Pilot Algorithm Designed to Help Early Detection of HMG-CoA Reductase Inhibitor-Induced Hepatotoxicity
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Objectives: To enable early detection of adverse drug reactions (ADRs) in patients using HMG-CoA reductase inhibitors (statins), we developed an algorithm that automatically detects liver injury caused by statins from Electronic Medical Record (EMR) data. We verified the performance of our algorithm through manual ADR assessment and a direct chart review. Methods: The subjects in this study were patients who had been prescribed a statin for the first time among outpatients in Seoul St. Mary’s Hospital in Korea between January 2009 and December 2012. We extracted basic information about the patients, including laboratory information, underlying disease, diagnosis information, prescription information, and concomitant drugs. We developed an automatic ADR detection algorithm by using EMR data. We validated the results of the algorithm through a chart review. Results: We developed the algorithm to assess ADR occurrences based on alanine transaminase (ALT) and alkaline phosphatase (ALP) levels. According to the proposed algorithm, any of these result options could be attained: ADR-free, little association, strong association, and weak association or indeterminable. The results of the ADR assessments obtained using the proposed algorithm showed that the data of 126 patients (1.4% of all 9,241 patients) included suspicious figures, thus indicating the possibility of an ADR. In the EMR chart review for verifying the algorithm, ADRs of 33 patients were not associated with statin use; therefore, the ADR occurrence rate was found to be 1.0% (93/9,241). Therefore, the positive predictive value was calculated to be 73.8% (93/126; 95% confidence interval, 69.2%–77.6%). No differences were observed between statin types (p = 0.472). Conclusions: For early detection of statin-induced liver injury, we developed an automatic ADR assessment algorithm. We expect that algorithms that are more reliable can be developed if we conduct supplement clinical studies with a focus on adverse drug effects.
Abstract
Objectives: To enable early detection of adverse drug reactions (ADRs) in patients using HMG-CoA reductase inhibitors (statins), we developed an algorithm that automatically detects liver injury caused by statins from Electronic Medical Record (EMR) data. We verified the performance of our algorithm through manual ADR assessment and a direct chart review. Methods: The subjects in this study were patients who had been prescribed a statin for the first time among outpatients in Seoul St. Mary’s Hospital in Korea between January 2009 and December 2012. We extracted basic information about the patients, including laboratory information, underlying disease, diagnosis information, prescription information, and concomitant drugs. We developed an automatic ADR detection algorithm by using EMR data. We validated the results of the algorithm through a chart review. Results: We developed the algorithm to assess ADR occurrences based on alanine transaminase (ALT) and alkaline phosphatase (ALP) levels. According to the proposed algorithm, any of these result options could be attained: ADR-free, little association, strong association, and weak association or indeterminable. The results of the ADR assessments obtained using the proposed algorithm showed that the data of 126 patients (1.4% of all 9,241 patients) included suspicious figures, thus indicating the possibility of an ADR. In the EMR chart review for verifying the algorithm, ADRs of 33 patients were not associated with statin use; therefore, the ADR occurrence rate was found to be 1.0% (93/9,241). Therefore, the positive predictive value was calculated to be 73.8% (93/126; 95% confidence interval, 69.2%–77.6%). No differences were observed between statin types (p = 0.472). Conclusions: For early detection of statin-induced liver injury, we developed an automatic ADR assessment algorithm. We expect that algorithms that are more reliable can be developed if we conduct supplement clinical studies with a focus on adverse drug effects.
