Romanian Society of Pharmaceutical Sciences

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A PHARMACOEPIDEMIOLOGICAL STUDY ON THE SIDE EFFECTS OF INDAPAMIDE

CRISTINA-MARIA GAVRILESCU 1#, ANDREI CERNOMAZ 2#, RADU CRISAN-DABIJA 2*, RADUCU IONUT POPESCU 3, ROXANA MIHAELA BARBU 3, DANIELA BOISTEANU 2, OANA-ELENA ROHOZNEANU 4, BEATRICE MAHLER 5

1.Medical Department I, “Grigore T. Popa” University of Medicine and Pharmacy, Iași, Romania
2.Medical Department III, “Grigore T. Popa” University of Medicine and Pharmacy, Iași, Romania
3.Department of Morpho-Functional Sciences II, “Grigore T. Popa” University of Medicine and Pharmacy, Iași, Romania
4.Clinic of Pulmonary Diseases Iași, Clinical Hospital of Pneumophtisiology Iași, Romania
5.“Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania

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Although thiazide-like diuretics were initially known to have little or no metabolic side-effects, some later evidence showed some of their adverse reactions. We aimed to survey their side-effects in long term administration. We conducted a prospective pharmacovigilance study on the metabolic side-effects of indapamide in the Vth Internal Medicine Clinic Iași, Romania, between 2016 and 2018. Thirty hypertensive patients were monitored regarding glycaemia, uricemia and kaliemia before starting indapamide administration (T0), after at least three months of administration (T1) and after at least some other three months of withdrawal (T2). A significant increase of glycaemia and uricemia appeared after three months of administration of indapamide, which disappeared in most of the cases after stopping the treatment. A significant decrease of kaliemia was also noted under treatment and it was reversible after stopping indapamide. The incrimination of indapamide in producing hyperglycaemia, hyperuricemia or hypokalaemia was certain or probable in eight cases and possible in five cases according to the WHO-UMC (2010) algorithm for causality assessment. Thiazide-like diuretics may expose to the same metabolic risks as thiazide-type diuretics. Precautious administration in case of already present hypokalaemia could be protective. Larger studies are needed in order to define the dose, the period of administration or other associated factors that could expose to an increased risk of side-effects.