Socio-economic inequalities in the use of drugs for the treatment of chronic diseases in Italy.

BACKGROUND: Since the use of medicines is strongly correlated to population health needs, higher drug consumption is expected in socio-economical deprived areas. However, no systematic study investigated the relationship between medications use in the treatment of chronic diseases and the socioeconomic position of patients. The purpose of the study is to provide a description, both at national level and with geographical detail, of the use of medicines, in terms of consumption, adherence and persistence, for the treatment of major chronic diseases in groups of population with different level of socioeconomic position.  METHODS: A cross-sectional study design was used to define the "prevalent" users during 2018. A longitudinal cohort study design was performed for each chronic disease in new drug users, in 2018 and the following year. A retrospective population-based study, considering all adult Italian residents (i.e. around 50.7 million people aged ≥ 18 years). Different medications were used as a proxy for underlying chronic diseases: hypertension, dyslipidemia, osteoporosis, diabetes and chronic obstructive pulmonary disease. Only "chronic" patients who had at least 2 prescriptions within the same subgroup of drugs or specific medications during the year were selected for the analysis. A multidimensional measures of socio-economic position, declined in a national deprivation index at the municipality level, was used to identify and estimate the relationship with drug use indicators. The medicine consumption rate for each pharmacological category was estimated for prevalent users while adherence and persistence to pharmacologic therapy at 12 months were evaluated for new users. RESULTS: The results highlighted how the socioeconomic deprivation is strongly correlated with the use of medicines: after adjustment by deprivation index, the drug consumption rates decreased, mainly in the most disadvantaged areas, where consumption levels are on average higher than in other areas. On the other hand, the adherence and persistence indicators did not show the same trend. CONCLUSIONS: This study showed that drug consumption is influenced by the level of deprivation consistently with the distribution of diseases. For this reason, the main levers on which it is necessary to act to reduce disparities in health status are mainly related to prevention. Moreover, it is worth pointing out that the use of a municipal deprivation indicator necessarily generates an ecological bias, however, the experience of the present study, which for the first-time deals with the complex and delicate issue of equity in Italian pharmaceutical assistance, sets the stage for new insights that could overcome the limits.

Prevalence of and secular trends in diagnosed diabetes in Italy: 1980-2013.

BACKGROUND AND AIMS: The aim of this research was to examine the prevalence of diabetes in Italy over a 34-year period. METHODS AND RESULTS: Self-reported diabetes was assessed in eight health interview surveys of representative samples of Italian population aged 20 years and over. Crude and standardised prevalence were calculated by age, sex, educational level and area of residence. Logistic models were fitted to calculate the contribution of age and BMI to the trend in prevalence. In 2013 nearly 3.4 million Italians had a diagnosis of diabetes, more than twice as many as in 1980. The crude prevalence of diabetes in men rose from 3.3% in 1980 to 7.1% in 2013 (+115%), and from 4.7% to 6.8% in women (+45%). The prevalence was almost stable during the eighties, and started to rise from the beginning of the nineties. One third of the increase in men and two thirds in women is due to the ageing of the population, since the age-standardised prevalence increased by 79% in men and 14% in women. The prevalence of overweight and obesity increased less steeply than diabetes, and their contribution to the trend in diabetes is less relevant than age. Prevalence rose more in the elderly, in low-educated men, and in high-educated women. CONCLUSION: Given that the ageing population plays a considerable role in explaining the trend, and that the number of people in the oldest age groups will continue to grow, the rise in the number of individuals with diabetes will represent a severe challenge for the national health system.

A systematic review of acute pancreatitis as an adverse event of type 2 diabetes drugs: from hard facts to a balanced position.

The question whether antidiabetes drugs can cause acute pancreatitis dates back to the 1970s. Recently, old concerns have re-emerged following claims that use of incretins, a new class of drugs for type 2 diabetes, might increase the relative risk of acute pancreatitis up to 30-fold. Given that diabetes is per se a potent risk factor for acute pancreatitis and that drug-related acute pancreatitis is rare and difficult to diagnose, we searched the medical databases for information linking acute pancreatitis and type 2 diabetes drugs. Among the biguanides, both phenformin and metformin (the latter in patients with renal insufficiency) have been cited in case reports as a potential cause of acute pancreatitis. Sulphonylureas, as both entire class and single compound (glibenclamide), have also been found in cohort studies to increase its risk. No direct link was found between pancreatic damage and therapy with metaglinide, acarbose, pramlintide or SGLT-2 inhibitors. In animal models, thiazolinediones have demonstrated proprieties to attenuate pancreatic damage, opening perspectives for their use in treating acute pancreatitis in humans. Several case reports and the US Food and Drug Administration pharmacovigilance database indicate an association between acute pancreatitis and incretins, dipeptidyl peptidase-4 (DPP-4) inhibitors, and GLP-1 receptor agonists. To date, however, a clear-cut odds ratio for this association has been reported in only one of eight pharmacoepidemiological studies. Finally, none of the intervention trials investigating these compounds, including two large randomized controlled trials with cardiovascular endpoints, confirmed the purportedly increased risk of acute pancreatitis with incretin use.

