Early Clinical Experience of Finerenone in People with Chronic Kidney Disease and Type 2 Diabetes in Japan—A Multi-Cohort Study from the FOUNTAIN (FinerenOne mUltidatabase NeTwork for Evidence generAtIoN) Platform
Abstract
:1. Introduction
2. Methods
2.1. Study Design, Data Source, and Patient Selection
2.2. Variables
2.3. Statistical Analyses
2.4. Ethics Statement
3. Results
3.1. Baseline Characteristics at Finerenone Initiation in the Main Cohort
3.2. Baseline Characteristics in the Subgroups
3.3. Incidence of Clinical Outcomes after Finerenone Initiation
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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MDV (N = 967) | RWD Co. (N = 62) | |
---|---|---|
Age (years) | ||
Mean ± SD | 69.5 ± 12.4 | 72.4± 10.4 |
Median (Q1, Q3) | 72 (62, 79) | 74 (67, 80) |
Gender, female, n (%) | 264 (27.3) | 17 (27.4) |
Index year, n (%) | ||
2022 | 101 (10.4) | 28 (45.2) |
2023 | 866 (89.6) | 34 (54.8) |
Hemoglobin A1c, % | ||
Mean ± SD | 7.4 ± 1.5 | 7.3 ± 1.1 |
Median (Q1, Q3) | 7.0 (6.4, 8) | 7.0 (6.5, 7.8) |
Missing, n (%) | 827 (85.5) | 1 (1.6) |
eGFR, mg/min/1.73 m2 | ||
Mean ± SD | – | 43.4 ± 18.1 |
Category, n (%) | ||
Stage 2 60–89 | – | 2 (3.2) |
Stage 3 30–59 | – | 33 (53.2) |
Stage 4 15–29 | – | 27 (43.6) |
Finerenone dose initiation, n (%) | ||
10 mg | 854 (88.3) | 58 (93.6) |
20 mg | 113 (11.7) | 4 (6.5) |
Comorbidity, n (%) | ||
Hypertension | 894 (92.5) | 59 (95.2) |
Hyperlipidemia | 568 (58.7) | 44 (71.0) |
Congestive heart failure | 577 (59.7) | 41 (66.1) |
Prior hospitalization for heart failure | 212 (21.9) | 10 (16.1) |
Coronary heart disease | 372 (38.5) | 23 (37.1) |
Peripheral vascular disease | 137 (14.2) | 14 (22.6) |
Atrial fibrillation | 154 (15.9) | 10 (16.1) |
Acute coronary syndrome | 177 (18.3) | 16 (25.8) |
Myocardial infarction | 87 (9) | 8 (12.9) |
Cerebrovascular disease | 215 (22.2) | 15 (24.2) |
Neuropathy | 198 (20.5) | 9 (14.5) |
Retinopathy | 149 (15.4) | 9 (14.5) |
Charlson Comorbidity Index | ||
Mean ± SD | 8.2 ± 3.1 | 10.2 ± 3.5 |
Median (Q1, Q3) | 8 (6, 10) | 9 (8–12) |
Diabetes Complication Severity Index | ||
Mean ± SD | 5.2 ± 1.8 | 6.7 ± 2.1 |
Median (Q1, Q3) | 5 (4, 6) | 6 (5, 8) |
Comedications, n (%) | ||
ACEi or ARB | 776 (80.3) | 50 (80.7) |
ACEi | 350 (36.2) | 27 (43.6) |
ARB | 717 (74.2) | 45 (72.6) |
ARNI | 208 (21.5) | 10 (16.1) |
Calcium-channel blockers | 481 (49.7) | 30 (48.4) |
Beta-blockers | 297 (30.7) | 22(35.5) |
