Baqsimi ® (glukagon näspulver)

För fullständig produktresumé för Baqsimi® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Vilka Real-World effekts- och säkerhetsdata för vuxna finns för Baqsimi® (glukagon näspulver)?

I en Real-World studie av användning hos vuxna resolverades 96,2 % av måttliga till allvarliga hypoglykemiska händelser inom 30 minuter efter administrering av glukagon näspulver. Inga allvarliga läkemedelsrelaterade biverkningar rapporterades.

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Use of Glucagon Nasal Powder in Adults in a Real-World setting

Effectiveness Results

The effectiveness analysis included 69 adults who experienced1

  •  151 (96.2%) moderate or severe hypoglycemic events that resolved with awakening or returning to normal status within 30 minutes    of nasal glucagon (NG) administration

  •           - 12 of these events were severe, included patients who were unconscious or had convulsions, and all resolved with awakening or return to normal within 15 minutes of NG administration.
  •  6 moderate hypoglycemic events (3.8%) which did not resolve within 30 minutes 
            
  •            - 5 resolved within 30 to 45 minutes
               - 1 patient couldn’t report a return to normal because of a persistent headache.

No additional emergency health services or injectable glucagon was required for the participants to return to normal status.1

Safety Results

The main safety analysis included 74 adults.1

87.8% of participants reported at least 1 adverse reaction or symptom through a questionnaire (Adult Real-World Use Study: Most Common Adverse Reactions or Symptoms Reported With NG Through Questionnaires).

Most of the adverse reactions or symptoms were of low to moderate severity, and the most commonly reported was nasal irritation, which resolved in less than 1 hour in most participants. No serious drug-related adverse event was reported.1

Adult Real-World Use Study: Most Common Adverse Reactions or Symptoms Reported With NG Through Questionnaires1

Adverse Reaction, n (%) 

Total number of hypoglycemic events 
N=179a

Nasal irritation

105 (58.7) 

Headache

58 (32.4) 

Nausea

24 (13.4) 

Vomiting

13 (7.3) 

Abbreviation: NG = nasal glucagon (glucagon nasal powder).

aThe main safety analysis included 74 adults who experienced a total of 179 hypoglycemic events.

Please find the baseline characteristics of the safety cohort in (Adult Real-World Use Study With NG: Baseline Demographics and Clinical Characteristics).1

Adult Real-World Use Study With NG: Baseline Demographics and Clinical Characteristics1

Parametera

N=74b

Age, y

46.2 (15.0)

DM duration, y

26.3 (13.6)

Participants using insulin pump, n (%)

39 (52.7)

Number of daily insulin injections, n

4.2 (0.87)

Daily insulin dose, units

49.5 (21.7)

Time since most recent severe hypoglycemic event, n (%)

0 - 30 days

16 (21.6)

31 - 90 days

13 (17.6)

91 - 180 days

9 (12.2)

181 days - 1 year

5 (6.8)

>1 year

24 (32.4)

Never

7 (9.5)

Abbreviation: DM = diabetes mellitus; NG = nasal glucagon (glucagon nasal powder).

aAll values are mean (SD) unless otherwise stated.

bThe main safety analysis population included 74 adults (179 events) who experienced ≥1 hypoglycemic event and received ≥1 dose of NG.

Study Design

This was a phase 3, open-label, multicenter, single-arm study evaluated the effectiveness and ease of use of NG 3 mg in the treatment of moderate or severe hypoglycemic events in adults (aged 18 to 75 years) with type 1 diabetes mellitus (T1DM) in a real-world setting.1

Participants and caregivers were trained to administer NG.1

The primary outcome measure was the proportion of participants and proportion of events in which awakening or returning to normal status occurred within 30 minutes of NG administration as determined by the caregivers.1

The study defined 

  • a severe hypoglycemic event as an event in which the adult with diabetes mellitus (DM) is clinically incapacitated and requires third-party assistance.
  • a moderate hypoglycemic event as an event in which the adult with DM shows signs and symptoms of neuroglycopenia with blood glucose at or near the time of treatment of ≤3.3 mmol/L (≤60 mg/dL).1

Ease of Use and Caregiver Satisfaction Questionnaire

Caregivers completed a questionnaire to assess ease of use and caregiver satisfaction.1

Please find the results of the questionnaire in the (Adult Real-World Use Study: Ease of Use of NG Based on Assessment by Caregivers).1

Adult Real-World Use Study: Ease of Use of NG Based on Assessment by Caregivers1

Ease of Use and Caregiver Satisfaction Categories

% of Caregiversa

<30 sec to administer NG 

70.4

30 to <60 sec to administer NG  

92.7

1 to <2 min to administer NG  

97.7

Understanding NG kit instructions (very easy, easy, relatively easy)

96.6

Ease of administering NG (very easy, easy, relatively easy)

89.4

Overall satisfaction (very satisfied, satisfied, relatively satisfied)

94.4

Abbreviation: NG = nasal glucagon (glucagon nasal powder).

aThe main safety analysis population included 74 adults (179 events) who experienced ≥1 hypoglycemic event and received ≥1 dose of NG.

References

1Seaquist ER, Dulude H, Zhang XM, et al. Prospective study evaluating the use of nasal glucagon for the treatment of moderate to severe hypoglycaemia in adults with type 1 diabetes in a real-world setting. Diabetes Obes Metab. 2018;20(5):1316-1320. https://doi.org/10.1111/dom.13278

Datum fӧr senaste ӧversyn 2019 M07 24


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