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.
Keywords: Chronic stable angina; Observational study; Quality of life; Ranolazine.
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