World Data from an Observational Study
Holger Diedrichs Herzzentrum1 *, Ulrike Wollenberg , Kristin Schmerbach ,Abstract
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. Нis study was conducted to assess the use of ranolazine as well as its safety and eٹcac\ in patients with stable angina pectoris from diوٴerent 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 aіer 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 eٹcac\ evaluation. $іer 3 months, the mean (±SD) number of AP episodes per week significantl\ 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 significantl\ reduced from 3.4 ± 3.4 to 0.8 ± 1.5 (p<0.0001). Improvement occurred independent of diagnosed coronary heart disease (CHD). Нe 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 significantl\ 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
Нe adjuvant therapy with ranolazine is an eوٴective treatment option with a positive benefit-risk balance for patients with angina pectoris of diوٴerent causes, e.g. small vessel disease, endothelial dysfunction, including those without prior CHD diagnosis.
Introduction
Stable angina pectoris is a common manifestation of chronic ischaemic heart disease (CIHD). Ðe pharmacologic management of CIHD aims at relieving ischaemic symptoms and preventing cardiovascular events [1]. First-line treatment of angina pectoris includes a short-acting nitrate for chest pain relief as well as betablockers and calcium-channel inhibitors for controlling heart rate and symptoms [1]. However, despite treatment with these agents and/or revascularisation, many patients remain symptomatic [2]. In order to meet the need for a drug with an anti-ischaemic mechanism complementary and therefore potentially additive to those of the existing agents, international guidelines recently included the inhibitor of the late sodium current ranolazine as second-line treatment [1,2,4]. Ranolazine 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 anti-anginal therapies.
Participants
In total, 2,858 patients with stable angina pectoris with or without concomitant diseases being treated with ranolazine were included in the study. Ðe decision to treat the subject with ranolazine had to be taken previously to study enrolment but not more than 4 weeks before. Physicians performed dosing of ranolazine as outlined in the summary of product characteristics [10]. Ðe recommended initial dose of ranolazine is 375 mg twice daily. $Ñer 2-4 weeks, the dose should be titrated to 500 mg twice daily and, according to the patient’s response, further titrated to a recommended maximum dose of 750 mg twice daily. Selection of patients was subject of the investigator’s discretion. Only those patients were monitored who suÙÙ´ered from stable angina pectoris and were treated with ranolazine for the first time ever. Ðis also included those patients who already received a ranolazine prescription from their cardiologist provided that their therapy did not start earlier than 2 to a maximum of 4 weeks previously and the dosage still equalled the recommended starting dose.
Author Info
1 Kerpener Straße 62, 50937, Cologne, GermanyReceived: 01-Jun-2025, Manuscript No. jccd-24-12345; Editor assigned: 03-Jun-2025, Pre QC No. jccd-24-12345; Reviewed: 17-Jun-2025, QC No. jccd-24-12345; Revised: 20-Jun-2025 Accepted Date: 20-Jun-2025 Published: 27-Jun-2025
Citation: @ Wollenberg U, Schmerbach K, Limberg R, Schiffhorst G, Zeiher AM (2015) Application of Ranolazine in Stable Angina Pectoris Therapy (ARETHA): Real-World Data from an Observational Study. J Clin Exp Cardiolog 6: 412. doi:10.786/2155-9880.1000412
