Table 2.

Efficacy and Safety of Low dose tamoxifen

Efficacy of low-dose tamoxifen
Efficacy Endpoints	Difference between low-dose tamoxifen and placebo	95% CI	p-value	p-value 2df at t1 and t2
Percent Mammographic Dense area (square root transformed)*
At t1	−0.21	−0.40 to −0.03	0.02	0.02
At t2	−0.23	−0.44 to −0.03	0.03
Percent Mammographic Dense area (mean)*
At t1	−2.9%	−3.35 to −2.47	0.02	0.02
At t2	−3.13%	−3.57 to −2.68	0.03
Insulin-like Growth Factor-1 (IGF-1)**†
At t1	−34.53	−45.75 to −23.30	<.0001	<0.0001
At t2	−16.99	−29.41 to −4.56	0.008
Insulin-like Growth Factor Binding Protein-3***‡
At t1	295.53	−23.52 to 614.59	0.07	0.02
At t2	433.44	79.81 to 787.06	0.02
Free IGF-1 (IGF-1/IGF-BP3)*100
At t1	−0.89	−1.15 to −0.64	<.0001	<.0001
At t2	−0.66	−0.95 to −0.38	<.0001
Safety of low-dose tamoxifen
Safety Biomarkers	Difference between low-dose tamoxifen and placebo at t2	95% Confidence Interval	p-value
Lipids
Total cholesterol	−2.59	−21.30 to 16.10	0.80
Low-density lipoprotein	−3.23	−18.30 to 11.80	0.70
High-density lipoprotein	1.13	−6.60 to 8.90	0.80
Triglycerides	21.51	−14.50 to 57.10	0.20
Pro-coagulation markers
Anti-thrombin-III levels	−8.9	−22.90 to 5.20	0.20
Bone markers
Bone-specific Alkaline Phosphatase	−0.27	−1.80 to 1.30	0.70
Urinary N-telopeptide, cross-linked	1.1	−9.00 to 11.20	0.80

^*Adjusted for baseline mammographic dense area

^**†Adjusted for baseline IGF-1 levels

^***‡Adjusted for baseline IGF-BP3