Table 1.

Baseline variables and outcomes in MAP.3

VariableExemestanePlaceboHR (95% CI)P value
Baseline
 Number of women2,2852,275NANA
 Median age (interquartile range), y62.5(38.5–88.2)62.4(37.1–89.9)NANA
Breast cancer risk factors
 5-year Gail risk >1.66%: n (%)929(40.7)905(39.8)NANA
 Age ≥60 years: n (%)1,114(48.8)1,126(49.5)NANA
 Prior history of IEN: n (%)
  ADH, ALH, LCIS pooled185(8.1)188(8.3)NANA
  DCIS- treated with mastectomy56(2.5)56(2.5)NANA
Bone variables
 Prior bisphosphonate use: n (%)427(18.7)414(18.2)NANA
 Current osteoporosis at baseline: n (%)303(13.3)293(12.9)NANA
 History of clinical fractures: n (%)409(17.9)400(17.6)NANA
Outcomes, primary endpoint: n [annual incidence (%)]
 Invasive breast cancer11(0.19)32(0.55)(0.18–0.70)0.002
Outcomes, secondary endpoints: n [annual incidence (%)]
 Breast cancer endpoints
  Invasive BC: ER positive7(0.12)27(0.46)0.27 (0.12–0.60)<0.001
  Invasive BC: ER negative4(0.07)5(0.09)0.80 (0.21–2.98)0.74
  DCIS9(0.16)14(0.24)0.65 (0.28–1.51)0.31
  Combined invasive BC + DCIS20(0.35)44(0.77)0.47 (0.27–0.79)0.004
  Combined IEN: ADH, ALH, LCIS4(0.07)11(0.20)0.36 (0.11–1.12)0.08
Adverse events (assessed in n women)n = 2,240n = 2,248
 Musculoskeletal
  Bone: clinical fractures149(6.7)143(6.4)NA0.72
  Bone: new osteoporosis37(1.7)30(1.3)NA0.39
  Musculoskeletal: arthritis247(11)196(9)NA0.01
  Arthralgia665(30)606(27)NA0.04
  Myalgia147(7)192(9)NA0.01
 Gastrointestinal events
  Diarrhea118(5)75(3)NA0.002
  Nausea155(7)122(5)NA0.04
 Cardiovascular106(4.7)111(4.9)NA0.78
 Endocrine: hot flashes900(40)718(32)NA<0.001
 Sexual function: vaginal dryness352(16)343(15)NA0.68
 Other cancers43(1.9)38(1.7)NA0.58
SF-36 and MENQOL
 SF-36: bodily painNANANA<0.001
 MENQOL: vasomotorNANANA<0.001
 MENQOL: sexualNANANA0.01