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Article ; Online: Effect of glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors on time to outcome in type 2 diabetes cardiorenal outcome trials.

Rizzi, Alessandro / Kloecker, David E / Pitocco, Dario / Khunti, Kamlesh / Davies, Melanie J / Zaccardi, Francesco

2024 Volume 18, Issue 2, Page(s) 102945

Abstract: Introduction: In randomized controlled trials (RCTs), treatment effects are commonly reported as hazard ratio, a measure often misinterpreted as a relative risk reduction. The acceleration factor (AF) indicates the extent to which a treatment increases/ ... ...

Abstract	Introduction: In randomized controlled trials (RCTs), treatment effects are commonly reported as hazard ratio, a measure often misinterpreted as a relative risk reduction. The acceleration factor (AF) indicates the extent to which a treatment increases/decreases the time before the occurrence of an outcome and gives useful insights in the interpretation of trials' results. Methods: Using individual time-to-event data reconstructed from Kaplan-Meier plots, we estimated AFs for the primary outcomes (POs) and all-cause mortality in glucagon-like peptide-1 receptor agonists (GLP1-RAs) or sodium-glucose cotransporter-2 inhibitors (SGLT2-is) cardiorenal outcome trials in subjects with type 2 diabetes. Results: AFs were estimated from 28 Kaplan-Meier plots of 19 RCTs. Compared to placebo, most GLP1-RAs increased the time before the onset of POs (from 9 % to 59 %) and all-cause mortality (from 8 to 13 %). Similarly, SGLT2-is increased time before the onset of POs (from 19 % to 87 %) and all-cause mortality (from 13 % to 42 %). Conclusions: The AFs provide a complementary and easier-to-interpret measure of treatment effect that could be useful to improve the shared decision-making.
MeSH term(s)	Humans ; Cardiovascular Diseases ; Diabetes Mellitus, Type 2/complications ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/epidemiology ; Glucagon-Like Peptide-1 Receptor/agonists ; Glucagon-Like Peptide-1 Receptor Agonists ; Glucose ; Sodium-Glucose Transporter 2 ; Sodium-Glucose Transporter 2 Inhibitors/therapeutic use ; Sodium-Glucose Transporter 2 Inhibitors/pharmacology
Chemical Substances	Glucagon-Like Peptide-1 Receptor ; Glucagon-Like Peptide-1 Receptor Agonists ; Glucose (IY9XDZ35W2) ; Sodium-Glucose Transporter 2 ; Sodium-Glucose Transporter 2 Inhibitors
Language	English
Publishing date	2024-01-12
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2273766-2
ISSN	1878-0334 ; 1871-4021
ISSN (online)	1878-0334
ISSN	1871-4021
DOI	10.1016/j.dsx.2024.102945
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Article ; Online: Correction: An updated algorithm for an effective choice of continuous glucose monitoring for people with insulin-treated diabetes.

Maiorino, Maria Ida / Buzzetti, Raffaella / Irace, Concetta / Laviola, Luigi / Napoli, Nicola / Pitocco, Dario / Esposito, Katherine

Endocrine

2024

Language	English
Publishing date	2024-01-31
Publishing country	United States
Document type	Published Erratum
ZDB-ID	1194484-5
ISSN	1559-0100 ; 1355-008X ; 0969-711X
ISSN (online)	1559-0100
ISSN	1355-008X ; 0969-711X
DOI	10.1007/s12020-023-03635-w
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Zs.A 3884: Show issues

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Article ; Online: IDegLira for the real-world treatment of type 2 diabetes in Italy. Final results from the REX observational study.

Fadini, Gian Paolo / Buzzetti, Raffaella / Pitocco, Dario / Tortato, Elena / Scatena, Alessia / Lamacchia, Olga / Lastoria, Giusi / Simoni, Lucia / Consoli, Agostino

Diabetes, obesity & metabolism

2024 Volume 26, Issue 5, Page(s) 1746–1756

Abstract: Aim: The study was designed to generate real-world evidence on IDegLira in the Italian clinical practice in two groups of patients with type 2 diabetes (T2D), switching to IDegLira either from a basal only (basal group) or basal-bolus insulin regimen ( ... ...

