Skip to main content
Top
Published in: Cardiovascular Drugs and Therapy 5/2016

01-10-2016 | ORIGINAL ARTICLE

Algorithms to Identify Statin Intolerance in Medicare Administrative Claim Data

Authors: Lisandro D. Colantonio, Shia T. Kent, Lei Huang, Ligong Chen, Keri L. Monda, Maria-Corina Serban, Angelika Manthripragada, Meredith L. Kilgore, Robert S. Rosenson, Paul Muntner

Published in: Cardiovascular Drugs and Therapy | Issue 5/2016

Login to get access

Abstract

Purpose

To compare characteristics of patients with possible statin intolerance identified using different claims-based algorithms versus patients with high adherence to statins.

Methods

We analyzed 134,863 Medicare beneficiaries initiating statins between 2007 and 2011. Statin intolerance and discontinuation, and high adherence to statins, defined by proportion of days covered ≥80 %, were assessed during the 365 days following statin initiation. Definition 1 of statin intolerance included statin down-titration or discontinuation with ezetimibe initiation, having a claim for a rhabdomyolysis or antihyperlipidemic event followed by statin down-titration or discontinuation, or switching between ≥3 types of statins. Definition 2 included beneficiaries who met Definition 1 and those who down-titrated statin intensity. We also analyzed beneficiaries who met Definition 2 of statin intolerance or discontinued statins.

Results

The prevalence of statin intolerance was 1.0 % (n = 1320) and 5.2 % (n = 6985) using Definitions 1 and 2, respectively. Overall, 45,266 (33.6 %) beneficiaries had statin intolerance by Definition 2 or discontinued statins and 55,990 (41.5 %) beneficiaries had high adherence to statins. Compared with beneficiaries with high adherence to statins, those with statin intolerance and who had statin intolerance or discontinued statins were more likely to be female versus male, and black, Hispanic or Asian versus white. The multivariable adjusted odds ratio for statin intolerance by Definitions 1 and 2 comparing patients initiating high versus low/moderate intensity statins were 2.82 (95%CI: 2.42–3.29), and 8.58 (8.07–9.12), respectively, and for statin intolerance or statin discontinuation was 2.35 (2.25–2.45).

