Should rosuvastatin be withdrawn from the market?
2004; Elsevier BV; Volume: 364; Issue: 9445 Linguagem: Inglês
10.1016/s0140-6736(04)17301-7
ISSN1474-547X
AutoresS. Florentinus, Eibert R. Heerdink, Olaf H. Klungel, Anthonius de Boer,
Tópico(s)Lipoproteins and Cardiovascular Health
ResumoSidney Wolfe (June 26, p 2189)1Wolfe SM Dangers of rosuvastatin identified before and after FDA approval.Lancet. 2004; 363: 2189-2190Summary Full Text Full Text PDF PubMed Scopus (67) Google Scholar pleads for the removal of rosuvastatin from the market, suggesting an increased risk of proteinuria and haematuria with increased rosuvastatin dose, as well as a possibly higher rate of rhabdomyolysis than with other drugs. AstraZeneca has launched an extensive marketing campaign to promote the drug as the most potent statin available, which has led to a debate about promotional activities by pharmaceutical companies.2The Lancet The statin wars: why AstraZeneca must retreat.Lancet. 2003; 362: 1341Summary Full Text Full Text PDF PubMed Scopus (40) Google Scholar Results of studies3Leufkens HG Urquhart J Prescriber profile and postmarketing surveillance.Lancet. 1993; 342: 1178Abstract PubMed Scopus (7) Google Scholar indicate that newly marketed drugs are often prescribed by only a small proportion of doctors, and possibly channelled into an idiosyncratic group of patients. In view of the controversy that surrounds rosuvastatin, we believe the attitude of doctors towards prescribing of the drug should be assessed, and the first users of the drug identified. Here, we present medication history data for the period January, 1999, to December, 2003, from 123 community pharmacies, representing about a million inhabitants of the Netherlands, linked to detailed information of 195 family doctors from 104 practices.4Tinke JL Griens AMGF SFK: data en feiten, 2003. SFK, Den Haag2003Google Scholar, 5Otters HBM van der Wouden JC Schellevis FG van Suijlekom-Smit LWA Koes BW Trends in prescribing antibiotics for children in Dutch genereal practice.J Antimicrob Chemother. 2004; 53: 361-366Crossref PubMed Scopus (95) Google Scholar In the 9 months after its introduction in March, 2003, onto the Dutch market, rosuvastatin had a total market share of 5% of all prescriptions for statins. By December, 2003, 35% of all patients in which statin therapy was initiated or changed, had been prescribed rosuvastatin. We identified 599 patients in whom rosuvastatin was prescribed during our study period, of whom 251 (42%) had not previously used lipid-lowering drugs (table). Most of the patients (67%) used a maximum daily dose of 10 mg, and only two individuals used a daily dose of 80 mg. Rosuvastatin is not recommended for patients with predisposing factors for myopathy or rhabdomyolysis, including concurrent use of fibrates, hypothyroidism, and age older than 70 years. However, we noted concurrent fibrate use in 14 patients (2%), concurrent levothyroxine use in four patients (0.7%), and 124 patients (21%) were aged older than 70 years. 137 (23%) patients on rosuvastatin therefore had additional risk factors for rhabdomyolysis, and for 50 (37%) of those rosuvastatin was the first lipid-lowering drug used.TableCharacteristics of patients on different maximum doses of rosuvastatin in the first 9 months after market introductionMaximum daily dose rosuvastatinTotal (599)10 mg (n=404)20 mg (n=146)40 mg (n=47)80 mg (n=2)No previous use of lipid-lowering drugs198 (49%)46 (32%)7 (15%)0251 (42%)Prescribed by specialist157 (39%)81 (56%)32 (68%)1 (50%)271 (45%)Aged older than 70 years97 (24%)22 (15%)5 (11%)0124 (21%)Concomitant use of fibrates5 (1%)6 (4%)3 (6%)014 (2%)Concomitant use of levothyroxine004 (9%)04 (0·7%)Data are number (%). Open table in a new tab Data are number (%). We noted a rapid adoption of rosuvastatin by prescribers. In more than a third of all decisions to initiate a (new) statin therapy, the newest drug on the market was chosen, not only for patients with lack of effect on previous lipid-lowering drugs, but for more than 40% of patients new to lipid-lowering treatments. More than 90% of patients used rosuvastatin at a maximum daily dose of 10 mg or 20 mg, limiting the renal risk associated with higher doses. However, at least 23% of patients who used rosuvastatin had additional risk factors for myopathy or rhabdomyolysis. Given the yet unproven safety record of rosuvastatin, we are concerned that family doctors and specialists are so keen to prescribe it, even to individuals with no previous experience with lipid-lowering drugs, and to some who have predisposing risk-factors for a potentially lethal side-effect. Should rosuvastatin be withdrawn from the market?Authors' reply Full-Text PDF
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