Alkaline Water: Help or Hype for Uric Acid and Cystine Urolithiasis?

PURPOSE: The consumption of alkaline water, water with an average pH of 8 to 10, has been steadily increasing globally as proponents claim it to be a healthier alternative to regular water. Urinary alkalinization therapy is frequently prescribed in patients with uric acid and cystine urolithiasis, and as such we analyzed commercially available alkaline waters to assess their potential to increase urinary pH. MATERIALS AND METHODS: Five commercially available alkaline water brands (Essentia, Smart Water Alkaline, Great Value Hydrate Alkaline Water, Body Armor SportWater, and Perfect Hydration) underwent anion chromatography and direct chemical measurements to determine the mineral contents of each product. The alkaline content of each bottle of water was then compared to that of potassium citrate (the gold standard for urinary alkalinization) as well as to other beverages and supplements used to augment urinary citrate and/or the urine pH. RESULTS: The pH levels of the bottled alkaline water ranged from 9.69 to 10.15. Electrolyte content was minimal, and the physiologic alkali content was below 1 mEq/L for all brands of alkaline water. The alkali content of alkaline water is minimal when compared to common stone treatment alternatives such as potassium citrate. In addition, several organic beverages, synthetic beverages, and other supplements contain more alkali content than alkaline water, and can achieve the AUA and European Association of Urology alkali recommendation of 30 to 60 mEq per day with ≤ 3 servings/d. CONCLUSIONS: Commercially available alkaline water has negligible alkali content and thus provides no added benefit over tap water for patients with uric acid and cystine urolithiasis.

Clinical Efficacy of Diet Intervention Combined with Bismuth Potassium Citrate in Helicobacter pylori-Related Chronic Atrophic Gastritis.

Objective: To investigate the clinical impact of dietary intervention in combination with bismuth potassium citrate in the management of chronic atrophic gastritis (CAG) caused by Helicobacter pylori. Methods: From April 2019 to October 2022, 160 patients with newly identified Helicobacter pylori-related CAG were treated at our facility. They were split into two groups at random: the bismuth potassium citrate medication group (n = 80) and the diet intervention + bismuth potassium citrate experimental groups (n = 80). The bismuth potassium citrate treatment group was given bismuth potassium citrate capsule treatment only, and the diet intervention + bismuth potassium citrate treatment group was given diet intervention based on bismuth potassium citrate capsule. The diet intervention score, symptom score, and pathological score of the two groups were observed at baseline and after treatment, and the relationship between dietary intervention and symptoms and pathology of Helicobacter pylori-related CAG was analyzed. Results: During the baseline period, there was no discernible difference in the diet intervention score, symptom score, or pathology score between the two groups (P > .05); after the diet intervention combination treatment, the diet intervention score, diet intervention + bismuth potassium citrate experimental groups symptom score, and pathology score were considerably lower than those in the bismuth potassium citrate treated group (P < .05). Conclusions: Dietary intervention combined with bismuth potassium citrate exhibited more effective treatment than bismuth potassium citrate-only treatment in Helicobacter pylori-related CAG, which hinted us proper diet has a positive impact on improving the therapeutic efficacy of bismuth potassium citrate.

Bismuth, esomeprazole, metronidazole, and minocycline or tetracycline as a first-line regimen for Helicobacter pylori eradication: A randomized controlled trial.

