Tadalafil in idiopathic or heritable pulmonary arterial hypertension compared to pulmonary arterial hypertension associated with connective tissue disease
Abstract
Patients (pts) with PAH associated with connective tissue disease (APAH-CTD) have a worse prognosis compared to idiopathic (I) or heritable (H)PAH. Our objective was to evaluate the clinical outcomes in these two subgroups.
In a 16 week (wk), double-blind, placebo (PBO) controlled trial with blinded 52 wk extension, pts were randomized to PBO, 20 or 40mg tadalafil (Tad) qd (APAH-CTD: n=16, 21 and 19, respectively; I/HPAH: n=54, 50 and 46, respectively); subgroup efficacy analyses included six-minute walk test (6MWT, 40mg) at Wk16 (assessed by rank permutation tests) and clinical worsening (CW, PBO and 40mg) at Wk16 and up to 68wks (20 and 40mg). Pts on 20mg without CW at 16wks remained on 20mg; all others received 40mg in the extension.
Mean changes in 6MWT from baseline to Wk16 were 32m in APAH-CTD and 38m in I/HPAH for 40mg Tad dose. PBO-corrected treatment effects on 6MWT at Wk 16 were 49m in APAH-CTD (P=0.03) and 22m in I/HPAH (P=0.04). The% of pts with CW in the Tad 40mg and PBO subgroups at Wk16 were 11 and 25% in APAH-CTD, respectively; and 4 and 15% in I/HPAH, respectively. In pts who received Tad 20 or 40mg up to 68wks, CW was 35% in APAH-CTD (n=40) and 24% in I/HPAH (n=96).
Tad 40mg improves 6MWT at Wk16 in APAH-CTD and I/HPAH; however, with PBO 6MWT decreased in APAH-CTD but not in I/HPAH pts. In addition, CW was numerically less with Tad in both subgroups at Wk16 compared to PBO. At Wk68, CW was numerically higher in APAH-CTD vs. I/HPAH. These latter data are…
How strong is the evidence?
Evidence Hub reads this as a randomized trial. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 96 participants or records.
Read the paper
Related studies
- Safety and efficacy of COVID‐19 vaccines: A systematic review and meta‐analysis of controlled and randomized clinical trials
- Accuracy Comparison between Robot-Assisted Dental Implant Placement and Static/Dynamic Computer-Assisted Implant Surgery: A Systematic Review and Meta-Analysis of In Vitro Studies
- Determinants of passive antibody efficacy in SARS-CoV-2 infection: a systematic review and meta-analysis
- Cleaning efficacy of EDDY versus ultrasonically-activated irrigation in root canals: a systematic review and meta-analysis
- Bonding Efficacy of Universal Resin Adhesives to Zirconia Substrates: Systematic Review and Meta-Analysis
- In vitro antimicrobial activity of extracts and essential oils of Cinnamomum, Salvia, and Mentha spp. against foodborne pathogens: A meta-analysis study
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.