Potential cardiovascular consequences of switching from atorvastatin to generic simvastatin in the Netherlands

Abstract

Background The statin authorisation form implemented in the Netherlands in January 2009 has led to significant switching of patients from atorvastatin to generic simvastatin, but often to less than equipotent doses. We sought to assess the potential consequences of this. Methods A modelling analysis was undertaken using data from a pharmacy database covering the majority of drug prescriptions in the Netherlands. Recent meta-analyses provided data on the dose-specific, lipid-modifying potencies of atorvastatin and simvastatin, and the relationship between reduction in low-density lipoprotein cholesterol (LDL-C) achieved by statin therapy and relative reduction in risk of cardiovascular disease (CVD). Results In the first quarter of 2009, 33.7%, 47.2% and 19.1% of Dutch patients initially on atorvastatin were switched to less potent, equipotent and more potent doses of simvastatin, respectively. The net effect was estimated to be a 6.8% increase in LDL-C. Assuming a pre-switch LDL-C of 2 mmol/L, the predicted relative increases (95%CI) in the risks of all-cause mortality and major cardiovascular events were 1.7% (0.9%-2.6%) and 2.8% (1.6%-4.1%), respectively. Conclusions In the Netherlands, policy-driven switching from atorvastatin to generic simvastatin led overall to less potent doses being used, with possible significant clinical implications.

Ten-year mortality risk of patients undergoing elective PCI: long-term follow-up of the GENetic Determinants of Restenosis (GENDER) study

“…Although the death rates from cardiovascular diseases (CVD) have declined over the last decades, the burden of disease remains high and CVD remains one of the leading causes of morbidity and mortality in Western developed countries [1,2] including the Netherlands. [3][4][5][6] Tremendous efforts worldwide are put into research and development of novel treatment modalities for CVD to further halt the disease burden, and frequent updates of primary and secondary prevention guidelines should result in the most optimal treatment of each patient with CVD. Besides major improvements in pharmacological treatment with for instance statins, beta-blockers, angiotensin-converting-enzyme inhibitors and antiplatelet agents, interventional treatment modalities such as percutaneous coronary intervention (PCI) have markedly improved the outcome of patients with coronary artery disease.…”

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“…Statistical models suggested that this inadequate dosing would lead to a 5.6% increase in LDL-cholesterol levels. This, together with the fi ndings of a meta-regression study [4] showing that every 25 mg/dL (0.65 mmol/L) reduction in LDL-cholesterol lowers the risk of serious cardiovascular events by 14%, indicates that inadequate simvastatin dosing might increase cardiovascular risk by at least 5.5% [1].…”

“…A notable abstract on generics substitution of statins was presented at the 2010 Congress of the European Society of Cardiology [1]. Some of the resulting media coverage was equally interesting, stating, for example, that 'Patients should stay on Pfi zer's Lipitor, and not switch to generics' [2].…”

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