Table 3.
Predictors of 50% Reduction in Hot Flash Frequency after 8 Weeks of Placebo Intervention
| Univariate1 | First Multivariable Model1,4 | Final Model1,4 | ||||
|---|---|---|---|---|---|---|
|
| ||||||
| Univariate Predictor (unit increase) | OR | p-value | OR | p-value | ||
|
| ||||||
| Ethnicity | <0.001 | 0.002 | <0.001 | |||
| White | 1.00 | 1.00 | 1.00 | |||
| African American | 7.52 (3.31, 17.08) | 5.09 (2.07, 12.48) | 5.61 (2.41, 13.07) | |||
| Other / unknown | 0.89 (0.23, 3.47) | 0.89 (0.21, 3.86) | 0.88 (0.22, 3.56) | |||
|
| ||||||
| Current smoking | <0.001 | 0.086 | 0.038 | |||
| No | 1.00 | 1.00 | 1.00 | |||
| Yes | 3.50 (1.70, 7.23) | 2.05 (0.90, 4.66) | 2.30 (1.05, 5.06) | |||
|
| ||||||
| Screening HF severity2 | 1.79 (1.27, 2.52) | <0.001 | 1.50 (1.02, 2.20) | 0.037 | 1.45 (1.00, 2.10) | 0.047 |
|
| ||||||
| Age at screening2 | 0.62 (0.42, 0.93) | 0.021 | 0.75 (0.47, 1.20) | 0.23 | ||
|
| ||||||
| BMI, kg/m2 | 0.11 | 0.99 | ||||
| < 30 (ref) | 1.00 | 1.00 | ||||
| ≥ 30 | 1.63 (0.90, 2.95) | 1.00 (0.50, 2.00) | ||||
|
| ||||||
| PHQ-9 Depression >=5 | 1.68 (0.90, 3.17) | 0.11 | 1.86 (0.90, 3.86) | 0.096 | ||
|
| ||||||
| Full-time employment | 0.16 | 0.92 | ||||
| No | 1.00 | 1.00 | ||||
| Yes | 0.67 (0.38, 1.18) | 0.97 (0.50, 1.89) | ||||
|
| ||||||
| ≤ High school / GED | 0.18 | 0.99 | ||||
| No | 1.00 | 1.00 | ||||
| Yes | 1.64 (0.80, 3.34) | 1.00 (0.42, 2.38) | ||||
|
| ||||||
| Menopause Status | 0.36 | |||||
| Transition (ref) | ||||||
| Postmenopause | 0.62 (0.29, 1.30) | |||||
| Indeterminate | 0.93 (0.31, 2.75) | |||||
|
| ||||||
| SCL Anxiety > 0.3 | 1.23 (0.66, 2.29) | 0.52 | ||||
|
| ||||||
| AE3 reported at Week 4 | 0.55 | |||||
| No | 1.00 | |||||
| Yes | 0.84 (0.47, 1.50) | |||||
|
| ||||||
| Screening HF frequency standard deviation2 | 1.06 (0.83, 1.34) | 0.66 | ||||
|
| ||||||
| Years of hot flashes2 | 1.04 (0.80, 1.34) | 0.79 | ||||
|
| ||||||
| Alcohol use | 0.85 | |||||
| < 1 drink / day | 1.00 | |||||
| ≥ 1 drink / day | 0.93 (0.45, 1.94) | |||||
1
Combined placebo group, N=247. Models adjusted for MS FLASH Protocol and clinic site.
2
Odds ratio indicates the likelihood of improvement based on a unit increase in the continuous variable as follows: HF severity, 0.5 points; age, 5 years; HF frequency standard deviation, 1; years of HF, 5 years.
3
Adverse events included fatigue, nausea, insomnia, headache, dry mouth, vivid dreams, appetite changes, drowsiness, and increased sweating.
4
The first model included all variables entered with P<=0.20 in univariate analysis. The final model included all variables at P<0.05 in multivariable analysis.