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Randomized Controlled Trial
. 2019 Sep;62(9):1575-1580.
doi: 10.1007/s00125-019-4920-3. Epub 2019 Jun 1.

Beneficial impact of intensified multifactorial intervention on risk of stroke: outcome of 21 years of follow-up in the randomised Steno-2 Study

Peter Gæde  1   2 , Jens Oellgaard  3 , Christina Kruuse  4 , Peter Rossing  5   6 , Hans-Henrik Parving  7 , Oluf Pedersen  8
Affiliations
Randomized Controlled Trial

Beneficial impact of intensified multifactorial intervention on risk of stroke: outcome of 21 years of follow-up in the randomised Steno-2 Study

Peter Gæde et al. Diabetologia. 2019 Sep.

Abstract

Aims/hypothesis: Epidemiological studies have shown that diabetes is a well-established independent but modifiable risk factor for stroke. The aim of this post hoc analysis of data from the Steno-2 Study was to examine whether multiple risk factor intervention reduced the risk for stroke in individuals with type 2 diabetes and microalbuminuria.

Methods: In the Steno-2 Study, 160 individuals with type 2 diabetes and microalbuminuria were randomised to intensified or conventional multiple risk factor intervention, targeting classical cardiovascular disease risk factors for a mean of 7.8 years, and then followed for a total mean of 21.2 years. The primary endpoint in this post hoc analysis was time to first stroke event.

Results: During follow-up, 30 participants experienced a total of 39 strokes. Individuals randomised to conventional therapy were more likely to experience a stroke than those in the intensive-therapy group, with 29 total strokes occurring in 21 participants (26%) in the conventional-therapy group vs a total of ten strokes in nine participants (11%) in the intensive-therapy group (HR 0.31 [95% CI 0.14, 0.69]; p = 0.004). Also, the number of recurrent strokes was significantly reduced with intensive therapy.

Conclusions/interpretation: Intensified multiple risk factor intervention in patients with type 2 diabetes and microalbuminuria reduces the risk for strokes as well as the number of recurrent cerebrovascular events.

Trial registration: ClinicalTrials.gov NCT00320008.

Keywords: Microalbuminuria; Multifactorial intervention; Stroke; Type 2 diabetes.

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Figures

Fig. 1
Fig. 1
CONSORT diagram showing participant flow throughout the Steno-2 trial. The first 7.8 years were the active intervention period, after which time the randomisation was neutralised and continued as a post-trial observational follow-up study with all remaining participants being offered the same treatment as the original intensive-therapy group. At the time of randomisation, the mean age was 55.1 years and 66% were male. All participants had microalbuminuria. Reproduced from [8] under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium
Fig. 2
Fig. 2
Cumulative incidence frequency plot of time to first stroke. The hazard for stroke was reduced by 69% in the intensive-therapy group (p=0.004). Solid line, intensive-therapy group; dashed line, conventional-therapy group
See this image and copyright information in PMC

References

    1. The GBD 2016 Lifetime Risk of Stroke Collaborators Global, regional, and country-specific lifetime risks of stroke, 1990 and 2016. N Engl J Med. 2018;379(25):2429–2437. doi: 10.1056/NEJMoa1804492. - DOI - PMC - PubMed
    1. Gregg EW, Li Y, Wang J, et al. Changes in diabetes-related complications in the United States, 1990–2010. N Engl J Med. 2014;370(16):1514–1523. doi: 10.1056/NEJMoa1310799. - DOI - PubMed
    1. Gæde P, Oellgaard J, Carstensen B, et al. Years of life gained by multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: 21 years follow-up on the Steno-2 randomised trial. Diabetologia. 2016;59(11):2298–2307. doi: 10.1007/s00125-016-4065-6. - DOI - PMC - PubMed
    1. Gæde J, Oellgaard J, Ibsen R, et al. A cost analysis of intensified vs conventional multifactorial therapy in individuals with type 2 diabetes: a post hoc analysis of the Steno-2 study. Diabetologia. 2019;62(1):147–155. doi: 10.1007/s00125-018-4739-3. - DOI - PMC - PubMed
    1. Gæde PH. Intensified multifactorial intervention in patients with type 2 diabetes and microalbuminuria: rationale and effect on late-diabetic complications. Dan Med Bull. 2006;53(3):258–284. - PubMed

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