PMID- 26697177
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20151223
LR  - 20201001
IS  - 2045-8932 (Print)
IS  - 2045-8940 (Electronic)
IS  - 2045-8932 (Linking)
VI  - 5
IP  - 4
DP  - 2015 Dec
TI  - Sex and menopause differences in response to tadalafil: 6-minute walk distance 
      and time to clinical worsening.
PG  - 701-6
LID - 10.1086/683829 [doi]
AB  - Pulmonary arterial hypertension (PAH) is a female-predominant disease, but there 
      are little data on treatment response by sex and menopausal status. In this 
      retrospective analysis of the Pulmonary Arterial Hypertension and Response to 
      Tadalafil (PHIRST) randomized clinical trial, we assessed treatment response 
      between the sexes by examining change in 6-minute walk distance (6MWD) and time 
      to clinical worsening (TCW). We examined the effect of menopausal status on the 
      same treatment measures. 6MWD was recorded before and after 16 weeks of treatment 
      with tadalafil or placebo in the PHIRST study cohort of 340 subjects (264 
      females, 76 males). A univariate analysis was used to assess the effect of sex on 
      change in 6MWD and TCW. Multivariate linear regression and Cox proportional 
      hazards models were built for 6MWD and TCW, respectively. Women were subdivided 
      by age as a surrogate for menopausal status. The linear trend test and the 
      log-rank test were performed on change in 6MWD and TCW by age. For 
      tadalafil-treated patients, a significant difference in change in 6MWD by sex 
      (mean: 48.6 m for males vs. 34.7 m for females; P = 0.01) was found, but it was 
      not significant in multivariate analysis (P = 0.08). There was a trend toward a 
      female age-dependent effect in change in 6MWD; the premenopausal group showed the 
      greatest improvement. A significant sex- or age-dependent effect on TCW was not 
      present. In conclusion, this retrospective analysis of the PHIRST trial suggests 
      that men and premenopausal women may experience greater functional improvement 
      when treated with tadalafil than older women, but there was no consistent sex or 
      menopausal effect on TCW.
FAU - Rusiecki, Jennifer
AU  - Rusiecki J
AD  - Pulmonary Allergy and Critical Care Medicine, Heart and Vascular Institute, 
      Vascular Medicine Institute, University of Pittsburgh/University of Pittsburgh 
      Medical Center, Pittsburgh, Pennsylvania, USA.
FAU - Rao, Youlan
AU  - Rao Y
AD  - United Therapeutics, Research Triangle Park, North Carolina, USA.
FAU - Cleveland, Jody
AU  - Cleveland J
AD  - United Therapeutics, Research Triangle Park, North Carolina, USA.
FAU - Rhinehart, Zachary
AU  - Rhinehart Z
AD  - Pulmonary Allergy and Critical Care Medicine, Heart and Vascular Institute, 
      Vascular Medicine Institute, University of Pittsburgh/University of Pittsburgh 
      Medical Center, Pittsburgh, Pennsylvania, USA.
FAU - Champion, Hunter C
AU  - Champion HC
AD  - Pulmonary Allergy and Critical Care Medicine, Heart and Vascular Institute, 
      Vascular Medicine Institute, University of Pittsburgh/University of Pittsburgh 
      Medical Center, Pittsburgh, Pennsylvania, USA.
FAU - Mathier, Michael A
AU  - Mathier MA
AD  - Pulmonary Allergy and Critical Care Medicine, Heart and Vascular Institute, 
      Vascular Medicine Institute, University of Pittsburgh/University of Pittsburgh 
      Medical Center, Pittsburgh, Pennsylvania, USA.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Pulm Circ
JT  - Pulmonary circulation
JID - 101557243
PMC - PMC4671744
OTO - NOTNLM
OT  - 6-minute walk distance
OT  - menopause
OT  - pulmonary arterial hypertension
OT  - sex differences
OT  - tadalafil
EDAT- 2015/12/24 06:00
MHDA- 2015/12/24 06:01
PMCR- 2015/12/01
CRDT- 2015/12/24 06:00
PHST- 2015/12/24 06:00 [entrez]
PHST- 2015/12/24 06:00 [pubmed]
PHST- 2015/12/24 06:01 [medline]
PHST- 2015/12/01 00:00 [pmc-release]
AID - PC2013185 [pii]
AID - 10.1086/683829 [doi]
PST - ppublish
SO  - Pulm Circ. 2015 Dec;5(4):701-6. doi: 10.1086/683829.