Clinical experience with BIAsp 30: Results from the Philippine cohort of the global a1chieve study

OBJECTIVE: To evaluate the safety, effectiveness and health-related quality of life (HRQoL) parameters of A1chieve study participants in the Philippine cohort, who were treated with BIAsp 30.METHODOLOGY: A1chieve is a non-interventional, six-month, observational study of 66,726 people with type 2 diabetes mellitus (T2DM), including both insulin users and non-insulin users, started on insulin detemir, insulin aspart, or BIAsp 30 in 28 countries across four continents. The present study evaluates the safety, effectiveness and HRQoL in 1,252 subjects from the Philippine cohort of the A1chieve study who were treated with BIAsp 30.RESULTS: At baseline, the mean age, duration of diabetes and mean BMI were found to be 55.5±11.7 years, 7.2 ± 5.6 years and 25.4 ± 5.3 kg/m2, respectively. Seventy-eight percent (78%) of subjects were insulin naïve and 22% were prior insulin users. At baseline, glycemic control was poor (HbA1c = 9.9%) in the entire cohort. Overall there was a 2.7% reduction in mean HbA1c and 44.2% subjects achieved the HbA1c target of CONCLUSION: BIAsp 30 is safe and efficacious for initiating and intensifying insulin therapy for Filipino T2DM patients.

Reference intervals in thyroid function tests in the third trimester in pregnant Filipino women

BACKGROUND: Pregnancy has been associated with differences in thyroid function.1 Maternal thyroid dysfunction has been shown to be associated with fetal and obstetric complications and prompt management is of importance. It has thus been recommended by the British and American Thyroid Association11,12 that trimester-specific thyroid function test reference ranges be used in the assessment of thyroid dysfunction. Normative values across the trimesters of pregnancy have been conducted in several countries13,17,19 and in the Philippines. Reference rangesin the first and second trimesters of pregnancy were conducted by Patal and Hamin et al. which showed values of TSH 0.14-3.84 uIU/mL, FT4 10.44-21.58 pmol/L, FT3 2.4-5.82 pmol/L in the first trimester and TSH 0.10-4.30 uIU/mL, FT4 9.10-19.40 pmol/L, FT3 2.70- 5.190 pmol/L in the second trimester, respectively.OBJECTIVE: To establish third trimester reference intervals for free thyroid hormones (free triiodothyronine [FT3], free thyroxine [FT4]) and thyrotropin [TSH] from thyroid peroxidase antibody [TPOAb]-negative Filipinopregnant women.DESIGN: This is a prospective, cross-sectional study which included consecutive 200 healthy third-trimester pregnant Filipino women attending Philippine General Hospital (PGH) out-patient services. Serum TSH, FT4, FT3, and TPOAb were measured.MAIN OUTCOME MEASURES: Reference intervals are based on 2.5th and 97.5th percentiles for TSH, FT4, and FT3 among TPOAb-negative third-trimester pregnant Filipino patients.ANALYSIS: All numerical data were entered in MS Excel and analyzed using STATA 12. FT3, FT4 and TSH were expressed as mean ±SD, range at 2.5th to 97.5th percentiles.RESULTS: The reference ranges for TSH, FT4 and FT3 in TPOAb-negative third-trimester pregnant population are as follows: TSH= 0.2-3.0 uIU/mL; FT4 = 9.16-18.64 pmol/L and FT3= 2.09-3.7 pmol/L.CONCLUSION: Reference ranges for thyroid function tests for the third trimester of TPOAb-negative pregnant Filipino women were determined in this study and are as follows: TSH= 0.2-3.0uIU/mL; FT4 = 9.16-18.64pmol/L and FT3= 2.09-3.7pmol/L.

Safety and effectiveness of insulin aspart in type 2 diabetic patients: results from the ASEAN cohort of the A1chieve study.

