Provider-based initiation and management of pharmacologic therapy for gestational diabetes mellitus.

OBJECTIVE: After failure of diet and exercise prescribed for gestational diabetes mellitus (GDM), pharmacotherapy initiation is recommended. The objective of this study was to examine the association between provider type and timing of pharmacotherapy initiation. METHODS: This was a retrospective cohort study of women with a singleton pregnancy and diagnosis of A2GDM (GDM requiring pharmacotherapy) delivering in a tertiary care center between 2009 and 2019. Variables including maternal demographics, GDM characteristics, and provider type (general obstetrician/gynecologists (OBGYN), maternal-fetal medicine (MFM), or endocrinology) were assessed. The percent of abnormal glucose values at pharmacotherapy initiation was compared among provider types via univariable and multivariable analyses. RESULTS: A total of 428 women were included in the analysis. Eighteen percent were managed by MFM, 54% by general OBGYN, and 28% by endocrinology. Insulin was prescribed in 45.8% of women. In univariable analysis, the percent of abnormal glucose values was higher in women managed by MFMs, compared with general OBGYN and endocrinology (58.0%±25.1, 50.0%±23.1, and 50.3%±26.8, respectively, p = .041). Women started on insulin as first-line pharmacotherapy were more likely to be managed by endocrinology (p < .001). After adjusting for confounding variables, provider type was not significantly associated with percent of abnormal glucose values at pharmacotherapy initiation, but endocrinology was more likely to initiate insulin (aOR = 9.33, 95% CI 4.27-20.39). CONCLUSIONS: Provider type was not associated with percent of elevated glucose values at the time of pharmacotherapy initiation for A2GDM, but it was associated with insulin usage as first-line pharmacotherapy.

Translation, revision, and validation of the Chinese version of the Satisfaction with Oral Anti-Diabetic Agent Scale (C-SOADAS) in patients with type 2 diabetes mellitus.

OBJECTIVE: The aim of this study was to translate, adapt, and validate the Satisfaction with Oral Anti-Diabetic Agent Scale (SOADAS) in type 2 diabetes mellitus (DM) patients taking oral antidiabetic drugs (OADs) in Taiwan. PATIENTS AND METHODS: The SOADAS was translated to Chinese and was modified based on reviews of two physicians, five diabetes educators, and two patient focus groups. A cross-sectional interviewer-administered survey was conducted in adult patients with type 2 DM who were taking OADs. The Chinese version of the SOADAS (C-SOADAS), the EuroQol 5 dimensions 3-level (EQ-5D-3L) questionnaire, and a demographic questionnaire were administered to participants. Instrument structure, internal consistency, convergent validity, and known-group validity were assessed. RESULTS: A total of 260 DM patients were recruited. The mean score of an individual item ranged from 3.6 to 3.9, while the mean total score (out of 25 possible points) was 18.7 points. Overall, floor and ceiling effects were negligible. The Cronbach's α value was 0.81. All the four predetermined hypotheses for known-group validity assessment were fulfilled. In convergent validity testing, the C-SOADAS total scores were found to be correlated with EuroQol-Visual Analog Scale (EQ-VAS) scores (r = 0.2; p < 0.01) but not with EuroQol 5 dimensions (EQ-5D) index scores (r = 0.02; p = 0.81). CONCLUSION: The 5-item C-SOADAS appears to be a psychometrically acceptable measure of OAD treatment satisfaction among type 2 DM patients in Taiwan. The tool may be incorporated into clinical practice to quickly assess treatment outcomes from patients' perspectives.

Alogliptin: safety, efficacy, and clinical implications.

