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      Real World Use of Antidiabetic Drugs in the Years 2011–2017: A Population-Based Study from Southern Italy

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          Abstract

          Diabetes mellitus is a metabolic disease characterized by chronic hyperglycemia. The availability of new antidiabetic drugs (ADs) has led to complex treatment patterns and to changes in the patterns of specific drug utilization. The aim of this population-based study was to describe the pattern of antidiabetic drugs (ADs) use in Southern Italy in the years 2011–2017, in relation to the updated type 2 diabetes mellitus (T2DM) therapy guidelines. A retrospective cohort study was conducted on T2DM patients using data from the Palermo Local Health Unit (LHU) claims database and diabetologist registry. The first-line treatment was investigated and incident treatments were identified and characterized at baseline in terms of demographics, complications, comorbidities, concomitant drugs and clinical parameters. Persistence to AD treatment was also evaluated. During the study period, one-third of first ever ADs users started the treatment with ADs other than metformin, in contrast to guideline recommendations. Among 151,711 incident AD treatments, the male to female ratio was 1.0 and the median age was 66 (57–75) years. More than half (55.0%) of incident treatments discontinued the therapy during the first year of treatment. In Italy, general practitioners (GPs) can only prescribe first-generation ADs, while the prescription of more recently marketed ADs, such as GLP-1RA, DPP4i and SGLT2i, is restricted to diabetologists only, based on a therapeutic plan. The role of GPs in the management of T2DM in Italy should be re-evaluated.

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          Most cited references37

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          2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD

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            Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies

            Summary Background Uncertainties persist about the magnitude of associations of diabetes mellitus and fasting glucose concentration with risk of coronary heart disease and major stroke subtypes. We aimed to quantify these associations for a wide range of circumstances. Methods We undertook a meta-analysis of individual records of diabetes, fasting blood glucose concentration, and other risk factors in people without initial vascular disease from studies in the Emerging Risk Factors Collaboration. We combined within-study regressions that were adjusted for age, sex, smoking, systolic blood pressure, and body-mass index to calculate hazard ratios (HRs) for vascular disease. Findings Analyses included data for 698 782 people (52 765 non-fatal or fatal vascular outcomes; 8·49 million person-years at risk) from 102 prospective studies. Adjusted HRs with diabetes were: 2·00 (95% CI 1·83–2·19) for coronary heart disease; 2·27 (1·95–2·65) for ischaemic stroke; 1·56 (1·19–2·05) for haemorrhagic stroke; 1·84 (1·59–2·13) for unclassified stroke; and 1·73 (1·51–1·98) for the aggregate of other vascular deaths. HRs did not change appreciably after further adjustment for lipid, inflammatory, or renal markers. HRs for coronary heart disease were higher in women than in men, at 40–59 years than at 70 years and older, and with fatal than with non-fatal disease. At an adult population-wide prevalence of 10%, diabetes was estimated to account for 11% (10–12%) of vascular deaths. Fasting blood glucose concentration was non-linearly related to vascular risk, with no significant associations between 3·90 mmol/L and 5·59 mmol/L. Compared with fasting blood glucose concentrations of 3·90–5·59 mmol/L, HRs for coronary heart disease were: 1·07 (0·97–1·18) for lower than 3·90 mmol/L; 1·11 (1·04–1·18) for 5·60–6·09 mmol/L; and 1·17 (1·08–1·26) for 6·10–6·99 mmol/L. In people without a history of diabetes, information about fasting blood glucose concentration or impaired fasting glucose status did not significantly improve metrics of vascular disease prediction when added to information about several conventional risk factors. Interpretation Diabetes confers about a two-fold excess risk for a wide range of vascular diseases, independently from other conventional risk factors. In people without diabetes, fasting blood glucose concentration is modestly and non-linearly associated with risk of vascular disease. Funding British Heart Foundation, UK Medical Research Council, and Pfizer.
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              Intensive Blood Glucose Control and Vascular Outcomes in Patients with Type 2 Diabetes

