[Efficacy and safety of sildenafil therapy in pulmonary artery hypertension: a meta-analysis].
OBJECTIVE
To evaluate the short-term efficacy and safety of sildenafil in treatment of pulmonary artery hypertension (PAH).


METHODS
Literatures in regard to sildenafil treatment of PAH were searched in PubMed (from 01/01/1968 to 01/05/2006), Embase (from 1980 to 2006) and China National Knowledge Infrastructure (CNKI) (from 1994 to 2006). Randomized-controlled trials (RCTs) of sildenafil versus placebo in the treatment of PAH were conducted. The quality of the included trials was evaluated by two reviewers independently. Meta-analysis was done by using the Cochrane Collaboration's RevMan 4.2.8.


RESULTS
Ten literatures were retrieved. Four RCTs, including 328 patients, were included and were graded in terms of the quality of randomization, allocation, concealment and blinding. One study was graded as level A and the other three were graded as level B. The meta-analysis showed that compared with placebo treatment, sildenafil therapy can (1) improve the exercise capacity of the PAH patients measured as distance covered in a 6 minute walk test with an increase of 55.76 meters on average in 6 minutes' walk (95% confidence interval, 41.26 to 70.25; P < 0.01), (2) increase the exercise time of the PAH patients by 221.13s on average (95% confidence interval, 146.13 to 296.14; P < 0.01), (3) decrease the pulmonary artery systolic pressure by 11.51 mmHg on average (95% confidence interval, 1.41 to 21.60, P = 0.03), and (4) alleviate the exacerbation of clinical conditions with a total odds ratio (OR) of 0.36 (95% confidence interval, 0.16 to 0.78, P = 0.01); however, it failed to alleviate the headache and hypotension in comparison with the placebo group. No sexual disturbance was seen in the patients treated with sildenafil.


CONCLUSIONS
Sildenafil therapy improves the clinical symptoms and exercise capacity, and decreases the pulmonary artery systolic pressure of the PAH patients; and causes no serious side effects.
Kuang
Tu-guang
TG
Beijing Institute of Respiratory Medicine-Beijing Chaoyang Hospital, Capital University of Medical Sciences, Beijing 100020, China.
Wang
Jun
J
Zhai
Zhen-guo
ZG
Guo
Xiu-hua
XH
Wang
Chen
C
D006801:Humans; D006976:Hypertension, Pulmonary / Q000188:drug therapy* / Q000503:physiopathology; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011651:Pulmonary Artery / Q000187:drug effects* / Q000503:physiopathology; D011687:Purines / Q000009:adverse effects / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic; D000068677:Sildenafil Citrate; D013450:Sulfones / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000009:adverse effects / Q000627:therapeutic use
D010879:Piperazines; D011687:Purines; D013450:Sulfones; D014665:Vasodilator Agents; D000068677:Sildenafil Citrate