Chaira Medica Association

Chieri, Italy

Chaira Medica Association

Chieri, Italy
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Corona G.,Maggiore Bellaria Hospital | Giorda C.B.,Metabolism and Diabetes Unit | Cucinotta D.,Policlinico di Messina | Guida P.,University of Bari | Nada E.,Chaira Medica Association
Journal of Endocrinological Investigation | Year: 2013

Introduction: No data on the prevalence of erectile dysfunction (ED) in subjects with newly diagnosed Type 2 diabetes mellitus (T2DM) are currently available. Aim: The aim of the present study was to estimate the prevalence of ED and its associated causes in a sample of male patients with recently diagnosed DM (<24 months) attending a diabetes care center. Methods: The study comprised two phases: a cross-sectional analysis and a longitudinal reassessment of the data collected during the first phase. During the first phase, 1503 subjects (mean age 58.7±8.9 yr) from 27 centers were interviewed: 666 (43.3%) reported experiencing ED, 499 of which (mean age 58.8±8.8 yr) agreed to participate in the study (final enrolment rate, 33.3%). Concurrent morbidities were hypertension (55.3%), dyslipidemia (39.5%), and coronary heart disease (7.8%); chronic complications were neuropathy (8.9%), nephropathy (12.6%) and retinopathy (7.6%) in about one third of the sample at enrolment. Results: Overall, about 20% of the patients reported having used ED drugs, but more than 50% had abandoned therapy because of the drug's ineffectiveness or high cost. The prevalence of hypogonadism was 46.9% (total testosterone level, 3.5 ng/ml). Some 20% of patients reported symptoms suggestive of depression. Conclusion: The present study provides data showing a high prevalence of ED, hypogonadism and depressive symptoms among male patients with newly diagnosed T2DM. Further analysis of the data will elucidate the specific determinants of such conditions and their longitudinal significance. ©2013, Editrice Kurtis.


Giorda C.,Metabolism and Diabetes Unit | Picariello R.,Epidemiology Unit | Nada E.,Chaira Medica Association | Tartaglino B.,Chaira Medica Association | And 4 more authors.
PLoS ONE | Year: 2012

Despite the heightened awareness of diabetes as a major health problem, evidence on the impact of assistance and organizational factors, as well as of adherence to recommended care guidelines, on morbidity and mortality in diabetes is scanty. We identified diabetic residents in Torino, Italy, as of 1st January 2002, using multiple independent data sources. We collected data on several laboratory tests and specialist medical examinations to compare primary versus specialty care management of diabetes and the fulfillment of a quality-of-care indicator based on existing screening guidelines (GCI). Then, we performed regression analyses to identify associations of these factors with mortality and cardiovascular morbidity over a 4 year- follow-up. Patients with the lowest degree of quality of care (i.e. only cared for by primary care and with no fulfillment of GCI) had worse RRs for all-cause (1.72 [95% CI 1.57-1.89]), cardiovascular (1.74 [95% CI 1.50-2.01]) and cancer (1.35 [95% CI 1.14-1.61]) mortality, compared with those with the highest quality of care. They also showed increased RRs for incidence of major cardiovascular events up to 2.03 (95% CI 1.26-3.28) for lower extremity amputations. Receiving specialist care itself increased survival, but was far more effective when combined with the fulfillment of GCI. Throughout the whole set of analysis, implementation of guidelines emerged as a strong modifier of prognosis. We conclude that management of diabetic patients with a pathway based on both primary and specialist care is associated with a favorable impact on all-cause mortality and CV incidence, provided that guidelines are implemented. © 2012 Giorda et al.


Giorda C.B.,Metabolism and Diabetes Unit | Picariello R.,Epidemiology Unit | Nada E.,Chaira Medica Association | Tartaglino B.,Chaira Medica Association | And 5 more authors.
Nutrition, Metabolism and Cardiovascular Diseases | Year: 2014