Abstract	Aim: The study was designed to generate real-world evidence on IDegLira in the Italian clinical practice in two groups of patients with type 2 diabetes (T2D), switching to IDegLira either from a basal only (basal group) or basal-bolus insulin regimen (BB group). Materials and methods: This was a non-interventional, multicentre, single-cohort, prospective study assessing the long-term glycaemic control in patients with T2D, who switched to IDegLira from a basal insulin ± glucose-lowering medication regimen with or without a bolus insulin component for approximately 18 months, conducted in 28 Italian diabetes centres. The primary endpoint was the change in glycated haemoglobin (HbA1c) levels from baseline to 6 months after IDegLira initiation. Results: The study included 358 patients with a mean age 67.2 years and diabetes duration of 15.7 years. HbA1c significantly decreased from IDegLira start to all study time points in the overall population (basal group -1.19%; BB group -0.60% at the end of observation). Patients achieving HbA1c <7% levels increased from 12.9% (n = 43) to 40.3% (n = 110) at 18 months. Fasting blood glucose and body weight also significantly decreased in both groups, although more in the BB group. Overall, 14.3% of completed patients had an intensification of treatment (mainly in the basal group) and 48.6% had a simplification of treatment (mainly in the BB group). Conclusions: Switching to IDegLira in a real-world clinical setting is a valid therapeutic option for patients with T2D with inadequate glycaemic control on basal or BB insulin regimen and/or need to simplify their insulin therapy, with specific reasons and therapeutic goals according to different T2D management trajectories.
MeSH term(s)	Humans ; Aged ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/epidemiology ; Hypoglycemic Agents/therapeutic use ; Glycated Hemoglobin ; Prospective Studies ; Blood Glucose ; Insulin, Long-Acting ; Liraglutide/therapeutic use ; Drug Combinations ; Insulin/therapeutic use ; Italy/epidemiology ; Insulin, Regular, Human/therapeutic use
Chemical Substances	IDegLira ; Hypoglycemic Agents ; Glycated Hemoglobin ; Blood Glucose ; Insulin, Long-Acting ; Liraglutide (839I73S42A) ; Drug Combinations ; Insulin ; Insulin, Regular, Human
Language	English
Publishing date	2024-02-08
Publishing country	England
Document type	Observational Study ; Journal Article
ZDB-ID	1454944-x
ISSN	1463-1326 ; 1462-8902
ISSN (online)	1463-1326
ISSN	1462-8902
DOI	10.1111/dom.15486
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Zs.A 5442: Show issues

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Article ; Online: Intensive glucose control and recurrent cardiovascular events: 14-year follow-up investigation of the ACCORDION study.

Kloecker, David E / Davies, Melanie J / Pitocco, Dario / Khunti, Kamlesh / Zaccardi, Francesco

Diabetes/metabolism research and reviews

2023 Volume 39, Issue 5, Page(s) e3634

Abstract: Aims: While cardiovascular disease in patients with type 2 diabetes commonly progresses with the occurrence of repeated events, most trials consider the effect of glucose-lowering strategies only on the first event. We examined the Action to Control ... ...

