Effects of alosetron: A Synthesis of Findings from 29 Studies

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Original Abstract of the Article

Major Research Findings

Alosetron is a drug that acts as an antagonist of serotonin receptors (5-HT3AR) and is used to treat diarrhea-predominant irritable bowel syndrome (IBS-D). 27 research has revealed high-resolution structures of alosetron and 5-HT3AR complexes, suggesting that alosetron binds to the binding site of 5-HT3AR, inhibiting excessive intestinal movement that causes diarrhea. 8 research reports that alosetron inhibited stress-induced diarrhea observed in Mongolian gerbils placed in a new environment. 23 research showed that alosetron is effective in improving quality of life and reducing daily activity restrictions in women with severe IBS-D. 22 research showed that alosetron reduced visceral pain, similar to that seen in IBS patients, in temperature-stressed rats. 26 research showed that alosetron significantly improved resource use, health-related quality of life, safety, and symptom improvement in IBS-D patients compared to conventional drug therapy. 15 research showed that alosetron has an effect on inhibiting stress-induced diarrhea and has been shown to be effective in IBS-like animal models. 5 research showed that alosetron slowed gastrointestinal transit time and improved rectal sensation in IBS patients.

Benefits and Risks

Benefit Summary

Alosetron may improve IBS-D symptoms, particularly diarrhea, abdominal pain, and urgency. 23 , 25 , 19 It may also lead to improved quality of life and reduced daily activity restrictions. 23

Risk Summary

Alosetron can cause side effects such as constipation. 5 Serious side effects such as ischemic colitis and complications of constipation have been reported. 3 Given these risks, alosetron is only recommended for patients with severe IBS-D and should be prescribed under a risk management program. , 2 , 29

Comparison between Studies

Commonalities among Studies

Many studies have shown that alosetron improves IBS-D symptoms. 23 , 25 , 19 , 26 , 15 , 5 It has also been suggested that alosetron inhibits intestinal motility by blocking serotonin receptors (5-HT3AR). 27

Differences among Studies

Research on the efficacy and safety of alosetron has varied in dose and study design. 25 , 26 Also, the patient populations studied differed, resulting in variations in the findings. 19 , 1

Consistency and Contradictions in Results

Many studies have shown that alosetron is effective in treating IBS-D. 23 , 25 , 19 , 26 , 15 However, the risk of serious side effects has also been pointed out, 3 and the use of alosetron should be carefully managed under a risk management program. , 2 , 29

Points to Note Regarding Application in Real Life

Alosetron is recommended only for patients with severe IBS-D and should be taken under the guidance of a physician. Also, if you experience side effects such as constipation, consult your doctor. 5 Alosetron should not be used by pregnant women or breastfeeding women. 24

Limitations of Current Research

Long-term safety and efficacy research on alosetron is not yet sufficient. 3 , 7 Also, the effects of alosetron may vary from person to person. 11

Directions for Future Research

Further research on the long-term safety and efficacy of alosetron is needed. 3 Research is also needed to elucidate the causes of individual variations in the effects of alosetron. 11

Conclusion

Alosetron may be an effective treatment option for patients with severe IBS-D. 23 , 25 , 19 , 26 However, there is a risk of serious side effects, 3 so it is important to take it under the guidance of a physician. When taking alosetron, it is important to understand the risks and benefits and to discuss with your doctor to choose a treatment that is right for you. 9

Literature analysis of 29 papers
Positive Content
22
Neutral Content
1
Negative Content
6
Article Type
6
4
7
13
29
1.

Sex and age differences in the pharmacokinetics of alosetron.

Author: KochK M, PalmerJ L, NoordinN, TomlinsonJ J, BaidooC

Sex difference in clearance

Alosetron, a drug used to treat irritable bowel syndrome, is cleared more slowly by metabolism in women than in men. This difference is more pronounced in elderly patients. Smoking also increases clearance of alosetron.

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

2.

