Limitations of real-world treatment with atorvastatin monotherapy for lowering LDL-C in high-risk cardiovascular patients in the US.
BACKGROUND
Guidelines endorse statin therapy for lowering low-density lipoprotein cholesterol (LDL-C) to recommended levels, in patients with cardiovascular disease (CVD) risk, if needed, after lifestyle changes. Atorvastatin is a common statin with greater LDL-C lowering efficacy than most other statins; its availability in generic form will likely increase its use. This study assessed attainment of guideline-recommended LDL-C levels in high-risk CVD patients treated with atorvastatin monotherapy.


METHODS
Analyses of two retrospective US cohorts of patients who received a prescription for atorvastatin monotherapy between January 1, 2008 and December 31, 2010 (index date defined as first prescription date) in the GE Centricity Electronic Medical Record (EMR) (N=10,693) and Humana Medicare (N=16,798) databases. Eligible patients were ≥18 years, diagnosed with coronary heart disease or atherosclerotic vascular disease, with ≥1 LDL-C measurement between 3 months and 1 year postindex date, and continuously enrolled for 1 year prior to and following the index date.


RESULTS
Of the eligible patients, 21.8%, 29.6%, 29.9%, and 18.7% (GE Centricity EMR) and 25.4%, 32.9%, 27.8%, and 14.0% (Humana Medicare) received 10, 20, 40, and 80 mg doses of atorvastatin, respectively. The mean ± standard deviation (SD) follow-up LDL-C levels were 2.1±0.8 mmol/L (83±30 mg/dL) and 2.3±0.8 mmol/L (88±31 mg/dL) for the GE Centricity EMR and Humana Medicare cohorts, respectively. Regardless of dose, only 28.3%-34.8% of patients had LDL-C levels <1.8 mmol/L (<70 mg/dL), and 72.0%-78.0% achieved LDL-C <2.6 mmol/L (<100 mg/dL) in both cohorts. As many as 41% and 13% of patients had LDL-C levels ≥0.5 mmol/L (≥20 mg/dL) above LDL-C 1.8 mmol/L (70 mg/dL) and 2.6 mmol/L (100 mg/dL), respectively, in both cohorts; these percentages were generally similar across atorvastatin doses.


CONCLUSIONS
In this real-world US setting, a large number of high-risk CVD patients did not attain guideline-recommended LDL-C levels with atorvastatin monotherapy. More than 65% of the patients had LDL-C levels >1.8 mmol/L (>70 mg/dL), and of these, 30%-40% had LDL-C levels ≥0.5 mmol/L (≥20 mg/dL) above this, regardless of dose. This suggests that more effective lipid-lowering strategies, such as statin uptitration, switching to a higher efficacy statin, and/or combination therapy, may be required to achieve optimal LDL-C lowering in high-risk patients.
Merck & Co, Inc., Whitehouse Station, NJ, USA.
Elizabeth
E
Marrett
Merck & Co, Inc., Whitehouse Station, NJ, USA.
Changgeng
C
Zhao
College of Health and Public Affairs, University of Central Florida, Orlando, FL, USA.
Ning Jackie
NJ
Zhang
Merck & Co, Inc., Whitehouse Station, NJ, USA.
Qiaoyi
Q
Zhang
Merck & Co, Inc., Whitehouse Station, NJ, USA.
Dena R
DR
Ramey
Merck & Co, Inc., Whitehouse Station, NJ, USA.
Joanne E
JE
Tomassini
Merck & Co, Inc., Whitehouse Station, NJ, USA.
Andrew M
AM
Tershakovec
Merck & Co, Inc., Whitehouse Station, NJ, USA.
David R
DR
Neff
D000368:Aged; D000369:Aged, 80 and over; D000069059:Atorvastatin; D015415:Biomarkers / Q000097:blood; D002318:Cardiovascular Diseases / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control*; D008078:Cholesterol, LDL / Q000097:blood*; D015536:Down-Regulation; D050171:Dyslipidemias / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D005260:Female; D006538:Heptanoic Acids / Q000627:therapeutic use*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017410:Practice Guidelines as Topic; D011758:Pyrroles / Q000627:therapeutic use*; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
D015415:Biomarkers; D008078:Cholesterol, LDL; D006538:Heptanoic Acids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011758:Pyrroles; D000069059:Atorvastatin
lipid-lowering therapy; managed-care; statin therapy