Insulin lispro protamine suspension in the treatment of patients with type 1 and type 2 diabetes mellitus: a systematic review of published data

Abstract

Introduction: Insulin lispro protamine suspension (ILPS) is a protamine-based insulin lispro formulation that allows 24-h coverage while limiting the number of daily injections. ILPS was developed to be the basal insulin component of premixed biphasic formulations with insulin lispro, i.e., the lispro/ILPS 25/75 and 50/50 mixed compounds, but has recently also been marketed as a basal insulin analog formulation, with an indication for the therapy of diabetic patients.

Areas covered: This article reviews the available literature on pharmacokinetics/pharmacodynamics (PK/PD), efficacy and safety of ILPS administered as basal insulin, or in premixed biphasic formulations, in patients with type 1 and type 2 diabetes mellitus.

Expert opinion: The results of this review suggest that ILPS may be associated with a favorable time–action profile, basal and postprandial glycemic control, and efficacy in terms of rates of patients reaching glycosylated hemoglobin targets; an increased risk of hypoglycemic episodes, compared to other basal insulins, seems to be related to the percentage of patients upgrading from once- to twice-daily injections. This increased risk might be linked with the concomitant use of insulin secretagogues in patients on higher daily dosages and is generally not observed in patients using one injection of ILPS a day. Thus, ILPS can be considered a valid option both as basal insulin and as basal component of the actual premixed formulations of lispro for the therapy of diabetic patients.

Keywords:

• basal insulin
• insulin lispro
• insulin lispro protamine suspension (ILPS)
• premixed formulations

Acknowledgments

The authors thank E. Cavallucci (Eli Lilly Italia) and F. Aglietti (Eli Lilly Italia) for their invaluable support in literature searching and retrieving. The authors thank also L. Cantini (professional medical writer) for his support in drafting this manuscript (funded by Eli Lilly Italia).

Notes

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