Background
Methods
Inclusion criteria
Data collection
Items in PAS questionnaire | |
---|---|
1. | Pain in the bones |
2. | Feeling tired easily |
3. | Mood swings |
4. | Feeling “blue” or depressed |
5. | Pain in the abdomen |
6. | Feeling weak |
7. | Feeling irritable |
8. | Pain in the joints |
9. | Forgetfulness |
10. | Difficulty to stand up |
11. | Headaches |
12. | Dry skin |
13. | Being thirsty |
14. | Pruritus |
Ethics statement
Statistical analyses
Results
Patients
Inclusion criteria | |||||||
---|---|---|---|---|---|---|---|
Study population | Cinacalcet | PTHa ≥ 500 ng/L | |||||
(N = 305) | (N = 44, 14.4%) | (N = 261, 85.6%) | |||||
Variables | N | N | N |
p
| |||
Ageb, years | 305 | 66.6 ± 15.3 | 44 | 63.3 ± 14.2 | 261 | 67.1 ± 15.4 |
0.122
|
Gender (males), % | 305 | 60 | 44 | 71 | 261 | 58 |
0.126
|
BMIc,b, kg/m2
| 301 | 28.6 ± 6.9 | 44 | 28.3 ± 6.3 | 257 | 28.7 ± 7.1 |
0.697
|
>30 kg/m2, % | 301 | 33.8 | 44 | 29.5 | 257 | 34.5 |
0.522
|
Type of dialysis, % | 304 | 44 | 261 |
0.340
| |||
Hemodialysis | 91.8 | 95.5 | 91.2 | ||||
Peritoneal dialysis | 8.2 | 4.5 | 8.8 | ||||
Dialysis vintageb, months | 305 | 27.5 ± 34.5 | 44 | 23.1 ± 24.5 | 261 | 28.3 ± 35.9 |
0.362
|
On transplant waiting list, % | 300 | 44 | 256 |
0.636
| |||
Yes | 8.3 | 11.4 | 7.9 | ||||
No | 91.7 | 88.6 | 92.1 | ||||
Primary etiology of nephropathy, % | 300 | 43 | 257 |
0.211
| |||
Diabetic nephropathy | 16.0 | 23.3 | 14.8 | ||||
Vascular nephropathy | 16.3 | 20.9 | 15.6 | ||||
Glomerulonephritis | 10 | 11.6 | 9.7 | ||||
Pyelonephritis | 4.7 | 7.0 | 4.3 | ||||
Hereditary nephropathy | 7.7 | 11.6 | 7.0 | ||||
Others/Unknown | 45.3 | 36.2 | 48.7 | ||||
Comorbidities, % | 305 | 44 | 261 | ||||
Cardiovascular diseases | 49.5 | 45.5 | 50.2 |
0.561
| |||
Diabetes | 44.9 | 31.8 | 47.1 |
0.590
| |||
Respiratory diseases | 11.5 | 15.9 | 10.7 |
0.319
| |||
Cancer | 13.1 | 6.8 | 14.2 |
0.181
| |||
Hypertension | 85.9 | 88.6 | 85.4 |
0.573
| |||
Smoking | 13.4 | 13.6 | 13.4 |
0.675
| |||
Clinical signs, % | 305 | 44 | 261 | ||||
Reported in medical records | 27.2 | 31.8 | 26.4 |
0.458
| |||
Reporded in PASd questionnaire | 44.9 | 31.8 | 47.1 |
0.059
| |||
Pain in the bones
e
| 125 | 17 | 12 | 6 | 110 | 21 |
0.317
|
Feeling tired easily
e
| 131 | 47 | 13 | 50 | 115 | 46 |
0.054
|
Mood swings
e
| 124 | 23 | 13 | 20 | 108 | 23 |
0.216
|
Feeling “blue” or depressed
e
| 123 | 6 | 12 | 6 | 108 | 6 |
0.184
|
Pain in the abdomen
e
| 124 | 12 | 11 | 4 | 110 | 13 |
0.055
|
Feeling weak
e
| 126 | 48 | 12 | 23 | 111 | 49 |
0.067
|
Feeling irritable
e
| 123 | 20 | 12 | 21 | 108 | 20 |
0.081
|
Pain in the joints
e
| 128 | 40 | 13 | 52 | 112 | 39 |
0.130
|
Forgetfulness
e
| 126 | 12 | 14 | 12 | 109 | 12 |
0.317
|
Difficulty to stand up
e
| 121 | 18 | 10 | 6 | 108 | 20 |
0.020
|
Headache
e
| 115 | 5 | 11 | 13 | 101 | 5 |
0.372
|
Dry skin
e
| 122 | 35 | 13 | 49 | 106 | 30 |
0.325
|
Being thirsty
e
| 121 | 51 | 13 | 51 | 105 | 51 |
0.265
|
Pruritus
e
| 122 | 20 | 12 | 49 | 107 | 16 |
0.302
|
Symptomatic patients, % | 122 | 58 | 12 | 52.3 | 107 | 59 |
0.402
|
Biological parameters | |||||||
PTHa,b, ng/L | 305 | 619 ± 226 | 44 | 468 ± 262 | 261 | 644 ± 210 |
<0.0001
|
within KDIGO target
f
, %
| 305 | 64.3 | 44 | 81.8 | 261 | 61.3 |
0.009
|
Serum calciumb, mg/L | 305 | 87.0 ± 7.1 | 44 | 81.8 ± 7.1 | 261 | 87.1 ± 7.2 |
