medwireNews: Improvements in cardiovascular risk factors remain 5 years after the end of intensive multifactorial treatment of people newly diagnosed with type 2 diabetes in the ADDITION-Europe trial, report the investigators.
Simon Griffin (University of Cambridge, UK) and study co-authors report data from the 10-year follow-up of people with screen-detected type 2 diabetes who had received 5 years of either intensive multifactorial treatment or standard care, after which they all received standard care.
Among the 3031 people who participated in this long-term follow-up, those in the intensive treatment group mostly sustained their original improvements in the risk factors of bodyweight, blood pressure, total cholesterol, and glycated hemoglobin, although the latter rose markedly from its nadir 1 year after diagnosis.
However, after the randomized period ended, the previously identified between-group differences began to disappear. People formerly allocated to intensive treatment continued to receive significantly more antihypertensive medications than those who had received standard care throughout (86.4 vs 82.4%), but prescriptions of other medications were equivalent, and their cardiovascular risk factor profiles did not significantly differ.
Similar to the 5-year outcomes, there was no significant between-group difference in the risk for a first cardiovascular event, but there remained a tendency for people in the intensive care group to have fewer events, at a rate of 14.3 per 1000 person–years compared with 16.1 per 1000 person–years in the standard care group, giving a nonsignificant hazard ratio of 0.87 (95% confidence interval 0.73–1.04).
Likewise, the all-cause mortality rates were 14.3 versus 15.6 per 1000 person–years, giving a hazard ratio of 0.90 (95% confidence interval 0.76–1.07).
In a commentary accompanying the publication in The Lancet Diabetes & Endocrinology, Kohjiro Ueki (National Center for Global Health and Medicine, Tokyo, Japan) and co-authors stress that “a prospective cohort in which patients are exposed to good control of risk factors in the first decade after diagnosis is rare.”
They say: “Despite the lack of statistical significance—probably partly due to improvements in clinical practice when the study was done—these findings lend support to early multifactorial intervention in type 2 diabetes.”
The contrast of cardiovascular event rates in ADDITION-Europe with the much higher ones in older trials such as the UKPDS indicates that “intensive multifactorial treatment of type 2 diabetes in primary care is now pragmatically feasible and might contribute to prevention of cardiovascular events,” say the commentators.
And they conclude: “It will be interesting to see whether the possible benefits from intensive multifactorial treatment in ADDITION-Europe will become more evident in the next decade, or whether they will fade as in the Veterans Affairs Diabetes Trial.”
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Lancet Diabetes Endocrinol 2019; 7: 925–937
Lancet Diabetes Endocrinol 2019; 7: 891–893