Emgality® (Galcanezumab)

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Was galcanezumab associated with palpitations or tachycardia in clinical trials?

The incidences of categorical or sustained increase in pulse at any time post baseline were similar between placebo and galcanezumab, regardless of if they had elevated pulse at baseline.

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The information contained in this letter may not completely match the current local labeling for GALCANEZUMAB. Please see local labeling approved in your country. 

Analysis of Increased Pulse or Heart Rate

The cardiovascular adverse event profile of galcanezumab was evaluated using integrated data from a total of 5 placebo-controlled studies with up to 6 months of galcanezumab exposure (with 573.4 patient-years of exposure).1

Galcanezumab doses were pooled prior to the analysis, as galcanezumab doses were different across studies.1

In these studies, the majority of patients were female (>75%) and Caucasian (>75%), with a mean age of 41 to 42 years.2

Increases in pulse or heart rate were evaluated as

  • categorical increases, or
  • sustained increases.2

This integrated analysis found that there were no significant differences between galcanezumab and placebo in the frequency of categorical or sustained increases in pulse, regardless of presence of increased pulse at baseline.2 These findings were consistent with, and expand upon, an earlier analysis of cardiovascular safety based on data from 3 placebo-controlled studies.3

Categorical Increases in Pulse Similar to Placebo

Categorical increase in pulse was defined as treatment-emergent high >100 bpm with ≥15 bpm increase from baseline.2

The incidence of patients with categorical increase in pulse was low and similar between placebo and galcanezumab, and was not affected by presence of elevated pulse at baseline (Categorical Increases in Pulse: Placebo-Controlled Group).2

Categorical Increases in Pulse:a Placebo-Controlled Group2,4

 

PBO
n/N (%)

GMB Pooledb
n/N (%)

Safety population

34/1582 (2.1)

31/1580 (2.0)

Safety population with elevated pulse at baselinec

1/14 (7.1)

0/7 (0.0)

Abbreviations: GMB = galcanezumab; PBO = placebo.

aDefined as treatment-emergent high >100 bpm with ≥15 bpm increase from baseline.

bAll galcanezumab doses combined.

cPulse >100 bpm at baseline was considered elevated.

Sustained Increases in Pulse Similar to Placebo

Sustained increase in pulse was defined as elevation >100 bpm with ≥15 bpm increase for 2 consecutive office visits.2

The percentages of patients with a sustained increase in pulse at any time post baseline were similar between treatment groups, regardless of if they had elevated pulse at baseline (Sustained Increases in Pulse: Placebo-Controlled Group).2

Sustained Increases in Pulse:a Placebo-Controlled Group2

 

PBO
n/N (%)

GMB Pooledb
n/N (%)

Safety population

1/1537 (0.1)

2/1544 (0.1)

Safety population with elevated pulse at baseline

0/13 (0.0)

0/7 (0.0)

Abbreviations: GMB = galcanezumab; PBO = placebo.

aDefined as elevation >100 bpm with ≥15 bpm increase for 2 consecutive office visits.

bAll galcanezumab doses combined.

Postmarketing Reports of Adverse Events Related to Increased Heart Rate or Palpitations

Postmarketing spontaneous reports in the Eli Lilly and Company spontaneous adverse event database through 27 March 2021 show that 

  • palpitations and heart rate increased were rarely reported, and
  • heart rate abnormal, heart rate irregular, sinus tachycardia, supraventricular tachycardia, tachycardia, and ventricular tachycardia were very rarely reported.4

Rarely reported is defined as an adverse event that has been reported at an estimated rate of ≥0.01% and <0.1% according to the reporting system information.4 Very rarely reported is defined as an adverse event that has been reported at an estimated rate of <0.01% according to the reporting system information.

Postmarketing data do not necessarily represent the rate of occurrence of an adverse event in a treated population, but they represent a reporting rate of a particular adverse event to the company. Spontaneous reporting of adverse events can be highly variable and is not appropriately controlled clinical information on which to base an assessment of whether a particular drug product is the causal agent of an event.5

Spontaneous reporting has limited use due to

  • lack of control population
  • under-reporting or reporting bias, and
  • missing or incomplete information regarding medical history or concomitant medications.5

References

1Oakes T, Kovacs R, Rosen N, et al. Evaluation of cardiovascular risks in patients treated with longer-term exposure to galcanezumab. Neurology. 2021;96(15 Suppl):2344. https://n.neurology.org/content/96/15_Supplement/2344

2Oakes TM, Kovacs R, Rosen N, et al. Evaluation of cardiovascular risks in patients treated with longer-term exposure to galcanezumab. Poster presented at: 73rd American Academy of Neurology Meeting (AAN Virtual); April 17-22, 2021. Accessed May 5, 2021. http://lillyscience.lilly.com/download/6b3qbWdDjwtIwA2UzahuEp?utm_source=email&scannedLink=true.

3Oakes 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

4Data on file, Eli Lilly and Company and/or one of its subsidiaries.

5Goldman SA. Limitations and strengths of spontaneous reports data. Clin Ther. 1998;20(suppl 3):C40-C44. http://dx.doi.org/10.1016/S0149-2918(98)80007-6

Fecha de la última revisión: 2021 M05 07


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