Lipid Levels and Glycaemic Control in Malaysian Diabetes Patients

VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 8 0 7 – A 9 1 8

GA, USA, 3John Theurer Cancer Center, Hackensack, NJ, USA, 4Memorial Sloan-Kettering Cancer Center, New York, NY, USA, 5Centre Hospitalier Lyon-Sud, Pierre-Bénite, France, 6UCLA Medical Centre, Los Angeles, CA, USA, 7ICON Clinical Research, San Francisco, CA, USA, 8Bristol-Myers Squibb, Paris, France, 9Universität Heidelberg, Mannheim, Germany, 10Uppsala Universitet, Uppsala, Sweden

Objectives: Understand time to and reasons for discontinuation or switching of imatinib in pts with CP-CML (≥ 12 months follow-up) in routine clinical practice.  Methods: SIMPLICITY (NCT01244750) is an ongoing study of pts receiving first-line imatinib prior to 2010 (retrospective) or first-line imatinib, dasatinib or nilotinib since 2010 (prospective) in the US and Europe.  Results: 252 retrospective (median follow-up: 60 months) and 405 prospective (median follow-up: 37 months) imatinib pts were included. In the retrospective and prospective cohorts, 17.9% and 17.0% of pts had a treatment interruption, and 14.3% and 29.9% discontinued imatinib (regional differences were noted and will be presented). Median time to first discontinuation was 5.3 months (retrospective) and 4.4 months (prospective). The most common reason for discontinuation was intolerance (64.7% retrospective and 61.7% prospective). Types of intolerance (MedDRA) differed: retrospective – blood/ lymphatic system (36.4%) and GI disorders (27.3%); prospective – skin/subcutaneous tissue (28.2%) and GI disorders (26.8%). Discontinuations due to primary resistance were lower in the retrospective cohort (8.8% vs. 15.7%). Fewer pts in the retrospective cohort switched to second-line TKI; 9.1% (47.8% dasatinib, 52.2% nilotinib) compared with 25.2% (62.7% dasatinib, 36.3% nilotinib) in the prospective cohort. Median time to switch was 7.7 months (retrospective) and 4.5 months (prospective). 69.6% (retrospective) and 61.6% (prospective) of pts switched owing to intolerance. Similar intolerances led to discontinuation or switching, although in retrospective pts, GI disorders caused more pts to switch (37.5% vs 27.9%).  Conclusions: The proportion of pts with treatment interruptions was similar between cohorts; however, twice as many pts discontinued imatinib, and more switched to second-line TKI, in the prospective vs. retrospective cohort, perhaps due to treatment landscape changes. Intolerance was the primary reason for discontinuation, including switching. These findings suggest intolerance remains an issue and highlights the need for effective management of adverse events as well as second-generation treatment options.

DIABETES/ENDOCRINE DISORDERS – Clinical Outcomes Studies PDB1 Is There an Association Between Diabetic Microvascular Complications and Serum Cholesterol? a Retrospective Analysis among Malaysian Patients with T2DM Abdul Aziz SH1, Azmi S1, Feisul MI2, Abdat A1, Goh A1 Burhani Consulting, Petaling Jaya, Malaysia, 2Ministry of Health, Malaysia, Putrajaya, Malaysia

1Azmi

Objectives: There is evidence that dyslipidemia in diabetes is related to microvascular disease complications. We explored the association between plasma triglycerides (TG) and high density lipoprotein (HDL) cholesterol with microvascular disease in Malaysian diabetics. Methods: We utilised data from the National Diabetes Registry of patients being followed up in Malaysian public sector primary care clinics in year 2012. Outcomes of interest were the presence of microvascular complications, namely retinopathy or nephropathy. Logistic regression was performed to explore the odds of microvascular complications with higher triglycerides (TG) and HDL levels, controlling for other risk factors available in NDR data namely HbA1c, duration of diabetes, hypertension and the use of statins.  Results: A total of 110,220 patients with diabetes were included in the study. The mean age of patients was 62.36 years and 16,795 (15.2%) patients had either nephropathy or retinopathy. In patients with either nephropathy or retinopathy, the mean plasma TG and HDL-cholesterol were 1.90 mmol/L and 1.27 mmol/L, respectively. Higher TG (> 1.7 mmol/L) and lower HDL (≤  1.1mmol/L) levels were found to be significantly associated with the presence of nephropathy (adj. OR 1.21; p< 0.001 and adj. OR 1.29; p< 0.001, respectively) but not the presence of retinopathy (adj. OR 1.01; p< 0.652 and adj. OR 1.00; p< 0.896, respectively).  Conclusions: As has been shown in other studies, our analysis indicates that nephropathy was associated with higher plasma TG and lower HDL levels in this patient population. However, no association was found with retinopathy. PDB2 Protective Effect of Metformin Against Tuberculosis in Diabetic Patients P S, Marupuru S, Senapati P, Sekhar M S MCOPS, Manipal University, Manipal, India

