Abstract
ObjectiveTo evaluate the incidence of diabetic retinopathy in patients with Type 2 Diabetes Mellitus, to identify the risk factors associated with the incidence of retinopathy and to develop a risk table to predict four-year retinopathy risk stratification for clinical use, from a four-year cohort study.DesignThe MADIABETES Study is a prospective cohort study of 3,443 outpatients with Type 2 Diabetes Mellitus, sampled from 56 primary health care centers (131 general practitioners) in Madrid (Spain).ResultsThe cumulative incidence of retinopathy at four-year follow-up was 8.07% (95% CI = 7.04–9.22) and the incidence density was 2.03 (95% CI = 1.75–2.33) cases per 1000 patient-months or 2.43 (95% CI = 2.10–2.80) cases per 100 patient-years. The highest adjusted hazard ratios of associated risk factors for incidence of diabetic retinopathy were LDL-C >190 mg/dl (HR = 7.91; 95% CI = 3.39–18.47), duration of diabetes longer than 22 years (HR = 2.00; 95% CI = 1.18–3.39), HbA1c>8% (HR = 1.90; 95% CI = 1.30–2.77), and aspirin use (HR = 1.65; 95% CI = 1.22–2.24). Microalbuminuria (HR = 1.17; 95% CI = 0.75–1.82) and being female (HR = 1.12; 95% CI = 0.84–1.49) showed a non-significant increase of diabetic retinopathy. The greatest risk is observed in females who had diabetes for more than 22 years, with microalbuminuria, HbA1c>8%, hypertension, LDL-Cholesterol >190 mg/dl and aspirin use.ConclusionsAfter a four-year follow-up, the cumulative incidence of retinopathy was relatively low in comparison with other studies. Higher baseline HbA1c, aspirin use, higher LDL-Cholesterol levels, and longer duration of diabetes were the only statistically significant risk factors found for diabetic retinopathy incidence. This is the first study to demonstrate an association between aspirin use and diabetic retinopathy risk in a well-defined cohort of patients with Type 2 Diabetes Mellitus at low risk of cardiovascular events. However, further studies with patients at high cardiovascular and metabolic risk are needed to clarify this issue.
Highlights
Diabetic Retinopathy (DR) is the most common microvascular complication in diabetes mellitus (DM)
For follow-up patients, data at baseline visit showed that individuals who developed DR (n = 194) had a higher duration of DM, higher HbA1c levels, and greater use of insulin and aspirin versus non incidence cases (n = 2,211) (Table 2)
Previous findings, as seen in the LALES study [22] and the San Luis Valley Diabetes Study [23], report higher rates of DR, between 3 and 3.5 times higher than our study. Both these studies had a higher proportion of patients with elevated glucose levels and who were being treated with insulin, what is important due to the relationship insulin and glucose levels have with DR [24]
Summary
Diabetic Retinopathy (DR) is the most common microvascular complication in diabetes mellitus (DM). Worldwide, it remains a significant cause of acquired visual loss and blindness in the 20 to 60 years-old age group [1,2,3]. In an effort to detect DR at an optimal stage for intervention, the American Diabetes Association (ADA) recommends that, after the diagnosis of Type 2 DM (T2DM), patients should receive an initial dilated and comprehensive eye examination by an ophthalmologist, and subsequent annual examinations. Initial data from the Health Plan Employer Data and Information Set (HEDIS) indicate that, in reality, only 35% to 50% of patients between 30 and 64 years-old receive the annual eye examination [5]. Presence of DR is linked to an increased risk of vision loss, and a two to three-fold excess risk of coronary disease [6,7,8,9] and ischemic stroke [10]
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