OBJECTIVES

Blood glucose levels of the majority of Filipino patients with type 2 diabetes (T2D) remain uncontrolled. Insulin degludec/insulin aspart (IDegAsp) is a fixed‑ratio coformulation of the long‑acting basal insulin degludec and the rapid acting prandial insulin aspart. The realworld ARISE (A Ryzodeg® Initiation and Switch Effectiveness) study investigated clinical outcomes across six countries in people with T2D who initiated IDegAsp. This publication presents the clinical outcomes of the Filipino cohort from a subgroup analysis of the ARISE study.

This 26-week, openlabel, noninterventional study examined outcomes in adults with T2D initiating or switching to IDegAsp (N=185) from other antidiabetic treatments per local clinical guidance.

Compared with the baseline, there was a significant improvement in glycated hemoglobin at the end of the study (EOS) (estimated difference [ED] −1.4 [95% confidence interval −1.7, −1.1]; P < 0.0001). Fasting plasma glucose (ED −46.1 mg/dL [−58.2, −34.0]; P < 0.0001) and body weight (ED −1.0 kg [−2.0, −0.1]; P = 0.028) were significantly reduced at EOS compared with baseline. IDegAsp was associated with a decrease in the incidence of selfreported healthcare resource utilization. Adverse events were reported in eight (4.3%) participants.

Initiating or switching to IDegAsp was associated with improved glycemic control, lower body weight, and lower HRU for people with T2D in the Philippines. No new, unexpected AEs were reported.

Objective: To determine the frequency of hypoglycemia in insulin-treated patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) in the non-interventional International Operations Hypoglycemia Assessment Tool (IO HAT) study. Methodology: This sub-analysis included Filipino patients with T1DM or T2DM, aged 18 years and older, treated with insulin for more than 12 months, who completed the two-part self-assessment questionnaires (SAQ1 and SAQ2) and patient diaries that recorded hypoglycemia during retrospective (6 months/4 weeks before baseline) and prospective period (4 weeks after baseline (ClinicalTrials.gov number: NCT02306681). Results: A total of 671 patients were enrolled and completed the SAQ1 (62 patients with T1DM and 609 patients with T2DM). Almost all patients (100% in T1DM and 99.3% in T2DM) experienced at least 1 hypoglycemic event prospectively. The incidence of any hypoglycemia was also high in the prospective period compared to retrospective period (72.6 [95% CI: 64.8, 80.9] events PPY and 43.6 [95% CI: 37.8, 49.9] events PPY; p=0.001, respectively) in T1DM patients. Conclusion Among insulin-treated patients, higher rates of hypoglycemia were reported prospectively than retrospectively. This indicates that the patients in real-life setting often under-report hypoglycemia. Patient education can help in accurate reporting and appropriate management of hypoglycemia and diabetes.
Hypoglycemia ; Philippines

The Asia-Pacific region carries a high disease burden, with over half of the global diabetic population residing in this region. Increasing evidence shows that without targeted intervention, the progression from impaired glucose tolerance (IGT) to type 2 diabetes occurs more frequently in Asians compared with Caucasians. Furthermore, IGT is independently associated with an increased risk of cardiovascular disease, and should be managed as early as possible. Because diabetes is now a major public health issue, strategies aimed at prevention and treatment are urgently required. Lifestyle modification, including weight loss, dietary changes and increased physical activity, play a major role in controlling the disease. Significant evidence also supports the effectiveness of a combination of lifestyle modification and pharmacologic therapy, such as metformin, in delaying the onset of diabetes. Although the importance of lifestyle interventions is well recognized throughout Asia, many countries do not have formal recommendations to guide the diagnosis and management of individuals at risk of progression to diabetes. At a recent regional meeting, experts from the Asian region convened to develop consensus recommendations to guide clinicians in the management of Asian patients with pre-diabetes. These consensus recommendations provide a clear and concise approach to the management of individuals with IGT based on the available evidence and current best clinical practice.

