Biomedical subjects

Annibale Biggeri

Publications and source records attributed to Annibale Biggeri.

At least 19 recordsLinked to original sources

PubMed2006

Maternal complications and procedures in pregnancy and at birth and wheezing phenotypes in children.

RATIONALE: There is increasing interest in the potential influence of fetal and early life conditions on childhood wheezing. OBJECTIVES: To investigate the associations between maternal complications and procedures in pregnancy and at birth and the risk of various wheezing phenotypes in young children. METHODS: We studied 15,609 children, aged 6-7 yr, enrolled in a population-based study. Standardized questionnaires were completed by the children's mothers. RESULTS: Of the children, 9.5% (1,478) had transient early wheezing, 5.4% (884) had persistent wheezing, and 6.1% (948) had late-onset wheezing. Maternal hypertension or preeclampsia was associated with an increased risk of all three wheezing phenotypes (for transient early wheezing: odds ratio [OR], 1.40; 95% confidence interval [95% CI], 1.08-1.82; for persistent wheezing: OR, 1.59; 95% CI, 1.15-2.19; and for late-onset wheezing: OR, 1.47; 95% CI, 1.06-2.01). Use of antibiotics for urinary tract infections was associated with transient early wheezing (OR, 1.52; 95% CI, 1.16-2.00), whereas antibiotic administration at delivery was associated with both transient early wheezing (OR, 1.21; 95% CI, 1.01-1.46) and persistent wheezing (OR, 1.39; 95% CI, 1.10-1.75). Children who had a mother with diabetes were also more likely to have persistent wheezing (OR, 1.72; 95% CI, 0.99-3.00). Neither amniocentesis/chorionic villus sampling, nor weight gain in pregnancy, nor cesarean section was associated with the subsequent development of wheezing. Maternal asthma or atopy was not an effect modifier of the associations found. CONCLUSIONS: Some maternal complications during pregnancy and at delivery may increase the risk of developing different phenotypes of wheezing in childhood.

Child↗

PubMed2006

Canine faecal contamination and parasitic risk in the city of Naples (southern Italy).

BACKGROUND: Dogs are associated with more than 60 zoonotic diseases among which, parasitosis and, in particular, helminthosis, can pose serious public-health concerns worldwide. Many canine gastrointestinal parasites eliminate their dispersion elements (eggs, larvae, oocysts) by the faecal route. The quantity of canine faeces deposited on public and private property in cities worldwide is both a perennial nuisance and an important health issue. Public sites such as playgrounds, parks, gardens, public squares and sandpits may be an important source of human infection. The aim of this study was to evaluate the extent of both canine faecal contamination in the city of Naples (southern Italy), and presence of canine parasitic elements, with particular regard to those which are potential agents of zoonosis. A regular grid of sub-areas (1 km x 700 m) was overlaid on the city map using a Geographical Information System (GIS). In each sub-area the straightest 1 km transect was drawn and digitalized on-screen in the GIS. Between February and May 2005 canine faeces were counted along the 1 km transects in 143 sub-areas, and 415 canine faecal samples were collected and submitted to coprological examinations. Negative binomial regression models and Gaussian random effects models were used to analyze the association between faeces count and human population density taking into account for extraPoisson variability. Logistic regression model was used to evaluate the association between positivity to parasitic elements and number of canine faeces. RESULTS: Out of the 143 studied sub-areas, 141 (98.6%) contained canine faeces. There was a strong spatial gradient with 48% of the total variability accounted by between neighbourhood variability; a positive association between the number of faeces and the human population density was found. Seventy (over 415, 16.9%) canine faecal samples were positive for parasitic elements. There was no association between positivity to parasitic elements and the number of canine faeces. Eggs of Toxocara canis, Toxascaris leonina, Ancylostoma caninum and Trichuris vulpis were found, as well as oocysts of Isospora canis. CONCLUSION: In conclusion, the results of the present study, conducted using GIS both for planning and sampling and for evaluation and presentation of findings, showed the presence of canine faecal contamination in the city of Naples, and the presence of canine parasitic elements, some of which are potential agents of zoonosis.

