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1.
Diabetes Obes Metab ; 23(7): 1484-1495, 2021 07.
Article in English | MEDLINE | ID: mdl-33606897

ABSTRACT

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.


Subject(s)
Brain Ischemia , Cardiovascular Diseases , Diabetes Mellitus, Type 2 , Pharmaceutical Preparations , Sodium-Glucose Transporter 2 Inhibitors , Stroke , Cardiovascular Diseases/epidemiology , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/epidemiology , Glucagon-Like Peptide-1 Receptor , Glucose , Humans , Hypoglycemic Agents/therapeutic use , Italy/epidemiology , Observational Studies as Topic , Sodium , Sodium-Glucose Transporter 2 Inhibitors/therapeutic use
2.
Glob Heart ; 14(4): 373-378, 2019 12.
Article in English | MEDLINE | ID: mdl-31727267

ABSTRACT

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.


Subject(s)
Community Health Services/organization & administration , Hypertension/prevention & control , Adult , Aged , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/prevention & control , Ecuador/epidemiology , Feasibility Studies , Female , Health Promotion/methods , Humans , Hypertension/epidemiology , Male , Middle Aged , Program Evaluation , Prospective Studies , Risk Factors , Rural Health/statistics & numerical data , Treatment Outcome
3.
Clin Chim Acta ; 495: 1-7, 2019 Aug.
Article in English | MEDLINE | ID: mdl-30910596

ABSTRACT

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.


Subject(s)
Algorithms , Blood Chemical Analysis/methods , Emergency Service, Hospital , Limit of Detection , Non-ST Elevated Myocardial Infarction/blood , Non-ST Elevated Myocardial Infarction/diagnosis , Troponin T/blood , Aged , Aged, 80 and over , Cohort Studies , Female , Humans , Male , Middle Aged , Patient Admission , ROC Curve , Time Factors
4.
Eur J Prev Cardiol ; 25(16): 1735-1743, 2018 11.
Article in English | MEDLINE | ID: mdl-29664343

ABSTRACT

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.


Subject(s)
Cardiovascular Agents/therapeutic use , Outcome and Process Assessment, Health Care/trends , Peripheral Arterial Disease/therapy , Practice Patterns, Physicians'/trends , Preventive Health Services/trends , Vascular Surgical Procedures/trends , Administrative Claims, Healthcare , Aged , Aged, 80 and over , Amputation, Surgical/trends , Databases, Factual , Female , Humans , Incidence , Italy/epidemiology , Limb Salvage/trends , Male , Middle Aged , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/mortality , Protective Factors , Registries , Risk Factors , Time Factors , Treatment Outcome , Vascular Surgical Procedures/adverse effects , Vascular Surgical Procedures/mortality
5.
Acta Diabetol ; 55(4): 355-362, 2018 Apr.
Article in English | MEDLINE | ID: mdl-29357034

ABSTRACT

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.


Subject(s)
Diabetes Mellitus/epidemiology , Diabetes Mellitus/therapy , Emigrants and Immigrants/statistics & numerical data , Ethnicity/statistics & numerical data , Adult , Aged , Diabetes Mellitus/ethnology , Female , Humans , Italy/epidemiology , Male , Middle Aged , Prevalence , Time Factors , Young Adult
6.
Acta Diabetol ; 54(2): 123-131, 2017 Feb.
Article in English | MEDLINE | ID: mdl-27718051

ABSTRACT

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.


Subject(s)
Cardiovascular Diseases/epidemiology , Diabetes Mellitus/epidemiology , Diabetic Angiopathies/epidemiology , Aged , Female , Humans , Male , Middle Aged , Multicenter Studies as Topic , Randomized Controlled Trials as Topic
7.
Eur Heart J Acute Cardiovasc Care ; 5(2): 117-24, 2016 Apr.
Article in English | MEDLINE | ID: mdl-25735300

ABSTRACT

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.


Subject(s)
Hyperglycemia/drug therapy , Hypoglycemic Agents/administration & dosage , Insulin Infusion Systems , Insulin/administration & dosage , Nurse's Role , Aged , Aged, 80 and over , Attitude of Health Personnel , Coronary Care Units/methods , Evidence-Based Medicine , Feasibility Studies , Female , Humans , Infusions, Intravenous , Male , Surveys and Questionnaires
8.
Eur J Prev Cardiol ; 23(9): 947-55, 2016 06.
Article in English | MEDLINE | ID: mdl-26525065

ABSTRACT

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.


