Effects of the introduction of fixed prices for statins on lipid levels in Germany

Abstract

Aim/ Background

Few or no data are currently available in Germany on the effects of different acceptance by the pharmaceutical manufacturers and the implementation of fixed prices for drugs, some of which are still under patent protection. We therefore investigated the extent to which patients who were prescribed atorvastatin in the third quarter of 2004 continued to receive lipid-lowering treatment during the first three quarters of 2005 and whether a change in treatment altered their risk-factor profile, particularly their cholesterol levels.

Methods

To prevent any study-related influence on prescribing practice, we conducted a retrospective study that included up to 50 patients from each of 52 GP or internist practices who were prescribed atorvastatin in the third quarter of 2004. We documented the patients’ risk-factor profile, age, sex, BMI, insurance status, and blood pressure as well as prescriptions of lipid-lowering drugs, drug dosage, lipid levels, the hospitalization rate and duration up to the end of the third quarter of 2005.

Results

A total of 1,249 patients (median 65 years, 90.5% in the statutory health insurance system, 56.5% male) with a mean BMI of 28.07 were enrolled in the study. Seventy-two percent had CHD, diabetes mellitus, or a history of a cerebrovascular event. After the fixed-price regulation came into effect, atorvastatin was replaced in 71.2% of the patients by another lipid-lowering agent, in 90.6% of cases by another statin. Just 15.3% of the patients received an equivalent dose and 44.5% a lower dose of the alternative statin. In 15.3% the lipid-lowering therapy was discontinued. Cholesterol levels remained constant during continuous atorvastatin therapy (LDL cholesterol 115.5 mg/dl, baseline 116.9 mg/dl); within a few weeks of the treatment being changed, 60.5% of the patients experienced an increase in LDL cholesterol to 124.3 (vs. 116.5 mg/dl), which according to the epidemiologic data was prognostically relevant and unfavorable, as well as an increase in hospitalizations (p = 0.01). The share of patients with LDL cholesterol levels <100 mg/dl fell by more than one third to 24.6%, compared to 34.6% in the group that continued to receive atorvastatin. The key factors influencing a change in treatment were the patients’ insurance status (treatment was changed in 76.6% of statutory health insurance patients and in 19.8% of privately insured patients) and the number of risk factors (the higher the number of risk factors the lower the change rate).