Animals↗

PubMed2006

Vulnerability to heat-related mortality: a multicity, population-based, case-crossover analysis.

BACKGROUND: Although studies have documented increased mortality during heat waves, little information is available on the subgroups most susceptible to these effects. We evaluated the effects of summertime high temperature on daily mortality among population subgroups defined by demographic characteristics, socioeconomic status, and episodes of hospitalization for various conditions during the preceding 2 years. METHODS: We studied a total of 205,019 residents of 4 Italian cities (Bologna, Milan, Rome, and Turin) age 35 or older who died during 1997-2003. The case-crossover design was applied to evaluate the association between mean apparent temperature (same and previous day) and all-cause mortality. Pooled odds ratios (ORs) and 95% confidence intervals (CIs) of dying at 30 degrees C (apparent temperature) relative to 20 degrees C were estimated accounting for time, population changes, and air pollution. RESULTS: We found an overall OR of 1.34 (CI = 1.27-1.42) at 30 degrees C relative to 20 degrees C. The odds ratio increased with age and was higher among women (OR = 1.45; 1.37-1.52) and among widows and widowers (1.50; 1.33-1.69). Low area-based income modestly increased the effect. Among the preexisting medical conditions investigated, effect modification was detected for previous psychiatric disorders (1.69; 1.39-2.07), depression (1.72; 1.24-2.39), heart conduction disorders (1.77; 1.38-2.27), and circulatory disorders of the brain (1.47; 1.34-1.62). Temperature-related mortality was higher among people residing in nursing homes, and a large effect was also detected for hospitalized subjects. CONCLUSIONS: Subsets of the population that are particularly vulnerable to high summer temperatures include the elderly, women, widows and widowers, those with selected medical conditions, and those staying in nursing homes and healthcare facilities.

Adult↗

PubMed2006

Impact of high temperatures on mortality: is there an added heat wave effect?

BACKGROUND: Mortality during sustained periods of hot weather is generally regarded as being in excess of what would be predicted from smooth temperature-mortality gradients estimated using standard time-series regression models. However, the evidence for an effect of continuous days of exceptional heat ("heat wave effect") is indirect. In addition, because some interventions may be triggered only during forecasted heat waves, it would be helpful to know what fraction of all heat-related deaths falls during these specific periods and what fraction occurs throughout the remainder of the summer. METHODS: Extended time-series data sets of daily mortality counts in 3 major European cities (London, 28 years of data; Budapest, 31 years; Milan, 18 years) were examined in relation to hot weather using a generalized estimating equations approach. We modeled temperature and specific heat wave terms using a variety of specifications. RESULTS: With a linear effect of same-day temperature above an identified threshold, an additional "heat wave" effect of 5.5% was observed in London (95% confidence interval = 2.2 to 8.9), 9.3% in Budapest (5.8 to 13.0), and 15.2% in Milan (5.7 to 22.5). Heat wave effects were reduced slightly when we relaxed the linear assumption and these effects were reduced substantially when temperature was modeled as an average value of lags 0 to 2 days. In London, fewer than half of all heat-related deaths could be attributed to identified heat wave periods. In Milan and Budapest, the fraction was less than one fifth. CONCLUSIONS: Heat wave effects were apparent in simple time-series models but were reduced in multilag nonlinear models and small when compared with the overall summertime mortality burden of heat. Reduction of the overall heat burden requires preventive measures in addition to those that target warnings and responses uniquely to heat waves.

Epidemiologic Methods↗

PubMed2006

Disease mapping in veterinary epidemiology: a Bayesian geostatistical approach.

