9 results on '"Paolo Chiodini"'
Search Results
2. The number of risk factors not at target is associated with cardiovascular risk in a type 2 diabetic population with albuminuria in primary cardiovascular prevention. Post-hoc analysis of the NID-2 trial
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Ferdinando Carlo Sasso, Vittorio Simeon, Raffaele Galiero, Alfredo Caturano, Luca De Nicola, Paolo Chiodini, Luca Rinaldi, Teresa Salvatore, Miriam Lettieri, Riccardo Nevola, Celestino Sardu, Giovanni Docimo, Giuseppe Loffredo, Raffaele Marfella, Luigi Elio Adinolfi, Roberto Minutolo, and NID-2 study group Investigators
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Type 2 diabetes mellitus ,Cardiovascular risk ,Diabetes complications ,Multifactorial treatment ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Abstract Background Nephropathy in Diabetes type 2 (NID-2) study is an open-label cluster randomized clinical trial that demonstrated that multifactorial intensive treatment reduces Major Adverse Cardiac Events (MACEs) and overall mortality versus standard of care in type 2 diabetic subjects with albuminuria and no history of cardiovascular disease. Aim of the present post-hoc analysis of NID- 2 study is to evaluate whether the number of risk factors on target associates with patient outcomes. Methods Intervention phase lasted four years and subsequent follow up for survival lasted 10 years. To the aim of this post-hoc analysis, the whole population has been divided into 3 risk groups: 0–1 risk factor (absent/low); 2–3 risk factors (intermediate); 4 risk factors (high). Primary endpoint was a composite of fatal and non-fatal MACEs, the secondary endpoint was all-cause death at the end of the follow-up phase. Results Absent/low risk group included 166 patients (52.4%), intermediate risk group 128 (40.4%) and high-risk group 23 (7.3%). Cox model showed a significant higher risk of MACE and death in the high-risk group after adjustment for confounding variables, including treatment arm (HR 1.91, 95% CI 1.04–3.52, P = 0.038 and 1.96, 95%CI 1.02–3.8, P = 0,045, respectively, vs absent/low risk group). Conclusions This post-hoc analysis of the NID-2 trial indicates that the increase in the number of risk factors at target correlates with better cardiovascular-free survival in patients with type 2 diabetes at high CV risk. Clinical Trial Registration ClinicalTrials.gov number, NCT00535925. https://clinicaltrials.gov/ct2/show/NCT00535925
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- 2022
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3. The effect of DPP-4 inhibitors, GLP-1 receptor agonists and SGLT-2 inhibitors on cardiorenal outcomes: a network meta-analysis of 23 CVOTs
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Dario Giugliano, Miriam Longo, Simona Signoriello, Maria Ida Maiorino, Bruno Solerte, Paolo Chiodini, and Katherine Esposito
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Cardiovascular outcome trials ,DPP-4 inhibitors ,GLP-1 receptor agonists ,SGLT-2 inhibitors ,Network meta-analysis ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Abstract Background Glucagon-like peptide-1 receptor agonists (GLP-1RA) and sodium glucose co-transporter-2 (SGLT-2) inhibitors reduce cardiorenal outcomes. We performed a network meta-analysis to compare the effect on cardiorenal outcomes among GLP-1 RAs, SGLT-2 inhibitors and dipeptidyl peptidase-4 (DPP-4) inhibitors. Methods We searched the PUBMED, Embase and Cochrane databases for relevant studies published up until 10 December 2021. Cardiovascular and renal outcome trials reporting outcomes on GLP-1RA, SGLT-2 inhibitors and DPP-4 inhibitors in patients with or without type 2 diabetes mellitus were included. The primary outcome was major adverse cardiovascular events (MACE); other outcomes were cardiovascular and total death, nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization for heart failure (HHF), and renal outcome. Results Twenty-three trials enrolling a total number of 181,143 participants were included. DPP-4 inhibitors did not lower the risk of any cardiorenal outcome when compared with placebo and were associated with higher risks of MACE, HHF, and renal outcome when compared with the other two drug classes. SGLT-2 inhibitors significantly reduced cardiovascular (RR = 0.88) and total (RR = 0.87) death, as compared with DPP-4 inhibitors, while GLP-1 RA reduced total death only (RR = 0.87). The comparison between GLP-1RA and SGLT-2 inhibitors showed no difference in their risks of MACE, nonfatal MI, nonfatal stroke, CV and total death; SGLT-2 inhibitors were superior to GLP-1RA in reducing the risk of HHF and the renal outcome (24% and 22% lower risk, respectively). Only GLP-1RA reduced the risk of nonfatal stroke (RR = 0.84), as compared with placebo. There was no head-to-head trial directly comparing these antidiabetic drug classes. Conclusions SGLT-2 inhibitors and GLP-1RA are superior to DPP-4 inhibitors in reducing the risk of most cardiorenal outcomes; SGLT-2 inhibitors are superior to GLP-1RA in reducing the risk of HHF and renal events; GLP-1RA only reduced the risk of nonfatal stroke. Both SGLT-2 inhibitors and GLP-1RA should be the preferred treatment for type 2 diabetes and cardiorenal diseases.
