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Statin
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CRESTOR™ Pharmacoepidemiology (PE) programme
Because clinical trials and spontaneous reports are limited methods for obtaining safety data, Pharmacoepidemiology - the study of the utilisation and effects of drugs in populations - complements these approaches and provides a more comprehensive assessment of a drug's safety.
In total, this programme consists of 9 studies, in four countries (UK, US, Canada and Netherlands) including over 50,000 CRESTOR™ treated patients who are identified from electronic medical records (EMR)/claims databases and populations followed over time to assess occurrence of adverse events (AEs).
The studies can be categorised as follows:
- Patient Characteristics Studies (four studies, four countries)
- Safety Evaluation Studies (fours studies, four countries)
- Prescription-Event Monitoring (PEM - UK)
Patient Characteristics
Studies These studies have the objective of examining the characteristics of new users of rosuvastatin compared to new users of other statins, including dose and concomitant medication use.
Safety Evaluation Studies
These studies have the objective of examining the rates of specific outcomes across statins and determining risk factors for these outcomes.
Prescription-Event Monitoring
The prescription-event monitoring study has the objective of examining the safety of rosuvastatin as used in general medical practice in the UK.
Rosuvastatin Pharmacoepidemiology Programme1
| Study Type | Questions It Answers | US | UK | Netherlands | Canada |
| Patient Characteristic Studies | Who are the early users of Rosuvastatin? | x | x | x | x |
| Safety Evaluation Studies | How often do certain adverse events happen and to the user of which statin? | x | x | x | x |
| Prescription Event Monitoring (PEM) | What adverse eventrs happen to users prescribed Rosuvastatin? | x |
*9 studies, in 4 countries which will include over 50,000 rosuvastatin treated patients. Johansson S, Ming E, Wallanger A, et al Pharmacoepi Drug Safety 2006; 15(7): 454-461.
Pharmacopepidemiology studies have several clear advantages over simply monitoring spontaneous AE reports:
- Information on drug exposure is known for each patient throughout the follow-up period incidence rates and relative risk of AEs can be calculated
- information is available for comparison cohorts
- it is possible to investigate multiple AEs in one study
- it is possible to examine safety issues in special populations
Results so far
The results from the independent Dutch and US studies showed that the incidence of predefined hospitalised events associated with the muscle, liver and kidney with CRESTOR™ was not different that that of other statins.1,2
US safety results
| Crestor™ Initiators (n=11249) | Other Statin Initiators (n=37282) | Hazard Ratios* | |||
| Events (n) | Incident Rate per 1000 Person -years (-95% CI) | Events (n) | Incident Rate per 1000 Person -years (-95% CI) | ||
| Myopathy | 2 | 0.2 (0.02,0.72) | 0 | 0.0 (0.00, 0.09) | NA |
| Rhabdomyolysis | 1 | 0.1 (0.00, 0.52) | 2 | 0.06 (0.01, 0.22) | 1.98 (0.18, 21.90) |
| Renal Dysfunction | 12 | 1.18 (0.61, 2.06) | 42 | 1.26 (0.91, 1.71) | 0.90 (0.47, 1.73) |
| Hepatic Dysfunction | 2 | 0.20 (0.02, 0.71) | 8 | 0.24 (0.10. 0.47) | 0.87 (0.18, 4.14) |
| In Hospital Death | 8 | 0.78 (0.34, 1.54) | 44 | 1.32 (0.96, 1.77) | 0.51 (0.24, 1.10) |
*CI=confidence intervals; NA=not applicable
*Adjusted for the numbers of matches per CRESTOR™ initiator by stratification in the Cox proportional hazards regression.
Netherlands safety results
| Crestor™ Initiators (n=10147) | Other Statin Initiators (n=37396) | No Statin (n=99935) | ||||
| Events (n) | Incident Rate per 1000 Person -years (CI) | Events (n) | Incident Rate per 1000 Person -years (CI) | Events (n) | Incident Rate per 1000 Person -years (CI) | |
| Myopathy | 0 | 0.00 (0.00, 0.38) | 1 | 0.03 (0.00, 0.16) | 0 | 0.00 (0.00, 0.03) |
| Rhabdomyolysis | 0 | 0.00 (0.00, 0.38) | 0 | 0.00 (0.00, 0.10) | 1 | 0.01 (0.00, 0.05) |
| Acute Renal Failiure | 3 | 0.31 (0.06, 0.91) | 7 | 0.20 (0.08, 0.40) | 3 | 0.03 (0.01, 0.08) |
| Hepatic Impairment | 0 | 0.00 (0.00, 0.38) | 4 | 0.11 (0.03, 0.29) | 7 | 0.06 (0.02, 0.12) |
| Death (all cause) | 52 | 5.34 (3.99, 7.01) | 409 | 11.48 (10.39, 12.6) | 927 | 7.99 (7.49, 8.52) |
In addition, the UK Prescription Event Monitoring (PEM) study, which investigated real-life use of CRESTOR™ in nearly 12,000 patients, found that CRESTOR™ was well tolerated when used in General Practice.3
The results obtained to date from the Pharmacoepidemiology programme provide further evidence that the safety profile of rosuvastatin is similar to that of other marketed statins.
Back to the main safety & tolerability page
References:
1. McAfee A, Ming E, Seeger J et al. Pharamcoepi Drug Safety 2006; 15 (7): 444-453;
2. Goettsch W, Heintjes E, Kastelein J et al. Pharmacoepi Drug Safety 2006; 15 (7):435-443;
3. Kasliwal R, Wilton L, Shakir S. Circulation 2006; 113 (8): e331 Abs P101.
 
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