Compared with placebo, IGF-I (primary endpoint) declined in all tamoxifen arms (P = 0.005), with a greater change on 5 mg/day compared to 10 mg/week or 1 mg/day (P = 0.019).
There were no significant differences between monotherapy groups, but they both significantly outperformed the PBO group (P <0.001 each), and MEM-DON was the only group that did not demonstrate a significant baseline-to-endpoint decline.
In the Snapshot analysis, the MEM-DON group significantly outperformed the PBO group (P <0.0001), the MEM group (P = 0.001), and the PBO-DON group (P = 0.0203) at endpoint, with all four groups showing a statistically significant baseline-to-endpoint decline.
1 The primary functional endpoint was decline in performance status, and there was a significant improvement in median time to decline from 10.4 months to 11.9 months, with a one-year deterioration-free rate of 48% versus 39% (P = 0.05), respectively.
The primary endpoint is decline of renal function at 12 months.
The results of this study group's first trial of FOS vs. alternate day prednisone vs. placebo with the primary endpoint of decline in kidney function [ 16] have recently been published in abstract form [ 17].
Results did not change, neither when missing values for geriatric screening tools were imputed either as a worst- or best-case scenario, nor when mortality was included as endpoint for functional decline and decline in QoL (see Additional file 2: Table S2 and S3).
However, little is known about the effect of environmental barriers on mortality, the ultimate endpoint of health decline.
Observational data from studies of people with type 2 diabetes appear to support this possibility (e.g. with associations of antihypertensive treatment with reduced risk of dementia as an endpoint of cognitive decline [ 30]) but current evidence from trials is limited and inconclusive.
However, recent clinical trials where AD patients were treated with γ-secretase inhibitors failed to reach their primary clinical endpoints; the cognitive decline was even worse in the treatment arm than in placebo [ 13, 14].
In a more recent prospective study utilizing the Chronic Renal Insufficiency Cohort (CRIC), Rahman et al. also did not find an association between baseline plasma Lp(a) levels and their endpoints of 50%% decline in eGFR or progression to ESRD [ 43].
