NICE recommends ivabradine as an option for treating chronic heart failure in certain patients (TA267; November 2012) and the clinical guideline on stable angina (CG126; July 2011) lists it as one of several potential monotherapy options for people who cannot tolerate beta blockers and calcium channel blockers or in whom both are contraindicated.
The UK Summary of Product Characteristics for ivabradine lists atrial fibrillation (AF) as a very rare side-effect. It recommends that patients treated with ivabradine be regularly clinically monitored for the occurrence of AF, and notes that the risk of developing AF may be higher in chronic heart failure patients treated with ivabradine.
The authors of the current research comment that the 15% relative increase in risk of developing AF seen in their research is greater than that previously reported in the product safety information. These risks however need to be balanced against the benefits of treatment. They acknowledge the limitations of their research, including the lack of information on AF incidence for some studies, use of data from the EMA scientific discussion, lack of sufficient data to allow assessment of the effect of treatment indication on risk, and the lack of data on the risk profile of patients who developed AF, to help determine if the risk is restricted to a small high-risk subgroup.