Multicentre controlled trial of tienilic acid in hyperuricaemic, hypertensive subjects, with intensive monitoring of liver function.

1 Tienilic acid, a diuretic with potent uricosuric properties, has been compared with conventional diuretic therapy, mainly thiazide, in a parallel group (random allocation) multicentre study in hyperuricaemic hypertensives (n = 96). 2 The study was designed to last 1 year but tienilic acid was withdrawn for suspected hepatotoxicity before the study was complete. Mean follow-up was 8.5 (range 1-12) months and the mean daily dose of tienilic acid was 278 (range 125-500 mg). 3 Blood pressure levels on tienilic acid and on conventional diuretics were similar. 4 Serum potassium and sodium levels were also similar in the two groups, but serum urea and creatinine rose somewhat more in the tienilic acid group. 5 Serum uric acid fell dramatically in the patients on tienilic acid from 0.56 to 0.32 mmol/l, but did not alter significantly in the control group. 6 There were no problems with renal failure or urate deposition probably because patients were instructed to drink plenty of fluid when tienilic acid was started, because initial dose was low and because all previous diuretics were stopped for 3 days before tienilic acid was started. 7 Mean liver function indices did not rise in either group. Mild elevation in liver enzymes occurred in one control patient and one patient on tienilic acid; the latter drug was stopped and the values returned to normal. 8 The general incidence of side-effects was low. 9 Our impression was that tienilic acid was a useful drug. Whether it could have been used safely with monitoring of liver function will not now be known.

RCT Entities:   Population Interventions Outcomes