BACKGROUND: Given the general unavailability, common adverse effects, and complicated administration of tetracycline, the clinical application of classic bismuth quadruple therapy (BQT) is greatly limited. Whether minocycline can replace tetracycline for Helicobacter pylori ( H . pylori ) eradication is unknown. We aimed to compare the eradication rate, safety, and compliance between minocycline- and tetracycline-containing BQT as first-line regimens. METHODS: This randomized controlled trial was conducted on 434 naïve patients with H . pylori infection. The participants were randomly assigned to 14-day minocycline-containing BQT group (bismuth potassium citrate 110 mg q.i.d., esomeprazole 20 mg b.i.d., metronidazole 400 mg q.i.d., and minocycline 100 mg b.i.d.) and tetracycline-containing BQT group (bismuth potassium citrate/esomeprazole/metronidazole with doses same as above and tetracycline 500 mg q.i.d.). Safety and compliance were assessed within 3 days after eradication. Urea breath test was performed at 4-8 weeks after eradication to evaluate outcome. We used a noninferiority test to compare the eradication rates of the two groups. The intergroup differences were evaluated using Pearson chi-squared or Fisher's exact test for categorical variables and Student's t -test for continuous variables. RESULTS: As for the eradication rates of minocycline- and tetracycline-containing BQT, the results of both intention-to-treat (ITT) and per-protocol (PP) analyses showed that the difference rate of lower limit of 95% confidence interval (CI) was >-10.0% (ITT analysis: 181/217 [83.4%] vs . 180/217 [82.9%], with a rate difference of 0.5% [-6.9% to 7.9%]; PP analysis: 177/193 [91.7%] vs . 176/191 [92.1%], with a rate difference of -0.4% [-5.6% to 6.4%]). Except for dizziness more common (35/215 [16.3%] vs . 13/214 [6.1%], P = 0.001) in minocycline-containing therapy groups, the incidences of adverse events (75/215 [34.9%] vs . 88/214 [41.1%]) and compliance (195/215 [90.7%] vs . 192/214 [89.7%]) were similar between the two groups. CONCLUSION: The eradication efficacy of minocycline-containing BQT was noninferior to tetracycline-containing BQT as first-line regimen for H . pylori eradication with similar safety and compliance. TRIAL REGISTRATION: ClinicalTrials.gov, ChiCTR 1900023646.

Dietary management of hypocitraturia in children with urolithiasis: results from a systematic review.

PURPOSE: Hypocitraturia is a low urinary excretion of citrate and a well-known risk factor for kidney stone development in children. This systematic review aimed to evaluate the dietary management of hypocitraturia in children with urolithiasis. METHODS: Literature search was performed on 30th September 2022 using Embase, PubMed, and Cochrane Central Controlled Register of Trials. Studies were included if children with stones and hypocitraturia were managed with diet supplements. RESULTS: Six papers were included. Four studies evaluated the role of oral potassium citrate associated with high fluid intake on stone resolution and recurrence. Two studies assessed the impact of oral potassium citrate on long-term stone recurrence after percutaneous nephrolithotomy and shock wave lithotripsy. All studies demonstrated that the association of potassium citrate and high fluid intake was well tolerated with no side effects and restored normal urine citrate excretion, allowed a reduction in stone size, and, following definitive treatments, was associated with a lower rate of stone regrowth and recurrence compared with controls. These effects were demonstrated across all pediatric ages. CONCLUSIONS: Our review infers that oral potassium citrate and high fluid assumption are safe and effective in restoring urine citrate excretion, treating and preventing stone recurrence with no serious adverse events, and should probably be the first-line treatment of pediatric patients with asymptomatic stones and hypocitraturia.

Urinary supersaturation in a Randomized trial among Individuals with Nephrolithiasis comparing Empiric versus selective therapy (URINE): design and rationale of a clinical trial.

Clinical guidelines disagree on whether the identification of abnormal urine chemistries should occur before starting diet and medication interventions to prevent the recurrence of kidney stone events. We describe the rationale and design of the Urinary supersaturation in a Randomized trial among Individuals with Nephrolithiasis comparing Empiric versus selective therapy (URINE) study, a randomized trial comparing two multi-component interventions to improve urinary supersaturation. Participants are randomized (1:1 ratio) to the empiric or selective arm. The target sample size is 56 participants. Adults ≥ 18 years of age with idiopathic calcium stone disease and two symptomatic stone events within the previous 5 years. Exclusion criteria include systemic conditions predisposing to kidney stones and pharmacologic treatment for stone prevention at baseline. Participants in the empiric arm receive standard diet therapy recommendations, thiazide, and potassium citrate. Participants in the selective arm receive tailored diet and nutrient recommendations and medications based on baseline and 1-month follow-up of 24-h urine testing results. The primary endpoints are urinary supersaturations of calcium oxalate and calcium phosphate at 2 months of follow-up. Secondary endpoints include side effects, diet and medication adherence, and changes in 24-h urine volume, calcium, oxalate, citrate, and pH. Short-term changes in urinary supersaturation may not reflect changes in future risk of stone events. The URINE study will provide foundational data to compare the effectiveness of two prevention strategies for kidney stone disease.

Comparison potassium sodium hydrogen citrate with sodium bicarbonate in urine alkalization: a prospective crossover-controlled trial.

