Emgality ® (galkanezumab)

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Emgality® ▼ (galcanezumab): Användning hos patienter med komorbid hypertoni

Behandling med galcanezumab resulterade inte i hemodynamiska förändringar i överensstämmelse med vasokonstriktion.

Detailed Information

Patients with recent acute cardiovascular events (including MI, unstable angina, CABG, stroke, DVT) and/or those deemed to be at serious cardiovascular risk were excluded from the galcanezumab clinical trials. Patients > 65 years of age were also excluded.1

No safety data are available in these patients.1

Comorbid Hypertension in Phase 3 Migraine Prevention Clinical Trials

Use in Patients With a History of Hypertension in Phase 3 Migraine Prevention Clinical Trials

CV Disease Risk

The CV safety profile of galcanezumab was evaluated2 in phase 3 randomized, double-blind, placebo-controlled studies in adult patients for the prevention of

  • episodic migraine (EVOLVE-1 and EVOLVE-2; 6 months),3,4 and

  • chronic migraine (REGAIN; 3 months).5

Patients with comorbid CV conditions and CV risk were included in the galcanezumab phase 3 migraine prevention studies. However, to minimize confounding at the case level and improve interpretation of the CV data, patients with acute CV events and/or serious CV risk were excluded from the clinical studies.2

Patients with comorbid CV disease and risk were grouped into a CV disease risk group (yes or no) based on reported medical history or pre-existing conditions.2

A patient had a baseline CV disease risk of

  • "yes" if they had 1 or more conditions that were part of the patients’ medical history or pre-existing conditions using broad and narrow terms from MedDRA SMQs, and

  • "no" if they did not have any of the preferred terms in the MedDRA SMQs as a pre-existing condition or medical history event.2

Hypertension was evaluated using the MedDRA SMQ Hypertension (SMQ narrow terms).2 

Baseline Hypertension

At baseline, the percentage of patients across all treatment groups taking anti-hypertensive medications was

  • approximately 6.7% to 8.8% in EVOLVE-1, EVOLVE-2, and REGAIN, and

  • 30.7% to 41.6% in the CV disease risk group "yes".2

Between 17% and 19% of all patients across the galcanezumab and placebo treatment groups in the phase 3 placebo-controlled studies had CV disease risk at baseline. Of those, hypertension was the most common condition in the CV disease risk "yes" subgroup for this pooled analysis set, occurring in 41.7% of the galcanezumab pooled group and 50.2% of placebo.2 

Blood Pressure and Pulse Changes

Treatment with galcanezumab did not result in hemodynamic changes consistent with vasoconstriction.2

Mean changes in blood pressure and pulse were small, with no clinically significant changes.2

Treatment-Emergent Hypertension

There were no statistically significant differences in treatment-emergent hypertension between the CV disease risk "yes" and "no" groups, as shown in Table 1.2 One patient treated with placebo discontinued due to treatment-emergent hypertension.2

Table 1. Treatment-Emergent Hypertension - Phase 3 Placebo-controlled Analysis Set2 

Hypertension SMQ

Treatment Group

All Patients (EVOLVE-1, EVOLVE-2, REGAIN)
n/N (%)

CV Disease Risk Group - YES
n/N (%)

CV Disease Risk Group - NO
n/N (%)

Patients with ≥1 narrow scope PT

PBO

18/1451 (1.24)

6/269 (2.23)

12/1182 (1.02)

GMB 120 mg

9/705 (1.28)

2/123 (1.63)

7/582 (1.20)

GMB 240 mg

7/730 (0.96)

3/124 (2.42)

4/606 (0.66)

GMB Pooled

16/1435 (1.11)

5/247 (2.02)

11/1188 (0.93)

Abbreviations: CV = cardiovascular; GMB = galcanezumab; PBO = placebo; PT = preferred term; SMQ = standardized MedDRA query.

Note: The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose .1 The results of a maintenance dose of galcanezumab 240 mg once monthly are also described here. Even though this dose has been tested in pivotal studies, it has not been approved and therefore is not recommended.

Changes in Use of CV Concomitant Medications

More patients in the CV disease risk "yes" group increased dose of or started new anti-hypertensive medications as shown in Table 2.2

Table 2. Dose Increase or New Start of Concomitant Anti-hypertensive Medicationsa - Phase 3 Placebo-controlled Analysis Set2

Medication Group

Treatment Group

All Patients (EVOLVE-1, EVOLVE-2, REGAIN)
n/N (%)

CV Disease Risk Group
YES
n/N (%)

CV Disease Risk Group
NO
n/N (%)

Anti-hypertensives

PBO

34/1451 (2.34)

21/269 (7.81)

13 /1182 (1.10)

GMB 120 mg

11/705 (1.56)

6/123 (4.88)

5/582 (0.86)

GMB 240 mg

12/730 (1.64)

4/124 (3.23)

8/606 (1.32)

GMB Pooled

23/1435 (1.60)

10/247 (4.05)

13/1188 (1.09)

Abbreviations: CV = cardiovascular; GMB = galcanezumab; PBO = placebo.

a Anti-hypertensives were not allowed for the acute treatment of migraine headaches during the phase 3 migraine prevention studies. Migraine preventives were not allowed at any time in EVOLVE-1 and EVOLVE-2; in REGAIN, up to 1/3 of enrolled patients were allowed to continue migraine prophylactic treatment with propranolol if the patient had been on a stable dose for at least 2 months prior to baseline and the dosing remained stable throughout the double-blind treatment period.

Note: The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose .1 The results of a maintenance dose of galcanezumab 240 mg once monthly are also described here. Even though this dose has been tested in pivotal studies, it has not been approved and therefore is not recommended.

Therapeutic Indication

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.1

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.1

References

1. Emgality [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

3. 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

4. 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

5. Detke H, Shufang W, Skljarevski V, et al. A Phase 3 Placebo-Controlled Study of Galcanezumab in Patients with Chronic Migraine: Results from the 3-month Double-Blind Treatment Phase of the REGAIN Study. Poster presented at: Diamond Headache Clinic Research & Educational Foundation (DHCREF) Headache Update 2017; July 13-16, 2017; Lake Buena Vista, Florida.

Glossary

CV = cardiovascular

MedDRA = Medical Dictionary for Regulatory Activities

SMQ = standard MedDRA query

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 2018 M04 16


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