A patient follow-up survey programme for alosetron: assessing compliance to and effectiveness of the risk management programme.

Author: MillerD, BennettL, HollisK, TennisP, CookS, AndrewsE

Diarrhea-predominant irritable bowel syndrome

Alosetron HCl, a drug for women with severe diarrhea-predominant irritable bowel syndrome, was re-introduced to the US market in 2002. To mitigate potential risks, a risk management program was implemented, including a patient follow-up study.

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

3.

Incidence of ischemic colitis and serious complications of constipation among patients using alosetron: systematic review of clinical trials and post-marketing surveillance data.

Author: ChangLin, CheyWilliam D, HarrisLucinda, OldenKevin, SurawiczChristina, SchoenfeldPhilip

Constipation complications
Ischemic colitis

Alosetron is a drug approved for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have failed conventional therapies. This systematic review found that alosetron is associated with ischemic colitis and serious complications of constipation.

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.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

4.

Effects of 5-hydroxytryptamine (serotonin) type 3 antagonists on symptom relief and constipation in nonconstipated irritable bowel syndrome: a systematic review and meta-analysis of randomized controlled trials.

Author: AndresenViola, MontoriVictor M, KellerJutta, WestColin P, LayerPeter, CamilleriMichael

Improved IBS symptoms
Constipation
Ischemic colitis

5-HT(3) antagonists significantly improved symptoms in patients with nonconstipated (NC) or diarrhea-predominant (D)-irritable bowel syndrome (IBS). They also had an increased risk of constipation, which was lower in those with D-IBS.

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, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
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.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

5.

Effects of alosetron on gastrointestinal transit time and rectal sensation in patients with irritable bowel syndrome.

Author: ThumshirnM, CoulieB, CamilleriM, ZinsmeisterA R, BurtonD D, Van DykeC

Alosetron had no significant effect on gastrointestinal transit or rectal sensory and motor mechanisms in non-constipated irritable bowel syndrome patients in this study.

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

6.

Irritable bowel syndrome.

Author: FordAlexander Charles, VandvikPer Olav

IBS prevalence
IBS symptoms
Unnecessary surgery risk

Irritable bowel syndrome (IBS) affects 5-20% of the population, depending on the diagnostic criteria. It's characterized by abnormal gastrointestinal function, heightened visceral perception, psychosocial factors, and genetic influences. People with IBS frequently experience other physical and mental symptoms and are more likely to undergo unnecessary surgeries.

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.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

7.

Systematic review: the safety and tolerability of pharmacological agents for treatment of irritable bowel syndrome--a European perspective.

Author: HeadingR, BardhanK, HollerbachS, LanasA, FisherG

Well tolerated
Ischemic colitis
Severe constipation

There is a significant lack of data on the safety and tolerability of therapies currently used to treat irritable bowel syndrome (IBS) in Europe.

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.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

10.

Partial agonism of 5-HT3 receptors: a novel approach to the symptomatic treatment of IBS-D.

Author: MooreNicholas A, SargentBruce J, ManningDavid D, GuzzoPeter R

IBS-D treatment
Partial agonist activity
Constipation

Irritable bowel syndrome (IBS) is a functional bowel disorder affecting 10-20% of the population. This review discusses the use of 5-HT(3) receptor antagonism for the treatment of IBS-D. While effective, traditional 5-HT(3) receptor antagonists can cause constipation. Novel compounds with partial agonist activity at the 5-HT(3) receptor are being developed to address this issue.

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

11.

Neural and psychological predictors of treatment response in irritable bowel syndrome patients with a 5-HT3 receptor antagonist: a pilot study.

Author: JarchoJ M, ChangL, BermanM, SuyenobuB, NaliboffB D, LiebermanM D, AmeenV Z, MandelkernM A, MayerE A

Treat IBS

Symptom improvement in irritable bowel syndrome (IBS) treatment trials varies widely. Reduced amygdala activity may be associated with symptom improvement in response to the 5-HT3R antagonist alosetron.

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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

12.