Loop diuretics | 218 (22.5) | 17 (27.4) |
Thiazide diuretics | 45 (4.7) | 2 (3.2) |
Steroidal MRA | 143 (14.8) | 5 (8.1) |
Non-steroidal MRA other than finerenone | 64 (6.6) | 1 (1.6) |
Statins | 571 (59.1) | 44 (71.0) |
Anticoagulants | 153 (15.8) | 11 (17.7) |
Potassium binders | 62 (6.4) | 2 (3.2) |
SGLT-2i | 694 (71.8) | 45 (72.6) |
GLP-1 RA | 268 (27.7) | 19 (30.7) |
SGLT-2i or GLP-1 RA | 760 (78.6) | 48 (77.4) |
SGLT-2i and GLP-1 RA | 202 (20.9) | 16 (25.8) |
Metformin | 322 (33.3) | 21 (33.9) |
Dipeptidyl peptidase 4 inhibitors | 480 (49.6) | 40 (64.5) |
Sulfonylureas | 133 (13.8) | 16 (25.8) |
Meglitinides | 122 (12.6) | 13 (21) |
Alpha-glucosidase inhibitors | 113 (11.7) | 4 (6.5) |
Thiazolidinediones | 30 (3.1) | 1 (1.6) |
Insulins | 295 (30.5) | 17 (27.4) |
MDV | RWD Co. | |||||
---|---|---|---|---|---|---|
SGLT-2i (N = 676) | GLP-1 RA (N = 256) | SGLT-2i and GLP-1 RA (N = 187) | SGLT-2i (N = 38) | GLP-1 RA (N = 15) | SGLT-2i and GLP-1 RA (N = 10) | |
Age (years) | ||||||
Mean ± SD | 68.1 ± 12.9 | 65.2 ± 12.5 | 63.4 ± 12.3 | 71.8 ± 10.0 | 71.9 ± 8.5 | 71.8 ± 8.3 |
Median (Q, Q3) | 71 (59, 77) | 67 (57, 75) | 65 (55, 74) | 74 (65, 79) | 72 (65, 79) | 72 (67, 77) |
Gender, female, n (%) | 176 (26) | 70 (27.3) | 44 (23.5) | 6 (15.8) | 6 (40) | 2 (20) |
Index year, n (%) | ||||||
2022 | 60 (8.9) | 35 (13.7) | 20 (10.7) | 12 (31.6) | 7 (46.7) | 4 (40) |
2023 | 616 (91.1) | 221 (86.3) | 167 (89.3) | 26 (68.4) | 8 (53.3) | 6 (60) |
Hemoglobin A1c, % | ||||||
Mean ± SD | 7.3 ± 1.4 | 7.9 ± 1.8 | 7.7 ± 1.7 | 7.4 ± 1.2 | 7.7 ± 1.3 | 8.1 ± 1.4 |
Median (Q1, Q3) | 7.1 (6.4, 7.9) | 7.3 (6.8, 8.5) | 7.3 (6.8, 8.3) | 7.1 (6.5, 8) | 7.4 (6.8, 8.3) | 7.7 (7, 9.1) |
Missing, n (%) | 579 (85.7) | 222 (86.7) | 162 (86.6) | 1 (2.6) | 0 (0) | 0 (0) |
eGFR, mg/min/1.73 m2 | ||||||
Mean ± SD | – | – | – | 46.5 ± 20.8 | 37.3 ± 13.2 | 37.1 ± 17.0 |
Category, n (%) | ||||||
Stage 2 60–89 | – | – | – | 2 (5.3) | 1 (6.7) | 1 (10) |
Stage 3 30–59 | – | – | – | 18 (47.4) | 7 (46.7) | 3 (30) |
Stage 4 15–29 | – | – | – | 18 (47.4) | 7 (46.7) | 6 (60) |
Finerenone dose initiation, n (%) | ||||||
10 mg | 598 (88.5) | 217 (84.8) | 158 (84.5) | 35 (92.1) | 15 (100) | 10 (100) |
20 mg | 78 (11.5) | 39 (15.2) | 29 (15.5) | 3 (7.9) | 0 (0) | 0 (0) |
Comorbidity, n (%) | ||||||
Hypertension | 627 (92.8) | 239 (93.4) | 175 (93.6) | 36 (94.7) | 13 (86.7) | 8 (80) |
Hyperlipidemia | 394 (58.3) | 174 (68) | 125 (66.8) | 25 (65.8) | 12 (80) | 8 (80) |
