Lower risk of death and cardiovascular events in patients with diabetes initiating glucagon-like peptide-1 receptor agonists or sodium-glucose cotransporter-2 inhibitors: A real-world study in two Italian cohorts.

AIM: To examine the efficacy and safety of glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter-2 (SGLT2) inhibitors compared with other antihyperglycaemic agents (AHAs) in large and unselected populations of the Lombardy and Apulia regions in Italy. MATERIALS AND METHODS: An observational cohort study of first-time users of GLP-1RAs, SGLT2 inhibitors or other AHAs was conducted from 2010 to 2018. Death and cardiovascular (CV) events were evaluated using conditional Cox models in propensity-score-matched populations. Adjusted hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated for each region and in a meta-analysis for pooled risks. RESULTS: After propensity-score matching, the Lombardy cohort included 18 716 and 11 683 patients and the Apulia cohort 9772 and 6046 patients for the GLP-1RA and SGLT2 inhibitor groups, respectively. Use of GLP-1RAs was associated with lower rates of death (HR 0.61, CI 0.56-0.65, Lombardy; HR 0.63, CI 0.55-0.71, Apulia), cerebrovascular disease and ischaemic stroke (HR 0.70, CI 0.63-0.79; HR 0.72, CI 0.60-0.87, Lombardy), peripheral vascular disease (HR 0.72, CI 0.64-0.82, Lombardy; HR 0.80, CI 0.67-0.98, Apulia), and lower limb complications (HR 0.67, CI 0.56-0.81, Lombardy; HR 0.69, CI 0.51-0.93, Apulia). Compared with other AHAs, SGLT2 inhibitor use decreased the risk of death (HR 0.47, CI 0.40-0.54, Lombardy; HR 0.43, CI 0.32-0.57, Apulia), cerebrovascular disease (HR 0.75, CI 0.61-0.91, Lombardy; HR 0.72, CI 0.54-0.96, Apulia), and heart failure (HR 0.56, CI 0.46-0.70, Lombardy; HR 0.57, CI 0.42-0.77, Apulia). In the pooled cohorts, a reduction in heart failure was also observed with GLP-1RAs (HR 0.89, 95% CI 0.82-0.97). Serious adverse events were quite low in frequency. CONCLUSION: Our findings from real-world practice confirm the favourable effect of GLP-1RAs and SGLT2 inhibitors on death and CV outcomes across both regions consistently. Thus, these drug classes should be preferentially considered in a broad type 2 diabetes population beyond those with CV disease.

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.).

Changes in prescribing patterns and clinical outcomes in elderly diabetic patients in 2000 and 2010: analysis of a large Italian population-based study.

PURPOSE: To describe prescribing patterns in elderly Italian diabetic patients of the Lombardy Region in 2000 and 2010 using an administrative database. Hospital admissions and mortality were also recorded and compared in the two index years. METHODS: Analyses were performed on the whole cohort of elderly diabetic patients and across age groups. Direct age standardization was done, with data from the Lombardy Region database for 2005 used as reference to compare diabetic populations in the two index years. Logistic regression models were used to analyze changes in hospital admissions and mortality and to calculate odds ratios. RESULTS: Using data retrieved from the Lombardy Region database we identified 176,384 and 283,982 elderly diabetic patients in 2000 and 2010, respectively. The overall rates of patients treated with antidiabetic drugs were 92.5% in 2000 and 97.0% in 2010. Between 2000 and 2010 the prescribing of glibenclamide declined by 30.0% (from 52.9 to 22.9%, p < 0.001) and that of biguanides rose by 17.4 % (from 47.5 to 64.8%, p < 0.001). In 2010 thiazolidinediones, dipeptidyl peptidase-4 inhibitors and incretin mimetic drugs were seldom prescribed. Drugs for cardiovascular prevention rose in all age classes from 2000 to 2010, and the rates of hospital admission overall fell from 32.0 to 26.8% (p < 0.001) during the same period, with the exception of those aged ≥85 years. Between 2000 and 2010 the mortality rate decreased in patients aged 65-74 years (from 3.4 to 2.9%, p < 0.0001) and rose significantly in those aged ≥85 years. CONCLUSIONS: The drug prescription profile of elderly diabetic patients changed from 2000 to 2010, with a tendency toward recommended drugs. These changes may possibly be linked to the decrease in both hospital admissions and mortality in the diabetic group aged 65-74 years.

