Effects of mitapivat: A Synthesis of Findings from 15 Studies

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Original Abstract of the Article

Major Research Findings

Misoprostol is a medication used to promote uterine contractions and prevent postpartum bleeding. Some studies have shown that misoprostol is as effective as methylergometrine in preventing postpartum hemorrhage. However, misoprostol may be associated with more side effects than methylergometrine. 5

Studies have investigated the dose-related effects of misoprostol when used to prevent and treat postpartum hemorrhage. Results suggest that higher doses of misoprostol are associated with an increased risk of death and fever. 11

Misoprostol is also a medication used to treat peptic ulcers. Several studies have shown that misoprostol significantly improves ulcer healing rates compared to placebo or cimetidine. 2

Misoprostol is used for labor induction. However, a study comparing oral and vaginal administration of misoprostol for labor induction found that the vaginal route was more effective. 15

Misoprostol has been shown to increase the risk of side effects like fever and chills after delivery. 6

Rectal misoprostol has been found to be more effective in managing the third stage of labor and associated with significantly fewer side effects compared to oral misoprostol. 12

Misoprostol is used for early medical abortion through oral and buccal routes, but the buccal route has shown to have a different side effect profile. 14

Misoprostol may increase the blood levels of drugs like indomethacin. 1

In early medical abortion, the vaginal route for misoprostol is more effective and preferred to the buccal route when used after methotrexate. 10

Vaginal misoprostol is more effective and has fewer side effects compared to oral misoprostol for second-trimester pregnancy termination. 9

In early medical abortion, vaginal misoprostol is associated with fewer failures than low-dose gemeprost, particularly at gestation > or =49 days when used with mifepristone. 8

Both buccal and sublingual administration of misoprostol are effective and have few adverse effects when used with 200 mg mifepristone for medical abortion through 63 days since the last menstrual period. 13

When used with mifepristone for early pregnancy termination, 800μg misoprostol is effective and can minimize gastrointestinal side effects. 4

A titrated oral misoprostol solution for labor induction has been shown to minimize the risk of uterine hyperstimulation but may have a slower response in women with intact membranes and unfavorable cervices. 7

Misoprostol has been shown to have cytoprotective activity in the gastrointestinal tract. 3

Benefits and Risks

Benefit Summary

Misoprostol has been shown to be effective in a variety of applications, including preventing and treating postpartum hemorrhage, treating peptic ulcers, inducing early medical abortion, and inducing labor. Several studies have demonstrated misoprostol's efficacy in these areas.

Risk Summary

Misoprostol can cause a range of side effects, including fever, chills, diarrhea, vomiting, and excessive uterine contractions. Higher doses of misoprostol may increase the risk of death and fever. Misoprostol may also increase blood levels of certain medications, such as indomethacin.

Comparison Between Studies

Similarities

All of these studies evaluate the efficacy and safety of misoprostol. Many studies suggest that misoprostol is effective in several applications compared to other medications. However, misoprostol has been shown to be associated with various risks of side effects.

Differences

These studies differ in their application of misoprostol, including administration method, dosage, and comparison medications. Direct comparison of study results is not feasible. Additionally, the number of participants and follow-up duration varies across studies.

Consistency and Inconsistencies

Some studies suggest that misoprostol is effective in a variety of applications, including preventing postpartum hemorrhage, treating peptic ulcers, and inducing early medical abortion. However, these studies differ in their use of misoprostol, administration methods, dosage, and comparison medications, making direct comparison of results difficult.

Misoprostol can cause various side effects, including fever, chills, diarrhea, vomiting, and excessive uterine contractions. The severity of these side effects may vary depending on the dosage of misoprostol. Higher doses of misoprostol may increase the risk of death and fever.

Misoprostol may increase blood levels of certain medications, such as indomethacin. Therefore, caution is necessary when administering misoprostol with these medications.

Practical Application

While several studies demonstrate misoprostol's effectiveness in various applications, it's important to remember the associated risks of side effects. Therefore, it's essential to consult with a healthcare professional before using misoprostol and consider the risks and benefits.

