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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. Source

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 Source

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. Source

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. Source

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. Source

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