Healthc Inform Res.  2017 Jul;23(3):199-207. 10.4258/hir.2017.23.3.199.

Pilot Algorithm Designed to Help Early Detection of HMG-CoA Reductase Inhibitor-Induced Hepatotoxicity

• Hong JY
• Kim HS
• Choi IY

• KMID: 2403310
• DOI: http://doi.org/10.4258/hir.2017.23.3.199

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.

Keyword

Hydroxymethylglutaryl-CoA Reductase Inhibitors; Drug-Related Side Effects and Adverse Reactions; Drug-Induced Liver Injury; Electronic Medical Records; Alanine Transaminase; Alkaline Phosphatase

MeSH Terms

Alanine Transaminase
Alkaline Phosphatase
Diagnosis
Drug-Induced Liver Injury
Drug-Related Side Effects and Adverse Reactions
Electronic Health Records
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Korea
Liver
Outpatients
Oxidoreductases*
Prescriptions
Seoul
Alanine Transaminase
Alkaline Phosphatase
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Oxidoreductases

Figure

• 

  Figure 1 Algorithm of statin-induced liver injury assessment active liver disorder. Active liver disorder (International Classification of Diseases [ICD] B15–19), viral hepatitis (ICD C22), malignant neoplasm of the liver and intrahepatic bile ducts (ICD K70–77) diseases of the liver. Normal record of liver function tests: ALT 9–45 IU/L, ALP 30–120 IU/L. ALT: alanine transaminase, ALP: alkaline phosphatase, UNL: upper normal limits.

• 

  Figure 2 Flow-chart of association of statin-induced liver injury assessment by algorithm.

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