Model-based geostatistics and Bayesian approaches are useful in the context of veterinary epidemiology when point data have been collected by appropriate study design. We take advantage of an example of Epidemiological Surveillance on urban settings where a two-stage sampling design with first stage transects is applied to study the risk of dog parasite infection in the city of Naples, 2004-2005. We specified Bayesian Gaussian spatial exponential models and Bayesian kriging were performed to predict the continuous risk surface of parasite infection on the study region. We compared the results with those obtained by the application of hierarchical Bayesian models on areal data (proportion of positive specimens by transect). The models results were consistent with each other and the Bayesian geostatistical approach proved to be more accurate in identifying areas at risk of zoonotic parasitic diseases. In general, larger risk areas were identified at the city border where wild dogs mixed with domestic dogs and human or urban barriers were less present.

Animal Diseases↗

PubMed2006

Changes in prevalence of asthma and allergies among children and adolescents in Italy: 1994-2002.

BACKGROUND: Several studies conducted during the 1990s indicated an increase in the prevalence of symptoms of asthma; more recent investigations suggest that the trend is stabilizing or may even be reversing. OBJECTIVE: We compared 2 cross-sectional surveys conducted in 1994 and 2002 in 8 areas in northern and central Italy, to evaluate prevalence changes for asthma, allergic rhinitis, and eczema. METHODS: The International Study of Asthma and Allergies in Childhood methods and questionnaires were used to investigate 6- to 7-year-old children (16,115 and 11,287 questionnaires completed by parents in 1994-1995 and 2002, respectively) and 13- to 14-year-old adolescents (19,723 and 10,267 questionnaires completed by adolescents in 1994-1995 and 2002, respectively). In each phase, the overall response rate was >90%. Prevalence changes were calculated as the absolute difference between the prevalence recorded on the 2 occasions. RESULTS: The prevalence of wheeze (past 12 months) increased slightly among children (change: 0.8%; 95% confidence interval [CI]: 0.0% to 1.6%) and was rather stable among adolescents. Symptoms of allergic rhinitis (children: change: 5.2%; 95% CI: 4.0% to 6.4%; adolescents: change: 4.1%; 95% CI: 1.9% to 6.3%) and symptoms of atopic eczema (children: change: 4.4%; 95% CI: 3.6% to 5.2%; adolescents: change: 2.1%; 95% CI: 1.2% to 3.0%) increased clearly in both age groups. There was some heterogeneity across the centers among adolescents, especially for allergic rhinitis, with larger increases seen in the 3 metropolitan areas. The changes observed paralleled profound family changes, ie, better parental education, higher rates of maternal employment, and lower rates of exposure to parental smoke. These factors, however, do not explain all of the observed changes in prevalence. CONCLUSIONS: The results indicate that the epidemiologic features of asthma and allergies in Italy are changing rapidly, although the causes are still uncertain.

Adolescent↗

PubMed2005

Using a calibration experiment to assess gene-specific information: full Bayesian and empirical Bayesian models for two-channel microarray data.

MOTIVATION: Microarray studies permit to quantify expression levels on a global scale by measuring transcript abundance of thousands of genes simultaneously. A difficulty when analysing expression measures is how to model variability for the whole set of genes. It is usually unrealistic to assume a common variance for each gene. Several approaches to model gene-specific variances are proposed. We take advantage of calibration experiments, in which the probes hybridized on the two channels come from the same population (self-self experiment). In this case it is possible to estimate the gene-specific variance, to be incorporated in comparative experiments on the same tissue, cellular line or species. RESULTS: We present two approaches to introduce prior information on gene-specific variability from a calibration experiment: an empirical Bayes model and a full Bayesian hierarchical model. We apply the methods in the analysis of human lipopolysaccharide-stimulated leukocyte experiments. AVAILABILITY: The calculations are implemented in WinBugs. The codes are available on request from the authors.

Algorithms↗

PubMed2005

Space-time models with time-dependent covariates for the analysis of the temporal lag between socioeconomic factors and lung cancer mortality.

