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Do Randomized Clinical Trials Tell the Whole Story? Statins as a Case in Point
Current Issue
Volume 1, 2013
Issue 1 (December)
Pages: 1-3   |   Vol. 1, No. 1, December 2013   |   Follow on         
Paper in PDF Downloads: 15   Since Aug. 28, 2015 Views: 866   Since Aug. 28, 2015
Authors
[1]
Jenny Bolcato, Pharmaceutical Service, Local Health Authority (ULSS 9), Treviso, Italy.
[2]
Cinzia Piovesan, Prevention Dept., Local Health Authority (ULSS 9), Treviso, Italy.
[3]
Pietro Giusti, Pharmaceutical and Pharmacological Studies University of Padova.
[4]
Alessandro Chinellato, Pharmaceutical Service, Local Health Authority (ULSS 9), Treviso, Italy.
Abstract
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.
Keywords
Effectiveness, Efficacy, Statins, Real Practice
Reference
[1]
Sabaté E, editor. Adherence to Long-Term Therapies: Evidence for Action. Geneva, Switzerland: World Health Organization. 2003.
[2]
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).
[3]
Jones PH, Davidson MH, Stein EA, Bays HE, McKenney JM, Miller E, Cain VA, Blasetto JW. STELLAR Study Group. Comparison of the Efficacy and Safety of Rosuvastatin Versus Atorvastatin, Simvastatin, and Pravastatin AcrossDoses (STELLAR* Trial). Am J Cardiol 2003;93:152–160.
[4]
Hunninghake DB, Stein EA, Dujovne CA, Harris WS, Feldman EB, Miller VT, Tobert JA, Laskarzewski PM, Quiter E, Held J, et al. The efficacy of intensive dietary therapy alone or combined with lovastatin in outpatients with hypercholesterolemia. N Engl J Med. 1993; 328(17):1213-9.
[5]
Deambrosis P, Terrazzani G, Walley T, Bader G, Giusti P, Debetto P, Chinellato A. Benefit of statins in daily practice? A six-year retrospective observational study. Pharmacol Res. 2009; 60(5):397-401.
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