Updates on treatment of irritable bowel syndrome.

Author: HammerleChristopher W, SurawiczChristina M

Improved IBS symptoms
Cardiovascular disease
Ischemic colitis

Irritable bowel syndrome (IBS) is a common disorder that causes abdominal pain, discomfort, and changes in bowel habits. Treatment can be challenging due to the complex nature of the disorder. New drugs are being developed that target different aspects of IBS, but some have been associated with serious 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

13.

Current US Food and Drug Administration-Approved Pharmacologic Therapies for the Treatment of Irritable Bowel Syndrome with Diarrhea.

Author: BrennerDarren M, SayukGregory S

IBS-D treatment

This review highlights the efficacy and safety of three pharmacologic agents approved for treating irritable bowel syndrome with diarrhea (IBS-D) in adults: rifaximin, eluxadoline, and alosetron.

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

14.

Dual role of 5-HT3 receptors in a rat model of delayed stress-induced visceral hyperalgesia.

Author: BradesiSylvie, LaoLijun, McLeanPeter G, WinchesterWendy J, LeeKevin, HicksGareth A, MayerEmeran A

Visceral pain relief

This study investigated the mechanism of action of alosetron, a 5-HT3 receptor antagonist, in a rat model of stress-induced visceral hyperalgesia. Alosetron was found to be ineffective when administered subcutaneously but completely reversed the effects of stress when injected intrathecally or when vagal afferents were desensitized with capsaicin. The results suggest that 5-HT3 receptors on central terminals of spinal afferents are involved in stress-induced visceral hyperalgesia, but not those on vagal afferents.

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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

16.

Effects of a bicarbonate-alkaline mineral water on digestive motility in experimental models of functional and inflammatory gastrointestinal disorders.

Author: FornaiM, ColucciR, AntonioliL, GhisuN, TuccoriM, GoriG, BlandizziC, Del TaccaM

Gastrointestinal motility improvement

This study investigated the effects of Uliveto, a bicarbonate-alkaline mineral water, in experimental models of diarrhea, constipation, and colitis.

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

Language : English

17.

Irritable bowel syndrome.

Author: de WitNiek, RubinGregory, JonesRoger Hugh

Cholecystectomy
Hysterectomy

Irritable bowel syndrome (IBS) affects 5-15% of the population and is associated with abnormal gastrointestinal motor function, enhanced visceral perception, psychosocial factors, and genetics. Individuals with IBS have an increased risk of having a cholecystectomy or hysterectomy compared to those without IBS.

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.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

18.

Diarrhea-Predominant and Constipation-Predominant Irritable Bowel Syndrome: Current Prescription Drug Treatment Options.

Author: WechslerEmily V, ShahEric D

IBS symptom relief

This review summarizes the clinical profiles of efficacy, safety, and tolerability of prescription drugs for irritable bowel syndrome (IBS), including cost-effectiveness of drugs for diarrhea-predominant IBS and constipation-predominant IBS.

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

19.

Ramosetron Reduces Symptoms of Irritable Bowel Syndrome With Diarrhea and Improves Quality of Life in Women.

Author: FukudoShin, KinoshitaYoshikazu, OkumuraToshikatsu, IdaMotoko, AkihoHiraku, NakashimaYoshihiro, NishidaAkito, HarumaKen

IBS-D treatment

This randomized, placebo-controlled, phase 3 study investigated the effectiveness of ramosetron for reducing symptoms of irritable bowel syndrome with diarrhea (IBS-D) in women.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
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

20.

Efficacy and safety of 5-hydroxytryptamine 3 receptor antagonists in irritable bowel syndrome: A systematic review and meta-analysis of randomized controlled trials.

Author: ZhengYongping, YuTing, TangYurong, XiongWenjie, ShenXiaoxue, JiangLing, LinLin

Abdominal pain relief
Bowel habit improvement
IBS symptom improvement
Rare serious side effects
Constipation risk

This systematic review found that 5-HT3 receptor antagonists are effective for treating non-constipated irritable bowel syndrome and diarrhea-predominant irritable bowel syndrome.

