Effects of tegaserod: A Synthesis of Findings from 25 Studies

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Original Abstract of the Article

Major research findings

Tegaserod is a serotonin receptor type 4 (5-HT4) partial agonist that is used to treat irritable bowel syndrome. 20 Tegaserod has been shown to stimulate gastrointestinal motility and increase gastric volumes before and after a meal in healthy volunteers. 9 Tegaserod also has been shown to improve postprandial gastric compliance in functional dyspepsia patients. 9 However, tegaserod has been associated with unfavorable cardiovascular safety profiles, such as an increased risk of abdominal surgery. 20 7 Tegaserod also inhibits voltage-gated K+ (Kv) channels in rabbit coronary arterial smooth muscle cells in a concentration-dependent manner. 15

Benefits and risks

Benefits summary

Tegaserod has been shown to be effective in treating irritable bowel syndrome and functional dyspepsia. 20 Tegaserod can also improve gastric compliance and increase gastric volumes, which can be beneficial for patients with functional dyspepsia. 9

Risk summary

Tegaserod has been associated with an increased risk of abdominal surgery, 20 7 and it can also inhibit voltage-gated K+ (Kv) channels in the heart. 15 This could lead to serious cardiovascular complications. 20

Comparison between studies

Commonalities

Many studies have shown that tegaserod is effective in treating irritable bowel syndrome and functional dyspepsia, but also that it is associated with unfavorable cardiovascular safety profiles. 20 7 9

Differences

There are some differences in the results of studies on tegaserod. For example, some studies have shown that tegaserod is more effective in treating irritable bowel syndrome than others. 20 There are also differences in the reported incidence of adverse cardiovascular events associated with tegaserod. 20 7

Consistency and contradictions of results

The results of research on tegaserod are consistent in showing its effectiveness in treating irritable bowel syndrome and functional dyspepsia, 20 7 9 but there are also some contradictions in the results of studies on the cardiovascular safety profile of tegaserod. 20 7

Notes on real-life application

Tegaserod should be used with caution, as it is associated with an increased risk of abdominal surgery. 20 7 It is also important to be aware of the potential for cardiovascular complications, such as arrhythmias. 20 15 Patients with any underlying cardiovascular conditions should talk to their doctor before taking tegaserod. 20

Limitations of current research

The research on tegaserod is limited by the fact that it has been withdrawn from the market in many countries. 20 19 This makes it difficult to conduct large-scale studies on the long-term effects of tegaserod. 20

Future research directions

Further research is needed to clarify the cardiovascular safety profile of tegaserod. 20 Studies are also needed to investigate the long-term effects of tegaserod. 20

Conclusion

Tegaserod is a serotonin receptor type 4 (5-HT4) partial agonist that has been shown to be effective in treating irritable bowel syndrome and functional dyspepsia, 20 but it is also associated with unfavorable cardiovascular safety profiles, such as an increased risk of abdominal surgery. 20 7 Tegaserod should be used with caution, as it can lead to serious cardiovascular complications. 20

Literature analysis of 25 papers
Positive Content
21
Neutral Content
1
Negative Content
3
Article Type
8
3
1
10
25
1.

Tegaserod, a 5-hydroxytryptamine type 4 receptor partial agonist, is devoid of electrocardiographic effects.

Author: MorganrothJoel, RüeggPeter C, Dunger-BaldaufCornelia, Appel-DingemanseSilke, BliesathHarald, LefkowitzMartin

IBS treatment
Cardiac arrhythmias

This study investigated the cardiac safety profile of tegaserod, a promotility agent for irritable bowel syndrome (IBS), by analyzing electrocardiographic data from clinical trials. The aim was to assess whether tegaserod affects cardiac repolarization, which could lead to potentially life-threatening arrhythmias.

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.

Language : English

2.

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

3.

Double-blind, randomized, placebo-controlled study to evaluate the effects of tegaserod on gastric motor, sensory and myoelectric function in healthy volunteers.