AIM: To examine the clinical safety and effectiveness of insulin aspart (IAsp) therapy in type 2 diabetes (T2D) patients from the ASEAN cohort of the international, 24-week, non-interventional A1chieve study. METHODS: T2D patients from Indonesia, Malaysia, Philippines and Singapore, who started IAsp therapy with or without oral glucose-lowering drugs, were included. The primary endpoint was the incidence of serious adverse drug reactions (SADRs), including major hypoglycaemic events. Secondary endpoints included hypoglycaemia, glycated haemoglobin A1c [HbA1c], fasting plasma glucose [FPG], postprandial plasma glucose [PPPG], systolic blood pressure [SBP], body weight and lipids. Quality of life (QoL) was assessed using the EQ-5D questionnaire. RESULTS: Overall, 312 T2D patients (222 insulin-naive and 90 insulin-experienced) with a mean ± SD age of 56.6 ± 11.2 years, BMI of 24.2 ± 3.9 kg/m(2) and diabetes duration of 7.0 ± 5.7 years were included. The mean daily IAsp dose was 0.51 ± 0.31 U/kg at baseline titrated up to 0.60 ± 0.29 U/kg at Week 24. No SADRs or major hypoglycaemic events were reported in the entire subgroup. The proportion of patients who reported overall hypoglycaemia decreased from baseline to Week 24 (7.1% vs. 0.3%, p < 0.0001). The mean HbA1c improved from 9.5 ± 1.6% at baseline to 7.6 ± 1.3% after 24 weeks (p < 0.001). The mean FPG, post-breakfast PPPG and SBP also improved (p < 0.001). Health-related QoL scores increased in the entire subgroup (mean increase: 9.8 ± 14.6 points, p < 0.001). CONCLUSIONS: Starting IAsp therapy was well-tolerated and was associated with significantly improved overall glycaemic control in the ASEAN cohort.

Switching from biphasic human insulin to biphasic insulin aspart 30 in type 2 diabetes: results from the ASEAN subgroup of the A1chieve study.

AIM: To evaluate the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in ASEAN type 2 diabetes (T2D) patients switched from biphasic human insulin (BHI) in the non-interventional 24-week A1chieve study. METHODS: Indonesian, Malaysian, Filipino and Singaporean patients switched from BHI to BIAsp 30 at their physicians' discretion were included. The incidence of serious adverse drug reactions (SADRs), including major hypoglycaemia was the primary endpoint. Changes in hypoglycaemia, glycated haemoglobin A1c (HbA1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPPG), lipids, body weight and systolic blood pressure were also evaluated. Quality of life (QoL) was measured using the EQ-5D questionnaire. RESULTS: For the 465 patients included (mean ± SD age: 56 ± 10.3 years, diabetes duration: 9.7 ± 7.1 years, baseline HbA1c: 9.4 ± 1.8%), the mean pre-study BHI dose was 0.62 ± 0.28 IU/kg and 63.4% were dosing BHI twice daily (bid). The mean baseline BIAsp 30 dose was 0.65 ± 0.27 U/kg, titrated up to 0.71 ± 0.28 U/kg over 24 weeks, and most patients continued bid dosing. No SADRs or major hypoglycaemic episodes were reported. The proportion of patients reporting overall hypoglycaemia decreased significantly from 10.8% at baseline to 3.4% at Week 24 (p < 0.0001). Significant improvements in glycaemic control were noted (HbA1c: -1.4 ± 1.7%, FPG: -56.7 ± 72.5 mg/dL, post-breakfast PPPG: -84.8 ± 82.8 mg/dL, p < 0.001). Mean QoL improved by +6.6 ± 14.6 points (p < 0.001). CONCLUSION: BIAsp 30 was well-tolerated and significantly increased glycaemic control in this ASEAN subgroup poorly controlled on BHI.

Safety and effectiveness of biphasic insulin aspart 30 in type 2 diabetes: results from the ASEAN cohort of the A1chieve study.

AIM: To determine the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in the ASEAN cohort of the A1chieve study. METHODS: Type 2 diabetes patients from Indonesia, Malaysia, Philippines and Singapore prescribed BIAsp 30 therapy were included. The primary outcome was evaluation of serious adverse drug reactions including major hypoglycaemia over 24 weeks. Secondary outcomes were changes in hypoglycaemic events, serious adverse events (SAEs) and effectiveness parameters. RESULTS: This sub-analysis included 2798 patients (insulin-naive, 1903; insulin-experienced, 895) with mean age ± SD, 55.3 ± 10.8 years, BMI, 24.9 ± 4.6 kg/m(2) and diabetes duration, 7.5 ± 5.9 years. Baseline HbA1c in the entire cohort was poor (9.9%, 85 mmol/mol). A total of 15 SAEs were reported in 7 insulin-experienced patients (1 moderate event was related to BIAsp 30). Overall hypoglycaemia at Week 24 was 0.88 events/patient-year compared to 1.71 events/patient-year reported at baseline (change in proportion of patients affected, p < 0.0001). No major hypoglycaemia was reported at Week 24. BIAsp 30 significantly improved glucose control (HbA1c, fasting plasma glucose and postprandial plasma glucose, p < 0.001) at Week 24. The proportion of patients achieving HbA1c <7.0% at Week 24 was 35.3% compared to 3.5% at baseline. The lipid profile and systolic blood pressure also improved significantly (p < 0.001). Quality of life was positively impacted (mean change in visual analogue scores from EQ-5D = 10.6 ± 13.8 points, p < 0.001). CONCLUSION: BIAsp 30 was well-tolerated and improved glucose control while decreasing the risk of hypoglycaemia.

