Side Effects of midostaurin: A Synthesis of Findings from 16 Studies

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Original Abstract of the Article

Main Research Findings

Midostaurin is a multikinase inhibitor that has shown efficacy and safety in treating various cancers, particularly FLT3-mutated positive acute myeloid leukemia (AML) and KIT-mutated positive advanced systemic mastocytosis (SM). 6 、 10 、 11 、 12

Reasons for Side Effects

Midostaurin inhibits protein kinases such as FLT3 and KIT to suppress the growth of cancer cells. However, these kinases are also present in normal cells, therefore midostaurin can affect normal cells and cause side effects. 10 、 8

Common Side Effects

Gastrointestinal

The most common side effect of midostaurin is found in the gastrointestinal system. Nausea, vomiting, diarrhea, constipation, and abdominal pain may occur. 5 、 11 、 12

Hematopoietic System

Midostaurin may suppress the hematopoietic function of the bone marrow, potentially causing side effects such as anemia, leukopenia, and thrombocytopenia. 11

Liver

Midostaurin can increase liver enzyme levels. 11

Countermeasures for Side Effects

Gastrointestinal

Drug therapy such as antiemetics, antidiarrheals, and probiotics is effective for digestive side effects. Dietary therapy and lifestyle improvement may also be effective. 5

Hematopoietic System

Treatment such as blood transfusion and hematopoietic factors is effective for hematopoietic side effects. 5

Liver

If liver enzyme levels are elevated, midostaurin administration may need to be stopped or reduced. 5

Comparison between Studies

Commonalities between Studies

Multiple studies have confirmed the efficacy and safety of midostaurin. 6 、 10 、 11 、 12

Differences between Studies

The efficacy and side effects of midostaurin vary depending on the patient's condition, treatment history, dosage, etc. 6 、 10 、 11 、 12

Precautions for Application in Real Life

It is important to use midostaurin under the guidance of a physician with the appropriate dosage and method of administration. If you experience any side effects, consult your doctor immediately. 5

Limitations of Current Research

Further research is needed on the long-term safety and efficacy of midostaurin. 11

Directions for Future Research

Research is needed on the long-term safety and efficacy of midostaurin, preventive and mitigating measures for side effects, and optimal dosage and method of administration. 5 、 11 、 12

Conclusion

Midostaurin is an effective drug for treating FLT3-mutated positive AML and KIT-mutated positive advanced SM, but it is important to be aware of side effects. 6 、 10 、 11 、 12 、 5

If you are considering taking midostaurin, consult your doctor and understand the risks and benefits of side effects before receiving appropriate treatment.

Literature analysis of 16 papers
Positive Content
14
Neutral Content
2
Negative Content
0
Article Type
5
0
0
3
16
1.

Adverse side effects of methylphenidate among mentally retarded children with ADHD.

Author: HandenB L, FeldmanH, GoslingA, BreauxA M, McAuliffeS

Attention deficit hyperactivity disorder treatment
Motor tics
Social withdrawal

Methylphenidate may increase the risk of motor tics and social withdrawal in mentally retarded children with attention deficit hyperactivity disorder.

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.
Controlled Clinical TrialA clinical trial that evaluates the effectiveness of a treatment by comparing a group that receives the intervention with a group that receives a placebo or standard treatment.
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

2.

Side effects of methylphenidate in children with attention deficit hyperactivity disorder: a systemic, placebo-controlled evaluation.

Author: BarkleyR A, McMurrayM B, EdelbrockC S, RobbinsK

ADHD treatment
Decreased appetite
Headaches
Insomnia
Stomachaches

Methylphenidate was found to be an effective treatment for attention deficit hyperactivity disorder (ADHD) in children, with few, generally mild side effects. The most common side effects reported by parents were decreased appetite, insomnia, stomachaches, and headaches.

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.

Drug and placebo side effects in methylphenidate-placebo trial for attention deficit hyperactivity disorder.

Author: FineS, JohnstonC

None mentioned
Side effects mistaken for ADHD symptoms

This study highlights the potential for misinterpretation of side effects from methylphenidate, a medication used to treat ADHD. The study found that side effects were reported on both placebo and methylphenidate, and many were similar to ADHD symptoms. This suggests that parents and teachers may mistakenly attribute ADHD symptoms to the medication, which could lead to poor adherence to treatment.

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.

Short-term side effects of stimulant medication are increased in preschool children with attention-deficit/hyperactivity disorder: a double-blind placebo-controlled study.

Author: FirestoneP, MustenL M, PistermanS, MercerJ, BennettS

Anxiety
Mood changes

Methylphenidate was generally well-tolerated by preschool children with ADHD, with no children withdrawing due to adverse effects. The most common side effects, generally observed at the higher dose (0.5 mg/kg), included decreased appetite, insomnia, and mood changes. Interestingly, some side effects were associated with improved behavior.

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

5.

Treatment of Advanced Systemic Mastocytosis with Midostaurin: Practical Guidance for Optimal Therapy and Management.

Author: PapayannidisCristina, FedericoVincenzo, FianchiLuana, PregnoPatrizia, PuglieseNovella, RomanoAlessandra, GrifoniFederica Irene

Inhibits KIT mutation
Well-established role
Adverse events
Dose adjustments

This review provides expert guidance on optimizing midostaurin management in patients with advanced systemic mastocytosis, including initiation, response evaluation, adverse event management, and considerations for the Covid-19 pandemic.

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

6.

Post-transplantation maintenance with sorafenib or midostaurin for FLT3 positive AML patients - a multicenter retrospective observational study.

