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Randomized Controlled Trial
. 2014 Jun;31(6):647-56.
doi: 10.1111/dme.12410. Epub 2014 Apr 1.

Does early intensive multifactorial therapy reduce modelled cardiovascular risk in individuals with screen-detected diabetes? Results from the ADDITION-Europe cluster randomized trial

J A Black  1 , S J Sharp, N J Wareham, A Sandbaek, G E H M Rutten, T Lauritzen, K Khunti, M J Davies, K Borch-Johnsen, S J Griffin, R K Simmons
Affiliations
Free PMC article
Randomized Controlled Trial

Does early intensive multifactorial therapy reduce modelled cardiovascular risk in individuals with screen-detected diabetes? Results from the ADDITION-Europe cluster randomized trial

J A Black et al. Diabet Med. 2014 Jun.
Free PMC article

Abstract

Aims: Little is known about the long-term effects of intensive multifactorial treatment early in the diabetes disease trajectory. In the absence of long-term data on hard outcomes, we described change in 10-year modelled cardiovascular risk in the 5 years following diagnosis, and quantified the impact of intensive treatment on 10-year modelled cardiovascular risk at 5 years.

Methods: In a pragmatic, cluster-randomized, parallel-group trial in Denmark, the Netherlands and the UK, 3057 people with screen-detected Type 2 diabetes were randomized by general practice to receive (1) routine care of diabetes according to national guidelines (1379 patients) or (2) intensive multifactorial target-driven management (1678 patients). Ten-year modelled cardiovascular disease risk was calculated at baseline and 5 years using the UK Prospective Diabetes Study Risk Engine (version 3β).

Results: Among 2101 individuals with complete data at follow up (73.4%), 10-year modelled cardiovascular disease risk was 27.3% (sd 13.9) at baseline and 21.3% (sd 13.8) at 5-year follow-up (intensive treatment group difference -6.9, sd 9.0; routine care group difference -5.0, sd 12.2). Modelled 10-year cardiovascular disease risk was lower in the intensive treatment group compared with the routine care group at 5 years, after adjustment for baseline cardiovascular disease risk and clustering (-2.0; 95% CI -3.1 to -0.9).

Conclusions: Despite increasing age and diabetes duration, there was a decline in modelled cardiovascular disease risk in the 5 years following diagnosis. Compared with routine care, 10-year modelled cardiovascular disease risk was lower in the intensive treatment group at 5 years. Our results suggest that patients benefit from intensive treatment early in the diabetes disease trajectory, where the rate of cardiovascular disease risk progression may be slowed.

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Figures

FIGURE 1
FIGURE 1
Distribution of 10-year modelled cardiovascular risk at baseline and 5.7-year follow-up in the ADDITION-Europe trial cohort by treatment group.
FIGURE 2
FIGURE 2
Difference in modelled cardiovascular disease risk between treatment groups at 5.7-year follow up in the ADDITION-Europe trial cohort, adjusted for baseline risk and accounting for clustering by general practice.
See this image and copyright information in PMC

References

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