Lundström, Hanna1; Siersma, Volkert1; Nielsen, Anni B Sternhagen1; Brodersen, John1; Reventlow, Susanne1; Andersen, Per K2; de Fine Olivarius, Niels1
1 The research unit for general practice, The Capital Region of Denmark2 unknown
a 19 year follow-up of the study Diabetes Care in General Practice (DCGP)
AIMS/HYPOTHESIS: The estimation of effect size in clinical trials commonly disregards recurrent outcomes. We investigated the effectiveness of a complex intervention on recurrent outcomes in patients with type 2 diabetes. METHODS: In the Diabetes Care in General Practice (DCGP) randomised controlled trial, 1,381 patients newly diagnosed with type 2 diabetes were randomised to 6 years of structured personal care or routine care (ClinicalTrials.gov NCT01074762). The trial had 19 years of registry-based follow-up and was analysed with Cox regression models. Repeated occurrences in the same patient of outcomes (any diabetes-related endpoint, myocardial infarction [MI], stroke, peripheral vascular disease and microvascular disease) were accounted for with the Wei, Lin and Weissfeld method. RESULTS: As previously shown, the intervention reduced the rates of first occurrence of both MI and any diabetes-related endpoint. However, for all outcomes, the HR for a second event showed a statistically non-significant tendency to be increased. We estimated a combined HR for all marginal failure times, regardless of whether they were first, second or later events. This showed that the intervention had no effect on the rate of any of the outcomes, including MI (HR 0.89, 95% CI 0.76, 1.05) and any diabetes-related endpoint (HR 0.98, 95% CI 0.87, 1.09). CONCLUSIONS/INTERPRETATION: In the DCGP study, a smaller proportion of patients who received structured care experienced a first occurrence of MI or any diabetes-related endpoint compared with patients who received routine care. However, the patients who received structured care tended to experience more recurrent outcomes, so the total outcome rate was not affected by the intervention.