Development and Validation of Algorithms to Identify Statin Intolerance in a US Administrative Database

Value in Health

Volumn 19, Issue 6, 2016, Pages 852-860

  Schulman, Kathy L ^a   Lamerato, Lois E ^b   Dalal, Mehul R ^c   Sung, Jennifer ^c   Jhaveri, Mehul ^c   Koren, Andrew ^c   Mallya, Usha G ^c   Foody, JoAnne M ^d  

^a Outcomes Research Solutions   (United States)

^b HENRY FORD HEALTH SYSTEM   (United States)

^c SANOFI   (France)

^d BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

administrative data; cardiovascular risk; claims data; electronic medical record; hypercholesterolemia; statin intolerance; validation

Indexed keywords

ATORVASTATIN; CREATINE KINASE; FLUINDOSTATIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; MEVINOLIN; PITAVASTATIN; PRAVASTATIN; ROSUVASTATIN; SIMVASTATIN;

ABDOMINAL PAIN; ADULT; AMNESIA; ANAPHYLAXIS; ANGIONEUROTIC EDEMA; ARTHRALGIA; ARTICLE; BLOATING; CARDIOVASCULAR RISK; COMORBIDITY; CONFUSION; CONSTIPATION; CREATINE KINASE BLOOD LEVEL; DATA BASE; DERMATITIS; DIARRHEA; DRUG IDENTIFICATION; DRUG INTOXICATION; DRUG UTILIZATION; DUODENITIS; DYSLIPIDEMIA; EDEMA; ELECTRONIC MEDICAL RECORD; ERYTHEMA; FASCIA PAIN; FEMALE; FLATULENCE; FLUSHING; GASTRITIS; HEALTH CARE MANAGEMENT; HUMAN; HYPERCHOLESTEROLEMIA; HYPERLIPIDEMIA; JOINT STIFFNESS; LABORATORY TEST; LIGAMENT PAIN; LIMB DISCOMFORT; LIMB PAIN; LIVER FUNCTION TEST; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MUSCLE ACHE; MUSCLE CRAMP; MUSCLE DISCOMFORT; MUSCLE SORENESS; MUSCLE SPASM; MUSCULOSKELETAL DISEASE; MYALGIA; MYOPATHY; MYOSITIS; NAUSEA; PAIN; PREDICTIVE VALUE; PRIORITY JOURNAL; PRURITUS; RASH; RHABDOMYOLYSIS; ROSACEA; SENSITIVITY AND SPECIFICITY; SIDE EFFECT; TITRIMETRY; TOXIC MYOPATHY; URTICARIA; VALIDATION STUDY; VOMITING; WEAKNESS; ADVERSE DRUG REACTION; AGED; ALGORITHM; ELECTRONIC HEALTH RECORD; FACTUAL DATABASE; UNITED STATES;

AGED; ALGORITHMS; DATABASES, FACTUAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; ELECTRONIC HEALTH RECORDS; FEMALE; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; MALE; MIDDLE AGED; UNITED STATES;

EID: 84966633280     PISSN: 10983015     EISSN: 15244733     Source Type: Journal    
DOI: 10.1016/j.jval.2016.03.1858     Document Type: Article

References (34)

