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)
- CLINORIL is 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)
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CLINORIL SUMMARY
What is the most important information I should know about medicines called non-steroidal anti-inflammatory drugs (NSAIDs)?
Sulindac is a non-steroidal, anti-inflammatory indene derivative.
CLINORIL is indicated for acute or long-term use in the relief of signs and symptoms of the following:
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Osteoarthritis
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Rheumatoid arthritis **
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Ankylosing spondylitis
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Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis)
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Acute gouty arthritis
**The safety and effectiveness of CLINORIL 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 Clinoril (Sulindac)
Effects of intervention with sulindac and inulin/VSL#3 on mucosal and luminal factors in the pouch of patients with familial adenomatous polyposis. [2011.05]
BACKGROUND/AIM: In order to define future chemoprevention strategies for adenomas or carcinomas in the pouch of patients with familial adenomatous polyposis (FAP), a 4-weeks intervention with (1) sulindac, (2) inulin/VSL#3, and (3) sulindac/inulin/VSL#3 was performed on 17 patients with FAP in a single center intervention study. Primary endpoints were the risk parameters cell proliferation and glutathione S-transferase (GST) detoxification capacity in the pouch mucosa; secondary endpoints were the short chain fatty acid (SCFA) contents, pH, and cytotoxicity of fecal water... CONCLUSION: Our study revealed non-significant decreased cell proliferation and increased detoxification capacity after treatment with sulindac or VSL#3/inulin; however, combining both regimens did not show an additional effect.
Randomized phase II trial of sulindac, atorvastatin, and prebiotic dietary fiber for colorectal cancer chemoprevention. [2011.02]
Sulindac, atorvastatin, or prebiotic dietary fiber may reduce colorectal cancer (CRC) risk. However, clinical trial data are currently limited... Data from this multicenter, phase II trial do not provide convincing evidence of CRC risk reduction from 6-month interventions with atorvastatin, sulindac, or ORAFTI(R)Synergy1, although statistical power was limited by the relatively small sample size.
Ornithine decarboxylase-1 polymorphism, chemoprevention with eflornithine and sulindac, and outcomes among colorectal adenoma patients. [2010.10.06]
The ornithine decarboxylase-1 (ODC1) polymorphism at position +316 affects binding by transcriptional activators and repressors and modulates the risk of metachronous colorectal adenomas, particularly in association with aspirin use. We investigated the effects of ODC1 after treatment with difluoromethylornithine (eflornithine)/sulindac or placebo...
Levels of rectal mucosal polyamines and prostaglandin E2 predict ability of DFMO and sulindac to prevent colorectal adenoma. [2010.09]
BACKGROUND & AIMS: Combination of polyamine and prostaglandin E2 (PGE2)-synthesis inhibitors reduced the risk of colorectal adenoma (CRA) by 70% in patients who received polypectomies. We studied effects of the combination of difluoromethylornithine (DFMO) and sulindac on biomarkers and investigated factors that modify their efficacy... CONCLUSIONS: A combination of DFMO and sulindac significantly suppressed production of rectal mucosal polyamines but not PGE2. No relationship was found between changes in biomarker levels and response. However, baseline biomarker levels modified the effect of DFMO/sulindac for CRA prevention. Copyright (c) 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.
Sulindac and sulindac metabolites in nipple aspirate fluid and effect on drug targets in a phase I trial. [2010.01]
Regular use of nonsteroidal anti-inflammatory drugs (NSAID) has been associated with reduced risk of breast cancer. Sulindac, a nonselective NSAID with both cyclooxygenase-2-dependent and -independent activities, is a candidate for breast chemoprevention.These results are the first to show partitioning of sulindac and metabolites to human breast tissue and the first evidence for a potential dose-dependent effect of sulindac on growth differentiation factor 15 levels in NAF.
Clinical Trials Related to Clinoril (Sulindac)
Sulindac in Preventing Melanoma in Healthy Participants Who Are at Increased Risk of Melanoma [Completed]
This randomized phase II trial is studying how well sulindac works in preventing melanoma in
healthy participants who are at increased risk of melanoma. Sulindac may stop the growth of
tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known
whether sulindac is more effective than a placebo in preventing melanoma in individuals with
many moles and abnormal moles.
Urinary Biomarker Study With Sulindac and Difluoromethylornithine [Withdrawn]
Comparison of Sulindac, Aspirin, and Ursodiol in Preventing Colorectal Cancer [Terminated]
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
development or recurrence of cancer. It is not yet known whether sulindac, aspirin, or
ursodiol is more effective in preventing colorectal cancer.
PURPOSE: This randomized phase II trial is studying how well sulindac works compared to
aspirin or ursodiol in preventing colorectal cancer.
A Randomized Study of Sulindac in Oral Premalignant Lesions [Active, not 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.
Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP) [Recruiting]
The purpose of this randomized, double-blind, Phase III trial is to determine if the
combination of eflornithine plus sulindac is superior to sulindac or eflornithine as single
agents in delaying time to the first occurrence of any FAP-related event. This includes: 1)
FAP related disease progression indicating the need for excisional intervention involving
the colon, rectum, pouch, duodenum and/or 2) clinically important events which includes
progression to more advanced duodenal polyposis, cancer or death.
Reports of Suspected Clinoril (Sulindac) Side Effects
Pancreatitis Chronic (4),
Drug Hypersensitivity (4),
Portal Venous GAS (3),
Malaise (3),
Adverse Event (3),
Enteritis (3),
Muscle Spasms (3),
Renal Impairment (3),
Diarrhoea (3),
Abasia (2), more >>
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Page last updated: 2011-12-09
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