Cardiovascular Risk Profile in Prostate Cancer Patients Treated with GnRH Agonists versus Antagonists: An Italian Real-World Analysis.

PURPOSE: To evaluate and compare the incidence of cardiovascular (CV) events in a large contemporary cohort of patients diagnosed with prostate cancer (PCa) and in treatment with GnRH agonists or GnRH antagonists. PATIENTS AND METHODS: An Italian observational retrospective cohort study based on administrative databases of three local health units and two Regions was performed. PCa patients treated with GnRH agonists or antagonist were included between January 01, 2013 and December 31, 2016. Index date (ID) was the date of first GnRH agonist/antagonist prescription during inclusion period. Follow-up was from ID to December 31, 2017. Patients were excluded if they were under abiraterone treatment or combination therapy with antiandrogens during follow-up. The incidence rate of CV events (acute myocardial infarction, ischemic heart diseases, cerebrovascular diseases, cardiac dysrhythmias, heart failure, atherosclerosis, aneurism, other CV-related conditions) was calculated among patients not switching to androgen deprivation therapy (ADT) in the overall cohort and in a sub-cohort of patients without previous CV events. RESULTS: In total, 9785 (mean age 76.8 ± 8.5) patients were included: 9158 (93.6%) were treated with a GnRH agonist and 627 (6.4%) with a GnRH antagonist. Of them, 9627 did not switch to ADT and were considered in the analyses. The incidence of CV events was significantly higher in patients treated with GnRH agonists rather than antagonists (8.8 vs 6.2, p=0.002). Mean time to CV event was beyond 1 year of treatment in both groups. In the multivariable regression analysis, the risk of experiencing CV events was significantly lower in patients treated with GnRH antagonist rather than those treated with GnRH agonists [HR (95% CI): 0.76 (0.60-0.95), p=0.018]. These findings were confirmed in the sub-cohort of patients without previous CV events. CONCLUSION: This Italian observational study shows that most patients received a GnRH agonist rather than a GnRH antagonist prescription. GnRH antagonist seems to have a better CV risk profile than GnRH agonist, both in patients with and without a history of CV events.

The cost of preterm labor and preterm birth for mothers with uncomplicated pregnancies and their infants in Italy: a retrospective cohort study.

BACKGROUND: Preterm labor (PTL)/preterm birth (PTB) impose significant burden on health-care systems. Women with uncomplicated pregnancies at risk of PTL/PTB have not been widely investigated, and published evidence on the costs of these women and their infants in Italy is absent. We aimed to describe women with uncomplicated pregnancies and associated costs for these women and their infants. METHODS: Data on women aged 12-44 years with uncomplicated pregnancies who delivered between 1 September 2009 and 31 December 2014 with PTL diagnosis alone or PTL and PTB were included from four Italian databases. Costs were examined during pregnancy, delivery, and 3 years after delivery for mothers and infants, overall and by gestational age (GA). RESULTS: A total of 3058 mothers linked to 3333 infants were included. Costs during pregnancy were €1777. Costs during delivery for PTL/PTB mothers and their infants ranged from €3174 (GA ≥37) to €21007 (GA <28). Combined maternal and infant costs appeared higher for births with lower GAs (<37) in the three-year follow-up. CONCLUSIONS: In Italy, PTL/PTB mothers with uncomplicated pregnancies with infants at lower GAs appeared to incur higher medical costs compared to mothers with infants at higher GAs in all three time periods, with particularly marked differences found when considering mother and infant combined costs.

Insulin Glargine U100 Utilization in Patients with Type 2 Diabetes in an Italian Real-World Setting: A Retrospective Study.

BACKGROUND: This study is aimed at estimating the proportion of type 2 diabetes mellitus (T2DM) patients treated with basal insulin (insulin glargine U100) and at evaluating daily insulin dose, treatment pattern, and adherence to treatment of these patients. METHODS: Data from administrative and laboratory databases of 3 Italian Local Health Units were retrospectively collected and analyzed. All patients with a diagnosis of T2DM between 01/01/2012 and 31/12/2012 were considered, and those with at least a prescription of insulin glargine between 01/01/2013 and 31/12/2014 were included and followed up for one year. For each patient, we evaluated HbA1c levels both at baseline and during the follow-up period and the daily average dose of insulin. Medication adherence was defined by using medication possession ratio (MPR) and reported as proportion of patients with MPR ≥ 80%. RESULTS: 7,422 T2DM patients were available for the study. According to the antidiabetic medication prescribed, patients were categorized into four groups: insulin glargine only, insulin glargine plus oral glucose-lowering drugs, insulin glargine plus rapid-acting insulin, and insulin glargine plus DPP-4 inhibitors. Median daily dose of insulin among insulin glargine only patients was higher than in other groups (35 IU vs. 20 IU, p < 0.05), and a higher percentage of them achieved a target HbA1c value of less than 7.0% (53.8% vs. 30%, p < 0.001). Adherence to insulin treatment was lowest (41%) in the insulin glargine only group compared to other groups (ranging from 58.4% to 64.4%), p < 0.001. CONCLUSIONS: A large proportion of T2DM patients treated with insulin fail in achieving the glycemic target of HbA1c level < 7%, irrespective of treatment regimen; however, basal insulin only is associated with lower therapeutic unsuccess. Adherence to antidiabetes medications is also suboptimal in these patients and should be addressed to improve long-term outcomes of reducing and preventing microvascular and macrovascular complications.

Healthcare usage and economic impact of non-treated obesity in Italy: findings from a retrospective administrative and clinical database analysis.

OBJECTIVES: Investigate the prevalence of obesity in Italy and examine its resource consumption and economic impact on the Italian national healthcare system (NHS). DESIGN: Retrospective, observational and real-life study. SETTING: Data from three health units from Northern (Bergamo, Lombardy), Central (Grosseto, Tuscany) and Southern (Naples, Campania) Italy. PARTICIPANTS: All patients aged ≥18 years with at least one recorded body mass index (BMI) measurement between 1 January 2009 and 31 December 2012 were included. INTERVENTIONS: Information retrieved from the databases included primary care data, medical prescriptions, specialist consultations and hospital discharge records from 2009-2013. Costs associated with these data were also calculated. Data are presented for two time periods (1 year after BMI measurement and study end). PRIMARY AND SECONDARY OUTCOME MEASURES: Primary-to estimate health resources consumption and the associated economic impact on the Italian NHS. Secondary-the prevalence and characteristics of subjects by BMI category. RESULTS: 20 159 adult subjects with at least one documented BMI measurement. Subjects with BMI ≥30 kg/m2 were defined as obese. The prevalence of obesity was 22.2% (N=4471) and increased with age. At the 1-year observation period, obese subjects who did not receive treatment for their obesity experienced longer durations of hospitalisation (median length: 5 days vs 3 days), used more prescription drugs (75.0% vs 57.7%), required more specialised outpatient healthcare (mean number: 5.3 vs 4.4) and were associated with greater costs, primarily owing to prescription drugs and hospital admissions (mean annual cost per year per patient: €460.6 vs €288.0 for drug prescriptions, €422.7 vs € 279.2 for hospitalisations and €283.2 vs €251.7 for outpatient care), compared with normal weight subjects. Similar findings were observed for the period up to data cut-off (mean follow-up of 2.7 years). CONCLUSIONS: Untreated obesity has a significant economic impact on the Italian healthcare system, highlighting the need to raise awareness and proactively treat obese subjects.