Elsevier

International Journal of Cardiology

Volume 205, 15 February 2016, Pages 111-116
International Journal of Cardiology

Ranolazine reduces angina frequency and severity and improves quality of life: Observational study in patients with chronic angina under ranolazine treatment in Greece (OSCAR-GR)

https://doi.org/10.1016/j.ijcard.2015.10.180Get rights and content

Abstract

Objective

Primary objectives were to evaluate tolerability, compliance, and perception of ranolazine effectiveness for chronic stable angina in a routine clinical setting. The secondary objective was safety evaluation.

Methods

Prospective, multi-centre, observational, study with a 6-month follow-up and study visits at baseline, 3- and 6 months in patients with chronic stable angina. Ranolazine was administered according to the summary of product characteristics and investigator discretion. Data was collected on patient and disease characteristics, concomitant therapy, angina frequency and severity, quality of life (QoL), perception of effectiveness, compliance, and adverse events.

Results

Between July 2010 and July 2012, 189 patients were enrolled at 20 centres. Ranolazine decreased the proportion of patients experiencing angina attacks from 88.4% at baseline to 26.5% at 6 months (p < 0.001). Heart rate and blood pressure were not appreciably affected. The proportion of patients without symptoms on normal exertion (Canadian Cardiovascular Society grading class I) increased from 22.3% to 75.3% (p < 0.001); patients reporting limitations in daily activities decreased from 80.4% to 35.5%. (p < 0.001). Patient- and physician-assessed QoL improved (both p < 0.001). Therapeutic efficacy was rated “good” or “very good” in 67.7% of cases by physicians, and by 63.5% of the patients. Physicians rated compliance “good” or “very good” in 73.5% of cases. Adverse events were consistent with previous reports, and consisted of 40 events in 24 patients; 12 were serious.

Conclusions

Ranolazine was associated with decreased angina frequency and severity, and improvements in QoL. The benefits provided by ranolazine in controlled clinical trials are maintained in the clinical setting.

Introduction

Stable angina pectoris results from an imbalance between myocardial oxygen supply and demand. The pathogenic mechanism usually involves macrovascular damage to coronary arteries. The estimated global prevalence of angina due to ischemic heart disease is 1.62% [1], and it is often the first sign of cardiovascular disease. The estimated global age-adjusted mortality from ischemic heart disease is 105.7/100 000 [2]. These numbers differ according the local prevalence of cardiovascular risk factors. In Western societies, ischemic heart disease is the major cause of morbidity and mortality. Mortality has decreased in recent years [2], due to improved knowledge of pathogenic mechanisms, aggressive management of risk factors, development of better techniques for diagnosis and revascularisation, and advances in pharmacological therapies.

Chronic stable angina often causes a reduction in quality of life (QoL) [3]. Most pharmacological therapies for angina increase myocardial oxygen supply through vasodilation, or reduce myocardial oxygen demand by slowing heart rate or modifying cardiac efficiency or workload [4]; however, side effects or haemodynamic issues may limit therapeutic options [5]. Ranolazine improves cardiac perfusion and contractility through a novel mechanism that involves blocking the late inward sodium current, thereby preventing the ischemia-induced influx of sodium and calcium. This improves cardiac relaxation and reduces left ventricular stiffness, thereby reducing extravascular compressive forces on small vessels, improving myocardial blood flow and ameliorating cardiac ischemia [6], [7], [8]. The increase in coronary blood flow from improved diastolic compliance occurs without clinically significant variation of hemodynamic parameters [9].

The efficacy of adjunctive ranolazine therapy for increasing exercise duration and time to ischemia or reducing the frequency of angina attacks in patients with chronic stable angina has been demonstrated in several large controlled clinical trials [10], [11], [12], [13], [14].

In this study, we investigated the relationship between ranolazine therapy and patient satisfaction, quality of life, physicians' assessment of therapy, and safety in patients with chronic stable angina treated in a routine clinical setting in Greece.

Section snippets

Methods

The Observational Study in patients with Chronic Angina under Ranolazine treatment in Greece (OSCAR GR) study was a multi-centre, observational study with a prospective longitudinal design and 6-month follow-up. It was conducted between July 2010 and July 2012 at 20 centres located in Greece to investigate tolerability, perceived efficacy, compliance and effect on QoL in patients with confirmed chronic stable angina treated with ranolazine in routine clinical practice. The data collected were

Patients

The study enrolled 189 patients in 20 centres distributed across Greece. The cohort was comprised mostly of men (70.4%) and 56.6% of patients had already been revascularised. Their characteristics at baseline are summarised in Table 2. All patients had a confirmed diagnosis of chronic stable angina and were receiving medical therapy for angina, thus ranolazine was administered as add-on therapy consistent with its European indication. Physician-cited reasons for initiating ranolazine treatment

Discussion

This prospective observational study provides data on the use of ranolazine to treat chronic stable angina in routine clinical practice in Greece. More than half of our patients had undergone revascularization therapy (56.6%), which is comparable to the rates observed in the MARISA study (62%) and the TERISA study (59%) [11], [17], but higher than the rates in the CARISA (37%) and ERICA (21%)study populations [10], [13]. Concomitant antianginal therapy did not change appreciably over the course

Conclusions

Addition of ranolazine to medical therapy for chronic stable angina in routine clinical practice was associated with an improvement of disease control obtained with a decrease in angina frequency and CCS angina classification, as well as improvements in QoL. The benefits provided by ranolazine in controlled clinical trials are maintained also in the real world clinical setting.

Conflicts of interest

Dr. Alexopoulos has received speaker honoraria from Astra Zeneca and Advisory Board fees from Astra Zeneca, Boehringer Ingelheim, Bayer, and the Medicines Company.

Dr. Kochiadakis states that there are no conflicts of interest.

Dr. Afthonidis states that there are no conflicts of interest.

Dr. Barbetseas states that there are no conflicts of interest.

Dr. Kelembekoglou states that there are no conflicts of interest.

Dr. Limberi states that there are no conflicts of interest.

Dr. Spanos states that

Acknowledgments

This study was sponsored by Menarini Hellas. Appointed CRO conducted the trial on behalf of the sponsor. Medical writing assistance was provided by Anna Riccardi of Madison Srl. Support for this assistance was funded by A. Menarini Farmaceutica Internazionale S.r.l.

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This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.

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