Backgrounds and aims: To compare direct costs of four different care models and health outcomes in adults with type 2 diabetes. Methods and results: We used multiple independent data sources to identify 25,570 adults with type 2 diabetes residing in Turin, Italy, as of 1 July 2003. Data extracted from administrative data databases were used to create four care models ranging in organization from highly structured care (integrated primary and specialist care) to progressively less structured care (unstructured care). Regression analyses, adjusted for main confounders, were applied to examine the differences between the models in direct costs, mortality, and diabetes-related hospitalizations rates over a 4-year period. In patients managed according to the unstructured care model (i.e., usual care by a primary care provider and without strict guidelines adherence), excess of all-cause mortality was 84% and 4-year direct cost was 8% higher than in those managed according to the highly structured care model. Cost ratio analysis revealed that the major cost driver in the unstructured care model was hospital admissions, which were 31% higher than the rate calculated for the more structured care models. In contrast, spending on prescription medications and specialist consultations was higher in the highly structured care model. Conclusion: A diabetes care model that integrates primary and specialty care, together with practices that adhere to guideline recommendations, was associated with a reduction in all-cause mortality and hospitalizations, as compared with less structured models, without increasing direct health costs. © 2014 Elsevier B.V.


Giorda C.B.,Metabolism and Diabetes Unit | Sacerdote C.,University of Turin | Nada E.,Chaira Medica Association | Marafetti L.,Metabolism and Diabetes Unit | And 2 more authors.
Endocrine | Year: 2015

Concerns raised by several animal studies, case reports, and pharmacovigilance warnings over incretin-based therapy potentially exposing type two diabetes patients to an elevated risk of pancreatitis have cast a shadow on the overall safety of this class of drugs. This systematic review evaluates the data from observational studies that compared treatment with or without incretins and the risk of pancreatitis. We searched PubMed for publications with the key terms incretins or GLP-1 receptor agonists or DPP-4 inhibitors or sitagliptin or vildagliptin or saxagliptin or linagliptin or alogliptin or exenatide or liraglutide AND pancreatitis in the title or abstract. Studies were evaluated against the following criteria: design (either cohort or case–control); outcome definition (incidence of pancreatitis); exposure definition (new or current or past incretins users); and comparison between patients receiving incretins or not for type 2 diabetes. Two authors independently selected the studies and extracted the data. Six studies meeting the inclusion criteria were reviewed. No difference was found in the overall risk of pancreatitis between incretin users and non-users (odds ratio 1.08; 95 % CI [0.84–1.40]). A risk increase lower than 35 % cannot be excluded according to the power calculation. This systematic review and meta-analysis suggests that type 2 diabetes patients receiving incretin-based therapy are not exposed to an elevated risk of pancreatitis. Limitations of this analysis are the low prevalence of incretin users and the lack of a clear distinction by the studies between therapy with DPP-4 inhibitors or with GLP-1 receptor agonists. © 2014, Springer Science+Business Media New York.


Giorda C.B.,Metabolism and Diabetes Unit | Picariello R.,Epidemiology Unit | Nada E.,Chaira Medica Association | Tartaglino B.,Chaira Medica Association | And 4 more authors.
The Lancet Diabetes and Endocrinology | Year: 2014

Background: Previous studies have yielded conflicting results about the association between incretin therapies and acute pancreatitis. We aimed to compare the occurrence of acute pancreatitis in a population of patients with type 2 diabetes who received incretins compared with those who received other antidiabetic treatment. Methods: In our population-based matched case-control study, we extracted information from an administrative database from Piedmont, Italy (containing data for 4·4 million inhabitants). From a dataset of 282 429 patients receiving treatment with antidiabetic drugs for type 2 diabetes, we identified 1003 cases older than 41 years who had been admitted to hospital for acute pancreatitis between Jan 1, 2008, and Dec 31, 2012, and 4012 controls who were matched for sex, age, and time of start of antidiabetic therapy. We compared incretin exposure in cases and controls with a conditional logistic regression model, expressed as odds ratios (ORs [95% CI]). We adjusted all analyses for risk factors of acute pancreatitis, as ascertained by hospital discharge records, and concomitant use of metformin or glibenclamide. Findings: The mean age of cases and controls (72·2 years [SD 11·1]) was high, as expected in an unselected diabetic population in Europe. After adjustment for available confounders, use of incretins in the 6 months before hospital admission was not associated with increased risk of acute pancreatitis (OR 0·98, 95% CI 0·69-1·38; p=0·8958). Interpretation: Our findings suggest that, in an unselected population, use of incretins is not associated with an increased risk of acute pancreatitis. Larger studies are needed to clarify whether age or type of incretin therapy could affect the risk of acute pancreatitis in patients with type 2 diabetes. Funding: Chaira Medica Association, Chieri, Italy. © 2014 Elsevier Ltd.


