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Hospitalization and Survival in Patients Utilizing Epoprostenol for Injection in the PROSPECT Observational Study.
Chest. 2014 Oct 9;
Authors: Frantz RP, Schilz RJ, Chakinala MM, Badesch DB, Frost AE, McLaughlin VV, Barst RJ, Rosenberg DM, Miller DP, Hartline BK, Benton WW, Farber HW
Abstract
Abstract: Background:Few studies have prospectively reported outcomes in pulmonary arterial hypertension (PAH) patients treated with epoprostenol in the modern-day era of oral therapy and combination treatments. The Registry to PROSPECTively Describe Use of Epoprostenol for Injection [Veletri, prolonged Room Temperature Stable Epoprostenol (RTS-Epo)] in Patients with Pulmonary Arterial Hypertension (PROSPECT) was established to prospectively describe the course of PAH in patients prescribed RTS-Epo. Methods:PROSPECT is a multicenter, US-based drug registry of primarily Group I PAH patients treated with RTS-Epo who were parenteral-naïve or parenteral-transitioned at enrollment. Patients were followed until discontinuation of RTS-Epo, withdrawal, loss to follow-up, death, or end of study (maximum 1 year). One-year freedom from hospitalization (FH) and survival estimates were summarized by prostacyclin history (parenteral-naïve or parenteral-transitioned), gender, and chronic renal insufficiency (CRI). Results:A total of 336 patients were included. The overall one-year FH estimate was 51.0% ±2.8% and was lower in parenteral-naive patients than parenteral-transitioned patients (42.8% ±4.3% vs. 57.1% ±3.7%, respectively; p=0.002). FH estimates were lower in male patients than female patients (38.3% ±5.9% vs. 54.6% ±3.2%, respectively; p<0.015) and in patients with CRI than patients without CRI (17.0% ±8.4% vs. 53.7% ±2.9%, respectively; p<0.001). The overall one-year survival estimate was 84.0% ±2.1%. Survival was poorer in parenteral-naive patients, male patients, and patients with CRI. Conclusions:Risk of hospitalization and mortality remain high in PAH patients. In particular, patients who are parenteral-naïve at initiation of RTS-Epo therapy, male patients, and patients with CRI require close monitoring and aggressive clinical management.
Background: Few studies have prospectively reported outcomes in pulmonary arterial hypertension (PAH) patients treated with epoprostenol in the modern-day era of oral therapy and combination treatments. The Registry to PROSPECTively Describe Use of Epoprostenol for Injection [Veletri, prolonged Room Temperature Stable Epoprostenol (RTS-Epo)] in Patients with Pulmonary Arterial Hypertension (PROSPECT) was established to prospectively describe the course of PAH in patients prescribed RTS-Epo.
Methods: PROSPECT is a multicenter, US-based drug registry of primarily Group I PAH patients treated with RTS-Epo who were parenteral-naïve or parenteral-transitioned at enrollment. Patients were followed until discontinuation of RTS-Epo, withdrawal, loss to follow-up, death, or end of study (maximum 1 year). One-year freedom from hospitalization (FH) and survival estimates were summarized by prostacyclin history (parenteral-naïve or parenteral-transitioned), gender, and chronic renal insufficiency (CRI).
Results: A total of 336 patients were included. The overall one-year FH estimate was 51.0% ±2.8% and was lower in parenteral-naive patients than parenteral-transitioned patients (42.8% ±4.3% vs. 57.1% ±3.7%, respectively; p=0.002). FH estimates were lower in male patients than female patients (38.3% ±5.9% vs. 54.6% ±3.2%, respectively; p<0.015) and in patients with CRI than patients without CRI (17.0% ±8.4% vs. 53.7% ±2.9%, respectively; p<0.001). The overall one-year survival estimate was 84.0% ±2.1%. Survival was poorer in parenteral-naive patients, male patients, and patients with CRI.
Conclusions: Risk of hospitalization and mortality remain high in PAH patients. In particular, patients who are parenteral-naïve at initiation of RTS-Epo therapy, male patients, and patients with CRI require close monitoring and aggressive clinical management.
PMID: 25320967 [PubMed - as supplied by publisher]