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- 2022
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4. Improvement of glycemic control and reduction of major cardiovascular events in 18 cardiovascular outcome trials: an updated meta-regression
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Maria Ida Maiorino, Miriam Longo, Lorenzo Scappaticcio, Giuseppe Bellastella, Paolo Chiodini, Katherine Esposito, and Dario Giugliano
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Cardiovascular outcome trials ,Type 2 diabetes ,DPP-4i ,GLP-1RA ,SGLT-2i ,Cardiorenal outcomes ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Abstract Background Besides providing reassurance about cardiovascular (CV) safety of newer diabetes drugs, cardiovascular outcome trials (CVOTs) have also shown encouraging benefits on some CV endpoints. The contribution of the better glycemic control in the reduction of major cardiovascular events (MACE) remains an open question. The aim of this study is to evaluate the associations between the reduction of HbA1c and risk of MACE, MACE components, hospitalization for heart failure (HF) and all-cause death in CVOTs. Methods An electronic search up to July 2021 was conducted to determine eligible trials. Systematic review identified eighteen CVOTs reporting prespecified CV outcomes. Pooled summary estimates and 95% confidence intervals (CI) were calculated according to the random effects model using the Paule-Mandel method; restricted maximum likelihood estimators were used to estimate model parameters in the metaregression. Results The eighteen CVOTs evaluated 161,156 patients and included four trials with dipeptidyl-peptidase-4 inhibitors (DPP-4i), eight trials with glucagon-like peptide-1 receptor agonists (GLP-1RA) and six trials with sodium-glucose cotransporter-2 inhibitors (SGLT-2i). Random-effects model meta-analysis showed an association between treatment and risk of MACE (hazard ratio [HR] 0.90; 95% CI 0.86, 0.94, P
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- 2021
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5. GLP-1 receptor agonists and cardiorenal outcomes in type 2 diabetes: an updated meta-analysis of eight CVOTs
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Dario Giugliano, Lorenzo Scappaticcio, Miriam Longo, Paola Caruso, Maria Ida Maiorino, Giuseppe Bellastella, Antonio Ceriello, Paolo Chiodini, and Katherine Esposito
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Cardiovascular outcome trials ,Type 2 diabetes ,GLP-1RA ,Cardiorenal outcomes ,Lixisenatide ,Liraglutide ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Abstract Background A meta-analysis is presented of cardiovascular outcome trials (CVOTs) comparing glucagon-like peptide-1 receptor agonists (GLP-1RA) versus placebo on cardiorenal outcomes in patients with type 2 diabetes mellitus (T2DM). Methods We did an electronic search up to June 30, 2021, for eligible trials. We did a meta-analysis of available trial data using a random-effects model to calculate overall hazard ratios (HRs) and 95% CI (confidence intervals). We included data from 8 CVOTs and 60,080 patients (72.4% with established cardiovascular disease). Results GLP-1RA reduced major cardiovascular events (MACE) by 14% (HR = 0.86, 95% CI 0.79–0.94, P = 0.006) with a non-significant heterogeneity between subgroups of patients with and without cardiovascular disease (P = 0.127). GLP-1RA also reduced the risk of cardiovascular death by 13% (P = 0.016), nonfatal stroke by 16% (P = 0.007), hospitalization for heart failure by 10% (P = 0.023), all-cause mortality by 12% (P = 0.012), and the broad composite kidney outcome by 17% (P = 0.012), which was driven by a reduction in macroalbuminuria only (HR = 0.74, 0.67–0.82, P
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- 2021
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6. Efficacy and durability of multifactorial intervention on mortality and MACEs: a randomized clinical trial in type-2 diabetic kidney disease
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Ferdinando Carlo Sasso, Pia Clara Pafundi, Vittorio Simeon, Luca De Nicola, Paolo Chiodini, Raffaele Galiero, Luca Rinaldi, Riccardo Nevola, Teresa Salvatore, Celestino Sardu, Raffaele Marfella, Luigi Elio Adinolfi, Roberto Minutolo, and NID-2 Study Group Investigators
