Glucagon-like peptide 1 receptor agonists (GLP1RAs) are widely used for the treatment of type 2 diabetes mellitus (T2DM) and, at higher doses, obesity. Both T2DM and obesity are associated with a higher risk of cancer, which can be reduced by intentional weight loss, whereas effects of a reduction in hyperglycaemia are uncertain. GLP1RAs might have further direct effects, either beneficial or detrimental, on the development of specific malignancies. Evidence from preclinical and clinical studies suggests heterogeneous effects of GLP1RAs on cancer risk: the incidence of hepatocellular, oesophageal, endometrial, ovarian and prostate cancers might be reduced, whereas safety concerns persist with respect to thyroid (both medullary and non-medullary) carcinomas. Conversely, initial concerns on the risk of pancreatic cancer have not been confirmed. Nonetheless, the interpretation of current data is limited by detection and prescription biases in observational studies as well as insufficient follow-up and number of events in randomized trials. In this Review, we summarize current preclinical and clinical evidence, showing that the risk-benefit profile of GLP1RAs remains favourable in individuals with T2DM and obesity, although caution is warranted in those with a low cardiometabolic risk, for whom the potential risks of cancer might outweigh any expected benefits; conversely, the potential use of GLP1RAs as adjuvant therapies for certain forms of cancer needs to be further investigated.

Background and objectives: Mental health literacy (MHL) supports early recognition and management of mental disorders. The Mental Health Literacy Scale (MHLS) is the only validated tool covering all MHL domains. This study translated and validated the MHLS in Italian and evaluated its psychometric properties in a non-clinical adult sample. Methods: Following international guidelines, the MHLS was translated and administered to 354 Italian-speaking adults. A subsample of 84 repeated the test twice at one-week interval. Participants also completed the HLS-EU-Q16 and DASS-21. Internal consistency, test-retest reliability, concurrent validity and exploratory factor analysis were performed. Results: The Italian MHLS showed good internal consistency (Cronbach's alpha = 0.821) and test-retest reliability (r = 0.73; p < 0.001). Scores were higher in women and in individuals with a psychiatric diagnosis, and correlated weakly with general health literacy and perceived stress. No associations emerged with anxiety or depression. Factor analysis suggested a four-factor structure explaining 42.1% of the variance, reflecting attitudes toward mental illness, symptom recognition, help-seeking and information-seeking. Conclusions: The Italian MHLS is a valid and reliable instrument for assessing MHL in adults. It can be used in research and prevention to clarify public knowledge and attitudes toward mental health.

The primary analysis of the SELECT randomized clinical trial suggests that semaglutide reduced the rates of cardiovascular (CV) death, myocardial infarction, and stroke in patients with established CV disease (CVD) and overweight or obesity without diabetes. However, the effect of semaglutide on hospitalizations in this population remains unknown. To determine the impact of semaglutide on total hospital admissions and duration of hospital stay. The SELECT trial included patients aged 45 years or older with established CVD and a body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) of 27 or higher without diabetes at 804 clinical settings across North America, South America, Europe, Asia, Africa, and Australia. Patients were randomized from October 2018 to March 2021. This prespecified exploratory analysis was conducted from February 2024 to September 2025. Once-weekly subcutaneous semaglutide, 2.4 mg, or placebo. The total number of hospital admissions and days in hospital between the semaglutide and placebo groups. A total of 17 604 patients (median [IQR] age, 61.0 [55.0-68.0] years; 4872 female patients [27.7%]; median [IQR] BMI, 32.1 [29.7-35.7]) were followed up for a median (IQR) period of 41.8 (33.0-47.0) months. There were 11 287 hospital admissions. The number of total hospitalizations was lower in the semaglutide group vs placebo for any indication (18.3 vs 20.4 admissions per 100 patient-years; mean ratio [MR], 0.90; 95% CI, 0.85-0.95; P < .001) and for serious adverse events (15.2 vs 17.1 admissions per 100 patient-years; MR, 0.89; 95% CI, 0.84-0.94; P < .001). The number of days hospitalized for any indication per 100 patient-years was lower in the semaglutide group vs placebo (157.2 vs 176.2 days; rate ratio [RR], 0.89; 95% CI, 0.82-0.98; P = .01), as well as hospitalizations for serious adverse events (137.6 vs 153.9 days; RR, 0.89; 95% CI, 0.81-0.98; P = .02). No heterogeneity was observed for the reduction of hospital admissions with semaglutide in selected subgroups, including BMI, age, and sex. In this prespecified exploratory analysis of the SELECT randomized clinical trial, the trial cohort had a high rate of hospital admissions. Treatment with once-weekly semaglutide was associated with significant reductions in hospital admissions and overall time spent in hospital, extending its benefits beyond CV risk reduction. ClinicalTrials.gov Identifier: NCT03574597

