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

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Original Abstract of the Article

Major Research Findings

Lubiprostone is a medication approved by the US Food and Drug Administration (FDA) for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C). 1 、 8 Lubiprostone works by increasing fluid secretion in the intestines, making stools softer and easier to pass. 1 This medication has shown effectiveness in both short- and long-term studies, improving bowel movement frequency, stool consistency, and overall quality of life for patients with constipation. 1 Lubiprostone has also proven to be effective in treating IBS-C, improving global symptoms, abdominal pain, and constipation-related symptoms. 1 Importantly, there is no evidence of a rebound effect in constipation or IBS symptoms when stopping lubiprostone. 1 While generally well-tolerated, the most common side effects reported include nausea, headache, and diarrhea. 1

Reasons for Side Effects

The primary side effects of lubiprostone stem from its mechanism of action—increasing fluid secretion in the intestines. 8 This increased fluid secretion can lead to intestinal distention, causing symptoms like nausea, diarrhea, and abdominal pain. 8 Lubiprostone's ability to stimulate bowel movements can also contribute to diarrhea. 1

Common Side Effects

Nausea

About 38.8% of patients taking lubiprostone have reported side effects such as nausea. 15 In particular, cancer patients with a low BMI (body mass index) were found to have a higher incidence of nausea. 15

Headache

About 8.8% of patients taking lubiprostone have reported headaches. 15

Diarrhea

About 14% of patients taking lubiprostone have reported diarrhea. 15 In particular, cancer patients with a low BMI were found to have a higher incidence of diarrhea. 15

Side Effect Countermeasures

Nausea

If you experience nausea, measures such as eating small meals several times a day or avoiding fatty foods may be effective. 8

Headache

If you have a severe headache, consult your doctor and ask for a prescription for appropriate medication. 1

Diarrhea

If you have severe diarrhea, consult your doctor and ask for a prescription for appropriate medication. 1

Comparison Between Studies

Commonalities

Multiple studies have confirmed that lubiprostone is effective for chronic idiopathic constipation and constipation-predominant irritable bowel syndrome (IBS-C). 1 、 8 Lubiprostone is generally considered safe. 1 、 8

Differences

There are some differences in the results of studies on the side effects of lubiprostone. For example, the incidence of side effects such as nausea and diarrhea may vary depending on the study. 15 This is thought to be influenced by various factors, such as the age, sex, severity of constipation, and concomitant medications of the study subjects. 15

Points to Note Regarding Real-Life Applications

Lubiprostone is a medicine effective for the treatment of constipation, but it is important to understand that there is a risk of side effects. 1 In particular, people with a low BMI may be more prone to side effects such as nausea and diarrhea, so caution is needed. 15 When taking lubiprostone, consult your doctor and confirm the appropriate dosage and precautions. 1

Limitations of Current Research

Research on lubiprostone is still insufficient. In particular, further research is needed on long-term side effects and drug interactions. 1

Directions for Future Research

Future research is needed to assess the long-term safety of lubiprostone, drug interactions, and comparative efficacy for various types of constipation. 1

Conclusion

Lubiprostone is a medicine effective for the treatment of chronic idiopathic constipation and constipation-predominant irritable bowel syndrome (IBS-C), but it is important to understand that there is a risk of side effects such as nausea, headache, and diarrhea. 1 When taking lubiprostone, consult your doctor and confirm the appropriate dosage and precautions. 1

Literature analysis of 25 papers
Positive Content
21
Neutral Content
2
Negative Content
2
Article Type
2
2
1
18
25
2.

[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

3.

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

5.

Efficacy and safety of oral lubiprostone in constipated patients with or without irritable bowel syndrome: a randomized, placebo-controlled and dose-finding study.

Author: FukudoS, HongoM, KanekoH, UenoR

Improved constipation
Safe treatment

Lubiprostone, a prostone analog, effectively improved constipation symptoms in Japanese patients with or without irritable bowel syndrome in a dose-dependent manner with a good safety profile.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number 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

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.

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

8.

Safety evaluation of lubiprostone in the treatment of constipation and irritable bowel syndrome.

Author: ChamberlainSherman M, RaoSatish S C

Treat IBS-C
Treat constipation
Abdominal pain
Bloating
Diarrhea
Dyspnea
Nausea

Lubiprostone, a medication for constipation, causes fluid and electrolyte secretion in the small bowel, leading to laxation. While generally safe and effective, common side effects include nausea, diarrhea, abdominal pain, and bloating.

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

9.

The safety of novel drugs used to treat irritable bowel syndrome.

Author: MozaffariShilan, NikfarShekoufeh, AbdollahiMohammad

Constipation
Diarrhea

Most reported adverse events for novel gastrointestinal drugs were related to the GI tract with mild-to-moderate severity.

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.

Language : English

10.

Evaluation and treatment of colonic symptoms.

Author: PasanenMark E

Fecal impaction
Fecal incontinence

Constipation is a complex condition that requires careful evaluation to determine the underlying cause. Treatment options include lifestyle changes, laxatives, and biofeedback.

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.

Management of constipation in patients with Parkinson's disease.

Author: Pedrosa CarrascoAnna J, TimmermannLars, PedrosaDavid J

Improved quality of life
Reduced constipation

Dietetic interventions with probiotics and prebiotics may be moderately supported for constipation in Parkinson's disease.