The relationship between socioeconomic factors and mortality for lung cancer is investigated. To identify the proper lag time between socioeconomic factors and lung cancer mortality, a space-time hierarchical Bayesian model with time-dependent covariates is adopted. A real example on lung cancer mortality, males, in Tuscany (Italy) during the period 1971-1999, is provided. Results confirm the presence of an association between mortality for lung cancer and socioeconomic factors with a temporal lag (latency time) of at least 10 years.

Adolescent↗

PubMed2005

Adult myeloid leukaemia and radon exposure: a Bayesian model for a case-control study with error in covariates.

The possible association between radon exposure in dwellings and adult myeloid leukaemia had been explored in an Italian province by a case-control study. A total of 44 cases and 211 controls were selected from death certificates file. No association had been found in the original study (OR = 0.58 for > 185 vs 80 < or = Bq/cm). Here we reanalyse the data taking into account the measurement error of radon concentration and the presence of missing data. A Bayesian hierarchical model with error in covariates is proposed which allows appropriate imputation of missing values. The general conclusion of no evidence of association with radon does not change, but a negative association is not observed anymore (OR = 0.99 for > 185 vs 80 < or = Bq/cm). After adjusting for residential house radon and gamma radiation, and for the multilevel data structure, geological features of the soil is associated with adult myeloid leukaemia risk (OR = 2.14, 95 per cent Cr.I. 1.0-5.5).

Adult↗

PubMed2005

Extremely low-frequency electromagnetic fields do not affect DNA damage and gene expression profiles of yeast and human lymphocytes.

We studied the effects of extremely low-frequency (50 Hz) electromagnetic fields (EMFs) on peripheral human blood lymphocytes and DBY747 Saccharomyces cerevisiae. Graded exposure to 50 Hz magnetic flux density was obtained with a Helmholtz coil system set at 1, 10 or 100 microT for 18 h. The effects of EMFs on DNA damage were studied with the single-cell gel electrophoresis assay (comet assay) in lymphocytes. Gene expression profiles of EMF-exposed human and yeast cells were evaluated with DNA microarrays containing 13,971 and 6,212 oligonucleotides, respectively. After exposure to the EMF, we did not observe an increase in the amount of strand breaks or oxidated DNA bases relative to controls or a variation in gene expression profiles. The results suggest that extremely low-frequency EMFs do not induce DNA damage or affect gene expression in these two different eukaryotic cell systems.

Blood Proteins↗

PubMed2004

Effect of polyphenolic extracts from red wine and 4-OH-coumaric acid on 1,2-dimethylhydrazine-induced colon carcinogenesis in rats.

BACKGROUND: Total polyphenolic extracts from red wine protect against azoxymethane (AOM)-induced colon carcinogenesis in rats. Since red wine contains more than 200 different polyphenolic compounds, it is still unclear which substances are responsible for this effect. AIM OF THE STUDY: We investigated the effect of high molecular weight polyphenols (HMWP), low molecular weight polyphenols (LMWP) and total polyphenolic extracts from red wine (WE) on colon carcinogenesis. We also tested the effect of 4-OH-coumaric acid, a potent phenolic antioxidant present in wine and fruit. METHODS: F344 rats were treated weekly with 1,2-dimethylhydrazine (DMH) (30 mg/kg b.w. subcutaneously x 10 times). One week after the final DMH injection rats were divided into five groups and fed: a) a high fat (HF) diet containing 23% corn oil (w/w), as control or the same basal diet supplemented with b) 0.11 % (w/w) WE; c) 0.027% (w/w) HMWP d) 0.083% (w/w) LMWP or e) 0.1 % (w/w) 4-OH-coumaric acid. The dietary treatments continued until sacrifice, 16 weeks after the last DMH injection. RESULTS: WE treated rats had significantly fewer (p < 0.05) colorectal adenomas than controls, while rats in other treatment groups did not differ significantly from controls (colorectal adenomas/rat were: 2.2 +/- 0.3; 1.4 +/- 0.2; 2.9 +/- 0.5; 2.6 +/- 0.4; 2.3 +/- 0.3; in controls, WE, HMWP, LMWP and 4-OH-coumaric acid groups, respectively; means +/- SE). The mean number of colorectal carcinomas per rat was similar among all experimental groups. Proliferative activity in the normal colon mucosa did not vary among experimental groups. CONCLUSIONS: Total polyphenolic extracts (WE) from red wine, but neither the HMWP nor the LMWP, have some inhibitory effect on the process of colon carcinogenesis by DMH reducing the number of adenomas.