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Diabetic nephropathy ,Multifactorial intervention ,Intensified treatment ,CV risk factors ,Very high CV risk ,MACE ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Abstract Background Multiple modifiable risk factors for late complications in patients with diabetic kidney disease (DKD), including hyperglycemia, hypertension and dyslipidemia, increase the risk of a poor outcome. DKD is associated with a very high cardiovascular risk, which requires simultaneous treatment of these risk factors by implementing an intensified multifactorial treatment approach. However, the efficacy of a multifactorial intervention on major fatal/non-fatal cardiovascular events (MACEs) in DKD patients has been poorly investigated. Methods Nephropathy in Diabetes type 2 (NID-2) study is a multicentre, cluster-randomized, open-label clinical trial enrolling 395 DKD patients with albuminuria, diabetic retinopathy (DR) and negative history of CV events in 14 Italian diabetology clinics. Centres were randomly assigned to either Standard-of-Care (SoC) (n = 188) or multifactorial intensive therapy (MT, n = 207) of main cardiovascular risk factors (blood pressure 40/50 mg/dL for men/women and
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- 2021
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7. Preventing major adverse cardiovascular events by SGLT-2 inhibition in patients with type 2 diabetes: the role of kidney
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Dario Giugliano, Luca De Nicola, Maria Ida Maiorino, Giuseppe Bellastella, Carlo Garofalo, Paolo Chiodini, Antonio Ceriello, and Katherine Esposito
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SGLT-2 inhibitors ,Type 2 diabetes ,MACE ,Diabetic kidney disease ,Statin therapy ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Abstract Cardiovascular outcome trials (CVOTs) have demonstrated a significant reduction of major adverse cardiovascular events (MACE) in patients with type 2 diabetes (T2D) treated by SGLT-2 inhibitors. This holds true in the presence of background therapy with statins in most patients. Noteworthy, this SGLT-2 inhibitors effect is unique because, at variance with other components of cardiorenal protection, MACE prevention does not appear to be a class effect. Here, we present meta-analysis of the four key CVOTs indicating a major role of renal function in determining the extent of MACE prevention, with the benefit increasing in more severe kidney disease, that is, a high-risk condition where effectiveness of the traditional approach with statins is reduced.
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- 2020
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8. Improvement of glycemic control and reduction of major cardiovascular events in 18 cardiovascular outcome trials: an updated meta-regression
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Lorenzo Scappaticcio, Katherine Esposito, Giuseppe Bellastella, Maria Ida Maiorino, Paolo Chiodini, Dario Giugliano, Miriam Longo, Maiorino, M. I., Longo, M., Scappaticcio, L., Bellastella, G., Chiodini, P., Esposito, K., and Giugliano, D.
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Blood Glucose ,Male ,Time Factors ,Endocrinology, Diabetes and Metabolism ,Meta-regression ,Type 2 diabetes ,Review ,DPP-4i ,Cardiovascular outcome trials ,Glycemic control ,Risk Factors ,Cause of Death ,Stroke ,Randomized Controlled Trials as Topic ,Hazard ratio ,Cardiorenal outcome ,Middle Aged ,GLP-1RA ,Hospitalization ,Treatment Outcome ,Cardiovascular Diseases ,Female ,Cardiology and Cardiovascular Medicine ,medicine.medical_specialty ,MACE ,Incretins ,Risk Assessment ,Glucagon-Like Peptide-1 Receptor ,Internal medicine ,Diabetes mellitus ,medicine ,Humans ,Diseases of the circulatory (Cardiovascular) system ,Sodium-Glucose Transporter 2 Inhibitors ,Glycemic ,Aged ,Glycated Hemoglobin ,Dipeptidyl-Peptidase IV Inhibitors ,business.industry ,Cardiorenal outcomes ,SGLT-2i ,Protective Factors ,medicine.disease ,Confidence interval ,Cardiovascular outcome trial ,Diabetes Mellitus, Type 2 ,RC666-701 ,business ,Mace ,Biomarkers - Abstract