0.681
|
Calcemia, % | 305 | 44 |
0.935
| ||||
≤ 84 mg/L
| 42.6 | 43.2 | 42.5 | ||||
84-104 mg/L
| 57.4 | 56.8 | 57.5 | ||||
> 104 mg/L
| 0 | 0 | 261 | 0 | |||
Serum phosphorusb, mg/L | 305 | 54.4 ± 16.5 | 44 | 50.9 ± 17.6 | 261 | 55.0 ± 16.3 |
0.129
|
Phosphatemia, % | 305 | 44 |
0.675
| ||||
<25 mg/L
| 2.6 | 2.3 | 2.7 | ||||
25-45 mg/L
| 28.6 | 34.1 | 27.6 | ||||
>45 mg/L
| 68.9 | 63.6 | 69.7 | ||||
Serum alkaline phosphataseb, UI/L | 299 | 103.4 ± 56.9 | 43 | 124.3 ± 97.0 | 256 | 99.9 ± 46.3 |
0.009
|
Bicarbonatemiab, mmol/L | 303 | 22.2 ± 3.4 | 44 | 22.4 ± 2.8 | 258 | 22.1 ± 3.5 |
0.618
|
Albuminb, g/L | 291 | 36.3 ± 4.6 | 42 | 36.7 ± 4.1 | 249 | 36.2 ± 4.6 |
0.504
|
Hemoglobinb, g/dL | 279 | 10.3 ± 1.6 | 44 | 10.6 ± 1.5 | 235 | 10.3 ± 1.6 |
0.245
|
Vitamin Db, ng/mL | 209 | 19.2 ± 13.5 | 31 | 15.8 ± 10.4 | 178 | 19.7 ± 13.9 |
0.138
|
Ionised calciumb, mmol/L | 58 | 1.1 ± 0.2 | 3 | 0.9 ± 0.8 | 55 | 1.1 ± 0.1 |
0.031
|
Treatment, % | 305 | 44 | 261 | ||||
Vitamin D (per os) | 63.9 | 72.7 | 62.5 |
0.189
| |||
Calcium | 68.9 | 81.8 | 66.7 |
0.045
| |||
Phosphorus binders | 59.3 | 61.4 | 59 0 |
0.768
| |||
Cinacalcet at inclusion | 14.4 | 100 | 0 |
<0.0001
| |||
Cinacalcet at 3 months | 27.2 | 56.8 | 22.2 |
<0.0001
|
Cluster analysis
Variables | Group 1a
| Group 2a
| Group 3a
| Group 4a
| |
---|---|---|---|---|---|
(N = 113, 37.2%) | (N = 73, 24.0%) | (N = 75, 24.7%) | (N = 43, 14.1%) |
p
| |
Clinical signs, % | |||||
All clinical signs | 64 | 55 | 56 | 54 |
0.512
|
Clinical signs reported in PASb
| 55 | 45 | 37 | 33 |
0.031
|
Biological parameters | |||||
PTHc,d, ng/L | 666 ± 182 | 630 ± 199 | 635 ± 233 | 449 ± 255 |
<0.0001
|
within KDIGO target, %
| 51 | 66 | 69 | 86 |
0.0004
|
Serum calciumd, mg/L | 89 ± 7 | 82 ± 6 | 89 ± 6 | 87 ± 7 |
<0.0001
|
Hypocalcemia, %
| 29 | 81 | 27 | 42 |
<0.0001
|
Serum phosphorusd, mg/L | 58 ± 17 | 62 ± 13 | 44 ± 12 | 52 ± 17 |
<0.0001
|
Hyperphosphatemia, %
| 81 | 96 | 25 | 67 |
<0.0001
|
Hypophosphatemia, %
| 4 | 4 | 0 | 2 |
<0.0001
|
Serum alkaline phosphatased, UI/L | 100 ± 44 | 78 ± 29 | 120 ± 53 | 123 ± 99 |
<0.0001
|
Under median value, %
| 50 | 84 | 21 | 53 |
<0.0001
|
Treatments, % | |||||
Vitamin D and analogs | 73 | 84 | 24 | 77 |
<0.0001
|
Calcium supplementation | 68 | 95 | 35 | 86 |
<0.0001
|
Calcium-free phosphorus binders | 58 | 93 | 25 | 65 |
<0.0001
|
Cinacalcet | 0 | 0 | 3 | 98 |
<0.0001
|
Variables | Group 1a
| Group 2a
| Group 3a
| Group 4a
| |
---|---|---|---|---|---|
(N = 113, 37.2%) | (N = 73, 24%) | (N = 75, 24.7%) | (N = 43, 14.1%) |
p
| |
Socio-demographic | |||||
Ageb, years | 65 ± 17 | 66 ± 14 | 72 ± 13 | 63 ± 15 |
0.008
|
Gender (males), % | 56 | 66 | 55 | 70 |
0.217
|
Dialysis | |||||
Type of dialysis, % |
0.330
| ||||
Hemodialysis
| 90 | 96 | 91 | 95 | |
Peritoneal dialysis
| 10 | 4 | 9 | 5 | |
Dialysis vintageb, months | 27 ± 32 | 19 ± 22 | 38 ± 48 | 24 ± 24 |
0.007
|
Comorbidities, % | |||||
Cardiovascular diseases | 48 | 62 | 41 | 47 |
0.086
|
Diabetes | 46 | 55 | 41 | 30 |
0.070
|
BMIc, kg/m2
| 29 | 30 | 27 | 28 |
0.217
|
>30 kg/m
2
, %
| 37 | 42 | 23 | 30 |
0.091
|
Biological parameters | |||||
Albuminb, g/L | 37 ± 5 | 36 ± 5 | 36 ± 5 | 37 ± 4 |
0.396
|
Hemoglobinb, g/dL | 10.0 ± 1.6 | 10.4 ± 1.5 | 10.6 ± 1.7 | 10.6 ± 1.5 |
0.046
|