[Effectiveness of a nurse-led educational intervention for patients admitted for acute coronary syndrome]. / Efficacia di un intervento educativo infermieristico in pazienti ricoverati per una sindrome coronarica acuta.

OBJECTIVE: To assess the effectiveness of a nurse-led class with phone follow-up, to help patients achieve lifestyle changes after an acute coronary syndrome (ACS). METHODS: Each patient < or = 75 years, admitted to a intensive cardiac care unit (ICCU) for ACS from September 2003 to December 2004, who attended the education class (case) was matched with two patients paired for age, sex and admission time, admitted for ACS to ICCUs in the other hospitals in the same area (controls). One year later the two groups were blindly interviewed on the phone, using a structured questionnaire about their lifestyles. RESULTS: One-hundred-nineteen cases and 238 controls were phoned and 84% cases and 61% controls completed the interview. Cases reported a more correct lifestyle: they ate > or = 4 portions/day of fruit or vegetables (55% vs. 36%, p = 0.003) and > or = 2 portions/week of fish (48% vs. 32%, p = 0.010), reported > or = 30 min/day of physical activity (67% vs. 59%, p = 0.262) and stopped smoking (82% vs. 71% of previous smokers, p = 0.264). CONCLUSION: An educational intervention led by cardiology nurses, with a group meeting and personal phone follow-up, improved lifestyle habits one year after an ACS.

Development of an algorithm for ruling-out non-ST elevation myocardial infarction in the emergency department using high sensitivity troponin T assay.

INTRODUCTION: Chest pain and its clinical manifestations are the most common reasons for presentation to the emergency department (ED). Given that the prevalence of chest pain due to acute myocardial infarction (AMI) in the ED is modest, clinicians should use cardiac troponins to safely and rapidly rule out AMI, avoiding the delayed release of low risk patients. The study aims to develop and validate an algorithm to early rule-out of non-ST elevation myocardial infarction (NSTEMI) in subjects admitted to the ED with symptoms of myocardial infarction. METHODS: High sensitivity cardiac Troponin T (hs-cTnT) serial measurements (baseline, T0; after 1 h, T1; after 3 h, T3) were used to develop and validate the algorithm, respectively, in 6403 and 773 consecutive admissions suggestive of AMI. RESULTS: Patients were classified as having or not having NSTEMI according to clinical assessment, diagnostic imaging, and serial measurements ofhs-cTnT; ROC curve analysis allowed to find changes in consecutive hs-cTnT associated with diagnostic sensitivity close to 100%. Only patients with hs-cTnTat T0 lower than 14 ng/L resultedto be eligible for the safe rule-out of NSTEMI. CONCLUSIONS: Although some points remain to be improved, the results obtained indicate that algorithms for fast NSTEMI rule-out are feasible and safe.

Long-Term Outcomes of a Cohort of Hypertensive Subjects in Rural Ecuador.

