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Next Course 23-24 May 2012
Staying Current and in Control in the Constantly Changing Global Regulatory Pharmacovigilance Environment

Safety Profile of Rosuvastatin

Background

Rosuvastatin is a medicine which reduces blood cholesterol. It was first made available in the UK in March 2003 and is the newest in a group of medicines called “statins”. The objective of this research was to monitor the safety of rosuvastatin when used by general practitioners in England using the method known as “prescription-event monitoring”.

Methods

Patients using rosuvastatin were identified from prescriptions issued by GPs from August to December 2003. Basic clinical information focusing on medical events occurring after the first prescription of rosuvastatin was collected after an interval of at least six months. More detailed information was sought in relation to patients who experienced serious medical events. Various medical and numerical analyses were performed, particularly in relation to the starting dose of rosuvastatin.

Results

We identified 11,680 patients prescribed rosuvastatin of whom 5,880 (50%) were male and the average age was 64 years. The most common starting dose was 10 milligrams per day (73% of patients). On average, patients were treated for almost 10 months, with 2,047 (18%) stopping treatment during the course of the study. The most common medical event reported was muscle pain and this was also the most frequent reason given for stopping treatment. Muscle pain is a recognised side-effect of all statins and, rarely, may lead to serious muscle damage. However, no such cases were reported in this study. Infrequently, blood tests of liver function may become abnormal with statins. This was found to be three times more likely to happen in patients who started rosuvastatin at a high dose (40 milligrams per day), compared to those who started at 10 milligrams per day.

Conclusion

Rosuvastatin was generally prescribed as recommended in product information and was found to be reasonably well-tolerated. Abnormal blood tests of liver function occurred more frequently at high doses than at low doses. Our results add to the safety information for rosuvastatin available from clinical trials and other research based on observation of normal clinical use.