Association of glycemic control with progression of diabetic retinopathy in type 2 diabetes mellitus patients in Malaysia

Huri, Hasniza Zaman; Huey, Chua Chew; Mustafa, Norasyikin; Mohamad, Nor Fadhilah; Kamalden, Tengku Ain

doi:10.1590/s2175-97902018000217484

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Brazilian Journal of Pharmaceutical Sciences

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Article • Braz. J. Pharm. Sci. 54 (02) • 2018 • https://doi.org/10.1590/s2175-97902018000217484 copy

Association of glycemic control with progression of diabetic retinopathy in type 2 diabetes mellitus patients in Malaysia

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Abstract

The risk of having microvascular complication is high among Type 2 Diabetes Mellitus (T2DM) patients. However, factors associated with the glycemic control and progression of diabetic retinopathy (DR) in T2DM patients is limited. This study aims to determine association between anti-diabetic agents, glycemic control and progression of diabetic retinopathy in a Malaysian population. A retrospective study conducted in a tertiary teaching hospital in Malaysia, from January 2009 until March 2014. This study enrolled 104 patients aged 40-84 years, with a mean age 63.12 ± 9.18 years. patients had non-proliferative diabetic retinopathy (NPDR, 77%) and 35% had proliferative diabetic retinopathy (PDR). Diabetic macula edema (DME) was present in 20% of NPDR patients, compared with 7% in PDR. Alpha-glucosidase inhibitor (p=0.012), age (p=0.014) and number of antidiabetic agents used (p=0.015) were significantly associated with stages of diabetic retinopathy. Family history of T2DM (p=0.039) was associated with DME. Identifying factors influencing the progression of diabetic retinopathy may aid in optimizing the therapeutic effects of anti-diabetic agents in T2DM patients.

Keywords:
Type 2 Diabetes Mellitus; Anti-diabetic agents; Microvascular complication; Diabetic macula edema; Diabetic retinopathy; Malaysia

^α Stages of DR	Mean of FBG	Standard deviation	p-value
Mild NPDR yes no	7.333 7.592	3.7211 4.3625	0.776
Moderate NPDR yes no	8.553 7.097	4.5521 3.9623	0.107
Severe NPDR yes no	8.700 7.236	4.1294 4.1561	0.159
PDR yes no	6.400 8.109	3.7535 4.2937	*0.046
DME yes no	7.778 7.379	4.1978 4.1820	0.645

Universidade de São Paulo, Faculdade de Ciências Farmacêuticas Av. Prof. Lineu Prestes, n. 580, 05508-000 S. Paulo/SP Brasil, Tel.: (55 11) 3091-3824 - São Paulo - SP - Brazil
E-mail: bjps@usp.br

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[1] *Correspondence: H. Z. Huri. Department of Pharmacy, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia. Tel: +603 79676659. Fax: +603 7967 4964. E-mail: hasnizazh@um.edu.my

Terms	Definition
Targeted Glycemic Control	Patients with advanced micovascular complications and extensive comorbid conditions who achieved targeted goal of glycated haemoglobin, HbA1C < 8%.
Comorbidities	Chronic co-existing medical conditions as listed in (Chronic Disease List) and common medical conditions that may present along with the T2DM patients with DR
Diabetic retinopathy, DR	Microvascular complication of diabetes mellitus, which is a progressive disease that will cause blindness and visual disability due to vessel damage at the retina. In this study, the diagnosis of DR was obtained from patient medical record.
Non-proliferative diabetic retinopathy, NPDR	A less severe stage in DR that shown in fundoscopy of the presence of microaneurysms with or without intraretinal haemorrhages or definite venous beading or intraretinal microvascular abnormalities (Australian Diabetes Society, 2008)
Proliferative diabetic retinopathy, PDR	A severe stage in DR that shown in fundoscopy the presence of neovascularization with or without vitreous and/or preretinal haemorrhage (Australian Diabetes Society, 2008)
Diabetic Macula Edema, DME	Presence of retinal thickening or hard exudates in posterior pole, near to center or distant from macula (Australian Diabetes Society, 2008)

Demographic Characteristics	Number of patient (Percentage %)
Gender Male	52(50.0)
Age (years) 18-64 >64	56(53.8) 48(46.2)
Ethnicity Malay Chinese Indian Others	52(50.0) 27(26.0) 24(23.1) 1(1.0)
Duration of T2DM (years) <1 1-5 6-10 11-15 16-20 >20 Unknown	0(0.0) 4(3.8) 12(11.5) 24(23.1) 23(22.1) 33(31.7) 8(7.7)
Family History of T2DM Yes No Unknown	21(20.2) 28(26.9) 55(52.9)
BMI* Underweight(<18.5) Normal (18.5-24.9) Overweight (25-29.9) Obese (≥30) Unknown	1(1.0) 8(7.7) 8(7.7) 2(1.9) 85(81.7)

