| Summary: | Gerald Bertiger,1 Edward Jones,2 David N Dahdal,3 Dennis C Marshall,3 Raymond E Joseph3 1Hillmont GI, Flourtown, PA, USA; 2Delaware Valley Nephrology and Hypertension Associates, Philadelphia, PA, USA; 3Ferring Pharmaceuticals Inc., Parsippany, NJ, USA Background: We performed a post hoc analysis of two clinical trials to assess whether sodium picosulfate and magnesium (Mg2+) citrate (Prepopik® [P/MC]), a dual-action bowel preparation for colonoscopy, has an impact on serum Mg2+ levels and cardiac electrophysiology. Although rare, hypermagnesemia has been reported in patients consuming Mg2+-containing cathartics, especially patients who are elderly and have renal impairment. Methods: Data were analyzed from two prospective, Phase III, randomized, assessor-blinded, active-control, multicenter, pivotal studies that investigated split-dose/day-before P/MC. Serum Mg2+ and creatinine clearance (CrCl) were measured at screening, on the day of colonoscopy, and 24–48 hours, 7 days, and 4 weeks after colonoscopy; electrocardiograms also were obtained at these time points. Results: In total, 304 patients received split-dose P/MC and 294 patients received day-before P/MC. Only 10% of the patients had serum Mg2+ above the upper limit of normal (1.05 mmol/L) on the day of colonoscopy. There was a slight inverse correlation between CrCl and Mg2+ levels on the day of colonoscopy; however, even at the lowest CrCl, serum Mg2+ remained below clinically significant levels of 2.0 mmol/L. Increases in serum Mg2+ were transient, with levels returning to baseline within 24–48 hours, regardless of renal function. No patients with elevated Mg2+ experienced a corrected QT (QTc) interval >500 milliseconds or a QTc interval increase of ≥60 milliseconds from baseline. P/MC had no impact on PR or QRS interval. Conclusion: P/MC produces little impact on serum Mg2+ levels with no clinically significant effect on cardiac conduction in patients, including those with mild-to-moderate renal impairment. Keywords: bowel preparation, hypermagnesemia, renal impairment, sodium picosulfate
|
|---|
