Table 5.

Outcomes for subgroups with 2-year sustained weight gain, weight loss, or stable weight during the first 2 years of the follow-up (HR, 95% confidence intervals)

	Sustained weight gain			Sustained weight loss			Stable weight
Outcomes	HR	95% CI	P-value	HR	95% CI	P-value	HR	95% CI	P-value
All-cause mortality	1.000	0.896–1.115	0.996	1.315	1.182–1.463	<0.0001	0.824	0.751–0.904	<0.0001
CV mortality	1.109	0.968–1.272	0.136	1.175	1.020–1.353	0.025	0.828	0.734–0.933	0.0019
Primary composite endpointa	1.040	0.939–1.152	0.453	1.049	0.942–1.168	0.385	0.940	0.859–1.028	0.172
Secondary composite endpointb	0.983	0.909–1.064	0.676	1.122	1.036–1.216	0.0046	0.933	0.871–0.999	0.0460
Total stroke	1.036	0.864–1.243	0.699	0.918	0.754–1.119	0.397	1.030	0.878–1.208	0.717
Non-fatal stroke	0.983	0.804–1.202	0.868	0.876	0.704–1.090	0.235	1.106	0.928–1.318	0.259
Total MI	0.945	0.787–1.134	0.543	1.005	0.832–1.214	0.958	1.040	0.888–1.217	0.626
Non-fatal MI	0.904	0.745–1.096	0.304	1.014	0.832–1.236	0.892	1.068	0.906–1.260	0.432
Revascularization	0.944	0.845–1.054	0.304	1.195	1.070–1.335	0.0017	0.919	0.834–1.012	0.0858
HF hospitalization	1.024	0.853–1.228	0.801	1.196	0.995–1.437	0.0563	0.865	0.748–1.013	0.0725

Weight gain, weight loss, and stable weight were treated as time varying covariables in multivariable adjusted models (Cox regression model adjusted for age, sex, ever smoker, previous cardiovascular event, previous diabetes, LDL, HbA1c, eGFR, allocation to glargine, and allocation to omega 3 fatty acid.). 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.