Pulmonary circulation
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Pulmonary circulation · Mar 2014
Effects of dose and age on adverse events associated with tadalafil in the treatment of pulmonary arterial hypertension.
There are limited data on the management of pulmonary arterial hypertension (PAH) in the elderly; therefore, this analysis compared the safety and efficacy of tadalafil between patients ≥65 and <65 years old. This was a post hoc analysis of the randomized, double-blind, placebo-controlled phase 3 Pulmonary Arterial Hypertension and Response to Tadalafil (PHIRST-1) study. Patients who completed the 16-week study or who discontinued because of clinical worsening and were not receiving tadalafil 40 mg were eligible for a long-term, open-label extension study. ⋯ Common AEs (including headache, dyspepsia, and myalgia) were similar in both groups and tended to decrease in incidence with longer treatment duration. No differences in AEs were observed between elderly patients who received tadalafil 20 or 40 mg. In conclusion, the safety and efficacy of tadalafil for treatment of PAH are similar between elderly patients and patients <65 years old.