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. 2017 Aug 2;60(9):1594–1600. doi: 10.1007/s00125-017-4364-6

Table 1.

Summary of REMOVAL study outcomes

Outcomes Baseline (mean ± SD) Difference or ratio (metformin vs placebo) Main effect (p value) Treatment-by-visit interactiona (p value) Effect of metformin over 3 years: clinical interpretation
Primary outcome
 Mean cIMT(mm) 0.782 ± 0.162 −0.005 0.166 No significant reduction in progression of arteriosclerosis
Secondary outcomes
 HbA1c (%) 8.1 ± 0.8 −0.13 0.006 0.016 Reduction at 3 months by 0.24% (2.6 mmol/mol) (p < 0.0001) but not sustained thereafter
 HbA1c (mmol/mol) 64.0 ± 9.0 −1.4 0.006 0.016
 LDL-cholesterol (mmol/l) 2.20 ± 0.71 −0.13 0.012 0.310 Sustained reduction by 0.13 mmol/l
 eGFR (ml min−1 [1.73 m]−2) 92.0 ± 21.2 +4.0 <0.0001 0.662 Increased 4 ml min−1 (1.73 m)−2 at 3 months, then declined in parallel with placebo; requires further investigation
 Retinopathy (two-step change from baseline) 0.76 (OR) 0.568 No effect
 Weight (kg) 84.0 ± 14.7 −1.17 <0.0001 0.274 Sustained reduction by 1.17 kg
 Insulin dose (U/kg) 0.65 ± 0.28 −0.005 0.545 0.002 After 6 months, reduced by 2 U/day (p = 0.045; post hoc analysis)
 Endothelial function (reactive hyperaemia index; AU) 2.26 ± 0.74 −0.06 0.302 0.566 No significant change
Tertiary outcomes
 Severe hypoglycaemia (per patient year) 0.16 1.23 (IRR) 0.442 No significant change
 Treatment satisfaction 31.77 ± 3.94 −0.12 0.668 0.629 No significant change
 Maximal common cIMT(mm) 0.918 ± 0.196 −0.013 0.0093 Significant reduction in progression of atherosclerosis
 Occurrence of vitamin B12 deficiency (<150 pmol/l) 2.76 (HR) 0.0094 Risk of vitamin B12 deficiency more than doubled vs placebo

Data were analysed by ANCOVA other than for carotid outcomes (repeated measures regression), retinopathy (logistic regression), hypoglycaemia (negative binomial regression) and vitamin B12 (Cox proportional hazards)

All analyses were pre-specified unless otherwise stated

aPresented for data analysed by ANCOVA only

AU, arbitrary units; eGFR, estimated GFR; IRR, incidence rate ratio