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Sulindac (Sulindac) - Summary

 



Cardiovascular Risk

  • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. (See WARNINGS.)

  • Sulindac tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. (See WARNINGS.)

Gastrointestinal Risk

  • NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. (See WARNINGS.)

 

SULINDAC SUMMARY

Sulindac is a non-steroidal, anti-inflammatory indene derivative designated chemically as (Z)-5-fluoro-2-methyl-1-[[ p -(methylsulfinyl) phenyl]methylene]-1 H -indene-3-acetic acid.

Carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

Sulindac tablets are indicated:

  1. For the relief of signs and symptoms of rheumatoid arthritis.*

  2. For the relief of signs and symptoms of osteoarthritis.

  3. For acute or long-term use in the relief of signs and symptoms of the following:

    - Ankylosing spondylitis

    - Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis)

    - Acute gouty arthritis

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* The safety and effectiveness of sulindac have not been established in rheumatoid arthritis patients who are designated in the American Rheumatism Association classification as Functional Class IV (incapacitated, largely or wholly bedridden, or confined to wheelchair; little or no self-care).

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NEWS HIGHLIGHTS

Published Studies Related to Sulindac

Risk of cardiovascular events in a randomized placebo-controlled, double-blind trial of difluoromethylornithine plus sulindac for the prevention of sporadic colorectal adenomas. [2009.03]
Nonsteroidal anti-inflammatory drugs (NSAID) have been associated with adverse cardiovascular (CV) outcomes in cancer prevention and other clinical trials. A recent meta-analysis suggested that baseline CV risk is associated with NSAID-associated adverse CV events...

Suppressive effect of sulindac on branch duct-intraductal papillary mucinous neoplasms. [2009]
BACKGOUND: When considering surgery for branch duct-intraductal papillary mucinous neoplasms (BD-IPMNs) with suspected malignancy, it should be recognized that these lesions are frequently multifocal and are usually found in elderly patients with potential comorbidities that could affect the outcome of surgery. Clinical trials of chemoprevention have been conducted for a wide variety of malignancies... CONCLUSIONS: Although a larger scale randomized controlled study is needed in future, the present results suggest the promise of chemoprevention of carcinoma derived from BD-IPMNs by sulindac.

Concomitant DFMO and sulindac chemoprevention of colorectal adenomas: a major clinical advance. [2008.11]
In a randomized, placebo-controlled, double-blind clinical trial by Meyskens et al. the combination of difluoromethylornithine and sulindac has been shown to be strikingly effective for prevention of sporadic colorectal adenomas...

Difluoromethylornithine plus sulindac for the prevention of sporadic colorectal adenomas: a randomized placebo-controlled, double-blind trial. [2008.06]
Preclinical studies of chemoprevention drugs given in combination at low doses show remarkable efficacy in preventing adenomas with little additional toxicities, suggesting a strategy to improve risk to benefit ratios for preventing recurrent adenomas... Recurrent adenomatous polyps can be markedly reduced by a combination of low oral doses of DFMO and sulindac and with few side effects.

Difluoromethylornithine Plus Sulindac for the Prevention of Sporadic Colorectal Adenomas: A Randomized Placebo-Controlled, Double-Blind Trial. [2008]
Preclinical studies of chemoprevention drugs given in combination at low doses show remarkable efficacy in preventing adenomas with little additional toxicities, suggesting a strategy to improve risk to benefit ratios for preventing recurrent adenomas... Recurrent adenomatous polyps can be markedly reduced by a combination of low oral doses of DFMO and sulindac and with few side effects.

more studies >>

Clinical Trials Related to Sulindac

Sulindac Capsules Compared With Sulindac Tablets in Healthy Volunteers [Completed]
RATIONALE: Giving healthy volunteers sulindac capsules or sulindac tablets may help doctors learn which form of the drug may be more effective in preventing cancer.

PURPOSE: This randomized clinical trial is studying sulindac capsules to see how well they work compared with sulindac tablets in healthy volunteers.

Sulindac in Preventing Breast Cancer in Women at High Risk for Breast Cancer [Active, not recruiting]
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of sulindac may prevent breast cancer.

PURPOSE: This randomized phase I trial is studying the effects of sulindac, to prevent breast cancer, in women at high risk for breast cancer.

Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps [Active, not recruiting]
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of eflornithine and sulindac may prevent colorectal cancer. It is not yet known whether eflornithine and sulindac are more effective than a placebo in preventing colorectal cancer.

PURPOSE: This randomized phase III trial is studying eflornithine and sulindac to see how well they work compared to a placebo in preventing colorectal cancer in patients with colon polyps.

Eflornithine Plus Sulindac in Preventing Colorectal Cancer in Patients Who Have Had Surgery to Remove Benign Colorectal Polyps [Active, not recruiting]
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of eflornithine and sulindac may be an effective way to prevent the development of colorectal cancer in patients who have had surgery to remove benign colorectal polyps.

PURPOSE: Randomized, double-blinded, phase II trial to determine the effectiveness of eflornithine plus sulindac compared to a placebo in preventing colorectal cancer in patients who have had surgery to remove benign colorectal polyps.

A Randomized Study of Sulindac in Oral Premalignant Lesions [Recruiting]
The purpose of this study is to see if a drug called sulindac can prevent the development of changes in the mouth that are related to oral pre-cancer growths (oral epithelial dysplasia) or oral cancer. Sulindac is an anti-inflammatory drug that has already been tested in people with arthritis (inflammation of a joint).

This study is being done by Memorial Sloan-Kettering Cancer Center in New York, Amrita Institute of Medical Sciences and Research Center in Cochin, India, and Regional Cancer Centre (RCC) in Trivandrum, India.

You have been chosen to take part in this study because you have been diagnosed with oral intra-epithelial neoplasm (white or red patches of oral cavity). People with pre-cancerous mouth growths are at greater risk of developing mouth cancer compared to those who do not have such growths.

Therefore, we are asking you to take part in this study. If you decide to join, you will be questioned by the staff in charge of this study to make sure that you meet other eligibility criteria for participation.

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Page last updated: 2009-10-20

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