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Headache
Published in Philip B. Gorelick, Fernando D. Testai, Graeme J. Hankey, Joanna M. Wardlaw, Hankey's Clinical Neurology, 2020
During the susceptible period, regular medication can be taken in anticipation of attacks: Verapamil in doses up to 960 mg daily with careful monitoring of the electrocardiogram is very effective in cluster headache.52Greater occipital nerve injection with lidocaine and depomethylprednisolone.53Prednisone 50 mg daily, for 3 days and then reduced rapidly to a dose (usually about 25 mg/day) that is just sufficient to prevent the attacks. This is effective in about 80% of cases in whom it should be maintained for the duration of the bout before weaning off slowly. It should be used no more than once a year to avoid aseptic necrosis.Galcanezumab, a CGRP monoclonal antibody, 300 mg SC monthly.54Frovatriptan 2.5 mg nightly.55
Headache Disorders
Published in Sahar Swidan, Matthew Bennett, Advanced Therapeutics in Pain Medicine, 2020
In recent years, four monoclonal antibodies targeting CGRP or the CGRP receptor have been tested in humans for the prevention of migraine: galcanezumab, eptinezumab, erenumab, and fremanezumab.31 High-quality RCTs have demonstrated the efficacy of these antibodies in decreasing migraine days in episodic migraine as well as chronic migraine. Fremanezumab showed efficacy in reducing monthly migraines in a phase III trial of 1130 patients with chronic migraine.32 Erenumab—the only monoclonal antibody that targets the CGRP receptor—demonstrated similar efficacy for episodic migraine in addition to chronic migraine.33 The reported reduction in monthly migraine has been approximately three to six episodes per month and significantly greater than placebo. Of note, patients with chronic migraine were excluded from the previously cited studies if they had failed preventative treatment with two to three prophylactic medications. Despite the promising results of these positive trials, additional studies are needed to determine the long-term efficacy, safety, and cost-effectiveness of monoclonal antibodies. An analysis of a 5-year study of erenumab revealed sustained treatment effect and safety at week 64, with 25% of patients reporting 100% reduction in monthly migraine days.34 Erenumab, galcanezumab, and fremanezumab are all currently FDA-approved for migraine prevention. The long-term safety is still questioned, as well as the role of these agents as first-line treatments or only after multiple medications failures. As CGRP is an essential vasodilatory protein for cerebral and coronary arteries, its potential contraindication in patients with coronary artery disease, past stroke, or uncontrolled hypertension for example has not been well-studied but should be taken into consideration when there is a thought of prescribing these agents.
Efficacy and safety of galcanezumab for migraine: evidences from direct and indirect comparisons
Published in International Journal of Neuroscience, 2023
Xing Wang, Jinlei Song, Chao You
Eligible articles should fulfill the following criteria relating to participants, interventions, comparators, outcomes, and study design. Participates: adult patients who were diagnosed with migraine on the basis of the International Classification of Headache Disorders, second edition (ICHD-II) or the third edition (ICHD-III, beta version) [21]. Intervention: galcanezumab, despite of doses. Control: placebo or no treatment. Outcomes: primary efficacy outcome was monthly change in migraine headache days (MHDs). Primary safety outcome was treatment-emergent adverse events (TEAEs). Secondary outcomes were 50, 75 and 100% response rates (which were defined as a reduction of the frequency of headache attacks by at least 50, 75 and 100% respectively), and serious adverse events (SAEs). Study type: Randomized controlled trials.
Reductions in acute medication use and healthcare resource utilization in patients with chronic migraine: a secondary analysis of a phase 3, randomized, double-blind, placebo-controlled study of galcanezumab with open-label extension (REGAIN)
Published in Journal of Medical Economics, 2022
Joshua A. Tobin, Shivang Joshi, Janet H. Ford, Russell M. Nichols, Shonda A. Foster, Dustin Ruff, Holland C. Detke, Sheena K. Aurora
The findings described herein indicate that in addition to significant and clinically meaningful reductions in migraine headache days29, galcanezumab also reduces acute medication use and medication overuse in patients with chronic migraine. Galcanezumab treatment was also associated with reductions in HCRU over 1 year. Clinicians are in need of preventive treatments that are effective, safe, and tolerable for this debilitating neurological disease. When ineffectively treated, this patient population is at great risk of developing medication overuse headache with substantial additional burden, including poor health-related quality of life, severe headache-related disability, and higher direct and indirect costs17,44,45. Overall, this research indicates that galcanezumab is a suitable treatment option for clinicians to consider when treating patients with chronic migraine and has the potential to reduce utilization of healthcare services and acute headache medications.
A long-term open-label safety study of galcanezumab in Japanese patients with migraine
Published in Expert Opinion on Drug Safety, 2021
Koichi Hirata, Takao Takeshima, Fumihiko Sakai, Yoshihisa Tatsuoka, Norihiro Suzuki, Hisaka Igarashi, Tomomi Nakamura, Akichika Ozeki, Hiroyoshi Yamazaki, Vladimir Skljarevski
Galcanezumab is one of 4 recently developed monoclonal antibodies that target the calcitonin gene-related peptide (CGRP) or its receptor and which can be used for the prevention of episodic migraine (EM) or chronic migraine (CM) [12]. Galcanezumab selectively binds to and blocks the activity of CGRP, which has been shown to contribute to neurogenic inflammation, vasodilation, and nociceptive modulation in migraine [13]. Two global randomized controlled trials (RCTs) in patients with EM [14,15] and one in patients with CM [16], predominantly in Caucasian patients, have demonstrated that once-monthly subcutaneous (SC) injections of 120-mg or 240-mg galcanezumab were safe, well tolerated, and effective in reducing the mean number of monthly migraine headache days compared with placebo. Furthermore, galcanezumab was also shown to be safe in a 12-month open-label study in the global population [17] and is safe and effective for patients over a wide range of ages [18]. More recently, a 6-month placebo-controlled RCT (I5Q-JE-CGAN) conducted in Japanese patients with EM reported similar results [19]. In spite of the safety and tolerability profile previously demonstrated in a number of relatively short clinical trials, the long-term safety of galcanezumab has not been investigated in a large cohort of Japanese patients with migraine. This is the first study to assess the long-term safety and tolerability of galcanezumab 120 mg or 240 mg in Japanese patients with either EM or CM.