Effects of atogepant: A Synthesis of Findings from 17 Studies

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Original Abstract of the Article

Major Research Findings

Atogepant is an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist indicated for the preventive treatment of episodic migraine. Several studies have demonstrated the efficacy of atogepant in reducing the frequency of migraine headaches. 13 found that atogepant significantly improved patient-reported outcomes in patients with migraine, including the Migraine-Specific Quality-of-Life Questionnaire (MSQ) Role Function-Restrictive (RFR) domain and the Activity Impairment in Migraine-Diary (AIM-D) Performance of Daily Activities (PDA) and Physical Impairment (PI) domains. Furthermore, 7 showed that coadministration of atogepant with topiramate resulted in a 25% decrease in atogepant exposure, although this was considered clinically insignificant.

Benefits and Risks

Benefits Summary

Atogepant is a promising treatment option for migraine prevention. It has been shown to reduce the frequency of migraine headaches and improve quality of life for many patients.

Risks Summary

Common side effects of atogepant include constipation, nausea, and dizziness. Atogepant is a substrate of CYP3A4 and its levels can increase with CYP3A4 inhibitors. 1 Atogepant levels can decrease with CYP3A4 inducers. It is also a substrate of OATP and its levels can increase with OATP inhibitors. 1 The long-term safety of atogepant requires further investigation.

Comparison of Studies

Similarities in Studies

Multiple studies have shown that atogepant is effective in reducing migraine frequency. These studies typically compare atogepant to placebo and assess outcomes such as migraine frequency, severity, and impact on daily life.

Differences in Studies

The studies differ in the dosage of atogepant used, the methods of assessment, and the characteristics of the patient population. The types of migraines and the severity of the migraines can vary among the study participants.

Consistency and Contradictions of Results

Several studies consistently show that atogepant can reduce migraine frequency. However, there is variability in the magnitude of the effect and the frequency of adverse events across different studies.

Implications for Real-World Application

Atogepant holds significant promise for migraine prevention. However, it is important to remember that it can cause side effects. Patients should discuss the benefits and risks of atogepant with their healthcare provider to make an informed decision. It is crucial to be aware of potential drug interactions, especially with CYP3A4 and OATP inhibitors and inducers. Atogepant should be used under the guidance of a healthcare professional.

Limitations of Current Research

Further research is needed to assess the long-term safety and efficacy of atogepant. There is also a need for more studies to determine which types of migraine patients are most likely to benefit from atogepant.

Future Research Directions

Long-term safety and efficacy studies are needed. More research is required to identify the patient types that benefit most from atogepant. Determining the optimal dosage and duration of treatment for different patients is also a crucial area for future investigation.

Conclusion

Atogepant offers a promising new treatment option for migraine prevention. However, it is important to be aware of potential side effects and drug interactions. If you are experiencing migraine headaches, consult with your healthcare provider to discuss the best treatment options for you.

Literature analysis of 17 papers
Positive Content
15
Neutral Content
2
Negative Content
0
Article Type
1
2
2
8
17
2.

Atogepant Has No Clinically Relevant Effects on the Pharmacokinetics of an Ethinyl Estradiol/Levonorgestrel Oral Contraceptive in Healthy Female Participants.

Author: AnkromWendy, XuJialin, ValleeMarie-Helene, DockendorfMarissa F, ArmasDanielle, BoinpallyRamesh, MinK Chris

LNG increase

Atogepant, a potential migraine prevention drug, was studied for its effect on oral contraceptive pharmacokinetics. Coadministration of atogepant with a single dose of ethinyl estradiol/levonorgestrel did not significantly affect the contraceptive's pharmacokinetics, suggesting it is safe to use with oral contraceptives.

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

Language : English

3.

Metabolic and toxicological considerations regarding CGRP mAbs and CGRP antagonists to treat migraine in COVID-19 patients: a narrative review.

