Daily and intermittent rosuvastatin 5 mg therapy in statin intolerant patients: an observational study

Abstract

Objective:

To examine the efficacy and tolerability of rosuvastatin 5 mg at daily and non-daily dosing regimens.

Research design and methods:

A retrospective survey was conducted at nine primary, secondary and tertiary healthcare centres in the United Kingdom.

Main outcome measures:

Changes in lipid fractions from baseline values after more than 3 months’ treatment.

Results:

A total of 325 patients were identified. These patients were aged 63 ± 10 years, 50% male and prescription was mostly for primary prevention of cardiovascular disease (CVD) (59%). Co-morbidities included: established CVD present in 41%, type 2 diabetes mellitus (15%), hypertension (74%) and smoking (9%). Adverse effects had been documented to simvastatin (75%) or atorvastatin (63%). A total of 289 patients (89%) tolerated rosuvastatin well and were still adherent after a median follow-up of 14.9 (3–79) months. The remainder (n = 36; 11%) discontinued the medication after median 5 months’ treatment due to adverse effects. Efficacy was assessed in 224 patients who had adequate data. Baseline lipids were total cholesterol (TC) 7.41 ± 1.50 mmol/L, triglycerides (TG) 2.26 (range 0.36–18.4) mmol/L; high density lipoprotein cholesterol (HDL-C) 1.43 ± 0.47 mmol/L and low density lipoprotein cholesterol (LDL-C) 4.76 ± 1.38 mmol/L. Daily rosuvastatin (n = 134) reduced mean TC by 31%, TG 15% and LDL-C 43% (p < 0.001). Rosuvastatin 5 mg 2–3 times weekly (n = 79) reduced TC 26%, TG 16% and LDL-C 32% (p < 0.001). Weekly rosuvastatin (n = 11) reduced TC 17%, LDL-C by 23% (p < 0.001) but had no effect on TGs. Targets were attained in 17% of CHD-risk equivalent patients and 41% of primary prevention patients by National Cholesterol Education Program criteria and 27% and 68% using UK targets. No myositis or rhabdomyolysis was observed and alanine aminotransferase (ALT) and creatine kinase (CK) were similar to baseline.

Conclusions:

In this retrospective observational multicentre study, rosuvastatin 5 mg was found to be safe and biochemically effective either as daily or intermittent therapy in patients intolerant to other conventional statin regimens.

Key words::

• Drug tolerance
• Medication adherence
• Myalgia
• Myositis
• Statin

Transparency

Declaration of funding

This study was funded by an unrestricted research grant to the principal investigator by Astra-Zeneca. The study was investigator designed and led and Astra-Zeneca had no input or involvement in the data gathering or analysis processes or in the writing of the manuscript.

Claire Meek^a

Anthony S. Wierzbicki^b

Christina Jewkes^c

Martin A. Crook^b,e

Declaration of financial/other relationships

A.V. was the principal investigator of this study. A.V., P.J.T. and A.J. have received lecture honoraria and travel grants from Astra-Zeneca and Merck Sharp & Dohme. C.M., A.S.W., C.J. and M.A.C. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgements

The authors would like to thank the staff involved Gamlingay and Potton Medical Centres in Bedfordshire and Cambridgeshire, Leagrave Surgery in Luton, the Lister Hospital in Stevenage, the West Suffolk Hospital in Bury St. Edmunds, Ipswich Hospital, Guy’s & St. Thomas’ and Lewisham Hospitals in London and Heartlands Hospital, Birmingham, for their help in retrieving this data.