Procoralan (ivabradine) is a new medicinal product for the treatment of stable angina pectoris in patients with normal sinus rhythm, for whom β-blockers are contraindicated, or who are intolerant to β-blockers. Procoralan represents a new group of drugs, which selectively reduces the heart rate.
Efficacy, measured as endurance in an exercise test, was not worse than the efficacy achieved with atenolol or amlodipine. The reduction in short-acting nitrate consumption was similar to the reduction seen in the amlodipine-arm. No extra efficacy was seen when ivabradin was used as adjunctive therapy in amlodipine-treated patients. Ivabradin has not been tested as add-on treatment to long-acting nitrates.
The most frequent adverse effect is visual disturbance. Cardiac adverse effects such as bradycardia (dose dependent), ventricular extrasystoles and AV-block occur to the same extent as with amlodipine and atenolol.
Ivabradine has not been tested specifically in the patient group for whom it is authorized (i.e.patients for whom β-blockers are contraindicated, or who are intolerant to β-blockers).
The cost of a daily dose is 22 d.kr, compared to 1 d.kr for a daily dose of atenolol or amlodipine. It is possible to apply for individual reimbursement.
According to IRF, Procoralan should only be considered in patients, who do not respond to other treatment.
Procoralan was marketed in Denmark on April 25, 2006.
Institute for Rational Pharmacotherapy, 10 May 2006