5-Aminosalicylic Acid in the Treatment of Crohn's Disease: A 16-Week Double-Blind, Placebo-Controlled, Multicentre Study with Pentasa®

Rasmussen, Sten Nørby; Lauritsen, K; Tage-Jensen, U; Nielsen, Ole Haagen; Bytzer, P; Jacobsen, Ole Stig; Ladefoged, Karin; Vilien, M.; Binder, Vibeke; Rask-Madsen, J

doi:10.3109/00365528708991929

Cited by 123 publications

(38 citation statements)

References 15 publications

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“…This problem seemed to be overcome by the galenic preparation of this new formulation (6). However, this study and an earlier one not published before the stare of this trial indicate that 5-ASA at doses recommended by the manufacturer is not effective in the treatment of active Crohn's disease (10). As this preparation has to be given in higher doses in ulcerative colitis as well in order to be effective (1 3 ), it seems conceivable chat the dose chosen for the present trial was too low.…”

Section: Discussionmentioning

confidence: 40%

“…As this preparation has to be given in higher doses in ulcerative colitis as well in order to be effective (1 3 ), it seems conceivable chat the dose chosen for the present trial was too low. If the autho rs had known the results of the above mentioned trial ( 10) and the data on ulcerative colitis, they would probably have ch osen a higher dose from the beginning. However, the lack of efficacy might not be due solely to the dosage used.…”

Section: Discussionmentioning

confidence: 99%

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Oral 5-Aminosalicyclic Acid Versus 6-Methylprednisolone in Active Crohn's Disease

Schölmerich¹,

Jenss²,

Hartmann³

et al. 1990

Canadian Journal of Gastroenterology

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The response to 5-aminosalicylic acid (5-ASA) in active Crohn's disease was studied in comparison to methylprednisolone in a 24 week randomized double-blind multicentre study. Sixty-two patients were included in the analysis. Thirty were treated with 500 mg 5-ASA qid and 32 with methylprednisolone (starting dose 48 mg for one week, then reduced weekly to 32, 24, 20, 16 and 12 mg with maintenance at 8 mg/day for the remaining 18 weeks). Mean age, earlier surgical intervention, localization of Crohn's disease and extraintestinal manifestations were not different in both groups. The Crohn's disease activity index (CDAI) and the van Hees index were not significantly different in both treatment groups at the entrance examination (median CDAI 232 in the 5-ASA group and 220 in the methylprednisolone group). According to the protocol, treatment was stopped due to insufficient efficacy in 73% of the patients receiving 5-ASA and in 34% of the patients receiving methylprednisolone (x2test P=0.0019). The area under the curve for the CDAl was significantly greater in 5-ASA (median 170) than in methylprednisolone (P≤0.007) (68). Eleven per cent of patients taking 5-ASA and 26% of patients taking methylprednisolone presented relevant side effects to treatment (not significant). It is concluded from these data that 5-ASA at the dose used in this study is not efficient in the treatment of active Crohn's disease. Considering recent studies in ulcerative colitis, a trial using a higher dose is indicated.

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Section: Discussionmentioning

confidence: 40%

Section: Discussionmentioning

confidence: 99%

Oral 5-Aminosalicyclic Acid Versus 6-Methylprednisolone in Active Crohn's Disease

Schölmerich¹,

Jenss²,

Hartmann³

et al. 1990

Canadian Journal of Gastroenterology

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“…In total, six placebo-controlled trials with varying dosages of mesalamine have been performed to date. Two earlier studies did not detect a benefit of mesalamine over placebo in inducing remission [12,13] . Tremaine and colleagues observed a significantly greater number of patients that responded (defined as either a decrease of CDAI ≥ 70 or CDAI < 150), but this benefit was rather small (9 patients with mesalamine treatment vs 4 patients in the placebo group).…”

Section: -Asamentioning

confidence: 99%

Conventional therapy for Crohn’s disease

Büning

Lochs²

2006

WJG

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Crohn's disease (CD) is a multifactorial disorder of unknown cause. Outstanding progress regarding the pathophysiology of CD has led to the development of innovative therapeutic concepts. Numerous controlled trials have been performed in CD over the last years. However, many drugs have not been approved by regulatory authorities due to lack of efficacy or severe side effects. Therefore, well-known drugs, including 5-ASA, systemic or topical corticosteroids, and immunosuppressants such as azathioprine, are still the mainstay of CD therapy. Importantly, biologicals such as infliximab have shown to be efficacious in problematic settings such as fistulizing or steroid-dependent CD. This review is intended to give practical guidelines to clinicians for the conventional treatment of CD. We concentrated on the results of randomized, placebo-controlled trials and meta-analyses, when available, that provide the highest degree of evidence. We provide evidence-based treatment algorithms whenever possible. However, many clinical situations have not been answered by controlled clinical trials and it is important to fill these gaps through expert opinions. We hope that this review offers a useful tool for clinicians in the challenging treatment of CD.

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“…The two first studies investigated 1.5 g of mesalamine (Pentasa, corresponding to 3 g of SFS), given for 16 or 6 weeks, respectively [15, 16]. The authors observed no benefit of mesalamine over placebo (40 vs. 30 or 35%, respectively) in inducing remission of CD.…”

Section: First-line Treatment Optionsmentioning

confidence: 99%

Therapy of Mild to Moderate Luminal Crohn’s Disease

et al. 2005

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The management of luminal Crohn’s disease, the most common form of initial presentation of the disease, depends on the location and the severity of the lesions. Mild to moderate disease represents a relatively large proportion of patients with a first flare of luminal disease, which may also be associated with perianal disease. As quality of life of these patients correlates with disease activity, adequate therapy is a central goal of the overall patient management. Treatment options include mainly sulfasalazine, budesonide and systemic steroids, while the role of mesalazine and antibiotics remains controversial. The role of biological therapies in mild to moderate disease has not been thoroughly evaluated and will not be discussed here.

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5-Aminosalicylic Acid in the Treatment of Crohn's Disease: A 16-Week Double-Blind, Placebo-Controlled, Multicentre Study with Pentasa®

Cited by 123 publications

References 15 publications

Oral 5-Aminosalicyclic Acid Versus 6-Methylprednisolone in Active Crohn's Disease

Oral 5-Aminosalicyclic Acid Versus 6-Methylprednisolone in Active Crohn's Disease

Conventional therapy for Crohn’s disease

Therapy of Mild to Moderate Luminal Crohn’s Disease

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