Korean Circ J.  2003 Aug;33(8):656-662. 10.4070/kcj.2003.33.8.656.

Clinical Presentation of Adverse Drug Reaction of Dalteparin in Acute Coronary Syndrome

• Hwang ES
• Chae IH
• Park KW
• Kim YS
• Choi JO
• Oh SI
• Kim CH
• Sohn DW
• Oh BH
• Lee MM
• Park YB
• Choi YS

• KMID: 1858772
• DOI: http://doi.org/10.4070/kcj.2003.33.8.656

Abstract

BACKGROUND AND OBJECTIVES
Heparin is crucial in the treatment of acute coronary syndrome. However, unfractionated heparin has pharmacokinetic, biophysical and biological limitations, but its low molecular weight has been used to overcome these limitations. The aim of this study was to find the optimal dose of dalteparin in Koreans. Instead, significant rises in the levels of aminotransferase were found in the liver during the study.
SUBJECTS AND METHODS
A clinical investigation was conducted, at Seoul National University Hospital, between December 2000 and February 2001. The anti-Xa activity was checked just before the first, and 4 hours after, the second and ninth doses of dalteparin. Liver function tests were obtained on the first and follow-up day (day 6 or 7).
RESULTS
Of the 17 patients who completed 10 doses of dalteparin, 13 showed significant rises in the levels of liver aminotransferase. In 5 cases, the levels of aminotransferase rose to 3 times, and in one case, to over 10 times the upper normal limit. All of the patients were asymptomatic, and the levels showed a decline one or two days later. The follow-up aminotransferase level was normalized in 8 out of 11 patients whose liver function tests were followed up.
CONCLUSION
Previous studies have shown that 120 IU/kg of dalteparin was the optimal dose in Western countries. Whether this is the optimal dose for Koreans has not been proven, and there have been no studies to elucidate its adverse effects (e.g. hepatotoxicity) in Koreans. Therefore, large scale, randomized trials may be warranted to determine the pharmacodynamics and kinetics of dalteparin in Koreans.

Keyword

Coronary disease; Heparin; Low molecular weight heparin; Dalteparin

MeSH Terms

Acute Coronary Syndrome*
Coronary Disease
Dalteparin*
Drug-Related Side Effects and Adverse Reactions*
Follow-Up Studies
Heparin
Heparin, Low-Molecular-Weight
Humans
Kinetics
Liver
Liver Function Tests
Molecular Weight
Seoul
Dalteparin
Heparin
Heparin, Low-Molecular-Weight