PubMed | University of Turin, Metabolism and Diabetes Unit, Epidemiology Unit and Chaira Medica Association
Type: Journal Article | Journal: BMJ open | Year: 2015

The SAVOR TIMI-53 study reported a significant increase in the risk of hospitalisation for heart failure (HF) in patients treated with a DPP-4 inhibitor (DPP-4i) in comparison with placebo. A recent case-control study in part confirmed this risk signal. Our aim was to compare the occurrence of HF in relation to DPP-4i use versus any antidiabetic treatment.Population-based matched case-control study conducted using administrative data.The Italian Region of Piedmont (4.4 million inhabitants).From a database of 282,000 patients treated with antidiabetic drugs, we identified 14,613 hospitalisations for HF, 7212 incident cases, and 1727 hospital re-admissions between 2008 and 2012; each case was matched for gender, age and antidiabetic therapy with 10 controls; cases and controls were compared for exposure to DPP-4i.ORs and 95% CIs were calculated by fitting a conditional logistic model. All analyses were adjusted for available risk factors for HF.We found no increased risk of hospitalisation for HF associated with the use of DPP-4i (OR for admission for HF 1.00 (0.94 to 1.07), incident HF1.01 (0.92 to 1.11), recurrent HF 1.02 (0.84 to 1.22)). All-cause mortality was 6% lower in DPP-4i users (p<0.001), whereas insulin users showed an excess of risk for any type of hospital admission (19%) and death (20%) (p<0.001).Our findings suggest that, in an unselected population of diabetic patients, the use of DPP-4i is not associated with an increased risk of HF. The favourable impact on all-cause mortality should be viewed with caution and also other explanations investigated.


Giorda C.B.,Metabolism and Diabetes Unit | Cercone S.,Rome | Nada E.,Chaira Medica Association
Endocrine | Year: 2015

The treatment objective in diabetes is prevention of the onset or progression of complications. Intensive treatment reduces the risk of complications. The aim of the study was to evaluate glycemic control in patients with type 2 diabetes mellitus treated with metformin monotherapy at the maximal-tolerated dose. This retrospective, multicenter, observational study, enrolled patients ≥45-year old receiving metformin as monotherapy for at least 36 months. Data were collected on demographic and disease characteristics, clinical status, lifestyle, comorbidities, and diabetes complications at baseline, 9, 18, and 24 months. Primary study variables were percentage of patients achieving HbA1c <7 % and mean HbA1c reduction after 9 months. Eligible patients (n = 524, mean age 65.9 ± 7.9 years) had a mean age at diagnosis of 57.5 ± 7.9 years. A second antidiabetic drug was added in 24 % of patients (126/524); time to treatment escalation was 44.7 ± 25.1 months. Regarding primary study variables, 61.7 % of patients (322/522) achieved HbA1c of 7.0 % at 9 months, compared to 37.0 % of patients (194/524) at baseline; mean HbA1c was reduced from 7.30 ± 0.95 to 6.84 ± 0.86 % after 9 months. The estimated mean time of exposure above 7 % was 19 months, 15 months for patients ≥65-year old, and 21 months for younger patients. Regression analysis revealed that patients with longer disease duration, and patients <65-year old responded less well to metformin. A substantial number of patients continued to receive monotherapy instead of intensified therapy and were exposed to hyperglycemia. © 2015 Springer Science+Business Media New York


Giorda C.B.,Metabolism and Diabetes Unit | Nada E.,Chaira Medica Association | Tartaglino B.,Chaira Medica Association | Marafetti L.,Metabolism and Diabetes Unit | Gnavi R.,Epidemiology Unit
Diabetes, Obesity and Metabolism | Year: 2014