Comparison of direct costs of type 2 diabetes care: different care models with different outcomes.

BACKGROUNDS AND AIMS: To compare direct costs of four different care models and health outcomes in adults with type 2 diabetes. METHODS AND RESULTS: We used multiple independent data sources to identify 25,570 adults with type 2 diabetes residing in Turin, Italy, as of 1 July 2003. Data extracted from administrative data databases were used to create four care models ranging in organization from highly structured care (integrated primary and specialist care) to progressively less structured care (unstructured care). Regression analyses, adjusted for main confounders, were applied to examine the differences between the models in direct costs, mortality, and diabetes-related hospitalizations rates over a 4-year period. In patients managed according to the unstructured care model (i.e., usual care by a primary care provider and without strict guidelines adherence), excess of all-cause mortality was 84% and 4-year direct cost was 8% higher than in those managed according to the highly structured care model. Cost ratio analysis revealed that the major cost driver in the unstructured care model was hospital admissions, which were 31% higher than the rate calculated for the more structured care models. In contrast, spending on prescription medications and specialist consultations was higher in the highly structured care model. CONCLUSION: A diabetes care model that integrates primary and specialty care, together with practices that adhere to guideline recommendations, was associated with a reduction in all-cause mortality and hospitalizations, as compared with less structured models, without increasing direct health costs.

Direct costs in diabetic and non diabetic people: the population-based Turin study, Italy.

BACKGROUND AND AIMS: We compared direct costs of diabetic and non diabetic people covered by the Italian National Health System, focusing on the influence of age, sex, type of diabetes and treatment. METHODS AND RESULTS: Diabetic people living in Turin were identified through the Regional Diabetes Registry and the files of hospital discharges and prescriptions. Data sources were linked to the administrative databases to assess health care services used by diabetic (n = 33,792) and non diabetic people(n = 863,123). Data were analyzed with the two-part model; the estimated direct costs per person/year were €3660.8 in diabetic people and €895.6 in non diabetic people, giving a cost ratio of 4.1. Diabetes accounted for 11.4% of total health care expenditure. The costs were attributed to hospitalizations (57.2%), drugs (25.6%), to outpatient care (11.9%), consumable goods (4.4%) and emergency care (0.9%). Estimated costs increased from € 2670.8 in diabetic people aged <45 years to € 3724.1 in those aged >74 years, the latter representing two third of the diabetic cohort; corresponding figures in non diabetic people were € 371.6 and € 2155.9. In all expenditure categories cost ratios of diabetic vs non diabetic people were higher in people aged <45 years, in type 1 diabetes and in insulin-treated type 2 diabetes. CONCLUSION: Direct costs are 4-fold higher in diabetic than in non diabetic people, mainly due to care of the elderly and inpatient care. In developed countries, demographic changes will have a profound impact on costs for diabetes in next years.

Reduction incidence of myocardial infarction associated with a national legislative ban on smoking.

AIM: The aim of the present study was to assess change in admissions for acute myocardial infarction (AMI) in the period immediately subsequent to the coming into force of law no. 3/2003 ''Protection of the health of non-smokers''. METHODS: Four Italian regions (Piedmont, Friuli Venezia Giulia, Lazio and Campania) took part in the study. Data regarding admissions for AMI were taken from the daily discharge papers of patients aged between 40 and 64 (cod. ICD9-CM 410.), in the period 10 January-10 March 2001-2005. Repeated admissions were excluded. Admission rates standardised by age and overall total, and specifically by region, age and gender were calculated. The hypothesis of a significant reduction between 2005 and 2004 was also checked. RESULTS: The results showed a decrease in the number of cases and in the standardised rates between 2004 and 2005. The number of admissions estimated with a linear regression model for 2005 was significantly higher than that really observed (+13%). The decrease between the 2005 and 2004 rates was noteworthy for all four regions. Analysis by gender shows that the effect is observed only in male patients and in the age classes 45-49 and 50-54. CONCLUSION: This study shows that there has been an appreciable reduction in the incidence of heart attacks in the period immediately subsequent to the coming into force of the non-smoking Law in the populations surveyed, and that this reduction mainly regards men of working age. The reduction reverses a trend that has been evident for a number of years, namely that of a decidedly upward trend in the number of admissions for AMI.