Author: ShimonyShai, YeshurunMoshe, WolachOfir, RamRon, RozovskiUri, ShargianLiat, ZukermanTsila, AmitOdelia, Bar-OnYael, KrayemBaher, AvniBatya, PeretzGalit, RaananiPia, PasvolskyOren

Treat acute myeloid leukemia
Side effects

The role of FLT3 inhibition after allogeneic stem-cell transplantation (AlloSCT) for acute myeloid leukemia is unclear, especially with the widespread use of tyrosine kinase inhibitors (TKIs) before transplantation. This study examined the outcomes of 41 patients who received post-transplant TKIs. The results showed that post-transplant TKIs were safe and effective, even in patients who had received TKIs before transplantation.

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.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

7.

Oral adherence in adults with acute myeloid leukemia (AML): results of a mixed methods study.

Author: BryantAshley Leak, LeBlancThomas W, AlbrechtTara, ChanYa-Ning, RichardsonJaime, FosterMatthew, DangMalisa, DudleyWilliam, OwenbySusie, WujcikDebra

Decreased adherence
Oral medication side effects

This study aims to identify and summarize adherence to oral medications (OMs) in patients with acute myeloid leukemia (AML).

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

Language : English

8.

Novel Therapies in Acute Myeloid Leukemia.

Author: MukherjeeSudipto, SekeresMikkael A

AML treatment

Optimal treatment decisions for acute myeloid leukemia (AML) should be personalized based on individual patient characteristics. While treatment options have expanded, more research is needed on patient selection, long-term efficacy and safety, and sequencing of therapies.

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

10.

Comparison of the Kinase Profile of Midostaurin (Rydapt) with That of Its Predominant Metabolites and the Potential Relevance of Some Newly Identified Targets to Leukemia Therapy.

Author: ManleyPaul W, CaravattiGiorgio, FuretPascal, RoeselJohannes, TranPhi, WagnerTrixie, WartmannMarkus

AML treatment
Mastocytosis treatment

Midostaurin is a multitargeted protein kinase inhibitor that has shown efficacy in treating acute myeloid leukemia (AML). This study highlights the importance of metabolites in drug efficacy and suggests that midostaurin's effects in AML are likely influenced by the combined activities of both the parent drug and its metabolites.

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

11.

Efficacy and safety of midostaurin in patients with advanced systemic mastocytosis: 10-year median follow-up of a phase II trial.

Author: DeAngeloD J, GeorgeT I, LinderA, LangfordC, PerkinsC, MaJ, WesterveltP, MerkerJ D, BerubeC, CoutreS, LiedtkeM, MedeirosB, SternbergD, DutreixC, RuffieP-A, CorlessC, GraubertT J, GotlibJ

SM remission
Anemia
Gastrointestinal side effects
Hyperlipasemia

Midostaurin, a multikinase inhibitor, showed promising results in a Phase II trial of patients with advanced systemic mastocytosis. The study found that midostaurin had an overall response rate of 69% and resulted in a significant reduction in bone marrow mast cell burden and serum tryptase levels. Median overall survival for the entire cohort was 40 months.

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

Language : English

12.

Clinical potential of midostaurin in advanced systemic mastocytosis.

Author: ChandesrisMarie Olivia, DamajGandhi, LortholaryOlivier, HermineOlivier

Treat AdSM
Digestive side effects

Midostaurin is an effective and safe treatment for advanced systemic mastocytosis (AdSM).

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.

Antitumor and normal cell protective effect of PKC412 in the athymic mouse model of ovarian cancer.

Author: KimMyungshin, ParkIn-Yang, LimJihyang, KimYonggoo, HanKu Taek, ChungWon Heui, HanKyungja

Reduced immunosuppression
Reduced tumor burden
Reduced weight loss

This study examines the antitumor effects of PKC412, a protein kinase C inhibitor, alone and in combination with paclitaxel in a mouse model of ovarian cancer. The combination demonstrated synergistic effects in reducing tumor burden and mitigating paclitaxel-induced side effects, suggesting potential clinical application.

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

14.

Reduction of diabetic macular edema by oral administration of the kinase inhibitor PKC412.

Author: CampochiaroPeter A,

Improved visual acuity
Reduced macular edema
Gastrointestinal side effects
Liver toxicity

This study evaluated the efficacy and safety of PKC412, an oral kinase inhibitor, in treating diabetic macular edema. The results showed that doses of 100 mg/d or higher significantly reduced macular edema and improved visual acuity. However, there was concern regarding liver toxicity, making local delivery an appealing approach.

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 protein kinase C inhibitor CGP41251 suppresses cytokine release and extracellular signal-regulated kinase 2 expression in cancer patients.

Author: ThavasuP, PropperD, McDonaldA, DobbsN, GanesanT, TalbotD, BraybrookJ, CaponigroF, HutchisonC, TwelvesC, ManA, FabbroD, HarrisA, BalkwillF

Cancer treatment

CGP41251, a protein kinase C (PKC) inhibitor, significantly reduced in vivo signaling pathways in cancer patients. This finding suggests that PKC inhibitors may be a promising target for cancer therapy.

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.
Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

16.

Reversal of multidrug resistance by the staurosporine derivatives CGP 41251 and CGP 42700.

Author: UtzI, SpitalerM, RybczynskaM, LudescherC, HilbeW, RegenassU, GrunickeH, HofmannJ

Antitumor activity
Reverse multidrug resistance

CGP 42700, a staurosporine derivative with low protein kinase C inhibiting activity, effectively reversed mdr1-mediated multidrug resistance in cancer cells, similar to CGP 41251, a known protein kinase C inhibitor. CGP 42700 may be less toxic and have fewer side effects than other chemosensitizers because it does not inhibit protein kinase C or cell proliferation.

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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