Safety and effectiveness of biphasic insulin aspart 30 in type 2 diabetes patients switched from biphasic human insulin 30: results from the Filipino cohort of the A1chieve study.

AIM: To evaluate the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in Filipino patients with type 2 diabetes previously treated with biphasic human insulin 30 (BHI 30). METHODS: Safety and effectiveness outcomes were measured in all patients switching from BHI 30 to BIAsp 30 in the Filipino cohort of the 24-week, multinational, prospective, non-interventional A1chieve study. RESULTS: A total of 111 Filipino patients (mean age ± SD, 57.4 ± 12.8 years; BMI, 25.8 ± 5.6 kg/m(2)) with mean diabetes duration of 9.9 ± 7.1 years switched therapy from BHI 30 to BIAsp 30. The mean pre-study BHI 30 dose was 0.65 ± 0.28 IU/kg and the baseline BIAsp 30 dose was 0.65 ± 0.26 U/kg titrated up to 0.70 ± 0.26 U/kg by Week 24. No serious adverse drug reactions were reported. Overall hypoglycaemia was reduced from 5.62 to 1.98 events/patient-year. Minor and nocturnal hypoglycaemia decreased and no major hypoglycaemia was reported at Week 24. Glucose control improved from baseline to Week 24 (HbA1c, -2.2 ± 2.1% [24 ± 23 mmol/mol]; FPG, -72.0 ± 71.8 mg/dL; PPPG, -145.5 ± 125.4 mg/dL). A total of 24 patients achieved HbA1c levels <7.0% at Week 24 compared to 6 patients reporting this target at baseline. Quality of life was positively impacted at Week 24 (change in visual analogue scores, 15.3 ± 16.9 points). CONCLUSION: Switching from BHI 30 to BIAsp 30 improved glycaemic control without increasing the risk of hypoglycaemia.

Cushing's syndrome in pregnancy.

A 22-year-old G(1)P(0) was admitted at 26 weeks gestation for preeclampsia, hyperglycaemia and cushingoid features. Elevated 24-h urine free cortisol (UFC) and suppressed plasma adrenocorticotrophic hormone (ACTH) suggested ACTH-independent Cushing's syndrome. Ultrasound showed left adrenal mass. She delivered preterm at 28 weeks due to severe preeclampsia and fetal distress. The infant expired after 4 days. Blood pressure was controlled after delivery and the patient was discharged on ketoconazole. Adrenalectomy was planned postpartum; however, she withdrew consent and was lost to follow-up. A 33-year-old G(1)P(1) presented with gestational diabetes. Pregnancy was complicated by premature delivery at 31 weeks for fetal distress. The baby improved and survived. Three months postpartum, she was evaluated for osteoporosis after sustaining a fracture from a fall. Cushingoid facies, elevated 24-h UFC, suppressed ACTH and a right adrenal mass on MRI confirmed an ACTH-independent Cushing's syndrome. She underwent adrenalectomy and improved.

Impact of waist circumference measurement variation on the diagnosis of metabolic syndrome

INTRODUCTION: While waist circumference (WC) is widely used as an index for visceral fat accumulation and purportedly the primary pathology responsible for the metabolic syndrome (MS), its proposed cut-off value varies depending on the disparate diagnostic criteria used as well as on the gender, race and ethnic group being evaluated. Due to the strong association between MS and central obesity, waist circumference should be incorporated into the routine physical exam when assessing cardiovascular disease and diabetes risk. Currently however, there is no standard location for the measurement of WC. On literature review, we found no scientific rationale for preferring any one WC site to the others hence, this study.OBJECTIVE: This study aims to (1) determine waist circumference measurement var iat ions among MS patients, (2005 NCEP-ATP III/AHA/NHLB criteria), at three levels: (A) umbilical level, (B) midline level (between the inferior margin of the ribs and the superior border of the iliac crest) and (C) level of the superior border of the iliac crest.RESEARCH DESIGN AND METHODS: Across - sectional analytical study among adult patients, aged 40 to 69 years, diagnosed with MS using 2005 NCEP-ATP III/AHA/ NHLB criteria seen at the Philippine General Hospital, as part of the Asia-Oceania Survey on Metabolic Syndrome and Diabetes initiated by the Japan Diabetes Society.RESULTS: A total of 187 MS individuals were included in the study (56% females). Both males and females were obese stage 1 (25.5 kg/m2 and 26.7 kg/m2 respectively). The mean WC measurements at level A in men was 92.9 cm (81.36 - 104.44 cm) and 93.83 cm (83.4 - 104.26 cm) in women; at level B, the mean WC in men was 90.73 cm (75.49 - 105.97 cm) and 91.51 cm (80.62 - 102.4 cm) in women; and at level C, the mean WC in men was 93.5 cm (81.97 - 105.03 cm) and 95.12 cm (85.11 - 105.13 cm) in women. Results showed that WC measurements at three levels did not significantly differ among MS patients when stratified to age and sex. However, when waist circumference was measured at three levels among all patients with MS, there was significant difference in WC taken at level B and level C (Sig = 0.009). Waist circumference at level A was similar and less variable to WC level B than WC at levelC.CONCLUSIONS: Among patients with MS as defined by NCEPATP III/AHA/NHLB criteria, waist circumference at level B (midpoint level between the lower ribs and superior border of the iliac crest) was smaller than waist circumference at level A (umbilical level) and smaller than level C (superior border of the iliac crest) (WCB