Subject(s)
Cardiovascular Diseases/prevention & control , General Practice , Precision Medicine , Preventive Health Services , Aged , Aged, 80 and over , Cardiovascular Diseases/diagnosis , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/mortality , Checklist , Double-Blind Method , Feasibility Studies , Female , Health Status , Humans , Incidence , Italy/epidemiology , Male , Middle Aged , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome
9.
J Diabetes Res ; 2015: 173956, 2015.
Article in English | MEDLINE | ID: mdl-25961051

ABSTRACT

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.


Subject(s)
Diabetes Mellitus/drug therapy , Hyperglycemia/drug therapy , Hypoglycemia/chemically induced , Hypoglycemia/prevention & control , Hypoglycemic Agents/adverse effects , Insulin/adverse effects , Adult , Aged , Blood Glucose/analysis , Diabetes Mellitus/blood , Diabetes Mellitus/nursing , Hospitalization , Humans , Hyperglycemia/blood , Hyperglycemia/nursing , Hypoglycemia/blood , Hypoglycemia/nursing , Hypoglycemic Agents/therapeutic use , Insulin/blood , Insulin/therapeutic use , Male , Middle Aged , Prospective Studies
10.
Eur J Clin Pharmacol ; 70(8): 965-74, 2014 Aug.
Article in English | MEDLINE | ID: mdl-24820766

ABSTRACT

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.


Subject(s)
Diabetes Mellitus/drug therapy , Drug Utilization/statistics & numerical data , Practice Patterns, Physicians' , Aged , Aged, 80 and over , Diabetes Mellitus/mortality , Female , Hospitalization/statistics & numerical data , Humans , Italy/epidemiology , Male
11.
Eur J Intern Med ; 25(3): 270-5, 2014 Mar.
Article in English | MEDLINE | ID: mdl-24556165

ABSTRACT

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.


Subject(s)
Cardiovascular Diseases/therapy , Diabetes Complications/therapy , Diabetes Mellitus, Type 2/therapy , Adult , Aged , Aged, 80 and over , Databases, Factual , Diabetes Mellitus, Type 2/drug therapy , Female , Humans , Hypoglycemic Agents/therapeutic use , Male , Middle Aged , Quality Indicators, Health Care , Sex Factors , Treatment Outcome
12.
Acute Card Care ; 15(4): 83-7, 2013 Dec.
Article in English | MEDLINE | ID: mdl-24191843

ABSTRACT

Chest pain is one of the most frequent reasons for presentation to the emergency department (ED), although the estimated prevalence of AMI (acute myocardial infarction) in the ED is about 4%. One criterion for diagnosis of AMI is the demonstration of a rise and/or fall in cardiac troponins, but time is needed for this to happen. Thus, the use of an additional 'early marker' of cardiac injury may aid to exclude AMI rapidly. The aim of the study was to evaluate the possibility of excluding AMI with the determination of heart-type fatty acid-binding protein (H-FABP) on baseline samples of patients referring to the ED for chest pain. 26 AMI patients and 41 non-AMI comparisons were included in the study. Both H-FABP and high sensitivity cardiac troponin T (hs-cTnT) were measured in baseline samples from these subjects. H-FABP had a negative predictive value of 100%, thus indicating the possibility of its usage in a rule-out strategy for AMI in ED for patients presenting with chest pain.


Subject(s)
Chest Pain/diagnosis , Emergency Service, Hospital , Fatty Acid-Binding Proteins/blood , Myocardial Infarction/diagnosis , Patient Admission , Adult , Aged , Aged, 80 and over , Biomarkers/blood , Chest Pain/blood , Diagnosis, Differential , Electrocardiography , Fatty Acid Binding Protein 3 , Female , Follow-Up Studies , Humans , Male , Middle Aged , Myocardial Infarction/blood , ROC Curve , Retrospective Studies , Time Factors
13.
N Engl J Med ; 368(19): 1800-8, 2013 05 09.
Article in English | MEDLINE | ID: mdl-23656645

ABSTRACT

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.).


Subject(s)
Cardiovascular Diseases/prevention & control , Fatty Acids, Omega-3/therapeutic use , Aged , Cardiovascular Diseases/mortality , Double-Blind Method , Fatty Acids, Omega-3/adverse effects , Female , General Practice , Hospitalization , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Primary Prevention , Proportional Hazards Models , Risk Factors , Treatment Failure
14.
Diabetes Res Clin Pract ; 93(1): 123-30, 2011 Jul.
Article in English | MEDLINE | ID: mdl-21621869

ABSTRACT

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.


