Patient-led versus physician-led titration of insulin glargine in patients with uncontrolled type 2 diabetes: a randomized multinational ATLAS study.

OBJECTIVE: Self-adjustment of insulin dose is commonly practiced in Western patients with type 2 diabetes but is usually not performed in Asian patients. This multinational, 24-week, randomized study compared patient-led with physician-led titration of once-daily insulin glargine in Asian patients with uncontrolled type 2 diabetes who were on 2 oral glucose-lowering agents. METHODS: Patient-led (n = 275) or physician-led (n = 277) subjects followed the same dose-titration algorithm guided by self-monitored fasting blood glucose (FBG; target, 110 mg/dL [6.1 mmol/L]). The primary endpoint was change in mean glycated hemoglobin (HbA1c) at week 24 in the patient-led versus physician-led titration groups. RESULTS: Patient-led titration resulted in a significantly higher drop in HbA1c value at 24 weeks when compared with physician-led titration (-1.40% vs. -1.25%; mean difference, -0.15; 95% confidence interval, -0.29 to 0.00; P = .043). Mean decrease in FBG was greatest in the patient-led group (-2.85 mmol/L vs. -2.48 mmol/L; P = .001). The improvements in HbA1c and FBG were consistent across countries, with similar improvements in treatment satisfaction in both groups. Mean daily insulin dose was higher in the patient-led group (28.9 units vs. 22.2 units; P<.001). Target HbA1c of <7.0% without severe hypoglycemia was achieved in 40.0% and 32.9% in the patient-led and physician-led groups, respectively (P = .086). Severe hypoglycemia was not different in the 2 groups (0.7%), with an increase in nocturnal and symptomatic hypoglycemia in the patient-led arm. CONCLUSION: Patient-led insulin glargine titration achieved near-target blood glucose levels in Asian patients with uncontrolled type 2 diabetes who were on 2 oral glucose-lowering drugs, demonstrating that Asian patients can self-uptitrate insulin dose effectively when guided.

Initial combination therapy with vildagliptin plus metformin in drug-naïve patients with T2DM: a 24-week real-life study from Asia.

AIMS: To assess the effectiveness and safety of vildagliptin/metformin initial combination therapy in drug-naïve patients with type 2 diabetes mellitus (T2DM). METHODS: INITIAL was a 24-week prospective, observational study in T2DM patients with glycated hemoglobin (HbA1c) ≥ 7.5%, and prescribed vildagliptin/metformin as initial combination therapy. The primary endpoint was change in HbA1c from baseline to week 24. Key secondary endpoints were HbA1c change from baseline to week 12, proportion of patients achieving HbA1c ≤7.0%, change in body weight at 12 and 24 weeks, change in HbA1c by sub-groups (baseline HbA1c, age, body mass index [BMI], dosage strength, co-morbidities) from baseline to week 24, and safety. RESULTS: A total of 532 patients were enrolled. The mean age, HbA1c, and BMI were 49.6 ± 11.27 years, 9.3 ± 1.57%, and 26.7 ± 4.50 kg/m2, respectively. Cardiovascular risk factors present at baseline were dyslipidemia (30.1%), hypertension (29.7%), and obesity (20.9%). The mean reductions in HbA1c from baseline to week 12 (-1.6 ± 1.59%) and 24 (-1.9 ± 1.70%) were statistically significant (p < .001). At 24 weeks, 39.6% of patients achieved HbA1c ≤ 7.0%, and the mean body weight reduction was -1.1 ± 2.62 kg. HbA1c reductions were consistently seen from baseline to weeks 12 and 24 in the various sub-groups. Overall, 48 (9.0%) patients reported adverse events, including one hypoglycemic episode. There were no serious adverse events or deaths. CONCLUSIONS: Overall, in a relatively young drug-naïve T2DM Asian study population with high baseline HbA1c and often associated with cardiovascular risk factors, vildagliptin/metformin combination therapy was associated with significant and clinically relevant HbA1c reduction from baseline. This effect was seen at week 12, was maintained over 24 weeks, and was accompanied by good tolerability.

Consensus statement: appropriate consumer education and communication programs for weight- loss agents in Asia.

