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The European Medicines Agency has started a review of the medicine Corlentor/Procoralan (ivabradine). Corlentor/Procoralan is used to treat the symptoms of adults with long-term stable angina (chest pain due to obstruction in the arteries in the heart) or long-term heart failure (when the heart cannot pump enough blood to the rest of the body).
The review follows preliminary results from the SIGNIFY study, which was evaluating whether treatment with Corlentor/Procoralan in patients with coronary heart disease reduces the rate of cardiovascular events (such as heart attack) when compared with placebo (a dummy treatment). Patients in the study received up to 10 mg twice daily, which is higher than the currently authorised maximum daily dose (7.5 mg twice daily), and the results showed a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with the medicine in a subgroup of patients who had symptomatic angina (Canadian Cardiovascular Society class II – IV). The European Medicines Agency will now evaluate the impact of the data from the SIGNIFY study on the balance of benefits and risks of Corlentor/Procoralan and issue an opinion on whether the marketing authorisation should be maintained, varied, suspended or withdrawn across the EU.
While the review is ongoing and pending further communication, patients should speak to their doctor or pharmacist if they have any questions or concerns.