Objectives: AMPK-activating antidiabetic drug metformin inhibits the intracellular growth of Mycobacterium tuberculosis (Mtb), restricts disease immunopathology, and enhances Mtb-specific host immunity, reduces inflammation and promotes disease resolution. This study was based on the hypothesis that AMPK-activating metformin boost the host immunity and thereby protect against TB infections in diabetics. Objective of the study was to determine the protective effect of metformin against TB in diabetics.  Methods: A case-control study was conducted using hospital databases of patients admitted with newly diagnosed diabetics (without any previous history of TB infection) in Medicine department of a tertiary care hospital in South India during 1st January 2011 to 31st December 2015. The newly diabetics diagnosed with TB were selected as Study Group (SG= 152) and without TB were as Control Group (CG= 299). Exposure statuses of metformin in both groups were analyzed.  Results: Mean age (±SD) of study population was found to be 54.67 ± 11.85 years. Male diabetics have significantly higher risk for developing TB compared to female patients (83.8% vs 16.7%, respectively; p<  0.01). The diabetics with uncontrolled hyperglycemia (HbA1c > 8%) have a twice higher risk for developing TB ( OR=  2.05; 95% CI 1.10 to 3.83). The risk of developing TB for diabetics who were on

A895

metformin was lesser compared to non-metformin users (OR=  0.25 ; 95% CI 0.16 to 0.40). Since, OR < 1, the exposure is a protective factor for TB. Thus, the usage of metformin can decrease the risk of TB 3.9-fold times in diabetic patients.  Conclusions: The chance of developing tuberculosis was higher in diabetics with poor glycemic control. The use of metformin was found to have clinically significant protective effect against tuberculosis in type 2 diabetic patients. PDB3 Indirect Comparison of Triamcinolone Acetonide with Ranibizumab and Aflibercept for the Treatment of Diabetic Macular Edema Park S, CHOI YR, Jeung S, Choi I, Suh D Chung-Ang University, Seoul, South Korea

Objectives: To conduct indirect comparison of the effectiveness on improving best corrected visual acuity (BCVA) in diabetic macular edema (DME) patient treated with intravitreal triamcinolone acetonide (triamcinolone) 4mg with ranibizumab 3mg and aflibercept 2mg each.  Methods: An indirect comparison of triamcinolone was conducted with ranibizumab and aflibercept based on the respective phase II/III clinical trials to compare changes from baseline BCVA outcomes in patients taking one-time triamcinolone 4mg injection with those taking monthly ranibizumab 3mg injection and monthly aflibercept 2mg injection through 3 months of follow-up respectively. 10 studies were identified based on the inclusion and exclusion criteria of our study. To compare triamcinolone with ranibizumab, 4 studies on triamcinolone vs. placebo including 71 patients and 3 studies on ranibizumab vs. placebo including 308 patients were used. Subsequently, a study on triamcinolone vs. laser photocoagulation including 584 patients and 2 studies on aflibercept vs. laser photocoagulation including 572 patients were used to compare triamcinolone with aflibercept indirectly.  Results: The results of the indirect comparison showed significant difference between triamcinolone 4mg and ranibizumab 3mg in treatment of DME. Improvement of BCVA by 3 months were higher with triamcinolone 4mg vs. ranibizumab 3mg by 1.90 ETDRS letters [95% Confidence interval (CI): -2.91 to -0.90, p< 0.05]. Indirect comparison resulted that aflibercept 2mg showed improvement of BCVA by 2.22 ETDRS letters compared to triamcinolone 4mg by 3 months [95% Confidence interval (CI): -1.20 to 5.64, p= 0.10].  Conclusions: This indirect comparison concluded that triamcinolone 4mg significantly improved BCVA compared to ranibizumab 3mg in patients with DME during 3 month treatment. Triamcinolone 4mg is associated with less effective in improving BCVA compared to Aflibercept 2mg, but it is statistically insignificant. PDB4 Lipid Levels and Glycaemic Control in Malaysian Diabetes Patients Abdat A1, Azmi S1, Feisul MI2, Goh A1, Abdul Aziz SH1 Burhani Consulting, Petaling Jaya, Malaysia, 2Ministry of Health, Malaysia, Putrajaya, Malaysia