Abstract	Aims: While cardiovascular disease in patients with type 2 diabetes commonly progresses with the occurrence of repeated events, most trials consider the effect of glucose-lowering strategies only on the first event. We examined the Action to Control Cardiovascular Risk in Diabetes trial and its observational follow-up study (ACCORDION) to investigate the effect of intensive glucose control on multiple events and further identify any subgroup effects. Materials and methods: A recurrent events analysis, using a negative binomial regression model, was applied to estimate the treatment effect on different consecutive cardiovascular disease events, including non-fatal myocardial infarction, non-fatal stroke, hospitalisation from heart failure, and cardiovascular death. Interaction terms were used to identify potential effect modifiers. The robustness of the results was confirmed in sensitivity analyses using alternative models. Results: The median duration of follow-up was 7.7 years. Of the 5128 participants in the intensive and 5123 in the standard glucose control arm, respectively, 822 (16.0%) and 840 (16.4%) participants experienced a single event; 189 (3.7%) and 214 (4.2%) participants experienced two events; 52 (1.0%) and 40 (0.8%) experienced three events; and 1 (0.02%) and 1 (0.02%) experienced four events. There was no evidence of a treatment effect, with a rate difference of 0.0 (-0.3, 0.3) per 100 person-years comparing intensive versus standard intervention, although with non-significantly lower event rates in younger patients with HbA1c < 7% and higher event rates in older patients with HbA1c ≥ 9%. Discussion: Intensive glucose control may not affect cardiovascular disease progression except in select subgroups. Since time-to-first event analysis may miss beneficial or harmful effects of glucose control on the risk of cardiovascular disease, recurrent events analysis should be routinely analysed in cardiovascular outcome trials, particularly when investigating long-term treatment effects. Clinical trial reg no: NCT00000620, clinicaltrials.gov.
MeSH term(s)	Humans ; Aged ; Diabetes Mellitus, Type 2/complications ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/chemically induced ; Hypoglycemic Agents/adverse effects ; Blood Glucose ; Follow-Up Studies ; Cardiovascular Diseases/epidemiology ; Cardiovascular Diseases/etiology ; Cardiovascular Diseases/prevention & control ; Glycated Hemoglobin
Chemical Substances	Hypoglycemic Agents ; Blood Glucose ; Glycated Hemoglobin
Language	English
Publishing date	2023-04-04
Publishing country	England
Document type	Journal Article
ZDB-ID	1470192-3
ISSN	1520-7560 ; 1520-7552
ISSN (online)	1520-7560
ISSN	1520-7552
DOI	10.1002/dmrr.3634
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Zs.A 2119: Show issues

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Article ; Online: Translating trial results into interpretable risk estimates: Systematic analysis of cardiorenal outcome trials of glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors.

Rizzi, Alessandro / Kloecker, David E / Pitocco, Dario / Khunti, Kamlesh / Davies, Melanie J / Zaccardi, Francesco

Nutrition, metabolism, and cardiovascular diseases : NMCD

2023 Volume 34, Issue 5, Page(s) 1129–1133

Abstract: Background and aims: In a randomised controlled trial (RCT), the between-arm difference in the average probability of an event per unit of time (i.e., yearly incidence risk difference, YIRD) is an easy-to-interpret treatment effect metric. We aimed to ... ...

Abstract	Background and aims: In a randomised controlled trial (RCT), the between-arm difference in the average probability of an event per unit of time (i.e., yearly incidence risk difference, YIRD) is an easy-to-interpret treatment effect metric. We aimed to quantify the YIRD in cardiorenal RCTs of GLP-1RAs or SGLT-2is. Methods and results: We digitally searched for RCTs published up to March 1st, 2023, including subjects with type 2 diabetes randomised to GLP-1RAs or SGLT-2is and investigating cardiorenal outcomes or death. We extracted information from Kaplan-Meier (KM) plots to obtain time-to-event individual data and estimate within-arm yearly incidence risk and YIRD. Data from 19 RCTs (28 kM plots) were analysed: comparing treatment to placebo, in GLP-1RA RCTs the YIRD ranged from 0.2 % (95 % CI: -0.7 %, 1.1 %) to -1.9 % (-3.1, -0.7), for primary outcome; and from -0.2 % (-0.5, 0.2) to -0.4 % (-0.7 %, -0.0 %), for mortality. With the exception of SOLOIST-WHF (YIRD 11.9 % for primary outcome), corresponding estimates in SGLT-2is RCTs were: from -0.1 % (-0.4, 0.1) to -5.0 % (-7.7, -2.6), for primary outcome; and from -0.1 % (-0.2, 0.1) to -1.9 % (-4.4 %, 0.6 %), for mortality. Conclusion: The YIRD metric complements other relative treatment effect estimates and helps quantify the absolute benefit of GLP-1RAs and SGLT-2is.
MeSH term(s)	Humans ; Diabetes Mellitus, Type 2/diagnosis ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/epidemiology ; Glucagon-Like Peptide-1 Receptor/agonists ; Glucagon-Like Peptide-1 Receptor Agonists ; Glucose ; Hypoglycemic Agents/adverse effects ; Sodium ; Sodium-Glucose Transporter 2 Inhibitors/adverse effects ; Randomized Controlled Trials as Topic
Chemical Substances	Glucagon-Like Peptide-1 Receptor ; Glucagon-Like Peptide-1 Receptor Agonists ; Glucose (IY9XDZ35W2) ; Hypoglycemic Agents ; Sodium (9NEZ333N27) ; Sodium-Glucose Transporter 2 Inhibitors
Language	English
Publishing date	2023-12-20
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	1067704-5
ISSN	1590-3729 ; 0939-4753
ISSN (online)	1590-3729
ISSN	0939-4753
DOI	10.1016/j.numecd.2023.12.012
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Zs.A 3149: Show issues