PURPOSE: Excessive alkalization will increase the incidence of nephrolithiasis. Sodium bicarbonate (NaHCO3) and potassium sodium hydrogen citrate (PSHC) are commonly used drugs for urinary alkalization. We designed a trial to compare PSHC with NaHCO3 in the urine alkalization for the Chinese healthy participants and to explore the effects of PSHC and NaHCO3 on circadian rhythms of urine pH value. METHOD: This study was a prospective, crossover, randomized, controlled trial, in which a total of 34 healthy volunteers participated in two study phases and took PSHC and NaHCO3 at the maintenance dose, respectively. RESULT: The average level of urine pH of PSHC participants in 24 h was significantly higher than that of NaHCO3 (P < 0.001). The urine pH value of participants taking PSHC and NaHCO3 or under physiological conditions showed significant variation in 24 h (P < 0.05) and fitted to a mathematical model (Fourier series). Under physiological conditions, the average urine pH value in the daytime was higher than that in the night, and reached the peak at about 10:00, 16:00, and 22:00. The peak of urine pH at 24 h after taking PSHC and NaHCO3 was both higher than the baseline. The peak time of urine pH and the curve trend were similar, but the peak value in PSHC group was significantly higher than that in NaHCO3 group. CONCLUSIONS: There was a circadian rhythm of urine pH value under physiological conditions. PSHC was more effective in urinary alkalization than NaHCO3 at the current maintenance oral dose and administration time without changing the rhythm of urine pH value. CLINICAL TRIAL REGISTRATION: NCT04352153.

Alkali Citrate Content of Common Over-the-Counter and Medical Food Supplements.

Objective: Potassium citrate effectively decreases kidney stone recurrence, but it is costly and associated with side effects. While several over-the-counter supplements and medical foods purport to provide sufficient citrate to prevent recurrent stones, corroborating data on their actual citrate content is limited. Materials and Methods: Nine common nonprescription products were purchased online. Reported citrate content was obtained from packaging, promotional materials, or ingredient labels. Using a single serving of each product, actual citrate, sodium, potassium, calcium, magnesium, and oxalate content was measured using spectrophotometry and chromatography. Total alkali citrate, cost, and amounts of each component per 10 mEq of alkali citrate were also calculated. Results: Nearly all products contained more citrate than advertised, except for Litholyte® powder, Litholyte® Coffee, and Horbäach® potassium citrate. Per serving, Moonstone® powder, LithoBalance™, and KSP tabs™ contained the most citrate (means of 63.9, 33.5, and 26.9 mEq, respectively). Moonstone and LithoBalance had the greatest discrepancy between total citrate and alkali citrate (15.7 and 11.8 mEq per serving, respectively). NOW® potassium citrate was least expensive ($0.04/10 mEq alkali citrate). KSP tabs delivered the most daily sodium (mean 158 mg/10 mEq alkali citrate, Litholyte Coffee provided the most potassium (mean of 13 mEq/10 mEq alkali citrate), and Kidney COP® provided the most calcium (mean 147 mg/10 mEq alkali citrate). Conclusion: Some common over-the-counter products contain sufficient alkali to potentially promote a citraturic response; Moonstone provides the most alkali citrate, but at a higher cost than other products. Sodium, potassium, and calcium from these products must also be considered in daily consumption.

Vonoprazan on the Eradication of Helicobacter pylori Infection.