PURPOSE: Alogliptin is the newest dipeptidyl peptidase 4 (DPP-4) inhibitor approved for the treatment of type 2 diabetes either alone or in combination with other antidiabetic agents. The purpose of this review is to highlight the clinical studies that led to Food and Drug Administration approval of alogliptin and to provide insight into the place in therapy for the management of type 2 diabetes mellitus. SUMMARY: As a DPP-4 inhibitor, alogliptin raises postprandial levels of glucagon-like peptide 1, leading to insulin secretion and glucose homeostasis. When given as monotherapy, alogliptin has the ability to reduce glycoslate hemoglobin A1c (HbA1c) by 0.4% to 1.0%. Combination therapy yielded similar reductions with some variability depending on the agent with which alogliptin was combined. The mean HbA1c reduction seen with alogliptin is relative to the degree of HbA1c elevation at baseline. Alogliptin appears to be weight neutral and is relatively well tolerated with few adverse effects. Furthermore, alogliptin has proven to result in comparable efficacy and tolerability in the elderly as in the younger population. CONCLUSION: Alogliptin alone or in combination with other antidiabetic agents has shown a significant reduction in HbA1c while remaining safe and tolerable. The efficacy profile of alogliptin is comparable to other DPP-4 inhibitors. Additional long-term research is necessary with regard to long-standing efficacy and effects on beta-cell function.

Pharmacokinetic and toxicological considerations for the treatment of diabetes in patients with liver disease.

INTRODUCTION: Patients with type 2 diabetes have an increased risk of chronic liver disease (CLD) such as non-alcoholic fatty liver disease and steatohepatitis and about one-third of cirrhotic patients have diabetes. However, the use of several antidiabetic agents may be a cause for concern in the case of hepatic impairment (HI). AREAS COVERED: An extensive literature search was performed to analyze the influence of HI on the pharmacokinetics (PK) of glucose-lowering agents and the potential consequences for clinical practice as far as the efficacy/safety balance of their use in diabetic patients with CLD is concerned. EXPERT OPINION: Almost no PK studies have been published regarding metformin, sulfonylureas, thiazolidinediones and α-glucosidase inhibitors in patients with HI. Only mild changes in PK of glinides, dipeptidyl peptidase-4 inhibitors and sodium glucose cotransporters type 2 inhibitors were observed in dedicated PK studies in patients with various degrees of HI, presumably without major clinical relevance although large clinical experience is lacking. Glucagon-like peptide-1 receptor agonists have a renal excretion rather than liver metabolism. Rare anecdotal case reports of hepatotoxicity have been described with various glucose-lowering agents contrasting with numerous reassuring data. Nevertheless, caution should be recommended, especially in patients with advanced cirrhosis, including with the use of metformin.

Progress in liver transporter-mediated drug interactions with oral antidiabetic agents / 中国药学杂志

OBJECTIVE: To summarize the liver transporter-mediated drug interactions with oral antidiabetic agents.

Congenital Malformations In The Fetuses Of Type 2 Diabetic Women Treated with Oral Antidiabetic Agents During Embryogenesis / 대한산부인과학회잡지

OBJECTIVE: The use of oral hypoglycemic drugs in pregnant women has been limited and therefore there is scanty information on their safety. Concern about possible adverse effects of these drugs on the fetus led us to collect the cases of unintentional fetal exposure to oral antidiabetic agent during embryogenesis for comparision with an appropriately matched control group from the same clinic population. METHODS: Eight type 2 diabetic pregnant women with accidental exposure to oral antidiabetic agent during early pregnancy and 20 type 2 diabetic pregnant women matched for age, weight, and glycemic control but not exposed to oral antidiabetic agent were studied retrospectively. RESULTS: Three neonates (38%) in the exposed group had congenital malformations and still birth, compared with 5 (25%) in the control group (Odds ratio 1.8 (0.2-13.8), P>0.05). In the control group, the mean of HbA1c of 5 mothers of neonates with anomalies and stillbirth were higher than that of 15 mothers of neonates without anomaly (8.8% vs 6.2%, p=0.1) and the anomalies were major congenital malformation including three congenital heart diseases (1 ventricular septal defect, 2 patent ductus arteriosus) and one renal agenesis. In the exposed group, the mean of HbA1c of 3 mothers of neonates with anomalies and stillbirth were higher than that of 5 mothers of neonates without anomaly (9.0% vs 6.3%, p=0.4) and the anomlies were urachal sinus and facial palsy which was not commonly described in diabetic embryopathy. CONCLUSION: Although this study, due to the limited number of pregnancies examined, does not exclude an association between treatment with oral antidiabetic agent at the time of embryogenesis and congenital malformations in the offspring, the risk of our results is lower than that of others. The final answer will demand a much larger number of pregnancies studied prospectively.