Side Effects of sulindac: A Synthesis of Findings from 25 Studies

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Original Abstract of the Article

Main Research Findings

Sulindac, a nonsteroidal anti-inflammatory drug (NSAID), has been studied extensively for its chemopreventive potential in familial adenomatous polyposis (FAP), a genetic disorder characterized by the development of hundreds of colorectal polyps. 2 Several clinical trials have demonstrated that sulindac can effectively reduce the size and number of polyps in FAP patients. 2 , 18 , 9 , 16 However, sulindac is not without its drawbacks. Despite its effectiveness, sulindac has not been approved for chemoprevention by the FDA due to the occurrence of serious gastrointestinal side effects. 2 Additionally, some patients have developed aggressive tumors even after experiencing a reduction in polyp size. 2 Therefore, ongoing research focuses on developing safer and more effective alternatives, such as COX-2 selective inhibitors. 2 , 17

Reasons for Side Effects

The side effects of sulindac are a common issue with NSAIDs. These side effects arise from the inhibition of prostaglandins, which are protective molecules for the gastrointestinal system. 2 , 6 Sulindac works by inhibiting both COX-1 and COX-2 enzymes, responsible for prostaglandin synthesis. 6 This inhibition disrupts the protective function of prostaglandins, leading to gastrointestinal inflammation and ulceration. 7

Common Side Effects

Gastrointestinal Side Effects

Gastrointestinal side effects are the most frequent side effects associated with sulindac. 2 , 21 These can include stomach pain, fullness, nausea, vomiting, diarrhea, constipation, and indigestion. 5 In some cases, sulindac can lead to the development of gastrointestinal ulcers. 7 , 19

Other Side Effects

Beyond gastrointestinal issues, sulindac can also cause various other side effects. 4 , 2 These may include headache, dizziness, tinnitus, vision changes, rash, itching, difficulty breathing, kidney damage, liver damage, anemia, and thrombocytopenia. 4 , 2 Notably, there is a concern that sulindac might increase the risk of cardiovascular events. 7 Additionally, sulindac is not recommended for pregnant women as it can potentially harm the fetus. 12

Countermeasures for Side Effects

Gastrointestinal Side Effects

Taking sulindac with food or in combination with antacids is a commonly recommended strategy to mitigate gastrointestinal side effects. 7 , 19 Reducing the dosage of sulindac can also be helpful. 7 If ulcers develop, appropriate treatment is necessary. 7 , 19

Other Side Effects

If you experience other side effects, consulting with your doctor is crucial. 4 , 2 For increased cardiovascular risk associated with sulindac, appropriate management is required. 7 Pregnant women should avoid sulindac due to the potential harm to the fetus. 12

Comparison Between Studies

Commonalities Between Studies

Multiple studies consistently demonstrate that sulindac effectively reduces and regresses colorectal polyps in patients with familial adenomatous polyposis (FAP). 18 , 9 , 16 There is also a general agreement that sulindac has the potential to prevent colorectal cancer. 25 , 19

Differences Between Studies

While there is a consistent finding that sulindac can cause gastrointestinal side effects, the severity and frequency of these side effects vary across different studies. 2 , 7 , 21 The increased risk of cardiovascular events associated with sulindac is not consistently reported in all research. 7

Points to Note Regarding Application in Real Life

While research suggests that sulindac can be beneficial for preventing colorectal cancer, it is crucial to be aware of its potential gastrointestinal side effects. 2 , 7 If you are considering using sulindac, a thorough discussion with your doctor is essential to weigh the risks and benefits before making a decision. 19

Limitations of Current Research

The long-term effects and safety of sulindac still require further investigation. 4 , 2 Additionally, there is a lack of definitive studies proving that sulindac is effective in preventing colorectal cancer. 2 , 19

Future Research Directions Needed

Further research is necessary to fully understand the long-term effects and safety of sulindac. 4 , 2 Additionally, robust studies are needed to confirm the effectiveness of sulindac in preventing colorectal cancer. 2 , 19

Conclusion

Sulindac holds potential as a chemopreventive agent for colorectal cancer, particularly in patients with familial adenomatous polyposis. However, its use is limited by the risk of gastrointestinal side effects. 2 , 21 Before considering sulindac for chemoprevention, it is crucial to have an open conversation with your doctor to carefully assess the risks and benefits and make an informed decision. 19

Literature analysis of 25 papers
Positive Content
22
Neutral Content
0
Negative Content
3
Article Type
3
1
1
11
25
1.

