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Cumulative incidence and risk factors of creatine kinase elevation associated with telbivudine

  • Pharmacoepidemiology and Prescription
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Abstract

Purpose

An increasing number of studies are reporting a high frequency of creatine kinase (CK) elevation during telbivudine therapy; however, few reports have focused on the cumulative incidence and risk factors of CK elevation. This study was performed to investigate the cumulative incidence and risk factors of CK elevation in Chinese patients treated with telbivudine.

Methods

In this observational study, patients with chronic hepatitis B receiving telbivudine therapy between July 2008 and December 2013 were enrolled. The cumulative incidence of CK elevation was analyzed using the Kaplan–Meier method combined with the log rank test. Risk factors were determined using Cox proportional hazards regression models.

Results

A total of 207 eligible patients were analyzed. The cumulative incidence of CK elevation at 12, 24, 36, 48, 60, and 72 months was 51.2 %, 68.9 %, 75.1 %, 78.1 %, 78.1 %, and 78.1 %, respectively. Multivariate analysis revealed that male and lower baseline estimated glomerular filtration rate (eGFR) were significant risk factors for CK elevation.

Conclusions

The cumulative incidence of CK elevation after long-term telbivudine use is quite high, and gender and baseline eGFR may be useful predictors. However, when combined with regular monitoring of CK levels, especially for patients with lower eGFR, telbivudine is a relatively safe nucleoside analog treatment for chronic hepatitis B.

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Acknowledgments

We thank Dr. Xiaoqin Wang (Fudan University) for the helpful suggestions.

This study was financially supported by the Special Research Fund of the Ministry of Health for the Non-Profit Sector (201302010), the National Natural Science Foundation of China (81271833, 81471933), the Major Science and Technology Special Project of China (2012ZX10002007-001-002, 2013ZX10002001), and the “973” Project (2012CB519001).

Author information

Authors and Affiliations

  1. Department of Pharmacy, HuaShan Hospital, Fudan University, No. 12 Middle Wu Lu Mu Qi Road, Shanghai, 200040, China

    Li Chen, Bicui Chen, Yue Zhao & Bin Wang

  2. College of Pharmacy, Fudan University, Shanghai, China

    Cai Cheng

  3. Department of Infectious Diseases, HuaShan Hospital, Fudan University, No. 12 Middle Wu Lu Mu Qi Road, Shanghai, 200040, China

    Jiming Zhang

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  1. Li Chen
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  2. Cai Cheng
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Correspondence to Jiming Zhang or Bin Wang.

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Conflict of interest

The authors declare that they have no competing interests.

Ethics approval and consent to participate

This study was approved by the ethical committee of HuaShan Hospital, and informed consent was obtained from all study patients.

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Chen, L., Cheng, C., Chen, B. et al. Cumulative incidence and risk factors of creatine kinase elevation associated with telbivudine. Eur J Clin Pharmacol 72, 235–241 (2016). https://doi.org/10.1007/s00228-015-1978-9

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  • DOI: https://doi.org/10.1007/s00228-015-1978-9

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