Side Effects of tegaserod: A Synthesis of Findings from 27 Studies

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Original Abstract of the Article

Major Research Findings

Tegaserod was a drug developed for the treatment of constipation-predominant irritable bowel syndrome (IBS-C). It works by stimulating the 5-HT4 receptor, which promotes intestinal peristalsis and improves bowel movements. However, it was found to have a significant risk of cardiac side effects, 12 , , 10 , 16 , 11 , 5 , 6 , 25 , 1 , 20 , 4 , 9 , 3 , 15 , 21 , 26 , 27 , 7 , 19 , 8 , 22 , , 13 , 2 , 18 , 24 , 17 and its use has been discontinued.

Reason for Side Effects

The reason for the cardiac side effects of tegaserod is thought to be its action on other receptors in addition to the 5-HT4 receptor. For example, 1 shows that tegaserod acts as a partial agonist on the 5-HT1B receptor. The 5-HT1B receptor is known to cause contraction of the coronary arteries, and it is thought that tegaserod may cause coronary artery stenosis.

Common Side Effects

Gastrointestinal

Gastrointestinal symptoms are common side effects of tegaserod. 6 , 14 , 15 , 5 , 24 report diarrhea, abdominal pain, and bloating.

Cardiovascular

Tegaserod has been associated with a risk of cardiovascular side effects. 12 , , 10 , 16 , 11 , 5 , 6 , 25 , 1 , 20 , 4 , 9 , 3 , 15 , 21 , 26 , 27 , 7 , 19 , 8 , 22 , , 13 , 2 , 18 , 24 , 17 have reported ischemic colitis, atrial fibrillation, and QT prolongation.

Others

Tegaserod has also been reported to cause side effects such as headaches. 6 , 15 , 5 , 24 , 17 .

Measures to Counter Side Effects

Gastrointestinal

Dietary and lifestyle modifications may be effective for gastrointestinal side effects. It is important to stay hydrated and eat a diet high in fiber. It is also important to manage stress.

Cardiovascular

Those at high risk for cardiovascular side effects should avoid the use of tegaserod. If you have a history of heart disease, high blood pressure, or other conditions, talk to your doctor before taking it.

Others

If you experience severe headaches or other side effects, talk to your doctor.

Comparison Between Studies

Commonalities

Many studies have shown that tegaserod is effective in the treatment of IBS-C. However, because of the risk of cardiac side effects, its use has been discontinued.

Differences

The incidence and severity of tegaserod side effects vary from study to study. This is likely due to differences in the age, gender, health status, and dosage of the study participants.

Points to Note for Practical Applications

Tegaserod is not currently available on the market due to the risk of cardiac side effects. Other drug therapies or lifestyle modifications should be considered for the treatment of IBS-C.

Limitations of Current Research

Research on the side effects of tegaserod is still not comprehensive. In particular, long-term side effects are still poorly understood.

Future Research Directions

Further research on the side effects of tegaserod is needed. In particular, research on long-term side effects and the incidence of side effects in specific populations needs to be investigated. Research is also needed on methods to reduce the cardiac side effects of tegaserod.

Conclusion

Tegaserod was an effective drug for the treatment of IBS-C, but is not currently available on the market due to the risk of cardiac side effects. Other drug therapies or lifestyle modifications should be considered for the treatment of IBS-C. Further research on the side effects of tegaserod is needed.

Literature analysis of 27 papers
Positive Content
20
Neutral Content
1
Negative Content
6
Article Type
2
1
0
15
27
1.

Pharmacological characterization of tegaserod at the wild type and 124Cys variant of the human 5-HT1B receptor.

Author: HaenischBritta, BönischHeinz

Cardiac ischemic events

Sumatriptan and tegaserod are drugs that act as agonists at 5-HT1B receptors. Sumatriptan is a more potent agonist at a rare variant of the receptor.

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

2.

5-hydroxytryptamine and the gastrointestinal tract: where next?

Author: SangerGareth J

Treat IBS
Treat cancer
Treat constipation
Treat diarrhea
Treat dyspepsia
Treat gastroparesis

Drugs that modulate serotonin function in the gut have been successful in treating various disorders, but safety concerns with alosetron and tegaserod have highlighted the challenges in this field.

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.

Linaclotide, a synthetic guanylate cyclase C agonist, for the treatment of functional gastrointestinal disorders associated with constipation.