DFMO: targeted risk reduction therapy for colorectal neoplasia.

Author: LaukaitisChristina M, GernerEugene W

Reduced adenoma risk
Cardiovascular events
Ototoxicity

This study explored the effectiveness of reducing intracellular polyamine levels to decrease colorectal cancer (CRC) risk. A combination of difluoromethylornithine (DFMO) and non-steroidal anti-inflammatory drugs (NSAIDs) showed a significant reduction in adenoma recurrence. However, the treatment group had a slightly higher rate of cardiovascular events compared to the placebo group, along with mild ototoxicity. Targeted therapy for high-risk individuals with CRC could potentially improve patient benefit while minimizing side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

2.

Chemoprevention of carcinogenesis in familial tumors.

Author: IshikawaHideki

Reduced polyp number
Reduced polyp size
Gastrointestinal side effects

Sulindac is a drug that can reduce the size and number of polyps in familial adenomatous polyposis (FAP), a condition that increases the risk of colon cancer. However, sulindac is not routinely used to treat FAP because it can cause serious gastrointestinal side effects. New drugs that target cyclooxygenase-2 (COX-2) are showing promise for the treatment of FAP.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

3.

Chemoprevention of Colon Cancer by DFMO, Sulindac, and NO-Sulindac Administered Individually or in Combinations in F344 Rats.

Author: MadkaVenkateshwar, PatlollaJagan M R, VenkatachalamKarthikkumar, ZhangYuting, PathuriGopal, StrattonNicole, LightfootStanley, JanakiramNaveena B, MohammedAltaf, RaoChinthalapally V

CRC chemoprevention
Reduced tumor growth

Non-steroidal anti-inflammatory drugs (NSAIDs) show promise for colorectal cancer (CRC) chemoprevention. This study evaluated the efficacy of nitric-oxide releasing Sulindac (NO-Sulindac) compared to Sulindac and in combination with difluoromethylornithine (DFMO).

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

4.

[Role of suindac in the treatment of familial adenomatous polyposis coli].

Author: LandauerS, HalimiC, CaulinC, BergmannJ F

Colorectal polyp regression
Cancer risk
Digestive side-effects

Sulindac is an effective treatment for colorectal adenomatous polyps in patients with familial adenomatous polyposis. However, it does not affect other manifestations of the disease and polyps may recur after cessation of therapy. Total colectomy is the recommended procedure for most patients with familial adenomatous polyposis.

English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : French

6.

R-flurbiprofen suppresses distal nonmucin-producing colorectal tumors in azoxymethane-treated rats, without suppressing eicosanoid production.

Author: MartinJonathan E, Le LeuRichard K, HuYing, YoungGraeme P

Colorectal cancer prevention
Gastrointestinal side effects

This study tested the potency of low-toxicity R-flurbiprofen in the azoxymethane (AOM)-rat model of carcinogenesis. R-flurbiprofen, at a dose of 30 mg/kg body wt per day, was well tolerated by the animals and showed protection against the development of colon cancer.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Difluoromethylornithine plus sulindac for the prevention of sporadic colorectal adenomas: a randomized placebo-controlled, double-blind trial.

