Do Randomized Clinical Trials Tell the Whole Story? Statins as a Case in Point
Exploratory randomized controlled trials present numerous exclusion criteria, being conducted in selected patient populations with defined characteristics established before enrolment. As such, the efficacy results may not reflect a drug’s behaviour in an unselected population in actual clinical practice; beneficial changes of a given intervention are thus referred to as effectiveness. This is an important point when selecting a therapeutic intervention, with potential significant impact on health care costs. As a case in point, we conducted a retrospective observational analysis between 2006 and 2011 on 3751 individuals starting statins for the first time, covering a two-month period; subjects were stratified according to drug and prescribed dosage. Data were compared with those published in the STELLAR study of 2003, and shown to frequently deviate from the latter. Considering the variability of statins in terms of efficacy vs. effectiveness, it is not unreasonable to ask why physicians prescribed more costly drugs for patients starting first-time therapy, when effective (and perhaps safer), less expensive drugs were available. This analysis leads one to question why Guidelines are still based on efficacy studies only.
Effectiveness, Efficacy, Statins, Real Practice
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Modifica alla nota 13 di cui alla determina n 163 del 15/07/2011. Determinazione AIFA 14/11/2012 (G.U. 277 del 27/11/2012).
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