To assess the extent to which people with diabetes in low- and middle-income countries (LMIC) of Asia and the Middle East met evidence-based care recommendations through a systematic review of published literature.
Aim: This study aimed to assess the cost-effectiveness of starting insulin therapy with biphasic insulin aspart 30 (BIAsp 30) in people with type 2 diabetes inadequately controlled on oral glucose-lowering drugs in Saudi Arabia, India, Indonesia, and Algeria.
Methods: The IMS CORE Diabetes Model was used to evaluate economic outcomes associated with starting BIAsp 30, using baseline characteristics and treatment outcomes from the A(1)chieve study. Time horizons of 1 and 30 years were applied, with country-specific costs for complications, therapies, and background mortality. Incremental cost-effectiveness ratios (ICERs) are expressed as cost per quality-adjusted life-year (QALY) in local currencies, USD, and fractions of local GDP per capita (GDPc). Cost-effectiveness was pre-defined using the World Health Organization definition of <3.0 times GDPc. Comprehensive sensitivity analyses were performed.
Results: In the primary 30-year analyses, starting BIAsp 30 was associated with a projected increase in life expectancy of >1 year and was highly cost-effective, with ICERs of -0.03 (Saudi Arabia), 0.25 (India), 0.48 (India), 0.47 (Indonesia), and 0.46 (Algeria) GDPc/QALY. The relative risk of developing selected complications was reduced in all countries. Sensitivity analyses including cost of self-monitoring, treatment costs, and deterioration of glucose control with time showed the results to be robust. In a 1-year analysis, ICER per QALY gained was still cost-effective or highly cost-effective.
Conclusion: Starting BIAsp 30 in people with type 2 diabetes in the A(1)chieve study was found to be cost-effective across all country settings at 1- and 30-year time horizons, and usefully increased predicted life expectancy.
This review aimed to explore the extent of the use of diabetes risk assessment tools and to determine influential variables associated with the implementation of these tools. CINAHL, Google Scholar, ISI Citation Indexes, PubMed, and Scopus were searched from inception to January 2013. Studies that reported the use of diabetes risk assessment tools to identify individuals at risk of diabetes were included. Of the 1719 articles identified, 24 were included. Follow-up of high risk individuals for diagnosis of diabetes was conducted in 5 studies. Barriers to the uptake of diabetes risk assessment tools by healthcare practitioners included (1) attitudes toward the tools; (2) impracticality of using the tools and (3) lack of reimbursement and regulatory support. Individuals were reluctant to undertake self-assessment of diabetes risk due to (1) lack of perceived severity of type 2 diabetes; (2) impracticality of the tools; and (3) concerns related to finding out the results. The current use of non-invasive diabetes risk assessment scores as screening tools appears to be limited. Practical follow up systems as well as strategies to address other barriers to the implementation of diabetes risk assessment tools are essential and need to be developed.
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.
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.
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.
AIM:
To determine the safety and effectiveness of insulin detemir (IDet) in type 2 diabetes patients from the ASEAN cohort of the A1chieve study.
METHODS:
Patients from Indonesia, Malaysia, Philippines and Singapore prescribed IDet at the discretion of their physicians were included. The primary outcome was the incidence of serious adverse drug reactions including major hypoglycaemia over 24 weeks. Secondary endpoints included changes in the frequency of hypoglycaemia, serious adverse events and effectiveness assessments.
RESULTS:
This sub-analysis included 1540 patients (insulin-naive, 1239; insulin-experienced, 301) with mean age ± SD 56.4 ± 10.9 years, BMI 25.4 ± 4.6 kg/m(2) and diabetes duration 6.9 ± 5.3 years. Insulin-naive patients received a baseline IDet dose of 0.24 ± 0.11 U/kg titrated up to 0.37 ± 0.21 U/kg by Week 24. The pre-study insulin dose in insulin-experienced patients was 0.41 ± 0.25 U/kg and baseline IDet dose was 0.31 ± 0.24 U/kg titrated up to 0.40 ± 0.20 U/kg by Week 24. Overall hypoglycaemia decreased from 1.73 to 0.46 events/patient-year from baseline to Week 24 (change in proportion of patients affected, p < 0.0001). At Week 24, 1 major hypoglycaemic event was reported in 1 insulin-experienced patient. IDet significantly improved glucose control (p < 0.001) at Week 24. The lipid profile and systolic blood pressure improved (p < 0.001) and body weight did not change significantly. Quality of life was positively impacted (p < 0.001).
