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| Naji, M. |
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| Motta, Antonella |
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| Aletan, Dirar |
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| Mohamed, Tarek |
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| Ertürk, Emre |
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| Taccardi, Nicola |
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| Kononenko, Denys |
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| Petrov, R. H. | Madrid |
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| Alshaaer, Mazen | Brussels |
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| Bih, L. |
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| Casati, R. |
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| Muller, Hermance |
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| Kočí, Jan | Prague |
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| Šuljagić, Marija |
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| Kalteremidou, Kalliopi-Artemi | Brussels |
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| Azam, Siraj |
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| Ospanova, Alyiya |
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| Blanpain, Bart |
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| Ali, M. A. |
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| Popa, V. |
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| Rančić, M. |
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| Ollier, Nadège |
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| Azevedo, Nuno Monteiro |
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| Landes, Michael |
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| Rignanese, Gian-Marco |
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Choy, Anna Maria
University of Dundee
in Cooperation with on an Cooperation-Score of 37%
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article
Population-Level Incidence and Monitoring of Adverse Drug Reactions with Long-term Amiodarone Therapy
Abstract
<b>Introduction</b>: Amiodarone is associated with significant long-lasting adverse drug reactions (ADRs). Guidelines recommend laboratory monitoring during long-term use. However, data of compliance with laboratory monitoring is lacking.Aims: The aim of this study was to assess laboratory monitoring of liver and thyroid function during amiodarone prescribing from 1989-2011 in the Tayside, UK, population (approximately 400,000) in relation to National guidelines recommending laboratory monitoring every 6 months. We also report the population-level incidence of abnormal liver and thyroid function in relation to total exposure of amiodarone.<b><br/></b><b>Methods</b>: Utilising well-established record linkage database, a longitudinalretrospective analysis of 1413 patients on long-term amiodarone was carried out, analysing prescribing, biochemical and clinical data.<b><br/></b><b>Results</b>: Forty-six per cent (46%), 28% and 21% of patients underwent liver, thyroid, and combined testing respectively in accordance with guideline recommendations. Thirteen per cent and 17% of patients did not have any ALT or TSH testing, respectively. During follow-up, 117 (9.5%) patients had an ALT 3xULN and 16% patients had an abnormal TSH, (n=125, <0.4mU/l and n=28, >10mU/l). One-hundredand forty patients (10%) required thyroxine replacement therapy and 40 (3%) required on hyperthyroid medication. Total amiodarone exposure increased the likelihood of abnormal biochemical testing 2.5-fold after 4 years therapy for liver and thyroid function (p<0.0005)<b><br/></b><b>Conclusion</b>: In this population-based study, adherence to laboratory monitoringguidelines was sub-optimal. There was a positive correlation with total amiodarone exposure and biochemical abnormalities and development of thyroid disease compared to the general population, highlighting the need for improvement and continued amiodarone monitoring.