Recent trial results have demonstrated that neither the use of an ACE inhibitor nor a statin significantly reduce albumin levels in the urine of adolescents with type 1 diabetes.
Investigators in the AdDIT (Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial) set out to evaluate whether adolescents with high levels of albumin excretion would benefit from angiotensin-converting–enzyme (ACE) inhibitors and statins. For children with type 1 diabetes, adolescence is a period of risk for long-term complications. Glycaemic control is difficult to achieve and rapid increases in albumin excretion during puberty may occur.
This double-blind, randomised, placebo-controlled trial was conducted in the UK, Canada and Australia. A population of 4407 individuals with type 1 diabetes aged between 10 and 19 years was screened, and those with an albumin-to-creatinine ratio (ACR) in the upper third were identified.
Of these, 443 were randomised to receive: ACE inhibitor plus placebo; statin plus placebo; ACE inhibitor plus statin; or placebo plus placebo. The primary outcome (change in albumin excretion) was assessed according to the ACR calculated every 6 months over 2 to 4 years. This outcome was chosen because studies have indicated that increases in ACR during puberty are associated with risk markers for cardiovascular disease.
Secondary outcomes included development of microalbuminuria, progression of retinopathy, and changes in glomerular filtration rate (GFR), lipid levels and measures of cardiovascular risk.
There was no significant effect on the primary outcome from the ACE-inhibitor therapy, statin therapy, or combination of the two. ACE inhibitors did reduce the cumulative incidence of microalbuminuria, although it was not considered significant.
Statin use produced significant improvements in lipid levels, although neither drug had significant effects on cardiovascular markers, GFR or progression of retinopathy.
Serious adverse events were similar across the groups, but there is an important potential risk to pregnancies in this population.
Although neither therapy altered the primary outcome of the study period, the authors state that it will be essential to follow the present cohort to assess whether the early intervention with ACE inhibitors or statins provide a delayed “legacy effect” of reduced vascular complications.
To read the original article, click here (log in or purchase required).
This site is intended for healthcare professionals only
