A random comparison of fosinopril and nifedipine GITS in patients with primary renal disease

Objective To investigate in a random comparison the capacity of an angioten sin converting enzyme inhibitor (fosinopril), and that of a long-acting dih ydropiridine (nifedipine GITS) to modify the decay in renal function in pat ients with primary renal disease, exhibiting a progressive increase in seru m creatinine during the previous 2 years. Methods A randomized, open-label, multicenter study with a minimum follow-u p of 3 years. A total of 241 patients were included in the study. All of th em were hypertensive and had a 25% or at least 0.5 mg/dl increase in the va lue of serum creatinine during the 24 months prior to entering the study. I nitial doses of fosinopril and nifedipine GITS were 10 and 30 mg respective ly, and titration to 30 and 60 mg was performed if needed to obtain the exp ected blood pressure goal (< 140/90 mmHg). Furosemide, atenolol, and doxazo sin were added as second, third, and fourth drugs if necessary, for blood p ressure control. The primary end-point of the study was the appearance of d ouble the serum creatinine values and/or the need to enter a dialysis progr amme. Secondary end-points were cardiovascular events, death, changes in 24 h proteinuria, and the evolution of serum creatinine. Data reflect the ana lysis performed by intention to treat. Results Mean age of the group was 54 +/- 14, and 59% were males. Primary gl omerulonephritis (31 %), nephrosclerosis (26%) and polycystic kidney diseas e (19%) were the three most frequent diagnostic findings. After 3 years of follow-up, 21% (27/127) of patients treated with fosinopril, and 36% (40/11 2) of those receiving nifedipine GITS presented a primary end-point, (OR 0. 47, 95% confidence intervals 0.26-0.84, P = 0.01). Renal survival was signi ficantly better when fosinopril constituted the first step therapy (P = 0.0 02). These results did not seem to be influenced by the type of primary ren al disease. Proteinuria decreased at the end of the study by a mean of 57% in the fosinopril group and increased by 7% in the group receiving dihydrop iridine. Blood pressure control did not differ among groups for diastolic v alues. During followup, however, the patients receiving ACEi showed systoli c blood pressure values 4-6 mmHg lower. Conclusion In patients with chronic renal failure and hypertension due to p rimary renal disease, fosinopril significantly differed from nifedipine GIT S by its capacity to slow the progressive decay in renal function. The drug s also differed by their capacity to lower blood pressure. The better contr ol, in particular of systolic blood pressure, in the fosinopril arm could h ave contributed in a relevant manner to the attainment of a better outcome when the ACE was employed. (C) 2001 Lippincott Williams & Wilkins.