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      Serum magnesium concentrations in patients receiving sodium picosulfate and magnesium citrate bowel preparation: an assessment of renal function and electrocardiographic conduction

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          Abstract

          Background

          We performed a post hoc analysis of two clinical trials to assess whether sodium picosulfate and magnesium (Mg 2+) citrate (Prepopik ® [P/MC]), a dual-action bowel preparation for colonoscopy, has an impact on serum Mg 2+ levels and cardiac electrophysiology. Although rare, hypermagnesemia has been reported in patients consuming Mg 2+-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 Mg 2+ 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 Mg 2+ above the upper limit of normal (1.05 mmol/L) on the day of colonoscopy. There was a slight inverse correlation between CrCl and Mg 2+ levels on the day of colonoscopy; however, even at the lowest CrCl, serum Mg 2+ remained below clinically significant levels of 2.0 mmol/L. Increases in serum Mg 2+ were transient, with levels returning to baseline within 24–48 hours, regardless of renal function. No patients with elevated Mg 2+ 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 Mg 2+ levels with no clinically significant effect on cardiac conduction in patients, including those with mild-to-moderate renal impairment.

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          Most cited references 31

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          World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.

            (2004)
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            Magnesium metabolism and its disorders.

            Magnesium is the fourth most abundant cation in the body and plays an important physiological role in many of its functions. Magnesium balance is maintained by renal regulation of magnesium reabsorption. The exact mechanism of the renal regulation is not fully understood. Magnesium deficiency is a common problem in hospital patients, with a prevalence of about 10%. There are no readily available and easy methods to assess magnesium status. Serum magnesium and the magnesium tolerance test are the most widely used. Measurement of ionised magnesium may become more widely available with the availability of ion selective electrodes. Magnesium deficiency and hypomagnesaemia can result from a variety of causes including gastrointestinal and renal losses. Magnesium deficiency can cause a wide variety of features including hypocalcaemia, hypokalaemia and cardiac and neurological manifestations. Chronic low magnesium state has been associated with a number of chronic diseases including diabetes, hypertension, coronary heart disease, and osteoporosis. The use of magnesium as a therapeutic agent in asthma, myocardial infarction, and pre-eclampsia is also discussed. Hypermagnesaemia is less frequent than hypomagnesaemia and results from failure of excretion or increased intake. Hypermagnesaemia can lead to hypotension and other cardiovascular effects as well as neuromuscular manifestations. Causes and management of hypermagnesaemia are discussed.
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              Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride

              (2009)
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                Author and article information

                Journal
                Clin Exp Gastroenterol
                Clin Exp Gastroenterol
                Clinical and Experimental Gastroenterology
                Clinical and Experimental Gastroenterology
                Dove Medical Press
                1178-7023
                2015
                28 July 2015
                : 8
                : 215-224
                Affiliations
                [1 ]Hillmont GI, Flourtown, PA, USA
                [2 ]Delaware Valley Nephrology and Hypertension Associates, Philadelphia, PA, USA
                [3 ]Ferring Pharmaceuticals Inc., Parsippany, NJ, USA
                Author notes
                Correspondence: Gerald Bertiger, Hillmont GI, 1811 Bethlehem Pike, Building C-300 Flourtown Commons, Flourtown, PA 19031, USA, Tel +1 215 402 0800, Fax +1 215 836 2429, Email gbertiger@ 123456hillmontgi.com
                Article
                ceg-8-215
                10.2147/CEG.S79216
                4524271
                © 2015 Bertiger et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License

                The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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                Original Research

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