BACKGROUND: In contrast with the abundance of global epidemiological descriptive data on cardiovascular diseases and their risk factors, information on the outcomes of real populations prospectively followed up in their life and care settings is much rarer, especially in low-income countries. OBJECTIVES: This study sought to evaluate the feasibility and the overall results of a hypertension control program, based mainly on a network of community nonprofessional health promoters, in the poor rural region of Borbon (Ecuador). METHODS: This is a prospective cohort study describing the results of a program of hypertension diagnosis, treatment and follow-up from 2004 to 2015 in the area, carried out mainly by the health promoters. RESULTS: The number of hypertensive patients identified and followed over the years increased from 1,024 in 2004 to 1,733 in 2015. The percentage of patients with no visits during a year was reduced to <10%, whereas the proportion of hypertensive subjects attending all 4 scheduled annual checks approached and, in some years, exceeded 50%. From 2004 to 2015, the proportion of patients at high or very high cardiovascular risk progressively decreased from 26.6% in 2004 to 17.5% in 2015 (p for trend <0.01), whereas the proportion of hypertensive patients at low or very low risk increased from 30.4% in 2004 to 45.0% in 2015 (p for trend <0.01). CONCLUSIONS: In a poor, disadvantaged area, a strategy of control mainly based on the involvement and responsibility of community health promoters (with health professionals as supporters more than direct actors) can achieve adequate follow-up of the population of hypertensive patients and improve their global cardiovascular risk level.

Prevalence and management of diabetes in immigrants resident in the Lombardy Region: the importance of ethnicity and duration of stay.

AIMS: To describe the prevalence and management of diabetes among immigrants according to ethnic group and duration of stay, compared to Italian citizens. METHODS: Diabetic immigrant and Italian residents aged 20-69 years in the administrative database of the Lombardy Region. Immigrants were classified by region of origin and as long-term residents (LTR) and short-term residents (STR). Age- and sex-adjusted prevalence and indicators of diabetes management were calculated for immigrants by region of origin and by length of stay using Cox proportional models. RESULTS: In 2010 19,992 immigrants (mean age 49.1 ± 10.8, 53.7% males) and 195,049 Italians (mean age 58.7 ± 9.3, 61.1 males) with diabetes were identified. Immigrants had a higher adjusted diabetes prevalence than Italians (OR 1.48; 95% CI 1.45-1.50). STR received significantly fewer recommended cardiovascular drugs (antiplatelets, statins and ACE-inhibitors/ARBs) than Italians, although prescription was higher among LTR from some ethnic groups. Immigrants were less likely to be seen by a diabetologist and to do at least one HbA1c test per year. Although the recommended tests/visits were more often done for the LTR than the STR, in the majority of ethnic groups these indicators were still far from optimal. CONCLUSION: The prevalence and management of diabetes differ between immigrants and Italians, although some improvement can be seen among LTR.

Peripheral arterial disease: Changes in clinical outcomes and therapeutic strategies in two cohorts, from 2002 to 2008 and from 2008 to 2014. A population-based study.

Background The aim of our study was to evaluate whether treatments for peripheral artery disease changed in two different cohorts identified in 2002 and 2008, and whether this had an impact on mortality and major clinical outcomes after six years of follow-up. Methods Using administrative health databases of the largest region in Northern Italy, we identified patients admitted to hospital for peripheral artery disease in 2002 and 2008. Both cohorts were followed for six years. All cause death, acute coronary syndrome, stroke and major amputations, cardiovascular prevention drugs and revascularization procedures were collected. Incidence of events was plotted using adjusted cumulative incidence function estimates. The risk, for each outcome, was compared between 2002-2008 and 2008-2014 using a multivariable Fine and Gray's semiparametric proportional subdistribution hazards model. Results In 2002 and 2008, 2885 and 2848 patients were identified. Adjusting for age, sex, Charlson comorbidity index and severity of peripheral artery disease we observed a significant reduction (in 2008 vs. 2002) in the risk of acute coronary syndrome (28%), stroke (27%) and major amputation (17%). No change was observed in the risk of death. The percentages of patients with peripheral artery revascularizations, during the hospital stay, increased: 43.8% in 2002 vs. 49.0% in 2008, p < 0.001. From 2002 to 2008 there was a significant absolute increase in the prescription of lipid-lowering drugs (+18%), antiplatelets (+7.2%) and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (+11.8%), p < 0.001. Conclusions In six years of follow-up we observed a reduction in risk of major cardiovascular events in 2008-2014 in comparison with the 2002-2008 cohort. Increasing use of revascularization interventions and cardiovascular prevention drugs could have contributed to the better prognosis.

