Total and low-density lipoprotein cholesterol in high-risk patients treated with atorvastatin monotherapy in the United Kingdom: analysis of a primary-care database

Abstract

Objective:

British clinical guidelines recommend statins as first-line lipid-modifying treatment (LMT) for patients at high risk of cardiovascular disease (CVD). We undertook an observational study to assess total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) levels in high-risk patients who were treated with atorvastatin monotherapy by UK general practitioners.

Methods:

This retrospective database study included patients with a prescription for atorvastatin monotherapy between November 30, 2008, and November 30, 2011, with the index date defined as the first atorvastatin prescription during this period. Eligible high-risk patients with evidence of coronary heart disease (CHD), atherosclerotic vascular disease (AVD), diabetes mellitus (DM), or familial hypercholesterolemia (FH) were required to have ≥1 TC and LDL-C measurement between 3 and 12 months after the index date, and continuous enrollment 1 year before and 1 year after the index date. Cholesterol levels were assessed using the National Institute for Health and Care Excellence (NICE) guidelines: TC <4.0 mmol/L or LDL-C <2.0 mmol/L.

Results:

Of 2999 high-risk patients (60.2% men; mean [SD] age = 67.9 [10.6] years) meeting selection criteria, 23.9% 28.2%, 36.2%, and 11.6% received prescriptions for atorvastatin 10, 20, 40, and 80 mg, respectively (percentages do not sum to 100 because of rounding). Across all doses, the mean (SD) follow-up TC was 4.08 (0.80) mmol/L and LDL-C 2.08 (0.65) mmol/L. A large proportion of patients (88.8%) had TC < 5.0 mmol/L. However, only 45.8% had TC < 4.0 mmol/L, and 46.5% had LDL-C < 2.0 mmol/L. Although a larger proportion of patients with CHD/AVD + DM reached guideline-recommended lipid levels, only 63.7% of such patients had TC < 4.0 or LDL-C < 2.0 mmol/L, which are the current targets for this subgroup as recommended by NICE.

Conclusions:

Less than half of UK high-CVD-risk patients receiving atorvastatin monotherapy achieved guideline-recommended treatment targets for TC, and less than two-thirds of patients with CHD/AVD + DM had values below TC (4.0 mmol/L) or LDL-C (2.0 mmol/L) targets. More effective lipid-lowering strategies may be warranted to optimize cholesterol lowering and target attainment in high-risk patients. Limitations of this study include its retrospective, observational nature.

Keywords::

• Atherosclerosis
• Cardiovascular disease
• Cholesterol
• Drug therapy
• Diabetes
• Statins

Transparency

Declaration of funding

The present study and this communication were financially supported by Merck & Co. Inc.

Author contributions: Category 1 – Analysis and interpretation of data: C.Z. conducted statistical analyses, and all authors interpreted data. Category 2 – (a) Drafting the article: S.W.G., K.J., E.M.; (b) Revising it for intellectual content: All authors. Category 3 – (a) Final approval of the completed article: All authors. Study guarantor – C.Z. had access to all data analyzed and takes responsibility for the analysis and this report.

Declaration of financial/other relationships

C.Z., D.R.R., and A.M.T. have disclosed that they are employees of and/or stock/shareholders in Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc. K.J., Q.Z., and E.M. have disclosed that they were employees of and/or stock/shareholders in Merck Sharp & Dohme Corp. when the study was conducted and manuscript prepared. S.W.G. received financial support from Merck.

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.