Delivery of neostigmine and glycopyrrolate by iontophoresis: a nonrandomized study in individuals with spinal cord injury. Issue 3 (March 2018)

• Record Type: Journal Article
• Authors: Korsten, Mark; Lyons, Brian; Radulovic, Miroslav; Cummings, Tradd M.; Sikka, Gautam; Singh, Kamaldeep; C. Hobson, Joshua; Sabiev, Anton; Spungen, Ann; Bauman, William
• Is Part Of: Spinal cord. Volume 56:Issue 3(2018:Mar.)
• Page Start: 212
• Page End: 217
• Publication Date: 2018-03
• Subjects: Spinal cord -- Wounds and injuries -- Periodicals; 617.482044
• DOI: 10.1038/s41393-017-0018-2
• Languages: English
• ISSNs: 1362-4393

Abstract

Abstract Study design Phase I Clinical Trial. Objectives In this proof-of-principle study, the effectiveness and safety of transdermal administration of neostigmine/glycopyrrolate to elicit a bowel movement was compared to intravenous administration in patients with spinal cord injury. Setting James J. Peters Veterans Affairs Medical Center (Bronx, NY). Methods Individuals were screened for responsiveness (Physical Response) to intravenous neostigmine (0.03 mg/kg)/glycopyrrolate (0.006 mg/kg). Intravenous neostigmine/glycopyrrolate responders (Therapeutic Response) were administered low-dose transdermal neostigmine/glycopyrrolate [(0.05 mg/kg)/(0.01 mg/kg)] by iontophoresis. Non-responders to low-dose transdermal neostigmine/glycopyrrolate were administered high-dose transdermal neostigmine/glycopyrrolate [(0.07 mg/kg)/(0.014 mg/kg)] by iontophoresis. Bowel movement, bowel evacuation time, and cholinergic side effects were recorded. Visits were separated by 2 to 14 days. Results Eighteen of 25 individuals (72.0%) had a bowel movement (20 ± 22 min) after intravenous neostigmine/glycopyrrolate. Of these 18 individuals, 5 individuals experienced a bowel movement with low-dose transdermal neostigmine/glycopyrrolate. Another five individuals had a bowel movement after high-dose transdermal neostigmine/glycopyrrolate administration. Fewer side effects were observed in individuals who received neostigmine/glycopyrrolate transdermally compared to those who were administered intravenous neostigmine/glycopyrrolate. Conclusions Transdermal administration of neostigmine/glycopyrrolate by iontophoresis appears to be a practical, safe, and effective approach to induce bowel evacuation in individuals with spinal cord injury.