A meta‑analysis of the safety and efficacy of bosentan therapy combined with prostacyclin analogues or phosphodiesterase type‑5 inhibitors for pulmonary arterial hypertension

• Published in: Experimental and therapeutic medicine Vol. 18; no. 6; pp. 4740 - 4746
• Main Authors: Dang, Zhan-Cui, Tang, Bo, Li, Bin, Liu, Shou, Ge, Ri-Li, Li, Zhan-Qiang, Lu, Dian- Xiang
• Format: Journal Article
• Language: English
• Published: Athens Spandidos Publications 01.12.2019; Spandidos Publications UK Ltd; D.A. Spandidos
• Subjects: Analysis; Bias; Bosentan; Clinical trials; Collaboration; Drug therapy; Drugs; Endothelin; Epoprostenol; Evidence-based medicine; Heart; Hypertension; Iloprost; Medical research; Meta-analysis; Mortality; Pathogenesis; Platelet aggregation inhibitors; Prostacyclin; Public health; Pulmonary arteries; Pulmonary hypertension; Quality; Studies; Treprostinil; Vardenafil; Vasodilator agents; Web sites (World Wide Web); World health
• ISSN: 1792-0981; 1792-1015
• DOI: 10.3892/etm.2019.8142

Bosentan is an effective drug for the treatment of pulmonary arterial hypertension (PAH). The aim of the present meta-analysis was to examine the evidence concerning the efficacy and safety of bosentan therapy combined with prostacyclin analogues or phosphodiesterase type 5 (PDE-5) inhibitors for treating PAH. Eligible published studies were collected from Embase, PubMed, The Cochrane Library and the www. clinicaltrials.gov website. Heterogeneity was assessed using the Cochran Q-statistic test. Results were presented as risk ratios or mean differences with 95% confidence intervals (CI). A total of five studies, comprising 310 patients were included for analysis. No significant improvements in six-minute walk distance (6MWD; mean difference, 16.43 m), clinical worsening (risk ratio, 0.54) and the World Health Organization functional classification (class I: risk ratio, 1.17; class II: risk ratio, 1.18) were observed in patients treated with bosentan in combination with prostacyclin analogues or PDE-5 inhibitors. However, a significant reduction in the mean pulmonary artery pressure (mPAP; 95% CI: -17.06, -6.83; P<0.0001) following bosentan combination therapy was observed. Comparisons of adverse event rates in the bosentan combination therapy (55.6%) and monotherapy (51.8%) suggested that there is no reduction in adverse events (risk ratio, 1.10). The results indicated that bosentan combined with prostacyclin analogues or PDE-5 inhibitors may not improve 6MWD, cardiac function, clinical worsening and adverse events. However, bosentan combined with prostacyclin analogues or PDE-5 inhibitor therapy was able to significantly reduce mPAP compared with the effect of bosentan monotherapy. Key words: meta-analysis, bosentan combination therapy, prostacyclin analogues, phosphodiesterase type 5 inhibitors, pulmonary arterial hypertension