CHARACTERIZATION OF TEGASEROD-TREATED PATIENTS IN A MANAGED CARE POPULATION

Abstract

Purpose: Irritable bowel syndrome with constipation is characterized by abdominal pain (A), bloating (B) and constipation (C). Tegaserod maleate, a highly selective serotonin (5-HT4) receptor agonist, is approved for women with IBS with constipation. This study describes the diagnostic characteristics, comorbidities and concomitant medications associated with tegaserod utilization in a managed care setting. Methods: A retrospective, longitudinal comparative study of tegaserod users was conducted utilizing medical and pharmacy administrative claims data from a large, geographically diverse managed care organization. Continuously enrolled, benefit-eligible members “new” to tegaserod therapy were identified between 8/1/02 - 6/30/03 and characterized as having at least 1 IBS-related medical claim for A, B, C or IBS (IBS group) or other GI-related claims (GI group). Descriptive statistics, including demographics, comorbidities and GI-related medication use during the 6 month period prior to the first tegaserod prescription, were reported for both groups. Results: Of 3,365 new tegaserod users, 2,770 (82%) had at least 1 medical claim consistent with IBS, A, B or C: 48% had claims for IBS, 40% A, 11% B, and 38% C. Overall, compared to the GI group, the IBS group was more female (93% vs. 88%) and younger (46 ± 14 vs. 49 ± 15). In termsof comorbidities, the IBS group had significantly higher rates of psychiatric disorders (20% vs. 10%), back pain (17% vs. 11%), and migraines/headaches (11% vs. 5%) than the GI group. Prior GI-related drug utilization was different between the two groups: the IBS group used significantly more laxatives (23% vs. 11%), antispasmodics (22% vs. 12%) and antidepressants/SSRI (38% vs. 34%) than the GI group; the GI group used significantly more promotility agents (12% vs. 8%) than the IBS group. On average, the IBS group had more prescriptions (standardized to 30 days) of tegaserod than the GI group (2.32 ± 1.63 vs. 2.00 ± 1.44). Conclusions: In this study population, 82% of patients prescribed tegaserod had diagnostic claims consistent with IBS, A, B or C. Associated comorbidities and concomitant drug utilization in the IBS group appeared comparable to other studies. These data suggest that tegaserod utilization is associated with a clinically appropriate population.