Adiponectin levels and its association with hyperglycaemia in adult Filipino participants in the 2003--04 National Nutrition and Health Survey.

Our objective was to determine the association of serum adiponectin levels with the presence of IFG or DM in Filipinos. This case control study used sera of adult participants in the Philippines' NNHeS: 2003-04. Subjects were divided into: normoglycaemic control, impaired fasting glucose, and type 2 diabetes mellitus. Seventy-seven prediabetic and 83 diabetic subjects were included in the prediabetic and diabetic groups, respectively. There was no significant difference in adiponectin values between control and prediabetic subjects. Diabetic subjects had significantly lower mean serum adiponectin levels (10.7 versus 14.2 microg/ml, p=0.0198) compared with age- and BMI-matched control subjects. Diabetic subjects were found most frequently (43.53%) in the lowest tertile (1.6-7.2 microg/ml) and least frequently (20%) in the highest tertile (14-84 microg/ml) of adiponectin values. We conclude that Filipinos with diabetes mellitus had significantly lower adiponectin levels compared with normoglycaemic subjects.

Well-differentiated epithelial thyroid cancer management in the Asia Pacific region: a report and clinical practice guideline.

CONTEXT: Thyroid cancer is among the 10 most common malignancies in populations in the Asia Pacific region, where access to various relevant health care resources varies widely. OBJECTIVE: An expert consensus conference was held to define regional patterns of practice and guidelines for optimal management of well-differentiated epithelial thyroid carcinomas. RESULTS: Practice patterns vary from country to country, as would be anticipated form their variety of ethnic and racial populations, health care systems, economies, and cultures. Thyroid cancer care is provided by a number of medical and surgical specialists, usually including endocrinologists. The thyroid surgical skills, experience, and outcomes vary widely in the region. Radioiodine is available, to a greater or lesser extent, is almost all countries. Laboratory services for thyroid function monitoring are universally accessible; thyroglobulin assays are available in most countries. Recombinant thyrotropin is approved for use in only two countries, but can be accessed in some others on a "named patient" compassionate need basis. Access to advanced imaging, for exampke, positron emission tomography (PET) scanning, is limited to a few countries. CONCLUSIONS: In light of these realities, appropriate strategies for initial treatment and postoperative monitoring of patients with thyroid cancer have been defined, and these are presented and discussed.

Hyperglycemia and type 2 diabetes among Filipino women in the Philippines, Hawaii, and San Diego.

BACKGROUND: Diabetes risk increases as immigrant populations adopt western lifestyles. We compared the prevalence of fasting hyperglycemia among Filipino women aged 40-79 years in the Philippines, Hawaii, and San Diego. METHODS: Data were obtained from the (1) Philippine National Nutrition Survey (1998), (2) Native Hawaiian Health Research Project (1997-2001), and (3) University of California San Diego Filipino Women's Health Study (1995-1999). Fasting glucose after an 8h fast, blood pressure, and body mass index (BMI) were measured in all three regions; a 75 g oral glucose tolerance test was performed in San Diego and Hawaii. RESULTS: The proportion of Filipinas with BMI > or = 30 kg/m2 was higher in Hawaii (20%) compared to women in San Diego (9.3%) or the Philippines (5.2%, p<0.001). Fasting hyperglycemia prevalence (fasting plasma glucose > or = 126 mg/dl or fasting whole blood glucose > or = 110 mg/dl) did not differ among Filipinas in the Philippines (11.8%), San Diego (14.1%), and Hawaii (14.7%, p = 0.323). Type 2 diabetes prevalence was similar among Filipinas in San Diego (31.6%) and Hawaii (24.9%, p = 0.79). CONCLUSIONS: Despite regional differences in obesity, fasting hyperglycemia was similar among Filipinas in the Philippines, San Diego, and Hawaii and type 2 diabetes prevalence was similar among Filipinas in San Diego and Hawaii.