CONCLUSION:
IDet was well-tolerated and improved glycaemic control without increasing the risk of hypoglycaemia or weight gain.
Numerous studies with compelling evidence had shown a clear relationship between dyslipidaemia and cardiovascular (CV) events in patients with diabetes mellitus. This was an observational study based on secondary data from the online registry database Adult Diabetes Control and Management (ADCM) looking into the determinants of uncontrolled dyslipidaemia in type 2 diabetes mellitus patients. Independent predictors were identified using multivariate logistic regression. A total of 303 centres (289 health clinics, 14 hospitals) contributed a total of 70,889 patients (1972 or 2.8% patients were from hospital). About thirty eight percent were reported to have dyslipidaemia. There were 40.7% patients on lipid-lowering agents and of those above age 40 years old, only 38.1% of them were on a statin. Malay ethnicity and younger age groups (<50 years old) were two major determinants of uncontrolled LDL-C, TG and HDL-C. Female gender and uncontrolled blood pressure were determinants of uncontrolled LDL-C, and poor glycaemic control was related independently to high TG. This study has highlighted the suboptimal management of diabetic dyslipidaemia in Malaysia. Pharmacological treatment of dyslipidaemia could be more effective. Healthcare stakeholders in this country, especially in the primary care, have to recognize these shortfalls and take immediate remedial measures.
AIMS: We examined the relationship of hypoglycemic symptoms with health-related quality of life and worry about hypoglycemia among type 2 diabetic patients using oral antihyperglycemic agents (AHA) in the Asia-Pacific region.
METHODS: A total of 2257 type 2 diabetic patients with at least 6 months of oral AHA were enrolled in China, Korea, Malaysia, Thailand, and Taiwan. Quality of life was measured with the EuroQol Visual Analog Scale (EQ-VAS) and EuroQol-5 Dimensions questionnaire (EQ-5D), and worry about hypoglycemia with the worry subscale of the Hypoglycemic Fear Survey-II (HFS).
RESULTS: The mean (SD) age was 58.7 (10.2) years and HbA(1c) was 7.5% (1.5). The proportion of patients with an HbA(1c) <6.5% and <7% was 24.9% and 41.8%, respectively. Hypoglycemic symptoms in the prior 6 months were reported by 35.8% of patients. Mean scores on the EQ-VAS and the EQ-5D were significantly lower for patients who had hypoglycemic symptoms compared to those who did not (73.6 vs. 76.9, p<0.001; 0.88 vs. 0.90, p<0.0001, respectively), whereas mean score on the HFS was significantly higher (12.5 vs. 6.3, p<0.001). In multivariate models, hypoglycemic symptoms were independently associated with scores on the EQ-5D, EQ-VAS, and HFS (all p ≤ 0.01-0.001). Symptom severity was positively associated with fear of hypoglycemia (all p ≤ 0.001).
CONCLUSION: Hypoglycemic symptoms were associated with reduced quality of life and increased patient worry in patients with type 2 diabetes treated with AHA.