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.

Randomised clinical trial: alosetron improves quality of life and reduces restriction of daily activities in women with severe diarrhoea-predominant IBS.

Author: CremoniniF, NicandroJ P, AtkinsonV, ShringarpureR, ChuangE, LemboA

IBS-D symptom improvement
Improved QOL
Reduced work absence
Constipation risk
Ischemic colitis risk

Alosetron was effective in improving health-related quality of life, reducing daily activity restrictions, and increasing treatment satisfaction in women with severe irritable bowel syndrome with diarrhea.

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

25.

A randomized, double-blind, placebo-controlled study to assess efficacy and safety of 0.5 mg and 1 mg alosetron in women with severe diarrhea-predominant IBS.

Author: KrauseRichard, AmeenVanessa, GordonSusan H, WestMarquita, HeathAmy T, PerschyTeresa, CarterEric G

IBS treatment
Constipation

This randomized, double-blind, placebo-controlled study assessed the efficacy and tolerability of alosetron in treating chronic, severe diarrhea-predominant irritable bowel syndrome (d-IBS) in women. While alosetron was effective in managing d-IBS symptoms, constipation was the most common adverse event, highlighting the need for careful patient selection and monitoring.

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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

26.

Alosetron versus traditional pharmacotherapy in clinical practice: effects on resource use, health-related quality of life, safety and symptom improvement in women with severe diarrhea-predominant irritable bowel syndrome.

Author: OldenKevin W, CheyWilliam D, ShringarpureReshma, Paul NicandroJean, ChuangEmil, EarnestDavid L

IBS-D treatment
Improved HRQOL
Reduced healthcare costs

This study compared the treatment outcomes of alosetron versus traditional pharmacotherapy (TP) in women with severe diarrhea-predominant irritable bowel syndrome (IBS-D). The study found that alosetron was associated with improved resource use, work productivity, health-related quality of life, and global symptom response compared to TP.

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.

Language : English

27.

High-resolution structures of multiple 5-HT<sub>3A</sub>R-setron complexes reveal a novel mechanism of competitive inhibition.

Author: BasakSandip, KumarArvind, RamseySteven, GibbsEric, KapoorAbhijeet, FilizolaMarta, ChakrapaniSudha

Nausea and vomiting treatment

Setrons are a class of drugs that are used to treat nausea and vomiting. These drugs work by blocking the 5-HT<sub>3A</sub> receptor, a serotonin receptor that is involved in regulating gut movement. Using cryo-EM, researchers have been able to study the structure of the 5-HT<sub>3A</sub> receptor in complex with three different setrons: palonosetron, ondansetron, and alosetron. This research has provided insights into how these drugs bind to the receptor and block its activity. The research also revealed that these drugs may inhibit serotonin binding by inducing a conformational change in the receptor.

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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Research Support, U.S. Gov't, Non-P.H.S.Research funding provided by US government agencies other than the Public Health Service.

Language : English

28.

Evaluation of harm in the pharmacotherapy of irritable bowel syndrome.

Author: ShahEric, KimSharon, ChongKelly, LemboAnthony, PimentelMark

Treatment of irritable bowel syndrome

This study examines the side effects of medications used to treat irritable bowel syndrome (IBS) with diarrhea and constipation. It looks at treatments recommended by the American College of Gastroenterology and uses a systematic review to assess the number of patients who experience harm from each medication.

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.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

29.

The risk of ischaemic colitis in irritable bowel syndrome patients treated with serotonergic therapies.

Author: LewisJames H

Treat IBS
Ischemic colitis

Ischaemic colitis (IC) is a common form of ischaemic injury to the gastrointestinal (GI) tract. While most cases are self-limited, it may be more severe in patients with irritable bowel syndrome (IBS) or those taking serotonergic drugs, including alosetron, tegaserod, and cilansetron.

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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