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Emgality ® (galkanezumab)
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No cardiovascular adverse events are listed in the list of adverse events of the summary of product characteristics of Emgality.1
Patients with certain major cardiovascular diseases were excluded from clinical studies. No safety data are available in these patients.1
Evaluation of Cardiovascular Safety in the Migraine Prevention Studies
The CV safety profile of galcanezumab was evaluated in phase 3 randomized, double-blind, placebo-controlled studies in adult patients for the prevention of
This pooled analysis of 2886 adult patients included a total of 1435 patients that received monthly doses of galcanezumab (120 mg or 240 mg) administered subcutaneously.5
The majority of patients were female (>80%) and Caucasian (>75%), with a mean age of 41 to 42 years.5
Migraine Prevention: Cardiovascular TEAEs and SAEs
Evaluation of CV TEAEs did not reveal any clinically important differences compared to placebo (Table 1).6 A low proportion of galcanezumab-treated patients and placebo-treated patients reported CV TEAEs across all 9 SMQs, with the highest frequency reported in the Hypertension SMQ. No statistically significant differences were observed between both galcanezumab dose groups and placebo in any SMQ based on the narrow scope preferred terms.
There were no significant differences between galcanezumab and placebo in the frequency of CV SAEs or discontinuations due to CV TEAEs.5-7
Table 1. Migraine Prevention: CV TEAEs - Phase 3, Placebo-Controlled Analysis Set6,7
|
SMQab |
PBO |
GMB
120 mg |
GMB
240 mg |
GMB
Pooled |
|
Cardiac arrhythmias, n (%) |
6 (0.41) |
2 (0.28) |
3 (0.41) |
5 (0.35) |
|
OR vs PBOc |
--- |
0.68 |
1.00 |
0.84 |
|
Cardiac failure, n (%) |
1 (0.07) |
0 (0.00) |
0 (0.00) |
0 (0.00) |
|
OR vs PBOc |
--- |
0.00 |
0.00 |
0.00 |
|
Cardiomyopathy, n (%) |
0 (0.00) |
0 (0.00) |
0 (0.00) |
0 (0.00) |
|
OR vs PBOc |
--- |
--- |
--- |
--- |
|
CNS vascular disorder, n (%) |
0 (0.00) |
0 (0.00) |
1 (0.14) |
1 (0.07) |
|
OR vs PBOc |
--- |
--- |
--- |
--- |
|
Embolic and thrombotic events, n (%) |
4 (0.28) |
0 (0.00) |
4 (0.55) |
4 (0.28) |
|
OR vs PBOc |
--- |
0.00 |
1.99 |
1.01 |
|
Hypertension, n (%) |
18 (1.24) |
9 (1.28) |
7 (0.96) |
16 (1.11) |
|
OR vs PBOc |
--- |
1.03 |
0.77 |
0.90 |
|
Ischemic heart disease, n (%) |
1 (0.07) |
1 (0.14) |
1 (0.14) |
2 (0.14) |
|
OR vs PBOc |
--- |
2.05 |
1.99 |
2.02 |
|
Pulmonary hypertension, n (%) |
0 (0.00) |
0 (0.00) |
0 (0.00) |
0 (0.00) |
|
OR vs PBOc |
--- |
--- |
--- |
--- |
|
Torsades de pointes/QT prologation, n (%) |
2 (0.14) |
1 (0.14) |
1 (0.14) |
2 (0.14) |
|
OR vs PBOc |
--- |
1.03 |
0.99 |
1.01 |
Abbreviations: CNS = central nervous system; CV = cardiovascular; GMB = galcanezumab; MedDRA = Medical Dictionary for Regulatory Activities; N = number of patients in the analysis population; n = number of patients within each specific category; PBO = placebo; SMQ = Standardized MedDRA Query; TEAE = treatment-emergent adverse event.
a Each preferred term for the SMQ represents the narrow scope terms only.
b MedDRA version 19.1.
c Mantel-Haenszel odds ratio stratified by study and 95% CI (CI calculated if ≥ 4 events in numerator and ≥ 1 event in denominator).
Migraine Prevention: Exposure-Adjusted Incidence Rates for CV TEAEs
There were no significant differences between any galcanezumab dose group and placebo in the EAIRs for the 9 SMQs and associated preferred terms in the phase 3, placebo-controlled analysis set.7
In the longer-term analysis sets up to 12 months, there were no increases in the EAIRs with longer treatment duration for CV TEAEs.7
1. Emgality [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2. Stauffer VL, Dodick DW, Zhang Q, et al. Evaluation of galcanezumab for the prevention of episodic migraine: the EVOLVE-1 randomized clinical trial. JAMA Neurol. 2018;75(9):1080-1088. http://dx.doi.org/10.1001/jamaneurol.2018.1212
3. Skljarevski V, Matharu M, Millen BA, et al. Efficacy and safety of galcanezumab for the prevention of episodic migraine: results of the EVOLVE-2 phase 3 randomized controlled clinical trial. Cephalalgia. 2018;38(8):1442-1454. http://dx.doi.org/10.1177/0333102418779543
4. Detke HC, Goadsby PJ, Wang S, et al. Galcanezumab in chronic migraine: the randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018;91(24):e2211-e2221. http://dx.doi.org/10.1212/WNL.0000000000006640
5. Bangs ME, Kudrow D, Wang S, et al. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine studies. BMC Neurology. 2020;20(1):25. http://dx.doi.org/10.1186/s12883-020-1609-7. Published correction appears in BMC Neurology. 2020;20(1):90. http://dx.doi.org/10.1186/s12883-020-01675-7
6. Oakes TM, Kovacs R, Rosen N, et al. Evaluation of cardiovascular outcomes in adult patients with episodic or chronic migraine treated with galcanezumab: data from three phase 3 randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2, and REGAIN studies. Headache. 2020;60(1):110-123. http://dx.doi.org/10.1111/head.13684
7. Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Glossary
CV = cardiovascular
EAIR = exposure-adjusted incidence rate
SAE = serious adverse event
SMQ = standard MedDRA query
TEAE = treatment-emergent adverse event
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Datum fӧr senaste ӧversyn 2020 M05 27