Clinical study
Medication nonadherence and the outcomes of patients with quiescent ulcerative colitis

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Abstract

Purpose

We conducted a prospective study to determine the effects of nonadherence with mesalamine among patients with quiescent ulcerative colitis.

Methods

We followed a cohort of 99 consecutive patients who had ulcerative colitis in remission for more than 6 months and who were taking maintenance mesalamine. Medication adherence rates were calculated based on pharmacy records and a validated formula. Nonadherence was defined as refilling less than 80% of prescribed medication. Patients were followed prospectively and evaluated either in clinic or via telephone at 6, 12, and 24 months. The primary outcome was clinical recurrence of ulcerative colitis. Proportional hazards models were used to adjust for confounders.

Results

At 6 months, 12 patients (12%) had clinical recurrence of disease symptoms, all of whom were nonadherent with medication. At 12 months, 19 of 86 patients had recurrent disease, 13 (68%) of whom were nonadherent. Patients who were not adherent with medication had more than a fivefold greater risk of recurrence than adherent patients (hazard ratio = 5.5; 95% confidence interval: 2.3 to 13; P < 0.001).

Conclusion

Nonadherence with medication increases the risk of clinical relapse among patients with quiescent ulcerative colitis. Future research should be directed at behavioral interventions to improve adherence.

Section snippets

Patients

Patients followed at the University of Chicago Adult Gastroenterology Outpatient Clinic were enrolled. Patients were recruited consecutively from May 1998 through October 1998, either during a clinic visit or via telephone after a patient-initiated request for a medication refill. Eligibility criteria included a history of quiescent ulcerative colitis for at least the preceding 6 months and maintenance treatment with mesalamine (Asacol, Procter and Gamble, Cincinnati, Ohio). The diagnosis of

Results

Ninety-nine consecutive patients with ulcerative colitis in remission and who were being treated with mesalamine were recruited during an 8-month period (Table 1). Thirty-nine patients developed recurrent symptoms during follow-up. The annual incidence of relapse was about 20%.

By 6 months, 12 patients (12%) had clinical recurrence of their disease, all of whom were nonadherent with medication. The median percentage of prescribed mesalamine refilled was 51% (range, 0% to 76%), compared with 77%

Discussion

In this prospective study, we found that clinical recurrence of ulcerative colitis was associated with nonadherence to prescribed mesalamine. A previous study, which followed patients for 48 weeks to identify risk factors for recurrent ulcerative colitis, did not find any association between medication adherence and clinical relapse (20). However, medication adherence was measured by asking patients and was greater than 95% for all participants. Direct patient inquiry is inaccurate as patients

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    This research was funded by grants from Procter and Gamble Pharmaceuticals, Cincinnati, Ohio, and the David and Reva Logan Center for Gastrointestinal Research, Chicago, Illinois.

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