{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T13:51:51Z","timestamp":1782481911936,"version":"3.54.5"},"reference-count":13,"publisher":"Aboutscience Srl","issue":"1","license":[{"start":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T00:00:00Z","timestamp":1782432000000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Grhta"],"abstract":"<jats:p>Introduction: Type 2 diabetes mellitus (T2DM) is a common chronic disease with management, associated with cardiovascular and renal comorbidities. In January 2022, AIFA Note 100 extended prescribing authority for innovative antidiabetic drugs (SGLT-2 inhibitors, GLP-1 receptor agonists, and DPP-4 inhibitors) to General Practitioners, influencing treatment patterns and management of high-risk patients.Methods: A retrospective observational analysis used administrative data from two Local Health Authorities in Italy, comparing three cohorts: Pre-COVID (2018), COVID (2020-2021), and Post-Note 100 (February 1, 2022 to January 31, 2023). Adults (\u226518 years) with at least one prescription of non-insulin glucose-lowering drugs (ATC A10B) were included. Profiles were described, focusing on acarbose, DPP-4 inhibitors, metformin, pioglitazone, SGLT-2 inhibitors, GLP-1 receptor agonists, and sulfonylureas. Clinical characteristics included comorbidities, heart failure, hypertension, and chronic kidney disease. Healthcare costs (pharmaceuticals, outpatient specialist care, and hospitalizations) were analyzed.Results: Over 140,000 subjects were included. In the Post\u2013Note 100 phase, GLP-1 receptor agonists and SGLT-2 inhibitors increased among new users (GLP-1 receptor agonists: 1.2% to 9.3%; SGLT-2 inhibitors: 2.6% to 14.1%) and among prevalent users, with a reduction in sulfonylureas and a decline in metformin monotherapy. Among patients with \u2265 2 comorbidities, SGLT-2 inhibitors became the most prescribed class. Use rose in heart failure, while both GLP-1 receptor agonists and SGLT-2 inhibitors increased in chronic kidney disease.Conclusions: Expansion of prescribing eligibility introduced by AIFA Note 100 led to a shift toward innovative therapies, aligning prescribing with guidelines, particularly in comorbid patients. Real-world data highlight the impact and support the evaluation of long-term outcomes.<\/jats:p>","DOI":"10.33393\/grhta.2026.3790","type":"journal-article","created":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T13:28:57Z","timestamp":1782480537000},"page":"167-176","source":"Crossref","is-referenced-by-count":0,"title":["Impact of AIFA Note 100 on innovative antidiabetic  prescribing eligibility in two Italian local health  authorities: drug utilization and patient characteristics"],"prefix":"10.33393","volume":"13","author":[{"given":"Giacomo Matteo","family":"Bruno","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Chiara","family":"Valentino","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-8414-424X","authenticated-orcid":false,"given":"Stefano","family":"Buda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-2968-0826","authenticated-orcid":false,"given":"Arrigo","family":"Paciello","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0879-4303","authenticated-orcid":false,"given":"Stefano","family":"Palcic","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giorgio Lorenzo","family":"Colombo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"18642","published-online":{"date-parts":[[2026,6,26]]},"reference":[{"key":"19978","unstructured":"Ministero della Salute, Direzione Generale della Prevenzione, Ufficio 5 DGPRE. Legge 16 marzo 1987, n. 115, recante \u201cDisposizioni per la prevenzione e la cura del diabete mellito\u201d. Relazione 2024: stato delle conoscenze e delle nuove acquisizioni in tema di diabete mellito. Ministero della Salute; 2024. Online https:\/\/www.salute.gov.it\/new\/sites\/default\/files\/2025-10\/Relazione%20diabete%202024.pdf (Accessed March 2026)"},{"key":"19979","doi-asserted-by":"crossref","unstructured":"Zinman B, Wanner C, Lachin JM, et al.; EMPA-REG OUTCOME Investigators. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373(22):2117-2128. https:\/\/doi.org\/10.1056\/NEJMoa1504720 PMID:26378978","DOI":"10.1056\/NEJMoa1504720"},{"key":"19980","doi-asserted-by":"crossref","unstructured":"Marso SP, Daniels GH, Brown-Frandsen K, et al.; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375(4):311-322. https:\/\/doi.org\/10.1056\/NEJMoa1603827 PMID:27295427","DOI":"10.1056\/NEJMoa1603827"},{"key":"19981","doi-asserted-by":"crossref","unstructured":"Heerspink HJL, Stef\u00e1nsson BV, Correa-Rotter R, et al.; DAPA-CKD Trial Committees and Investigators. Dapagliflozin in patients with chronic kidney disease. N Engl J Med. 2020;383(15):1436-1446. https:\/\/doi.org\/10.1056\/NEJMoa2024816 PMID:32970396","DOI":"10.1056\/NEJMoa2024816"},{"key":"19982","doi-asserted-by":"crossref","unstructured":"Davies MJ, Aroda VR, Collins BS, et al. Management of hyperglycemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2022;45(11):2753-2786. https:\/\/doi.org\/10.2337\/dci22-0034 PMID:36148880","DOI":"10.2337\/dci22-0034"},{"key":"19983","unstructured":"Societ\u00e0 Italiana di Diabetologia (SID). Associazione Medici Diabetologi (AMD). Standard italiani per la cura del diabete mellito 2022. SID-AMD; 2022. https:\/\/www.siditalia.it\/pdf\/LG_379_diabete_ed2022_feb2023.pdf"},{"key":"19984","unstructured":"National Institute for Health and Care Excellence (NICE). Type 2 diabetes in adults: management. NICE; 2022, NICE guideline NG28. Online https:\/\/www.nice.org.uk\/guidance\/ng28 (Accessed March 2026)"},{"key":"19985","unstructured":"Agenzia Italiana del Farmaco (AIFA). Determina Nota 100 \u2013 Gazzetta Ufficiale n. 19 del 25 gennaio 2022. AIFA; 2022. Online https:\/\/www.aifa.gov.it\/nota-100 (Accessed March 2026)"},{"key":"19986","unstructured":"Agenzia Italiana del Farmaco (AIFA). Rapporto di monitoraggio Nota 100 \u2013 9 mesi. AIFA; 2022. Online https:\/\/www.aifa.gov.it\/documents\/20142\/1728125\/NOTA_100_9mesi_28.02.2023.pdf (Accessed March 2026)"},{"key":"19987","unstructured":"Agenzia Italiana del Farmaco (AIFA). Rapporto di monitoraggio Nota 100 \u2013 18 mesi. AIFA; 2023. Online https:\/\/www.aifa.gov.it\/documents\/20142\/1728125\/NOTA_100_18mesi_28.11.2023.pdf (Accessed March 2026)"},{"key":"19988","doi-asserted-by":"crossref","unstructured":"Perrone V, Ripellino C, Cappuccilli M, et al. The economic impact of multimorbidity in Italy: evaluation of direct costs and scenario analysis of patients with type 2 diabetes, heart failure, and chronic kidney disease using real-world data. Glob Reg Health Technol Assess. 2025;12(1):205-213. https:\/\/doi.org\/10.33393\/grhta.2025.3509 PMID:41001212","DOI":"10.33393\/grhta.2025.3509"},{"key":"19989","doi-asserted-by":"crossref","unstructured":"Silva-Tinoco R, Cuatecontzi-Xochitiotzi T, Morales-Buenrostro LE, et al. Prevalence of chronic kidney disease in individuals with type 2 diabetes within primary care: a cross-sectional study. J Prim Care Community Health. 2024;15:21501319241259325. https:\/\/doi.org\/10.1177\/21501319241259325 PMID:38840565","DOI":"10.1177\/21501319241259325"},{"key":"19990","doi-asserted-by":"crossref","unstructured":"Rossing P, Caramori ML, Chan JCN, et al.; Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2022 clinical practice guideline for diabetes management in chronic kidney disease. Kidney Int. 2022;102(5S):S1-S127. 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