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Hypoglycemia in patients receiving disopyramide phosphate
Drug Intelligence & Clinical Pharmacy
|September 1, 1983
Summary
Postmarketing surveillance linked disopyramide phosphate to hypoglycemia, particularly in elderly patients or those with liver or kidney issues. Clinical studies confirmed disopyramide significantly lowered glucose levels in healthy volunteers.
Area of Science:
- Pharmacology
- Clinical Medicine
- Endocrinology
Background:
- Postmarketing surveillance identified hypoglycemia risk with disopyramide phosphate (Norpace) use for ventricular arrhythmias.
- Elderly patients and those with hepatic or renal impairment may be at increased risk.
Purpose of the Study:
- To investigate the potential glucoregulatory effect of disopyramide in humans.
- To assess the impact of disopyramide on glucose levels in both fed and fasted states.
Main Methods:
- A clinical study involving nine healthy male volunteers dosed to steady-state disopyramide concentration.
- A placebo-controlled study with 11 healthy male subjects examining glucose levels under fed and fasted conditions.
Main Results:
- Disopyramide administration suggested a glucoregulatory effect in humans.
- A statistically significant decrease in glucose levels was observed in both fed and fasted states.
- No classical signs or symptoms of hypoglycemia were reported in the clinical studies.
Conclusions:
- Disopyramide phosphate may possess a glucoregulatory effect, leading to decreased glucose levels.
- While statistically significant, the observed glucose decrease did not manifest as clinical hypoglycemia in healthy subjects.
- Further research is warranted to fully elucidate the clinical significance of disopyramide's effect on glucose metabolism.