Author: MeyskensFrank L, McLarenChristine E, PelotDaniel, Fujikawa-BrooksSharon, CarpenterPhilip M, HawkErnest, KelloffGary, LawsonMichael J, KidaoJayashri, McCrackenJohn, AlbersC Gregory, AhnenDennis J, TurgeonD Kim, GoldschmidSteven, LancePeter, HagedornCurt H, GillenDaniel L, GernerEugene W

Adenoma recurrence prevention

This study evaluated the efficacy of a combination of difluoromethylornithine (DFMO) and sulindac in preventing colorectal adenoma recurrence. The combination therapy significantly reduced the recurrence of adenomas, including advanced adenomas, with minimal side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

9.

Primary chemoprevention of familial adenomatous polyposis with sulindac.

Author: GiardielloFrancis M, YangVincent W, HylindLinda M, KrushAnne J, PetersenGloria M, TrimbathJill D, PiantadosiSteven, GarrettElizabeth, GeimanDeborah E, HubbardWalter, OfferhausG Johan A, HamiltonStanley R

Regression of adenomas

Nonsteroidal antiinflammatory drugs can cause regression of adenomas, but their ability to prevent adenomas is unknown.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

10.

The NSAID sulindac is chemopreventive in the mouse distal colon but carcinogenic in the proximal colon.

Author: MladenovaDessislava, DanielJoseph J, DahlstromJane E, BeanElaine, GuptaRuta, PickfordRussell, CurreyNicola, MusgroveElizabeth A, Kohonen-CorishMaija R J

Colorectal cancer prevention
Side effects

This study investigates the effectiveness of sulindac, a non-steroidal anti-inflammatory drug, for chemoprevention in mismatch repair deficient colorectal cancers.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

11.

Screening pharmaceuticals for possible carcinogenic effects: initial positive results for drugs not previously screened.

Author: FriedmanGary D, UdaltsovaNatalia, ChanJames, QuesenberryCharles P, HabelLaurel A

None reported
Cancer risk

This study found that further studies are indicated regarding sulindac, hyoscyamine, nortriptyline, oxazepam, fluoxetine, paroxetine, hydrochlorothiazide, and nifedipine, as these drugs may have carcinogenic effects.

Evaluation StudyResearch that systematically evaluates the effectiveness of a particular program or policy. It measures its outcomes and provides important information for future decision-making.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

12.

Prostaglandin inhibitors in preterm labour.

Author: LoudonJenifer A Z, GroomKate M, BennettPhilip R

Preterm delivery prevention
Ductal constriction
Renal function impairment

This study reviews the use of anti-inflammatory drugs to prevent preterm delivery. Indomethacin is the only tocolytic drug proven to delay delivery beyond 37 weeks and reduce low birth weight, but it can have fetal side effects. COX-2-selective drugs have shown potential, but their use is currently limited to randomized controlled trials.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

13.

Sustained dapsone-induced remission of hypocomplementemic urticarial vasculitis--a case report.

Author: EiserA R, SinghP, ShaniesH M

Treats HUV
Emphysema
Side effects

This study reports a case of hypocomplementemic urticarial vasculitis (HUV) that was resistant to multiple therapies, but achieved remission with dapsone. The patient also developed vasculitis-related emphysema, highlighting the potential for serious complications.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

14.

Criteria for implementation of large and multiagent clinical chemoprevention trials.

Author: MeyskensF L

Prevent cancer
Reduce risk
Secondary adverse events

This paper discusses the development of multiagent chemoprevention trials. The development of multiagent chemoprevention trials requires that each agent is active and additively or synergistically so in combination in preclinical models. Additionally, side effects of each agent should be non-overlapping and low to non-existent.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

16.

Long-term chemoprevention in patients with adenomatous polyposis coli: an observational study.

Author: NeuhannTeresa M, HaubKatharina, Steinke-LangeVerena, MorakMonika, LanerAndreas, LocherMelanie, Holinski-FederElke

Effective chemoprevention
Long-term management
Advanced adenomas
Upper GI polyp burden

This study provides evidence for the effectiveness and safety of long-term sulindac chemoprevention in patients with familial polyposis, supporting its potential as a management option.

Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

17.

Clinically Relevant Anti-Inflammatory Agents for Chemoprevention of Colorectal Cancer: New Perspectives.