1. [1] Taylor, F., Huffman, M.D., Macedo, A.F., et al. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev, 1, 2013, CD004816.
2. [2] Cholesterol Treatment Trialists’ (CTT) Collaboration. Efficacy and safety of LDL-lowering therapy among men and women: meta-analysis of individual data from 174,000 participants in 27 randomised trials. Lancet 385 (2015), 1397–1405.
3. [3] Stone, N.J., Robinson, J.G., Lichtenstein, A.H., 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. J Am Coll Cardiol 63 (2014), 2889–2934.
4. [4] Jacobson, T.A., Ito, M.K., Maki, K.C., et al. National Lipid Association recommendations for patient-centered management of dyslipidemia, part 1: full report. J Clin Lipidol 9 (2015), 129–169.
5. [5] Lardizabal, J.A., Deedwania, P.C., Benefits of statin therapy and compliance in high risk cardiovascular patients. Vasc Health Risk Manag 6 (2010), 843–853.
6. [6] Cohen, J.D., Brinton, E.A., Ito, M.K., Jacobson, T.A., 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 6 (2012), 208–215.
7. [7] Naci, H., Brugts, J., Ades, T., Comparative tolerability and harms of individual statins: a study-level network meta-analysis of 246,955 participants from 135 randomized, controlled trials. Circ Cardiovasc Qual Outcomes 6 (2013), 390–399.
8. [8] Silva, M., Matthews, M.L., Jarvis, C., et al. Meta-analysis of drug-induced adverse events associated with intensive-dose statin therapy. Clin Ther 29 (2007), 253–260.
9. [9] Newman, C.B., Tobert, J.A., Statin intolerance: reconciling clinical trials and clinical experience [editorial]. JAMA 313 (2015), 1011–1012.
10. [10] Finegold, J.A., Manisty, C.H., Goldacre, B., et al. What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug? Systematic review of randomized placebo-controlled trials to aid individual patient choice. Eur J Prev Cardiol 21 (2014), 464–474.
11. [11] de Jong, H.J.I., Klungel, O.H., van Dijk, L., et al. Use of statins is associated with an increased risk of rheumatoid arthritis. Ann Rheum Dis 71 (2012), 648–654.
12. [12] Maji, D., Shaikh, S., Solanki, D., Gaurav, K., Safety of statins. Indian J Endocrinol Metab 17 (2013), 636–646.
13. [13] Bruckert, E., Hayem, G., Dejager, S., et al. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients—the PRIMO study. Cardiovasc Drugs Ther 19 (2005), 403–414.
14. [14] Buettner, C., Davis, R.B., Leveille, S.G., et al. Prevalence of musculoskeletal pain and statin use. J Gen Intern Med 23 (2008), 1182–1186.
15. [15] El-Salem, K., Ababneh, B., Rudnicki, S., et al. Prevalence and risk factors of muscle complications secondary to statins. Muscle Nerve 44 (2011), 877–881.
16. [16] Nichols, G.A., Koro, C.E., Does statin therapy initiation increase the risk for myopathy? An observational study of 32,225 diabetic and nondiabetic patients. Clin Ther 29 (2007), 1761–1770.
17. [17] Zhang, H., Plutzky, J., Skentzos, S., et al. Discontinuation of statins in routine care settings: a cohort study. Ann Intern Med 158 (2013), 526–534.
18. [18] Parker, B.A., Capizzi, J.A., Grimaldi, A.S., et al. Effect of statins on skeletal muscle function. Circulation 127 (2013), 96–103.
19. [19] Banach, M., Rizzo, M., Toth, P.P., et al. Statin intolerance—an attempt at a unified definition. Position paper from an International Lipid Expert Panel. Arch Med Sci 11 (2015), 1–23.
20. [20] Ahmad, Z., Statin intolerance. Am J Cardiol 113 (2014), 1765–1771.
21. [21] Mancini, G.J., Tashakkor, A.Y., Baker, S., et al. Diagnosis, prevention, and management of statin adverse effects and intolerance: Canadian Working Group Consensus update. Can J Cardiol 29 (2013), 1553–1568.
22. [22] Guyton, J.R., Bays, H.E., Grundy, S.M., Jacobson, T.A., An assessment by the Statin Intolerance Panel: 2014 update. J Clin Lipidol 8 (2014), S72–S81.
23. [23] Nicholls, S.J., Brandrup-Wognsen, G., Palmer, M., Barter, P.J., Meta-analysis of comparative efficacy of increasing dose of atorvastatin versus rosuvastatin versus simvastatin on lowering levels of atherogenic lipids (from VOYAGER). Am J Cardiol 105 (2010), 69–76.
24. [24] Weng, T.-C., Yang, Y.-K., Lin, S.-J., Tai, S.-H., A systematic review and meta-analysis on the therapeutic equivalence of statins. J Clin Pharm Ther 35 (2010), 139–151.
25. [25] Zutt, R., van der Kooi, A.J., Linthorst, G.E., et al. Rhabdomyolysis: review of the literature. Neuromuscul Disord 24 (2014), 651–659.
26. [26] Viera, A.J., Garrett, J.M., Understanding interobserver agreement: the kappa statistic. Fam Med 37 (2005), 360–363.
27. [27] Landis, J.R., Koch, G.G., The measurement of observer agreement for categorical data. Biometrics 33 (1977), 159–174.
28. [28] Thacker, E.L., Muntner, P., Zhao, H., et al. Claims-based algorithms for identifying Medicare beneficiaries at high estimated risk for coronary heart disease events: a cross-sectional study. BMC Health Serv Res, 14, 2014, 195.
29. [29] Hsieh, C.-Y., Chen, C.-H., Li, C.-Y., Lai, M.-L., Validating the diagnosis of acute ischemic stroke in a National Health Insurance claims database. J Formos Med Assoc 114 (2015), 254–259.
30. [30] Saczynski, J.S., Andrade, S.E., Harrold, L.R., et al. A systematic review of validated methods for identifying heart failure using administrative data. Pharmacoepidemiol Drug Saf 21 (2012), 129–140.
31. [31] Hlatky, M.A., Ray, R.M., Burwen, D.R., et al. Use of Medicare data to identify coronary heart disease outcomes in the Women's Health Initiative. Circ Cardiovasc Qual Outcomes 7 (2014), 157–162.
32. ® [package insert], 2014, AstraZeneca Pharmaceuticals, Wilmington, DE.
33. [33] Huddy, K., Dhesi, P., Thompson, P.D., Do the frequencies of adverse events increase, decrease, or stay the same with long-term use of statins?. Curr Atheroscler Rep, 15, 2013, 301.
34. [34] Robison, C.D., Bair, T.L., Horne, B.D., et al. Hypothyroidism as a risk factor for statin intolerance. J Clin Lipidol 8 (2014), 401–407.