Clinical & Experimental Cardiology
Open Access

Abstract

Application of Ranolazine in Stable Angina Pectoris Therapy (ARETHA): Real-World Data from an Observational Study

Holger Diedrichs, Ulrike Wollenberg, Kristin Schmerbach, Roger Limberg, Guido Schiffhorst and Andreas Michael Zeiher

Objective: Ranolazine, a late sodium current inhibitor, is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antiischaemic therapies. This study was conducted to assess the use of ranolazine as well as its safety and efficacy in patients with stable angina pectoris from different causes in a real world scenario.

Methods: Patients with stable angina pectoris (AP) receiving ranolazine were enrolled in this non-interventional study. Data were documented at baseline and after 3 months of ranolazine treatment. Endpoints included changes in the number of AP attacks per week, frequency of using short-acting nitrates, current status of the CCS classification, overall estimate of quality of life assessed by both, the physician and the patient, and safety.

Results: In total, 1,537 patients were eligible for efficacy evaluation. After 3 months, the mean (±SD) number of AP episodes per week significantly decreased from 4.4 ± 4.0 at baseline to 1.1 ± 1.8 (p<0.0001), and the weekly use of short-acting nitrates was significantly reduced from 3.4 ± 3.4 to 0.8 ± 1.5 (p<0.0001). Improvement occurred independent of diagnosed coronary heart disease (CHD). The CCS classification improved in 69.0% of patients and remained stable in 27.1%. Quality of life, assessed on a numerical analogue scale by physicians and patients, improved significantly by 43.7% and 44.9%, respectively (p<0.0001). Safety analysis was based on 2,726 patients. A total of 63 adverse drug reactions (ADRs) occurred in 37 patients (1.4%) and led to discontinuation in 34 patients (1.2%). By the end of the observation period, all ADRs were resolved or resolving.

Conclusion: The adjuvant therapy with ranolazine is an effective treatment option with a positive benefit-risk balance for patients with angina pectoris of different causes, e.g. small vessel disease, endothelial dysfunction, including those without prior CHD diagnosis.