Ivabradine is a selective I f current inhibitor that is used to lower the heart rate (HR) of patients with angina and/or heart failure. It is approved for use in several countries, including the United Kingdom, Australia, Saudi Arabia, and the United States. The drug was studied in several clinical trials, and it exhibited beneficial effects on the approved indicators. However, there are some concerns with the safety profile of this drug, especially its effect in reducing HR and causing severe bradycardia. Therefore, the current review assessed the benefit-risk balance of ivabradine. A literature review of the major published studies that assessed the efficacy and safety of ivabradine was performed. The online VigiBase adverse drug reaction (ADR) reporting system was also accessed to investigate reports associated with this drug. A full benefit-risk assessment was performed using the collected data from the above-mentioned resources. Most of the reviewed studies concluded that ivabradine exerted beneficial effects with a tolerable safety profile. Specifically, a favorable benefit-risk profile was found when ivabradine was used for patients with an HR ≥70 beats per minute. Reports revealed that the most common ADR was bradycardia, which was expected. Other safety risks or ADRs were comparable to other prescribed drugs. This review presents an up-to-date analysis of ivabradine from the latest literature and reports. These studies suggest that ivabradine exhibits an acceptable and favorable benefit-risk profile, and this drug should be considered as a viable option in patients with angina pectoris and chronic heart failure.
Keywords: CHF; angina; benefit–risk balance; ivabradine; regulatory action.