Prognostic value of serial electrocardiographic voltage and repolarization changes in essential hypertension: the HEART Survey study.

BACKGROUND: The interpretation of serial electrocardiographic (ECG) changes in hypertensive subjects is uncertain. We tested the hypothesis that serial changes in repolarization and voltage are independent determinants of outcome. METHODS: The Hypertrophy at ECG And its Regression during Treatment (HEART) Survey was a prospective observational study performed at 61 centers. We studied 711 subjects with hypertension and ECG left-ventricular hypertrophy (LVH) at entry. Tracings from 496 subjects at entry and one or more visits during follow-up were available for central reading. RESULTS: The prevalence of ECG LVH progressively decreased by 49.6% at 3 years. The crude rate of a prespecified primary composite end point of cardiovascular events was 4.17 per 100 subjects per year (95% confidence interval [CI], 3.27 to 5.33). We used Cox regression models of ECG LVH indexes as time-varying covariates at baseline and at follow-up. Time-varying LVH, defined as an absence of ST-T alterations ("strain"), was associated with a lower event rate hazard ratio (HR), 0.47; 95% CI, 0.28 to 0.78; P = .0035), whereas the LVH changes defined in terms of ECG voltages did not achieve significance (HR, 0.91; 95% CI, 0.74 to 1.13; P = .39). The crude event rate in subjects with versus without in-treatment ST-T alterations on the last available ECG before the event or before censoring was 8.38 versus 3.17 per 100 subjects per year (P < .0001). CONCLUSIONS: In this study of subjects with hypertension and ECG LVH at entry, serial changes in repolarization significantly predicted the prognosis, independent of voltage change (which was not significantly predictive in this study). The persistence or new development of ST-T alterations identifies subjects at very high risk of cardiovascular events.

Are all people with diabetes and cardiovascular risk factors or microvascular complications at very high risk? Findings from the Risk and Prevention Study.

AIMS: To verify whether it is possible, in people with diabetes mellitus (DM) considered at very high cardiovascular (CV) risk, stratify this risk better and identify significant modifiable risk factor (including lifestyle habits) to help patients and clinicians improve CV prevention. METHODS: People with DM and microvascular diseases or one or more CV risk factors (hypertension, hyperlipidemia, smoking, poor dietary habits, overweight, physical inactivity) included in the Risk and Prevention study were selected. We considered the combined endpoint of non-fatal acute myocardial infarction and stroke and CV death. A multivariate Cox proportional analysis was carried out to identify relevant predictors. We also used the RECPAM method to identify subgroups of patients at higher risk. RESULTS: In our study, the rate of major CV events was lower than expected (5 % in 5 years). Predictors of CV events were age, male, sex, heart failure, previous atherosclerotic disease, atrial fibrillation, insulin treatment, high HbA1c, heart rate and other CV diseases while being physically active was protective. RECPAM analysis indicated that history of atherosclerotic diseases and a low BMI defined worse prognosis (HR 4.51 95 % CI 3.04-6.69). Among subjects with no previous atherosclerotic disease, men with HbA1c more than 8 % were at higher CV risk (HR 2.77; 95 % CI 1.86-4.14) with respect to women. CONCLUSIONS: In this population, the rate of major CV events was lower than expected. This prediction model could help clinicians identify people with DM at higher CV risk and support them in achieving goals of physical activity and HbA1c.

High pulse pressure and low mean arterial pressure: two predictors of death after a myocardial infarction.