[Cardiovascular risk factors in a community in Piedmont: changes after 11 years and a comparison with other regional and national data]. / Fattori di rischio cardiovascolare in una comunità del Piemonte: variazioni a distanza di undici anni e confronto con altri dati regionali e nazionali.

BACKGROUND: In 1986 the Cardiology Department, including an outpatient clinic, was established in the community hospital of Savigliano (Italy). In 1987, as a part of a cardiovascular community prevention program, an epidemiological survey on cardiovascular risk factors was carried out. Similar indicators have been object of the study held in 1998 by ANMCO-Istituto Superiore di Sanità: the Italian Cardiovascular Epidemiological Observatory. So, 11 years later, we have had the chance to compare the changes, in the same community, of three important risk factors: tobacco smoking, arterial blood pressure, and obesity. METHODS: The 1987 survey included 280 subjects, aged 20 to 59 years. The 1998 survey has examined 200 subjects, aged 35 to 74 years. In both cases the subjects have been randomly selected from the Electoral Registers; subjects were asked to answer a questionnaire on tobacco smoking; arterial blood pressure measured using a cuff manometer was registered and weight and height have been recorded. In order to have comparable data we have only considered subjects 35 to 59 years old. RESULTS: One hundred and fifty-seven subjects (84 males and 73 females) were included in the 1987 survey and 123 (60 males and 63 females) in the 1998 survey. In 1987, the percentage of smokers was 40.7% (61.4% of males and 17.8% of females), with an average of 23.4 cigarettes/day among males and 14.7 among females. In 1998, the percentage of smokers has dropped to 18.6%, without any differences between sexes, with an average of 11.9 cigarettes/day among males and 12.7 among females. The mean values of blood pressure were lower in 1998 than in 1987 both in males (129.4/85.7 vs 138.0/88.2 mmHg) and females (119.3/80.2 vs 138.4/86.5 mmHg). Although not statistically significant, the percentage of individuals with systolic blood pressure > or = 160 mmHg or diastolic blood pressure > or = 95 mmHg was lower in 1998 (15.9% among males and 14.2% among females) than in 1987 (25.6% among males and 22.8% among females). The mean values of body mass index were unchanged (from 25.4 to 25.2 kg/m2 in males and from 23.4 to 23.1 kg/m2 in females). CONCLUSIONS: The incidence of tobacco smoking and of hypertension has shown a significant reduction in the population of Savigliano between 1987 and 1998. No significant variation was found in body mass index or in the prevalence of obesity. The distribution of these three risk factors seems to be lesser than that reported in northern Italy.

Mortality, incidence of cardiovascular diseases, and educational level among the diabetic and non-diabetic populations in two large Italian cities.

AIMS: We investigated if diabetes modifies the effect of the association of education with mortality and incidence of cardiovascular diseases. METHODS: We identified 44,889 diabetics using multiple data sources. They were followed up from January 2002 up to December 2005, and their mortality, incidence of myocardial infarction and stroke, by educational level were analysed, and compared with those of the local non-diabetic population. RESULTS: The all-cause Standardized Mortality Ratios among diabetics, compared with non-diabetics, were 170 for men and 175 for women. Standardized Incidence Ratios were 199 for myocardial infarction, and 183 for stroke in men and, respectively, 281, and 179 in women. Among non-diabetics there was a clear inverse relation with educational level for all outcomes, whereas among diabetics no significant social difference in incidence was found; slight social differences in mortality were present among men, but not among women. The effect of diabetes on social differences was enhanced in the youngest population. CONCLUSIONS: Diabetes increases the risk of death and the incidence of vascular diseases, but reduces their inverse association with education. This is likely related to the high accessibility and good quality of health care provided by the local networks of diabetic centres and primary care.

The impact of diabetes on prescription drug costs: the population-based Turin study.

AIMS/HYPOTHESIS: The aim of our study was to compare prescription drug costs in diabetic and non-diabetic individuals in a large population-based Italian cohort covered by the National Health System. METHODS: We identified diabetic residents in Turin on 31 July 2003 through multiple independent data sources (diabetes registry, hospital discharges and prescriptions data sources). All prescriptions registered in the 12 month period 1 August 2003 to 31 July 2004 were examined to compare prevalence of treatment and costs in diabetic (n = 33,797) and non-diabetic individuals (n = 863,876). A log-linear model was employed to estimate age- and sex-adjusted ratios of costs. RESULTS: Costs per person per year were 830.90euros in diabetic patients and 182.80euros in non-diabetic individuals (age- and sex-adjusted rate ratio 2.8, 95% CI 2.7-2.9). Diabetes treatment accounted for 18.5% of the total cost. Compared with non-diabetic individuals, the excess of expenditure was particularly high in diabetic patients aged <45 years (rate ratio 9.3), in those with type 1 diabetes (rate ratio 7.7) and in insulin users (rate ratio 4.8). The cost of diet-treated patients was similar to those treated with oral drugs. Diabetes was associated with an increased prevalence of treatment for most drug categories; one-third of the diabetic cohort received ACE inhibitors, anti-thrombotic drugs and statins. CONCLUSIONS/INTERPRETATION: This population-based study shows that diabetes has a great impact on prescription drug costs, independently of main confounders, particularly in insulin-treated patients, suggesting that a wide range of comorbidities affect their health. Costs are expected to further increase if the transferability of knowledge provided by evidence-based guidelines on diabetic patients is completed over the coming years.