It is particularly important for pregnant or breastfeeding women, those with liver or kidney disease, and those taking other medications to consult with a doctor before using misoprostol.

Limitations

These studies have limitations, including small sample sizes, short follow-up periods, and biased sample selection. Therefore, generalizing these study results should be approached with caution.

Future Research

More research is needed to further investigate the efficacy and safety of misoprostol. Future studies should aim to identify the optimal dosage, administration methods, and safe co-medications.

Conclusion

Several studies suggest that misoprostol is effective in various applications, including preventing postpartum hemorrhage, treating peptic ulcers, inducing early medical abortion, and inducing labor. However, it's important to be aware of the possible side effects, including fever, chills, diarrhea, vomiting, and excessive uterine contractions. Consulting with a healthcare professional before using misoprostol and considering the risks and benefits is essential.

Future research should focus on identifying the optimal dosage, administration methods, and safe co-medications for misoprostol.

Literature analysis of 15 papers
Positive Content
13
Neutral Content
2
Negative Content
0
Article Type
14
0
1
1
15
1.

Effects of misoprostol on the pharmacokinetics of indomethacin in human volunteers.

Author: RainsfordK D, JamesC, HuntR H, StetskoP I, RischkeJ A, KarimA, NicholsonP A, SmithM, HantsbargerG

No interference with absorption
Increased indomethacin concentration

Misoprostol did not interfere with the absorption of indomethacin but enhanced its steady-state maximum concentration.

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.

Misoprostol in peptic ulcer disease.

Author: WatkinsonG, AkbarF A

Mucosal protection
Pain relief
Smoking reduction effect
Ulcer healing
Diarrhea

Misoprostol, a synthetic prostaglandin E1 analog, was compared to placebo and cimetidine in treating gastric and duodenal ulcers. Misoprostol showed significantly better results than placebo and comparable results to cimetidine in terms of ulcer healing and pain relief. The most common side effect was diarrhea.

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.

Language : English

3.

Gastrointestinal cytoprotective effects of misoprostol. Clinical efficacy overview.

Author: DajaniE Z, NissenC H

Cytoprotective activity
Inhibit fecal blood loss
Inhibit gastric microbleeding
Reduce acid and chloride secretion

Misoprostol, a synthetic analog of prostaglandin E1, was found to have cytoprotective activity in humans. The drug significantly inhibited aspirin-induced gastric microbleeding and fecal blood loss. Misoprostol also reduced acid and chloride secretion and attenuated the drop in transmucosal potential difference induced by sodium taurocholate.

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

4.

Early abortion induction by a combination of mifepristone and oral misoprostol: a comparison between two dose regimens of misoprostol and their effect on blood pressure.

Author: el-RefaeyH, TempletonA

Early pregnancy termination
Blood pressure changes
Gastrointestinal side effects

Misoprostol, a PGE1 analogue, was found to be effective in terminating early pregnancy when administered to women pretreated with mifepristone, with two different regimens compared to minimize gastrointestinal side effects.

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.

Language : English

5.

Misoprostol compared with methylergometrine for the prevention of postpartum haemorrhage: a double-blind randomised trial.

Author: AmantF, SpitzB, TimmermanD, CorremansA, Van AsscheF A

Reduced haemorrhage
Side effects

Misoprostol and methylergometrine provide similar protection against postpartum hemorrhage, but misoprostol is associated with more side effects, including fever and shivering.

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.

Language : English

6.

Side-effects of oral misoprostol in the third stage of labour--a randomised placebo-controlled trial.

Author: HofmeyrG J, NikodemV C, de JagerM, DrakelyA

Prevents postpartum hemorrhage
Hypertension
Pyrexia
Shivering

Oral misoprostol 600 micrograms was associated with increased postpartum shivering (44% vs. 11%), pyrexia (38% vs. 6%), and hypertension compared to placebo.

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.

Language : English

7.

Titrated oral misoprostol solution for induction of labour: a multi-centre, randomised trial.

