Irene Marzona

N-3 fatty acids in patients with multiple cardiovascular risk factors

BACKGROUND Trials have shown a beneficial effect of n-3 polyunsaturated fatty acids in patients with a previous myocardial infarction or heart failure. We evaluated the potential benefit of such therapy in patients with multiple cardiovascular risk factors or atherosclerotic vascular disease who had not had a myocardial infarction. METHODS In this double-blind, placebo-controlled clinical trial, we enrolled a cohort of patients who were followed by a network of 860 general practitioners in Italy. Eligible patients were men and women with multiple cardiovascular risk factors or atherosclerotic vascular disease but not myocardial infarction. Patients were randomly assigned to n-3 fatty acids (1 g daily) or placebo (olive oil). The initially specified primary end point was the cumulative rate of death, nonfatal myocardial infarction, and nonfatal stroke. At 1 year, after the event rate was found to be lower than anticipated, the primary end point was revised as time to death from cardiovascular causes or admission to the hospital for cardiovascular causes. RESULTS Of the 12,513 patients enrolled, 6244 were randomly assigned to n-3 fatty acids and 6269 to placebo. With a median of 5 years of follow-up, the primary end point occurred in 1478 of 12,505 patients included in the analysis (11.8%), of whom 733 of 6239 (11.7%) had received n-3 fatty acids and 745 of 6266 (11.9%) had received placebo (adjusted hazard ratio with n-3 fatty acids, 0.97; 95% confidence interval, 0.88 to 1.08; P=0.58). The same null results were observed for all the secondary end points. CONCLUSIONS In a large general-practice cohort of patients with multiple cardiovascular risk factors, daily treatment with n-3 fatty acids did not reduce cardiovascular mortality and morbidity. (Funded by Società Prodotti Antibiotici and others; ClinicalTrials.gov number, NCT00317707.).

Potentially severe drug interactions in elderly outpatients: results of an observational study of an administrative prescription database

Purpose:  To estimate the prevalence of potentially severe drug–drug interactions (DDIs) and their relationship with age, sex and number of prescribed drugs.

Prevalence, incidence and mortality of diagnosed diabetes: Evidence from an Italian population-based study

Diabet. Med. 29, 385–392 (2012)

Trends in drug prescriptions to diabetic patients from 2000 to 2008 in Italy's Lombardy Region: A large population-based study

OBJECTIVE To analyze the prescribing patterns of antidiabetic and cardiovascular medications among diabetics in the most highly populated Italian Region, from 2000 to 2008. METHODS Data were obtained from the Lombardy Region administrative health databases. The standardized prevalence of antidiabetic and cardiovascular drugs use was calculated within each study year. The prescription trends of initial treatment with antidiabetic drugs were also analyzed. RESULTS From 2000 to 2008 there was an increase in the proportion of patients treated with biguanides (from 53.4% to 66.5%; p<0.0001) while those receiving sulfonylurea decreased (from 78.6% to 56.4%; p<0.0001). A sharp increase of metformin (as monotherapy) as initial treatment was also observed (from 15.2% to 48.8%; p<0.0001). The percentage of patients receiving renin-angiotensin system inhibitors, lipid-lowering drugs and antiplatelets increased between 2000 and 2008, from respectively 45.1% to 63.3%, 13.6% to 43.2% and 21.6% to 40.9 (p<0.0001). Multivariate analyses indicated that changes in prescriptions were statistically significant for both antidiabetic and cardiovascular drugs. CONCLUSION This study documents progressive changes in the prescription of antidiabetic and cardiovascular drugs in accordance with guidelines. However, the use of metformin as first line therapy was still suboptimal and cardiovascular preventive strategies were only partially implemented in community practice.

Sex differences in cardiovascular outcomes, pharmacological treatments and indicators of care in patients with newly diagnosed diabetes: Analyses on administrative database

