Sustained effects in hypercholesterolaemic patients on combined simvastatin/ezetimibe treatment: observational cohort study in clinical practice

ABSTRACT

Background: In order to reduce individual cardiovascular risk, many patients require life-long lipid-lowering therapy, often as a drug combination approach. We aimed to describe the usage pattern, effectiveness and tolerability of long-term treatment with lipid-lowering agents, with particular focus on an oral combination of simvastatin (SIM 10, 20, 40 or 80 mg) plus ezetimibe (EZ 10 mg).

Methods: A prospective, observational study in 512 general practices throughout Germany. From a sample of patients at moderate or high cardiovascular risk who had previously taken part in a half-year study of an SIM/EZ combination, 5485 patients were documented after 1 year of treatment (mean 58 ± 16 weeks) with regard to lipid parameters, adverse drug reactions (ADRs) and adverse events.

Results: At the start of follow-up, 78.6% of patients were still on the SIM/EZ combination. At the end of follow-up, mean low density lipoprotein cholesterol (LDL-C) in patients on the combination versus those on other lipid-lowering therapy was reduced by 29.3 vs. 17.6% compared with baseline, total cholesterol by 23.1 vs. 14.5%, mean high density lipoprotein cholesterol (HDL-C) was increased by 15.9 vs. 13.4%, and mean triglycerides were reduced by 16.1 vs. 7.9%. Individual LDL-C targets were achieved by 56.6% on the SIM/EZ combination versus 35.9% on other therapy. In the long term (but not the short term), low acceptance of nutrition counselling as rated by the physician was associated with poor lipid levels. ADRs during follow-up occurred in 18 patients (0.3%; all cases non-serious), with seven cases of myalgia, and three cases each of nausea or arthralgia.

Conclusions: This observational study showed that long-term therapy with the SIM/EZ combination resulted in sustained beneficial effects on serum lipids and was well-tolerated. Compared to patients with therapy discontinuations or switches, those remaining on the combination had better outcomes regarding lipid status.

Key words: :

• Adherence
• Cholesterol absorption inhibition
• Efficacy
• Hypercholesterolaemia
• Intervention
• Long-term
• Safety
• Tolerability

Acknowledgements

Declaration of interest: The study was sponsored and performed by essex Pharma, Munich, and MSD, Haar, Germany. The analysis was performed by MedPharmTec, Munich. The authors acknowledge the input of D. Pittrow, MD, PhD, Institute for Clinical Pharmacology of Technical University of Dresden for the interpretation of the data. S. Hildemann and B. Karmann are employees of essex Pharma, Munich.