The Asia-Pacific region carries a high disease burden, with over half of the global diabetic population residing in thisregion. Increasing evidence shows that without targeted intervention, the progression from impaired glucose tolerance(IGT) to type 2 diabetes occurs more frequently in Asians compared with Caucasians. Furthermore, IGT is independently associated with an increased risk of cardiovascular disease, and should be managed as early as possible. Because diabetes is now a major public health issue, strategies aimed at prevention and treatment areurgently required. Lifestyle modification, including weight loss, dietary changes and increased physical activity, play a major role in controlling the disease. Significant evidence also supports the effectiveness of a combination of lifestylemodification and pharmacologic therapy, such as metformin, in delaying the onset of diabetes. Although the importanceof lifestyle interventions is well recognized throughout Asia, many countries do not have formal recommendations to guide the diagnosis and management of individuals at risk of progression to diabetes. At a recent regional meeting,experts from the Asian region convened to develop consensus recommendations to guide clinicians in themanagement of Asian patientswith pre-diabetes. These consensus recommendations provide a clear and conciseapproach to the management of individuals with IGT based on the available evidence and current best clinical practice.
Glucose Intolerance ; Asia

Objectives: This study aimed to determine the incidence and risk factors for post-thyroidectomy hypocalcemia. Methodology: This was a retrospective study of 242 patients who underwent total or completion thyroidectomy from 2011-2014 at the St. Luke’s Medical Center, Quezon City, Philippines. The overall and type-specific incidences of hypocalcemia were determined. Patient and surgery-related factors were assessed and hypocalcemic events described. Results: Overall incidence of hypocalcemia is 11.98% distributed into symptomatic (10.74%) and asymptomatic (1.24%). The following patient-related factors were not found to be significantly associated with hypocalcemia: age, gender, thyroid disease and thyroid gland weight. Among surgery-related factors, the presence of concomitant complications of thyroidectomy (hoarseness and/or hematoma) and inadvertent parathyroidectomy were significantly associated with hypocalcemia both in the univariate [p=0.046; OR 2.369 (95%CI: 0.995-5.643) and p=0.027; OR 2.426 (95%CI: 1.084-5.432), respectively] and multivariate analyses [p=0.025; OR 2.842 (95%CI: 1.142-7.069) and p=0.013; OR 2.941 (95%CI: 1.252-6.907), respectively]. Other surgery-related factors were not found to be significantly associated with hypocalcemia: extent of thyroidectomy [total vs completion]; neck dissection; surgery duration (hours); and surgeon [consultant vs. trainee]. Among those with symptomatic hypocalcemia, manifestations occurred 29.85±23.07 hours post-operatively and these were: Chvostek’s (80.8%), acral paresthesia (76.9%), perioral numbness (46.1%), carpopedal spasm (15.3%), Trousseau’s (7.7%) and cramps (3.8%). Those who presented with manifestations of hypocalcemia but with normal serum iCa post-operatively comprised 33.9% of the study population and the majority presented with Chvostek’s sign (52%) and acral paresthesia (50%). Conclusion In this study, hoarseness and/or hematoma and inadvertent parathyroidectomy are risk factors for post-thyroidectomy hypocalcemia. Closer monitoring of these patients for hypocalcemia may be necessary.
Thyroidectomy ; Incidence ; Risk Factors

Objective: This study describes the clinical data of adult patients who underwent Fine Needle Aspiration Biopsy (FNAB) of thyroid nodule(s) with a cytologic diagnosis of Atypia or Follicular Lesion of Undetermined Significance (AUS or FLUS) at St. Luke’s Medical Center from January 2012 to October 2013. Methodology: Adult patients who underwent FNAB of the thyroid nodule with a cytologic diagnosis of AUS or FLUS were studied retrospectively using the ultrasound result, initial consultation form and operative techniques of these patients. The cytologic and histopathologic diagnoses were retrieved through the electronic Healthcare-Results Management System. Results and Conclusion A third (34%) of the patients with a cytologic diagnosis of AUS or FLUS (8.9%) underwent surgery. Of the 68 patients who underwent surgery, 44 were benign and 24 were malignant with a malignancy rate of 35.3%. Preoperatively, there were no ultrasound characteristics or microscopic descriptions significantly associated with malignancy. The recommendation of the Bethesda System to do a repeat FNAB in these thyroid nodules should, therefore, be reconsidered.
Biopsy, Fine-Needle ; Thyroid Nodule ; Cytology

Objectives: This study aims to evaluate the effectiveness of initial insulin therapy versus oral hypoglycemic agents in glucose control among newly diagnosed Type 2 diabetes patients. Methodology: This is a systematic review and meta-analysis of RCTs with quality grade B searched using the medical subject headings (MeSH): diabetes mellitus type 2, insulin, oral hypoglycemic agent, with adults newly diagnosed with type 2 DM as subjects and given insulin (± metformin) vs. OHA. Results were summarized as graphs and forest plots using the random effects due to foreseen sources of heterogeneity using Review Manager version 5.1. Results: Presence of substantial heterogeneity prevents us from making a conclusion. All four studies showed lower post treatment BMI among participants in the insulin treatment arm. An opposite finding was expected as insulin is known to cause weight gain. Main adverse effect was hypoglycemia. Conclusion Among newly diagnosed type 2 DM patients, there is insufficient evidence for or against the use of insulin compared to oral hypoglycemic agents as initial management in terms of improvement in glycemic control, decrease in insulin resistance, and improvement in beta cell function.
Diabetes Mellitus, Type 2 ; Glycemic Control

