Paser (Aminosalicylic Acid) - Summary

PASER SUMMARY

PASER granules are a delayed release granule preparation of aminosalicylic acid (p-aminosalicylic acid: 4-aminosalicylic acid) for use with other anti-tuberculosis drugs for the treatment of all forms of active tuberculosis due to susceptible strains of tubercle bacilli. The granules are designed for gradual release to avoid high peak levels not useful (and perhaps toxic) with bacteriostatic drugs. Aminosalicylic acid is rapidly degraded in acid media; the protective acid-resistant outer coating is rapidly dissolved in neutral media so a mildly acidic food such as orange, apple or tomato juice, yogurt or apple sauce should be used.

PASER is indicated for the treatment of tuberculosis in combination with other active agents. It is most commonly used in patients with Multi-drug Resistant TB (MDR-TB) or in situations when therapy with isoniazid and rifampin is not possible due to a combination of resistance and/or intolerance. When PASER is added to the treatment regimen in patients with proven or suspected drug resistance, it should be accompanied by at least one and preferably two other new agents to which the patient's organism is known or expected to be susceptible.

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NEWS HIGHLIGHTS

Media Articles Related to Paser (Aminosalicylic Acid)

Arthritis Drug Raises Risk of Tuberculosis
Source: MedicineNet Ankylosing Spondylitis Specialty [2009.07.10]
Title: Arthritis Drug Raises Risk of Tuberculosis
Category: Health News
Created: 7/10/2009 7:00:00 AM
Last Editorial Review: 7/10/2009

Tuberculosis
Source: MedicineNet Erythema Nodosum Specialty [2008.01.17]
Title: Tuberculosis
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 1/17/2008

Extensively Drug-Resistant Tuberculosis (XDR TB)
Source: MedicineNet ICU Psychosis Specialty [2007.05.30]
Title: Extensively Drug-Resistant Tuberculosis (XDR TB)
Category: Diseases and Conditions
Created: 5/30/2007
Last Editorial Review: 5/30/2007

Opinions: Fighting TB; Currency Transaction Tax
Source: Health News from Medical News Today [2009.11.19]
Innovation, Coordination Needed To 'Bring TB Research Into The 21st Century' Though tuberculosis "is one of the world's leading killers … few citizens, scientists and policymakers are demanding more attention to TB research, treatment and prevention.

Global Fund Approves $2.4B For Ninth Round Grants
Source: HIV / AIDS News From Medical News Today [2009.11.16]
During its recent board meeting in Addis Ababa, Ethiopia, the Global Fund to Fight AIDS, Tuberculosis and Malaria approved $2.4 billion for the three diseases, PlusNews reports. The money is for the fund's "ninth round of grants, bringing the total amount of approved funding since its inception in 2001 to $18.4 billion," according to the publication.

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Published Studies Related to Paser (Aminosalicylic Acid)

Development of a Web-based concept for patients with ulcerative colitis and 5-aminosalicylic acid treatment. [2009.06.18]
BACKGROUND: Ulcerative colitis (UC) is a lifelong disease with increasing incidence. UC requires frequent outpatient clinic visits and continuous medical treatment. Web-based self-management in other chronic diseases influences disease course, and increases self-adherence, compliance and quality of life (QoL). Lack of easy access to inflammatory bowel disease clinics and patient education, their understanding of the importance of early treatment at relapse, poor compliance and self-adherence can be partly solved by a newly developed Web-based concept. AIMS: To describe the development and validation of the Web-based 'Constant-Care' concept... CONCLUSION: Patient education and training through a Web-based program (www.constant-care.dk) seems to be a feasible concept for increasing patients' ability to self-initiate treatment and increase the level of disease-specific knowledge. Relevant adjustment of the concept was implemented. The final outcome of the 'Constant-Care' concept is pending.

Effect of weekend 5-aminosalicylic acid (mesalazine) enema as maintenance therapy for ulcerative colitis: results from a randomized controlled study. [2007.09]
BACKGROUND: 5-aminosalicylic acid (5-ASA) is known to be effective in the treatment of active ulcerative colitis (UC). The aim of the current study was to investigate the effect of 5-ASA enemas, as a maintenance therapy for UC, when administered twice weekly as a weekend treatment regimen, compared to daily oral 5-ASA alone. We hypothesized that the weekend enema therapy would be better tolerated by patients who worked or attended school... CONCLUSIONS: This study demonstrated the beneficial effects of adding weekend 1 g 5-ASA enema to daily 3 g oral 5-ASA as maintenance therapy for UC.

Meta-analysis: the efficacy of rectal beclomethasone dipropionate vs. 5-aminosalicylic acid in mild to moderate distal ulcerative colitis. [2007.07.01]
BACKGROUND: Beclomethasone dipropionate (BDP) is a second-generation steroid with topical effects and minimal systemic activity for patients with ulcerative colitis (UC). AIM: To review all available literature to assess the efficacy of enema/foam BDP compared with enema/foam 5-aminosalicylic acid (5-ASA) in the control of left-sided mild-moderate UC... CONCLUSION: The randomized controlled trials identified in this review showed that rectal BDP has equal effect as 5-ASA to control symptoms in UC.

Randomised controlled trial of azathioprine and 5-aminosalicylic acid for treatment of steroid dependent ulcerative colitis. [2006.01]
BACKGROUND AND AIMS: There are limited evidence based data concerning the use of azathioprine in ulcerative colitis. We aimed to compare the efficacy of azathioprine and oral 5-aminosalicylic acid in inducing remission of steroid dependent ulcerative colitis... CONCLUSIONS: Azathioprine is significantly more effective than 5-aminosalicylic acid in inducing clinical and endoscopic remission and avoiding steroid requirement in the treatment of steroid dependent ulcerative colitis.

Trial of trefoil factor 3 enemas, in combination with oral 5-aminosalicylic acid, for the treatment of mild-to-moderate left-sided ulcerative colitis. [2005.06.01]
BACKGROUND: Current treatment of ulcerative colitis is imperfect. Trefoil peptides are known to stimulate repair in many models of injury, including animal models of colitis. AIM: To assess the efficacy of trefoil factor family-3 enema treatment in a clinical trial... CONCLUSION: Increasing the dose of 5-aminosalicylic acid was moderately effective in reducing the Ulcerative Colitis Disease Activity Index but was insufficient to induce remission. Trefoil factor family-3 enemas were well-tolerated but did not provide additional benefit above that of adding additional 5-aminosalicylic acid alone.

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Clinical Trials Related to Paser (Aminosalicylic Acid)

High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in Children [Recruiting]
The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's disease.

High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease [Recruiting]
The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 4 grams three times daily for 2 weeks followed by 4 grams twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's disease.

The Influence of 5–Aminosalicylates on Thiopurine Metabolite Levels [Completed]
The purpose of this study is to determine the influence of different 5-aminosalicylate concentrations on the metabolism of azathioprine or 6-mercaptopurine in patients with inflammatory bowel disease.

Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis [Completed]
OBJECTIVES:

I. Assess the safety and efficacy of 4-aminosalicylic acid in patients with mildly to moderately severe ulcerative colitis.

Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease [Active, not recruiting]
OBJECTIVES:

I. Assess the efficacy and safety of 4-aminosalicylic acid in patients with active Crohn's disease of the small bowel.

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