OBJECTIVES: Although the negative prognostic implication of a clinical history of arterial hypertension in myocardial infarction (MI) survivors is well known, the predictive role of the blood pressure (BP) regimen after MI is not well defined. The aim of this study was to investigate the prognostic significance of different BP indices in post-MI. METHODS AND RESULTS: We evaluated the relationship between baseline systolic, diastolic, pulse and mean arterial pressure (MAP), measured by sphygmomanometry at discharge from hospital or within 3 months of an MI, and total and cardiovascular mortality in 11 116 patients enrolled in the GISSI-Prevenzione trial. Over 3.5 years of follow-up, 999 patients died, 657 of them from cardiovascular causes. Low mean and high pulse pressure were significantly associated with total and cardiovascular mortality after controlling for potential confounders in the multivariate analysis. As compared with patients with less extreme BP values, patients with MAP of 80 mmHg or less (n = 1241; 11.2%) had a 48% higher risk of cardiovascular death [95% confidenceinterval (CI) 1.16-1.87; P = 0.001] and those with pulse pressure greater than 60 mmHg (n = 958; 8.6%) had a 35% higher risk (95% CI 1.09-1.69; P = 0.007); only four subjects (0.04%) had both a high pulse pressure and a low MAP (relative risk of cardiovascular death 3.48; 95% CI 0.48-25.88; P = 0.218). CONCLUSIONS: Our results show for the first time an additional prognostic importance of two easily measurable components of BP, definitely high pulse pressure (> 60 mmHg) and low MAP (< or = 80 mmHg), in a large sample of non-selected patients surviving MI who entered a modern programme of cardiovascular prevention.

Aspirin for the primary prevention of cardiovascular events in women and men: a sex-specific meta-analysis of randomized controlled trials.

CONTEXT: Aspirin therapy reduces the risk of cardiovascular disease in adults who are at increased risk. However, it is unclear if women derive the same benefit as men. OBJECTIVE: To determine if the benefits and risks of aspirin treatment in the primary prevention of cardiovascular disease vary by sex. DATA SOURCES AND STUDY SELECTION: MEDLINE and the Cochrane Central Register of Controlled Trials databases (1966 to March 2005), bibliographies of retrieved trials, and reports presented at major scientific meetings. Eligible studies were prospective, randomized controlled trials of aspirin therapy in participants without cardiovascular disease that reported data on myocardial infarction (MI), stroke, and cardiovascular mortality. Six trials with a total of 95 456 individuals were identified; 3 trials included only men, 1 included only women, and 2 included both sexes. DATA EXTRACTION: Studies were reviewed to determine the number of patients randomized, mean duration of follow-up, and end points (a composite of cardiovascular events [nonfatal MI, nonfatal stroke, and cardiovascular mortality], each of these individual components separately, and major bleeding). DATA SYNTHESIS: Among 51,342 women, there were 1285 major cardiovascular events: 625 strokes, 469 MIs, and 364 cardiovascular deaths. Aspirin therapy was associated with a significant 12% reduction in cardiovascular events (odds ratio [OR], 0.88; 95% confidence interval [CI], 0.79-0.99; P = .03) and a 17% reduction in stroke (OR, 0.83; 95% CI, 0.70-0.97; P = .02), which was a reflection of reduced rates of ischemic stroke (OR, 0.76; 95% CI, 0.63-0.93; P = .008). There was no significant effect on MI or cardiovascular mortality. Among 44,114 men, there were 2047 major cardiovascular events: 597 strokes, 1023 MIs, and 776 cardiovascular deaths. Aspirin therapy was associated with a significant 14% reduction in cardiovascular events (OR, 0.86; 95% CI, 0.78-0.94; P = .01) and a 32% reduction in MI (OR, 0.68; 95% CI, 0.54-0.86; P = .001). There was no significant effect on stroke or cardiovascular mortality. Aspirin treatment increased the risk of bleeding in women (OR, 1.68; 95% CI, 1.13-2.52; P = .01) and in men (OR, 1.72; 95% CI, 1.35-2.20; P<.001). CONCLUSIONS: For women and men, aspirin therapy reduced the risk of a composite of cardiovascular events due to its effect on reducing the risk of ischemic stroke in women and MI in men. Aspirin significantly increased the risk of bleeding to a similar degree among women and men.