AIM:To assess the effect of all the approved classes of medications for type 2 diabetes on Major Adverse Cardiovascular events (MACE) and all-cause mortality. METHODS:We performed a pairwise and network meta-analysis, including randomised controlled trials with a duration of at least 40 weeks, comparing medications versus placebo or an active comparator, in which MACE and deaths were adjudicated. RESULTS:We included 93 studies. In pairwise meta-analyses, versus all comparators, GLP-1 receptor agonists (GLP1RA), SGLT-2 inhibitors (SGLT2i), metformin and pioglitazone were associated with a significant reduction of MACE and sulfonylureas with increased MACE. Furthermore, tirzepatide, SGLT2i and GLP1RA were associated with a significantly reduced all-cause mortality. In the principal (frequentist) network meta-analysis, metformin (OR 0.69, 95% CI 0.53-0.89), SGLT2i (0.82, 0.75-0.90), GLP1RA (0.87, 0.83-0.92) and tirzepatide (0.82, 0.72-0.93) were associated with a significant reduction of MACE versus placebo; no effect was observed for insulin, DPP4 inhibitors (DPP4i) or sulfonylureas. Tirzepatide (0.72, 0.64-0.82), SGLT2i (0.85, 0.80-0.91) and GLP1RA (0.85, 0.80-0.91) were associated with a significantly reduced mortality versus placebo; no effect was detected for other drugs. The sensitivity (Bayesian) analysis did not confirm the significance of results for pioglitazone on MACE. The certainty of evidence was moderate-to-high for GLP1RA, SGLT2i, Tirzepatide, DPP4i; low for metformin; low-to-moderate for other drugs. CONCLUSION:SGLT2i, GLP1RA, tirzepatide and (with lower quality of evidence) pioglitazone and metformin are associated with a reduced incidence of cardiovascular events; tirzepatide, SGLT2i and GLP1RA are also associated with a reduced all-cause mortality.

Background: Pharmacological treatment of obesity has changed rapidly, but direct comparisons across approved and emerging agents remain scarce. We compared the efficacy and safety of approved and investigational pharmacotherapies for obesity. Methods: We searched MEDLINE, Embase, and CENTRAL from inception to March 6, 2026, for randomised controlled trials of at least 52 weeks enrolling adults with obesity (body-mass index >=27 kg/m2). Approved or investigational obesity pharmacotherapies were compared with placebo or another active treatment. The primary outcome was percentage total body weight loss (TBWL) at study endpoint. Random-effects frequentist network meta-analysis, RoB 2, and CINeMA were used. Findings: The review included 70 randomised trials with 83 721 participants; 65 trials contributed to the primary endpoint network. All active treatments reduced body weight versus placebo. The largest placebo-subtracted effects at study endpoint were observed with retatrutide 12 mg (22.1%), retatrutide 8 mg (20.7%), cagrilintide plus semaglutide 2.4/2.4 mg (17.2%), tirzepatide 15 mg (16.9%), and tirzepatide 10 mg (16.7%). Among approved agents, tirzepatide 10-15 mg and semaglutide 2.4 mg ranked highest. The efficacy gradient was preserved at 52 and 104 weeks. Safety outcomes were uncommon and imprecisely estimated, although discontinuation increased with higher-dose orforglipron. Interpretation: Tirzepatide and semaglutide 2.4 mg currently provide the strongest weight-loss evidence among approved treatments. Emerging incretin-based therapies could further extend efficacy, but comparative interpretation remains limited by indirect evidence, sparse head-to-head trials, and restricted long-term safety data.Funding None.

