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The DIabetic Retinopathy Candesartan Trials (DIRECT) Programme, rationale and study design
Nish Chaturvedi1, Anne Katrin Sjoelie, Anders Svensson
1International Centre for Circulatory Health Department of Epidemiology and Public Health, Imperial College at St Mary's, London, W2 1PG, UK. n.chaturvedi@ic.ac.uk
Journal of the Renin-Angiotensin-Aldosterone System : JRAAS
|February 14, 2003
Summary
Candesartan treatment shows potential in preventing diabetic retinopathy progression in both Type 1 and Type 2 diabetes patients. Further research will clarify its role in managing this common diabetes complication.
Area of Science:
- Ophthalmology
- Endocrinology
- Cardiology
Background:
- Diabetic retinopathy is a leading cause of vision loss in diabetic patients.
- Current treatments focus on managing blood glucose and blood pressure.
- The role of angiotensin II receptor blockers (ARBs) in diabetic retinopathy is under investigation.
Purpose of the Study:
- To evaluate the efficacy of candesartan in preventing the incidence and progression of diabetic retinopathy.
- To assess the impact of candesartan on urinary albumin excretion in diabetic patients.
Main Methods:
- The DIabetic Retinopathy Candesartan Trials (DIRECT) Programme involves three randomized, double-masked, placebo-controlled studies.
- Participants include patients with Type 1 and Type 2 diabetes, with or without retinopathy, and varying blood pressure levels.
- Patients are followed for at least three years, with retinal photographs and urinary albumin excretion as primary and secondary endpoints, respectively.
Main Results:
- The DIRECT Programme is designed to provide robust data on candesartan's effects.
- Specific results regarding incidence and progression rates, and changes in albuminuria are pending study completion.
Conclusions:
- The DIRECT Programme aims to establish candesartan as a therapeutic option for diabetic retinopathy.
- Positive outcomes could significantly advance the clinical management of diabetes and its ocular complications.