Is global cardiovascular risk considered in current practice? Treatment and control of hypertension, hyperlipidemia, and diabetes according to patients' risk level.

OBJECTIVES: To assess the pharmacological treatment and the control of major modifiable cardiovascular risk factors in everyday practice according to the patients' cardiovascular risk level. METHODS: In a cross-sectional study general practitioners (GPs) had to identify a random sample of their patients with cardiovascular risk factors or diseases and collect essential data on the pharmacological treatment and control of hypertension, hyperlipidemia, and diabetes according to the patients' cardiovascular risk level and history of cardiovascular disease. Participants were subjects of both sexes, aged 40-80 years, with at least one known cardiovascular risk factor or a history of cardiovascular diseases. RESULTS: From June to December 2000, 162 Italian GPs enrolled 3120 of their patients (2470 hypertensives, 1373 hyperlipidemics, and 604 diabetics). Despite the positive association between the perceived level of global cardiovascular risk and lipid-lowering drug prescriptions in hyperlipidemic subjects (from 26% for lowest risk to 56% for highest risk p < 0.0001) or the prescription of combination therapy in hypertensives (from 41% to 70%, p < 0.0001) and diabetics (from 24% to 43%, p = 0.057), control was still inadequate in 48% of diabetics, 77% of hypertensives, and 85% of hyperlipidemics, with no increase in patients at highest risk. Trends for treatment and control were similar in patients with cardiovascular diseases. CONCLUSIONS: Even in high-risk patients, despite a tendency towards more intensive treatment, pharmacological therapy is still under used and the degree of control of blood pressure, cholesterol level and diabetes is largely unsatisfactory.

[Knowledge and lifestyles of patients: a survey on patients admitted with acute coronary syndrome in the CCU of an Italian hospital]. / Le conoscenze e gli still di vita dei pazienti: indagine sui pazienti ricoverati per sindrome coronarica acuta nell'Unità Coronarica dell'Ospedale di Desio.

AIM AND METHODS: The lifestyles before hospital admission, knowledge on their illness and lifestyles after the acute coronary event were analysed with questionnaires, in three different samples of patients: a. all the patients admitted for acute coronary event from may 2003 to may 2005 to explore lifestyles before acute coronary event (416 patients) b. all the patients admitted from may 2003 to april 2004 (before the start of health information meetings organised by nurses), to explore the knowledge of the illness and its causes (132 patients) c. a sample of 83 patients followed in day hospital, to explore the lifestyles after the acute coronary event. RESULTS: Lifestyles before the event. Most patients have incorrect lifestyles: 50% eat cheese every day and never exercise for at least 30 minutes everyday. Even after the acute coronary event, some incorrect lifestyles are still present. Seventy-five percent of patients have incorrect or insufficient knowledge on illness and risk factors at discharge and only 50% is willing to increase the amount of fruit and vegetables in their diet. CONCLUSIONS: Although confirmed by other studies, these results are worrying and call for the systematic adoption of secondary prevention strategies with effective interventions aimed at increasing knowledge and modifying lifestyles.

[An health education program for patients admitted to CCU for an acute coronary event]. / Organizzazione di un incontro di educazione alla salute dedicato ai pazienti ricoverati per sindrome coronarica acuta: l'esperienza degli infermieri dell'ospedale di Desio.