Author: MohammedAltaf, YarlaNagendra Sastry, MadkaVenkateshwar, RaoChinthalapally V

CRC prevention
Polyp prevention
Side effects

Several agents, including non-steroidal anti-inflammatory drugs (NSAIDs) and statins, have shown potential as chemopreventive agents for colorectal cancer (CRC). However, limitations in their approval for chemoprevention use in high-risk individuals and patients with early stages of CRC remain.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

18.

Treatment of colonic and rectal adenomas with sulindac in familial adenomatous polyposis.

Author: GiardielloF M, HamiltonS R, KrushA J, PiantadosiS, HylindL M, CelanoP, BookerS V, RobinsonC R, OfferhausG J

Regression of polyps
None mentioned

Sulindac, a nonsteroidal anti-inflammatory drug, has shown promise in reducing the number of polyps in patients with familial adenomatous polyposis (FAP), a disorder characterized by the development of numerous colorectal polyps. However, no controlled trials have been conducted in FAP patients who haven't undergone surgery.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

19.

Aspirin and non-steroidal anti-inflammatory drugs for cancer prevention: an international consensus statement.

Author: CuzickJack, OttoFlorian, BaronJohn A, BrownPowel H, BurnJohn, GreenwaldPeter, JankowskiJanusz, La VecchiaCarlo, MeyskensFrank, SennHans Jörg, ThunMichael

Colorectal cancer prevention
Peptic ulcers

Aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) have a chemopreventive effect on colorectal cancer, but data on their risk-benefit profile for cancer prevention are insufficient. Aspirin, with its known cardiovascular benefit, is the most likely NSAID for chemoprevention, although further studies are needed to optimize its use.

Consensus Development ConferenceA conference organized by the National Institutes of Health (NIH) to develop consensus and recommendations on medical issues.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

20.

Compositions for treatment of cancer and inflammation.

Author: Lev-AriShahar, LichtenbergDov, ArberNadir

Arthritic pain relief
Cancer treatment
Lower celecoxib dosage
Reduced side effects
Cardiovascular toxicity

Combining celecoxib, a drug used to treat arthritis, with curcumin, a natural compound found in turmeric, may be a safer and more effective treatment for arthritis and cancer. The combination is more effective at lower doses than celecoxib alone, potentially reducing the risk of side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

23.

Calcium-activated endoplasmic reticulum stress as a major component of tumor cell death induced by 2,5-dimethyl-celecoxib, a non-coxib analogue of celecoxib.

Author: PyrkoPeter, KardoshAdel, LiuYen-Ting, SorianoNathaniel, XiongWenyong, ChowRobert H, UddinJasim, PetasisNicos A, MircheffAustin K, FarleyRobert A, LouieStan G, ChenThomas C, SchönthalAxel H

Antitumor effect
Apoptosis induction
Side effects

This study investigated the antitumor effects of 2,5-dimethyl-celecoxib (DMC), a structural analog of celecoxib that lacks cyclooxygenase-2-inhibitory function. DMC potently triggered the endoplasmic reticulum (ER) stress response and subsequent apoptotic cell death in various tumor cell lines, suggesting its potential as a non-coxib alternative to celecoxib for anticancer purposes.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

24.

Aspirin, steroidal and non-steroidal anti-inflammatory drugs for the treatment of Alzheimer's disease.

Author: JaturapatpornDarin, IsaacMokhtar Gad El Kareem Nasr, McCleeryJenny, TabetNaji

Abnormal lab results
Bleeding
Cognitive decline
Death
Elevated LFT
Elevated creatinine
Face edema
Hyperglycemia
Hypertension
Nausea
Vomiting

Aspirin, steroids, and NSAIDs did not demonstrate significant improvement in cognitive decline in Alzheimer's disease (AD) patients. Aspirin was associated with increased bleeding, steroids with hyperglycemia and abnormal lab results, and NSAIDs with nausea, vomiting, and elevated creatinine levels.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

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