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Article ; Online: Type 1 diabetes recurrence after SARS-CoV-2 infection in a subject with pancreas transplantation.

Popolla, Valentina / Rizzi, Alessandro / Tartaglione, Linda / Pontecorvi, Alfredo / Pitocco, Dario

Endocrinology, diabetes & metabolism

2022 Volume 6, Issue 1, Page(s) e364

Abstract: Background: During COVID-19 pandemic, several studies have demonstrated a strong link between SARS-CoV-2 infection and diabetes mellitus. Hyperglycaemia is a frequent event during the infection, also in patients without a history of diabetes. ... ...

Abstract	Background: During COVID-19 pandemic, several studies have demonstrated a strong link between SARS-CoV-2 infection and diabetes mellitus. Hyperglycaemia is a frequent event during the infection, also in patients without a history of diabetes. Furthermore, several cases of diabetic ketoacidosis during COVID-19 disease have been described. No data are available about the effects of SARS-CoV-2 infection on glycaemic control in pancreas transplant patients. Case presentation: A 45-year-old woman affected by type 1 diabetes mellitus was treated with kidney-pancreas transplantation in 2015, 6 years before COVID-19 infection. After transplantation, insulin therapy was stopped with a good glycaemic control during the following years.After SARS-CoV-2 infection, she developed severe hyperglycaemia requiring insulin therapy again. During the acute phase of the infection, the detection of antibodies against islet cells (ICA) and against glutamic acid decarboxylase (GAD) was found positive. Conclusions: The onset of hyperglycaemia after SARS-CoV-2 infection might be the result of a direct virus-induced toxicity or the effect of a virus-mediated activation of autoimmunity.
MeSH term(s)	Female ; Humans ; Middle Aged ; Diabetes Mellitus, Type 1/complications ; Diabetes Mellitus, Type 1/diagnosis ; COVID-19 ; Pancreas Transplantation/adverse effects ; Pandemics ; SARS-CoV-2 ; Insulin ; Hyperglycemia/etiology ; Insulin, Regular, Human
Chemical Substances	Insulin ; Insulin, Regular, Human
Language	English
Publishing date	2022-10-28
Publishing country	England
Document type	Case Reports
ISSN	2398-9238
ISSN (online)	2398-9238
DOI	10.1002/edm2.364
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Article ; Online: Comment on risk factors differ by first manifestation of cardiovascular disease in type 1 diabetes: The impact of microvascular complications.

Pitocco, Dario / Tartaglione, Linda / Pontecorvi, Alfredo

Diabetes research and clinical practice

2020 Volume 164, Page(s) 108182

MeSH term(s)	Cardiovascular Diseases/epidemiology ; Cardiovascular Diseases/etiology ; Diabetes Mellitus, Type 1/complications ; Diabetes Mellitus, Type 1/epidemiology ; Diabetes Mellitus, Type 2 ; Diabetic Angiopathies/epidemiology ; Diabetic Angiopathies/etiology ; Humans ; Risk Factors
Language	English
Publishing date	2020-04-30
Publishing country	Ireland
Document type	Letter ; Comment
ZDB-ID	632523-3
ISSN	1872-8227 ; 0168-8227
ISSN (online)	1872-8227
ISSN	0168-8227
DOI	10.1016/j.diabres.2020.108182
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Zs.A 2047: Show issues

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Article ; Online: Implications of Gestational Weight Gain in Studies of Gestational Diabetes.

