Statin Use and Severe Acute Liver Injury Among Patients with Elevated Alanine Aminotransferase
Santosh K Verma,1,2 Joanna Huang,3 Howard G Hutchinson,4 Irisdaly Estevez,1 Kammy Kuang,1 Shannon L Reynolds,1 Sebastian Schneeweiss1,5 1Science, Aetion, Inc, New York, NY, USA; 2Department of Family Medicine and Community Health, University of Massachusetts Medical School, Worcester, MA, USA; 3Paye...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2022-12-01
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| Series: | Clinical Epidemiology |
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| Online Access: | https://www.dovepress.com/statin-use-and-severe-acute-liver-injury-among-patients-with-elevated--peer-reviewed-fulltext-article-CLEP |
| _version_ | 1811197500599566336 |
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| author | Verma SK Huang J Hutchinson HG Estevez I Kuang K Reynolds SL Schneeweiss S |
| author_facet | Verma SK Huang J Hutchinson HG Estevez I Kuang K Reynolds SL Schneeweiss S |
| author_sort | Verma SK |
| collection | DOAJ |
| description | Santosh K Verma,1,2 Joanna Huang,3 Howard G Hutchinson,4 Irisdaly Estevez,1 Kammy Kuang,1 Shannon L Reynolds,1 Sebastian Schneeweiss1,5 1Science, Aetion, Inc, New York, NY, USA; 2Department of Family Medicine and Community Health, University of Massachusetts Medical School, Worcester, MA, USA; 3Payer Evidence, AstraZeneca, Wilmington, DE, USA; 4Global Medicines Development, AstraZeneca, Wilmington, DE, USA; 5Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USACorrespondence: Santosh K Verma, Director, Science, Aetion, Inc, 50 Congress Street, Suite 1025, Boston, MA, 02109, USA, Tel +1 401-765-8817, Email santosh.verma@aetion.comIntroduction: While serious liver injury among statin users is extremely rare, baseline liver enzyme testing is still recommended prior to initiating therapy. The benefit of such screening should be reevaluated based on empirical evidence. This study compared the risk of severe acute liver injury (SALI) between statin initiators with an elevated ALT (> 35U/L) matched to statin initiators with a normal ALT level (≤ 35U/L). Statin initiators with an elevated ALT were additionally compared against matched non-users.Methods: The study created cohorts from Optum and MarketScan claims data. Exposed and comparison cohorts were propensity score (PS) matched in each dataset and findings were pooled using meta-analysis. Proportional hazards regression was used to estimate hazard ratios (HRs), and a prespecified non-inferiority margin for SALI was set at a HR of 1.8.Results: 232,889 patients with elevated ALT were PS-matched to 232,889 with normal ALT level. The overall incidence rate of SALI was about 19/100,000 person-years among statin initiators. Statin initiators with elevated ALT had no meaningfully increased risk of SALI compared to those with normal ALT (HR=1.15; 95% CI 0.75 to 1.75). Comparing statin initiators with non-initiators with elevated ALT values equally yielded no increased risk (HR=0.76; 95% CI 0.52 to 1.11).Conclusion: In this large population-based study, SALI in statin users was rare. Importantly, the results showed no evidence that baseline ALT status is a reliable indicator for an increased risk of severe liver injury among statin initiators.Keywords: statins, liver injury, liver failure, alanine aminotransferase |
| first_indexed | 2024-04-12T01:14:52Z |
| format | Article |
| id | doaj.art-d743cbc0c630436e8fa9d51e83c79c85 |
| institution | Directory Open Access Journal |
| issn | 1179-1349 |
| language | English |
| last_indexed | 2024-04-12T01:14:52Z |
| publishDate | 2022-12-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Clinical Epidemiology |