BACKGROUND: This study aimed to investigate the efficacy and safety of vonoprazan in the eradication of Helicobacter pylori (H. pylori). METHODS: A total of 120 cases of H. pylori-infected outpatients were selected and randomly divided into the traditional quadruple therapy, vonoprazan triple therapy, and vonoprazan quadruple therapy groups. The traditional quadruple therapy group patients were orally treated with esomeprazole (20 mg) 30 minutes before breakfast and supper, amoxicillin (1000 mg orally) 30 minutes after breakfast and supper, furazolidone (100 mg orally) 30 minutes after breakfast and supper, and bismuth potassium citrate (0.6 g orally) 30 minutes before breakfast and supper. The vonoprazan triple therapy group patients were treated with vonoprazan (20 mg orally) 30 minutes following breakfast and supper, amoxicillin (1000 mg orally) 30 minutes following breakfast and supper, and bismuth potassium citrate (0.6 g orally) 30 minutes before breakfast and supper. The vonoprazan quadruple therapy group patients were treated with vonoprazan (20 mg orally) 30 minutes following breakfast and supper, amoxicillin (1000 mg orally) 30 minutes after breakfast and supper, furazolidone (100 mg orally) 30 minutes after breakfast and supper, and bismuth potassium citrate (0.6 g orally) 30 minutes before breakfast and supper. The 3 groups were treated for 14 days, and adverse reactions, such as vomiting and abdominal distension, were recorded during the treatment period. The 14C urea breath test was used to detect whether H. pylori was successfully eradicated in the patients. RESULTS: The eradication rates of the vonoprazan triple therapy, vonoprazan quadruple therapy, and the traditional quadruple therapy groups were 80%, 95%, and 97.5%, respectively. The eradication rate was higher in the vonoprazan triple therapy and in the vonoprazan quadruple therapy groups compared with that noted in the control group. The adverse reactions were mild in these groups, and the main adverse reactions were nausea, abdominal distension, diarrhea, and constipation. The adverse reaction rate was 25%, 7.5%, and 15%, respectively. This rate was lower in the vonoprazan triple therapy and vonoprazan quadruple therapy groups than that noted in the control group. CONCLUSION: Both vonoprazan triple therapy and vonoprazan quadruple therapy regimens could increase the eradication rate of H. pylori. Vonoprazan triple therapy exhibited reduced side effects and could be applied in the eradication of H. pylori in the clinic.

Bismuth, esomeprazole, metronidazole, and minocycline or tetracycline as a first-line regimen for Helicobacter pylori eradication: A randomized controlled trial / 中华医学杂志(英文版)

BACKGROUND@#Given the general unavailability, common adverse effects, and complicated administration of tetracycline, the clinical application of classic bismuth quadruple therapy (BQT) is greatly limited. Whether minocycline can replace tetracycline for Helicobacter pylori ( H . pylori ) eradication is unknown. We aimed to compare the eradication rate, safety, and compliance between minocycline- and tetracycline-containing BQT as first-line regimens.@*METHODS@#This randomized controlled trial was conducted on 434 naïve patients with H . pylori infection. The participants were randomly assigned to 14-day minocycline-containing BQT group (bismuth potassium citrate 110 mg q.i.d., esomeprazole 20 mg b.i.d., metronidazole 400 mg q.i.d., and minocycline 100 mg b.i.d.) and tetracycline-containing BQT group (bismuth potassium citrate/esomeprazole/metronidazole with doses same as above and tetracycline 500 mg q.i.d.). Safety and compliance were assessed within 3 days after eradication. Urea breath test was performed at 4-8 weeks after eradication to evaluate outcome. We used a noninferiority test to compare the eradication rates of the two groups. The intergroup differences were evaluated using Pearson chi-squared or Fisher's exact test for categorical variables and Student's t -test for continuous variables.@*RESULTS@#As for the eradication rates of minocycline- and tetracycline-containing BQT, the results of both intention-to-treat (ITT) and per-protocol (PP) analyses showed that the difference rate of lower limit of 95% confidence interval (CI) was >-10.0% (ITT analysis: 181/217 [83.4%] vs . 180/217 [82.9%], with a rate difference of 0.5% [-6.9% to 7.9%]; PP analysis: 177/193 [91.7%] vs . 176/191 [92.1%], with a rate difference of -0.4% [-5.6% to 6.4%]). Except for dizziness more common (35/215 [16.3%] vs . 13/214 [6.1%], P = 0.001) in minocycline-containing therapy groups, the incidences of adverse events (75/215 [34.9%] vs . 88/214 [41.1%]) and compliance (195/215 [90.7%] vs . 192/214 [89.7%]) were similar between the two groups.@*CONCLUSION@#The eradication efficacy of minocycline-containing BQT was noninferior to tetracycline-containing BQT as first-line regimen for H . pylori eradication with similar safety and compliance.@*TRIAL REGISTRATION@#ClinicalTrials.gov, ChiCTR 1900023646.

Efficacy and safety of high-dose esomeprazole-amoxicillin dual therapy for Helicobacter pylori rescue treatment: a multicenter, prospective, randomized, controlled trial.