Subject(s)
Diabetes Mellitus/drug therapy , Drug Prescriptions/statistics & numerical data , Drug Utilization/statistics & numerical data , Drug Utilization/trends , Humans , Hypoglycemic Agents/therapeutic use , Hypolipidemic Agents/therapeutic use , Italy , Metformin/therapeutic use , Platelet Aggregation Inhibitors/therapeutic use , Sulfonylurea Compounds/therapeutic use
15.
Diabetes Care ; 34(7): 1445-50, 2011 Jul.
Article in English | MEDLINE | ID: mdl-21593302

ABSTRACT

OBJECTIVE: The study objectives were 1) to assess the effectiveness and safety of a standardized protocol for the transition to subcutaneous insulin and oral feeding in diabetic or hyperglycemic patients with acute coronary syndrome (ACS) who were receiving intravenous insulin and glucose at the time of the transfer from the intensive cardiac care unit to a general ward and 2) to identify predictors of transition outcome. RESEARCH DESIGN AND METHODS: This was a prospective observational study. The protocol specifies that patients receive a 100% of their daily subcutaneous insulin requirement from the first day of oral feeding, calculated from the intravenous insulin rate during the final 12 h divided into two: 50% basal and 50% prandial. RESULTS: In 142 patients (93 male, 49 female, age range 47-88 years, 135 with known diabetes) the first day after transition, 44.8% of blood glucose (BG) measurements were within the strict range of 100-140 mg/dL before meals and 100-180 mg/dL after meals, and 70.8% were within the broader ranges of 80-160 mg/dL and 80-200 mg/dL, respectively. Pre- or postprandial hypoglycemia (BG<70 mg/dL) occurred in 11 patients (7.7%) on the first day and in 38 patients (26.8%) on the first 3 days after transition. Old age, high doses of intravenous insulin, and wide BG variations in the 24 h before insulin infusion was stopped were predictive of poor BG control after transition. CONCLUSIONS: This study shows the effectiveness and safety of a standardized protocol for the transition from intravenous to subcutaneous insulin in patients with ACS when regular oral feeding was resumed.


Subject(s)
Acute Coronary Syndrome/complications , Blood Glucose/metabolism , Clinical Protocols/standards , Diabetes Complications/drug therapy , Hypoglycemic Agents/administration & dosage , Insulin/administration & dosage , Adult , Aged , Aged, 80 and over , Eating , Female , Humans , Hypoglycemic Agents/adverse effects , Infusions, Intravenous , Injections, Subcutaneous , Insulin/adverse effects , Intensive Care Units , Male , Middle Aged , Patient Care Team , Prospective Studies
16.
Assist Inferm Ric ; 30(1): 16-23, 2011.
Article in Italian | MEDLINE | ID: mdl-21539074

ABSTRACT

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.


Subject(s)
Acute Coronary Syndrome/nursing , Patient Education as Topic/methods , Acute Coronary Syndrome/prevention & control , Aged , Case-Control Studies , Female , Humans , Life Style , Male , Middle Aged
17.
G Ital Cardiol (Rome) ; 10(4): 249-55, 2009 Apr.
Article in Italian | MEDLINE | ID: mdl-19475880

ABSTRACT

BACKGROUND: Most patients discharged after an acute coronary event or a coronary revascularization do not have adequate knowledge of the nature of their disease and of the importance of a correct lifestyle. The aim of this study was to assess the effectiveness of an educational intervention led by nurses for patients admitted to hospital for coronary heart disease (CHD). METHODS: Since May 2003, regular health education meetings for inpatients with CHD and their relatives have been held by the nurses of the Cardiology Division of the Desio hospital. The topics covered are the nature of CHD, its risk factors and the prevention of recurrences. Before and after the meeting, a questionnaire is administered to explore patients' level of knowledge. RESULTS: From May 2003 to September 2004, 201 patients attended the meetings (151 men and 50 women, aged from 37 to 89 years). The majority (n=152, 76%) were admitted for an acute coronary syndrome. Attendance at the meeting significantly increased the patients' understanding of atherosclerosis (from 44 to 85%, p < 0.0001), coronary vessel function (from 56 to 92%, p < 0.0001) and the causes of cardiac necrosis or ischemia (from 58 to 88%, p < 0.0001). Their awareness of the importance of correct lifestyles increased, especially the number of patients willing to increase fruit and vegetable consumption (from 56 to 77%, p < 0.0001) or to increase physical activity (from 51 to 69%, p < 0.0001) to avoid a recurrence. CONCLUSIONS: A health education meeting organized by nurses for patients admitted for CHD improves their knowledge of their illness and awareness of the benefits of correct lifestyles to prevent worsening of their disease.