Conclusions

Definitions of statin intolerance presented herein can be applied to analyses using administrative claims data.
Appendix
Available only for authorised users
Literature
1.
go back to reference Baigent C, Keech A, Kearney PM, et al. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005;366:1267–78.CrossRefPubMed Baigent C, Keech A, Kearney PM, et al. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005;366:1267–78.CrossRefPubMed
2.
go back to reference Taylor F, Ward K, Moore TH et al. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev 2011:CD004816. Taylor F, Ward K, Moore TH et al. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev 2011:CD004816.
3.
go back to reference Stone NJ, Robinson JG, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association task force on practice guidelines. Circulation. 2014;129:S1–45.CrossRefPubMed Stone NJ, Robinson JG, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association task force on practice guidelines. Circulation. 2014;129:S1–45.CrossRefPubMed
4.
go back to reference Third Report of the National Cholesterol Education Program (NCEP. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106:3143–421. Third Report of the National Cholesterol Education Program (NCEP. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106:3143–421.
5.
go back to reference Mann D, Reynolds K, Smith D, Muntner P. Trends in statin use and low-density lipoprotein cholesterol levels among US adults: impact of the 2001 National Cholesterol Education Program guidelines. Ann Pharmacother. 2008;42:1208–15.CrossRefPubMed Mann D, Reynolds K, Smith D, Muntner P. Trends in statin use and low-density lipoprotein cholesterol levels among US adults: impact of the 2001 National Cholesterol Education Program guidelines. Ann Pharmacother. 2008;42:1208–15.CrossRefPubMed
6.
go back to reference Muntner P, Levitan EB, Brown TM, et al. Trends in the prevalence, awareness, treatment and control of high low density lipoprotein-cholesterol among United States adults from 1999 to 2000 through 2009-2010. Am J Cardiol. 2013;112:664–70.CrossRefPubMedPubMedCentral Muntner P, Levitan EB, Brown TM, et al. Trends in the prevalence, awareness, treatment and control of high low density lipoprotein-cholesterol among United States adults from 1999 to 2000 through 2009-2010. Am J Cardiol. 2013;112:664–70.CrossRefPubMedPubMedCentral
7.
8.
go back to reference Cohen JD, Brinton EA, Ito MK, Jacobson TA. Understanding statin use in America and gaps in patient education (USAGE): an internet-based survey of 10,138 current and former statin users. J Clin Lipidol. 2012;6:208–15.CrossRefPubMed Cohen JD, Brinton EA, Ito MK, Jacobson TA. Understanding statin use in America and gaps in patient education (USAGE): an internet-based survey of 10,138 current and former statin users. J Clin Lipidol. 2012;6:208–15.CrossRefPubMed
9.
go back to reference Parker BA, Capizzi JA, Grimaldi AS, et al. Effect of statins on skeletal muscle function. Circulation. 2013;127:96–103.CrossRefPubMed Parker BA, Capizzi JA, Grimaldi AS, et al. Effect of statins on skeletal muscle function. Circulation. 2013;127:96–103.CrossRefPubMed
10.
go back to reference Bruckert E, Hayem G, Dejager S, Yau C, Begaud B. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients--the PRIMO study. Cardiovasc Drugs Ther. 2005;19:403–14.CrossRefPubMed Bruckert E, Hayem G, Dejager S, Yau C, Begaud B. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients--the PRIMO study. Cardiovasc Drugs Ther. 2005;19:403–14.CrossRefPubMed
11.
go back to reference Wei MY, Ito MK, Cohen JD, Brinton EA, Jacobson TA. Predictors of statin adherence, switching, and discontinuation in the USAGE survey: understanding the use of statins in America and gaps in patient education. J Clin Lipidol. 2013;7:472–83.CrossRefPubMed Wei MY, Ito MK, Cohen JD, Brinton EA, Jacobson TA. Predictors of statin adherence, switching, and discontinuation in the USAGE survey: understanding the use of statins in America and gaps in patient education. J Clin Lipidol. 2013;7:472–83.CrossRefPubMed
12.
go back to reference Banach M, Rizzo M, Toth PP, et al. Statin intolerance - an attempt at a unified definition. Position paper from an international lipid expert panel. Arch Med Sci. 2015;11:1–23.CrossRefPubMedPubMedCentral Banach M, Rizzo M, Toth PP, et al. Statin intolerance - an attempt at a unified definition. Position paper from an international lipid expert panel. Arch Med Sci. 2015;11:1–23.CrossRefPubMedPubMedCentral
13.
go back to reference Guyton JR, Bays HE, Grundy SM, Jacobson TA, The National Lipid Association Statin Intolerance Panel. An assessment by the statin intolerance panel: 2014 update. J Clin Lipidol. 2014;8:S72–81.CrossRefPubMed Guyton JR, Bays HE, Grundy SM, Jacobson TA, The National Lipid Association Statin Intolerance Panel. An assessment by the statin intolerance panel: 2014 update. J Clin Lipidol. 2014;8:S72–81.CrossRefPubMed
14.
go back to reference Romano PS, Roos LL, Jollis JG. Presentation adapting a clinical comorbidity index for use with ICD-9-CM administrative data: differing perspectives. J Clin Epidemiol. 1993;46:1075–9.CrossRefPubMed Romano PS, Roos LL, Jollis JG. Presentation adapting a clinical comorbidity index for use with ICD-9-CM administrative data: differing perspectives. J Clin Epidemiol. 1993;46:1075–9.CrossRefPubMed
15.
go back to reference Gu Q, Burt VL, Dillon CF, Yoon S. Trends in antihypertensive medication use and blood pressure control among United States adults with hypertension: the National Health and Nutrition Examination Survey, 2001 to 2010. Circulation. 2012;126:2105–14.CrossRefPubMed Gu Q, Burt VL, Dillon CF, Yoon S. Trends in antihypertensive medication use and blood pressure control among United States adults with hypertension: the National Health and Nutrition Examination Survey, 2001 to 2010. Circulation. 2012;126:2105–14.CrossRefPubMed