1Azmi

Objectives: Several studies have shown an association between HbA1c and lipid control and that levels of HbA1c may predict dyslipidaemia. We explored the association of glycaemic control with lipid levels in Malaysian patients with diabetes mellitus and dyslipidaemia  Methods: We utilised retrospective data from the National Diabetes Registry to identify diabetic patients with dyslipidaemia followed up in Ministry of Health primary care clinics in 2012. Logistic regression analysis was performed to explore the association between uncontrolled lipid measures (total cholesterol (TC): ≥ 5.2 mmol/L, triglycerides (TG): > 1.7 mmol/L, and LDL: > 2.6 mmol/L separately) with HbA1c. The analysis controlled for other confounding factors captured in the NDR, namely age, sex, BMI and use of dyslipidaemia medication.  Results: A total of 71,814 diabetes patients with dyslipidaemia were included in the study. The mean age of patients was 60.4 (SD: 10.6) years and 61.8% were females. The mean HbA1c was 7.9% (SD: 2.0) in patients with uncontrolled TC and 8.6% (SD: 2.3) in patients with controlled TC. Higher HbA1c levels (> 6.5%) were found to be significantly associated with uncontrolled TC (adj. OR 1.56; p-value< 0.001), TG (adj. OR 1.68; p-value< 0.001) and LDL (adj. OR 1.49; p-value< 0.001).  Conclusions: Analysis showed that patients with higher HbA1c levels were more likely to have uncontrolled lipid levels. Patients with poorly controlled HbA1c should also be monitored closely for dyslipidaemia and managed appropriately. PDB5 Do More Men or Women with T2DM Achieve their Glycaemic Targets? An Exploratory Malaysian Study Azmi S1, Feisul MI2, Abdat A1, Goh A1, Abdul Aziz SH1 Burhani Consulting, Petaling Jaya, Malaysia, 2Ministry of Health, Malaysia, Putrajaya, Malaysia

1Azmi

Objectives: Gender has been shown to have an effect on health outcomes. In this study, we examined the impact of gender on diabetes glycaemic target achievement with relevance to the Malaysian population.  Methods: We took a two-pronged approach to the study. We performed an exploratory retrospective data analysis of diabetes patients in the Malaysian National Diabetes Registry (NDR) in 2012 and reviewed published literature to identify local or regional studies.  Results: Our retrospective analysis included 130,246 diabetes patients with a mean age of 59.78 years, mean diabetes duration of 7.03 years of whom 60.25% were females. We found that the glycaemic results were lower in men compared to women for mean HbA1c (8.04% vs 8.16%) and mean fasting blood glucose (7.97 mmol/L vs 8.15 mmol/L). Significantly more men achieved HbA1c target compared to women (29.97% vs 28.76%, P< 0.001). Our literature review found 12 articles that investigated genderrelated differences in glycaemic target achievement which comprised of 1 metaanalysis of trial data, 5 cohort studies and 6 cross-sectional studies. Nine studies indicated that men were more likely to achieve better glycaemic control, while 2 were equivocal and one found women had better results. To date, there have been no studies performed in Malaysia and closest studies in the region were from Nanjing and Hong Kong. The Hong Kong study indicated men achieved better glycaemic control with an opposite finding in the Nanjing study.  Conclusions: Our results, from both the data analysis as well as literature review, indicate that women tend