Table 2. Outcomes at 12 Months for Participants in a Study of the Association Between Levothyroxine Treatment and Thyroid-Related Symptoms Among Adults Aged 80 Years and Older With Subclinical Hypothyroidism.
| Outcomes | Mean (SD) | Adjusted Difference (95% CI)a | P Value | |||
|---|---|---|---|---|---|---|
| Baseline | 12 Months | |||||
| Levothyroxine | Placebo | Levothyroxine | Placebo | |||
| Co-primary outcomes | (n = 90) | (n = 122) | (n = 90) | (n = 122) | ||
| ThyPRO hypothyroid symptoms scoreb | 21.7 (19.5) | 19.8 (19.6) | 19.3 (18.2) | 17.4 (18.1) | 1.27 (−2.69 to 5.23) | .53 |
| ThyPRO tiredness scoreb | 25.2 (21.5) | 25.1 (19.5) | 28.2 (20.0) | 28.7 (19.9) | −0.10 (−4.51 to 4.31) | .96 |
| Prespecified secondary outcomes | ||||||
| Thyrotropin, mIU/L | 6.50 (1.80) (n = 90) | 6.20 (1.48) (n = 116) | 3.69 (1.81) (n = 90) | 5.49 (2.21) (n = 116) | −1.97 (−2.49 to −1.45) | <.001 |
| EuroQol-5Dc | 0.785 (0.199) (n = 90) | 0.811 (0.210) (n = 122) | 0.754 (0.268) (n = 90) | 0.785 (0.244) (n = 122) | −0.012 (−0.063 to 0.039) | .64 |
| EuroQol VASd | 75.27 (14.59) (n = 90) | 73.98 (14.26) (n = 122) | 74.16 (13.67) (n = 90) | 73.67 (13.58) (n = 122) | −0.42 (−3.57 to 2.72) | .79 |
| Handgrip strength, kg | 25.4 (9.4) (n = 81) | 24.7 (10.2) (n = 114) | 23.4 (9.7) (n = 81) | 23.0 (9.2) (n = 114) | −0.27 (−1.79 to 1.25) | .73 |
| Blood pressure, mm Hg | (n = 90) | (n = 122) | (n = 90) | (n = 122) | ||
| Systolic | 144.4 (19.4) | 146.2 (20.7) | 141.3 (19.0) | 142.6 (20.7) | −0.42 (−5.23 to 4.39) | .86 |
| Diastolic | 71.3 (11.8) | 72.3 (12.3) | 68.7 (11.9) | 69.6 (12.5) | −0.31 (−3.06 to 2.44) | .83 |
| Weight | 76.5 (13.1) (n = 90) | 75.1 (12.3) (n = 121) | 76.2 (12.7) (n = 90) | 73.9 (12.3) (n = 121) | 0.97 (0.11 to 1.82) | .03 |
| Body mass index | 27.7 (4.4) (n = 90) | 27.5 (3.9) (n = 121) | 27.6 (4.4) (n = 90) | 27.1 (3.9) (n = 121) | 0.38 (0.08 to 0.68) | .01 |
| Waist circumference, cm | 99.0 (11.6) (n = 90) | 98.0 (10.9) (n = 121) | 99.0 (11.4) (n = 90) | 96.5 (11.7) (n = 121) | 1.52 (0.09 to 2.95) | .04 |
Abbreviation: ThyPRO, Thyroid-Related Quality of Life Patient-Reported Outcome; VAS, visual analog scale.
a
Adjusted difference was estimated in linear regression models predicting change from baseline to 12-month visit (95% CI) with study site, sex, and randomization dose as stratification variables and study as random effect.
b
Range 0-100; higher scores indicate more symptoms. The mean scores in the general population are 14 for hypothyroid symptoms and 35 for tiredness.
c
Range 0.50-1.00; higher scores indicate a better quality of life.
d
Range 0-100; higher scores indicate better health.