Sodium nitrite in patients with peripheral artery disease and diabetes mellitus: Safety, walking distance and endothelial function

Emile R. Mohler, William R. Hiatt, Heather L. Gornik, Christopher G. Kevil, Arshed Quyyumi, William G. Haynes, Brian H. Annex

Research output: Contribution to journalArticle

Abstract

Nitrite stores decrease after exercise in patients with peripheral artery disease (PAD) and diabetes represents decreased nitric oxide (NO) bioavailability that may contribute to endothelial dysfunction and limit exercise duration. The primary objective of this placebo-controlled study was the safety and tolerability of multiple doses of oral sodium nitrite in patients with PAD, predominantly with diabetes, over a period of 10 weeks. The primary efficacy endpoint was endothelial flow-mediated dilatation (FMD) and secondary efficacy endpoints included a 6-minute walk test and quality of life assessment. Of the 55 subjects, the most common side effects attributed to sodium nitrite were a composite of headache and dizziness occurring in 21% with the 40 mg dose and 44% with the 80 mg dose. There was no clinically significant elevation of methemoglobin. FMD non-significantly worsened in the placebo and 40 mg groups, but was stable in the 80 mg group. Diabetic patients receiving 80 mg had significantly higher FMD compared with the placebo and 40 mg groups. There was no significant change in 6-minute walk test or quality of life parameters over time compared to placebo. In conclusion, sodium nitrite therapy is well tolerated in patients with PAD. The possible clinical benefit of sodium nitrite should be studied in a larger and fully powered trial.

Original languageEnglish (US)
Pages (from-to)9-17
Number of pages9
JournalVascular Medicine (United Kingdom)
Volume19
Issue number1
DOIs
StatePublished - Feb 1 2014
Externally publishedYes

Fingerprint

Sodium Nitrite
Peripheral Arterial Disease
Walking
Diabetes Mellitus
Placebos
Safety
Dilatation
Quality of Life
Exercise
Methemoglobin
Dizziness
Nitrites
Biological Availability
Headache
Nitric Oxide
Walk Test

Keywords

  • diabetes mellitus
  • endothelium
  • peripheral artery disease
  • vascular

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Sodium nitrite in patients with peripheral artery disease and diabetes mellitus : Safety, walking distance and endothelial function. / Mohler, Emile R.; Hiatt, William R.; Gornik, Heather L.; Kevil, Christopher G.; Quyyumi, Arshed; Haynes, William G.; Annex, Brian H.

In: Vascular Medicine (United Kingdom), Vol. 19, No. 1, 01.02.2014, p. 9-17.

Research output: Contribution to journalArticle

Mohler, Emile R. ; Hiatt, William R. ; Gornik, Heather L. ; Kevil, Christopher G. ; Quyyumi, Arshed ; Haynes, William G. ; Annex, Brian H. / Sodium nitrite in patients with peripheral artery disease and diabetes mellitus : Safety, walking distance and endothelial function. In: Vascular Medicine (United Kingdom). 2014 ; Vol. 19, No. 1. pp. 9-17.
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