Key Point: Postmarketing surveillance clearly demonstrates that the rate of rhabdomyolysis for rosuvastatin is similar to that for other currently marketed statins.

A comparison of postmarketing data for rosuvastatin, other statins, and ezetimibe has also been performed

Rates of rhabdomyolysis for rosuvastatin were calculated in 6-month intervals for the past 12 months by dividing the worldwide number of spontaneous reports of rhabdomyolysis received by AstraZeneca by the worldwide number of prescriptions for rosuvastatin (using data from IMS). These rates represent the most recent and comprehensive information to date

Data for comparator statins and ezetimibe were obtained from the Federal Drug Administration (FDA) Adverse Event Reporting System (AERS), available to the public through the Freedom of Information Act (FOIA). Rosuvastatin is not currently represented on this graph because the US data on FOI represent the timeframe up to and including 08/2003 (rosuvastatin became available in the
United States 08/2003)

As shown here, the worldwide semiannual reporting rate for rosuvastatin is in line with the
United States reporting rates for other statins and ezetimibe even when the limitations of comparative spontaneous reporting rates are considered

This is particularly noteworthy because new drugs are expected to have higher reporting rates of adverse events in their first 2 to 3 years of launch

As clearly depicted on the slide, the reporting rate of rhabdomyolysis for cerivastatin was much higher compared with the currently marketed lipid-lowering therapies

The limitations of comparative spontaneous reporting rates are as follows

The FDA AERS safety reports are spontaneous, not fully investigated, and do not imply a causal relationship

Spontaneous reporting rates are likely to be lower than the actual incidence of adverse events due to underreporting

Spontaneous reporting rates are susceptible to reporting bias, including an increase in reporting due to the “Weber effect”, increased publicity, and enhanced awareness of the potential side effects

Spontaneous reporting rates of rhabdomyolysis for rosuvastatin, other statins and ezetimibe do not represent head-to-head comparative studies and must be interpreted with caution