|Holger Diedrichs1*, Ulrike Wollenberg2, Kristin Schmerbach2, Roger Limberg2, Guido Schiffhorst3 and Andreas Michael Zeiher4|
|1Herzzentrum, Uniklinik Köln, Kerpener Straße 62, 50937, Cologne, Germany|
|2Berlin-Chemie AG, Glienicker Weg 125, 124 Berlin, Berlin, Germany|
|3IGES Institut GmbH, Friedrichstraße 180, 10117 Berlin, Berlin, Germany|
|4Klinikum der Johann-Wolfgang Goethe-Universität, Medizinische Klinik III|
|Corresponding Author :||Holger Diedrichs
Herzzentrum, Uniklinik Köln
Kerpener Straße 62, 50937, Cologne, Germany
E-mail: [email protected]
|Received: November 10, 2015 Accepted: December 19, 2015 Published: December 29, 2015|
|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:10.4172/2155-9880.1000412|
|Copyright: © 2015 Diedrichs H, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.|
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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.
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