What is Procoralan?
Procoralan is a salmon-colored tablet (oblong, 5 mg, triangular, 7.5 mg) to be taken by mouth. The active substance is ivabradine in dosages of 5 and 7.5 mg.
What is Procoralan used for?
Procoralan is used in the symptomatic treatment of chronic stable angina pectoris (pain in the chest, allamandibula and the back following physical exertion, due to problems in the flow of blood to the heart). Procoralan is used in patients with normal sinus rhythm (heart rate) who cannot be treated or who cannot tolerate beta-blocker therapy (another medicine to treat angina).
The medicine can only be administered with a prescription.
How is Procoralan used?
Procoralan should be taken by mouth during meals twice a day, in the morning and in the evening.
The recommended starting dose is 5 mg twice a day. In patients over 75 years it is possible to start with a dose of 2.5 mg up to the 5 mg dose. After 3-4 weeks of treatment the dose can be increased to 7.5 mg twice a day, depending on the individual response.
How does Procoralan work?
The symptoms of angina (pain in the chest, arm or jaw) are due to an insufficient supply of oxygenated blood to the heart. In chronic stable angina, these symptoms occur during physical exertion. Procoralan is a medicine that selectively reduces heart rate. The active ingredient contained in the medicine, ivabradine, acts by inhibiting the lf channels, or the specialized cells located in the sinus node, the natural pacemaker that controls the heart's contractions and regulates the heart rate. When the channels become blocked, the heart rate decreases, the heart works less and therefore requires less oxygenated blood. Procoralan therefore acts by reducing or preventing the symptoms of angina.
How was Procoralan studied?
Procoralan has been the subject of four 3 or 4 month clinical studies involving a total of 3, 222 patients, 2 168 of whom were treated with Procoralan. The medicine has been compared with placebo (a dummy treatment), atenolol or amlodipine (other anti medicines
angina). The medicine has also been studied as an adjunctive treatment in patients taking amlodipine simultaneously. Efficacy was assessed primarily through physical tests, for example to measure the amount of movement the patient could do before angina arose.
What benefits has Procoralan revealed during your studies?
Procoralan was significantly better than placebo in increasing resistance to exertion and as effective as atenolol and amlodipine. The addition of Procoralan to amlodipine therapy showed no additional benefit.
What are the risks associated with Procoralan?
The most common side effect, which appeared in over one in 10 patients, is constituted by luminous phenomena or 'phosphenes' (temporary luminous sensation in the visual field). Other side effects are blurry vision, bradycardia (very low heart rate), irregular heartbeat, headache (usually during the first month of treatment) and dizziness. For the full list of side effects reported with Procoralan, see the Package Leaflet.
Procoralan should not be used in patients who may be hypersensitive (allergic) to ivabradine or any of the other ingredients, in patients with a resting heart rate of less than 60 beats per minute, in patients with very low blood pressure, in affected patients from various cardiopathies (cardiogenic shock, heart rhythm disorders, heart attack, heart failure), in patients with severe liver problems and in pregnant or nursing patients. For the complete list of limitations, see the package insert.
Why has Procoralan been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Procoralan showed sufficient anti-angina efficacy and an acceptable safety profile as an alternative treatment for patients suffering from chronic stable angina pectoris with normal sinus rhythm which cannot be treated with beta-blockers. The CHMP considered that the benefits are risk-adjusted and therefore recommended that it be given marketing authorization.
More information on Procoralan:
On 25 October 2005, the European Commission granted Les Laboratoires Servier the marketing authorization for Procoralan valid throughout the European Union.
For the full version of the Procoralan evaluation (EPAR), click here.
Last update of this summary: March 2006
