Safety Profile in Special Patient Populations

Ranexa has been studied in chronic angina patients including patients with diabetes, heart failure and renal impairment, as well as geriatric patients.

Use in chronic angina patients with diabetes

• Approximately 30% of patients in clinical trials had chronic angina and diabetes.^2,3,5
• No dose adjustment is required in patients with diabetes.¹
  • A population pharmacokinetic evaluation of data from angina patients and healthy subjects showed no effect of diabetes on Ranexa pharmacokinetics.¹
• Ranexa should not be considered a treatment for diabetes.¹
• Ranexa produced small reductions in HbA1c in patients with comorbid diabetes.⁶
  • The clinical significance of the HbA1c reductions is unknown.¹

Use in chronic angina patients with heart failure

• Approximately 20% of patients in clinical trials had chronic angina and heart failure^2,3,5
• Heart failure (NYHA Class I to IV) had no significant effect on Ranexa pharmacokinetics.¹
• Ranexa had minimal effects on heart rate and blood pressure in patients with angina and heart failure NYHA Class I to IV.¹
• No dose adjustment of Ranexa is required in patients with chronic angina and heart failure.¹

Use in geriatric patients with chronic angina

• Of the chronic angina patients treated with Ranexa in controlled studies, 496 (48%) were ≥ 65 years of age, and 114 (11%) were ≥ 75 years of age.¹
• No overall differences in efficacy were observed between older and younger patients.¹
• There were no differences in safety for patients ≥ 65 years compared with younger patients.¹
• Patients ≥ 75 years of age taking Ranexa had a higher incidence of adverse events, serious adverse events, and drug discontinuations due to adverse events compared with those taking placebo.¹
• In general, dose selection for an elderly patient should usually start at the low end of the dosing range.¹

Use in chronic angina patients with renal impairment

• In patients with varying degrees of renal impairment, Ranexa plasma levels increased 50%.⁵
• The pharmacokinetics of Ranexa has not been assessed in patients on dialysis.⁵

Ranexa should not be used in patients with clinically significant hepatic impairment.