Author: HofmeyrG J, AlfirevicZ, MatonhodzeB, BrocklehurstP, CampbellE, NikodemV C

Induction of labor
Minimized hyperstimulation
Slower response

Titrated oral misoprostol solution for induction of labor after 34 weeks of pregnancy was as effective as vaginal dinoprostone. Both treatments resulted in similar vaginal delivery rates (38% vs. 36%) and cesarean section rates (16% vs. 20%). Misoprostol showed a slower response in women with intact membranes and unfavorable cervices.

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

8.

Double-blind randomized trial of mifepristone in combination with vaginal gemeprost or misoprostol for induction of abortion up to 63 days gestation.

Author: BartleyJ, BrownA, EltonR, BairdD T

Abortion induction
Fewer failures
Diarrhea
Vomiting

Vaginal misoprostol is the preferred prostaglandin for medical abortion in early pregnancy due to its higher complete abortion rate (98.7%) compared to low-dose gemeprost (96.2%), particularly at gestation > or =49 days.

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.

A comparison of oral misoprostol with vaginal misoprostol administration in second-trimester pregnancy termination for fetal abnormality.

Author: DickinsonJan E, EvansSharon F

Faster delivery time

Vaginal administration of misoprostol (400 mcg every 6 hours) was more effective than oral administration (400 mcg every 3 hours) in achieving delivery within 24 hours for second-trimester pregnancy termination. A vaginal misoprostol regimen was 1.9 times more likely to result in delivery within 24 hours than an oral regimen.

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

10.

Comparing vaginal and buccal misoprostol when used after methotrexate for early abortion.

Author: WiebeEllen R, TroutonKonia

Early abortion
Burning

Vaginal misoprostol is more effective and preferred to buccal misoprostol when used after methotrexate for early abortion.

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

11.

Misoprostol to prevent and treat postpartum haemorrhage: a systematic review and meta-analysis of maternal deaths and dose-related effects.

Author: HofmeyrG Justus, GülmezogluA Metin, NovikovaNatalia, LinderVerena, FerreiraSandra, PiaggioGilda

Postpartum hemorrhage prevention
Postpartum hemorrhage treatment
Maternal death
Pyrexia

Misoprostol at a dose of 400 microg was found to be safer than > 600 microg and just as effective in preventing blood loss and pyrexia.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, U.S. Gov't, Non-P.H.S.Research funding provided by US government agencies other than the Public Health Service.
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

12.

Rectal versus oral misoprostol for active management of third stage of labor: a randomized controlled trial.

Author: MansouriH A, AlsahlyN

Less side effects
Rectal misoprostol effective

The study found that rectal misoprostol is effective in the management of third stage of labor, and with a significant decrease in side effects compared to oral misoprostol.

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

13.

Comparison of 400 mcg buccal and 400 mcg sublingual misoprostol after mifepristone medical abortion through 63 days' LMP: a randomized controlled trial.

Author: RaghavanSheila, ComendantRodica, DigolIrena, UngureanuSergiu, DondiucIurie, TurcanuSteliana, WinikoffBeverly

Medical abortion

This study compares the efficacy of buccal and sublingual misoprostol in medical abortion.

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

14.

A randomized clinical trial comparing the short-term side effects of sublingual and buccal routes of misoprostol administration for medical abortions up to 63 days' gestation.

Author: ChaiJoyce, WongChing Yin Grace, HoPak Chung

Early pregnancy termination
Side effects

This is the first double-blind randomized trial comparing the side effect profiles of buccal misoprostol and sublingual misoprostol when used with mifepristone for early pregnancy termination.

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

15.

Misoprostol administered sublingually at a dose of 12.5 μg versus vaginally at a dose of 25 μg for the induction of full-term labor: a randomized controlled trial protocol.

Author: GattásDaniele Sofia Moraes Barros, da Silva JuniorJosé Roberto, SouzaAlex Sandro Rolland, FeitosaFrancisco Edson, de AmorimMelania Maria Ramos

Induction of labor
Side effects

Misoprostol is a medication that can be used to induce labor. This study looked at whether it is more effective to give misoprostol under the tongue or in the vagina.

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.
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.

Language : English

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