Abstract
Background and Aims
Pulmonary hypertension (PH) is not an uncommon progressive condition in prevalent hemodialysis (HD) patients, associated with high morbidity and mortality. Sildenafil drug has limited studies about the efficacy of the drug and optimal dose among prevalent HD patients with PH. Aim of the study to assess the effects of sildenafil drug on estimated Pulmonary Artery pressure value (ePAP) mmHg via transthoracic Doppler Echocardiography and 6-minute walk test ( 6MWT) among hemodialysis patients with pulmonary hypertension.
Method
Randomized, double-blind, placebo-controlled clinical trial, from December 2018 to May 2019, involving 60 eligible patients on regular adequate HD with PH, estimated Pulmonary Artery Pressure (ePAP) ≥35 mmHg via Doppler echocardiography. HD patients with mean age 52.6±10.8 year divided randomly into 3 groups: Group 1 (20 patients) received 25 mg sildenafil, group 2 (20 patients) received 50 mg sildenafil and group 3 (20 patients) who received placebo as daily dose treatment for 3 months duration. Every patient in the study was subjected to full history taking and clinical examination. Exclusion Criteria: Current treatment of pulmonary hypertension, patient with evident history of cardiac diseases or chronic pulmonary diseases or systemic autoimmune diseases, portal hypertension, HIV, patients with uncontrolled hypertension or severe anaemia or hypersensitivity to sildenafil, treatment with any drugs that may interact with sildenafil all were excluded from the study. Transthoracic echocardiography was done at the begging of the study and after three months in mid-week non-dialysis day for assessment of the change in ePAP, pulmonary artery pressure calculated using the modified Bernoulli equation, and assessment of right ventricular functions . Exercise capacity assessment by 6MWT to assess the clinical response to the drug, was done for every patient at the start of the study and after 3 months of treatment. Clinically meaningful change estimate for the 6MWT considered as increase more than 30 meters.
Results
Significant increase in mean of 6 MWT in both group 1,2 received 25 mg,50 mg sildenafil respectively after 3 m duration of treatment versus non-significant change in placebo group as basal 6 MWT was (171 ±45, 214 ±58, 175 ±39) meters in group 1,2 and placebo group respectively (p>0.05). Means 6 MWT post-treatment were (205 ±57, 258 ±59, 182 ±49) meters (P<0.001) in group 1, 2&3 respectively, as post Hoc test results, showed significant increase in 6MWT2 in group 2 in comparison to group 1 and placebo group (P<0.01), as shown in figure (1).There was a significant decrease in e PAP in each group of studied groups after treatment (P<0.01). As mean basal ePAP1 measures were (48 ±9, 43.5 ±16, 48.5 ±12) mmHg in group 1,2,3 respectively (P>0.05).There were no significant differences between the studied groups regarding means of ePAP2 post-treatment were ( 42 ±9, 39 ±15, 44.5±8) mmHg in group 1,2,3 respectively (P>0.05). However, the degree of severity of PH was more improved after treatment duration with sildenafil as in group 1 there were 5 patients downgraded from moderate to mild and 2 patients downgraded from severe to moderate after treatment. In group 2 there were 4 patients downgraded from moderate to mild PH and 2 patients downgraded from severe to moderate PH. In 3rd group (placebo group) only one patient downgraded from moderate to mild PH. There were 4 patients dropouts from the study two of them from group 2 (receiving 50mg) due to sildenafil related side effects appeared through the study.
Conclusion
This a clinical trial confirmed the efficiency of both 50mg and 25mg sildenafil daily dose in reducing e PAP and improving functional exercise capacity in chronic haemodialysis patients with pulmonary hypertension disease.
Vasoactive Substances in Pulmonary Embolism
