Ivabradine (Procoralan®, Servier) has been approved for use in heart failure. The licence has been granted for use in patients in New York Heart Association Class II to IV heart failure with systolic dysfunction, in those in sinus rhythm with a heart rate ≥75 bpm. It should be used in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
The licence follows the results of the SHIfT trial, involving more than 6,000 people, which demonstrated that patients with chronic systolic heart failure and a heart rate over 70 bpm had an 18% reduction (ARR = 4.2% p<0.0001) in the composite primary end point of cardiovascular death and hospitalisation due to heart failure.
Ivabradine selectively lowers heart rate and the study showed benefits were greater in patients with higher heart rates (>75 bpm). Within the indication, Servier says ivabradine reduced the risk of death from heart failure by 39% (ARR 2.2% p=0.0006), the risk of death from all types of cardiovascular disease by 17% (ARR 2.6% p=0.0166) and the risk of death from all causes by 17% (ARR 2.8% p=0.0109). It also significantly reduced the risk of heart failure patients requiring hospitalisation by 30% (ARR = 6.3% p<0.0001) and improved the quality of life of people living with the disease.