The antihypertensive effectiveness, influence on laboratory parameters and adverse reaction of FR 3068 (tienilic acid, FR), a new nonthiazide diuretic developed by Albert Rolland Co. of France with uricosuric properties, were evaluated by double-blind parallel group comparison with methyclothiazide (MCTZ).
Placebo was initially administered for a period of at least 2 weeks. Patients with systolic blood pressure of≥150 mHg and diastolic blood pressure of≥90 mmHg at the termination of the placebo control period were enrolled as subjects .
FR and MCTZ were administered in fixed dosages of 250 mg/day and 5 mg/day respectively. The duration of treatmentwas 8 weeks.
Blood pressure significantly decreased in both groups in 2 weeks. In MCTZ group, blood pressure showed a continuous, gradual decrease until Week 8. In FR group, a mild reduction in blood pressure was seen from Week 2 onwards, at Week 8 there being a further decrease.
Comparison of laboratory data before and after treatment revealed increase in BUN and serum Na+ in FR group.In MCTZ group, increase in some hematological indexes and serum creatinine value and decrease in serum Na+, K+ and Cl- were seen. Severe liver function disturbance was noted in one patient of FR group.
Serum uric acid increased in MCTZ group.In contrast, it decreased in FR demonstrating a distinct uricosuric effect.
Symptoms appearing during the treatment period which did not occur during the control period consisted of those of central nervous, autonomic nervous and gastrointestinal systems. These symptoms occurred in 15 of 50 patients in the FR group and 7 of 46 patients in the MCTZ group.
The usefulness of both drugs was globally assessed based on symptomatic change, antihypertensive effectiveness, adverse reaction, laboratory data abnormalities, etc. There was no significant intergroup difference at 5% level.