The effects of amlodipine and enalapril on renal function in adults with hypertension and nondiabetic nephropathies: a 3-year, randomized, multicenter, double-blind, placebo-controlled study.

BACKGROUND: Placebo-controlled trials have found that angiotensin-converting enzyme inhibitors (ACEIs) decrease proteinuria and slow the progression of nondiabetic nephropathies. However, head-to-head comparisons of ACEIs and calcium channel blockers (CCBs) have shown conflicting results. Indeed, a recent metaanalysis concluded that there is still uncertainty about the greater renoprotection seen with ACEIs or angiotensin II receptor blockers in nondiabetic patients with renal disease, particularly when using true glomerular filtration rate (GFR) as the primary outcome. OBJECTIVE: The objective of this 3-year, randomized, multicenter, double-blind, placebo-controlled study was to compare true GFR decline (measured by yearly 51Cr-EDTA blood clearance) in nondiabetic, nonnephrotic adult hypertensive patients with estimated creatinine clearance of 20 to 60 mL/min.1.73 m(2), when randomized to a CCB (amlodipine, 5-10 mg/d) or an ACEI (enalapril, 5-20 mg/d). METHODS: Patients (aged 18-80 years) entered a 4-week placebo run-in washout period and previous antihypertensive drugs were tapered off over 2 weeks. Add-on treatments were atenolol (50-100 mg/d), loop diuretics (furosemide, 20-500 mg/d or torsemide, 5-200 mg/d), alpha-blockers (prazosin, 2.5-5 mg/d or doxazosin, 1-16 mg/d), and centrally acting drugs (rilmenidine, 1-2 mg/d or methyldopa, 250-500 mg/d). The primary end point was true GFR measured by yearly (51)Cr-EDTA blood clearance. Secondary end points included a clinical composite of renal events and tolerability collected by a full clinical and laboratory evaluation at each study visit. Post hoc analyses for the change in GFR, proteinuria, and time to clinical events were also planned on baseline proteinuria subgroups (<1 and >or=1 g/d) before unblinding the database. RESULTS: Three hundred eighteen patients entered the run-in period and 263 patients (156 men/107 women; mean age, 58 years) were randomized to receive either amlodipine (5 mg/d, n=132) or enalapril (5 mg/d, n=131). Blood pressure declined from 165/102 mm Hg to 138/84 mm Hg and 138/85 mm Hg with amlodipine and enalapril, respectively (no between-group significance). Only 20.8% of the patients randomized to ACEI treatment received diuretics at the last observation. No statistically significant difference was found between amlodipine and enalapril in GFR decline (-4.92 and -3.98 mL/min.1.73 m(2), respectively, at last observation) and composite secondary end point after a median follow-up of 2.9 years, including in the subgroup of patients with proteinuria >1 g/d at baseline. Protein excretion rate decreased significantly from baseline in patients taking enalapril plus diuretics (median -270 mg/d; P<0.001) but not in patients taking amlodipine plus diuretics (-25 mg/d at last observation). CONCLUSION: In this cohort of nondiabetic, nonnephrotic hypertensive patients, no statistically significant difference in true GFR decline was found over 3 years between amlodipine-treated patients and enalapril-treated patients with main add-on treatment with ss-blockers, including in the subgroup of patients with proteinuria >1 g/d.

Factors influencing prognosis of pneumonia in elderly patients.

BACKGROUND AND AIMS: Polymorbidity reduces the survival of elderly patients with pneumonia. The aim of the proposed study was to identify factors determining mortality in such patients. METHODS: From January 1, 1999 to December 31, 2001, 2870 patients were admitted to the Clinic of Geriatric Medicine, Faculty of Medicine, Comenius University, Bratislava. From these, 199 patients treated for pneumonia (average age +/- SD 79.7 +/- 7.6 yr) were assigned to a retrospective study. 112 patients recovered and 87 died. The prognostic significance of the chosen factors was evaluated by comparing their incidence between the groups of surviving and non-surviving patients. RESULTS: Prognosis for patients with pneumonia is worsened significantly by: older age; immobilization syndrome; incontinence of urine and feces; presence of some clinical and laboratory characteristics at the time of diagnosis of pneumonia (respiratory insufficiency, absence of fever, leukocytosis); pneumonia acquired in hospital; immunosuppressive therapy and comorbid conditions (congestive heart failure, chronic renal insufficiency, anemia, hepatic, psychiatric and neoplastic diseases). According to multivariate analysis, the most significant mortality-predicting characteristics were: immobilization (odds ratio (OR) 9.36; 95% confidence interval (CI) 3.92-22.33); congestive heart failure (OR 8.26; 95% CI 3.08-22.14); immunosuppressive therapy (OR 7.47; 95% CI 2.54-21.98) and psychiatric diseases (OR 4.53; 95% CI 1.94-10.58). CONCLUSIONS: Patients with immobilization, congestive heart failure, immunosuppressive therapy, or psychiatric diseases run a high risk of death and require intensive medical care.