BACKGROUND The impact of diabetes on cardiovascular disease in both sexes is known, but the specifics have not been fully clarified. We investigated whether sex-related differences exist in terms of management and hospitalization in patients with newly diagnosed diabetes. METHODS We examined the rates of hospitalization for cardiovascular causes, mortality, treatments and management of patients with diabetes compared to subjects without, from administrative database. Interaction between sex and diabetes on clinical outcomes were calculated using a Cox regression model. Pharmacological treatments and recommended examinations by sex were calculated using logistic regression. RESULTS From 2002 to 2006, 158,426 patients with diabetes and 314,115 subjects without were identified and followed up for a mean of 33 months (± 17.5). Diabetes confers a higher risk for all clinical outcomes. Females with diabetes have a risk profile for hospitalization for coronary heart disease comparable to males without (4.6% and 5.3%). Interaction between sex and diabetes shows that females with diabetes had an added 19% higher risk of total death (95% CI 1.13-1.24). No differences were observed in hospitalizations, although females with diabetes were less likely to undergo revascularization after myocardial infarction. Females received cardiovascular prevention drugs less frequently than males and had a slight tendency to get fewer examinations. CONCLUSION Diabetes is linked to a higher increase of mortality in females relative to males. This might reflect sex differences in the use of revascularization procedures or therapeutic regimens. Closer attention and implementation of standard care for females are necessary from the onset of diabetes.

Diabetes mellitus as risk factor for atrial fibrillation hospitalization: Incidence and outcomes over nine years in a region of Northern Italy

AIMS Diabetes mellitus (DM) and atrial fibrillation (AF) are worldwide public health challenges and major causes of death and cardiovascular events. The association between DM and AF is controversial in literature and data on outcomes of individuals with both diseases have not been evaluated in population studies. We tested the hypothesis that DM is independently associated to AF hospitalization and assessed the risk of stroke and mortality in people with both conditions. METHODS We conducted a population-based cohort-study of DM patients and their corresponding controls identified in a administrative health database of the Lombardy Region. Both cohorts were followed for nine years. A multivariable Cox proportional-hazards-regression model was used to estimate the hazard ratio (HR) for first hospitalization for AF and for clinical outcomes. RESULTS Out of 9,061,258 residents, 285,428 (3.14%) DM subjects were identified, mean age 65.8±15 years, 49% were women. The cumulative incidence of AF in DM was 10.4% vs. 7.4% in non-DM. DM was a risk factor for AF (HR 1.32, 95% CI 1.30-1.34; p<0.0001). Oral anticoagulants were prescribed in 34.8% of DM patients with AF. DM associated with AF, presented the highest HR for stroke: 2.63; 95% CI 2.47-2.80 and for total death, HR 2.41; 95% CI 2.36-2.47. CONCLUSIONS In this population study, DM was an independent risk factor for AF hospitalization. DM patients with AF had the highest risk of stroke and total mortality. Early identification of AF and a structured plan to optimize the comprehensive management of DM and AF patients is mandatory.

Risk of dementia and death in patients with atrial fibrillation: A competing risk analysis of a population-based cohort

BACKGROUND Previous studies have stated that atrial fibrillation (AF) is associated with a higher risk of dementia. However, none have examined the competition between death and incident dementia in patients with AF. We evaluated the risk of incident dementia in patients with AF in comparison to people without this arrhythmia, considering of the competing risk of death. METHODS AF and non-AF cohorts were identified using the large administrative database of the Lombardy Region and followed for ten years. Patients with incident dementia were identified if they had an ICD 9 code referring to dementia at hospital discharge or a prescription for any anti-dementia drug. The association of AF with dementia or death was assessed with the multivariable Cox proportional-regression model, sensitivity analysis with a 1:1 propensity score matching and competing-risk analysis. RESULTS In 2003 a total of 27,431 patients were hospitalized for AF in the Lombardy Region, while the cohort of non-AF counted 1,600,200 people. AF was associated with a higher risk of dementia (17%) and death (51%) at multivariable Cox analysis. These results were confirmed by the model fitted after propensity score matching. However, competing risk analysis found the association between AF and incident dementia was no longer significant (HR 0.99; 95% CI 0.94-1.04). CONCLUSIONS In this real-world population the association between AF and dementia was no longer statistically significant when death was considered a competing risk.