The question whether antidiabetes drugs can cause acute pancreatitis dates back to the 1970s. Recently, old concerns have re-emerged following claims that use of incretins, a new class of drugs for type 2 diabetes, might increase the relative risk of acute pancreatitis up to 30-fold. Given that diabetes is per se a potent risk factor for acute pancreatitis and that drug-related acute pancreatitis is rare and difficult to diagnose, we searched the medical databases for information linking acute pancreatitis and type 2 diabetes drugs. Among the biguanides, both phenformin and metformin (the latter in patients with renal insufficiency) have been cited in case reports as a potential cause of acute pancreatitis. Sulphonylureas, as both entire class and single compound (glibenclamide), have also been found in cohort studies to increase its risk. No direct link was found between pancreatic damage and therapy with metaglinide, acarbose, pramlintide or SGLT-2 inhibitors. In animal models, thiazolinediones have demonstrated proprieties to attenuate pancreatic damage, opening perspectives for their use in treating acute pancreatitis in humans. Several case reports and the US Food and Drug Administration pharmacovigilance database indicate an association between acute pancreatitis and incretins, dipeptidyl peptidase-4 (DPP-4) inhibitors, and GLP-1 receptor agonists. To date, however, a clear-cut odds ratio for this association has been reported in only one of eight pharmacoepidemiological studies. Finally, none of the intervention trials investigating these compounds, including two large randomized controlled trials with cardiovascular endpoints, confirmed the purportedly increased risk of acute pancreatitis with incretin use. © 2014 John Wiley & Sons Ltd.


Giorda C.B.,Metabolism and Diabetes Unit | Nada E.,Chaira Medica Association | Tartaglino B.,Chaira Medica Association
Endocrine | Year: 2014

Renal or hepatic impairment, often encountered in patients with type 2 diabetes, influences the pharmacokinetics and bioavailability of antihyperglycemic agents. An emerging concern is whether pharmacotherapy with incretin-based agents, the most recent drug classes to be introduced for type 2 diabetes, can be safely used in patients with renal insufficiency or hepatic damage. This literature review examines the results of studies on these novel drug classes, with a view to provide the practitioner with a balanced, evidence-based position when considering incretin-based therapies in patients with type 2 diabetes and impaired kidney or liver function. All currently available dipeptidyl peptidase-4 (DPP-4) inhibitors appear to be appropriate pharmacotherapeutic choices in patients with declining renal function, with linagliptin affording the added advantage of not requiring dose adjustment or periodic monitoring of drug-related kidney function. In contrast, caution is warranted with the use of glucagon-like peptide-1 (GLP-1) receptor agonists in patients with moderate or severe renal impairment. The slightly wider evidence base for liraglutide than for exenatide or lixisenatide is not sufficient to support its use in severe renal impairment. What little evidence there is for incretin-based therapies in hepatic impairment has come from a few past hoc analysis of clinical trials, with most precautions and warnings reflecting the paucity of knowledge about incretin efficacy or safety in this condition. © 2014 Springer Science+Business Media.


PubMed | Metabolism and Diabetes Unit, MSD and Chaira Medica Association
Type: Journal Article | Journal: Endocrine | Year: 2016

The treatment objective in diabetes is prevention of the onset or progression of complications. Intensive treatment reduces the risk of complications. The aim of the study was to evaluate glycemic control in patients with type 2 diabetes mellitus treated with metformin monotherapy at the maximal-tolerated dose. This retrospective, multicenter, observational study, enrolled patients 45-year old receiving metformin as monotherapy for at least 36months. Data were collected on demographic and disease characteristics, clinical status, lifestyle, comorbidities, and diabetes complications at baseline, 9, 18, and 24months. Primary study variables were percentage of patients achieving HbA1c <7% and mean HbA1c reduction after 9months. Eligible patients (n=524, mean age 65.97.9years) had a mean age at diagnosis of 57.57.9years. A second antidiabetic drug was added in 24% of patients (126/524); time to treatment escalation was 44.725.1months. Regarding primary study variables, 61.7% of patients (322/522) achieved HbA1c of 7.0% at 9months, compared to 37.0% of patients (194/524) at baseline; mean HbA1c was reduced from 7.300.95 to 6.840.86% after 9months. The estimated mean time of exposure above 7% was 19months, 15months for patients 65-year old, and 21months for younger patients. Regression analysis revealed that patients with longer disease duration, and patients <65-year old responded less well to metformin. A substantial number of patients continued to receive monotherapy instead of intensified therapy and were exposed to hyperglycemia.

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