Objective: To determine the effect of laparoscopic adjustable gastric banding (LAGB) on weight loss and the association between initial body mass index (BMI) and successful weight loss, defined as >50% excess weight loss (EWL) among obese Filipino adults at St. Luke’s Medical Center. Methodology: Data from 97 patients who were at least 18 years old at the time of gastric banding were reviewed retrospectively. Patient follow-up was poor 2 years post-surgery, which precluded analysis of follow-up data beyond 2 years. Changes in weight loss parameters from baseline to the different observation periods were carried out using paired t- test. To determine the association of different factors with success in weight loss, Independent t-test and Chi-square tests were used. A p-value ≤0.05 was considered significant. Results: Majority of the patients were female (61%) and Southeast Asian (77%). Ages ranged from 18 to 68 years. Mean BMI was 44.1 ± 0.1 kg/m2 and mean excess weight was 61.4 ± 26.5 kg. Excess weight loss of 43.84 ± 25.09% and BMI reduction of 21.54 ± 13.39% were attained at 2 years. Lower initial BMI with a mean of 38.12±3.28 kg/m2 was associated with successful weight loss, 1 year after gastric banding (p<0.001). Conclusion Patients attained 43.84% EWL 2 years after gastric banding. Those with higher initial BMI were less likely to achieve successful weight loss 1 year after gastric banding.
Bariatric Surgery ; Obesity ; Weight Loss

Objective: To determine the effect of metformin on maternal and neonatal outcome among pregnant Filipino women with polycystic ovary syndrome (PCOS). Methodology: This is a retrospective cohort study of PCOS women who were on metformin treatment prior to achieving pregnancy. The women were divided into two groups: women who continued metformin during pregnancy and women who discontinued metformin at the time the pregnancy was confirmed. Determination of the effect of metformin on pregnancy outcomes were analyzed using chi-square test. Multivariate regression analysis was used to determine the factors related to spontaneous abortion. Result: A total of 101 women continued metformin during pregnancy while 60 women discontinued metformin. Women who continued metformin had lower rates of first trimester spontaneous abortion compared to those who discontinued metformin (5% versus 36.2%, p<0.001). There was no significant difference in gestational diabetes between those who continued and discontinued metformin during pregnancy (19.0% versus 32.6%, p=0.07). Logistic regression analysis showed that only metformin during pregnancy has a protective effect on abortion (OR=0.168; 95% CI 0.048,0.592; p=0.005). The differences in neonatal outcomes between the two groups did not achieve statistical significance. Conclusion In Filipino women with PCOS, continuous use of metformin during pregnancy reduces the rate of first trimester spontaneous abortion
Polycystic Ovary Syndrome ; Pregnancy Complications ; Metformin

Objective: To present the results from the Philippine cohort of the A1chieve study receiving insulin detemir (IDet) ± oral antidiabetic drugs. Methodology: A1chieve is a multinational, 6-month, observational study of 66,726 people with type 2 diabetes mellitus (T2DM), both insulin users and non-insulin users, started on IDet, insulin aspart or biphasic insulin aspart in 28 countries across four continents. This subgroup analysis evaluates the safety and effectiveness of IDet in 988 subjects from the Philippines. Results: At baseline the mean age, duration of diabetes and mean BMI were found to be 57±11.9 yrs, 6.9±5.3 yrs and 26±4.8 kg/m2 respectively. Majority of subjects were insulin-naive (84.3%) and glycemic control was poor in all the groups at baseline. At the end of 24 weeks, there were significant improvements following IDet initiation with a 2.1% reduction in mean HbA1c. The HbA1c target of <7% was achieved by 46.8% subjects at the study end. Although not statistically significant, there was a modest decrease in body weight in all the groups. There was no increase in the incidence of hypoglycemia among baseline insulin-naive subjects, while a significant reduction in hypoglycemia was seen among prior insulin users. Conclusions IDet appears to be an effective and safe option for individuals with T2DM in the Philippines. HbA1C was lowered to target, and there was no increase in incidence of hypoglycemia and body weight with IDet.
Diabetes Mellitus, Type 2 ; Insulin Detemir ; Philippines