Metabolism and Diabetes Unit

Sant'Ambrogio di Torino, Italy

Metabolism and Diabetes Unit

Sant'Ambrogio di Torino, 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 Medical Association
Journal of Sexual Medicine | Year: 2014

Introduction: Several data have emphasized the importance of early diagnosis of erectile dysfunction (ED) and meticulous cardiovascular investigation in the type 2 diabetic mellitus (T2DM) patients. Aim: To estimate the prevalence of ED and its associated determinants in a sample of male patients with new or recently diagnosed T2DM. Methods: The SUBITO-DE study is an observational, multicenter, prospective study involving 27 Italian diabetes centers. Male patients recently diagnosed with T2DM were consecutively interviewed by their attending physician at the diabetes care centers and asked whether they had experienced a change in their sexual function or found it unsatisfactory. Those responding positively were then invited to participate in the study. Main Outcome Measure: Several hormonal and biochemical parameters were studied. Results: A nonselected series of 1,503 patients was interviewed, 499 of which (mean age, 58.8±8.8 years) entered the study, yielding a final enrolment rate of 33.3%. ED was classified as mild in 19.4%, mild-to-moderate in 15.4%, moderate in 10.4%, and severe in 21.6% of patients, respectively. In addition, premature ejaculation, delayed ejaculation, and hypoactive sexual desire (HSD) were comorbid in 28.3%, 32.9%, and 58.4%, respectively. Finally, hypogonadism, showed an estimated prevalence of almost 20%. Both organic (at least one chronic DM-associated complication) and psychological factors (severe depressive symptoms) increased the risk of ED. Severe depressive symptoms were also associated with ejaculatory problems, HSD, and hypogonadism. Conclusions: A high prevalence of sexual dysfunction in men with recently diagnosed T2DM was detected. Early diagnosis of ED could help prevent emotional and physical discomfort in men and aid in identifying reversible cardiovascular risk factors. Screening of sexual dysfunction should become a part of routine care in the management of T2DM patients. Corona G, Giorda CB, Cucinotta D, Guida P, Nada E, and Gruppo di studio SUBITO-DE. Sexual dysfunction at the onset of type 2 diabetes: The interplay of depression, hormonal and cardiovascular factors. J Sex Med 2014;11:2065-2073. © 2014 International Society for Sexual Medicine.

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 | Picariello R.,Epidemiology Unit | Tartaglino B.,Chai. Medica Assoc. | Marafetti L.,Metabolism and Diabetes Unit | And 5 more authors.
BMJ Open | Year: 2015

Objective: 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 casecontrol 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. Design: Population-based matched case-control study conducted using administrative data. Setting: The Italian Region of Piedmont (4.4 million inhabitants). Participants: 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. Outcome measures: ORs and 95% CIs were calculated by fitting a conditional logistic model. All analyses were adjusted for available risk factors for HF. Results: 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)). Allcause 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). Conclusions: 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 | 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 | Manicardi V.,E Franchini Hospital | Diago Cabezudo J.,LifeScan
Expert Review of Pharmacoeconomics and Outcomes Research | Year: 2011

Diabetes mellitus is an increasingly common chronic disease that has a great impact not only in terms of clinical effects, but also in terms of economic burden worldwide. Expenditures due to diabetes derive essentially from direct and indirect costs. Current estimates of global healthcare expenditures due to diabetes are US$376 billion and are expected to increase to US$490 billion by 2030. In particular, costs associated with diabetes-related complications represent the most relevant part of the national healthcare expenditure for diabetes and are higher than the costs of managing diabetes itself. The major expenditure depends on the type and the number of complications: cardiovascular complications increase direct costs, especially for hospitalization. Moreover, diabetic comorbidity has a greater economic impact on the health expenditure in comparison with those patients without diabetes. In Europe, the CODE-2 study was the first attempt to evaluate the costs of diabetes: the annual costs per patient were estimated at €2384 and the highest value, €2991, was registered in Italy. This indicates an overall annual cost of €5170 million for the whole Italian population with diabetes. Current estimates for 2010 healthcare expenditure for diabetes are US$105 billion (10% of total healthcare expenditure, US$2046 per person) for the whole European region, and US$11 billion (9% of total healthcare expenditure, US$2087 per person) for Italy. More studies are needed in order to better define the real significance of the healthcare costs of diabetes in Italy. An effective therapy with a good metabolic control can reduce the risk of complications and represents a valid strategy from an economic point of view. © 2011 Expert Reviews Ltd.

Giorda C.B.,Metabolism and Diabetes Unit
Nutrition, Metabolism and Cardiovascular Diseases | Year: 2013

Organizational factors in diabetes care can influence long- and medium-term outcomes, affecting the prognosis to the same extent as new therapies. A growing body of evidence supports the hypothesis that diabetes team consultation can favorably impact on hospital utilization, the costliest item in diabetes management, as well as on hospitalization rates, inpatient hospital length of stay, and re-admission rates. Moreover, the model of diabetes care has been reported to influence guidelines adherence, an additional factor linked to the variability in the quality of diabetes care. The strongest predictor and effect modifier of the quality of diabetes care is specialist referral. Compared to patients seen in primary care or other settings, those visiting a diabetes center are more likely to be monitored according to guidelines, regardless of the severity-of-disease effect, and to receive structured education, as well as more aggressive treatment when needed. Finally, at least eight published studies suggest that when continuity of care is shared with diabetes clinics, all-cause mortality and major cardiovascular events are both reduced. The sharing of care pathways between primary care providers and diabetes teams is likely to be the best and most affordable solution in the complex management of this chronic condition. © 2012 Elsevier B.V.

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.

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