Pitocco, Dario / Di Leo, Mauro / Lanzone, Antonio

JAMA pediatrics

2019 Volume 173, Issue 9, Page(s) 889

Language	English
Publishing date	2019-09-02
Publishing country	United States
Document type	Journal Article
ZDB-ID	2701223-2
ISSN	2168-6211 ; 2168-6203
ISSN (online)	2168-6211
ISSN	2168-6203
DOI	10.1001/jamapediatrics.2019.2195
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Um IV Zs.74: Show issues

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Article: Role of Oxidative Stress in the Pathogenesis of Atherothrombotic Diseases.

Petrucci, Giovanna / Rizzi, Alessandro / Hatem, Duaa / Tosti, Giulia / Rocca, Bianca / Pitocco, Dario

Antioxidants (Basel, Switzerland)

2022 Volume 11, Issue 7

Abstract: Oxidative stress is generated by the imbalance between reactive oxygen species (ROS) formation and antioxidant scavenger system's activity. Increased ROS, such as superoxide anion, hydrogen peroxide, hydroxyl radical and peroxynitrite, likely contribute ... ...

Abstract	Oxidative stress is generated by the imbalance between reactive oxygen species (ROS) formation and antioxidant scavenger system's activity. Increased ROS, such as superoxide anion, hydrogen peroxide, hydroxyl radical and peroxynitrite, likely contribute to the development and complications of atherosclerotic cardiovascular diseases (ASCVD). In genetically modified mouse models of atherosclerosis, the overexpression of ROS-generating enzymes and uncontrolled ROS formation appear to be associated with accelerated atherosclerosis. Conversely, the overexpression of ROS scavenger systems reduces or stabilizes atherosclerotic lesions, depending on the genetic background of the mouse model. In humans, higher levels of circulating biomarkers derived from the oxidation of lipids (8-epi-prostaglandin F
Language	English
Publishing date	2022-07-20
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2704216-9
ISSN	2076-3921
ISSN	2076-3921
DOI	10.3390/antiox11071408
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Article ; Online: Effect of very long-term storage and multiple freeze and thaw cycles on 11-dehydro-thromboxane-B

Petrucci, Giovanna / Hatem, Duaa / Langley, Ruth / Cleary, Siobhan / Gentry-Maharaj, Aleksandra / Pitocco, Dario / Rizzi, Alessandro / Ranalli, Paola / Zaccardi, Francesco / Habib, Aida / Rocca, Bianca

Scientific reports

2024 Volume 14, Issue 1, Page(s) 5546

Abstract: Biological samples are often frozen and stored for years and/or thawed multiple times, thus assessing their stability on long-term storage and repeated freeze-thaw cycles is crucial. The study aims were to assess:-the long-term stability of two major ... ...

Abstract	Biological samples are often frozen and stored for years and/or thawed multiple times, thus assessing their stability on long-term storage and repeated freeze-thaw cycles is crucial. The study aims were to assess:-the long-term stability of two major enzymatic and non-enzymatic metabolites of arachidonic acid, i.e. urinary 11-dehydro-thromboxane-(Tx) B
MeSH term(s)	Humans ; Antioxidants ; Arachidonic Acid ; Creatinine ; Freezing ; Immunoenzyme Techniques ; Prostaglandins F ; Thromboxanes
Chemical Substances	Antioxidants ; Arachidonic Acid (27YG812J1I) ; Creatinine (AYI8EX34EU) ; Prostaglandins F ; Thromboxanes
Language	English
Publishing date	2024-03-06
Publishing country	England
Document type	Journal Article
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-024-55720-3
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