Randomized controlled trial of the CGRP receptor antagonist telcagepant for prevention of headache in women with perimenstrual migraine

Ho, Tony W.; Ho, Andrew P.; Ge, Yang; Assaid, Christopher; Gottwald, Regina; MacGregor, Anne; Mannix, Lisa K.; Oosterhout, Willebrordus P J van; Koppenhaver, Janelle M.; Lines, Christopher; Ferrari, Michel D.; Michelson, David

doi:10.1177/0333102415584308

Cited by 85 publications

(68 citation statements)

References 19 publications

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“…These animals also had renal damage that was independent from the increase in blood pressure [35]. Related with these findings, acute intravenous (i.v.)…”

Section: Tips 1346 No Of Pages 10mentioning

confidence: 57%

“…The cardiovascular effects of long-term blockade of the CGRP receptor with gepants were assessed in only two, relatively small and short-lasting, prophylactic treatment studies [34,35]. Little is known about the cardiovascular safety of the long-term blockade of the CGRP system with CGRP (receptor) antibodies.…”

Section: Cardiovascular Safety Of Blocking the Cgrp Systemmentioning

confidence: 99%

“…This estimation, although inevitably imprecise due to the various assumptions, corresponds remarkably well with the Cardiovascular safety of small-molecule CGRP receptor antagonists (gepants) has been primarily investigated in single-dose, acute treatment, studies in which the CGRP system was blocked for only a few hours (reviewed in [32,33]). The cardiovascular effects of long-term blockade of the CGRP receptor with gepants were assessed in only two, relatively small and short-lasting, prophylactic treatment studies [34,35]. Little is known about the cardiovascular safety of the long-term blockade of the CGRP system with CGRP (receptor) antibodies.…”

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confidence: 99%

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Wiping Out CGRP: Potential Cardiovascular Risks

MaassenVanDenBrink

Meijer

Villalón³

et al. 2016

Trends in Pharmacological Sciences

185

145

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“…These animals also had renal damage that was independent from the increase in blood pressure [35]. Related with these findings, acute intravenous (i.v.)…”

Section: Tips 1346 No Of Pages 10mentioning

confidence: 57%

Section: Cardiovascular Safety Of Blocking the Cgrp Systemmentioning

confidence: 99%

mentioning

confidence: 99%

See 1 more Smart Citation

Wiping Out CGRP: Potential Cardiovascular Risks

MaassenVanDenBrink

Meijer

Villalón³

et al. 2016

Trends in Pharmacological Sciences

185

145

View full text Add to dashboard Cite

“…A telcagepant preventive twice daily dosing study reported patients with clinically significantly liver function test (LFT) increases . A second study using telcagepant in prevention of menstrual migraine also suggested a potential liver problem, and the drug development program was stopped …”

Section: Small Molecule Cgrp Receptor Antagonists (Gepants)mentioning

confidence: 99%

History and Review of anti‐Calcitonin Gene‐Related Peptide (CGRP) Therapies: From Translational Research to Treatment

2018

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Objective – To briefly describe the history of and available data on anti‐calcitonin gene‐related peptide (CGRP) therapies for headache. Background – CGRP was proposed as a target for primary headache therapies. Translational research involved moving from delineating the relationships between CGRP and primary headaches and the clinical development of anti‐CGRP treatments. The first anti‐CGRP treatment, an intravenous CGRP‐receptor antagonist or gepant, olcegepant, was described as effective in terminating migraines in humans in 2004. Methods – The author briefly reviews some of the pathophysiology and translational research that led to the development of the gepants initially and then subsequently to the anti‐CGRP and anti‐CGRP receptor monoclonal antibodies. All accessible randomized controlled trials, abstracts, platform presentations, and press releases on the monoclonal antibody trials are summarized. The trajectory from bench research to the approval of the first anti‐CGRP receptor monoclonal antibody for clinical use in migraine prevention, erenumab, is discussed, as well as potential clinical uses of the anti‐CGRP treatments. Results – The US Food and Drug Administration (FDA) approved erenumab, an anti‐CGRP receptor monoclonal antibody, for prevention of migraine May 17, 2018. At the time of this writing (May 2018), 2 other anti‐CGRP monoclonal antibodies have been submitted to the FDA for the indication of prevention of migraine, galcanezumab and fremanezumab. Galcanezumab has reportedly shown effectiveness in preventing episodic cluster headache as well, although has not yet been submitted to the FDA for this indication. Eptinezumab will likely be submitted to the FDA for prevention of migraine later in 2018. Two gepants, ubrogepant and rimegepant, have completed positive pivotal trials for acute treatment of migraine, but have not yet been submitted to the FDA for this indication. Conclusions – The development of anti‐CGRP therapies opens a new era in the acute and preventive treatment of primary headache disorders.

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“…Though clinical trials of some CGRP antagonists (like Tolcegipant) have not demonstrated measurable clinical benefit as migraine treatments, CGRP receptor antagonists continue to show potential as anti-nociceptive agents that function without directly affecting inflammatory pathways [20]. …”

Section: How Do Pharmacological Interventions Take Advantage Of Pamentioning

confidence: 99%

Transmission pathways and mediators as the basis for clinical pharmacology of pain

Kirkpatrick

McEntire

Smith

et al. 2016

Expert Review of Clinical Pharmacology

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Introduction Mediators in pain transmission are the targets of a multitude of different analgesic pharmaceuticals. This review explores the most significant mediators of pain transmission as well as the pharmaceuticals that act on them. Areas Covered The review explores many of the key mediators of pain transmission. In doing so, this review uncovers important areas for further research. It also highlights agents with potential for producing novel analgesics, probes important interactions between pain transmission pathways that could contribute to synergistic analgesia, and emphasizes transmission factors that participate in transforming acute injury into chronic pain. Expert Commentary This review examines current pain research, particularly in the context of identifying novel analgesics, highlighting interactions between analgesic transmission pathways, and discussing factors that may contribute to the development of chronic pain after an acute injury.

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Randomized controlled trial of the CGRP receptor antagonist telcagepant for prevention of headache in women with perimenstrual migraine

Abstract: Telcagepant 140 mg taken perimenstrually for seven days was generally well tolerated, but was associated with transaminase elevations. Telcagepant did not reduce monthly headache frequency, but did reduce perimenstrual headaches.

Cited by 85 publications

References 19 publications

Wiping Out CGRP: Potential Cardiovascular Risks

Wiping Out CGRP: Potential Cardiovascular Risks

History and Review of anti‐Calcitonin Gene‐Related Peptide (CGRP) Therapies: From Translational Research to Treatment

Transmission pathways and mediators as the basis for clinical pharmacology of pain

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