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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.

journal_name

Curr Med Res Opin

journal_title

Current medical research and opinion

authors

Hildemann SK,Barho C,Karmann B,Darius H,Bode C

doi

10.1185/03007990802381406

subject

Has Abstract

pub_date

2008-10-01 00:00:00

pages

2777-84

issue

eissn

0300-7995

issn

1473-4877

pii

4659c

journal_volume

pub_type

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