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 outpatients with stable renal insufficiency [creatinine clearance (CL(CR)) 20 to 70 ml/min/1.73 m2 were randomised in a 1:1 ratio to receive valsartan or lisinopril in this single-centre, double-blind 13-week trial. Patients were stratified prior to randomisation according to CL(CR) - stratum 1: CL(CR) 20 to 30 ml/min/1.73 m2: stratum 2: CL(CR) 31 to 70 ml/min/1.73 m2. Stratum 1 patients received once-daily valsartan 40 mg or lisinopril 2.5 mg for 1 week, increasing to 80 mg or 5 mg, respectively, for 12 weeks. Stratum 2 patients received once-daily valsartan 40 mg for the first week or lisinopril 5 mg for 1 week increasing to 80 mg or 10 mg, respectively, for 12 weeks. In nonresponders, furosemide was added to monotherapy at 9 weeks. For the primary variable, valsartan 80 mg once daily and lisinopril 5/10 mg once daily successfully reduced sitting diastolic blood pressure from baseline at the 9-week monotherapy end-point (adjusted mean changes -7.97 mmHg and -8.75 mmHg, respectively). The adjusted mean difference between the valsartan and lisinopril treatment groups was 0.77 mmHg and was not statistically significant (95% CI: -1.68, 3.23; p = 0.538). There were similar reductions in sitting systolic blood pressure with both treatments, without any statistically significant difference between the two groups (adjusted mean difference at 9-week end-point: 0.61 mmHg; 95% CI: -3.11, 4.32; p = 0.75). The ratio of geometric mean changes from baseline in glomerular filtration rate (GFR) at 9 weeks was 0.92 and 0.93 for valsartan and lisinopril, 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 significant (p = 0.612). No significant treatment differences were observed for albumin fractional clearance, IgG fractional clearance or 24-hour 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 only adverse experience considered to be drug related. The results show valsartan to be as effective as lisinopril in lowering blood pressure and to be well tolerated with no deleterious effects on renal function in hypertensive patients with stable renal insufficiency.
|Number of pages||8|
|Journal||Clinical Drug Investigation|
|Publication status||Published - 1997|
ASJC Scopus subject areas
- Pharmacology (medical)