Congestive heart failure | 425 (62.9) | 148 (57.8) | 111 (59.4) | 24 (63.2) | 9 (60) | 6 (60) |
Prior hospitalization for heart failure | 171 (25.3) | 58 (22.7) | 43 (23.0) | 7 (18.4) | 1 (6.7) | 1 (10) |
Coronary heart disease | 272 (40.2) | 101 (39.5) | 82 (43.9) | 11 (29) | 3 (20) | 1 (10) |
Peripheral vascular disease | 87 (12.9) | 46 (18) | 31 (16.6) | 6 (15.8) | 4 (26.7) | 1 (10) |
Atrial fibrillation | 118 (17.5) | 22 (8.6) | 16 (8.6) | 7 (18.4) | 1 (6.7) | 0 (0) |
Acute coronary syndrome | 136 (20.1) | 45 (17.6) | 35 (18.7) | 12 (31.6) | 0 (0) | 0 (0) |
Myocardial infarction | 70 (10.4) | 19 (7.4) | 16 (8.6) | 7 (18.4) | 0 (0) | 0 (0) |
Cerebrovascular disease | 138 (20.4) | 68(26.6) | 40 (21.4) | 10 (26.3) | 3(20) | 2 (20) |
Neuropathy | 138 (20.4) | 65 (25.4) | 48 (25.7) | 4(10.5) | 3(20) | 2 (20) |
Retinopathy | 107 (15.8) | 38 (14.8) | 30 (16) | 8 (21.1) | 0 (0) | 0 (0) |
Charlson Comorbidity Index | ||||||
Mean ± SD | 8.1 ± 3.1 | 8.1 ± 3.0 | 8.0 ± 3.0 | 9.7 ± 3.9 | 8.8 ± 2.8 | 8.4 ± 3.1 |
Median (Q1, Q3) | 8 (6, 9) | 8 (6, 10) | 8 (6, 9) | 9 (7, 11) | 9 (7, 10) | 8 (6, 10) |
Diabetes Complication Severity Index | ||||||
Mean ± SD | 5.2 ± 1.8 | 5.2 ± 1.7 | 5.1 ± 1.7 | 6.3 ± 2.1 | 6.1 ± 1.7 | 5.8 ± 1.3 |
Median (Q1, Q3) | 6 (4, 6) | 6 (4, 6) | 5 (4, 6) | 6 (5, 8) | 6 (5, 7) | 6 (5, 7) |
Comedications, n (%) | ||||||
ACEi or ARB | 553 (81.8) | 213 (83.2) | 158 (84.5) | 31 (81.6) | 11 (73.3) | 6 (60) |
ACEi | 227 (33.6) | 89 (34.8) | 64 (34.2) | 14 (36.8) | 6 (40) | 3 (30) |
ARB | 523 (77.4) | 200 (78.1) | 153 (81.8) | 30 (79) | 8 (53.3) | 6 (60) |
ARNI | 184 (27.2) | 52 (20.3) | 46 (24.6) | 9 (23.7) | 1 (6.7) | 1 (10) |
Calcium-channel blockers | 326 (48.2) | 130 (50.8) | 96 (51.3) | 17 (44.7) | 7 (46.7) | 4 (40) |
Beta-blockers | 235 (34.8) | 77 (30.1) | 61 (32.6) | 15 (39.5) | 5 (33.3) | 3 (30) |
Loop diuretics | 170 (25.2) | 49 (19.1) | 40 (21.4) | 14 (36.8) | 3 (20) | 3 (30) |
Thiazide diuretics | 30 (4.4) | 17 (6.6) | 10 (5.4) | 1 (2.6) | 0 (0) | 0 (0) |
Steroidal MRA | 117 (17.3) | 29 (11.3) | 22 (11.8) | 3 (7.9) | 0 (0) | 0 (0) |
Non-steroidal MRA other than finerenone | 43 (6.4) | 16 (6.3) | 13 (7) | 1 (2.6) | 0 (0) | 0(0) |
Statins | 410 (60.7) | 169 (66) | 128 (68.5) | 27 (71.1) | 11 (73.3) | 7 (70) |
Anticoagulants | 114 (16.9) | 30 (11.7) | 22 (11.8) | 8 (21.1) | 1 (6.7) | 0 (0) |
Potassium binders | 41 (6.1) | 20 (7.8) | 14 (7.5) | 1 (2.6) | 0 (0) | 0 (0) |