UNLABELLED: In spite of the broad recognition of the importance of health education, time for structured one-to -one initiatives of health education during the hospital stay is limited. The organization of an health education meeting for patients admitted to CCU for an acute coronary event is described. METHODS: The planning and implementation of the initiative lasted two years and involved 7 nurses and one doctor. The organization required efforts related to the event itself (preparation of training aids, identification or contents and methods for delivery) but also organizative changes. Dietitians in fact had to be involved because the healthy diet recommended was different from the hospital diet. The assessment of the effectiveness of the health education was also planned: administration of a questionnaire to explore lifestyles and knowledge of the illness before and after the meeting; phone interviews after 3, 6 and 12 months from the meeting. RESULTS: Since may 2003, in the first 3 years 74 meetings have been organised, involving 507 patients and 329 relatives. Each meeting lasts 2 hours and contents delivered encompass the coronary event, risk factors and their modification, healthy lifestyles. Initial preliminary results on the impact of the meeting on lifestyle changes are promising. Initiatives are ongoing to include this activity among officially recognised nursing activities.

Effectiveness, safety and feasibility of an evidence-based insulin infusion protocol targeting moderate glycaemic control in intensive cardiac care units.

OBJECTIVES: To assess the effectiveness, safety and feasibility of the revised, simplified nurse-managed version of our insulin infusion protocol, adapted to the new recommended glycaemic target of 140 to 180 mg/dL (Desio Diabetes Diagram i.v. 140-180). METHODS: All clinical responses to the Desio Diabetes Diagram i.v. 140-180 in use for 3 years were recorded in patients with diabetes or hyperglycaemia admitted to our intensive cardiac care unit. To assess the feasibility, we asked nurses to complete an ad hoc questionnaire anonymously when the new insulin infusion protocol had been in use for 2 years. RESULTS: From December 2010 to December 2013, 276 patients (173 men, median age 75 years) were treated according to the Desio Diabetes Diagram i.v. 140-180. The median time to reach glycaemic target was 4 h (Q1-Q3 2-8) in 128 patients with blood glucose >180 mg/dL and 2 h (Q1-Q3 1-4) in 82 patients with blood glucose <140 mg/dL. Once the target had been reached, insulin infusion was maintained for a median of 38 h (Q1-Q3 24-48) with blood glucose between 140 and 180 mg/dL for 58.3% of the infusion time. Over a total of 11,863 h of infusion, seven blood glucose <70 mg/dL occurred. The Desio Diabetes Diagram i.v. 140-180 protocol was considered easy to use by 93% of nurses. CONCLUSIONS: The Desio Diabetes Diagram i.v. 140-180 protocol, fully managed by nurses, with insulin and glucose intravenous infusion proved effective, safe and feasible in maintaining blood glucose between 140 and 180 mg/dL in patients with diabetes or hyperglycaemia admitted to the intensive cardiac care unit for acute cardiac events.

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.

Primary prevention of cardiovascular events with low-dose aspirin and vitamin E in type 2 diabetic patients: results of the Primary Prevention Project (PPP) trial.

OBJECTIVE: We investigated in general practice the efficacy of antiplatelets and antioxidants in primary prevention of cardiovascular events in people with type 2 diabetes. RESEARCH DESIGN AND METHODS: The Primary Prevention Project (PPP) is a randomized, open trial with a two-by-two factorial design aimed to investigate low-dose aspirin (100 mg/day) and vitamin E (300 mg/day) in the prevention of cardiovascular events in patients with one or more cardiovascular risk factors. The primary end point was a composite end point of cardiovascular death, stroke, or myocardial infarction. A total of 1,031 people with diabetes in the PPP, aged >/=50 years, without a previous cardiovascular event were enrolled by 316 general practitioners and 14 diabetes outpatient clinics. RESULTS: The PPP trial was prematurely stopped (after a median of 3.7 years) by the independent data safety and monitoring board because of a consistent benefit of aspirin compared with the control group in a population of 4,495 patients with one or more major cardiovascular risk factors. In diabetic patients, aspirin treatment was associated with a nonsignificant reduction in the main end point (relative risk [RR] = 0.90, 95% CI 0.50-1.62) and in total cardiovascular events (0.89, 0.62-1.26) and with a nonsignificant increase in cardiovascular deaths (1.23, 0.69-2.19). In nondiabetic subjects, RRs for the main end point, total cardiovascular events, and cardiovascular deaths were 0.59 (0.37-0.94), 0.69 (0.53-0.90), and 0.32 (0.14-0.72), respectively. No significant reduction in any of the end points considered could be found with vitamin E in either diabetic or nondiabetic subjects. CONCLUSIONS: Our data suggest a lower effect of primary prevention of cardiovascular disease (CVD) with low-dose aspirin in diabetic patients as opposed to subjects with other cardiovascular risk factors. If confirmed, these findings might indicate that the antiplatelet effects of aspirin in diabetic patients are overwhelmed by aspirin-insensitive mechanisms of platelet activation and thrombus formation, thus making the balance between benefits and harms of aspirin treatment unfavorable. Further large-scale trials investigating the role of aspirin in the primary prevention of CVD in diabetic patients are urgently needed.

