preliminary assessment of its monthly acquisition cost compared with other PAH-active treatments. The patients’ clinical features, exercise capacity, WHO functional class and haemodynamic variables were measured at baseline and at 3 and at least 9 months after initiating vardenafil treatment.

Results: At the 3 months and a mean (SD) of 14 (3) months (range 9–18) follow-up assessments, the 6 min walking distance was significantly increased from baseline by 70.7 (78.4) m (p<0.001) and 83.4 (91.8) m (p<0.001), respectively. Furthermore, long-term treatment with vardenafil for a mean duration of >1 year was also associated with improvements in haemodynamic parameters, WHO functional class and serum uric acid concentrations. Overall, vardenafil treatment was well tolerated. No patients were withdrawn owing to adverse events and none died during the course of the study.

Conclusion: Long-term treatment with vardenafil is well tolerated and has sustained beneficial effects on PAH, as measured by patients’ exercise capacity, WHO functional class and haemodynamic parameters.

https://doi.org/10.1136/hrt.2009.169417

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    Footnotes

    • Funding This study was supported by Shanghai Pujiang Programme (08PJ14086) and China National 973 Project (2007CB512008).

    • Competing interests None.

    • Ethics approval Approval from the ethics committee of the PI institute, Shanghai Pulmonary Hospital, Tongji University.

    • Provenance and peer review Not commissioned; externally peer reviewed.