1,2-Dimethylhydrazine↗

PubMed2004

A longitudinal evaluation of two-year outcome in a community-based mental health service using graphical chain models. The South-Verona Outcome Project 9.

The 2-year outcome of 178 patients attending a community-based mental health service was assessed from a multidimensional perspective. The study investigated: (1) the effect of disease-related characteristics (such as diagnosis and illness duration) and of a series of outcome variables measured at baseline (global functioning, psychopathology, social disability, quality of life and satisfaction with services) on total costs of care over 2 years; and (2) the effect of costs of care and outcome variables measured at baseline on the corresponding outcome variables at 2 years. To gain insight into the multivariate longitudinal dependencies among variables, we used graphical Gaussian chain models, a new multivariate method that analyses the relationship between continuous variables taking into account the effect of antecedent and intervening variables, to reveal not only direct but also indirect correlations. Outcome variables showed the tendency to segregate, both at baseline and follow-up, into two distinct groups: a clinician-rated dimension (given by global functioning, social disability and psychopathology) and a patient-rated dimension (given by service satisfaction and subjective quality of life). Higher costs at 2 years were predicted by higher psychopathology at baseline, diagnosis of psychosis and longer duration of illness. Baseline values for each variable were the main predictors of the corresponding values at two years. Improvement in satisfaction with life at follow-up was experienced in those subjects with a lower functioning at baseline. This study throws some light on the complex relationships between clinical, social and economic variables affecting the medium-term outcome of mental health care.

Adult↗

PubMed2004

A comparison of non-iterative and iterative estimators of heterogeneity variance for the standardized mortality ratio.

This paper continues work presented in Böhning et al. (2002b, Annals of the Institute of Statistical Mathematics 54, 827-839, henceforth BMSRB) where a class of non-iterative estimators of the variance of the heterogeneity distribution for the standardized mortality ratio was discussed. Here, these estimators are further investigated by means of a simulation study. In addition, iterative estimators including the Clayton-Kaldor procedure as well as the pseudo-maximum-likelihood (PML) approach are added in the comparison. Among all candidates, the PML estimator often has the smallest mean square error, followed by the non-iterative estimator where the weights are proportional to the external expected counts. This confirms the theoretical result in BMSRB in which an asymptotic efficiency could be proved for this estimator (in the class of non-iterative estimators considered). Surprisingly, the Clayton-Kaldor iterative estimator (often recommended and used by practitioners) performed poorly with respect to the MSE. Given the widespread use of these estimators in disease mapping, medical surveillance, meta-analysis and other areas of public health, the results of this study might be of considerable interest.

Berlin↗

PubMed2004

Analyzing a randomized trial on breast self-examination with noncompliance and missing outcomes.