BACKGROUND AND AIM: The increasing prevalence of overweight and obesity worldwide demands increased efforts in the prevention and management of obesity. This article aims to present consensus statements promoting appropriate consumer education and communication programs for weight-loss agents in Asia. METHODS: Panel members from various disciplines developed consensus statements based on an expert meeting on the benefits of consumer education and communication programs for over-the-counter weight-loss agents. Key opinion leaders discussed relevant data that served as the basis of the recommendations. RESULTS: Obesity is a growing epidemic in Asia, turning the region into a potential market for weight-loss products and services. Current trends in direct-to-consumer advertising demonstrate the pervasiveness of false representations lacking adequate substantiation. Relevant issues and recommendations were established. CONCLUSIONS: Public education on weight management is a shared responsibility; there is a need to raise public awareness of obesity and its health-related consequences. Advertising guidelines should ensure responsible direct-to-consumer advertising of weight-loss agents.

Parathyroidectomy for refractory secondary hyperparathyroidism with severe bone disease / Journal of the ASEAN Federation of Endocrine Societies

Advances in the medical management of secondary hyperparathyroidism due to renal failure have decreased the use of parathyroidectomy as a treatment option. However, some patients with end-stage renal disease still progress to refractory hyperparathyroidism and debilitating bone disease, for which parathyroidectomy may be warranted. We describe a case of a 35-year-old female on chronic hemodialysis who presented with bone pains, deformities, decrease in height and recurrent pathologic fractures. She had markedly elevated parathyroid hormone (PTH), vitamin D deficiency, persistent hyperphosphatemia and hypocalcemia despite therapeutic measures. Subtotal parathyroidectomy was done with eventual improvement of biochemical abnormalities, resolution of bone pains and healing of fractures.

The diagnostic accuracy of ultrasound guided fine-needle aspiration biopsy and intraoperative frozen section examination in nodular thyroid disease / Journal of the ASEAN Federation of Endocrine Societies

OBJECTIVES:To determine the diagnostic accuracy of combined ultrasound-guided fine needle aspiration biopsy (USG-FNAB) and intraoperative frozen section examinationin (FSE) in diagnosing malignant thyroid nodules.METHODOLOGY:Retrospective review of patients undergoing thyroidectomy with intraoperative frozen section examination following ultrasound guided fine-needle aspiration biopsy. Sensitivity, specificity, positive and negative predictive values and accuracy were calculated with respect to final histology.RESULTS: A total of 2,239 nodules were subjected to USG-FNAB at the Diabetes, Thyroid and Endocrine Center, St. Luke's Medical Center between January 2007 and December 2009. Two hundred fifty-one nodules were surgically excised following USG-FNAB. Frozen section examinations were taken from 90 of 251 nodules. The USG-FNAB yielded 90.3% (n=1,721) adequate specimens and 9.7% (n=185) inadequate specimens. The histologic examination of the 251 surgically excised nodules revealed 182 (73%) benign and 69 (27%) malignant nodules. The sensitivity, specificity, positive and negative predictive values and accuracy rate of USG-FNAB cytology are 70.3%, 92.8%, 76.5%, 90.4% and 87.2%, respectively. The diagnosis by frozen section was benign in 56 cases (62%), malignant in 10 cases (11%) and deferred in 24 cases (27%). By FSE, the sensitivity, specificity, positive and negative predictive values and accuracy rate are 83.3%, 100%, 100%, 96.4% and 96.7%, respectively. A diagnostic accuracy of up to 97.2% was achieved when USG-FNAB and FSE were combined and when their findings were concordant. When USG-FNAB and FSE diagnoses were discordant, the FSE showed superior accuracy (83.3%) than cytology (16.7%). In the group of nodules with indeterminate or inadequate cytology, the diagnostic accuracy of frozen section is 100%.CONCLUSION:Ultrasound guided fine-needle aspiration biopsy is an accurate preoperative test for the evaluation of nodular thyroid disease. It helps to distinguish malignant from benign lesions. The intraoperative frozen section is a valuable test for confirming the cytologic diagnosis. It is especially important in identifying malignant thyroid nodule in cases with indeterminate cytology. The combination of USG-FNAB and FSE greatly improves the accuracy rate in thyroid cancer detection.