Gallstones were associated with the gastrointestinal adverse events of cinacalcet in hemodialysis patients with secondary hyperparathyroidism

Figures & data

Table 1. Baseline continuous variables of the study groups.

	Cinacalcet group, N = 23	Control group, N = 101	p value	Cinacalcet group with AE, N = 12	Cinacalcet group without AE, N = 11	p value
Age (years)	62 ± 10	68 ± 11	.017	64 ± 8	60 ± 10	.291
Time on HD (years)	13.6 ± 4.9	5.4 ± 5.2	<.001	13.6 ± 4.4	13.5 ± 5.1	.986
Dry weight (kg)	57.3 ± 9.8	54.8 ± 12.9	.380	53.7 ± 7.0	61.2 ± 10.4	.060
Corrected Ca (mg/dL)^a	9.3 ± 0.7	9.0 ± 0.7	.036	9.2 ± 0.6	9.3 ± 0.7	.673
Phosphorus (mg/dL)	5.6 ± 1.4	5.0 ± 1.2	.048	5.9 ± 1.5	5.2 ± 1.0	.230
ALP (IU/L)	228 ± 86	265 ± 127	.187	275 ± 91	176 ± 22	.003
Whole PTH (pg/mL)	120 ± 72	87 ± 51	.047	113 ± 23	127 ± 61	.646
Hemoglobin (g/dL)	11.3 ± 1.0	11.1 ± 0.9	.341	11.5 ± 0.7	11.1 ± 1.2	.419
TSAT (%)	19.8 ± 8.8	25.9 ± 11.4	.019	19.7 ± 7.4	20.0 ± 9.8	.925
Ferritin (ng/mL)	101 ± 162	162 ± 268	.293	142 ± 204	55 ± 54	.203
Total protein (g/dL)	6.5 ± 0.4	6.4 ± 0.5	.864	6.5 ± 0.5	6.4 ± 0.4	.379
Albumin (g/dL)	3.9 ± 0.2	3.8 ± 0.3	.011	4.0 ± 0.3	3.9 ± 0.2	.964
BUN (mg/dL)	60.1 ± 11.6	55.2 ± 13.9	.122	60.2 ± 13.0	59.9 ± 9.2	.937
Creatinine (mg/dL)	12.0 ± 2.8	9.5 ± 2.4	<.001	11.3 ± 2.6	12.9 ± 2.7	.177
Kt/V^b	1.6 ± 0.3	1.5 ± 0.3	.039	1.67 ± 0.16	1.59 ± 0.35	.541
Potassium (mEq/L)	5.2 ± 0.7	4.8 ± 0.8	.044	5.2 ± 0.7	5.1 ± 0.7	.664
LDL-C (mg/dL)	96 ± 26	81 ± 26	.013	98.1 ± 21.0	93.7 ± 29.6	.700
β2-MG (mg/L)	27.9 ± 3.7	25.9 ± 6.2	.044	28.2 ± 4.0	27.6 ± 3.2	.745

Values are mean ± SD; AE: adverse events.

^a Corrected Ca = serum calcium + (4-serum albumin); ALP: alkaline phosphatase; PTH: parathyroid hormone; TSAT: transferrin saturation; BUN: blood urea nitrogen; LDL-C: low-density lipoprotein cholesterol; β2-MG: β2-microglobulin.

^b Kt/V calculation is Daugirdas’s formula (1996): spKt/V = −ln(R − 0.008 × t) + (4 − 3.5 × R) 0.55 × UF/V: in which R is predialysis urea/postdialysis urea, t is dialysis time in hours.

Table 2. The relations of the categorical variables to the usage of cinacalcet.

Categorical variables	Cinacalcet group, N = 23	Control group, N = 101	Odds ratio	95% CI
Sex (male)	65.2% (15/23)	63.4% (64/101)	1.08	0.42–2.80
Antacids	82.6% (19/23)	66.3% (67/101)	2.41	0.76–7.65
History of upper GI diseases	39.1% (9/23)	23.8% (24/101)	2.06	0.79–5.36
Gallbladder polyps	34.8% (8/23)	35.6% (36/101)	0.96	0.37–2.49
Gallstones	47.8% (11/23)	15.8% (16/101)	4.87	1.84–12.9

Table 3. The relations of the categorical variables to the incidence of GI adverse events of cinacalcet.

Categorical variables	Cinacalcet group with adverse events, N = 12	Cinacalcet group without adverse events, N = 11	Odds ratio	95% CI
Sex (male)	66.7% (8/12)	63.6% (7/11)	1.14	0.21–6.37
Antacids	75% (9/12)	90.9% (10/11)	0.30	0.03–3.43
History of upper GI diseases	50.0% (6/12)	27.3% (3/11)	2.67	0.47–15.3
Gallbladder polyps	41.7% (5/12)	27.3% (3/11)	1.91	0.33–11.0
Gallstones	75% (9/12)	18% (2/11)	13.5	1.80–101