Author: TalleyN J, CamilleriM, BurtonD, ThomfordeG, KochK, RuckerM J, PetersonJ, ZinsmeisterA R, EarnestD L

Reduced gastric volume change
No significant effect on gastric function

Tegaserod, a selective serotonin 5-HT4 receptor agonist, decreased proximal gastric volume change after a meal but had no significant effects on gastric motor and sensory function in healthy individuals. Further studies are required in patients with disturbances of gastric motor and sensory function.

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

4.

The effects of tegaserod on oesophageal function and bolus transport in healthy volunteers: studies using concurrent high-resolution manometry and videofluoroscopy.

Author: FoxM, MenneD, StutzB, FriedM, SchwizerW

Improved peristalsis
Improved solid bolus transport

Tegaserod did not alter lower oesophageal sphincter pressure, but had significant effects on peristaltic function. This effect was associated with a non-significant trend to improved solid bolus transit.

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

5.

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

6.

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

7.

The Zelnorm epidemiologic study (ZEST): a cohort study evaluating incidence of abdominal and pelvic surgery related to tegaserod treatment.

Author: SeegerJohn D, QuinnSherry, EarnestDavid L, LemboAnthony, KuoBraden, RiveroElena, WalkerAlexander M

Tegaserod surgery risk

Tegaserod use was not associated with an increased risk of abdominal or pelvic surgery, including cholecystectomy.

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

Language : English

8.

The effects of tegaserod (HTF 919) on the pharmacokinetics and pharmacodynamics of digoxin in healthy subjects.

Author: ZhouH, HorowitzA, LedfordP C, HubertM, Appel-DingemanseS, OsborneS, McLeodJ F

Gastrointestinal motility disorders
Digoxin interaction

Tegaserod is a drug used to treat digestive tract motility disorders. This study examined the impact of multiple doses of tegaserod on the pharmacokinetics and pharmacodynamics of digoxin, a drug used for heart failure. The results showed that tegaserod slightly decreased digoxin exposure, but the reduction was not considered clinically significant. The study also found that tegaserod was well-tolerated in combination with digoxin and did not cause any changes in heart rate or QT interval.

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.
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.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

9.

Clinical trial: effects of tegaserod on gastric motor and sensory function in patients with functional dyspepsia.

Author: ThumshirnM, FruehaufH, StutzB, TougasG, SalterJ, FriedM

Dyspepsia treatment
Tegaserod efficacy
Limited data
Side effects

This study investigated the effects of tegaserod, a serotonin receptor type-4 partial agonist, on gastric compliance, accommodation, and sensory function in patients with functional dyspepsia. Tegaserod increased postprandial gastric compliance in patients with functional dyspepsia and gastric accommodation in healthy volunteers. These findings suggest a potential role for tegaserod in improving proximal gastric motor function in patients with functional dyspepsia.

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

10.

Tegaserod Maleate Inhibits Breast Cancer Progression and Enhances the Sensitivity of Immunotherapy.

Author: LiXiao, WuLiangliang, ZhengZhiying, LiuHanyuan, LiHaiyang, SunGuoqiang, SunGuangshun, ChengYe, WangHanjin, LiZhouxiao, ShiJunfeng, TangWeiwei

Effective drug needed

Breast cancer (BC) is a common and aggressive type of cancer. This study highlights the need for new and effective drugs to treat BC, as current treatments often face resistance and have limitations.

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

Language : English

11.

Tegaserod mimics the neurostimulatory glycan polysialic acid and promotes nervous system repair.

Author: BushmanJ, MishraB, EzraM, GulS, SchulzeC, ChaudhuryS, RipollD, WallqvistA, KohnJ, SchachnerM, LoersG

Nerve regeneration
PSA mimetic

Tegaserod, a 5-HT4 receptor agonist, has been identified as a mimetic of the neurostimulatory glycan polysialic acid (PSA). Tegaserod promotes nerve regeneration in a mouse model of peripheral nerve injury, demonstrating its potential for treatment of nervous system injuries.

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

Language : English

12.

[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

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

14.

The effects of tegaserod (HTF 919) on oesophageal acid exposure in gastro-oesophageal reflux disease.

Author: KahrilasP J, QuigleyE M, CastellD O, SpechlerS J

Decreased acid reflux in GERD

Tegaserod, a 5-HT4 receptor partial agonist, significantly decreases postprandial oesophageal acid exposure in patients with mild-to-moderate GERD. A dose of 1 mg/day reduced acid exposure by 50% in the postprandial period. The reduction in acid exposure may be due to enhanced acid clearance, improved gastric emptying, and/or reduced transient lower oesophageal sphincter relaxations.