Elevated risk of death and major cardiovascular events in subjects with newly diagnosed diabetes: Findings from an administrative database

AIMS To investigate the incidence of major cardiovascular complications and mortality in the first years of follow-up in patients with newly diagnosed diabetes. METHODS AND RESULTS We examined incidence rates of hospitalization for cardiovascular reasons and death among new patients with diabetes using the administrative health database of the nine million inhabitants of Lombardy followed from 2002 to 2007. Age and sex-adjusted rates were calculated and hazard ratios (HR) were estimated with a matched population without diabetes of the same sex, age (± 1 year) and general practitioner. There were 158,426 patients with newly diagnosed diabetes and 314,115 subjects without diabetes. Mean follow-up was 33.0 months (SD ± 17.5). 9.7% of patients with diabetes were hospitalized for cardiovascular events vs. 5.4% of subjects without diabetes; mortality rate was higher in patients with diabetes (7.7% vs. 4.4%). The estimated probability of hospitalization during the follow up was higher in patients with diabetes than in subjects without for coronary heart disease (HR 1.4, 95% CI 1.3-1.4), cerebrovascular disease (HR 1.3.95% CI 1.2-1.3), heart failure (HR 1.4, 95% CI 1.3-1.4) as was mortality (HR 1.4, 95% CI 1.4-1.4). Younger patients with diabetes had a risk of death or hospital admission for cardio-cerebrovascular events similar to subjects without diabetes ten years older. CONCLUSIONS The elevated morbidity and mortality risks were clear since the onset of diabetes and rose over time. These data highlight the importance of prompt and comprehensive patients care in addition to anti-diabetic therapy in patients with newly diagnosed diabetes.

Improving cardiovascular prevention in general practice: Results of a comprehensive personalized strategy in subjects at high risk

Background Although high cardiovascular risk patients should be the main target of preventive strategies, modifiable risk factors are often inadequately controlled. Aim To assess feasibility and results of a comprehensive personalized method for cardiovascular prevention in high risk patients followed by their general practitioner. Methods Between 2004 and 2007, 12,513 patients (mean age 64.0 ± 9.5 years; 61.5% males) with multiple cardiovascular risk factors or history of atherosclerotic disease were identified and followed for five years. If control of major modifiable cardiovascular risk factors (hypertension, hypercholesterolaemia, diabetes, obesity, smoking, unhealthy diet, physical inactivity) was sub-optimal, at baseline and yearly thereafter general practitioners planned with patients, with the help of a brief checklist, preventive interventions to improve the global risk profile. Main outcome was the control of the seven major modifiable cardiovascular risk factors during follow-up. Secondary outcome was the incidence of cardiovascular deaths and hospitalization for cardiovascular reasons according to the improvement in global cardiovascular risk profile during the first year. Results Control of all major modifiable risk factors except physical inactivity improved gradually and significantly (p < 0.0001) during follow-up. The improvement in the global cardiovascular risk profile during the first year was independently and significantly associated with a lower rate of major cardiovascular events in the following years (hazard ratio 0.939; 95% confidence interval 0.887–0.994, p = 0.03). Conclusions Our comprehensive, personalized method for cardiovascular risk prevention in people at high risk appears feasible in general practice. The improvement in the global cardiovascular risk profile was associated with a better prognosis.

Epidemiologic Trends in Hospitalized Ischemic Stroke from 2002 to 2010: Results from a Large Italian Population-Based Study

BACKGROUND To describe the incidence of ischemic stroke, short-term mortality, recurrences, and prescription patterns. METHODS Data from administrative health databases of the Lombardy Region from 2002 to 2010 (about 4 million people) were analyzed for stroke incidence and recurrence, mortality, and drug prescriptions after an ischemic stroke. RESULTS A total of 43,352 patients with a first hospital admission for ischemic stroke were identified. During 8 years, stroke incidence decreased from 3.2 of 1000 to 2.4 of 1000 (P < .001) in people aged 65-74 years, from 7.1 of 1000 to 5.3 of 1000 (P < .001) at ages 75-84 years and from 11.9 of 1000 to 9.4 of 1000 (P < .001) at age 85 years or older. Stroke recurrences dropped by 30% (from 10.0% to 7.0%, P < .001) and 30-day mortality rate also decreased. Prescription trends showed linear increase in antiplatelets and lipid-lowering drugs, respectively, from 60.2% to 65.0% (P < .001) and from 19.1% to 34.6% (P < .001), whereas antihypertensive prescriptions did not change appreciably. Anticoagulant prescription increased in patients with atrial fibrillation, from 64.8% to 72.1% in the 65-74 years age group, (P = .004) and from 40.2% to 53.7% in the 75-84 years age group (P < .001); less than 20% of the 85 years or older age group were treated with anticoagulants (P < .0001). CONCLUSIONS Stroke incidence, recurrence, and 30-day mortality decreased from 2002 to 2010 concomitant with an increase in prescriptions of secondary stroke prevention drugs.