SGLT-2i and GLP-1 RA | 192 (28.4) | 192 (75) | 183 (97.9) * | 13 (34.2) | 12 (80) | 10 (100) |
Metformin | 218 (32.3) | 112 (43.8) | 88 (47.1) | 13 (34.2) | 6 (40) | 5 (50) |
Dipeptidyl peptidase 4 inhibitors | 316 (46.8) | 59 (23.1) | 45 (24.1) | 24 (63.2) | 5 (33.3) | 3 (30) |
Sulfonylureas | 88 (13) | 40 (15.6) | 31 (16.6) | 9 (23.7) | 3 (20) | 3 (30) |
Meglitinides | 74 (11) | 49 (19.1) | 29 (15.5) | 6 (15.8) | 4 (26.7) | 3 (30) |
Alpha-glucosidase inhibitors | 74 (11) | 35 (13.7) | 25 (13.4) | 2 (5.3) | 1 (6.7) | 1 (10) |
Thiazolidinediones | 20 (3) | 17 (6.6) | 11 (5.9) | 1 (2.6) | 1 (6.7) | 1 (10) |
Insulins | 196 (29) | 147 (57.4) | 101 (54) | 10 (26.3) | 7 (46.7) | 5 (50) |
Number of Persons in Cohort | Number of Persons at Risk | Number of Events | Incidence Proportion (per 100 Persons) | |
---|---|---|---|---|
MDV | ||||
Hyperkalemia | 967 | 832 | 18 | 2.16 |
Hospitalization associated with hyperkalemia | 967 | 944 | 0 | 0 |
RWD Co. | ||||
Hyperkalemia | 62 | 37 | 1 | 2.70 |
Hospitalization associated with hyperkalemia | 62 | 48 | 0 | 0 |
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Sato, A.; Rodriguez-Molina, D.; Yoshikawa-Ryan, K.; Yamashita, S.; Okami, S.; Liu, F.; Farjat, A.; Oberprieler, N.G.; Kovesdy, C.P.; Kanasaki, K.; et al. Early Clinical Experience of Finerenone in People with Chronic Kidney Disease and Type 2 Diabetes in Japan—A Multi-Cohort Study from the FOUNTAIN (FinerenOne mUltidatabase NeTwork for Evidence generAtIoN) Platform. J. Clin. Med. 2024, 13, 5107. https://doi.org/10.3390/jcm13175107
Sato A, Rodriguez-Molina D, Yoshikawa-Ryan K, Yamashita S, Okami S, Liu F, Farjat A, Oberprieler NG, Kovesdy CP, Kanasaki K, et al. Early Clinical Experience of Finerenone in People with Chronic Kidney Disease and Type 2 Diabetes in Japan—A Multi-Cohort Study from the FOUNTAIN (FinerenOne mUltidatabase NeTwork for Evidence generAtIoN) Platform. Journal of Clinical Medicine. 2024; 13(17):5107. https://doi.org/10.3390/jcm13175107
Chicago/Turabian StyleSato, Atsuhisa, Daloha Rodriguez-Molina, Kanae Yoshikawa-Ryan, Satoshi Yamashita, Suguru Okami, Fangfang Liu, Alfredo Farjat, Nikolaus G. Oberprieler, Csaba P. Kovesdy, Keizo Kanasaki, and et al. 2024. "Early Clinical Experience of Finerenone in People with Chronic Kidney Disease and Type 2 Diabetes in Japan—A Multi-Cohort Study from the FOUNTAIN (FinerenOne mUltidatabase NeTwork for Evidence generAtIoN) Platform" Journal of Clinical Medicine 13, no. 17: 5107. https://doi.org/10.3390/jcm13175107