PMID- 25006420
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20140709
LR  - 20211021
IS  - 2045-8932 (Print)
IS  - 2045-8940 (Electronic)
IS  - 2045-8932 (Linking)
VI  - 4
IP  - 1
DP  - 2014 Mar
TI  - Effects of dose and age on adverse events associated with tadalafil in the 
      treatment of pulmonary arterial hypertension.
PG  - 45-52
LID - 10.1086/674901 [doi]
AB  - 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. Adverse events (AEs) and efficacy outcomes were assessed in patients >/=65 
      versus <65 years old, and the dose dependency of common AEs was determined. 
      Twenty-eight percent (112 of 405) of patients were >/=65 years of age (mean in this 
      subset, 72 +/- 5 years). Compared with younger patients, elderly patients were more 
      likely to be World Health Organization functional class III/IV (75% vs. 65%, 
      respectively) and to have lower exercise capacity as assessed by 6-minute walk 
      distance (6MWD; mean, 299 vs. 366 m). Compared with placebo, tadalafil increased 
      6MWD by a mean of 35 and 43 m in patients >/=65 and <65 years, respectively. 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.
FAU - Berman-Rosenzweig, Erika
AU  - Berman-Rosenzweig E
AD  - Department of Medicine, Columbia School of Medicine, New York, New York, USA.
FAU - Arneson, Carl
AU  - Arneson C
AD  - United Therapeutics Corporation, Research Triangle Park, North Carolina, USA.
FAU - Klinger, James R
AU  - Klinger JR
AD  - Division of Pulmonary, Sleep, and Critical Care Medicine, Rhode Island Hospital, 
      Alpert Medical School of Brown University, Providence, Rhode Island, USA.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Pulm Circ
JT  - Pulmonary circulation
JID - 101557243
PMC - PMC4070753
OTO - NOTNLM
OT  - elderly patients
OT  - pulmonary arterial hypertension (PAH)
OT  - tadalafil
EDAT- 2014/07/10 06:00
MHDA- 2014/07/10 06:01
PMCR- 2014/03/01
CRDT- 2014/07/10 06:00
PHST- 2013/08/26 00:00 [received]
PHST- 2013/11/09 00:00 [accepted]
PHST- 2014/07/10 06:00 [entrez]
PHST- 2014/07/10 06:00 [pubmed]
PHST- 2014/07/10 06:01 [medline]
PHST- 2014/03/01 00:00 [pmc-release]
AID - PC2013035 [pii]
AID - 10.1086/674901 [doi]
PST - ppublish
SO  - Pulm Circ. 2014 Mar;4(1):45-52. doi: 10.1086/674901.