Author: Vazquez RoqueMaria, CamilleriMichael

Long-term efficacy
Long-term safety
Intolerance
Nausea

Linaclotide is a novel drug with a unique mechanism of action, low bioavailability, and local action in the intestinal epithelial cells. It has demonstrated long-term efficacy and safety for the treatment of chronic constipation and irritable bowel syndrome with constipation.

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

4.

[New drugs for the treatment of constipation].

Author: AdamBirgit, LiebregtsTobias, GerkenGuido

Constipation treatment

This review discusses new therapeutic options for chronic idiopathic constipation and irritable bowel syndrome with constipation. It highlights prucalopride and lubiprostone, along with other promising medications currently under investigation. These new drugs offer alternatives for treating constipation after the withdrawal of tegaserod due to cardiac concerns.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
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 : German

6.

Review article: the safety profile of tegaserod.

Author: SchoenfeldP

Diarrhea
Headache

Tegaserod is generally safe and well-tolerated for the treatment of irritable bowel syndrome with constipation. The most common side effect is diarrhea, which is usually mild and transient.

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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

7.

Identification and Mechanistic Investigation of Drug-Drug Interactions Associated With Myopathy: A Translational Approach.

Author: HanX, QuinneyS K, WangZ, ZhangP, DukeJ, DestaZ, ElmendorfJ S, FlockhartD A, LiL

Myopathy

This study identifies drug-drug interactions (DDIs) that increase the risk of myopathy, a group of muscle diseases. The study found that loratadine and promethazine were involved in DDIs with several other drugs, and the interaction between loratadine and simvastatin was confirmed epidemiologically.

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.

Language : English

8.

Use of tegaserod along with polyethylene glycol electrolyte solution for colonoscopy bowel preparation: a prospective, randomized, double-blind, placebo-controlled study.

Author: SanakaM R, SuperD M, MullenK D, FergusonD R, McCulloughA J

Addition of tegaserod to polyethylene glycol electrolyte solution during colonoscopy preparation does not improve patient tolerance, quality of colonic preparation or the adverse 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.

Comparison of acupuncture and other drugs for chronic constipation: A network meta-analysis.

Author: ZhuLingping, MaYunhui, DengXiaoyan

Chronic constipation treatment
Side effects

Acupuncture is more effective than drugs in treating chronic constipation and has the fewest side effects.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
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.
Retracted PublicationCases where a publication has been formally withdrawn due to the discovery of serious errors or misconduct.

Language : English

10.

[Pharmacovigilance update].

Author: LivioF, BuclinT, BiollazJ

Cardiovascular events
Psychiatric disorders

Pharmacovigilance, the process of monitoring drug safety, is increasingly important in detecting new drugs that may increase the risk of common diseases. Several new drugs have been identified that may increase the risk of cardiovascular problems or psychiatric disorders.

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

11.

5-HT4 receptor agonists: similar but not the same.

Author: De MaeyerJ H, LefebvreR A, SchuurkesJ A J

Gastrointestinal promotility treatment
Hypomotility disorder treatment

Selective 5-HT(4) receptor agonists, like prucalopride, offer a promising treatment for gastrointestinal hypomotility disorders. They have a better safety profile compared to older non-selective agonists, minimizing potential target-unrelated 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

12.

Balancing drug risk and benefit: toward refining the process of FDA decisions affecting patient care.

Author: SchillerLawrence R, JohnsonDavid A

Drug withdrawal

The FDA's process for approving and monitoring drugs for functional bowel disorders needs to be reevaluated.

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

Language : English

13.

An Ex Vivo Study to Evaluate the Effect of Tegaserod on Platelet Activation and Aggregation.

Author: GurbelPaul A, BlidenKevin, BarnettScott D, WittCasey, ZouHeng, TantryUdaya

Irritable bowel syndrome treatment
Cardiovascular side effects
Platelet aggregation

This study aimed to assess the ex vivo effects of tegaserod, a 5-hydroxytryptamine-4 serotonin receptor agonist, on platelet aggregation.

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.

Language : English

16.

Translating 5-HT receptor pharmacology.

Author: SangerG J

Gastrointestinal prokinetic activity
Cardiac liability

Prucalopride is a selective 5-HT(4) receptor agonist that is being investigated as a potential treatment for chronic constipation.