Conflicting results have been reported in different populations on the association between two particular RAGE gene polymorphisms (-429T/C and -374T/A) and retinopathy in diabetic patients. Therefore this study was designed to assess the association between both gene polymorphisms with retinopathy in Malaysian diabetic patients. A total of 342 type 2 diabetic patients [171 without retinopathy (DNR) and 171 with retinopathy (DR)] and 235 healthy controls were included in this study. Genomic DNA was obtained from blood samples and the screening for the gene polymorphisms was done using polymerase chain reaction-restriction fragment length polymorphism approach. Overall, the genotype distribution for both polymorphisms was not statistically different (p>0.05) among the control, DNR and DR groups. The -429C minor allele frequency of DR group (12.0%) was not significantly different (p>0.05) when compared to DNR group (16.1%) and healthy controls (11.3%). The -374A allele frequency also did not differ significantly between the control and DNR (p>0.05), control and DR (p>0.05) as well as DNR and DR groups (p>0.05). This is the first study report on RAGE gene polymorphism in Malaysian DR patients. In conclusion, -429T/C and -374T/A polymorphisms in the promoter region of RAGE gene were not associated with Malaysian type 2 DR patients.
We conducted a six-month randomized-controlled-trial to evaluate the effectiveness of a colour-coded HbA1c-graphical record in improving HbA1c level among type 2 diabetes patients. There was an improvement in the mean HbA1c knowledge score but the usage of the colour-coded HbA1c-graphical record did not produce reduction in the HbA1c level.
Study site: Primary care clinic, University Malaya Medical Centre, Kuala Lumpur, Malaysia
Symptoms of hypoglycemia were reported by 35.8% of patients with type 2 diabetes treated with oral antihyperglycemic agents in the Asia-Pacific region. Symptoms were severe in 11.6% and very severe in 8.2% of patients experiencing hypoglycemia.
The objective of this study was to elucidate influencing factors of HbA1C in various health care settings. The glycaemic control was suboptimal in all settings. Multivariate analysis confirmed three factors were significant in HbA1C outcome; insulin (p=0.000), medication (p=0.043) and ethnicity (p=0.000).
AIMS:
To translate and examine the psychometric properties of the Malaysian version of the Morisky Medication Adherence Scale (MMAS) among patients with type 2 diabetes.
METHODS:
A standard "forward-backward" procedure was used to translate MMAS into Malay language. It was later validated on a convenience sample of 223 type 2 diabetes outpatients between May and September 2009. Reliability was tested for internal consistency. Validity was confirmed using convergent and known group validity.
RESULTS:
Employing the recommended scoring method, the mean±SD of MMAS scores was 6.13±1.72. Moderate internal consistency was found (Cronbach's α=0.675), the test-retest reliability value was 0.816 (p<0.001). A positive correlation between the eight- and four-item MMAS was found (r=0.792; p<0.01). A significant relationship between MMAS categories and HbA1c categories (χ(2)=20.261; p≥0.001) was found. The MMAS sensitivity and specificity, with positive and negative predictive values were 77.61%, 45.37%, 46.84% and 76.56%, respectively.
CONCLUSIONS:
The findings of this validation study indicate that the Malaysian version of the MMAS is a reliable and valid measure of medication adherence which can now be used.
Two previously healthy Malaysian women presented abruptly with severe diabetic ketoacidosis during pregnancy and immediate postpartum period. Their clinical courses, biochemical and immunological profiles were consistent with fulminant type 1 diabetes first described in the Japanese. Fulminant type 1 diabetes may not be as rare as currently reported outside Japan.
AIMS: This study was aimed to determine the prevalence of oral mucosal lesions (OML) in patients with diabetes mellitus (DM) and non-diabetic subjects without any oral habits and to investigate the association of DM with oral precancerous lesions.
METHODS: This cross-sectional study involved 420 diabetic and 420 non-diabetic control subjects without any oral habits. Detailed oral examination was performed based on international criteria.
RESULTS: A significantly greater proportion of subjects with DM (45%) had one or more OML in comparison to non-diabetics (38.3%). Patients with DM showed a significantly greater prevalence of geographic tongue, denture stomatitis and angular cheilitis than non-diabetics (p<0.05). The results also showed an association between occurrence of one or more OML and metabolic control of diabetic patients (p<0.05). For precancerous lesions, lichen planus was found in two diabetic patients while none of controls had any precancerous lesion (p>0.05).
CONCLUSIONS: Prevalence of OML was significantly higher in diabetic patients than non-diabetics and this prevalence was associated with the metabolic control of the patients. However, no association was observed between DM and oral precancerous lesions.
