Superiority of atorvastatin not proven

In patients with coronary heart disease, a life-prolonging effect of statins has only been shown for simvastatin and pravastatin. In the subgroup of patients with diabetes mellitus, this effect has only been shown for simvastatin. No such evidence is available for atorvastatin, fluvastatin, and lovastatin. This is the result of a comprehensive evaluation of the benefits and harms of a drug class (statins), which the German Institute for Quality and Efficiency in Health Care (IQWiG) has now presented.

For this evaluation, the Institute performed a search for national and international clinical trials on statins, and extracted and evaluated the most reliable data. The focus was on the therapeutic benefit of statins for patients.

The Institute's researchers established that studies in patients with acute coronary syndrome (a critical reduction of blood flow to the heart) that allowed conclusions about patient-relevant outcomes were only available for atorvastatin, pravastatin, and simvastatin. For this indication, a direct comparison of statins is only possible to a limited extent, as the relevant study designs and study publications partly showed major deficiencies. It can by no means be inferred from these trials that any of these 3 statins is better in reducing the risk of myocardial infarction or mortality than other statins.

IQWiG therefore refutes the statements made by the manufacturer of atorvastatin, Pfizer, who in 2004 and 2005 repeatedly made public claims that its drug atorvastatin (marketed under the trade name "Sortis") was superior to other statins. The manufacturer justified this general statement, among other things, with an allegedly better tolerability of atorvastatin in high-dose therapy. The most recent IQWiG working paper also reaches an opposite result here: For example, in the clinical trials analysed, patients receiving Sortis in the highest approved dose discontinued therapy more frequently due to adverse effects than patients receiving simvastatin.

Background: Modes of action of statins are varied

Statin therapy is one of the main interventions in patients with cardiovascular disease, the main cause of death in men and women in Germany. Statements regarding the superiority of a particular statin are therefore of vital importance for patients and physicians. The aim of IQWiG's evaluation is therefore above all to provide information on the current evidence available on long-term therapy with statins.

Controlled comparative trials have repeatedly shown that treatment with statins has various effects. Apparently, they not only lower serum cholesterol levels but also affect blood coagulation. They also have anti-inflammatory properties.

However, it is still unclear which of these various effects are ultimately relevant for the benefit of statin therapy, and which additional mechanisms, as yet unknown, are possibly involved. It is a matter of controversy whether and to what extent the lowering of LDL cholesterol positively affects a patient's state of health, as previous studies have shown that cholesterol-lowering drugs actually increase mortality in some cases. It is therefore important to investigate the potential life-prolonging effect of every cholesterol-lowering drug.

Contact: +49 (0)221-35685-0, info@iqwig.de