Effectiveness of a nurse-managed protocol to prevent hypoglycemia in hospitalized patients with diabetes.

BACKGROUND: Hypoglycemia due to inadequate carbohydrate intake is a frequent complication of insulin treatment of diabetic in-patients. Objective. To assess the effectiveness of a nurse-managed protocol to prevent hypoglycemia during subcutaneous insulin treatment. DESIGN: Prospective pre-post-intervention study. METHODS: In 350 consecutive diabetic in-patients the incidence of hypoglycemia (blood glucose < 70 mg/dL) during subcutaneous insulin treatment was assessed before (phase A) and after (phase B) the protocol was adopted to permit (1) the patient to opt for substitutive food to integrate incomplete carbohydrate intake in the meal; (2) in case of lack of appetite or repeatedly partial intake of the planned food, prandial insulin administered at the end of the meal to be related to the actual amount of carbohydrates eaten; (3) intravenous infusion of glucose during prolonged fasting. RESULTS: Eighty-four patients in phase A and 266 in phase B received subcutaneous insulin for median periods of, respectively, 7 (Q1-Q3 6-12) and 6 days (Q1-Q3 4-9). Hypoglycemic events declined significantly from 0.34 ± 0.33 per day in phase A to 0.19 ± 0.30 in phase B (P > 0.001). CONCLUSIONS: A nurse-managed protocol focusing on carbohydrate intake reduced the incidence of hypoglycemia in patients with diabetes receiving subcutaneous insulin in hospital.

Simple, shared guidelines raise the quality of antihypertensive treatment in routine care.

AIMS: To assess the impact of simple, collectively produced, evidence-based guidelines on optimizing the choice of antihypertensive drugs in routine care. METHODS AND RESULTS: Forty-eight physicians agreed to produce and test these guidelines for 1 year in their daily practice on a random sample of 1049 treated hypertensive patients (intervention group). A control group of 42 general practitioners recruited and followed up for 1 year a parallel nonintervention cohort of 722 treated hypertensive patients. After 1 year of follow-up, the patients in the nonintervention group had no changes in any of the predefined end points. In the intervention group, the use of diuretics and beta-blockers--drugs with documented preventive efficacy--increased, respectively, from 48.3% to 57.6% and from 22.0% to 29.7%; and the proportion of hypertensive patients receiving indicated drugs (with no contraindications) rose from 66.1% to 73.0%. The prescription of poorly tolerated drugs decreased from 12.4% to 7.2%, and noncompliance with the antihypertensive therapy decreased from 5.2% to 3.8%. In the intervention group, both systolic and diastolic blood pressure control improved (systolic pressure <140 mm Hg, from 23.3% to 39.5%; diastolic pressure <90 mm Hg, from 65.4% to 87.4%). CONCLUSIONS: An intervention strategy based on the collaborative production of simple evidence-based guidelines appears to be effective in raising the quality of antihypertensive therapy in routine care.