The cerivastatin withdrawal crisis: a "post-mortem" analysis.
In August 2001, cerivastatin was removed from European and USA markets because of a higher risk of rhabdomyolysis associated with its use in comparison with other statins. The objective of this study was to compare cholesterol-lowering drug use in Italy before and after the withdrawal of cerivastatin from the market, and to evaluate if the withdrawal influenced patients compliance and physicians prescribing habits. After August 2001, 48% of cerivastatin users discontinued any statin treatment. The major risk factor for discontinuation was a concomitant use of fibrate during the first 7 months of 2001 (OR = 2.3; 95% CI = -2.9). Comparing the discontinuation of statin therapy between 2001 and 2000 we can estimate that there was a 5% increase, corresponding to about 200,000 patients, who discontinued statin therapy during autumn 2001 because of cerivastatin emergency.
Maggini
Marina
M
National Center of Epidemiology, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Roma, Italy. mmaggini@iss.it
Raschetti
Roberto
R
Traversa
Giuseppe
G
Bianchi
Clara
C
Caffari
Bruno
B
Da Cas
Roberto
R
Panei
Pietro
P
D000368:Aged; D004363:Drug Utilization; D005260:Female; D006302:Health Services Research; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D006937:Hypercholesterolemia / Q000188:drug therapy*; D007558:Italy; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011725:Pyridines / Q000009:adverse effects* / Q000627:therapeutic use; D012206:Rhabdomyolysis / Q000139:chemically induced*; D018570:Risk Assessment
D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011725:Pyridines; C086276:cerivastatin