Withdrawal from treatment in the Syst-Eur Trial

Bulpitt, CJ; Beckett, NS; Fletcher, AE; Thijs, L; Staessen, JA; Dumitrascu, DL; Forette, F; Leonetti, G; Nachev, C; Tuomilehto, J; Fagard, RH; (2002) Withdrawal from treatment in the Syst-Eur Trial. Journal of hypertension, 20 (2). pp. 339-46. ISSN 0263-6352 DOI: https://doi.org/10.1097/00004872-200202000-00026

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OBJECTIVE: To investigate the reasons for withdrawal from double-blind randomized trials, and the reasons for changing treatment within a randomized therapeutic group. DESIGN : The Syst-Eur trial, in which 4695 older patients with systolic hypertension were randomized to active or placebo treatment. METHODS : The reasons for withdrawal from the trial were examined, both for patient-initiated and investigator-initiated withdrawals. In addition, the reasons for stopping the first-line treatment (nitrendipine), the second-line treatments (enalapril and hydrochlorothiazide) and the corresponding placebos, were determined. RESULTS : A total of 135 patients (6%) were withdrawn by the investigators from placebo treatment because their blood pressure was too high, and, similarly, 36 (1.6%) through patient initiation. The corresponding results for the actively treated patients were 14 (0.6%) and 7 (0.3%). Very few patients were withdrawn from the trial because of the adverse effects of treatment. However, 39 (4%) stopped taking active nitrendipine because of ankle oedema, compared with 4 (0.5%) on placebo. Similarly, 28 versus three stopped due to flushing. Forty-one (10%) stopped taking enalapril because of cough, against eight (2%) for enalapril placebo. In all, 15.0% stopped active nitrendipine, 20.2% enalapril and 6.3% hydrochlorothiazide, versus placebo 7.1, 9.1 and 5.1%. CONCLUSIONS : The numbers withdrawn from the trial for adverse treatment consequences were small in comparison to the cardiovascular benefits. Nevertheless the numbers stopping individual treatments were higher than expected.

Item Type: Article
Keywords: trials, hypertension, treatment, adverse effects, withdrawal, rates, Hypertension, mortality, morbidity, Aged, Antihypertensive Agents, therapeutic use, Blood Pressure, drug effects, Comparative Study, Double-Blind Method, Endpoint Determination, Europe, epidemiology, Follow-Up Studies, Human, Hypertension, drug therapy, Support, Non-U.S. Gov't, Time Factors, Treatment Failure, Withholding Treatment
Faculty and Department: Faculty of Epidemiology and Population Health > Dept of Non-Communicable Disease Epidemiology
PubMed ID: 11821721
Web of Science ID: 173784200026
URI: http://researchonline.lshtm.ac.uk/id/eprint/17006


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