A Prospective Randomized Observer-Blind 2-Year Trial of Azathioprine Monotherapy versus Azathioprine and Olsalazine for the Maintenance of Remission of Steroid-Dependent Ulcerative Colitis

Mantzaris, Gerassimos J.; Sfakianakis, Michael; Archavlis, Emmanuel; Petraki, Kalliopi; Christidou, Angeliki; Karagiannidis, A.; Triadaphyllou, G

doi:10.1111/j.1572-0241.2004.11481.x

Cited by 111 publications

(69 citation statements)

References 35 publications

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“…Additional information regarding risk of infection is available from the Th erapy, Resource, Evaluation, and Assessment Tool registry, an ongoing observational infl iximab safety registry in patients with CD, which contains approximately 6,000 patients with 16,000 years of long-term use results in steroid sparing ( 190 ), fewer admissions to hospital, and fewer operations ( 191 ). In a prospective 2-year trial, the addition of olsalazine did not enhance the effi cacy of azathioprine ( 192 ).…”

Section: Infectionsmentioning

confidence: 99%

Ulcerative Colitis Practice Guidelines in Adults: American College of Gastroenterology, Practice Parameters Committee

Kornbluth

Sachar

2010

American Journal of Gastroenterology

1,156

977

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Guidelines for clinical practice are aimed to indicate preferred approaches to medical problems as established by scientifi cally valid research. Double-blind placebo controlled studies are preferable, but compassionate-use reports and expert review articles are used in a thorough review of the literature conducted through Medline with the National Library of Medicine. When only data that will not withstand objective scrutiny are available, a recommendation is identifi ed as a consensus of experts. Guidelines are applicable to all physicians who address the subject regardless of specialty training or interests and are aimed to indicate the preferable but not necessarily the only acceptable approach to a specifi c problem. Guidelines are intended to be fl exible and must be distinguished from standards of care, which are infl exible and rarely violated. Given the wide range of specifi cs in any healthcare problem, the physician must always choose the course best suited to the individual patient and the variables in existence at the moment of decision. Guidelines are developed under the auspices of the American College of Gastroenterology and its Practice Parameters Committee and approved by the board of trustees. Each has been intensely reviewed and revised by the Committee, other experts in the fi eld, physicians who will use them, and specialists in the science of decision analysis. The recommendations of each guideline are therefore considered valid at the time of composition based on the data available. New developments in medical research and practice pertinent to each guideline will be reviewed at a time established and indicated at publication to assure continued validity. The recommendations made are based on the level of evidence found. Grade A recommendations imply that there is consistent level 1 evidence (randomized controlled trials), grade B indicates that the evidence would be level 2 or 3, which are cohort studies or case -control studies. Grade C recommendations are based on level 4 studies, meaning case series or poor-quality cohort studies, and grade D recommendations are based on level 5 evidence, meaning expert opinion.

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Section: Infectionsmentioning

confidence: 99%

Ulcerative Colitis Practice Guidelines in Adults: American College of Gastroenterology, Practice Parameters Committee

Kornbluth

Sachar

2010

American Journal of Gastroenterology

1,156

977

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“…From the efficacy standpoint, patients with steroid-dependent UC who are able to achieve remission with azathioprine and mesalamine and discontinue glucocorticoids can be maintained in remission with azathioprine alone (13).…”

Section: Discussionmentioning

confidence: 99%

Kaposi’s sarcoma in patients with ulcerative colitis receiving immunosuppressive drugs: Report of a case

Çetin¹,

Büyükberber²,

Yılmaz³

et al. 2011

Turk J Gastroenterol

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“…Mantzaris et al enrolled seventy patients and 34 received AZA. 47 Maintenance of remission at two years was 81% versus 82%. The mean age was 35 55,56 Both studies showed results favoring the AZA/5-ASA/ corticosteroid regimen over the 5-ASA/corticosteroid only regimen.…”

Section: Azathioprinementioning

confidence: 99%

“…Based on age range alone, 2 studies did not include elderly patients. 47,48 There were a total of 15 studies in which the estimated number of elderly patients could be calculated by adding 1 or 2 SD to the mean age, whichever provided the closest estimate to an elderly age. Using this method, approximately 16% of the study population had a mean age of 52.1 years (mean of 'mean plus 1 SD') or older.…”

Section: Immunosuppressant Age Summationmentioning

confidence: 99%

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Treatment of Ulcerative Colitis in the Elderly: A Systematic Review

Baggenstos

Hanson²,

Shaukat

2013

Clinical Medicine Insights: Geriatrics

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Ulcerative colitis (UC) is increasingly recognized as a disease affecting the elderly. Approximately 10%-30% of the UC population is over the age of 60 years. Additionally, younger patients with UC are aging and thus comprise a second group of elderly IBD patients. To date, there have been no clinical trials that have evaluated treatment efficacy of UC in the elderly population. The aim of our study was to conduct a systematic review of all randomized controlled trials (RCTs) addressing treatment outcome in UC; we also sought to identify the elderly population, defined as age 60 years or older, represented in these studies, to see if pooled data would lead to meaningful conclusions regarding treatment efficacy and safety profile in the elderly. A search of the MEDLINE database via PubMed and the EMBASE database via Scopus was performed to identify all RCTs evaluating medical therapy for UC in humans, published within the English language through September 2012. Studies were grouped into three categories: biological agent (BA) therapy; immunosuppressant (IS) therapy; and 5-aminosalicylic acid (5-ASA) therapy. To estimate the number of elderly patients in each study, mean age plus 1 and 2 standard deviations (SD) was calculated to find the closest approximation to age 60. Of 876 studies, 112 RCTs were included in the final analysis-20 studies for BA, 20 for IS, and 72 for 5-ASA agents. While nearly all studies reported either a mean or median age, only 38% additionally reported the SD and age range. The mean composite age was 39.2 years for the BA studies, 38.5 years for the IS studies, and 42.8 years for the 5-ASA studies, consistent with a young middle-aged patient. We estimated that no more than 16% of patients per study would have qualified as elderly, and in most cases a much smaller percentage (,8%). Additionally, there were no BA or IS RCTs that reported results by age subgroup analysis. Four studies in the 5-ASA group report age-specific analyses and showed no difference in treatment efficacy by age. None of the 112 RCTs reported age sub-analyses of safety, tolerability, adverse events, or withdrawal rates. There is insufficient evidence to evaluate efficacy of treatment and adverse events from treatment for UC in the elderly. With the rising number of elderly patients with UC, there is a need for more clinical trials that specifically address UC treatment in this unique population.

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A Prospective Randomized Observer-Blind 2-Year Trial of Azathioprine Monotherapy versus Azathioprine and Olsalazine for the Maintenance of Remission of Steroid-Dependent Ulcerative Colitis

Abstract: Patients with steroid-dependent UC successfully maintained in remission on AZA are not in need of 5-aminosalicylic acid compounds.

Cited by 111 publications

References 35 publications

Ulcerative Colitis Practice Guidelines in Adults: American College of Gastroenterology, Practice Parameters Committee

Ulcerative Colitis Practice Guidelines in Adults: American College of Gastroenterology, Practice Parameters Committee

Kaposi’s sarcoma in patients with ulcerative colitis receiving immunosuppressive drugs: Report of a case

Treatment of Ulcerative Colitis in the Elderly: A Systematic Review

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