Comparison of the efficacy and safety of 1.5 compared with 3.0 g oral slow-release mesalazine (Pentasa) in the maintenance treatment of ulcerative colitis

Fockens, Paul; Mulder, Cjj; Tytgat, G. N. J.; Blok, P.; Ferwerda, J.; Meuwissen, S. G. M.; Tuynman, Hare; Dekker, W.; Gasthuis, Kennemer; Hees, P A van

doi:10.1097/00042737-199511000-00003

Cited by 100 publications

(73 citation statements)

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“…Because of the well-documented effi cacy of sulfasalazine in the prevention of relapse, most ( 212,214 -218,221 -225 ) but not all ( 226 ) 5-ASA relapse-prevention trials have used sulfasalazine as the control. As with sulfasalazine, most ( 225,227,228 ) but not all ( 229,230 ) comparison studies of mesalamine have shown increased effi cacy with higher doses up to 4 g per day of 5-ASA. However, unlike sulfasalazine, larger doses of 5-ASA in the newer preparations are generally well tolerated, lending these analogues an advantage over sulfasalazine for the prevention of relapse.…”

Section: Once the Acute Attack Is Controlled A Maintenance Regimen Imentioning

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: Once the Acute Attack Is Controlled A Maintenance Regimen Imentioning

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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“…If one were to extrapolate data from these 4 studies, it would appear that mesalamine at a dose of 2.4 g/d is most effective in an elderly patient and that once daily dosing is a reasonable frequency schedule. 70 Additionally, relapse rates may be less frequent in the elderly. However, caution should be advised when interpreting these results, as the trends, while noteworthy, are not conclusive.…”

Section: Discussionmentioning

confidence: 99%

“…Four studies performed age subanlyses. 70,106,110,122 Sandborn et al report that in patients with clinical remission of UC, once-daily dosing of Asacol ® at doses of 1.6-2.4 g/d, when compared to the same daily doses but given as BID, was as effective for the maintenance of clinical remission over a 12 month period, with remission rates of 85.4% in both groups. 122 Furthermore, treatment outcomes were consistent between age subgroups younger or older than 65 years.…”

Section: Efficacy Of 5-asa Agentsmentioning

confidence: 99%

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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“…These abnormalities range from sterile asymptomatic pyuria [7] to nephrotic syndrome [8], nephrogenic diabetes insipidus [9,10], and acute [11][12][13] and chronic interstitial nephritis [14,15]. It should also be mentioned that sulfasalazine itself has been associated with renal disease [15,16].…”

Section: Discussionmentioning

confidence: 99%

“…The course of disease described in our patients is similar to that reported in other reports. When we reviewed the available literature, we found 3 cases of chronic interstitial nephritis reported where the serum creatinine level stabilized after withdrawal of 5-ASA and, in 2 of these cases, a trial of corticotherapy seemed ineffective [12,13]. On the other hand, in cases of acute renal disease induced by 5-ASA, withdrawal of the drug with or without steroids was followed by a significant improvement in renal function [8,9,11,14].…”

Section: Discussionmentioning

confidence: 99%

Chronic Interstitial Nephritis due to 5-Aminosalicylic Acid

Agharazii¹,

Marcotte²,

Boucher³

et al. 1999

Am J Nephrol

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Nephrotoxicity has recently been reported with the use of 5-aminosalicylic acid (5-ASA) which has structural similarities to phenacetin and aspirin. The present paper describes 2 cases of interstitial nephritis and 1 case of end-stage failure associated with 5-ASA treatment. The first patient presented with severe renal failure which was partially reversed with 5-ASA discontinuation and steroid therapy. The second had severe renal failure (serum creatinine 469 mmol/l) but renal function stabilized with 5-ASA withdrawal. The third patient had end-stage renal failure and underwent hemodialysis and a successful kidney transplant.

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Comparison of the efficacy and safety of 1.5 compared with 3.0 g oral slow-release mesalazine (Pentasa) in the maintenance treatment of ulcerative colitis

Cited by 100 publications

References 0 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

Treatment of Ulcerative Colitis in the Elderly: A Systematic Review

Chronic Interstitial Nephritis due to 5-Aminosalicylic Acid

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