Table 4.

Outcome analyses for subgroups with weight gain and weight loss (per 5% of body weight change) during the first year of follow (Cox proportional hazard analyses (HR, 95% confidence intervals)

	Weight gain (% body weight)			Weight loss (% body weight)
Outcome variables	HR	95% CI	P-value	HR	95% CI	P-value
All-cause mortality	0.857	0.827–0.887	<0.0001	1.167	1.127–1.208	<0.0001
CV mortality	0.917	0.874–0.962	0.0004	1.091	1.039–1.144	0.0004
Primary composite endpointa	0.910	0.878–0.944	<0.0001	1.099	1.060–1.140	<0.0001
Secondary composite endpointb	0.898	0.873–0.924	<0.0001	1.113	1.083–1.145	<0.0001
Total stroke	0.897	0.841–0.958	0.0012	1.114	1.044–1.190	0.0012
Non-fatal stroke	0.914	0.850–0.983	0.0160	1.094	1.017–1.176	0.0160
Total MI	0.956	0.897–1.018	0.1588	1.047	0.982–1.115	0.1588
Non-fatal MI	0.935	0.875–0.999	0.0460	1.070	1.001–1.143	0.0460
Revascularization	0.901	0.868–0.936	<0.0001	1.110	1.068–1.152	<0.0001
HF hospitalization	0.859	0.809–0.912	<0.0001	1.164	1.097–1.236	<0.0001

Weight gain and weight loss were treated as time varying covariables in multivariable adjusted models (Cox regression model adjusted for age, sex, ever smoker, previous cardiovascular event, LDL, HbA1c, eGFR, allocation to glargine, allocation to omega 3 fatty acid, duration of DM, waist circumference, systolic blood pressure, ACE or ARB medication, beta blocker medication, statin medication. Hip circumference, hypertension, and diastolic blood pressure were not included in the model because of collinearity.). HR’s compare the category vs. all subjects outside the category.

^aPrimary composite endpoint: composite of first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.

^bExpanded composite endpoint: composite of first occurrence of these three outcomes or revascularization or heart failure hospitalization.