MedicalResearch.com Interview with:
M. Loredana Marcovecchio, M.D.
Clinical Scientist and
Professor David Dunger M.D.
Director of Research
Professor of Paediatrics
University of Cambridge
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The efficacy and safety of ACE Inhibitors and statins in adolescents have been shown in the context of hypertension and familial hypercholesterolemia, respectively. However, there is a lack of data on the long-term use of these drugs in those with type 1 diabetes and, in particular, there is no clear indication for their use in patients with increased albumin excretion.
The Adolescent type 1 Diabetes cardio-renal Intervention Trial (AdDIT) was a multi-centre, international study, set up by investigators in the UK, Australia and Canada to explore if drugs already used to lower blood pressure (ACE inhibitors) and cholesterol levels (Statins) in adults with diabetes could reduce the risk of kidney, eye and cardiovascular disease in adolescents with Type 1 diabetes.
Neither ACE inhibitors nor statins significantly reduced the albumin-creatinine ratio during the 2-4 year trial period. However, some of the secondary outcomes suggest that the drugs may have important benefits.
Treatment with the ACE inhibitor resulted in a 43% reduction in the rates of progression to microalbuminuria, which was not statistically significant, but it could have important clinical implications. Preventing even intermittent cases of microalbuminuria is known to reduce the future risk of kidney and cardiovascular complications.
Statin therapy led to reduced levels of lipid levels, which could reduce long-term risk for cardiovascular complications.
These findings could translate into long-term benefits, but follow-up of this unique cohort will be essential. The essential biological samples and data provided by the participants will continue to inform our future understanding and our options for effective therapies for this vulnerable group of young people with type 1 diabetes.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: The AdDIT trial indicates that treatment with ACE Inhibitors and statins in adolescents with type 1 diabetes is safe and can lead to short-term effects on lipids levels and reduce rates of microalbuminuria.
It is too soon to know whether this short-term intervention will reduce long-term complications risk and follow up of the cohort is planned. As well as informing patients and care givers about benefits of drug therapy, AdDIT also provides unique information about identifying future risk for complications. The inclusion of a group at low-risk for complications (based on lower albumin excretion) into an Observations study (n 400) allowed us to compare outcomes across the full range of albumin excretion. As early as aged 10-16 years the albumin-creatinine ratio was highly predictive for the development of early signs of renal, retinal and CVD complications.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Future work is still needed to establish the full benefits of statins and ACE inhibitors in young people with Type 1 diabetes, mainly in relation to long-term complications. It is too soon to know whether this short-term intervention will reduce long-term complications risk and follow up of the cohort is planned. Follow up of the AdDIT cohort is undergoing to establish the full benefits of statins and ACE inhibitors in relation to long-term complications, and it will continue to inform our future understanding and our options for effective therapies for this vulnerable group of young people with type 1 diabetes.
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ACE Inhibitors and Statins in Adolescents with Type 1 Diabetes
N Engl J Med 2017; 377:1733-1745
November 2, 2017DOI: 10.1056/NEJMoa1703518
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