| spelling | doaj.art-d743cbc0c630436e8fa9d51e83c79c852022-12-22T03:54:00ZengDove Medical PressClinical Epidemiology1179-13492022-12-01Volume 141535154580339Statin Use and Severe Acute Liver Injury Among Patients with Elevated Alanine AminotransferaseVerma SKHuang JHutchinson HGEstevez IKuang KReynolds SLSchneeweiss SSantosh K Verma,1,2 Joanna Huang,3 Howard G Hutchinson,4 Irisdaly Estevez,1 Kammy Kuang,1 Shannon L Reynolds,1 Sebastian Schneeweiss1,5 1Science, Aetion, Inc, New York, NY, USA; 2Department of Family Medicine and Community Health, University of Massachusetts Medical School, Worcester, MA, USA; 3Payer Evidence, AstraZeneca, Wilmington, DE, USA; 4Global Medicines Development, AstraZeneca, Wilmington, DE, USA; 5Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USACorrespondence: Santosh K Verma, Director, Science, Aetion, Inc, 50 Congress Street, Suite 1025, Boston, MA, 02109, USA, Tel +1 401-765-8817, Email santosh.verma@aetion.comIntroduction: While serious liver injury among statin users is extremely rare, baseline liver enzyme testing is still recommended prior to initiating therapy. The benefit of such screening should be reevaluated based on empirical evidence. This study compared the risk of severe acute liver injury (SALI) between statin initiators with an elevated ALT (> 35U/L) matched to statin initiators with a normal ALT level (≤ 35U/L). Statin initiators with an elevated ALT were additionally compared against matched non-users.Methods: The study created cohorts from Optum and MarketScan claims data. Exposed and comparison cohorts were propensity score (PS) matched in each dataset and findings were pooled using meta-analysis. Proportional hazards regression was used to estimate hazard ratios (HRs), and a prespecified non-inferiority margin for SALI was set at a HR of 1.8.Results: 232,889 patients with elevated ALT were PS-matched to 232,889 with normal ALT level. The overall incidence rate of SALI was about 19/100,000 person-years among statin initiators. Statin initiators with elevated ALT had no meaningfully increased risk of SALI compared to those with normal ALT (HR=1.15; 95% CI 0.75 to 1.75). Comparing statin initiators with non-initiators with elevated ALT values equally yielded no increased risk (HR=0.76; 95% CI 0.52 to 1.11).Conclusion: In this large population-based study, SALI in statin users was rare. Importantly, the results showed no evidence that baseline ALT status is a reliable indicator for an increased risk of severe liver injury among statin initiators.Keywords: statins, liver injury, liver failure, alanine aminotransferasehttps://www.dovepress.com/statin-use-and-severe-acute-liver-injury-among-patients-with-elevated--peer-reviewed-fulltext-article-CLEPstatinsliver injuryliver failurealanine aminotransferase |
| spellingShingle | Verma SK Huang J Hutchinson HG Estevez I Kuang K Reynolds SL Schneeweiss S Statin Use and Severe Acute Liver Injury Among Patients with Elevated Alanine Aminotransferase Clinical Epidemiology statins liver injury liver failure alanine aminotransferase |
| title | Statin Use and Severe Acute Liver Injury Among Patients with Elevated Alanine Aminotransferase |
| title_full | Statin Use and Severe Acute Liver Injury Among Patients with Elevated Alanine Aminotransferase |
| title_fullStr | Statin Use and Severe Acute Liver Injury Among Patients with Elevated Alanine Aminotransferase |
| title_full_unstemmed | Statin Use and Severe Acute Liver Injury Among Patients with Elevated Alanine Aminotransferase |
| title_short | Statin Use and Severe Acute Liver Injury Among Patients with Elevated Alanine Aminotransferase |
| title_sort | statin use and severe acute liver injury among patients with elevated alanine aminotransferase |
| topic | statins liver injury liver failure alanine aminotransferase |
| url | https://www.dovepress.com/statin-use-and-severe-acute-liver-injury-among-patients-with-elevated--peer-reviewed-fulltext-article-CLEP |
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