EFFECT OF DOMPERIDONE ON THE HEALTH-RELATED QUALITY-OF-LIFE OF PATIENTS WITH SYMPTOMS OF DIABETIC GASTROPARESIS

OBJECTIVE - To describe the health-related quality of life (HRQOL) of patients with insulin-treated diabetes and symptoms of diabetic gastro paresis and to assess the impact of domperidone on HRQOL in these pati ents. RESEARCH DESIGN AND METHODS - This two-phase multicenter study w as part of a safety and efficacy investigation. Phase I involved dr-we ek single-blind treatment with domperidone 20 mg q.i.d. (n = 269). Pat ients demonstrating significant symptomatic improvement (n = 208) cont inued to phase II, a 4-week, double-blind, parallel-group study with p atients receiving placebo (n = 103) or domperidone (n = 105). Patients completed the Medical Outcomes Study Short-Form-36 Health Survey at s election and at the end of each phase. Physical component summary (PCS ) and mental component summary (MCS) scores served as primary paramete rs, and the eight subscales were secondary parameters. RESULTS - HRQOL scores of subjects enrolled in the trial were significantly lower tha n norms from the general population and people with diabetes (P < 0.00 1). Subjects experiencing symptomatic improvement after 4 weeks of sin gle-blind treatment demonstrated significant improvement in all HRQOL parameters (P < 0.001); PCS, MCS, and six subscale scores of nonrespon ders did not change. Between-group change score differences were signi ficant for PCS, MCS, and seven subscales (P < 0.05 to P < 0.001). Duri ng phase II, the domperidone group maintained their HRQOL; the placebo group showed a significant decline in PCS and four subscales (P < 0.0 5). The between-group difference in the PCS score change was statistic ally significant (-1.77 vs. 0.65, P = 0.05). CONCLUSIONS - Results sug gest that patients with symptoms of diabetic gastroparesis experience notable HRQOL impairment and that symptomatic relief with domperidone is accompanied by improvements in HRQOL that can be sustained over 4 w eeks of treatment.