Abasaglar ® (insulin glargin)

För fullständig produktresumé för Abasaglar® se FASS.

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

Abasaglar® (insulin glargin): Användning hos äldre

På grund av den progressiva försämringen av njurfunktionen kan äldre patienter behöva en minskning av insulindosen.

Detailed information

In elderly patients, 65 years of age or older, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.1-3

Caution should be exercised when Abasaglar is administered to elderly patients.4

In elderly patients with DM, the warning symptoms of hypoglycemia may be altered due to impaired counterregulatory hormonal responses. Elderly patients may be more prone to severe hypoglycemia due to a disconnect between the onset of hypoglycemic symptoms and cognitive dysfunction.2

Abasaglar Phase 3 Studies

In the Abasaglar phase 3 studies in patients with T1DM or T2DM, the safety outcomes that were evaluated for possible subgroup differences in response to study drug included the

  • TEAEs, overall incidence and preferred terms with >5% incidence (nasopharyngitis and upper respiratory tract infection)

  • overall incidence of allergic events from the special topic assessment

  • overall incidence of injection site reactions

  • overall incidence of SAEs, and

  • incidence of TEAR.4

There were no significant treatment-by-entry age interactions for any of the safety outcomes analyzed, indicating no significant differential treatment effects on the safety outcomes across age categories.4

The safety analyses were not performed in patients ≥75 years of age as there were too few of these patients with events of

  • upper respiratory tract infection

  • allergic events

  • injection site reactions

  • SAEs, or

  • TEAR.4

References

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

2. Ligthelm RJ, Kaiser M, Vora J, Yale JF. Insulin use in elderly adults: risk of hypoglycemia and strategies for care. J Am Geriatr Soc. 2012;60(8):1564-1570. http://dx.doi.org/10.1111/j.1532-5415.2012.04055.x

3. Kulozik F, Hasslacher C. Insulin requirements in patients with diabetes and declining kidney function: differences between insulin analogues and human insulin? Ther Adv Endocrinol Metab. 2013;4(4):113-121. http://dx.doi.org/10.1177/2042018813501188

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

Glossary

Abasaglar = Abasaglar® (insulin glargine) 100 units/mL

DM = diabetes mellitus

SAE = serious adverse event

T1DM = type 1 diabetes mellitus

T2DM = type 2 diabetes mellitus

TEAE = treatment-emergent adverse event

TEAR = treatment-emergent antibody response

Datum fӧr senaste ӧversyn 2018 M10 11

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