Table 3.
Summary of Hormone Replacement Therapy Study Characteristics and Cardiovascular Calcification Outcome (3 Studies)
Author and year | Mean study duration, mo | Target population | Study sample size | Intervention | Comparator | Primary or secondary end point | Imaging modality | Site | Reported outcomes | Interpretation |
---|---|---|---|---|---|---|---|---|---|---|
Basaria 2015 28 | 36 | ≥60 y with low to low‐normal testosterone levels | 308 | 7.5 g of 1% testosterone gel | Placebo | Primary | CT | Common carotid artery | CAC rate of change, Agatston units/year; mean difference (95% CI); −10.8 (−45.7 to 24.2) (P=0.54) | No significant attenuation |
Serum creatinine >2.5 mg/dL excluded | ||||||||||
Budoff 2017 29 | 12 | Men aged ≥65 y with symptomatic low testosterone levels (<275 ng/dL) | 170 | 1% testosterone gel | Placebo | Secondary | CT | Coronary artery | CAC rate of change Agatston units/year; mean difference (95% CI); −27 (−80 to 26) (P=0.31) | No significant attenuation |
eGFR <60 mL/min per 1.73 m2 excluded | ||||||||||
Harman 2014 30 | 48 | Postmenopausal women aged 42–58 y | 727 | 0.45 mg oral conjugated equine estrogen daily or 50 μg transdermal 17ß‐estradiol daily, each with 200 mg cyclical progesterone | Placebo | Secondary | CT | Coronary artery | CAC (hormone group minus placebo), % (95% CI);−3.6 (−11.4 to 4.1) for oral estrogen,(P=0.36); −2.1 (−10 to 5.7) for transdermal estrogen, (P=0.59) | No significant attenuation |
CAC indicates coronary artery calcification; CT, computed tomography; and eGFR, estimated glomerular filtration rate.