Single-Dose Pharmacokinetics of Different Oral Sodium Nitrite Formulations in Diabetes Patients
Open accessAbstract
Background: Diabetic foot ulcers, although associated with macrovascular disease and neuropathy, have a microvascular disease causing ischemia not amenable to surgical intervention. Nitrite selectively releases nitric oxide in ischemic tissues, and diabetes subjects have low nitrite levels that do not increase with exercise. This study explores the safety and pharmacokinetics of a single dose of sodium nitrite in subjects with diabetic foot ulcers. Subjects and Methods: Using a blinded, randomized crossover study design, 12 subjects with diabetes mellitus and active or healed foot ulcers received a single dose of sodium nitrite on two occasions 7–28 days apart, once with an immediate release (IR) formulation and once with an enteric-coated (EC) formulation for delayed release. Serum nitrite, nitrate, methemoglobin, sulfhemoglobin, blood pressure, pulse rate, complete blood count, chemistry panel, electrocardiogram, and adverse events were followed for up to 6 h after each dose. The IR and EC nitrite levels were analyzed by one-way analysis of variance and by pharmacokinetic modeling. Results: The IR formulation elevated nitrite levels between 0.25 and 0.75 h ( P <0.05). The EC formulation did not elevate nitrite levels significantly, but both formulations gave plasma nitrite levels previously suggested to be therapeutic (approximately 2–5 μM ). The IR formulation gave an asymptomatic blood pressure drop of 10/6 mm Hg ( P <0.003), and two subjects experienced mild flushing. There was no elevation of methemoglobin or other safety concerns. Pharmacokinetic modeling of plama nitrite levels gave r 2 values of 0.81 and 0.97 for the fits for IR and EC formulations, respectively. Conclusions: Oral sodium nitrite administration is well tolerated in diabetes patients.
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Treatment with sodium nitrite may have beneficial cardiovascular effects in humans by acutely decreasing blood pressure.
“there is some evidence that treatment with sodium nitrite may have beneficial cardiovascular effects in humans by acutely (by either mildly or moderately) decreasing blood pressure (32, 37, 63) (Table 1)”
From Inorganic nitrite supplementation for healthy arterial aging (2014) · cites this paper as [63]
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- Authors
- Greenway, F. L., Predmore, B. L., Flanagan, D. R., Giordano, T., Qiu, Y., Brandon, A., Lefer, D. J., Patel, R. P., & Kevil, C. G.
- Affiliations
- Pennington Biomedical Research Center (US)
- Emory University (US)
- University of Iowa (US)
- Theravasc, Inc.
- University of Alabama at Birmingham (US)
- Louisiana State University Health Sciences Center Shreveport (US)
- Corresponding author
- Greenway, Frank L.
- Venue
- Diabetes Technology & Therapeutics
- Publisher
- SAGE Publications
- Published
- 2012-07
- Volume
- 14
- Issue
- 7
- Pages
- 552-560
- ISSN
- 1520-9156 (ISSN-L)
- 1557-8593
- PMC
- PMC3389382
- OpenAlex
- W2008003710
- Cited by
- 43
- References
- 26
- Citations by year
- 2026: 1 · 2023: 2 · 2022: 3 · 2021: 5 · 2020: 5 · 2019: 3 · 2018: 4 · 2017: 4 · 2016: 3 · 2015: 8 · 2014: 2 · 2013: 2
- FWCI
- 3.08
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Diabetes Technology & Therapeutics (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Heart, Lung, and Blood Institute (R01HL093579, R01HL092141)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetic Foot Ulcer Assessment and Management
- Health Sciences › Medicine › Physiology › Nitric Oxide and Endothelin Effects
- Health Sciences › Medicine › Rehabilitation › Wound Healing and Treatments
- Keywords
- sodium nitrite, diabetic foot ulcer, pharmacokinetics, immediate-release formulation, enteric-coated formulation, nitric oxide, serum nitrite, methemoglobin, blood pressure, drug safety, diabetes mellitus
- MeSH terms
- Administration, Oral, Blood Pressure, Chemistry, Pharmaceutical, Chromatography, High Pressure Liquid, Delayed-Action Preparations, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Intestinal Absorption, Male, Middle Aged, Sodium Nitrite, Treatment Outcome, Diabetic Foot, Cross-Over Studies
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