Pooled data from randomised studies in around 7,500 post-menopausal women with osteoporosis showed an increased risk of myocardial infarction with strontium ranelate as compared with placebo (1.7% versus 1.1 %; relative risk 1.6 [95% CI 1.07-2.38]), and an increased risk of venous thrombotic and embolic events (1.9% versus 1.3 %; relative risk 1.5 [1.04-2.19]). Available data do not show evidence of an increased cardiovascular risk in patients without established, current or past history of ischaemic heart disease, peripheral arterial disease or cerebrovascular disease, or in those without uncontrolled hypertension.
Initial advice from the Pharmacovigilance Risk Assessment Committee (PRAC) was that strontium ranelate be suspended due to its cardiovascular risk. However the CHMP considered that regular screening and monitoring to exclude cardiovascular disease will sufficiently reduce the risk identified in patients who have no alternative treatment available to them. The Committee concluded that given the benefits seen in preventing fractures in patients at high risk, strontium ranelate should remain an option for patients with no history of cardiovascular disease who cannot take other medicines.
The recommendations for healthcare professionals are as follows:
• Protelos® should only be used to treat severe osteoporosis in postmenopausal women and men at high risk of fracture, for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance;
• Protelos® must not be used in patients with established, current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease, or those with uncontrolled hypertension;
• Doctors should continue to base their decision to prescribe Protelos® on an assessment of the individual patient’s risks. The patient’s risk of developing cardiovascular disease should be evaluated before starting treatment and on a regular basis thereafter, generally every 6 to 12 months;
• Protelos® should be stopped if the patient develops ischaemic heart disease, peripheral arterial disease or cerebrovascular disease, or if hypertension is uncontrolled;
• Doctors should review their patients currently on Protelos® as necessary.
The CHMP’s recommendation will now be sent to the European Commission, which will then issue a final decision.
A press release from the MHRA states that it will be issuing updated advice to healthcare professionals. Patients currently taking Protelos® for severe osteoporosis are advised to continue to take their medicine and contact their doctor if they have any questions. Doctors should review their patients currently on Protelos® as necessary.