16.
go back to reference Muntner P, Yun H, Sharma P, et al. Ability of low antihypertensive medication adherence to predict statin discontinuation and low statin adherence in patients initiating treatment after a coronary event. Am J Cardiol. 2014;114:826–31.CrossRefPubMed Muntner P, Yun H, Sharma P, et al. Ability of low antihypertensive medication adherence to predict statin discontinuation and low statin adherence in patients initiating treatment after a coronary event. Am J Cardiol. 2014;114:826–31.CrossRefPubMed
17.
go back to reference Choudhry NK, Shrank WH, Levin RL, et al. Measuring concurrent adherence to multiple related medications. Am J Manag Care. 2009;15:457–64.PubMedPubMedCentral Choudhry NK, Shrank WH, Levin RL, et al. Measuring concurrent adherence to multiple related medications. Am J Manag Care. 2009;15:457–64.PubMedPubMedCentral
20.
go back to reference Fitchett DH, Hegele RA, Verma S. Cardiology patient page. Statin intolerance Circulation. 2015;131:e389–91.CrossRefPubMed Fitchett DH, Hegele RA, Verma S. Cardiology patient page. Statin intolerance Circulation. 2015;131:e389–91.CrossRefPubMed
21.
go back to reference Rosenson RS, Baker SK, Jacobson TA, Kopecky SL, Parker BA, The National Lipid Association's Muscle Safety Expert P. An assessment by the statin muscle safety task force: 2014 update. J Clin Lipidol. 2014;8:S58–71.CrossRefPubMed Rosenson RS, Baker SK, Jacobson TA, Kopecky SL, Parker BA, The National Lipid Association's Muscle Safety Expert P. An assessment by the statin muscle safety task force: 2014 update. J Clin Lipidol. 2014;8:S58–71.CrossRefPubMed
22.
go back to reference Jamal SM, Eisenberg MJ, Christopoulos S. Rhabdomyolysis associated with hydroxymethylglutaryl-coenzyme a reductase inhibitors. Am Heart J. 2004;147:956–65.CrossRefPubMed Jamal SM, Eisenberg MJ, Christopoulos S. Rhabdomyolysis associated with hydroxymethylglutaryl-coenzyme a reductase inhibitors. Am Heart J. 2004;147:956–65.CrossRefPubMed
23.
24.
go back to reference Ganga HV, Slim HB, Thompson PD. A systematic review of statin-induced muscle problems in clinical trials. Am Heart J. 2014;168:6–15.CrossRefPubMed Ganga HV, Slim HB, Thompson PD. A systematic review of statin-induced muscle problems in clinical trials. Am Heart J. 2014;168:6–15.CrossRefPubMed
25.
go back to reference Armitage J, Bowman L, Wallendszus K, et al. Intensive lowering of LDL cholesterol with 80 mg versus 20 mg simvastatin daily in 12,064 survivors of myocardial infarction: a double-blind randomised trial. Lancet. 2010;376:1658–69.CrossRefPubMed Armitage J, Bowman L, Wallendszus K, et al. Intensive lowering of LDL cholesterol with 80 mg versus 20 mg simvastatin daily in 12,064 survivors of myocardial infarction: a double-blind randomised trial. Lancet. 2010;376:1658–69.CrossRefPubMed
26.
go back to reference de Lemos JA, Blazing MA, Wiviott SD, et al. Early intensive vs a delayed conservative simvastatin strategy in patients with acute coronary syndromes: phase Z of the a to Z trial. JAMA. 2004;292:1307–16.CrossRefPubMed de Lemos JA, Blazing MA, Wiviott SD, et al. Early intensive vs a delayed conservative simvastatin strategy in patients with acute coronary syndromes: phase Z of the a to Z trial. JAMA. 2004;292:1307–16.CrossRefPubMed
27.
go back to reference Cannon CP, Braunwald E, McCabe CH, et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004;350:1495–504.CrossRefPubMed Cannon CP, Braunwald E, McCabe CH, et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004;350:1495–504.CrossRefPubMed
28.
go back to reference Harris LJ, Thapa R, Brown M, et al. Clinical and laboratory phenotype of patients experiencing statin intolerance attributable to myalgia. J Clin Lipidol. 2011;5:299–307.CrossRefPubMed Harris LJ, Thapa R, Brown M, et al. Clinical and laboratory phenotype of patients experiencing statin intolerance attributable to myalgia. J Clin Lipidol. 2011;5:299–307.CrossRefPubMed
29.
go back to reference Pedersen TR, Kjekshus J, Berg K, et al. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian simvastatin survival study (4S). Atheroscler Suppl. 2004;5:81–7.CrossRefPubMed Pedersen TR, Kjekshus J, Berg K, et al. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian simvastatin survival study (4S). Atheroscler Suppl. 2004;5:81–7.CrossRefPubMed
30.
go back to reference Sacks FM, Pfeffer MA, Moye LA, et al. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events Trial investigators N Engl J Med. 1996;335:1001–9.PubMed Sacks FM, Pfeffer MA, Moye LA, et al. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events Trial investigators N Engl J Med. 1996;335:1001–9.PubMed
31.
go back to reference The Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med. 1998;339:1349–57.CrossRef The Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med. 1998;339:1349–57.CrossRef
32.
go back to reference Colantonio LD, Kent ST, Kilgore ML, et al. Agreement between Medicare pharmacy claims, self-report, and medication inventory for assessing lipid-lowering medication use. Pharmacoepidemiol Drug Saf. 2016. doi:10.1002/pds.3970.PubMed Colantonio LD, Kent ST, Kilgore ML, et al. Agreement between Medicare pharmacy claims, self-report, and medication inventory for assessing lipid-lowering medication use. Pharmacoepidemiol Drug Saf. 2016. doi:10.​1002/​pds.​3970.PubMed
Metadata
Title
Algorithms to Identify Statin Intolerance in Medicare Administrative Claim Data
Authors
Lisandro D. Colantonio
Shia T. Kent
Lei Huang
Ligong Chen
Keri L. Monda
Maria-Corina Serban
Angelika Manthripragada
Meredith L. Kilgore
Robert S. Rosenson
Paul Muntner
Publication date
01-10-2016
Publisher
Springer US
Published in
Cardiovascular Drugs and Therapy / Issue 5/2016
Print ISSN: 0920-3206
Electronic ISSN: 1573-7241
DOI
https://doi.org/10.1007/s10557-016-6680-3

Other articles of this Issue 5/2016

Cardiovascular Drugs and Therapy 5/2016 Go to the issue