1. This randomised, placebo-controlled, double-blind, parallel-group study was conducted to assess the effect of
tenidap sodium 120 mg, a novel anti-arthritic
cytokine modulating
drug, on the hypotensive efficacy of the
thiazide diuretics hydrochlorothiazide or
bendrofluazide. 2. Twenty-three male and female patients, aged 41-78 years, with mild to moderate, uncomplicated,
essential hypertension controlled with
thiazide diuretic therapy, received either a single daily dose of
tenidap sodium 120 mg or matched placebo for 22 days in addition to their
diuretic therapy. Changes between baseline and endpoint in supine and standing systolic and diastolic pressures and pulse rate were compared between treatment groups. 3. Daily treatment with
tenidap reduced the
anti-hypertensive efficacy of the
thiazide diuretics. Blood pressure tended to increase marginally and the increase in mean standing diastolic pressure observed with
tenidap was significantly greater than the change in the placebo group. All pressures tended to decrease in the placebo group and all endpoint measurements were within 7 mm Hg of baseline in both groups. 4. Treatment-related side effects of mild to moderate severity were reported in two subjects receiving
tenidap, but in neither case was treatment discontinued. Two subjects receiving placebo also experienced side effects considered to be treatment-related and both were withdrawn from the study. 5. The results of this study suggest that
tenidap may be given to patients treated for mild to moderate
essential hypertension controlled with
thiazide therapy; however, the patient's blood pressure should be regularly monitored.