​The MSD Company has notified the pharmacology department in the Ministry of Health of the cessation of the marketing of the drug Tredaptive, which is administered for treating dyslipidemia (lipid disorders).The discontinuation decision was taken following initial study results on the drug (the HPS2 THRIVE study) which led the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency to recommend that use of the drug be discontinued.
The research result failed to prove that treatment with the drug led to a reduction in the number of serious vascular events (including cardiac events and strokes). The study also indicated an increase in the incidences of side-effects in the study group which received the drug. According to the MSD notice, the side effects belong to the following categories: vascular and lymphatic systems, digestive system, infections, metabolism, skeletal and muscular systems, respiratory and dermal system. Following the decision by the department of pharmacology in the Ministry of Health, patients taking the drug are requested to visit their doctors in order to consider an alternative treatment. This is the place to stress that the drug must not be discontinued without the doctor’s knowledge and without consulting as to an alternative treatment.
The Ministry of Health notice follows the notice issued by the European Medicines Agency of January 10, 2013, and is an extension of the MSD notice which was approved by the Ministry of Health for caregiving doctors from December 27, 2012, not to begin treatment with Tredaptive for new patients and to consider the further treatment of patients with the drug in view of the results of this study. It is important to note that this notification is not being issued in view of the receipt of any new safety data beyond the data which was published on December 27, 2012, but rather it is the result of regulatory activity.
Note that the population which was selected for the study is not the same as the target population for treatment with Tredaptive in Israel. About 40% of the study population was of Chinese origin and an initial analysis indicates that treating Chinese subjects with Tredaptive is less efficacious, possibly due to a genetic variance, and therefore the results must be evaluated with great care. However, in line with the recommendation by the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency, the marketing is being suspended.