Recently, instrumental variables methods have been used to address non-compliance in randomized experiments. Complicating such analyses is often the presence of missing data. The standard model for missing data, missing at random (MAR), has some unattractive features in this context. In this paper we compare MAR-based estimates of the complier average causal effect (CACE) with an estimator based on an alternative, nonignorable model for the missing data process, developed by Frangakis and Rubin (1999, Biometrika, 86, 365-379). We also introduce a new missing data model that, like the Frangakis-Rubin model, is specially suited for models with instrumental variables, but makes different substantive assumptions. We analyze these issues in the context of a randomized trial of breast self-examination (BSE). In the study two methods of teaching BSE, consisting of either mailed information about BSE (the standard treatment) or the attendance of a course involving theoretical and practical sessions (the new treatment), were compared with the aim of assessing whether teaching programs could increase BSE practice and improve examination skills. The study was affected by the two sources of bias mentioned above: only 55% of women assigned to receive the new treatment complied with their assignment and 35% of the women did not respond to the post-test questionnaire. Comparing the causal estimand of the new treatment using the MAR, Frangakis-Rubin, and our new approach, the results suggest that for these data the MAR assumption appears least plausible, and that the new model appears most plausible among the three choices.

Adult↗

PubMed2004

Metabolic syndrome as a predictor of all-cause and cardiovascular mortality in type 2 diabetes: the Casale Monferrato Study.

OBJECTIVE: The aim of this study was to assess in an 11-year survival follow-up of a population-based cohort of type 2 diabetes the predictive role of World Health Organization-defined metabolic syndrome, independent of conventional cardiovascular risk factors. RESEARCH DESIGN AND METHODS: During the follow-up (1991-2001), 1,565 patients were regularly examined with centralized measurements of HbA(1c). The independent role of the metabolic syndrome as a predictor of all-cause and cardiovascular mortality was assessed with multivariate Cox proportional hazards modeling. RESULTS: At baseline, the prevalence of the metabolic syndrome was 75.6% (95% CI 73.6-77.9). Results are based on 685 deaths (520 with the metabolic syndrome and 165 without it) in 10,890.2 person-years of observations. With respect to subjects without the metabolic syndrome, those with the metabolic syndrome had a similar hazard ratio (HR) of cardiovascular mortality after adjustment for age, sex, smoking, total cholesterol level, and coronary heart disease. In contrast, relative to subjects with diabetes only, the HR of subjects with only one component of the syndrome was 2.92 (1.16-7.33), independent of other risk factors. CONCLUSIONS: We found that 1) the prevalence of the metabolic syndrome in a population-based cohort of type 2 diabetes is high (75.6%); 2) the metabolic syndrome is not a predictor of 11-year all-cause and cardiovascular mortality; and 3) more than twofold higher cardiovascular risk, independent of conventional risk factors, is evident in diabetic subjects with only one component of the syndrome compared with those with diabetes only. Categorizing type 2 diabetic subjects as having or not having the metabolic syndrome does not provide further prediction compared with the knowledge of its single components.

Aged↗

PubMed2004

Mortality from chronic obstructive pulmonary disease and pleural mesothelioma in an area contaminated by natural fiber (fluoro-edenite).

OBJECTIVES: The purpose of the present study was to investigate the association between mortality from chronic obstructive pulmonary disease (COPD) and exposure to fluoro-edenite, a newly discovered amphibolic fiber found in Biancavilla (Sicily), a municipality on the slope of the Etna volcano, where a high mortality from malignant mesothelioma had been previously observed. METHODS: Thirty-six municipalities located in the volcanic area of mount Etna were selected for study. An ecological regression model was applied with mortality from COPD as the dependent variable, mortality from mesothelioma as a proxy for exposure to fluoro-edenite, and lung cancer mortality, an urban-rural index, a deprivation index and an aging index as the predictors of COPD mortality. For each municipality, risk classes were determined for the continuous variables with the use of a finite mixture model. RESULTS: A significant association was found between COPD mortality and pleural neoplasm mortality among the women in this study. The association was less consistent for the men. CONCLUSIONS: Despite the limitations of this ecological study, the results cohere with the results of toxicologic and observational studies and suggest an etiologic role for fluoro-edenite in nonmalignant respiratory diseases.

Adult↗

PubMed2003

Progression to overt nephropathy in type 2 diabetes: the Casale Monferrato Study.