The impact of second-level specialized care on hospitalization in persons with diabetes: a multilevel population-based study.

AIMS: We evaluated whether differences in the use of specialized care have an impact on rates of hospitalization for diabetes. METHODS: In 2001 we determined the number of hours of second-level diabetes care provided by local health units (LHU) of the Piemonte Region (Italy) and created an indicator of the mean weekly number of hours of care per 1000 residents for each LHU. From the database of the Piemonte Hospital Information System, we extracted all hospitalizations for 20-75-year-old residents with a main discharge diagnosis of diabetes mellitus (n = 3457). For each LHU, we calculated the hospitalization rate, the percentage of unplanned hospital admissions, the mean length of hospital stay, the percentage of day-hospital admissions and the percentage of re-admissions for diabetes-related complications within 6 months. The association between the indicators of specialized care and of hospital care was studied using two-level generalized hierarchical linear regression models (level 1: patient; level 2: LHU), taking into account the clustered nature of the data. Age, educational level and an indicator of disease severity were used as adjustment parameters. RESULTS: In the tertile of LHUs that provided the greatest number of hours of diabetes care, we observed, compared with the lowest tertile fewer unplanned hospital admissions [odds ratio (OR) 0.37; 95% confidence interval (CI) 0.20-0.67], greater day-hospital use (OR 1.99; 0.72-5.49) and a lower mean duration of hospital stay (coefficient -0.26; 95% CI -0.45 to -0.06), independently of the socio-economic level, which was a separate risk factor. CONCLUSIONS: The intensity of specialized diabetes care greatly influences the characteristics of hospitalization.

Socioeconomic status, overweight and obesity in prepuberal children: a study in an area of Northern Italy.

The aim of this study was to determine whether socio-economical status (SES) is associated with overweight and obesity in prepuberal children. In an area of North-Western Italy a sample of 1420 children, aged 10-11 years, had his/her height and weight recorded, (overweight and obesity were defined, respectively, as relative body weight > or = 120% and > or = 140%), and parents were requested to compile a questionnaire exploring some demographic and social conditions. 23% of the sample resulted overweight or obese. Prevalence rate ratios (PRR) of overweight and obesity (together) were calculated, adjusting for parents' age, parents' area of birth, and school district. PRR for mother's lowest educational level compared to the highest was 1.59 (95% CI: 1.19-2.13), while for father's education was 1.21 (0.90-1.63). PRRs for 'unemployed' or 'manual' mother compared to 'upper non manual' were respectively 1.83 (1.20-2.79) and 2.20 (1.31-3.68), while for 'unemployed' or 'manual' father were 2.63 (1.97-2.63), and 1.63 (1.27-2.09). The cultural resources of the mother, and the economical resources of the family seem to influence the prevalence of weight gain in prepuberal children. This should be taken into account when planning programs for the prevention or reduction of obesity in children.

Cancer mortality by educational level in Italy.

Social differences in health concern both ethics and science. From a public health point-of-view, one must assess actual differences and then try to find explanations. This was made possible for the first time for cancer in Italy via nationwide record-linkage between the 1981 census and the national death index. Over the subsequent six months after census, the study-base included 31,000 deaths for cancer and 18 million person-years at risk. Rate ratio (RR) were estimated through a Poisson regression model adjusted by age and geographic area of residence. Educational level was used as social level indicator. Profound social differences were evident for buccal cavity (RR = 3.10 for lowest cf highest educational level), esophagus (RR = 3.00), stomach (RR = 3.43), and larynx (RR = 3.30) among men, and for stomach (RR = 2.25) and uterus (RR = 1.76) among women. Colon (RR = 0.62) and pancreas cancers (RR = 0.65) presented an inverse relationship among men, as did colon (RR = 0.37), breast (RR = 0.56), ovary (RR = 0.45), and melanoma (RR = 0.62) among women. In conclusion, the Italian population at the beginning of the 1980s had large social differences in the risk of dying from cancer, confirming the patterns commonly found in such other countries as Great Britain, France, and New Zealand. Some dissimilarities, useful for hypothesis generation on the mechanisms of inequality, were evident, such as the generally highest social differences found among northern Italian men and among southern Italian women.