Clinical Data

Prevention of Kidney Stones ⁽⁶⁾

Study	Year	Design	Population	Number of patients	Stone Type	Dose per day	Follow-up, years	ARR, %	RRR, %	Estimated NNT
Barceló et al. (1)	1993	RCT	Recurrent hypocitraturic adults	57	CaOx	30–60 mEq	3	52.2	65	≈2
Ettinger et al. (2)	1997	RCT	Recurrent CaOx formers	64	CaOx	42 mEq. potassium, 63 mEq. citrate	3	50.7	79.7	≈2
Soygür et al. (3)	2002	RCT	Post-SWL stone-free adults	110	CaOx	60 mEq	1 yr	28.6	100	≈4
Phillips et al. (4)	2015	Meta-analysis	Mixed recurrent stone formers	477	CaOx pre-dominant	Variable	1-4 yrs	RRR ~75	NA	≈2-3

Table 1: Key studies of citrate therapy and estimated NNT by stone phenotype. ARR = Absolute Risk Reduction, RRR = Relative Risk Reduction; NNT = Number Needed to Treat, SWL = extracorporeal Shock Wave Lithotripsy, CaOx= Calcium Oxalate

Efficacy data for treatment of Uric Acid Stones

Study	Year	Number of Patients	Outcome	Comment
Petritsch (16)	1977	140	Dissolution rate 79.3%	Urine pH titrated to 6.2 to 7.0
Salem et al. (15)	2019	147	Complete dissolution or residual fragments in 90 patients	Urine pH titrated to 6.2 to 6.8
Elsawy et al. (17)	2019	212	After 3 months: Complete dissolution in 97 patients Partial in 65 patients After 6 months: Further 54 patients achieved complete dissolution	Urine pH titrated to 6.2 to 6.8

Table 2: Pivotal efficacy studies for supporting use of potassium citrate in treatment of uric acid stones.

Safety Data

Study	Year	Adverse Events Active Group
Barceló et al. (1)	1993	Minor GI complaints; 3/18 (17%) mild nausea/epigastric pain/abdominal distention; GI intolerance dropouts: 2
Ettinger et al. (2)	1997	Adverse Event related discontinuations: 5/31 (16.1%) (gas/bloating/nausea; swallowing difficulty; rash) Diarrhoea 11.5%; ~11% overall difficulty swallowing
Soygür et al. (3)	2002	Safety reporting limited to exclusions and not separated into control/placebo: epigastric discomfort (n=6) and reluctance to receive medication (n=4)
Salem et al. (15)	2019	11 patients did not tolerate drug taste and/or had gastric upset, 5 patients developed hypertension, and 2 patients had potassium level higher than 5.5 mg/dl
Petritsch (16)	1977	4 patients had GI side effects (severe)
Elsawys et al. (17)	2019	22 patients had GI side effects 2 patients had Dizziness

Table 3: Safety data in all key studies