Serum magnesium concentrations in patients receiving sodium picosulfate and magnesium citrate bowel preparation: an assessment of renal function and electrocardiographic conduction
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 o...
Main Authors: | , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
Dove Medical Press
2015-07-01
|
Series: | Clinical and Experimental Gastroenterology |
Online Access: | http://www.dovepress.com/serum-magnesium-concentrations-in-patients-receiving-sodium-picosulfat-peer-reviewed-article-CEG |
id |
doaj-d167231a86c94301a539caba37c1394b |
---|---|
record_format |
Article |
spelling |
doaj-d167231a86c94301a539caba37c1394b2020-11-24T22:27:55ZengDove Medical PressClinical and Experimental Gastroenterology1178-70232015-07-012015default21522422828Serum magnesium concentrations in patients receiving sodium picosulfate and magnesium citrate bowel preparation: an assessment of renal function and electrocardiographic conductionBertiger GJones EDahdal DNMarshall DCJoseph REGerald 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 picosulfatehttp://www.dovepress.com/serum-magnesium-concentrations-in-patients-receiving-sodium-picosulfat-peer-reviewed-article-CEG |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Bertiger G Jones E Dahdal DN Marshall DC Joseph RE |
spellingShingle |
Bertiger G Jones E Dahdal DN Marshall DC Joseph RE Serum magnesium concentrations in patients receiving sodium picosulfate and magnesium citrate bowel preparation: an assessment of renal function and electrocardiographic conduction Clinical and Experimental Gastroenterology |
author_facet |
Bertiger G Jones E Dahdal DN Marshall DC Joseph RE |
author_sort |
Bertiger G |
title |
Serum magnesium concentrations in patients receiving sodium picosulfate and magnesium citrate bowel preparation: an assessment of renal function and electrocardiographic conduction |
title_short |
Serum magnesium concentrations in patients receiving sodium picosulfate and magnesium citrate bowel preparation: an assessment of renal function and electrocardiographic conduction |
title_full |
Serum magnesium concentrations in patients receiving sodium picosulfate and magnesium citrate bowel preparation: an assessment of renal function and electrocardiographic conduction |
title_fullStr |
Serum magnesium concentrations in patients receiving sodium picosulfate and magnesium citrate bowel preparation: an assessment of renal function and electrocardiographic conduction |
title_full_unstemmed |
Serum magnesium concentrations in patients receiving sodium picosulfate and magnesium citrate bowel preparation: an assessment of renal function and electrocardiographic conduction |
title_sort |
serum magnesium concentrations in patients receiving sodium picosulfate and magnesium citrate bowel preparation: an assessment of renal function and electrocardiographic conduction |
publisher |
Dove Medical Press |
series |
Clinical and Experimental Gastroenterology |
issn |
1178-7023 |
publishDate |
2015-07-01 |
description |
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 |
url |
http://www.dovepress.com/serum-magnesium-concentrations-in-patients-receiving-sodium-picosulfat-peer-reviewed-article-CEG |
work_keys_str_mv |
AT bertigerg serummagnesiumconcentrationsinpatientsreceivingsodiumpicosulfateandmagnesiumcitratebowelpreparationanassessmentofrenalfunctionandelectrocardiographicconduction AT jonese serummagnesiumconcentrationsinpatientsreceivingsodiumpicosulfateandmagnesiumcitratebowelpreparationanassessmentofrenalfunctionandelectrocardiographicconduction AT dahdaldn serummagnesiumconcentrationsinpatientsreceivingsodiumpicosulfateandmagnesiumcitratebowelpreparationanassessmentofrenalfunctionandelectrocardiographicconduction AT marshalldc serummagnesiumconcentrationsinpatientsreceivingsodiumpicosulfateandmagnesiumcitratebowelpreparationanassessmentofrenalfunctionandelectrocardiographicconduction AT josephre serummagnesiumconcentrationsinpatientsreceivingsodiumpicosulfateandmagnesiumcitratebowelpreparationanassessmentofrenalfunctionandelectrocardiographicconduction |
_version_ |
1725748431805218816 |