EFFICACY AND TOLERABILITY OF VALSARTAN COMPARED WITH LISINOPRIL IN PATIENTS WITH HYPERTENSION AND RENAL-INSUFFICIENCY

This study compared the efficacy and tolerability of valsartan with an angiotensin converting enzyme inhibitor, lisinopril, in hypertensive patients with renal insufficiency. A total of 188 male and female outp atients with stable renal insufficiency [creatinine clearance (CLCR) 2 0 to 70 ml/min/1.73m(2)] were randomised in a 1.1 ratio to receive val sartan or lisinopril in this single-centre, double-blind 13-week trial . Patients were stratified prior to randomisation according to CLCR - stratum 1: CLCR 20 to 30 ml/min/1.73m(2);stratum 2: CLCR 31 to 70 ml/m in/1.73m(2). Stratum 1 patients received once-daily valsartan 40mg or lisinopril 2.5mg for 1 week, increasing to 80mg or 5mg, respectively, for 12 weeks. Stratum 2 patients received once-daily valsartan 40mg fo r the first week or lisinopril 5mg for 1 week increasing to 80mg or 10 mg, respectively, for 12 weeks. In nonresponders, furosemide was added to monotherapy at 9 weeks. For the primary variable, valsartan 80mg o nce daily and lisinopril 5/10mg once daily successfully reduced sittin g diastolic blood pressure from baseline at the 9-week monotherapy end -point (adjusted mean changes -7.97mm Hg and -8.75mm Hg, respectively) . The adjusted mean difference between the valsartan and lisinopril tr eatment groups was 0.77mm Hg and was not statistically significant (95 % CI: -1.68, 3.23; p = 0.538). There were similar reductions in sittin g systolic blood pressure with both treatments, without any statistica lly significant difference between the two groups (adjusted mean diffe rence at 9-week end-point: 0.61mm Hg; 95% CI: -3.11, 4.32; p = 0.75). The ratio of geometric mean changes' from baseline in glomerular filtr ation rate (GFR) at 9 weeks was 0.92 and 0.93 for valsartan and lisino pril, respectively. The ratio at 9 weeks in GFR between valsartan and lisinopril was 0.99 (95% CI: 0.96, 1.03) and was not statistically sig nificant (p = 0.612). No significant treatment differences were observ ed for albumin fractional clearance, IgG fractional clearance or 24-ho ur urinary protein excretion. Four patients (4.3%) on valsartan and 2 patients (2.1%) on lisinopril reported adverse experiences. Dry cough of moderate severity for one of the patients on lisinopril was the onl y adverse experience considered to be drug related. The results show v alsartan to be as effective as lisinopril in lowering blood pressure a nd to be well tolerated with no deleterious effects on renal function in hypertensive patients with stable renal insufficiency.