OBJECTIVE: The aim of this study is to investigate if an association exists between single nucleotide polymorphism (SNP) in the tumor necrosis factor-alpha (TNF-alpha) and TNF-beta genes.
METHODS: The DNA was extracted and SNP in the human TNF-alpha and TNF-beta genes at positions -308 (G/A) and 252 (A/G), respectively, was analyzed using the polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) method. Plasma levels of TNF-alpha in different stages of pregnancy were quantified using enzyme linked immunosorbent assay (ELISA).
RESULTS: There was no significant difference in genotype and allele frequency of SNP at position -308 (G/A) in the promoter region of the human TNF-alpha gene as well as the SNP at position 252 (A/G) in the human TNF-beta gene between the GDM and control subjects. Using the logistic regression model, it was found that the SNP in the TNF-alpha as well as TNF-beta were not associated with development of GDM. In addition, the TNF-alpha levels in the plasma of GDM and control mothers were not significantly different.
CONCLUSIONS: In the population studied, the SNP in position -308 (G/A) of the human TNF-alpha or in position 252 (A/G) of the human TNF-beta gene is not an independent risk factor or a predictor for GDM.
Type II diabetes patients have increased risk of macrovascular complications compared with the general population. Arterial stiffness is considered as an independent predictor of macrovascular events. This study investigated arterial stiffness in newly diagnosed never treated diabetes and impaired glucose tolerance (IGT) patients without any traditional cardiovascular diseases (CVD) risk factors. After preliminary screening of 1620 individuals, 30 diabetic and 30 IGT patients were recruited and compared with age- and sex-matched 30 normoglycaemic subjects. The subjects were newly diagnosed, never treated, normotensive, non-obese, non-hyperlipidaemic and non-smoker. Haemodynamic variables, pulse wave velocity (PWV) and augmentation index (AI) were measured. The PWV was significantly higher in diabetic patients (10.37+/-2.64m/s vs. 8.70+/-1.29m/s; p=0.035) and was of borderline significant in IGT subjects (9.54+/-1.56m/s vs.8.70+/-1.29m/s, p=0.078) compared to normoglycaemic individuals. Augmentation index was higher of borderline significant in diabetic (134.53+/-17.32% vs. 129.17+/-11.18%, p=0.055) and IGT patients (132.02+/-16.11% vs. 129.17+/-11.18%, p=0.059) compared to normoglycaemic individuals. The study demonstrated that newly diagnosed never treated diabetic patients without any CV complications had early manifestation of macrovascular diseases as evident by increased arterial stiffness. The findings also revealed early manifestations of preclinical vasculopathy and potentially increased risk for development of macrovascular diseases at an early age in diabetic patients.
In this paper, the islet autoimmunity status and relation to clinical characteristics, beta cell function and cardio-metabolic risk factors in young-onset Asian diabetic patients are evaluated at baseline. The study population consisted of 912 patients (from China, India, Malaysia and Singapore) with age 12-40 years and diabetes duration <12 months. Autoantibodies to glutamic acid decarboxylase (GADA) and tyrosine phosphatase (IA-2A), beta cell function and cardio-metabolic risk parameters were assessed. Among our young patient cohort, 105 (11.5%) patients were GADA and/or IA-2A positives (Ab +ve). Ab +ve patients were younger, leaner, had more severe hyperglycaemia and lower beta cell function. The frequency of metabolic syndrome was significantly lower in Ab +ve patients (27%) compared to Ab -ve patients (54%). However, a substantial proportion of patients in both groups of patients had atherogenic dyslipidaemia, hypertension and albuminuria (micro or macro). In our study cohort, only one in 10 Asian youth with new-onset diabetes had evidence of islet autoimmunity. At least 60% of Ab +ve and 50% of Ab -ve patients demonstrated classical features of type 1 and type 2 diabetes respectively. Regardless of autoimmunity status, the cardio-metabolic risk factors, in particular atherogenic dyslipidaemia, hypertension and albuminuria were common in our patients with young-onset diabetes.