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Different pharmaceutical preparations of colchicine for Familial Mediterranean Fever: are they the same?

  • Pharmacovigilance
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Abstract

This study aimed to investigate the benefit of changing the pharmaceutical preparation of colchicine in Turkish Familial Mediterranean Fever (FMF) patients resistant to one preparation in terms of frequency of the attacks. Turkish adult FMF patients under treatment with an imported colchicine preparation—in the form of compressed tablet form—due to resistance to domestic colchicine preparations, which are film- or sugar-coated tablets, and not using anti-interleukin-1 or other biologic agents were included in the study. Baseline disease characteristics along with MEFV mutations were identified. Daily colchicine doses and attack frequencies before and after the pharmaceutical change were compared. Fifty patients resistant to coated tablet preparations of colchicine and under treatment with the compressed tablets were identified. The median duration of disease was 6 (interquartile range 2.7–14) years and duration under treatment with the imported colchicine was 21 (range 8–60) months. Eight (16%), ten (20%), and 32 (64%) patients had 0–3, 4–6, and more than 7 attacks per year, respectively, before the compressed tablets. After treatment with the compressed tablet form of colchicine, 44 (88%), 5 (10%), and 1 (2%) patients had 0–3, 4–6, and more than 7 attacks, respectively (p < 0.0001). Daily colchicine doses were similar before and after the pharmaceutical change (1.85 ± 0.47 vs 1.84 ± 0.37 mg, p = 0.9). Turkish FMF patients with ongoing attacks under domestic coated tablet preparations of colchicine may benefit from the compressed colchicine tablets. This may be explained by the difference in pharmacokinetic properties of different colchicine preparations.

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Funding

This study did not receive support from any funding source.

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Authors and Affiliations

  1. Department of Rheumatology, Trakya University Medical School, 22100, Edirne, Turkey

    Hakan Emmungil, Ufuk İlgen & Sezin Turan

  2. Department of Internal Medicine, Yıldırım Beyazıt University Atatürk Training and Research Hospital, Ankara, Turkey

    Samet Yaman

  3. Rheumatology Clinic, Liv Hospital, Ankara, Turkey

    Orhan Küçükşahin

Authors
  1. Hakan Emmungil
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  2. Ufuk İlgen
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  3. Sezin Turan
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  4. Samet Yaman
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  5. Orhan Küçükşahin
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Contributions

Conception and design: HE, Uİ, ST, SY, OK; data acquisition: HE, Uİ, ST, SY, OK; analysis and interpretation: HE, Uİ, ST, SY, OK; drafting and revision: HE, Uİ, ST, SY, OK; and supervision: HE, OK. All co-authors approved the final revised manuscript and agree to take responsibility for all aspects of the work.

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Correspondence to Ufuk İlgen.

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The authors declare that they have no conflict of interest.

Ethical approval

Institutional Review Board of Trakya University Medical School approved the study (Date/Number: 2019/150-06/44). All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Written informed consent was obtained from each patient to use clinical data for research purposes.

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Emmungil, H., İlgen, U., Turan, S. et al. Different pharmaceutical preparations of colchicine for Familial Mediterranean Fever: are they the same?. Rheumatol Int 40, 129–135 (2020). https://doi.org/10.1007/s00296-019-04432-3

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