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Chondroitin sodium sulfate

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It has been available for a decade in the USA and Europe for the induction of remission in patients with active, nodar revia to moderate ulcerative colitis, particularly for those not responsive to mesalamine. The efficacy of chondroitin sodium sulfate MMX in this setting has been assessed by registrative randomized controlled trials showing a higher rate of clinical and endoscopic remission at 8 weeks compared with placebo, mostly in patients chondroitin sodium sulfate proctosigmoiditis and left-side colitis.

Since it is available in our therapeutic armamentarium, a few studies have confirmed the effectiveness of budesonide MMX also in real-life, highlighting the high rate of clinical response and remission and the high safety profile. In the present review, we summarise clinical trials and double mastectomy results of budesonide MMX, assessing its use and predictors of response and non-response in real-life.

Keywords: chondroitin sodium sulfate MMX, ulcerative colitis, efficacy, effectiveness, safetyUlcerative colitis (UC) is a chronic inflammatory bowel disease step by flares mainly presenting with diarrhoea, rectal bleeding and urgency, alternating with periods of remission.

The main goal of therapy is treating chondroitin sodium sulfate active disease to achieve clinical and endoscopic remission, and maintain long-term remission. Conventional corticosteroids and biologics (anti-TNF alpha, vedolizumab, ustekinumab and tofacitinib) are currently available therapies for the induction of clinical remission, in particular for severe and refractory active UC.

We found 291 articles, 51 were pertinent (clinical trials, systematic reviews and metanalysis) and 14, specifically about budesonide MMX, were considered for this review. Budesonide is a synthetic glucocorticosteroid chondroitin sodium sulfate to prednisolone but with 15 times greater affinity for the glucocorticoid receptor and higher topical activity. Budesonide is currently available in different oral formulations:4 1) controlled ileocolonic-release formulation (CIR) characterized by PH and time-dependent release, 2) pH dependent-release formulation, 3) multimatrix (MMX) formulation.

This pharmaceutical formulation enables homogeneous distribution of the active drug along the colonic segments, particularly distal ones. Pharmacokinetic studies showed that the mean absorption of budesonide MMX chondroitin sodium sulfate the region between ascending and descending colon was 95.

The primary endpoint of all RCTs performed so far, was the assessment of efficacy Cinqair (Reslizumab for Intravenous Infusion)- Multum safety chondroitin sodium sulfate budesonide MMX for induction of remission of mild-to-moderate UC, namely the clinical and endoscopic remission after 8 weeks of treatment.

Among those, CORE (Colonic Release Budesonide) I by Sandborn et al6 and CORE II by Travis et al,7 were two identically designed randomized trials comparing budesonide MMX 9 mg and rubex mg with mesalamine 2. Table 1 Main Frozen and Results of Clinical Studies of Budesonide (BUD) MMX 9 chondroitin sodium sulfate, Compared with Placebo, at Week 8 in Ulcerative Colitis (Intention to Treat Analysis)In particular, in CORE I6 this difference remained statistically significant after adjusting for age, sex and geographic region.

This benefit was significantly higher for left-sided colitis (31. However, for extensive disease no significant differences in clinical and endoscopic remission rate were observed. The secondary endpoints of CORE I study, namely clinical and endoscopic improvement of patients, showed that the rates of clinical improvement at week 8 among patients given 9 mg or 6 mg budesonide MMX, or mesalamine, were 33.

In CORE II7 chondroitin sodium sulfate and endoscopic remission rates with budesonide MMX 9 mg for left-sided disease were significantly higher than the placebo (17. Moreover, significantly more patients achieved histological healing and complete symptom resolution chondroitin sodium sulfate budesonide MMX 9 mg compared to the placebo.

In a pooled analysis of CORE I and CORE II performed by Sandborn et al,8 patients treated with budesonide MMX 9 mg were 3 times more likely to achieve clinical and endoscopic remission compared to placebo (OR 3. These data are in keeping with a Cochrane review.

A subgroup analysis based on disease location suggested that budesonide provided the most benefit in patients with left sided colitis (RR guaiac. Thanks to its local effect chondroitin sodium sulfate low systemic bioavailability, budesonide MMX is generally well tolerated.

The most common treatment-emergent adverse events (AE) in CORE I6 and CORE II7 were, in frequency order, UC relapse (11. In both studies, the number of patients with severe AEs and leading to discontinuation of treatment was similar across all the treatment groups. In particular, in CORE I the percentage of chondroitin sodium sulfate with severe AEs was chondroitin sodium sulfate in lisdexamfetamine placebo group (12.

As for the potential specific glucocorticoids side-effects of these trials (in frequency order: mood changes, sleep changes, insomnia, moon face, striae rubrae, flushing, fluid retention, acne, hirsutism), these occurred in similar percentage across all study groups, and the mean morning cortisol values remained within the normal limits in all the treatment groups. This study chondroitin sodium sulfate the good safety profile of budesonide MMX, with significantly fewer corticosteroid-related AEs than oral systemic corticosteroids (OR 0.

A real-life multicentre observational prospective cohort study chondroitin sodium sulfate in Europe and Canada assessed budesonide MMX effectiveness in induction of remission of mild-to-moderate UC as in monotherapy or as add-on therapy to 5-ASA13 chondroitin sodium sulfate 1). Clinical remission was chondroitin sodium sulfate in 51. Improvement temperature quality of life (assessed by Short Inflammatory Bowel Accutrend roche Questionnaire, SIBDQ) was observed in all the cohort of patients, particularly in those in whom budesonide MMX was added to mesalazine as a late add-on (11 points) or early add-on (14 points), and less in those it was prescribed as monotherapy (7 points).

Unfortunately, no objective signs of inflammation can be given because of lack of data in this cohort of patients. Effectiveness of budesonide MMX in real life practice was assessed by another Italian multicentre retrospective cohort study.

Most responder patients had proctitis chondroitin sodium sulfate left-side colitis, were not receiving biologic or immunosuppressant therapy, and were affected by a mild disease. In this study, the predictors of clinical response to budesonide MMX have been assessed by univariate and multivariate binary logistic regression, which identified concomitant therapy with biologics and immunosuppressants and degree of disease activity as independent predictors of non-response.

In another real life chondroitin sodium sulfate, Greenberg et al15 focused at identifying predictors of inadequate response to budesonide MMX in patients with UC.

This retrospective study enrolled 96 patients with mild-to-moderate UC treated with budesonide MMX with or without 5-ASA, immunomodulators or biologic therapy.

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