              In patients with type 2 diabetes, the effects of intensive glucose control on vascular outcomes remain uncertain. We randomly assigned 11,140 patients with type 2 diabetes to undergo either standard glucose control or intensive glucose control, defined as the use of gliclazide (modified release) plus other drugs as required to achieve a glycated hemoglobin value of 6.5% or less. Primary end points were composites of major macrovascular events (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke) and major microvascular events (new or worsening nephropathy or retinopathy), assessed both jointly and separately. After a median of 5 years of follow-up, the mean glycated hemoglobin level was lower in the intensive-control group (6.5%) than in the standard-control group (7.3%). Intensive control reduced the incidence of combined major macrovascular and microvascular events (18.1%, vs. 20.0% with standard control; hazard ratio, 0.90; 95% confidence interval [CI], 0.82 to 0.98; P=0.01), as well as that of major microvascular events (9.4% vs. 10.9%; hazard ratio, 0.86; 95% CI, 0.77 to 0.97; P=0.01), primarily because of a reduction in the incidence of nephropathy (4.1% vs. 5.2%; hazard ratio, 0.79; 95% CI, 0.66 to 0.93; P=0.006), with no significant effect on retinopathy (P=0.50). There were no significant effects of the type of glucose control on major macrovascular events (hazard ratio with intensive control, 0.94; 95% CI, 0.84 to 1.06; P=0.32), death from cardiovascular causes (hazard ratio with intensive control, 0.88; 95% CI, 0.74 to 1.04; P=0.12), or death from any cause (hazard ratio with intensive control, 0.93; 95% CI, 0.83 to 1.06; P=0.28). Severe hypoglycemia, although uncommon, was more common in the intensive-control group (2.7%, vs. 1.5% in the standard-control group; hazard ratio, 1.86; 95% CI, 1.42 to 2.40; P<0.001). A strategy of intensive glucose control, involving gliclazide (modified release) and other drugs as required, that lowered the glycated hemoglobin value to 6.5% yielded a 10% relative reduction in the combined outcome of major macrovascular and microvascular events, primarily as a consequence of a 21% relative reduction in nephropathy. (ClinicalTrials.gov number, NCT00145925.) 2008 Massachusetts Medical Society
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                Author and article information

                Journal
                Int J Environ Res Public Health
                Int J Environ Res Public Health
                ijerph
                International Journal of Environmental Research and Public Health
                MDPI
                1661-7827
                1660-4601
                18 December 2020
                December 2020
                : 17
                : 24
                : 9514
                Affiliations
                [1 ]Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, 98125 Messina, Italy; mp.bertuccio@ 123456gmail.com (M.P.B.); salcrisafulli@ 123456unime.it (S.C.); vientile@ 123456unime.it (V.I.); luca.labbate@ 123456unime.it (L.L.)
                [2 ]Department of Clinical and Experimental Medicine, University of Messina, 98125 Messina, Italy; marcom1987@ 123456gmail.com
                [3 ]Palermo Local Health Unit, Department of Pharmacy, 90127 Palermo, Italy; dipfarmaceuticoasppa@ 123456gmail.com
                [4 ]Regional Referral Centre for Insulin Pump Implantation and Diabetes, Civic Hospital, Partinico, 90047 Palermo, Italy; vincenzoprovenzano54@ 123456gmail.com (V.P.); alexscorsone@ 123456gmail.com (A.S.)
                [5 ]Department of Epidemiologic Observatory, Health Department of Sicily, 90127 Palermo, Italy; salvatore.scondotto@ 123456regione.sicilia.it
                [6 ]Department of Diagnostic and Public Health, University of Verona, 37134 Verona, Italy; gianluca.trifiro@ 123456univr.it
                Author notes
                [* ]Correspondence: ylenia.ingrasciotta@ 123456unime.it ; Tel.: +39-090-2213877
                Author information
                https://orcid.org/0000-0002-9549-6111
                https://orcid.org/0000-0002-0644-8418
                https://orcid.org/0000-0001-8010-4042
                https://orcid.org/0000-0003-1147-7296
                Article
                ijerph-17-09514
                10.3390/ijerph17249514
                7765957
                33353081
                732a0c19-47ba-411a-a839-5063732cedaa
                © 2020 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                : 19 November 2020
                : 16 December 2020
                Categories
                Article

                Public health
                antidiabetic drugs,real world data,type 2 diabetes mellitus,therapy guidelines,southern italy

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