BACKGROUND: High-dose dual therapy (HDDT) with proton pump inhibitors (PPIs) and amoxicillin has attracted widespread attention due to its favorable efficacy in eradicating Helicobacter pylori (H. pylori). This study aimed to compare the efficacy and safety of high-dose PPI-amoxicillin dual therapy and bismuth-containing quadruple therapy for H. pylori rescue treatment. METHODS: This was a prospective, randomized, multicenter, non-inferiority trial. Patients recruited from eight centers who had failed previous treatment were randomly (1:1) allocated to two eradication groups: HDDT (esomeprazole 40 mg and amoxicillin 1000 mg three times daily; the HDDT group) and bismuth-containing quadruple therapy (esomeprazole 40 mg, bismuth potassium citrate 220 mg, and furazolidone 100 mg twice daily, combined with tetracycline 500 mg three times daily; the tetracycline, furazolidone, esomeprazole, and bismuth [TFEB] group) for 14 days. The primary endpoint was the H. pylori eradication rate. The secondary endpoints were adverse effects, symptom improvement rates, and patient compliance. RESULTS: A total of 658 patients who met the criteria were enrolled in this study. The HDDT group achieved eradication rates of 75.4% (248/329), 81.0% (248/306), and 81.3% (248/305) asdetermined by the intention-to-treat (ITT), modified intention-to-treat (MITT), and per-protocol (PP) analyses, respectively. The eradication rates were similar to those in the TFEB group: 78.1% (257/329), 84.2% (257/305), and 85.1% (257/302). The lower 95% confidence interval boundary (-9.19% in the ITT analysis, - 9.21% in the MITT analysis, and -9.73% in the PP analysis) was greater than the predefined non-inferiority margin of -10%, establishing a non-inferiority of the HDDT group vs. the TFEB group. The incidence of adverse events in the HDDT group was significantly lower than that in the TFEB group (11.1% vs. 26.8%, P  < 0.001). Symptom improvement rates and patients' compliance were similar between the two groups. CONCLUSIONS: Fourteen-day HDDT is non-inferior to bismuth-containing quadruple therapy, with fewer adverse effects and good treatment compliance, suggesting HDDT as an alternative for H. pylori rescue treatment in the local region. TRIAL REGISTRATION: Clinicaltrials.gov, NCT04678492.

Over-the-Counter Alkali Agents to Raise Urine pH and Citrate Excretion: A Prospective Crossover Study in Healthy Adults.

OBJECTIVE: To assess the effect of 2 over-the-counter alkalizing agents on 24 hour urinary parameters. MATERIALS AND METHODS: Ten healthy volunteers without a history of kidney stones were recruited to complete a baseline 24 hour urinalysis with a 4 day diet inventory. Participants then maintained the same diet on either LithoLyte (20 mEq 2 times per day) or KSPtabs (1 tablet 2 times per day) and submitted another 24 hour urinalysis. The process was repeated with the other supplement. Urinary alkali parameters were compared to baseline, and side effects were elicited with a questionnaire. RESULTS: LithoLyte intake resulted in a non-significant increase in citrate (597-758 mg/day, P =.058, an increase in urine pH (6.46-6.66, P =.028), and a decrease in urine ammonium (41-36 mmol/day, P =.005) compared to baseline. KSPtabs resulted in an increase in citrate (597-797 mg/day, P =.037) and urine pH (6.46-6.86, P =.037), with a non-significant decrease in ammonium (41-34 mmol/day, P =.059). No significant differences were seen comparing urinary analytes between LithoLyte and KSPtabs. With Litholyte, no side effects, mild, moderate, and severe side effects were seen in 50%, 40%, 10%, and 0%, respectively. With KSPtabs, rates were 60%, 20%, 10%, and 10%, respectively. CONCLUSION: In healthy participants without a history of kidney stones, LithoLyte and KSPtabs are effective over-the-counter alkali supplements, with a similar side effect profile to prescription potassium citrate.

The efficacy and safety of different bismuth agents in Helicobacter pylori first-line eradication: A multicenter, randomized, controlled clinical trial.

