The Long-Term Impact of Renin-Angiotensin System (RAS) Inhibition on Cardiorenal Outcomes (LIRICO): A Randomized, Controlled Trial.

BACKGROUND: The comparative effectiveness of treatment with angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or their combination in people with albuminuria and cardiovascular risk factors is unclear. METHODS: In a multicenter, randomized, open label, blinded end point trial, we evaluated the effectiveness on cardiovascular events of ACE or ARB monotherapy or combination therapy, targeting BP<130/80 in patients with moderate or severe albuminuria and diabetes or other cardiovascular risk factors. End points included a primary composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for cardiovascular causes and a revised end point of all-cause mortality. Additional end points included ESRD, doubling of serum creatinine, albuminuria, eGFR, BP, and adverse events. RESULTS: Because of slow enrollment, the trial was modified and stopped 41% short of targeted enrollment of 2100 participants, corresponding to 35% power to detect a 25% reduced risk in the primary outcome. Our analysis included 1243 adults, with median follow-up of 2.7 years. Efficacy outcomes were similar between groups (ACE inhibitor versus ARB, ACE inhibitor versus combination, ARB versus combination) as were rates of serious adverse events. The rate of permanent discontinuation for ARB monotherapy (6.3%) was significantly lower than for ACE inhibitor monotherapy (15.7%) or combined therapy (18.3%). CONCLUSIONS: Patients may tolerate ARB monotherapy better than ACE inhibitor monotherapy. However, data from this trial and similar trials, although as yet inconclusive, show no trend suggesting differences in mortality and renal outcomes with ACE inhibitors or ARBs as dual or monotherapy in patients with albuminuria and diabetes or other cardiovascular risk factors.

Epidemiology of end-stage renal disease in an interregional perspective: Registries of Puglia and Basilicata, southern Italy.

BACKGROUND: This report on the 1994-1998 Dialysis and Transplantation Registry (DTR) of Puglia and Basilicata provides the first epidemiological profile of ESRD in southern Italy. METHODS: Frequency measures of patients in renal replacement therapy (RRT) were computed for Puglia and Basilicata (inhabitants: 4,086,422 and 610,000 respectively). Hazard ratios (HR) of death in relation to sex, age, educational level, primary nephropathies, and modality of dialysis, were estimated by applying the Cox model to patients starting dialysis as first RRT in 1994-1998 in Puglia. RESULTS: The prevalence of treated ESRD in Puglia was 881 per million population (p.m.p.) (dialysis: 721 p.m.p.) in 1998, 713 p.m.p. (dialysis: 617 p.m.p.) in 1994. In Basilicata the prevalence of ESRD was 795 p.m.p. (dialysis: 669 p.m.p.) in 1998, 636 p.m.p. (dialysis: 575 p.m.p.) in 1994. Mean age at start of dialysis of incident cases of Puglia was 60 yr (median: 64 yr). Figures of diabetes, vascular diseases, and glomerulonephritis, were: 16%, 21%, 17%. Out of 2,152 incident patients on dialysis for at least one month, 293 started with peritoneal dialysis (PD). A 60-70% higher risk of death was observed for diabetic nephropathy and PD. In the Puglia/Basilicata DTR pooled analysis, lower educational level was associated with a 60% increased mortality risk. CONCLUSIONS: The associations of PD and low education with the risk of death are very likely to be due to comorbid conditions, unavailable in these databases as in most regional and national DTR. By looking at variations of rates and outcomes among areas, potential improvements of local DTR for planning and research uses are discussed.

Relationship between the atopy patch test and clinical expression of the disease in children with atopic eczema/dermatitis syndrome and respiratory symptoms.

BACKGROUND: The atopy patch test (APT) may be the only positive skin test result in patients with either atopic eczema/ dermatitis syndrome (AEDS) or respiratory abnormalities with or without AEDS. OBJECTIVE: To investigate the possible significance of APT to dust mite by comparing the positive result to this test with that of the skin prick test (SPT) in patients with different characteristics. METHODS: A total of 297 individuals (178 boys and 119 girls) aged 5 to 221 months (mean [SD] age, 64.5 [42.1] months; median age, 58 months) were included in this study. Participants were divided into 4 groups: current AEDS, current AEDS and respiratory symptoms, past AEDS and respiratory symptoms, and respiratory symptoms with neither current nor past AEDS (control group). All the patients underwent SPT and APT using house dust mite extract. RESULTS: In the study groups, the rate of positivity was significantly higher for APT, whereas in the control group, there were significantly more positive results to SPT (P < .001 for both). Multivariate analysis showed that there was a high probability of a positive APT result in patients with AEDS (odds ratio [OR], 17.4), with AEDS and respiratory disease (OR, 21.9), and with past AEDS and respiratory disease (OR, 22.8). CONCLUSIONS: These patients with AEDS showed 2 different patterns of allergic response to allergens, one IgE mediated (as evaluated by positive SPT results) and the other cell mediated (as evaluated by positive APT results). The former seems to follow the so-called atopic march model, and the latter persists even after the disappearance of AEDS and is likely to be implicated in the pathogenesis of respiratory allergy.