BACKGROUND: In November 2002, Lotronex® (alosetron HCl) was reintroduced to the U.S. market for women with severe diarrhea-predominant IBS who have failed to respond to conventional therapy, whose IBS symptoms are chronic, and for whom other explanatory gastrointestinal medical conditions have been ruled out. In support of the reintroduction, GlaxoSmithKline (GSK) implemented a risk management program (RMP). As part of the evaluation of the RMP, GSK sponsored a patient follow-up study, conducted by RTI Health Solutions, in which all users of Lotronex have the opportunity to participate.
OBJECTIVE: The primary objective of this epidemiological study is to measure how well physicians and patients are following the RMP requirements for prescribing and using Lotronex and how well patients comprehend the information provided to them.
METHODS: Patients voluntarily enroll in the study via pre-enrollment forms provided by their physicians or in the medication packaging. Following consent and formal enrollment, data are collected by mail at baseline, and by mail or telephone after five and ten weeks, and quarterly thereafter. Questions focus on patient clinical eligibility and compliance with education, prescribing, and dispensing requirements. Questions measuring patient comprehension of the educational materials were rigorously tested through cognitive interviewing and added to the baseline questionnaire.
RESULTS: Between December 9, 2002 and March 31, 2004, 4,196 patients enrolled in the study. Fifty-three percent (53%) of pre-enrollment forms came from patients who received them from their physician. Once enrolled, 67% continued to respond to the follow-up questionnaires with an average follow-up time of approximately 6 months. The response rate for each follow-up assessment was over 95%. Further, 89% of patients at baseline met the full clinical eligibility criteria for treatment with Lotronex. At baseline, over 90% of patients reported signing a physicianpatient agreement (PPA), having discussions with their physician about using Lotronex, and having read the medication guide.
CONCLUSION: Results indicate a high rate of compliance with respect to appropriate patient prescribing, patients signing the PPA, and reading and understanding the patient materials. This suggests that patients are engaged in active dialogue about their symptoms and the use of Lotronex.