BACKGROUND: The aim of this study was to evaluate the efficacy and safety of bismuth pectin capsules and bismuth pectin granules in the first-line quadruple treatment of Helicobacter pylori (H. pylori). METHODS: This study was a multicenter, randomized, open-labelled controlled clinical trial. Patients with a H. pylori infection were randomized into 4 groups (1:1:1:1) and treated with a 14-day bismuth-containing quadruple therapy. The 4 groups received either bismuth potassium citrate capsules (220 mg), colloidal bismuth pectin capsules (200 mg), bismuth pectin granules (150 mg), or bismuth pectin granules (300 mg). The primary outcome was the eradication rate of H. pylori. The secondary outcomes included symptom improvement, patient compliance, and incidence of adverse events. This study was registered at ClinicalTrials.gov (NCT04209933). RESULTS: A total of 240 patients were included in this study, and 211 patients completed the follow-up. An intention-to-treat analysis showed that the H. pylori eradication rates of the 4 groups were 73.3%, 76.7%, 75.0%, and 71.7%, respectively. The per-protocol analysis showed that the H. pylori eradication rates of the 4 groups were 86.3%, 82.1%, 83.3%, and 86.0%. There was no significant difference among the 4 groups in the H. pylori eradication rate (P > .05). There were also no significant differences in the symptom improvement rate, overall adverse reaction rate, or patient compliance among the 4 groups. CONCLUSIONS: Bismuth pectin capsules and bismuth pectin granules had similar efficacy and safety for H. pylori eradication compared to bismuth potassium citrate. These data suggest that bismuth pectin can be an alternative to bismuth potassium citrate to eradicate H. pylori when using bismuth-containing quadruple therapy.

Does potassium citrate administration change the type and composition of encrusted material on Double-J stent compared to primary stone?

PURPOSE: To evaluate the effect of potassium citrate administration on the composition of encrusted material on the ureteral stent after Double-J insertion. METHODS: We designed a randomized clinical trial for our study; 65 patients that underwent transurethral lithotripsy and Double-J stent insertion were included in the study after informed consent and divided into two groups. In the first group (33 patients) potassium citrate was prescribed after surgery till stent removal and the second group (32 patients) followed without prescribing this medication. After stent removal, encrusted materials on removed stents were analyzed then the type and composition of encrusted material compared with the primary stone that was removed. RESULTS: Our results revealed that the type and composition of primary stone and encrusted stone were similar in patients that do not receive potassium citrate (p-value of 0.073, 0.251 and 0.944 for calcium oxalate, uric acid, and calcium phosphate respectively). In patients that taking potassium citrate rate of calcium oxalate (p-value < 0.001) and uric acid (p-value < 0.001) material on encrusted stent significantly decreased compared with the non-intervention group. CONCLUSION: Results of this study revealed that taking of potassium citrate after ureteral stent insertion significantly decreases the formation of calcium oxalate and uric acid encrusted material on Double-J stent so it could be recommended for prevention of stent encrustation in patients that primary stone analysis are calcium oxalate and uric acid stone.

Potassium citrate vs. hydrochlorothiazide to reduce urinary calcium excretion in calcium oxalate stone patients with hypercalciuria: a prospective randomized study.

PURPOSE: Calcium oxalate (Ca-Ox) is the most common stone composition and one of the most common 24-h urine anomalies is hypercalciuria. The purpose of this study was to evaluate the efficacy of potassium citrate (K-CIT) for prevention of hypercalciuria in comparison with hydrochlorothiazide (HCT) in patients with calcium oxalate stones and hypercalciuria. MATERIALS AND METHODS: In this prospective randomized study, patients were randomized to receive either HCT (50 mg/day) or K-CIT (40 mEq/day) following achieving stone-free status. Treatment was continued for 6 months. 24 h urine analysis was performed prior to treatment and repeated at third month and measured parameters were volume, calcium, oxalate, citrate, sodium, and uric acid. Stone recurrence was evaluated with KUB and ultrasonography at 6th and 12th months. RESULTS: Data of 40 patients in each arm were evaluated. Mean 24 h urine calcium levels decreased to 205 ± 54.5 mg/day and 220.6 ± 96.3 mg/day in the K-CIT and HCT groups, respectively, and difference was not significant (p = 0.931). The reduction compared to pretreatment values was statistically significant in both groups. Urinary citrate levels also significantly increased in both groups and level of increase was significantly higher in K-CIT group. At 12th month, ultrasonography revealed stones in two patients in HCT group, and in one patient in the K-CIT group. CONCLUSIONS: K-CIT provided significantly reduced calcium and increased citrate excretion in patients Ca-Ox stone patients with hypercalciuria. The efficacy in decreasing calcium excretion was comparable to HCT treatment. K-CIT can be used for medical prophylaxis of Ca-OX stone patients with hypercalciuria.

Safety, efficacy, and acceptability of ADV7103 during 24 months of treatment: an open-label study in pediatric and adult patients with distal renal tubular acidosis.