참고문헌 (30)
- Shepherd G, "Adverse drug reaction deaths reported in United States vital statistics, 1999-2006", Ann Pharmacother, 46(2), pp.169~175 (2012)
- Brown JS, "Early detection of adverse drug events within population-based health networks : application of sequential testing methods", Pharmacoepidemiol Drug Saf, 16(12), pp.1275~1284 (2007)
- Park IW, "Onset time of hyperkalaemia after angiotensin receptor blocker initiation: when should we start serum potassium monitoring?", J Clin Pharm Ther, 39(1), pp.61~68 (2014)
- Jha AK, "Identifying adverse drug events : development of a computer-based monitor and comparison with chart review and stimulated voluntary report", J Am Med Inform Assoc, 5(3), pp.305~314 (1998)
- Haerian K, "Detection of pharmacovigilance-related adverse events using electronic health records and automated methods", Clin Pharmacol Ther, 92(2), pp.228~234 (2012)
- Hannan TJ, "Detecting adverse drug reactions to improve patient outcomes", Int J Med Inform, 55(1), pp.61~64 (1999)
- Grundy SM, "HMG-CoA reductase inhibitors for treatment of hypercholesterolemia", N Engl J Med, 319(1), pp.24~33 (1988)
- Kim HS, "Analysis and comparison of statin prescription patterns and outcomes according to clinical department", J Clin Pharm Ther, 41(1), pp.70~77 (2016)
- Kim HS, "Comparative analysis of the efficacy of low-and moderate-intensity statins in Korea", Int J Clin Pharmacol Ther, 54(11), pp.864~871 (2016)
- Stone NJ, "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, Circulation, pp.2014, 129(25 Suppl)[DOI]
- Kim HS, "Statin-related aminotransferase elevation according to baseline aminotransferases level in real practice in Korea", J Clin Pharm Ther, 41(3), pp.266~272 (2016)
- Benichou C, "Criteria of drug-induced liver disorders : report of an international consensus meeting", J Hepatol, 11(2), pp.272~276 (1990)
- Bellosta S, "Safety of statins: focus on clinical pharmacokinetics and drug interactions", Circulation, 109(23 Suppl 1), pp.III50~III57 (2004)
- Tantikul C, "The utility of the World Health Organization-The Uppsala Monitoring Centre (WHO-UMC) system for the assessment of adverse drug reactions in hospitalized children", Asian Pac J Allergy Immunol, 26(2-3), pp.77~82 (2008)
- Knopp RH, "Drug treatment of lipid disorders", N Engl J Med, 341(7), pp.498~511 (1999)
- Bhardwaj SS, "Lipid-lowering agents that cause drug-induced hepatotoxicity", Clin Liver Dis, 11(3), pp.597~613 (2007)
- Russo MW, "Spectrum of statin hepatotoxicity : experience of the drug-induced liver injury network", Hepatology, 60(2), pp.679~686 (2014)
- Farmer JA, "Comparative tolerability of the HMG-CoA reductase inhibitors", Drug Saf, 23(3), pp.197~213 (2000)
- Tolman KG, "Defining patient risks from expanded preventive therapies", Am J Cardiol, 85(12A), pp.15E~19E (2000)
- Sniderman AD., "Is there value in liver function test and creatine phosphokinase monitoring with statin use?", Am J Cardiol, 94(9A), pp.30F~34F (2004)
- Reuben A, "Acute Liver Failure Study Group. Drug-induced acute liver failure: results of a U.S. multicenter, prospective study", Hepatology, 52(6), pp.2065~2076 (2010)
- Russo MW, "Drug-induced liver injury associated with statins", Semin Liver Dis, 29(4), pp.412~422 (2009)
- Tavassoli N, "Detection and incidence of drug-induced agranulocytosis in hospital : a prospective analysis from laboratory signals", Eur J Clin Pharmacol, 63(3), pp.221~228 (2007)
- Bagheri H, "Detection and incidence of drug-induced liver injuries in hospital : a prospective analysis from laboratory signals", Br J Clin Pharmacol, 50(5), pp.479~484 (2000)
- Robb MA, "The US Food and Drug Administration's Sentinel Initiative : expanding the horizons of medical product safety", Pharmacoepidemiol Drug Saf, 21(Suppl 1), pp.9~11 (2012)
- Yoon D, "Detection of adverse drug reaction signals using an electronic health records database : Comparison of the Laboratory Extreme Abnormality Ratio(CLEAR)algorithm", Clin Pharmacol Ther, 91(3), pp.467~474 (2012)
- Klintmalm GB, "Cyclosporin A hepatotoxicity in 66 renal allograft recipients", Transplantation, 32(6), pp.488~489 (1981)
- Wagoner LE, "Cyclophosphamide as an alternative to azathioprine in cardiac transplant recipients with suspected azathioprine-induced hepatotoxicity", Transplantation, 56(6), pp.1415~1418 (1993)
- Sai K, "Development of a detection algorithm for statin-induced myopathy using electronic medical records", J Clin Pharm Ther, 38(3), pp.230~235 (2013)
- Warrer P, "Using text-mining techniques in electronic patient records to identify ADRs from medicine use", Br J Clin Pharmacol, 73(5), pp.674~684 (2012)