Author: TakizawaTsubasa, IharaKeiko, UnoShunsuke, OhtaniSeiya, WatanabeNarumi, ImaiNoboru, NakaharaJin, HoriSatoko, Garcia-AzorinDavid, MartellettiPaolo

CGRP-related drug therapy
COVID-19 vaccination
Migraine treatment
COVID-19 treatment
Drug interactions
Gepants

This expert opinion discusses the use of CGRP-targeted therapies for migraine and their potential interactions with COVID-19 treatments. Gepants may interact with certain COVID-19 drugs, while CGRP monoclonal antibodies have no known drug interactions.

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

4.

A Brief Review of Gepants.

Author: LiDiana, AbreuJessica, TepperStewart J

Improved side effect profile
Versatility in treating headaches

Gepants are small molecule antagonists of calcitonin gene-related peptide (CGRP) receptors. They are preferred over triptans due to their favorable side effect profile and versatility in treating headaches acutely and preventively.

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.

Evaluation of the pharmacokinetic interactions and safety of atogepant coadministered with esomeprazole.

Author: BoinpallyRamesh, ButlerMatthew, RojoJonathan, BorbridgeLisa, WangsadipuraVeronica, PapinskaAnna

No clinically meaningful interaction

This study investigated potential pharmacokinetic interactions between atogepant and esomeprazole. Coadministration with esomeprazole delayed atogepant time to peak plasma concentration (C<sub>max</sub>) by approximately 1.5 hours and reduced C<sub>max</sub> by approximately 23% with no significant change in area under the plasma concentration-time curve (AUC). This suggests that esomeprazole has no clinically meaningful effect on atogepant pharmacokinetics.

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

6.

Comparative Efficacy and Safety of Five Anti-calcitonin Gene-related Peptide Agents for Migraine Prevention: A Network Meta-analysis.

Author: SunWenfang, ChengHua, XiaBinbin, LiuXianjun, LiYali, WangXuemei, LiuChengjiang

Migraine prevention

This network meta-analysis compares the efficacy and safety of different doses of atogepant, a CGRP antagonist, to CGRP monoclonal antibodies for migraine prevention.

Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

7.

Pharmacokinetics and Safety of Coadministered Atogepant and Topiramate in Healthy Participants: A Phase 1, Open-Label, Drug-Drug Interaction Study.

Author: BoinpallyRamesh, McGeeneyDanielle, BorbridgeLisa, TrugmanJoel

Coadministration safety
Migraine prevention
Drug-drug interaction

This open-label, single-center, 2-cohort, phase 1 trial evaluated the potential pharmacokinetic (PK) 2-way drug-drug interactions (DDIs), safety, and tolerability of atogepant and topiramate in healthy adults. The 25% reduction in atogepant exposure when coadministered with topiramate is not considered to be clinically relevant and would not require dose adjustments.

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

Language : English

8.

Emerging drugs for the preventive treatment of migraine: a review of CGRP monoclonal antibodies and gepants trials.

Author: SilvestroMarcello, OrologioIlaria, SicilianoMattia, TrojsiFrancesca, TessitoreAlessandro, TedeschiGioacchino, RussoAntonio

Improved quality of life
Reduced migraine disability
Cost-effectiveness

This review examines the evolution of migraine prevention strategies, focusing on the recent advent of monoclonal antibodies against Calcitonin Gene-Related Peptide (CGRP) and gepants. These new agents offer significant advantages in terms of efficacy, safety, and tolerability compared to older preventative medications. However, their high cost may limit their use to more severe migraine phenotypes.

ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

9.

Safety and tolerability of monoclonal antibodies targeting the CGRP pathway and gepants in migraine prevention: A systematic review and network meta-analysis.

Author: MessinaRoberta, HuesslerEva-Maria, PuleddaFrancesca, HaghdoostFaraidoon, LebedevaElena R, DienerHans-Christoph

This study aims to compare the safety and tolerability of anti-calcitonin gene-related peptide monoclonal antibodies and gepants for migraine prevention.

Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.
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.

Headache: Treatment update.

Author: OgunlajaOyindamola I, GoadsbyPeter J

Migraine treatment

This article provides an overview of the new treatments available for migraine, a common cause of disability worldwide. The article discusses the benefits and limitations of different drug classes, including 5HT1F receptor agonists (ditans), small molecule CGRP receptor antagonists (gepants), and anti-CGRP monoclonal antibodies.

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.

Phase Ib, open-label, fixed-sequence, drug-drug interaction, safety, and tolerability study between atogepant and ubrogepant in participants with a history of migraine.

Author: BlumenfeldAndrew M, BoinpallyRamesh, De Abreu FerreiraRosa, TrugmanJoel M, DabruzzoBrett, AilaniJessica, LiptonRichard B

Migraine treatment

This phase Ib study assessed potential drug-drug interactions between ubrogepant and atogepant, CGRP receptor antagonists used for acute and preventive migraine treatment, respectively. Co-administration of ubrogepant with atogepant resulted in a statistically significant but clinically insignificant increase in ubrogepant exposure. The combination was safe and well-tolerated in adult participants with migraine.

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

12.

Gepants for Acute and Preventive Migraine Treatment: A Narrative Review.

Author: RissardoJamir Pitton, CapraraAna Letícia Fornari

Migraine prevention
Hemodynamic impairment

The new generation of CGRP antagonists, including rimegepant, ubrogepant, atogepant, and zavegepant, are effective for the acute and/or preventive treatment of migraines. While generally well-tolerated, long-term safety concerns remain, and careful pharmacovigilance is crucial. Further research is needed to assess their long-term effects and compare them with triptans, especially in elderly populations.

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.

Effect of Atogepant for Preventive Migraine Treatment on Patient-Reported Outcomes in the Randomized, Double-blind, Phase 3 ADVANCE Trial.

Author: LiptonRichard B, Pozo-RosichPatricia, BlumenfeldAndrew M, LiYe, SevertLawrence, StokesJonathan T, CreutzLela, GandhiPranav, DodickDavid

Improved quality of life

Atogepant, an oral calcitonin gene-related peptide receptor antagonist, demonstrated significant improvements in patient-reported outcomes, including Migraine-Specific Quality-of-Life Questionnaire (MSQ) Role Function-Restrictive (RFR) scores and both Activity Impairment in Migraine-Diary (AIM-D) domains.

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

14.

Atogepant for the prevention of episodic migraine in adults.

Author: SwitzerMaranda Paige, RobinsonJoseph Edward, JoynerKayla Rena, MorganKelsey Woods

Reduced MMD
Constipation
Nausea

Atogepant, a CGRP receptor antagonist, is an effective daily oral treatment for migraine prevention in patients with episodic migraine. It was associated with mild adverse effects like nausea and 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

15.

Focus on zavegepant: the first intranasal third-generation gepant.

Author: ScuteriDamiana, TarsitanoAssunta, ToninPaolo, BagettaGiacinto, CorasanitiMaria Tiziana

Migraine treatment
Hepatotoxicity

This study provides an overview of the novel, third-generation intranasal zavegepant, a CGRP receptor antagonist for the treatment of migraine. It discusses its development and future perspectives, highlighting the potential benefits of intranasal administration and the need for real-world, long-term postmarketing data.

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

17.

A systematic review with expert opinion on the role of gepants for the preventive and abortive treatment of migraine.

Author: ArgyriouAndreas A, MantovaniElisa, MitsikostasDimos-Dimitrios, VikelisMichail, TamburinStefano

Abortive treatment
Preventive treatment
Medication overuse headache

Gepants, a new class of drugs targeting calcitonin gene-related peptide (CGRP), may represent an abortive and preventive treatment option for migraine in patients who do not respond to traditional treatments.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

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