Subject(s)
Coronary Disease , Nursing , Patient Education as Topic , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Patient Education as Topic/methods
18.
Eur J Cardiovasc Nurs ; 8(3): 182-9, 2009 Sep.
Article in English | MEDLINE | ID: mdl-19179114

ABSTRACT

BACKGROUND: Diabetic patients with acute coronary syndromes (ACS) might benefit from tight glycemic control by means of insulin infusion. Nurse-implemented insulin infusion protocols (IIP) are available but none validated in patients with ACS admitted to a coronary care unit (CCU). AIMS: To assess feasibility, effectiveness and safety of a new nurse-managed IIP (Desio Diabetes Diagram, DDD) for intensive glucose control in patients with suspected ACS and known diabetes or blood glucose (BG) >200 mg/dL. METHODS AND RESULTS: To reach and maintain a target BG level of 100-139 mg/dL we adopted a nomogram based on the percent changes in the insulin infusion rate according to the current BG value and the percent change from previous BG level. Ninety-one consecutive patients (53 men, mean age 69.7+/-11.2 years) were treated with DDD IIP. Baseline BG was 202.2+/-86.8 mg/dL. The median time to achieve the target was 3 h (Q1-Q3 2-5 h). Afterwards target BG levels were maintained for 70.4+/-15.9% of the time. During 5004 h of insulin infusion BG never fell below 40 mg/dL. CONCLUSIONS: The nurse-managed DDD IIP was easily implemented in our CCU and permitted strict and safe glycemic control in hyperglycemic patients with ACS.


Subject(s)
Acute Coronary Syndrome/nursing , Hyperglycemia/drug therapy , Hyperglycemia/nursing , Hypoglycemic Agents/administration & dosage , Infusions, Intravenous/nursing , Insulin/administration & dosage , Acute Coronary Syndrome/complications , Aged , Attitude of Health Personnel , Blood Glucose/drug effects , Coronary Care Units , Critical Care/methods , Diabetes Mellitus, Type 1/complications , Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 1/nursing , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/nursing , Feasibility Studies , Female , Humans , Hyperglycemia/complications , Hypoglycemia/chemically induced , Hypoglycemia/nursing , Hypoglycemia/prevention & control , Hypoglycemic Agents/adverse effects , Infusions, Intravenous/methods , Insulin/adverse effects , Male , Middle Aged , Specialties, Nursing/methods
19.
BMJ ; 337: a1387, 2008 Sep 19.
Article in English | MEDLINE | ID: mdl-18805835

ABSTRACT

OBJECTIVES: To explore the predictive power of a risk stratification method for people with hypertension based on "essential" procedures (that is, available in economically less developed areas of the world), comparing it in the same population with the results given by the method suggested by the 1999 World Health Organization-International Society of Hypertension (WHO-ISH) guidelines. DESIGN: Prospective cohort study of outcomes according to cardiovascular risk profile at baseline. SETTING: Primary care in a poor rural area of the Ecuadorian forest. PARTICIPANTS: 504 people with hypertension prospectively monitored for a mean of 6.7 (SD 2.3) years. INTERVENTIONS: Essential data included blood pressure, medical history, smoking, age, sex, and diagnosis of diabetes; the WHO-ISH methods additionally included measurement of fasting blood glucose, total cholesterol, and creatinine, urinalysis, and electrocardiography. MAIN OUTCOME MEASURES: Cardiovascular events and total deaths. RESULTS: With both methods there was a highly significant association between the level of predicted risk and the incidence of cardiovascular events and of total deaths: up to three quarters of all cardiovascular events and two thirds of all deaths were reported among people classified as at high or very high risk with either method. The predictive discrimination of the essential method is comparable with the WHO-ISH with C statistics (95% confidence interval) of 0.788 (0.721 to 0.855) and 0.744 (0.673 to 0.815), respectively, for cardiovascular events and 0.747 (0.678 to 0.816) and 0.705 (0.632 to 0.778) for total mortality. CONCLUSIONS: The risk stratification of patients with hypertension with an essential package of variables (that is, available and practicable even in the economically less developed areas of the world) serves at least as well as the more comprehensive method proposed by WHO-ISH.


Subject(s)
Developing Countries , Hypertension/diagnosis , Adolescent , Adult , Aged , Cerebrovascular Disorders/epidemiology , Ecuador/epidemiology , Epidemiologic Methods , Female , Heart Failure/epidemiology , Humans , Hypertension/epidemiology , Male , Middle Aged , Myocardial Infarction/epidemiology , Poverty Areas , Rural Health
20.
Am J Hypertens ; 20(9): 997-1004, 2007 Sep.
Article in English | MEDLINE | ID: mdl-17765142

ABSTRACT

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.


Subject(s)
Electrocardiography , Hypertension/complications , Hypertrophy, Left Ventricular/diagnosis , Female , Humans , Hypertension/physiopathology , Hypertrophy, Left Ventricular/physiopathology , Male , Middle Aged , Multivariate Analysis , Prognosis , Prospective Studies
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