Inhaled low-dose iloprost for pulmonary hypertension: a prospective, multicenter, open-label study.

Abstract

BACKGROUND:

Inhaled iloprost (average >30 µg/d) has been considered an effective treatment for severe pulmonary hypertension (PH). Further evidence also showed that low-dose iloprost given intravenously was equally effective as high-dose iloprost in the therapy of systemic sclerosis.

HYPOTHESIS:

Patients with pulmonary hypertension will benefit from inhalation of low-dose iloprost.

METHODS:

Sixty-two patients with PH were enrolled and initiated with neubulizedlow-dose iloprost (2.5 µg per inhalation, 6× daily) for 24 weeks in 13 medical centers in China. Efficacy endpoints included changes in 6-minute walk distance (6MWD), World Health Organization functional class (WHO-FC), and hemodynamic parameters.

RESULTS:

Fourteen patients (22.6%) prematurely discontinued the study: 8 due to clinical worsening (6 in WHO-FCIII-IV at baseline), 4 because of protocol change, and 2 patients lost during follow-up. In the remaining 48 patients, 6MWD was increased from 356 ± 98 meters to 414 ± 99 meters (P < 0.001) and WHO-FC improved significantly (P = 0.006) after 24-week inhalation therapy. Cardiac output, cardiac index, and mixed venous oxygen saturation improved significantly compared with baseline (n = 34, P < 0.05). Most of the hemodynamic parameters improved significantly in patients in WHO-FC II (P < 0.05) but not in patients in WHO-FCIII-IV.

CONCLUSIONS:

Low-dose iloprost inhalation significantly improved exercise capacity and functional status in patients with PH. It was well tolerated. The improvement of hemodynamics was confirmed in patients with WHO-FCI-II but not in patients with WHO-FCIII-IV, suggesting the importance of early treatment in patients with advanced disease stages.

• Authors: Yun-Juan Sun, Chang-Ming Xiong, Guang-Liang Shan, Qing Gu, Wei-Jie Zeng, Xian-Ling Lu, Feng Zhu, Zhi-Hong Liu, Xin-Hai Ni, Jian-Guo He, Iloprost Therapy on Pulmonary Hypertension Study Group
• Journal: Clinical cardiology (Clin Cardiol) Vol. 35 Issue 6 Pg. 365-70 (Jun 2012) ISSN: 1932-8737 [Electronic] United States
• PMID: 22488211 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: © 2012 Wiley Periodicals, Inc.

Chemical References

• Iloprost

Topics

• Administration, Inhalation
• Adult
• China
• Exercise Tolerance (drug effects)
• Female
• Health Status Indicators
• Heart Rate
• Hemodynamics (drug effects)
• Humans
• Hypertension, Pulmonary (drug therapy, pathology)
• Iloprost (administration & dosage, therapeutic use)
• Male
• Middle Aged
• Oxygen Consumption
• Prospective Studies
• Statistics as Topic
• Time Factors
• Treatment Outcome