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

ABSTRACT 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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    • "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.
    Clinical and Experimental Gastroenterology 09/2014; 2014: 7:369 - 383. DOI:10.2147/CEG.S35691
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    • "Medicines adherence is a hugely complex area, influenced by a myriad of factors, and the subject of much research.11 At the same time, there is clear evidence indicating that non-adherence to maintenance mesalazine is associated with a significant rise in the risk of relapse.29 Consequently, it is here that the patient support programmes highlighted above will come into their own. "
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    ABSTRACT: Oral mesalazine represents a crucial front-line agent for the treatment of active ulcerative colitis (UC) and the maintenance of remission. Clinical aspects of mesalazine therapy are guided by robust evidence-based guidelines, although there is a relative paucity of guidance examining the specific administrative and professional issues faced by inflammatory bowel disease (IBD) nurses. As IBD nurses frequently influence treatment decisions in UC, this article was written to provide a practical review of the key evidence and issues affecting mesalazine treatment. Therefore, it may act as an additional resource for IBD nurses, to enhance prescribing decisions. Using the UK's Quality, Innovation, Productivity and Prevention (QIPP) agenda as a framework, it considers clinical and health service priorities affecting treatment decisions. The quality of care perspective naturally focuses on efficacy; recent interest in specific aspects of efficacy, such as the speed of symptom resolution allows targeting of mesalazine treatment to individual needs. Furthermore, innovative adherence programmes build on the latest evidence to develop robust, integrated patient support approaches. In terms of productivity, nurse-led activities and more sophisticated management strategies may offer the best routes towards reducing the costs of care. Key opportunities for preventing ill health include improving adherence to maintenance therapy and achieving mucosal healing. The principles and approaches highlighted by the QIPP agenda emphasise that prescribing decisions for mesalazine in UC must take account of the full spectrum of clinical and health service needs, and cannot focus on any one element in isolation.
    04/2014; 5(2):135-142. DOI:10.1136/flgastro-2013-100357
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    • "Once the adherence and non-adherence for each dose data were obtained, it was sought the remission rate for each condition. The superiority in the maintenance of remission of UURC in patients adherent to treatment was demonstrated in a prospective study published by Kane et al. in 2003 (14) . A cohort of 99 UURC patients in remission who used mesalazine maintenance therapy for more than 6 months was accompanied. "
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    ABSTRACT: Context Unspecified Ulcerative Rectocolitis is a chronic disease that affects between 0.5 and 24.5/105 inhabitants in the world. National and international clinical guidelines recommend the use of aminosalicylates (including mesalazine) as first-line therapy for induction of remission of unspecified ulcerative rectocolitis, and recommend the maintenance of these agents after remission is achieved. However, multiple daily doses required for the maintenance of disease remission compromise compliance with treatment, which is very low (between 45% and 65%). Use of mesalazina in granules (2 g sachet) once daily - Pentasa® sachets 2 g - can enhance treatment adherence, reflecting in an improvement in patients' outcomes. Objective To evaluate the evidence on the use of mesalazine for the maintenance of remission in patients with unspecified ulcerative rectocolitis and its effectiveness when taken once versus more than once a day. From an economic standpoint, to analyze the impact of the adoption of this dosage in Brazil's public health system, considering patients' adherence to treatment. Methods A decision tree was developed based on the Clinical Protocol and Therapeutic Guidelines for Ulcerative Colitis, published by the Ministry of Health in the lobby SAS/MS n° 861 of November 4 th, 2002 and on the algorithms published by the Associação Brasileira de Colite Ulcerativa e Doença de Crohn, aiming to get the cost-effectiveness of mesalazine once daily in granules compared with mesalazine twice daily in tablets. Results The use of mesalazine increases the chances of remission induction and maintenance when compared to placebo, and higher doses are associated with greater chance of success without increasing the risk of adverse events. Conclusion The use of a single daily dose in the maintenance of remission is effective and related to higher patient compliance when compared to the multiple daily dose regimens, with lower costs.
    Arquivos de gastroenterologia 12/2013; 50(4):297-303. DOI:10.1590/S0004-28032013000400011
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