AIMS:Management of insulin therapy in elderly individuals with type 2 diabetes (T2D) residing in nursing homes is often challenging due to comorbidities, cognitive impairment and limited access to specialist care. Continuous glucose monitoring (CGM) and telemedicine may help optimise glycaemic control in this vulnerable population. MATERIALS AND METHODS:In order to assess the efficacy and safety of a CGM and telemedicine-based management of insulin therapy in nursing home residents with T2D, a 12-week, randomised, controlled and open-label trial has been designed. Eighty-five patients on stable basal-bolus insulin therapy were assigned to either telemedicine-assisted insulin titration based on CGM data (intervention group) or standard care with capillary blood glucose monitoring (control group). The primary endpoint was the change in time in range (TIR, 70-180 mg/dL), with secondary outcomes including time below range (TBR), time above range (TAR), haemoglobin A1c (HbA1c), insulin dose and safety endpoints. RESULTS:TIR increased significantly in the intervention, but not in the control group, with a significant difference between study groups (p = 0.010). TBR showed a reduction in the intervention arm and an increase in the control arm with a significant difference between groups (p = 0.007). HbA1c and mean insulin daily units significantly also decreased in the intervention group, with significant differences between groups (p = 0.028 and p = 0.002, respectively). No safety issues potentially related to the intervention were identified during the study. CONCLUSION:In conclusion, remote insulin dose adjustment based on interstitial glucose monitoring ameliorates glucose control in nursing home residents with T2D on basal-bolus insulin therapy.

AIM:To assess whether there is a beneficial or detrimental effect of weight reduction on mental health. MATERIALS AND METHODS:Meta-analysis of randomized trials performed for weight loss, in which weight loss at endpoint was greater than 5% in the intervention arm and smaller than 5% in the control arm, obtained with any surgical, endoscopic, or EMA-approved pharmacological intervention. The endpoints were the incidence of overall and specific psychiatric adverse events. RESULTS:Weight loss was associated with a reduced risk of major depression (MH-OR 0.45 95% CI [0.21, 0.94], I2 = 0), and overall depression (MH-OR 0.72 [0.54, 0.97]); in subgroup analyses, a weight loss greater than 10% was associated with a lower incidence of depression than smaller weight loss (p = 0.04), whereas no difference was found between different interventions. No difference was detected in the incidence of anxiety (MH-OR 1.04 [0.78, 1.39]), of serious (M-H, OR CI 1.07 [0.78, 1.47]) and overall (MH-OR 1.09 [0.89, 1.34]) psychiatric adverse events, suicidal ideation (M-H, OR 0.87 [0.44, 1.70]), or suicide (M-H, OR 0.87 [0.44, 1.70]). An improvement in functional health status was detected, either as SF-36 Mental (SMD-IV 0.45 [0.37, 0.52]) or SF-36 Physical function (SMD-IV 0.29 [0.14, 0.44]) or IWQOL Lite Physical function (MD-IV 3.96 [1.60, 6.32]). CONCLUSION:Weight-reducing treatments were associated with a beneficial effect on quality of life and functional health status and a reduced risk of depression, without any safety signal for serious or non-serious psychiatric adverse events.

Fear of pain during insulin injection, using pen injectors, still represents a barrier to diabetes treatment. The development of smaller and thinner needles has improved comfort during the injection, but the influence of other needle geometry features, has been less thoroughly assessed. The aim of this review, is to evaluate the role that pen needle geometry plays in determining patient experience during insulin injection. A literature search was conducted in PubMed and Scopus to identify the publications assessing the effect of needle geometry and quality on insertion force and pain, experienced by the patient during injection. 22 studies were included in this review. All studies included, at minimum, an evaluation of the perceived injection pain, using a Visual Analogue Scale (VAS). The clinical evidence demonstrated that in addition to the pain reduction experienced with increasing needle gauge, other geometrical features such as shorter needle length, thinner wall design, improved tip geometry and coating with lubricant, are associated with reduced injection pain and improved patient experience. Furthermore, it was indicated that the needle features shown to help reduce the experienced pain, would not negatively affect the frequency and intensity of injection related site reactions or needle-related failures, such as breakage and bending. Pen needle geometry affects the insulin injection experience of diabetic patients. Increased needle gauge, shorter length, improved tip design and mechanical characteristics of the needle are all associated with a perceived reduction of the pain during insulin injection and an overall improved patient experience.

