TEGASEROD IMPROVES QUALITY OF LIFE OF PATIENTS WITH NON-DIARRHEA IRRITABLE BOWEL SYNDROME

Abstract

Purpose: Irritable bowel syndrome (IBS) is a chronic and episodic disorder with a significant impact on the quality of life (QoL) of sufferers. Tegaserod, a 5-HT4 receptor partial agonist, is effective, safe, and well tolerated in the treatment of patients with IBS with constipation (IBS-C), as well as those with IBS whose primary bowel habit is not diarrhea (non-D-IBS). Methods: This study assessed the impact of tegaserod on QoL in non-D-IBS patients. Patients (meeting Rome II criteria) enrolled in a clinical trial1 were randomized to receive tegaserod (T) 6 mg b.i.d. or placebo (P) for 12 weeks. QoL data were collected at baseline, Week 4, and Week 12 using the EuroQol EQ-5D questionnaire, a generic, well-validated questionnaire with five items related to mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Changes in health state were assessed by analysis of patients' scores at baseline, Week 4 and Week 12. Due to an imbalance at baseline between T and P group, EQ-5D utility scores were adjusted using an ANCOVA model. Results: QoL data were collected for 247 and 238 patients in the T and P groups, respectively. The adjusted baseline utility scores were 0.726 for both the T and P groups. At Week 4, the mean utility scores for the T and P groups increased to 0.794 and 0.760, respectively. The change from baseline utility score was significantly (p <0.05) greater for T) 0.068 than for P 0.034. At Week 12, the average utility score for patients in the T group was 0.788 compared with 0.746 for patients in the P group. The change from baseline utility score was significantly (p <0.05) greater with T 0.062, than with P 0.020. The incremental gain in quality adjusted life years (QALYs), calculated as the difference in the area under the curve between T and P, was equal to 0.0077. As a point of reference, a QALY gained equal to 0.00081 was estimated for alosetron, a treatment for IBS with diarrhea, compared to usual care. Conclusions: This is the first study to use the EQ-5D questionnaire to assess QoL in patients with IBS treated with tegaserod. In addition to providing global relief of the multiple symptoms of IBS, tegaserod significantly improved patients' QoL compared with placebo as early as 4 weeks after treatment initiation, and were confirmed at the end of the 12-week study.