PMID- 30888919
OWN - NLM
STAT- MEDLINE
DCOM- 20200427
LR  - 20221017
IS  - 1931-843X (Electronic)
IS  - 1540-9996 (Print)
IS  - 1540-9996 (Linking)
VI  - 28
IP  - 5
DP  - 2019 May
TI  - Ranolazine Reduces Angina in Women with Ischemic Heart Disease: Results of an 
      Open-Label, Multicenter Trial.
PG  - 573-582
LID - 10.1089/jwh.2018.7019 [doi]
AB  - Background: Persistent angina is prevalent in women, who more often present with 
      atypical angina, and experience less relief from antianginal therapies. The 
      impact of ranolazine on female-specific angina is unclear. A single-arm, 
      open-label trial was conducted to quantify the impact of ranolazine on angina in 
      women with ischemic heart disease (IHD). Materials and Methods: Women with IHD 
      and >/=2 angina episodes/week were recruited from 30 U.S. sites. Angina and 
      nitroglycerin (NTG) consumption were assessed using patient-reported diaries, 
      Seattle Angina Questionnaire (SAQ), Duke Activity Score Index (DASI), and Women's 
      Ischemia Symptom Questionnaire (WISQ) at baseline and at 4 weeks of treatment 
      with ranolazine 500 mg twice/day. A modified intent-to-treat analysis and 
      parametric or nonparametric methods were used as appropriate to analyze changes. 
      Results: Of 171 women enrolled, mean age was 65 +/- 12 years. Of the 159 women 
      included in the analysis, at week 4 compared to baseline, median angina frequency 
      decreased with ranolazine treatment from 5.0 to 1.5 attacks/week and median 
      change from baseline was -3.3 (95% confidence interval [CI]: -4.0 to -2.5; 
      p </= 0.0001). Median NTG consumption decreased from 2.0 to 0.0 per week over the 4 
      weeks and median change was -1.0 (95% CI: -2.0 to -0.5; p < 0.0001). All five SAQ 
      subscales showed mean improvements: physical limitation 9.2 (standard error [SE] 
      1.5; p < 0.0001), angina stability 31.8 (SE 2.7; p < 0.0001), angina frequency 
      17.7 (SE 1.6; p < 0.0001), treatment satisfaction 9.3 (SE 1.6; p < 0.0001), and 
      disease perception 2.9 (SE 0.8; p < 0.0001). DASI score also improved 2.9 (SE 
      0.8; p = 0.0014). WISQ subscales also showed significant improvements (all 
      p < 0.0001). Thirty-one women reported drug-related adverse events (AEs), 
      predominantly mild to moderate gastrointestinal symptoms. Conclusions: Women with 
      IHD treated with ranolazine for 4 weeks experienced less angina measured by SAQ 
      and WISQ. NTG use decreased, physical activity improved, and treatment 
      satisfaction improved. AEs were consistent with prior reports.
FAU - Mehta, Puja K
AU  - Mehta PK
AD  - 1 Division of Cardiology and Emory Women's Heart Center, Emory University School 
      of Medicine, Atlanta, Georgia.
FAU - Sharma, Shilpa
AU  - Sharma S
AD  - 2 Barbra Streisand Women's Heart Center, Cedars-Sinai Heart Institute, Los 
      Angeles, California.
FAU - Minissian, Margo
AU  - Minissian M
AD  - 2 Barbra Streisand Women's Heart Center, Cedars-Sinai Heart Institute, Los 
      Angeles, California.
FAU - Harsch, Manya R
AU  - Harsch MR
AD  - 3 Technomics Research, Minneapolis, Minnesota.
FAU - Martinson, Melissa
AU  - Martinson M
AD  - 3 Technomics Research, Minneapolis, Minnesota.
FAU - Nyman, John A
AU  - Nyman JA
AD  - 4 Division of Health Policy and Management, School of Public Health, University 
      of Minnesota, Minneapolis, Minnesota.
FAU - Shaw, Leslee J
AU  - Shaw LJ
AD  - 5 Department of Radiology, Weil Cornell Medicine, New York, New York.
FAU - Bairey Merz, C Noel
AU  - Bairey Merz CN
AD  - 2 Barbra Streisand Women's Heart Center, Cedars-Sinai Heart Institute, Los 
      Angeles, California.
FAU - Wenger, Nanette K
AU  - Wenger NK
AD  - 1 Division of Cardiology and Emory Women's Heart Center, Emory University School 
      of Medicine, Atlanta, Georgia.
LA  - eng
GR  - N01 HV068161/HV/NHLBI NIH HHS/United States
GR  - N01HV68162/HL/NHLBI NIH HHS/United States
GR  - R03 AG032631/AG/NIA NIH HHS/United States
GR  - N01HV68163/HL/NHLBI NIH HHS/United States
GR  - UL1 TR000124/TR/NCATS NIH HHS/United States
GR  - N01 HV068164/HV/NHLBI NIH HHS/United States
GR  - M01 RR000425/RR/NCRR NIH HHS/United States
GR  - K23 HL105787/HL/NHLBI NIH HHS/United States
GR  - R01 HL090957/HL/NHLBI NIH HHS/United States
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20190319
PL  - United States
TA  - J Womens Health (Larchmt)
JT  - Journal of women's health (2002)
JID - 101159262
RN  - 0 (Cardiovascular Agents)
RN  - A6IEZ5M406 (Ranolazine)
RN  - G59M7S0WS3 (Nitroglycerin)
SB  - IM
CIN - J Womens Health (Larchmt). 2019 May;28(5):561-562. PMID: 30614755
MH  - Aged
MH  - Angina Pectoris/*drug therapy
MH  - Cardiovascular Agents/*therapeutic use
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Myocardial Ischemia/*drug therapy
MH  - Nitroglycerin/therapeutic use
MH  - Ranolazine/*therapeutic use
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
PMC - PMC6537111
OTO - NOTNLM
OT  - and heart disease
OT  - angina
OT  - ranolazine
OT  - women
COIS- P.K.M., research support: Gilead; M.M., contracted by Gilead; M.R.H., contracted 
      by Gilead; M.M., research support: NINR, AHA, American Nurses Foundation and 
      honorarium from North American Center for CME; J.A.N., none; L.J.S., none; 
      C.N.B.M., consulting revenue paid to Cedars-Sinai from Gilead, Medscape, Research 
      Triangle Institute, research money from Gilead, Erika Glazer, payments for 
      lectures from Beaumont Hospital, European Horizon, Florida Hospital, INOVA, 
      Korean Cardiology Society, Practice Point Communications, Pri-Med, University of 
      Chicago, VBWG, University of Colorado, University of Utah, WomenHeart, Harold 
      Buchwald Heart-Health, Tufts; N.K.W., consulting and research support: Gilead 
      Sciences. ClinicalTrials.gov Identifier: NCT00644332.
EDAT- 2019/03/20 06:00
MHDA- 2020/04/28 06:00
PMCR- 2020/05/01
CRDT- 2019/03/20 06:00
PHST- 2019/03/20 06:00 [pubmed]
PHST- 2020/04/28 06:00 [medline]
PHST- 2019/03/20 06:00 [entrez]
PHST- 2020/05/01 00:00 [pmc-release]
AID - 10.1089/jwh.2018.7019 [pii]
AID - 10.1089/jwh.2018.7019 [doi]
PST - ppublish
SO  - J Womens Health (Larchmt). 2019 May;28(5):573-582. doi: 10.1089/jwh.2018.7019. 
      Epub 2019 Mar 19.