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Potassium-Magnesium Citrate Is an Effective Prophylaxis Against Recurrent Calcium Oxalate Nephrolithiasis

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Potassium-Magnesium Citrate Is an Effective Prophylaxis Against Recurrent Calcium Oxalate Nephrolithiasis 0022-5347/97/1586-2069$03.00/0 JOURNAL OF UROLOGY Vol. 158,2069-2073, December 1997 Copyright Q 1997 by AMERICANUROLOGICAL ASS~CIATION, INC. Printed in U.S.A. POTASSIUM-MAGNESIUM CITRATE IS AN EFFECTIVE PROPHYLAXIS AGAINST RECURRENT CALCIUM OXALATE NEPHROLITHIASIS BRUCE ETTINGER,* CHARLES Y. C. PAK, JOHN T. CITRON, CARL THOMAS, BEVERLEY ADAMS-HIJET AND ARLINE VANGESSEL From the Diuision of Research, Kaiser Permanente Medical Care Program, Oakland, California, the Department of Mineral Metabolism, Center for Mineral Metabolism and Clinical Research, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, Department of Medicine, Kaiser Permanente Medical Center, Walnut Creek, California, Department of Urology, Kaiser Permanente Medical Center, San Francisco, California, and Kaiser Foundation Research Institute, Kaiser Foundation Hospitals, Oakland, California ABSTRACT Purpose: We examined the efficacy of potassium-magnesium citrate in preventing recurrent calcium oxalate kidney calculi. Materials and Methods: We conducted a prospective double-blind study of 64 patients who were randomly assigned to receive placebo or potassium-magnesium citrate (42 mEq. potassium, 21 mEq. magnesium, and 63 mEq. citrate) daily for up to 3 years. Results. New calculi formed in 63.6%of subjects receiving placebo and in 12.9%of subjects receiving potassium-magnesiumcitrate. When compared with placebo, the relative risk of treat- ment failure for potassium-magnesium citrate was 0.16 (95%confidence interval 0.05 to 0.46). potassium-magnesium citrate had a statistically significant effect (relative risk 0.10,95%confi- dence interval 0.03 to 0.36) even after adjustment for possible confounders, including age, pretreatment calculous event rate and urinary biochemical abnormalities. Conclusions: Potassium-magnesium citrate effectively prevents recurrent calcium oxalate stones, and this treatment given for up to 3 years reduces risk of recurrence by 85%. KEYWORDS: calcium oxalate, citrates, kidney calculi, magnesium, potassium Potassium citrate effectively reduces recurrence of calcium vestigators at the University of Texas Southwestern Medical oxalate nephrolithiasis.' The salutary effect of citrate is at- Center at Dallas, Texas.l2 Compared with placebo, short- tributed to its ability to form a soluble complex with urinary term (1-week)treatment using potassium-magnesium citrate calcium and to correct excess urinary acidity.* Additionally, combined with constant dietary regimen increased urinary citrate enriched urine has been shown experimentally to citrate levels by 611, urinary magnesium levels by 43%, and have reduced tendency for nucleation, growth, and agglom- urinary pH by 0.6 unit.13 UMary saturation of calcium ox- eration of calcium oxalate crystals.*%3However, potassium alate decreased by 31%, inhibition of calcium oxalate crys- citrate shares with other potassium salts the tendency to tallization increased by 46%, and inhibition of calcium phos- irritate gastric mucosa, and this problem can limit patient phate crystallization increased by 90%. These effects were acceptability. In clinical trials of potassium citrate, incidence more prominent than those achieved using potassium citrate of gastrointestinal adverse events ranged from 9 to 17%.1-4 of equivalent potassium c0ntent.1~ Dietary magnesium deficiency has been suggested to cause We hypothesized that long-term use of this formulation increased risk of calcium calculi,6 and magnesium supple- might combine the beneficial urinary physicochemical effects mentation has been recommended as prophylaxis.6 By en- of citrate and magnesium, thereby reducing the risk of kid- riching urine with magnesium, the rate of calcium oxalate ney stone formation. Containing less than the usual amount Crystal growth in vitro can be slowed.7 However, clinical of potassium, this citrate salt could reduce incidence of gas- trials of magnesium supplementation did not consistently trointestinal side effects. Therefore, we tested tolerability show therapeutic effects,8-10 probably because supplementa- and effectivenessof potassium-magnesium citrate in patients tion fails to produce sufficiently high urinary magnesium diagnosed as having recurrent, active calcium oxalate neph- concentration. Isotope studies have indicated poor intestinal rolithiasis. absorption of magnesium sdts.11 In a clinical trial using magnesium hydroxide, only 4% of administered magnesium was excreted in urine within 24 hours.10 High dosages of METHODS magnesium salts are impractical because they cause diar- Subjects. From among calculus analyses done at Kaiser rhea. Permanente Medical Centers in Northern California, we se- Recently a new formulation of citrate containing potassium lected all reports of calculi containing at least 50% or more and magnesium at a lower (4:l) ratio was developed by in- calcium oxalate. After reviewing the medical records, we selected patients who had active, recurrent calculous disease Accepted for publication June 20, 1997. uests for reprints: Division of Research, Kaiser PeFanente and no secondary cause for nephrolithiasis. All subjects had M*edica"4 Care Program, 3505 Broadway, Oakland, Califorrua 94611- had 2 or more calculi within the previous 5 years and at least 5714. 