Session: FP21-HPA Axis: New Clinical Developments
Room 134 (Moscone Center)
Poster Board SUN-51
Design, Subjects, Measurements: We performed a cross-over randomised multi-centre trial, comparing 3 months of weight-adjusted thrice daily oral hydrocortisone (OHC) with 3 months on CSHI (NCT 01063569). Patients were examined at baseline and after 2 and 3 months in each treatment period. QoL was evaluated by Addiqol including the Addiqol short version, and the generic questionnaires SF-36 (Short Form-36) and PGWBI (Psychological General Well-Being Index). Statistical analyses were performed with linear mixed effects models with random intercepts.
Results: Thirty-three patients were included (8 males), the mean age (SD) was 48 years (11.7), and the mean AD duration 12.4 years (10.1). The median pre-treatment hydrocortisone equivalent dose was 0.36 mg/kg/d (range 0.21-0.74). Oral trial doses (median 0.23 mg/kg/day, range 0.2-0.5) were slightly lower than CSHI doses (median 0.28 mg/kg/24h, 0.24-0.5).There were no significant between-treatment differences for weight, waist- and hip circumference or systolic and diastolic blood pressure.
Addiqol scores increased during CSHI (p for trend <0.001) but where unchanged during OHC (p for trend =0.90), indicating that CSHI improves QoL in AD when compared to OHC (p for interaction =0.010). The Addiqol short version scores displayed a similar pattern (p for interaction =0.034).The PGWB total score improved during CSHI (p for trend=0.012), but the difference to OHC was not statistically significant (p for interaction=0.304). The subscales Vitality (p for trend <0.001) and Anxiety (p for trend =0.016) improved during CSHI, and scores were significantly better than for OHC (p for interaction=0.029 and p=0.04 respectively). The SF-36 detected QoL changes only in the Physical Function subscale, where CSHI scores improved (p for trend=0.076) and OHC scores were unchanged (p for trend=0.299), resulting in higher Qol scores for CSHI (p for interaction=0.027).
Conclusion: CSHI improves several QoL parameters in AD compared to OHC. Furthermore, the disease-specific Addiqol questionnaire was more responsive to QoL changes in AD than the generic SF-36 and PGWB questionnaires.
Nothing to Disclose: MO, SB, MI, RMN, SC, OK, ALH, SB, ESH, KL
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