Background Besides providing reassurance about cardiovascular (CV) safety of newer diabetes drugs, cardiovascular outcome trials (CVOTs) have also shown encouraging benefits on some CV endpoints. The contribution of the better glycemic control in the reduction of major cardiovascular events (MACE) remains an open question. The aim of this study is to evaluate the associations between the reduction of HbA1c and risk of MACE, MACE components, hospitalization for heart failure (HF) and all-cause death in CVOTs. Methods An electronic search up to July 2021 was conducted to determine eligible trials. Systematic review identified eighteen CVOTs reporting prespecified CV outcomes. Pooled summary estimates and 95% confidence intervals (CI) were calculated according to the random effects model using the Paule-Mandel method; restricted maximum likelihood estimators were used to estimate model parameters in the metaregression. Results The eighteen CVOTs evaluated 161,156 patients and included four trials with dipeptidyl-peptidase-4 inhibitors (DPP-4i), eight trials with glucagon-like peptide-1 receptor agonists (GLP-1RA) and six trials with sodium-glucose cotransporter-2 inhibitors (SGLT-2i). Random-effects model meta-analysis showed an association between treatment and risk of MACE (hazard ratio [HR] 0.90; 95% CI 0.86, 0.94, P 2 = 45.2%, Q statistic P = 0.040). In meta-regression, there was an association between the reduction in HbA1c at the end of the trial and the HR reduction for MACE (beta = − 0.298, P = 0.007), with significant heterogeneity (I2 = 40%, Q statistic P = 0.04); this association was totally driven by the risk reduction of non-fatal stroke, which explained 100% of between-study variance (beta = − 0.531, R2 = 100%), without heterogeneity (I2 = 24%, Q statistic P = 0.206). There was no association between the reduction in HbA1c and the HR for heart failure or all-cause death. Conclusions The reduction of HbA1c in eighteen CVOTs was significantly associated with reduction of non-fatal stroke, explaining all (R2 = 100%) of the between-study variance. While the contribution of glucose lowering in some CV benefits of newer agents does not influence their indications for the patient with type 2 diabetes, it may hopefully facilitate their use.
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- 2021
9. GLP-1 receptor agonists and cardiorenal outcomes in type 2 diabetes: an updated meta-analysis of eight CVOTs
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Antonio Ceriello, Miriam Longo, Katherine Esposito, Giuseppe Bellastella, Paola Caruso, Dario Giugliano, Lorenzo Scappaticcio, Maria Ida Maiorino, Paolo Chiodini, Giugliano, D., Scappaticcio, L., Longo, M., Caruso, P., Maiorino, M. I., Bellastella, G., Ceriello, A., Chiodini, P., and Esposito, K.
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Male ,Endocrinology, Diabetes and Metabolism ,Type 2 diabetes ,Cardiovascular outcome trials ,Risk Factors ,Efpeglenatide ,Cause of Death ,Original Investigation ,Clinical Trials as Topic ,Incidence ,Hazard ratio ,Cardiorenal outcome ,Middle Aged ,GLP-1RA ,Hospitalization ,Treatment Outcome ,Cardiovascular Diseases ,Female ,Kidney Diseases ,Cardiology and Cardiovascular Medicine ,medicine.medical_specialty ,Oral semaglutide ,Lixisenatide ,Placebo ,Incretins ,Risk Assessment ,Glucagon-Like Peptide-1 Receptor ,Albiglutide ,Diabetes mellitus ,Internal medicine ,medicine ,Humans ,Hypoglycemic Agents ,Diseases of the circulatory (Cardiovascular) system ,Dulaglutide ,Aged ,Cardio-Renal Syndrome ,business.industry ,Cardiorenal outcomes ,Semaglutide ,Liraglutide ,medicine.disease ,Confidence interval ,Cardiovascular outcome trial ,Diabetes Mellitus, Type 2 ,RC666-701 ,Heart failure ,Exenatide ,business ,Mace - Abstract
Background A meta-analysis is presented of cardiovascular outcome trials (CVOTs) comparing glucagon-like peptide-1 receptor agonists (GLP-1RA) versus placebo on cardiorenal outcomes in patients with type 2 diabetes mellitus (T2DM). Methods We did an electronic search up to June 30, 2021, for eligible trials. We did a meta-analysis of available trial data using a random-effects model to calculate overall hazard ratios (HRs) and 95% CI (confidence intervals). We included data from 8 CVOTs and 60,080 patients (72.4% with established cardiovascular disease). Results GLP-1RA reduced major cardiovascular events (MACE) by 14% (HR = 0.86, 95% CI 0.79–0.94, P = 0.006) with a non-significant heterogeneity between subgroups of patients with and without cardiovascular disease (P = 0.127). GLP-1RA also reduced the risk of cardiovascular death by 13% (P = 0.016), nonfatal stroke by 16% (P = 0.007), hospitalization for heart failure by 10% (P = 0.023), all-cause mortality by 12% (P = 0.012), and the broad composite kidney outcome by 17% (P = 0.012), which was driven by a reduction in macroalbuminuria only (HR = 0.74, 0.67–0.82, P Conclusions GLP-1RA have moderate benefits on MACE, and also reduce hospitalization for heart failure and all-cause mortality; they also have robust benefits on reducing the incidence of macroalbuminuria.
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- 2021
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