Identification of predictors of response to initial oral combination therapy in WHO-functional class II or III PAH patients: a post-hoc analysis of the AMBITION study
Abstract
AMBITION Study (NCT01178073) provided the first long-term clinical evidence for initial combination therapy with ambrisentan and tadalafil (COMB) compared with monotherapy of either agent (MONO), and the results contributed to the ESC/ERS guidelines recommending initial combination therapy in PAH patients with low and intermediate risk. However, predictors of response to initial oral combination therapy to identify PAH patients who benefit most from it have not been assessed.
To identify potential predictors of response to initial combination therapy with ambrisentan and tadalafil (COMB) in PAH patients with WHO-FC II or III in the AMBITION study.
We examined 302 COMB patients from the modified intention to treat (mITT) population enrolled in the AMBITION study (n=605). The mITT population includes PAH patients with risk factors related to heart failure with preserved ejection fraction (Ex-PAS) who were excluded from the primary analysis set (PAS). A responder (i.e. event-free subject) was defined as not having a clinical failure event. Univariate and multivariate analyses were performed to identify the factors associated with responders. Multivariate logistic regression analysis was used to determine independent risk for each factor that showed a significant difference between cohorts by interactive backward selection. Odds ratio (OR), 95% confidence intervals (CIs) and p-values are presented.
Univariate analysis showed that responders tended to be lower age, female,…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 605 participants or records.
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