BACKGROUND: A new prolonged-release formulation of potassium citrate and potassium bicarbonate, ADV7103, has been shown to improve metabolic control, palatability, and gastrointestinal safety in patients with distal renal tubular acidosis (dRTA) when compared to standard of care (SoC) treatments. The present work evaluates safety and efficacy of ADV7103 during 24 months. METHODS: Thirty pediatric and adult patients were included in an open-label extension study after a phase II/III trial. Safety and tolerability were assessed. Plasma bicarbonate and potassium levels, as well as urine parameters, were evaluated over time. Acceptability, adherence, and quality of life were also assessed. The evolution of clinical consequences of dRTA in the cohort was explored. RESULTS: There were 104 adverse events (AEs) reported, but only 9 gastrointestinal events observed in five patients (17%) were considered to be related to ADV7103 treatment. There were no AEs leading to treatment discontinuation. Plasma bicarbonate and potassium levels were in the normal ranges at the different visits, respectively, in 69-86% and 83-93% of patients. Overall adherence rates were ≥ 75% throughout the whole study in 79% patients. An average improvement of quality of life of 89% was reported at 24 months of study. CONCLUSIONS: Common AEs concerned metabolism and gastrointestinal disorders; the former being related to the disease. Less than half of the gastrointestinal AEs were related to ADV7103 treatment and they were mostly mild in severity. Metabolic parameters were maintained in the normal ranges in most patients. Patient satisfaction was high and adherence to treatment was good and remained stable. TRIAL REGISTRATION NUMBER: Registered as EudraCT 2013-003828-36 on the 3rd of September 2013.

Primary Sjögren's syndrome manifesting as sclerotic metabolic bone disease.

Primary Sjögren's syndrome (pSS) is a chronic slowly progressive autoimmune disease characterised by lymphocytic infiltration of salivary and lacrimal glands with varying degree of systemic involvement. Renal involvement, a recognised extraglandular manifestation of pSS, is commonly related to tubular dysfunction and generally manifests as distal renal tubular acidosis (RTA), proximal RTA, tubular proteinuria and nephrogenic diabetes insipidus. Untreated long-standing RTA is known to cause metabolic bone disease. Here, we present the report of a patient with sclerotic metabolic bone disease related to pSS with combined distal and proximal RTA and negative workup for other causes of sclerotic bone disease. A significant clinical and biochemical improvement, including recovery of proximal tubular dysfunction, was noted with alkali therapy. This case suggests the need to consider pSS in the diagnostic algorithm of a patient presenting with sclerotic bone disease.

Metabolic risk factors and the role of prophylaxis in pediatric urolithiasis.

Suppose that the recurrence in pediatric urolithiasis has a close relationship with metabolic abnormalities and is affected by residual burden and prophylaxis. If so, the recurrence rates could be reduced with effective surgery and appropriate prophylaxis. Here we retrospectively evaluate the metabolic risk factors data of 148 children who were operated on between January 2005 and March 2013 due to kidney stones. All patients underwent percutaneous nephrolithotomy (PCNL), and all were children. Thirteen children had a history of surgery performed to treat urological anomalies. Twenty-four-hour urine analysis, the residual status of surgery, BMI levels, and the number of metabolic abnormalities were noted. Only 18 (15%) of 122 patients without residual stones after PCNL had recurrence at follow-up whereas; nine (26%) of 26 patients with residual stones developed recurrence (p = 0.017). Recurrence was observed in 14 (16%) of 89 patients with a metabolic abnormality, and 13 (30%) of 44 patients with two or more metabolic abnormalities had recurrence at follow-up (p = 0.024). Those patients with no metabolic abnormalities did not develop recurrence. Stone recurrence was seen in six (8%) of 78 children who were given metabolic prophylaxis, compared to 21 (30%) of 70 patients who did not receive metabolic prophylaxis (p = 0.02). No stone recurrence was seen in nine children who were given Shohl's, whereas four (67%) of six patients who did not take Shohl's had recurrence (p = 0.022). Complete removal of stones by a suitable surgical method is essential to avoid recurrences. Detailed clinical and laboratory evaluations should be performed in children with urolithiasis. Appropriate specific prophylactic treatment (e.g., potassium citrate and Shohl's) and non-specific prophylactic treatment (e.g., avoiding animal proteins, salt, simple sugars, and increased water intake) should be given to prevent reformation of stones in patients with pediatric urolithiasis.