BackgroundDifferences in trial design may affect estimates of efficacy of psychotropic drugs. The purpose of this meta-analysis is to evaluate whether the use of Olanzapine (OLZ) as either investigational or control drug affects the observed efficacy of OLZ.MethodsWe performed a search for Randomized-Controlled Trials (RCTs) in which the efficacy of OLZ is assessed in patients with schizophrenia or schizoaffective disorder. We assessed overall efficacy of OLZ and performed subgroup analyses of studies with OLZ as intervention or comparator. Mixed-effect meta-regression analyses were performed.ResultsOf the 25 RCTs included, OLZ was considered as investigational drug or active control in 13 and 12 studies, respectively. The reduction of PANSS score was greater in trials in which OLZ was used as investigational drug. Multivariate meta-regression models showed that a higher PANSS score at baseline and trial duration were the main predictors of greater PANSS score reduction.ConclusionsTrials with OLZ used as investigational drug differ from those of trials with OLZ as comparator for baseline PANSS scores and study duration; these differences may produce differences in estimates of efficacy. As a consequence, the severity of illness at enrollment and trial duration should be carefully considered to ensure the reliability of indirect comparisons among antipsychotics.

The reduction of LDL cholesterol is associated with a reduction in cardiovascular morbidity and mortality, with no apparent threshold. The availability of new effective cholesterol-lowering drugs has induced Scientific Societies to recommend much lower targets for LDL cholesterol. Targets are differentiated on the basis of cardiovascular risk (the higher the risk, the lower the target). However, the determination of actual risk levels is problematic, particularly in the elderly. Clinical judgement is needed to adapt recommendations and identify proper targets in individual patients.

Background In lower extremity peripheral artery disease (PAD), the ankle-brachial index (ABI) is an easily reproducible diagnostic tool for PAD, but it loses reliability when > 1.4 due to calcification of the vessel wall. Patients with diabetes are at higher risk for wall calcification. In order to overcome the limitation and reliability of ABI, particularly in patients with diabetes, we decided to assess resistive (RI) and pulsatility index (PI) by ultrasound doppler of the dorsal metatarsal artery (DMA). Results We therefore analyzed 51 legs (32 patients), evaluating the correlation between PI, RI, and ABI. Patients with diabetes were 21 (65.6 %), accounting for 33 legs (64.7 %). Out of 51 legs assessed, 37 (72.5 %) cases had compressible arteries, whereas in 14 legs (27.5 %) ABI was not calculable due to wall calcification. PAD was significantly associated with lower both RI and PI of the DMA (both p < 0.000). RI, but not PI, showed a significant correlation (r = 0.535) with ABI, when ABI was less than 1.4, but not when ABI > 1.4. When analyzed separately, patients with diabetes showed a similar figure in comparison with those without diabetes (r = 0.600), RI, but not PI, showed a significant correlation with ABI. Conclusion Dorsal metatarsal artery resistive index (MARI) showed a significant inverse correlation with PAD, similarly to ABI, irrespective of the presence of diabetes. MARI seems to be an effective screening tool for PAD even in patients with wall calcification. Further studies are needed for confirming the results of the present pilot study.