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.

Psychotherapeutics and serotonin agonists and antagonists.

Author: MertzHoward

IBS treatment
Serious side effects

Current treatments for irritable bowel syndrome (IBS) include antidepressants, psychotherapy, and agents targeted at receptors in the enteric nervous system, such as alosetron and tegaserod.

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.

Lubiprostone for the treatment of adult women with irritable bowel syndrome with constipation.

Author: SoubraMahmoud, ScheyRon

IBS-C treatment
Adverse cardiovascular events
Diarrhea
Nausea

Lubiprostone is a drug used to treat irritable bowel syndrome with constipation (IBS-C). It activates chloride channels in the intestines, leading to increased fluid secretion and bowel movements. Lubiprostone has been shown to be effective and well-tolerated in women with IBS-C.

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.

Ex vivo study of human visceral nociceptors.

Author: McGuireCian, BoundoukiGeorge, HockleyJames R F, ReedDavid, Cibert-GotonVincent, PeirisMadusha, KungVictor, BroadJohn, AzizQasim, ChanChristopher, AhmedShafi, ThahaMohamed A, SangerGareth J, BlackshawL Ashley, KnowlesCharles H, BulmerDavid C

Visceral pain research

Two distinct populations of human visceral afferent fibers were identified, serosal and muscular, and their sensitivities to different stimuli were investigated. Serosal afferents were found to be more sensitive to bradykinin and ATP, consistent with a role as polymodal nociceptors, while muscular afferents were largely insensitive.

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.

Pharmacologic therapy for the irritable bowel syndrome.

Author: TalleyNicholas J

IBS treatment
Side effects

The management of the irritable bowel syndrome (IBS) remains unsatisfactory. For abdominal pain, antispasmodics are, at best, of only modest efficacy. Tricyclic antidepressants in low dose are useful but side effects and patient concerns remain limitations. Selective serotonin reuptake inhibitors are of uncertain efficacy in IBS. Opioid agonists, especially loperamide, are useful for diarrhea but not for pain in IBS; rebound constipation also remains a problem. Bile salt sequestering agents are not of established value in IBS but seem to be useful clinically in a small group of IBS patients with diarrhea. Aloestron, a 5HT(3) antagonist, should be reserved, if available, for women with severe diarrhea predominant IBS who have failed to respond to conventional therapy, and started at a low dose. Fiber and bulking agents may help constipation in some trials, but the evidence that they are efficacious in IBS is equivocal; they are frequently prescribed as first-line drugs for IBS regardless of the primary bowel disturbance but often increase bloating, gas, and pain. Laxatives are not of established value in IBS but are often taken by patients with constipation predominant IBS. Tegaserod, a partial 5HT(4) agonist, is now available in the United States and other countries for use in women with IBS whose primary bowel symptom is constipation; its efficacy in men and in those with alternating bowel habits is unknown. Probiotics are of uncertain efficacy. Chinese herbal medicine data are insufficient. Other new drugs in development include the cholecystokinin antagonists and novel visceral analgesics.

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

25.

Update on the role of drug therapy in non-ulcer dyspepsia.

Author: TalleyNicholas J

Non-ulcer dyspepsia treatment

Non-ulcer dyspepsia is a challenging condition to manage, with limited pharmacological options available. Emerging therapies include drugs that relax the gastric fundus and new prokinetics.

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

26.

Efficacy and tolerability of tegaserod in constipation dominant irritable bowel syndrome.

Author: ShahS H A, JafriS W, GulM, MohsinA, AfzalM N, ButtJ A, KhanI, NaqviA, RasheedI

Reduced IBS symptoms
Well tolerated

This study evaluated the efficacy and tolerability of tegaserod in treating irritable bowel syndrome with constipation (IBS-C). The results showed that tegaserod was effective and well-tolerated, improving symptoms such as bloating, urgency, and abdominal pain. The treatment was effective in both males and females.

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.

Language : English

27.

Recent advances in the pharmacological management of constipation predominant irritable bowel syndrome.

Author: NiewinnaKarolina, ZielińskaAnna, FichnaJakub

IBS-C treatment
Severe side effects

Irritable bowel syndrome with constipation (IBS-C) is a common and distressing condition. This review discusses the pathophysiology and current treatment options for IBS-C, highlighting promising new pharmacological agents in development.

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

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