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.

Recent advances in understanding and managing chronic constipation.

Author: PrichardDavid O, BharuchaAdil E

Constipation treatment
Undesirable side effects

Constipation is a common condition that can affect physical, mental, and social functioning. Current guidelines recommend empiric therapy, but limited surveys suggest that fewer than half of treated individuals are satisfied with treatment. Newer therapeutic agents, such as secretagogues and pro-kinetics, may offer more effective treatment options.

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

13.

Implications of the Opioid Epidemic for the Clinical Gastroenterology Practice.

Author: ThapaNamisha, KappusMatthew, HurtRyan, DiamondSarah

GI side effects

This article discusses opioid-related gastrointestinal side effects, which are common in patients with opioid use disorder. The article reviews the pathophysiology of these side effects, clinical presentation, diagnosis, and treatment options.

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

14.

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

15.

The Efficacy and Safety of Lubiprostone for Constipation in Cancer Patients Compared with Non-cancer Patients: A Retrospective Cohort Study.

Author: SadaHikaru, KajizonoMakoto, UshioSouichiro, EsumiSatoru, KitamuraYoshihisa, SendoToshiaki

Effective in cancer
Improved BM frequency
Caution in low BMI
Diarrhea and nausea
High discontinuation rate

This study evaluated the efficacy and safety of lubiprostone for constipation in cancer patients. Lubiprostone was as effective in cancer patients as in non-cancer patients, but it was associated with a higher incidence of diarrhea and nausea in cancer patients, especially those with a low BMI.

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.

Language : English

16.

Recommendations for the management of opioid-induced constipation - how to improve usability in clinical practice.

Author: OkdahlTina, EmmanuelAnton, MorlionBart, FarmerAdam, VarrassiGiustino, DrewesAsbjørn Mohr

Opioid constipation treatment

This review discusses the challenges of treating opioid-induced constipation and the need for simplified and behaviorally-oriented guidelines to improve management.

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.

Single-dose lubiprostone along with split-dose PEG solution without dietary restrictions for bowel cleansing prior to colonoscopy: a randomized, double-blind, placebo-controlled trial.

Author: StengelJoel Z, JonesDavid P

Colonoscopy preparation

This study compares the efficacy, safety, and patient tolerability of single-dose lubiprostone versus placebo pretreatment prior to a split-dose polyethylene glycol electrolyte (PEG-E) bowel preparation for colonoscopy.

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

19.

Pharmacologic treatment of constipation: what is new?

Author: PohlDaniel, TutuianRadu, FriedMichael

Constipation treatment
New drug options
Abdominal cramps
Bloating

This review discusses recent developments in the pharmacologic treatment of chronic constipation, including newly FDA-approved lubiprostone and emerging 5-HT receptor modifiers.

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

21.

Lubiprostone: chronic constipation and irritable bowel syndrome with constipation.

Author: LacyBrian E, CheyWilliam D

Constipation treatment
IBS-C treatment
Diarrhea
Headache
Nausea

Lubiprostone, a bicyclic fatty acid metabolite analog of prostaglandin E1, is FDA-approved for treating chronic constipation in men and women and women with irritable bowel syndrome with constipation (IBS-C). Lubiprostone specifically activates type-2-chloride channels on the apical membrane of epithelial cells, acting locally within the intestinal tract. It is rapidly metabolized and has very low systemic bioavailability. Animal studies have shown that lubiprostone increases gastrointestinal fluid secretion in a dose-dependent manner. Clinical studies in men and women with chronic constipation using 24 microg of lubiprostone twice daily demonstrated objective improvements in stool frequency and consistency, as well as symptoms of straining and incomplete evacuation. A multicenter study in patients with IBS-C found that 8 microg of lubiprostone twice daily improved both global and individual symptoms of IBS. Lubiprostone is generally well-tolerated, with serious adverse events being rare. The most common reported side effects are nausea, headache, and diarrhea. This monograph provides an overview of chloride channel function in the gastrointestinal tract, describes the structure, function, and pharmacokinetics of lubiprostone, and discusses the safety and efficacy of this new medication for treating chronic constipation and 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

22.

Opioid-induced bowel dysfunction: pathophysiology and management.

Author: BrockChristina, OlesenSøren Schou, OlesenAnne Estrup, FrøkjaerJens Brøndum, AndresenTrine, DrewesAsbjørn Mohr

Pain management
Addiction
Cognitive impairment
Nausea
Opioid-induced bowel dysfunction
Urinary retention

Opioids are widely used to treat severe pain but can cause bowel dysfunction, including constipation. This abstract explores the pathophysiology of opioid-induced bowel dysfunction and discusses various treatment strategies.

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

23.

Lubiprostone in constipation: clinical evidence and place in therapy.

Author: WilsonNicholas, ScheyRon

Colonic laxation
Increased peristalsis
Diarrhea
Nausea

Lubiprostone is a prostaglandin-derived bicyclic fatty acid available for the long-term treatment of constipation. Randomized, double-blind, placebo-controlled trials have shown it to be effective and free of serious adverse 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

24.

Opioid-induced constipation in chronic noncancer pain.

Author: WeberH Christian

OIC treatment

This review examines new medications for treating opioid-induced constipation (OIC), a common side effect of opioid use.

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.

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

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