Diabetes, Obesity and MetabolismEarly View RESEARCH LETTER Glucagon-like peptide-1 receptor agonists and mental health: A meta-analysis of randomized controlled trials Giovanni Antonio Silverii MD, Corresponding Author Giovanni Antonio Silverii MD giovanniantonio.silverii@unifi.it orcid.org/0000-0002-6695-3213 Experimental and Clinical Biomedical Sciences Department, Diabetology Unit, Florence University, Florence, Italy Correspondence Giovanni Antonio Silverii, MD, University of Florence, Experimental and Clinical Biomedical Sciences 'Mario Serio' Department, Largo Brambilla 3, 50134, Florence, Italy. Email: giovanniantonio.silverii@unifi.itSearch for more papers by this authorChristian Marinelli MD, Christian Marinelli MD Experimental and Clinical Biomedical Sciences Department, Diabetology Unit, Florence University, Florence, ItalySearch for more papers by this authorEdoardo Mannucci MD, Edoardo Mannucci MD orcid.org/0000-0001-9759-9408 Experimental and Clinical Biomedical Sciences Department, Diabetology Unit, Florence University, Florence, ItalySearch for more papers by this authorFrancesco Rotella MD, Francesco Rotella MD Health Sciences Department, Psychiatry Unit, Florence University, Florence, ItalySearch for more papers by this author Giovanni Antonio Silverii MD, Corresponding Author Giovanni Antonio Silverii MD giovanniantonio.silverii@unifi.it orcid.org/0000-0002-6695-3213 Experimental and Clinical Biomedical Sciences Department, Diabetology Unit, Florence University, Florence, Italy Correspondence Giovanni Antonio Silverii, MD, University of Florence, Experimental and Clinical Biomedical Sciences 'Mario Serio' Department, Largo Brambilla 3, 50134, Florence, Italy. Email: giovanniantonio.silverii@unifi.itSearch for more papers by this authorChristian Marinelli MD, Christian Marinelli MD Experimental and Clinical Biomedical Sciences Department, Diabetology Unit, Florence University, Florence, ItalySearch for more papers by this authorEdoardo Mannucci MD, Edoardo Mannucci MD orcid.org/0000-0001-9759-9408 Experimental and Clinical Biomedical Sciences Department, Diabetology Unit, Florence University, Florence, ItalySearch for more papers by this authorFrancesco Rotella MD, Francesco Rotella MD Health Sciences Department, Psychiatry Unit, Florence University, Florence, ItalySearch for more papers by this author First published: 06 March 2024 https://doi.org/10.1111/dom.15538Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinkedInRedditWechat CONFLICT OF INTERESTS STATEMENT GAS has received financial support and speaking fees from Astra Zeneca, Eli Lilly and Novo Nordisk outside the present paper; EM has received speaking fees from Astra Zeneca, Eli Lilly, Merck, Novo Nordisk and Sanofi, research grants from Eli Lilly and Novo Nordisk, outside the present paer; CM and FR have no conflict of interest to declare. Open Research PEER REVIEW The peer review history for this article is available at https://www.webofscience.com/api/gateway/wos/peer-review/10.1111/dom.15538. DATA AVAILABILITY STATEMENT The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials. Supporting Information Filename Description dom15538-sup-0001-supinfo.pdfPDF document, 1.8 MB Data S1. Supporting Information. 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AIMS:The revolution in the therapeutic approach to type 2 diabetes (T2D) requires a rethinking of the positioning of basal insulin (BI) therapy. Given the considerable number of open questions, a group of experts was convened with the aim of providing, through a Delphi consensus method, practical guidance for doctors. METHODS:A group of 6 experts developed a series of 29 statements on: the role of metabolic control in light of the most recent guidelines; BI intensification strategies: (1) add-on versus switch; (2) inertia in starting and titrating; (3) free versus fixed ratio combination; basal-bolus intensification and de-intensification strategies; second generation analogues of BI (2BI). A panel of 31 diabetologists, by accessing a dedicated website, assigned each statement a relevance score on a 9-point scale. The RAND/UCLA Appropriateness Method was adopted to assess the existence of disagreement among participants. RESULTS:Panelists showed agreement for all 29 statements, of which 26 were considered relevant, one was considered not relevant and two were of uncertain relevance. Panelists agreed that the availability of new classes of drugs often allows the postponement of BI and the simplification of therapy. It remains essential to promptly initiate and titrate BI when required. BI should always, unless contraindicated, be started in addition to, and not as a replacement, for ongoing treatments with cardiorenal benefits. 2BIs should be preferred for their pharmacological profile, greater ease of self-titration and flexibility of administration. CONCLUSION:In a continuously evolving scenario, BI therapy still represents an important option in the management of T2D patients.

AIMS:A systematic review and meta-analysis of published randomized controlled trials was conducted to collate evidence from studies implementing ancient grains and investigate the impact of ancient grain consumption on health outcomes of patients with Diabetes Mellitus (DM). DATA SYNTHESIS:Twenty-nine randomized controlled trials were included, and 13 were meta-analyzed. Interventions ranged from 1 day to 24 weeks; most samples were affected by DM type 2 (n = 28 studies) and the ancient grains used were oats (n = 10 studies), brown rice (n = 6 studies), buckwheat (n = 4 studies), chia (n = 3 studies), Job's Tears (n = 2 studies), and barley, Khorasan and millet (n = 1 study). Thirteen studies that used oats, brown rice, and chia provided data for a quantitative synthesis. Four studies using oats showed a small to moderate beneficial effect on health outcomes including LDL-c (n = 717, MD: 0.30 mmol/l, 95% CI: 0.42 to -0.17, Z = 4.61, p < 0.05, I2 = 0%), and TC (n = 717, MD: 0.44 mmol/l, 95% CI: 0.63 to -0.24, Z = 4.40, p < 0.05, I2 = 0%). Pooled analyses of studies using chia and millet did not show significant effects on selected outcomes. CONCLUSIONS:For adults affected by DM type 2, the use of oats may improve lipidic profile. Further experimental designs are needed in interventional research to better understand the effects of ancient grains on diabetes health outcomes. PROSPERO REGISTRATION:CRD42023422386.