Statin plus ezetimibe treatment in clinical practice: the SI-SPECT (Slovenia (SI) Statin Plus Ezetimibe in Cholesterol Treatment) monitoring of clinical practice study

ABSTRACT

Background: Poor results from lipid-lowering therapy are mainly due to inadequate dosing and increased adverse effects with high-dose statin monotherapy or drug combinations.

Objectives: The SI-SPECT (Slovenia (SI) Statin Plus Ezetimibe in Cholesterol Treatment) study evaluated the effectiveness of either ezetimibe (EZE) 10 mg as monotherapy or co-administered with on-going statin treatment (S + EZE) in clinical practice.

Design and methods: A total of 1053 dyslipidaemic patients (52% men, age 60.3 years, 42.9% with CHD, 32.0% with diabetes mellitus and 69.6% with hypertension) were enrolled. The majority (n = 986; 93.6%) were treated with EZE as ‘add-on’ to their already prescribed statin, the rest only received EZE (n = 67).

Main outcome measures: Baseline lipid levels were compared with those obtained 16 weeks after initiating treatment.

Results: Total (TC) and low density lipoprotein cholesterol (LDL-C), as well as triglycerides (TG) decreased significantly with S + EZE (by 25.3%, 31.4% and 28.9%, respectively; p < 0.0001 for all comparisons), while monotherapy with EZE resulted in a decrease of 20.8% for TC ( p < 0.0001), 28.0% for LDL-C ( p < 0.0001) and 28.8% for TG ( p = 0.016). At the end of the study 43.9% of patients achieved target TC (< 5.0 mmol/L for primary prevention and < 4.5 mmol/L for secondary prevention), 50.5% target LDL-C (< 3.0 mmol/L for primary prevention and < 2.5 mmol/L for secondary prevention) and 61.6% target TG (< 2.0 mmol/L). The overall incidence of adverse effects during the treatment period, and probably related to EZE use, was low (n = 6, 0.6% of patients).

Conclusions: (1) S + EZE combination therapy was effective and safe irrespective of the statin used, (2) the S + EZE combination resulted in significantly more patients reaching their recommended target lipid levels and (3) the lipid-lowering efficacy of EZE in monotherapy as well as of the S + EZE combination was related to initial lipid values. The much greater decrease of TG than expected could be, at least in part, due to better control/compliance regarding diet and drug treatment during the study and adherence to the need for an overnight fast before sampling.

Key Words::

• Dyslipidaemia
• Ezetimibe
• LDL-cholesterol
• Low density lipoprotein (LDL)
• Statin
• Triglycerides

Acknowledgements

Declaration of interests: The SI-SPECT monitoring program was made possible by an unrestricted research grant to the Cardiovascular Research Centre of the Slovenian Society of Cardiology, received from Merck Sharp & Dohme Idea Inc. (MSD, Slovenia) and Schering-Plough Central East AG (S-P, Slovenia) in 2004/2005.

The authors thank all the participating physicians contributing to the study.

ZF was the principal investigator for the study; DPM had access to all the data and both authors drafted, edited and reviewed the final manuscript. ZF has given talks sponsored by MSD and S.-P. and also attended conferences sponsored by various pharmaceutical companies, including MSD and S.-P. DPM has given talks sponsored by MSD and S.-P. and also attended conferences and participated in trials and advisory boards sponsored by various pharmaceutical companies, including MSD and S-P.