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.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
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

15.

The effects of tegaserod, a gastrokinetic agent, on voltage-gated K<sup>+</sup> channels in rabbit coronary arterial smooth muscle cells.

Author: AnJin Ryeol, JungHee Seok, SeoMi Seon, KangMinji, HeoRyeon, ParkHongzoo, SongGeehyun, JungWon-Kyo, ChoiIl-Whan, ParkWon Sun

Treat irritable bowel syndrome
Vascular Kv channel inhibition

Tegaserod, a gastroprokinetic agent used to treat irritable bowel syndrome, inhibits vascular Kv channels in a concentration- and use-dependent manner, with the Kv1.5 subtype being the major target.

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

16.

[Some practical questions on chronic stipsis treatment with prucalopride].

Author: BellacosaL, CogliandroR, CremonC, De GiorgioR, BarbaraG, StanghelliniV

Chronic constipation treatment

Prucalopride, a novel enterokinetic drug, is effective in improving bowel function and relieving digestive symptoms in patients with severe chronic constipation who have not responded to traditional laxatives. It is a selective agonist of 5-HT4 receptors, with low cardiovascular risk and minimal drug interactions.

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 : Italian

17.

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

18.

Comparative Efficacy of Various Pharmacological Interventions in the Treatment of Functional Dyspepsia: A Network Meta-Analysis.

Author: LiangLiang, YuJia, XiaoLing, WangGaohua

Dyspepsia treatment

Levosulpiride is the most effective pharmacological treatment for functional dyspepsia, followed by cinitapride and cisapride.

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.

Language : English

19.

Tegaserod: What's Old Is New Again.

Author: SayukGregory S, TackJan

CIC treatment
IBS-C treatment
Cardiovascular events

Tegaserod, a 5-HT<sub>4</sub> agonist, was approved for irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) but was withdrawn due to concerns about cardiovascular events. Following additional safety data and a restricted labeling, it was reapproved for IBS-C in 2019.

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.

Cardiovascular safety of prokinetic agents: A focus on drug-induced arrhythmias.

Author: GiudicessiJ R, AckermanM J, CamilleriM

Gastrointestinal motility
Cardiovascular safety

This review examines the development of prokinetic agents for gastrointestinal sensorimotor disorders. Despite the efficacy of several prokinetic agents, their use is often limited by adverse cardiovascular effects.

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.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

22.

Comparison of efficacy of pharmacological treatments for chronic idiopathic constipation: a systematic review and network meta-analysis.

Author: NelsonAlfred D, CamilleriMichael, ChirapongsathornSakkarin, VijayvargiyaPriya, ValentinNelson, ShinAndrea, ErwinPatricia J, WangZhen, MuradM Hassan

Bisacodyl effective

Current drugs for chronic idiopathic constipation show similar efficacy. Bisacodyl may be superior to prescription medications for increasing the number of complete spontaneous bowel movements per week.

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

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.

Irritable bowel syndrome: a "mesh" of a situation.

Author: BarnesMatthew G

Irritable bowel syndrome treatment
Mesh herniorrhaphy

This case report describes a 50-year-old woman who developed irritable bowel syndrome (IBS)-like symptoms after undergoing periumbilical Marlex mesh herniorrhaphy 13 years prior. A CT scan revealed that the Marlex mesh had fully eroded into the lumen of the small bowel, causing a partial obstruction. Resection of the involved section of small bowel resulted in complete resolution of the IBS-like symptoms.

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.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

25.

Electrophysiological characterization of isolated human atrial myocytes exposed to tegaserod.

Author: SuffrediniSilvia, CerbaiElisabetta, GiuntiGabriele, El MouelhiMohamed, PfannkucheHans-Jürgen, MugelliAlessadro

Chronic constipation treatment
IBS-C treatment
Cardiovascular events

Tegaserod, a 5-HT(4) receptor partial agonist, was found to have no arrhythmogenic properties in human atrial myocytes.

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

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