Query 11-04: How does real-world use of insulin glargine compare to NPH insulin in terms of effectiveness and safety (and ideally cost-effectiveness) for the management of type 1 diabetes mellitus?
This research was funded by the Drug Safety and Effectiveness Network (DSEN) and conducted by the following investigators: Cristiano Moura, Sasha Bernatsky, Michal Abrahamowicz, Louise Pilote and the CAN-AIM Team.
- Despite some evidence suggesting that the newer long-acting insulin analogues such as glargine might produce a better profile of basal insulin than neutral protamine Hagedorn (NPH) insulin in type 1 DM, a strong clinical benefit for this newer agent is not clear.
- To compare insulin glargine with NPH insulin in terms of effectiveness and safety for managing patients with type 1 diabetes mellitus (T1DM).
- CAN-AIM conducted a longitudinal analysis from an international database to compare therapy persistence, measured as discontinuation and switching, hypoglycemia, diabetes ketoacidosis (DKA), and microvascular complications (nephropathy, retinopathy, and neuropathy) among insulin glargine and NPH insulin initiators.
- Initiators of NPH were more likely to switch to another insulin therapy than initiators of glargine.
- We were unable to establish that the risk of hypoglycemia, DKA, and microvascular complications was different in initiators of NPH versus glargine.
- Our analyses did not confirm any clinical outcome differences between NPH and glargine in hypoglycemia, KDA, and microvascular complications. The higher rate of switches in NPH initiators could have been due to patient and physician choice rather than the adverse effects. Given the paucity of real-world comparisons of insulin therapy on T1DM population to date, our study is useful. However, future evaluations should try to elucidate causes for discontinuation and switching and the impact of these events on later clinical outcomes.
- Type 1 diabetes mellitus patients initiating NPH insulin are more likely to switch to another insulin therapy during their treatment. Our results did not clearly indicate that NPH initiators who persist in their therapy have any different risks of hypoglycemia, KDA, and microvascular complications than glargine initiators.
The final analysis using Marketscan for this query was finalized. With T1DM, we found that initiators of NPH insulin were more likely to switch to another insulin therapy after discontinuation (HR: 1.51; 95% CI 1.27-1.79) when compared to initiators of insulin glargine. The risk of hypoglycemia, DKA, and microvascular complications was not significantly different among NPH and glargine initiators.
Moura et al. Rates of therapy switching is higher among initiators insulin glargine versus of insulin NPH in a population-based type 1 diabetes mellitus cohort. 2016 (ICPE abstract)
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