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.)
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 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:
For the relief of signs and symptoms of rheumatoid arthritis.*
For the relief of signs and symptoms of osteoarthritis.
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
* 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).
Published Studies Related to 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 Sulindac
Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP) [Not yet 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 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.
Urinary Biomarker Study With Sulindac and Difluoromethylornithine [Not yet recruiting]
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.
S0820, Adenoma and Second Primary Prevention Trial [Not yet recruiting]
The investigators hypothesize that the combination of eflornithine and sulindac will be
effective in reducing a three-year event rate of adenomas and second primary colorectal
cancers in patients previously treated for Stages 0 through III colon cancer.
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.
Reports of Suspected Sulindac Side Effects
Respiratory Arrest (8),
Cardiac Arrest (8),
Toxicity TO Various Agents (7),
Gastrointestinal Haemorrhage (3),
Intentional Drug Misuse (3),
Renal Failure (3),
Weight Decreased (2),
Trigeminal Neuralgia (2),
Abdominal Discomfort (2), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 1 ratings/reviews, Sulindac has an overall score of 4. The effectiveness score is 4 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst.
Sulindac review by 56 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Marginally Effective|
|Side effects:|| || Moderate Side Effects|
|Condition / reason:|| || Baker's Cysts behind both knees|
|Dosage & duration:|| || 200 mg taken twice per day for the period of 3 weeks|
|Other conditions:|| || osteoarthritis|
|Other drugs taken:|| || Levoxyl; Estrogen replacement|
|Benefits:|| || After about a week, I started to see a small reduction in the size of the fluid-filled cysts behind my knees. Over the 3-week treatment period, there was about a 25 percent reduction in the size of the cysts. There was also a mild reduction in the pain associated with the cysts.
Another benefit was that I did not get upper GI pain & bleeding with this med, whereas NSAIDs had been causing black stools due to GI irritation & bleeding.|
|Side effects:|| || Within about 30 minutes of taking each dose of Sulindac, I experienced a colicky pain under my ribs on the right side. The pain was not extreme, but it was noticeable and unpleasant. Duration lasted 2 - 4 hours each time. This side effect persisted throughout the entire treatment period. |
|Comments:|| || Due to longstanding knee osteoarthritis, I am prone to fluid-filled cysts on the backside of my knees. The cysts cause pain, swelling, and reduced circulation to the lower leg. The cysts interfere with walking gait as well.
In past I had used NSAIDs to reduce the inflammation of these cysts, however due to NSAID-related side effects, this class of drug was put off-limits by my physician. His recommendation was that I try a drug in the pro-NSAID class, which is less irritating to the stomach.
In retrospect, I think that for me, the Sulindac was a trade-off: less stomach irritation exchanged for liver irritation with the Sulindac. Due to this side-effect, my doctor reduced frequency of medication to once per day. My response to the Sulindac was less robust than I had hoped for -- much less improvement than I had experienced previously with NSAIDs -- and it also took a long time (3 weeks) to reach the level of improvement that in past I would achieve in 3 days with OTC NSAIDs.
Page last updated: 2011-12-09