Baqsimi ® (glukagon näspulver)

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Baqsimi® (glukagon näspulver): Effekter på blodtryck och puls

Förändringarna i blodtryck och puls när glukagon näspulver administrerades i de pivotala vuxenstudierna var inte kliniskt signifikanta.

Detailed Information

Adult Pivotal Studies

In the adult pivotal studies, changes from baseline in either BP or pulse after administration of NG 3 mg or IM glucagon 1 mg were assessed as not clinically significant by the study investigators (Table 1, Table 2).1

Table 1. Summary of Changes in Vital Signs in Adults in Study 11

Parameter

NG
3 mg
(n=70)

NG
3 mg
(n=70)

NG
3 mg
(n=70)

IM Glucagon
1 mg
(n=69)

IM Glucagon
1 mg
(n=69)

IM Glucagon
1 mg
(n=69)

Before

45 Min After

Change

Before

45 Min After

Change

Mean SBP, mm Hg

129.7

133.4

3.7

129.5

126.5

-3.0

Mean DBP, mm Hg

78.0

81.0

3.0

78.2

76.0

-2.2

Mean pulse, bpm

67.7

65.8

-1.9

67.4

65.5

-1.9

Abbreviations: DBP = diastolic blood pressure; IM = intramuscular; NG = nasal glucagon (glucagon nasal powder); SBP = systolic blood pressure.

Table 2. Summary of Changes in Vital Signs in Adults in Study 21

Parameter

NG
3 mg
(n=82)

NG
3 mg
(n=82)

NG
3 mg
(n=82)

IM Glucagon
1 mg
(n=81)

IM Glucagon
1 mg
(n=81)

IM Glucagon
1 mg
(n=81)

Before

45 Min After

Change

Before

45 Min After

Change

Mean SBP, mm Hg

121.2

122.0

0.8

121.9

115.5

-6.4

Mean DBP, mm Hg

73.5

72.9

-0.6

73.9

67.4

-6.5

Mean pulse, bpm

73.5

70.1

-3.4

74.3

69.3

-5.0

Abbreviations: DBP = diastolic blood pressure; IM = intramuscular; NG = nasal glucagon (glucagon nasal powder); SBP = systolic blood pressure.

Effect of Glucagon on Blood Pressure and Pulse

Exogenous glucagon stimulates the release of catecholamines. Intravenous administration of glucagon has been shown to have positive inotropic and chronotropic effects. A transient increase in both BP and pulse rate may occur following the administration of glucagon.1

A review evaluated the hemodynamic effects of injectable glucagon in 24 studies in humans.2 

The studies evaluated had some limitations in that they 

  • were not randomized

  • were not blinded

  • lacked a control group, and 

  • were primarily in patients with pre-existing cardiovascular conditions.2

In the review, it was determined that if effects of glucagon on BP were seen, they were immediate and short-lasting with a maximum effect at 2 to 5 minutes and lasting less than 25 minutes.2

Blood pressure changes in response to a glucagon bolus were reported in 18 studies. In 11 studies, the observed mean arterial pressure increase was between 5% to 18% after receiving a glucagon bolus. Other studies reported no effects on BP after a glucagon bolus.2

People Taking Beta-Blockers

Patients taking beta-blockers might be expected to have a greater increase in both pulse and blood pressure, an increase of which will be transient because of glucagon's short half-life.3

Pheochromocytoma

In the presence of phaeochromocytoma, glucagon may stimulate the release of catecholamines from the tumour. NG is contraindicated in patients with phaeochromocytoma. 3

Treatment for Dramatic Increase in Blood Pressure

If a person develops a dramatic increase in BP, use of non-selective α-adrenergic blockade has been shown to be effective in lowering BP.1

References

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

2. Petersen KM, Bogevig S, Holst JJ, et al. Hemodynamic effects of glucagon: a literature review. J Clin Endocrinol Metab. 2018;103(5):1804-1812. http://dx.doi.org/10.1210/jc.2018-00050

3. Baqsimi [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Glossary

BP = blood pressure

IM = intramuscular

IV = intravenous

NG = nasal glucagon (glucagon nasal powder)

Datum fӧr senaste ӧversyn 2019 M08 26


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