Tadalafil in idiopathic or heritable pulmonary arterial hypertension (PAH) compared to PAH associated with connective tissue disease
| Autor: | Cathi Harmon, Christopher P. Denton, Fabio Dardi, Massimiliano Palazzini, Alessandra Manes, Nazzareno Galiè, Baohui Li, Lucio Varanese, Anne Esler, Gaia Mazzanti |
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| Přispěvatelé: | Galiè, Nazzareno, Denton, Christopher P., Dardi, Fabio, Manes, Alessandra, Mazzanti, Gaia, Li, Baohui, Varanese, Lucio, Esler, Anne, Harmon, Cathi, Palazzini, Massimiliano |
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Male
medicine.medical_specialty Drug-Related Side Effects and Adverse Reactions Hypertension Pulmonary Vasodilator Agents 030204 cardiovascular system & hematology Placebo Tadalafil Electrocardiography 03 medical and health sciences 0302 clinical medicine Internal medicine Post-hoc analysis medicine polycyclic compounds Humans Heritable pulmonary arterial hypertension Familial Primary Pulmonary Hypertension In patient Connective Tissue Diseases Adverse effect Physical Examination Heritable 030203 arthritis & rheumatology Dose-Response Relationship Drug business.industry Incidence (epidemiology) Medicine (all) Idiopathic Middle Aged medicine.disease Connective tissue disease Surgery Treatment Outcome Female Associated PAH Drug Monitoring business PHIRST-2 Cardiology and Cardiovascular Medicine medicine.drug PHIRST |
| Popis: | Background The primary objective of this post hoc analysis was to evaluate clinical outcomes of tadalafil in patients with pulmonary arterial hypertension (PAH) associated with connective tissue disease (CTD-PAH) compared with patients with idiopathic/heritable PAH (I/H-PAH) for primary and key secondary efficacy endpoints, and safety. This analysis included adult patients with CTD-PAH or I/H-PAH who participated in the PHIRST and PHIRST-2 studies. Methods Patients were randomized 1:1:1:1:1 to tadalafil (2.5, 10, 20, or 40mg) or placebo in the PHIRST study and the majority of these patients were subsequently assigned 40mg in PHIRST-2. Patients taking 20mg in PHIRST without demonstrating clinical worsening continued on 20mg in PHIRST-2. Outcomes analyzed included 6MWD, WHO-FC, and incidence and time to first occurrence of clinical worsening. Safety was assessed through evaluation of adverse events (AEs), clinical laboratory data, electrocardiograms, and physical examinations. Results Increased 6MWD in PHIRST was maintained in both CTD-PAH and I/H-PAH subgroups for 52weeks. Patients with CTD-PAH tended to be older, were more likely female, had lower exercise capacity, were more likely to have clinical worsening, and experienced AEs more frequently than patients with I/H-PAH. Conclusion The effect of tadalafil treatment in patients enrolled in both PHIRST studies was detectable for both I/H-PAH and CTD-PAH subgroups. In general, subgroup differences were modest. Patients with CTD-PAH may perform less well than patients with I/H-PAH in safety and efficacy measures in all treatment groups, which is similar to other studies demonstrating a worse prognosis for patients with CTD-PAH. |
| Databáze: | OpenAIRE |
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