Table 2

Clinical Outcomes

RanolazinePlacebop Value
Efficacy endpointsn = 462n = 465
 Primary endpoint
  Angina frequency, baseline, n/week6.6 (6.3–7.0)6.8 (6.4–7.2)0.54
  Angina frequency, on treatment, n/week3.8 (3.6–4.1)4.3 (4.0–4.5)0.008
 Secondary endpoints
  SL NTG use, baseline, n/week4.1 (3.7–4.6)4.5 (4.1–5.0)0.27
  SL NTG use, on treatment, n/week1.7 (1.6–1.9)2.1 (1.9–2.3)0.003
  Percentage of angina-free days, %67 (65–70)64 (61–67)0.068
  Subjects with ≥50% reduction in angina episodes, %47 (43–51)42 (38–46)0.034
  SF-36 mental component score, change from baseline1.0 (0.2–1.8)1.1 (0.3–1.9)0.77
  SF-36 physical component score, change from baseline2.9 (2.3–3.5)1.9 (1.3–2.5)0.005
  PGIC scale score4.0 (3.8–4.2)3.9 (3.7–4.1)0.41
  Diary compliance, %98 (95–98)98 (95–98)0.46
Safety endpointsn = 470n = 474
 Serious adverse events
  Serious adverse event16 (3.4)20 (4.2)0.51
  Death3 (0.6)2 (0.4)0.69
  Nonfatal myocardial infarction1 (0.2)3 (0.6)0.62
  Stroke/transient ischemic attack1 (0.2)4 (0.8)0.37
  Unstable angina or coronary revascularization6 (1.3)7 (1.5)0.79
 Notable nonserious adverse events
  Dizziness17 (3.6)6 (1.3)0.019
  Nausea17 (3.6)2 (0.4)<0.001
  Headache7 (1.5)9 (1.9)0.63
  Constipation8 (1.7)2 (0.4)0.063
  Hypoglycemia3 (0.6)0 (0.0)0.12
 Any adverse event126 (26.8)105 (22.2)0.096

Values are least-squares mean (95% confidence interval), n (%), or median (interquartile range) (arithmetic means for angina frequency and SL NTG use are presented in Online Table 5).

PGIC = Patient's Global Impression of Change; SF-36 = Medical Outcomes Short Form-36; SL NTG = sublingual nitroglycerin.

  • Analytic sample for the safety dataset includes patients who took any dose of the study drug whereas analytic sample for the efficacy dataset includes patients who completed 14 days of the study drug.