OBJECTIVE: The first sign of diabetic nephropathy is microalbuminuria, but its predictive role of progression to overt nephropathy in type 2 diabetes has not yet been clarified. The aims of this study were to assess during 7 years of follow-up the incidence rate of overt nephropathy and the predictive role of microalbuminuria and other baseline variables (blood pressure, lipids, fibrinogen, uric acid, smoking, and HbA(1c) cumulative average during follow-up). RESEARCH DESIGN AND METHODS: A prospective population-based study was performed in Casale Monferrato, Italy, including 1,253 type 2 diabetic patients recruited at baseline (1991-1992), 765 with normoalbuminuria (albumin excretion rate [AER] <20 microg/min) and 488 with microalbuminuria (AER 20-200 microg/min). All measurements were centralized. A nested case-control study within the cohort was performed, selecting four control subjects, frequency matched for age and attained individual time of follow-up with each case. Conditional regression analysis was performed to assess variables independently associated with risk of progression to overt nephropathy. RESULTS: Of 1,253 total patients, 1,103 (88.0%) were included in the follow-up examination (median 5.33 years); their age and duration of disease at baseline were 68.4 +/- 10.5 years and 10.4 +/- 6.6 years, respectively. Cases of overt nephropathy were 202, giving an incidence rate of 37.0/1,000 person-years (95% CI 32.3-42.6). In conditional logistic regression analyses, microalbuminuria provided a 42% increased risk with respect to normoalbuminuria (95% CI 0.98-2.06), independently of duration of diabetes, hypertension, and systolic blood pressure. Other variables independently associated with progression to overt nephropathy were HbA(1c) cumulative average (P = 0.002), apolipoprotein B (P = 0.013), fibrinogen (P = 0.02), and HDL cholesterol (P = 0.03). CONCLUSIONS: Of type 2 diabetic patients, 3.7% progress every year to overt nephropathy. Microalbuminuria is associated with a 42% increased risk of progression to overt nephropathy. Other independent predictors are HbA(1c), HDL cholesterol, apolipoprotein B, and fibrinogen.

Aged↗

PubMed2003

Low incidence of end-stage renal disease and chronic renal failure in type 2 diabetes: a 10-year prospective study.

OBJECTIVE: Data on the incidence of end-stage renal disease (ESRD) and chronic renal failure from population-based studies in Caucasian type 2 diabetic patients are lacking. To provide such data, a population-based cohort of type 2 diabetic patients was identified in Casale Monferrato, Italy, and prospectively examined from 1991 to 2001. RESEARCH DESIGN AND METHODS: During the follow-up period, patients were regularly examined with centralized measurements of plasma creatinine and HbA(1c). Independent predictors of progression to renal events were identified with multivariate Cox proportional hazards modeling, with sex, age, and individual follow-up time as confounders. RESULTS: We followed 1,408 of 1,540 (91.4%) patients (average follow-up time 6.7 years, range 0.011-11.1); 10 new cases of ESRD and 72 of chronic renal failure (plasma values of creatinine >or=2.0 mg/dl) were identified, giving incidence rates/1,000 person-years of 1.04 (95% CI 0.56-1.94) and 7.63 (6.06-9.61), respectively. Cumulative risks for chronic renal failure adjusted for competing mortality were 6.1 and 9.3% after 20 and 30 years from diagnosis of diabetes, respectively. Incidence rates and cumulative risks of chronic renal failure defined by plasma creatinine values >1.5 mg/dl increased to 13.1/1,000 person-years, 8.6 and 14.8%, respectively. In Cox regression analysis, predictors of progression (after adjustment for confounders) were hypertension (P = 0.078), diastolic blood pressure (P = 0.034), BMI (P = 0.03), and albumin excretion rate (AER) (P < 0.0001). CONCLUSIONS: We provide evidence that the individual risk of ESRD and chronic renal failure is low. AER and diastolic blood pressure are independent predictors of progression. These findings underline the relevance of primary prevention to reduce the number of diabetic patients with ESRD.

Aged↗