Clinical Characteristics	N	Number of patient (Percentage,%)
Number of Antidiabetic Agents used One Two More than two	104	48(46.2) 39(37.5) 17(16.3)
A1C Achieve targeted A1C (<8%) Not achieve target A1C (≥8%)	104	55 (52.9) 49 (47.1)
^αStages of DR and DME Mild NPDR Moderate NPDR Severe NPDR PDR DME	152	30(28.8) 30(28.8) 20(19.2) 36(34.6) 36(34.6)
^βClass of antidiabetic agents used Biguanide Sulphonylurea DPP4 inhibitor Alpha-glucosidase TZD Insulin	177	49(47.1) 41(39.4) 4(3.8) 11(10.6) 1(1.0) 71(68.3)
^βComorbidities Hypertension IHD Stroke Dyslipidemia CKD Asthma Gout Thyrotoxicosis BPH Atrial Fibrillation Sleep disorder Obesity Others	276	100(96.2) 24(23.1) 19(18.3) 52(50) 60(57.5) 4(3.8) 2(1.9) 2(1.9) 2(1.9) 2(1.9) 1(1.0) 1(1.0) 7(6.7)
Concurrent Medications used Antihypertensive Antihyperlipidemia Antithrombolytic agent Diuretic Antidepressant Antiangina Thyroid product Proton pump inhibitor Hematinic Supplement Others	367	100(96.2) 92(88.5) 60(57.7) 43(41.3) 4(3.8) 10(9.6) 3(2.9) 2(1.9) 14(13.5) 26(25) 13(12.5)

^βStages of DR	A1C %		p=value
^βStages of DR	< 8	≥ 8	p=value
Mild NPDR yes no	18 (17.3%) 37(53.6%)	12(11.5%) 37(35.6%)	0.478^a
Moderate NPDR yes no	13(12.5%) 42(40.4%)	17(16.3%) 32(30.8%)	0.305^a
Severe NPDR yes no	7(6.7%) 48(46.2%)	13(12.5%) 36(34.6%)	0.125^a
PDR yes no	22(21.2%) 33(31.7%)	36(34.6%) 68(65.4%)	0.309^a
DME yes no	19(18.3%) 36(34.6%)	17(16.3%) 32(30.8%)	1.000^a

Class of antidiabetic agents	Moderate NPDR		p-value
Class of antidiabetic agents	yes	no
Insulin yes no	22(21.2%) 49(47.1%)	8(7.7%) 25(24.0%)	0.636^a
Biguanide yes no	16(15.4%) 14(13.5%)	33(31.7%) 41(39.4%)	0.554^a
Sulphonylurea yes no	14(13.5%) 16(15.4%)	27(26.0%) 47(45.2%)	0.459^a
Alpha-glucosidase inhibitor yes no	7(6.7%) 23(22.1%)	4(3.8%) 70(67.3%)	*0.012^b
DPP4 inhibitor yes no	1(1.0%) 29(27.9%)	3(2.9%) 71(68.3%)	0.636^a

Demographic and Clinical Characteristic	A1C %		p-value
Demographic and Clinical Characteristic	<8	≥8	p-value
Age elderly (>64) non-elderly (18-64)	28(26.9%) 27(26%)	20(19.2%) 29(27.9%)	0.405^a
Gender Male Female	31(29.8%) 24(23.1%)	21(20.2%) 28(26.9%)	0.239^a
Ethnicity Malay Chinese Indian Others	24(23.1%) 22(21.2%) 9(8.7%) 0(0.0%)	28(26.9%) 5(4.8%) 15(14.4%) 1(1.0%)	*0.002^b
BMI underweight normal overweight obese unknown	1(1.0%) 3(2.9%) 6(5.8%) 2(1.9%) 43(41.3%)	0(0.0%0 5(4.8%) 2(1.9%) 0(0.0%) 42(40.4%)	0.170^b
Duration of T2DM 1-5 6-10 11-15 16-20 >20	1(1.0%) 5(5.2%) 10(10.4%) 12(12.5%) 23(24.0%)	3(3.1%) 7(7.3%) 14(14.6%) 11(11.5%) 10(10.4%)	0.137^b
Family History of T2DM yes no unknown	10(9.6%) 12(11.5%) 33(31.7%)	11(10.6%) 16(15.4%) 22(21.2%)	0.289^c
Number of antidiabetic agents 1 2 >2	31(29.8%) 17(16.3%) 7(6.7%)	17(16.3%) 22(21.2%) 10(9.6%)	0.085^c

Demographic and Clinical Characteristic	^βStages of DR and DME		p-value
	Mild NPDR
	yes	no
Age Elderly Non-elderly	20(19.2%) 10(9.6%)	28(26.9%) 46(44.2%)	*0.014^a
	Moderate NPDR
	yes	no
Number of antidiabetic agents 1 2 >2	12(11.5%) 8(7.7%) 10(9.6%)	36(34.6%) 31(29.8%) 7(6.7%)	*0.015^c
	DME
	yes	no
Family History of T2DM yes no unknown	11(10.6%) 5(4.8%) 20(19.2%)	10(9.6%) 23(22.1%) 35(33.7%)	*0.039^b