Vildagliptin caused no hypoglycaemia, was well adhered to and improved HbA(1c), making it a suitable treatment option for managing fasting. Study limitations are the sample size and the lack of diet and exercise data. When extrapolated to the global Muslim population with a similar clinical background, these findings could have considerable public health and clinical implications.
This open-label, nonrandomized study assessed single and repeat ascending doses of a new sublingual fentanyl (SLF) formulation in 48 healthy Japanese opiate-naïve subjects (47 completed). Subjects received single-dose SLF 100, 200, 400, or 800 µg followed by 13 doses 6 hourly, at their dose level. Subjects taking repeat-dose 400 and 800 µg were pretreated with naltrexone in order to block opiate-receptor-mediated effects on respiration, monitored by pulse oximetry and transcutaneous pco(2). Sublingual fentanyl was rapidly and consistently absorbed. After single doses, median t(first) was 0.08 to 0.25 hours and t(max) 0.50 to 1.00 hours. After repeat dosing, median t(max) (t(max,ss)) was 0.50 to 2.00 hours. Plasma concentrations were dose proportional both after single and repeat dosing, and naltrexone appeared to have no effect on SLF pharmacokinetics. Plasma fentanyl reached steady state within the 72-hour dosing period and accumulation was approximately 2-fold. After single doses, effects on respiratory variables were evident after the 400-µg and 800-µg doses. Transcutaneous pco(2) was not helpful in detecting respiratory depression. Thus, SLF yielded rapid absorption of fentanyl and dose-proportional plasma concentrations that, for 400 µg and 800 µg, were within the typical analgesic range. Respiratory depression in these opioid-naïve volunteers was manageable with simple clinical measures.
Aim: The current study estimates the societal impact of early intensified treatment compared with initial monotherapy with subsequent treatment intensification in newly diagnosed adults with type 2 diabetes mellitus in Mexico. Methods: An individual patient-level simulation and a static cohort model were employed to simulate the treatment pathway and the probability of experiencing complications of diabetes. The avoided number of events was translated into avoided productivity losses, which were monetized using wages. Results: Patients on early intensified treatment experienced approximately 13,000 fewer complication events over 10 years. This was translated into a societal impact of $54 million (USD). Conclusion: Early treatment intensification is likely to be of particular benefit to health outcomes and productivity losses.
I n the UK, type 2 diabetes mellitus in patients aged ≥ 65 years is a significant healthcare burden, compounded by an increasing elderly population. Intensive therapies to control blood glucose can be hazardous for this patient group and information is limited about welltolerated therapies. This retrospective, real-world survey recorded glycated haemoglobin A 1c (HbA 1C ) levels and incidences of hypoglycaemic events in 72 elderly and very elderly patients (65-74 years and ≥ 75 years, respectively) receiving the dipeptidyl peptidase-4 inhibitor vildagliptin as part of combination therapy. After vildagliptin initiation, mean HbA 1C levels decreased from 8.2% to 7.4% (p=0.0415), the mean change in the elderly and very elderly subgroups being similar (−0.8%, −0.9%, respectively); the mean incidence of hypoglycaemic events (1.4%) was unchanged. This observational survey provides real-life evidence that in patients aged ≥ 65 years with type 2 diabetes, vildagliptin is an effective, welltolerated add-on therapy with low hypoglycaemic risk. Br J Diabetes Vasc Dis 2011;11:239-242
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