1 calculus within the previous 2 years. Excluded were sub- Supported by United States Public Health Service Research who had obstructive uropathy, chronic urosepsis, renal Grants Pol-DK20543 jects and FD-R-000636. failure (serum creatinine greater than 1.8 mgJdl., normal 1.5 Editor's Note: This article is the third of 5 published in this or less), renal tubular acidosis, or lithotripsy treatment hue for which category 1 CME c-ts cap be earnd. In- hctions for obtained dtaare gwen anth the queshons within the previous 6 months. Patients were advised of the On Pages 2274 and 2275. study design and gave informed consent as specified by the 2069 2070 POTASSIUM-MAGNESIUM CITRATE PREVENTS NEPHROLITHIASIS Northern California Kaiser Permanente Institutional Re- at baseline and at each followup visit by using a Likert score view Board. (I-none, 2-slight, 3-some, 4-considerable). We deter- Outcomes. Study participants were given simple metabolic mined that subjects had a study related gastrointestinal assessment while following an unrestricted diet. Automated symptom if the symptom score was greater at any followup chemistry panels (SMA-24) and 24-hour urine collections visit than it was at the start of the study and if it had a value were obtained at the beginning of the study to determine of at least 3 on the Likert scale. At each visit subjects were baseline values, at 5 months, and every 4 months thereafter also asked if they found the study medication disagreeable. for as long as 37 months. We measured urine for total vol- These analyses included subjects who left the study because ume, creatinine level, pH, potassium, calcium, magnesium, of adverse effects. sodium, phosphate, chloride, sulfate, ammonium, oxalate Statistical analysis. Descriptive statistics were computed and citrate. Results of these tests were used to calculate for baseline variables in each group. For adverse events we urinary saturation of stone forming substances (calcium ox- used Fisher's exact test to compare differences in proportions alate, sodium urate, brushite LCaHPO, * 2waterl) and the between the 2 groups. amount of undissociated uric acid.14 Urine could not be ana- Repeated measures analysis of variance models were used lyzed for inhibition of either calcium oxalate crystallization to assess urinary biochemical parameters. A statistically sig- or calcium phosphate crystallization13 because the fresh nificant interaction between group and time factors indicated urine samples required could not be shipped to the Univer- intergroup differences in treatment response. Results were sity of Texas Southwestern Medical Center for Mineral Me- tabulated using baseline and mean followup values and were tabolism and Clinical Research in Dallas, where the analysis compared within each treatment group using paired t tests. was done, quickly enough hmSan Francisco. On the basis of Statistical significance levels as reported were not adjusted %hour urinary excretion, we defined low urine volume as for multiple testing. 1200 ml. or greater excreted, hypercalciuria as 300 mg. or Cox proportional hazards models were used to estimate greater calcium excreted for men and 250 mg. or greater for relative risk (potassium-magnesium citrate versus placebo) women, hyperuricosuria as 800 mg. or greater uric acid ex- of having a calculous event. Covariates assessed in the model creted for men and 750 mg. or greater for women, hyperox- included gender, age, rate of calculus formation within 3 aluria as 40 mg. or greater oxalic acid excreted and hypoci- years before the study, baseline calculus burden and pres- traturia as 320 mg. or greater citrate excreted. ence of urinary biochemical abnormalities. A similar analysis Pretreatment rates of calculus formation were based on all was done by adding as treatment failures the 6 patients (5 calculous events that occurred within 3 years before the who received potassium-magnesium citrate, 1 who received study. For each subject we obtained a coned view x-ray film placebo) who did not have a stone event but who left the of the kidneys at the start of the study and annually there- study after having an adverse reaction to the study drug. after. We calculated an index of obesity, body mass index, by Statistical significance level was a
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