Kane S, Huo D, Aikens J, et al.. Medication nonadherence and the outcomes of patients with quiescent ulcerative colitis

Department of Health Studies, University of Chicago, Chicago, Illinois, United States
The American Journal of Medicine (Impact Factor: 5). 01/2003; 114(1):39-43. DOI: 10.1016/S0002-9343(02)01383-9
Source: PubMed


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

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    • "Additionally non-adherence to maintenance therapy is associated with a strong increase in relapse rates[75]. Non-adherence to maintenance therapy occurs in about 30–45% of patients with conventional therapy[76]and 20–30% of patients taking TNF-inhibitors[77]. Risk factors for nonadherence include regimen complexity, mode of administration, concomitant immunomodulators, and side effects[78,79]. "
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    ABSTRACT: Crohn's Disease (CD) and Ulcerative Colitis (UC) are chronic, relapsing conditions resulting from uncontrolled inflammation of the intestinal mucosa. Both conditions are associated with significant disability and patients with CD face higher mortality rates compared to the general population. The increasing understanding of the immunological basis of the disease led to the introduction of biologic therapies targeting key pathways of the natural and adaptive immune response such as Tumor Necrosis Factor α (TNF-α) inhibitors and, more recently, integrin-receptor antagonists. Treatment with TNF-α inhibitors improved clinical and patient-reported outcomes for many patients who did not benefit from conventional therapy. However, a sizeable share of patients still face suboptimal outcomes due to primary or secondary therapy failure. With the introduction of VDZ, a biologic treatment targeting novel IBD-relevant biologic pathways, it is crucial to understand how to integrate such innovations into current clinical practice. To this end, a panel of 14 Italian experts in the management of IBD met for a roundtable discussion. Recommendations concerning the management of moderate-to-severe IBD based on experts’ opinions and literature review are discussed in the present report.
    Full-text · Article · Jan 2016
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    • "Imagine a patient with a disease that can be managed from a distance. For instance, patients with congestive heart failure or Crohn's disease can be monitored in the comfort of their own home through telehealth — using remote monitoring systems or the telephone (Car and Sheikh, 2003; Inglis, 2010; Kane et al., 2003; Hommel et al., 2013). The cost savings to the patient, and therefore, the health system can be significant (Car and Sheikh, 2003; Bashshur et al., 2009). "

    Full-text · Article · Aug 2015 · EBioMedicine
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    • "Patients who were non-adherent to their prescribed 5-ASA therapy had a greater than fivefold increased risk of clinical relapse. Moreover, adherent patients were shown to have an 89% chance of maintaining remission, compared with only 39% in non-adherent patients.57 Other consequences of non-adherence to 5-ASA therapy are an increased risk of developing colon cancer and increased health care costs.51,52,56 "
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    ABSTRACT: In 1977, 5-aminosalicylic acid (5-ASA) was discovered as a therapeutically active moiety of sulfasalazine (SASP) and was launched for topical and oral therapy of ulcerative colitis (UC) in 1984. As a first-step, delivery systems had to be developed to protect 5-ASA against absorption in the upper gastrointestinal tract, resulting in different and competing strategies (azo compounds, controlled release, and pH-dependent release). In a second step, at the beginning of the new century, coinciding with the expiration of patent protection for the first 5-ASA formulations, two component composite release mechanisms (pH-dependent and controlled release) were developed. Furthermore, the drug was formulated as granules instead of tablets, allowing higher unit strengths compared with tablets. Neither Salofalk Granu-Stix®, nor MMX 5-ASA, nor Pentasa® granules have initially been developed for once-daily (OD) dosing. A review of the achievements of 20 years of 5-ASA development has demonstrated that 5-ASA has equal efficacy compared with SASP at best, that there are no measurable differences in efficacy between various 5-ASA preparations, and that in a group of patients tolerating SASP, adverse event profiles of SASP and 5-ASA did not differ significantly, with SASP being the far cheaper substance. Therefore, drug adherence came into focus as a new goal for improving UC therapy. Although adherence is a complex and multifactorial construct, a simple dosing schedule may contribute to higher drug adherence and better efficacy of treatment. Simultaneously, the US 5-ASA market, estimated to be worth US$1.4 billion, is expected to grow continuously. Naturally, this very competitive market is not only driven by scientific progress but also by commercial interests. Thus, patents for minor changes to the formulation may serve as protection against drug companies trying to launch generic versions. Randomized controlled trials performed on OD dosing in induction of remission have demonstrated that OD administration of 5-ASA is as effective as conventional dosing in mild to moderate active UC. The three 5-ASA products MMX, Salofalk®, and Pentasa® employed in those studies so far have not shown differences in efficacy between OD and conventional dosing. No differences regarding safety outcomes have been detected between OD and conventional dosing, including incidence of adverse events, serious adverse events, or withdrawal from treatment due to an adverse event. Although the majority of patients prefer OD dosing to conventional dosing, it was not possible to detect differences in adherence between OD and multiple dose regimens in the clinical trial setting. Well-designed and controlled large-scale community-based studies are necessary to further investigate and prove the point of improved long-term adherence and treatment efficacy in OD dosing.
    Full-text · Article · Sep 2014 · Clinical and Experimental Gastroenterology
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