What is Ivabradine Anpharm used for and what is it used for?
Ivabradine Anpharm is a medicine used to treat long-term stable angina symptoms (chest, jaw and back pain caused by physical exertion) in adults with coronary artery disease (heart disease caused by blood vessel obstruction) that carry blood to the heart muscle). The medicine is used in patients who have a normal heart rhythm, but whose heart rate is at least 70 beats per minute. It is indicated in patients who cannot be treated with beta-blockers (another type of medicine used in the treatment of angina) or in combination with a beta-blocker in patients whose disease is not controlled with beta-blockers alone.
Ivabradine Anpharm is also used in patients with long-term heart failure (a condition in which the heart cannot pump enough blood to other parts of the body) that have a normal heart rate but a heart rate of at least 75 beats per minute . It is used in combination with a standard therapy including beta-blockers or in patients who cannot be treated with beta-blockers.
This medicine is the same as Procoralan, already authorized in the European Union (EU). The company that makes Procoralan has agreed that its scientific data can be used for Ivabradine Anpharm ("informed consent").
How is Ivabradine Anpharm used?
Ivabradine Anpharm is available as tablets (5 and 7.5 mg) and can only be obtained with a prescription. The recommended starting dose is 5 mg twice a day, with meals; your doctor may increase this dose to 7.5 mg twice a day or decrease it to 2.5 mg (half a 5 mg tablet) twice a day, depending on your heart rate and your patient's symptoms. In subjects over 75 years of age, a lower starting dose of 2.5 mg can be used twice a day. Treatment should be stopped if the heart rate decreases persistently below 50 beats per minute or if symptoms of bradycardia (slow heart rate) persist. If used for angina, treatment should be discontinued if no improvement in symptoms is observed after 3 months and the doctor should consider discontinuing treatment if the improvement in symptoms or reduction in heart rate is only limited.
For more information, see the summary of product characteristics (included with EPAR).
How does Ivabradine Anpharm work?
The symptoms of angina are due to an insufficient supply of oxygenated blood to the heart. In stable angina these symptoms occur during physical exertion. The active substance in Ivabradine Anpharm, ivabradine, works by blocking "If currents" in the sinoatrial node, which acts as a natural "pacemaker" by controlling heart contractions and regulating heart rate. When these currents become blocked, the heart rate decreases, causing the heart to work less and therefore need less oxygenated blood. Ivabradine Anpharm therefore reduces or prevents the symptoms of angina.
The symptoms of heart failure are due to the fact that the amount of blood pumped from the heart into the body is not enough. By reducing the heart rate, Ivabradine Anpharm reduces stress to the heart, slowing the progression of heart failure and improving symptoms.
What benefits of Ivabradine Anpharm have been shown in studies?
Ivabradine Anpharm has been studied in five main studies involving over 4, 000 adults with long-term stable angina. The medicine has been compared with placebo (a dummy treatment) in 360 patients, with atenolol (a beta-blocker) in 939 patients and with amlodipine (another medicine used to treat angina) in 1 195 patients. It was also compared with placebo as an adjunctive treatment to atenolol in 889 patients and as an adjunctive treatment to amlodipine in 728 patients. Each study lasted between three and four months. As a main measure of effectiveness, the duration of effort that patients could sustain on a bicycle or on a treadmill was considered, based on measurements taken at the beginning and end of each study. Studies have shown that the medicine is more effective than placebo in increasing resistance to exertion and as effective as atenolol and amlodipine. Ivabradine Anpharm was more effective than placebo even when it was used as an adjunctive therapy to atenolol. Conversely, the addition of Ivabradine Anpharm to amlodipine showed no additional benefit.
Ivabradine Anpharm was also compared with placebo in one main study involving 6 558 patients with moderate to severe long-term heart failure. As a main measure of effectiveness, the period until death due to heart disease or blood vessels was considered or until admission to the hospital due to the worsening of heart failure. Ivabradine Anpharm was more effective than placebo in preventing death due to cardiac or blood vessel disease or hospitalization due to worsening heart failure: 24.5% (793 patients out of 3 241) of patients treated with Ivabradine Anpharm died or was hospitalized for the first time due to a worsening of heart failure, compared to 28.7% (937 out of 3 264) of placebo-treated patients.
Another study compared Ivabradine Anpharm with a placebo in 19 102 patients with coronary artery disease and without clinical heart failure. The main measure of effectiveness was the reduction of the risk of death due to heart problems and non-lethal heart attack. In this study, a specific subgroup of patients with symptomatic angina showed a slight but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with Ivabradine Anpharm compared to placebo (with annual incidence rates of 3.4% against 2.9%). However, it should be noted that patients in this study were given higher doses than the recommended dose (up to 10 mg twice a day).
What are the risks associated with Ivabradine Anpharm?
The most common side effect of Ivabradine Anpharm (seen in more than 1 patient in 10) is light phenomena or "phosphenes" (a temporary luminous sensation in the visual field). For the full list of all side effects reported with Ivabradine Anpharm, see the package leaflet.
Ivabradine Anpharm should not be used in patients with a resting heart rate below 70 beats per minute, with very low blood pressure, with various types of heart disease (including cardiogenic shock, heart rhythm disturbances, heart attack, unstable heart failure or heart failure). acute (sudden) and unstable angina) or with severe liver problems. It must not be used in women who are pregnant, breast-feeding or in women of childbearing potential who are not using adequate contraception. Care should be taken when using Ivabradine Anpharm together with other medicines. For the full list of limitations, see the package leaflet.
Why has Ivabradine Anpharm been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Ivabradine Anpharm, being effective for long-term angina and having an acceptable safety profile, is an alternative treatment for patients who cannot take beta-blockers or whose pathology is not controlled with the latter. He also concluded that Ivabradine Anpharm is effective in long-term heart failure with an acceptable safety profile. The Committee decided that Ivabradine Anpharm's benefits are greater than its risks and recommended that it be given marketing authorization.
What measures are being taken to ensure the safe and effective use of Ivabradine Anpharm?
A risk management plan has been developed to ensure that Ivabradine Anpharm is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ivabradine Anpharm, including the appropriate precautions to be followed by healthcare professionals and patients.
In addition, the company that markets Ivabradine Anpharm must perform a new study on patients taking the medicine and on how it is used, as well as on compliance with risk mitigation measures.
Further information is available in the summary of the risk management plan.
More information on Ivabradine Anpharm
For the full version of EPAR and the summary of the Ivabradine Anpharm risk management plan, see the Agency website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports.
For more information about treatment with Ivabradine Anpharm, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
