DAPA-CKD: A regional analysis of kidney and cardiovascular ...
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DAPA-CKD: A regional analysis of kidney and cardiovascular outcomes Ricardo Correa-Rotter 1 , Priya Vart 2 , Niels Jongs 2 , Fan Fan Hou 3 , Glenn M. Chertow 4 , Anna Maria Langkilde 5 , John J. V. McMurray 6 , Peter Rossing 7,8 , C. David Sjöström 5 , Bergur V. Stefansson 5 , Robert D. Toto 9 , Walter Douthat 10 , Elizabeth Escudero 11 , Rey Isidto 12 , Dinesh Khullar 13 , Harpreet S. Bajaj 14 , David C. Wheeler 15 , Hiddo J. L. Heerspink 2,16 1 The National Medical Science and Nutrition Institute Salvador Zubiran, Mexico City, Mexico; 2 University Medical Center Groningen, Groningen, Netherlands; 3 Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China; 4 Stanford University School of Medicine, Stanford, USA; 5 Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; 6 University of Glasgow, Glasgow, UK; 7 Steno Diabetes Center Copenhagen, Gentofte, Denmark; 8 University of Copenhagen, Copenhagen, Denmark; 9 UT Southwestern Medical Center, Dallas, USA; 10 Hospital Privado Universitario de Cordoba, Cordoba, Argentina; 11 Hospital Arzobispo Loayza, Cayetano Heredia University, Lima, Peru; 12 Healthlink Medical, Dental, Surgical Clinics and Diagnostics Center, Iloilo City, Philippines; 13 Max Super Speciality Hospital, Saket, New Delhi, India; 14 LMC Diabetes and Endocrinology, Brampton, Ontario, Canada; 15 University College London, London, UK; 16 The George Institute for Global Health, Sydney, Australia Methods PO2364 Presented at The American Society of Nephrology Kidney Week (ASN), Nov 4–7, 2021 Supported by: References 1. Heerspink HJL, et al. N Engl J Med. 2020;383:1436-1446. 2. Dewan P, et al. JACC Heart Fail. 2019;7:336-346. 3. Ferreira JP, et al. Am Heart J. 2019;218:66-74. Acknowledgments This study was funded by AstraZeneca. Editorial support was provided by Nicola Truss, inScience Communications, Springer Healthcare Ltd, UK, and was funded by AstraZeneca. Presenting Author Disclosures R Correa-Rotter is consultant and has received honoraria from AbbVie, AstraZeneca, GlaxoSmithKline, Medtronic, and Boehringer Ingelheim, and has lectured for Amgen, Janssen, Takeda, AstraZeneca, and Boehringer Ingelheim and has received research support from GlaxoSmithKline, Novo Nordisk and AstraZeneca. Conclusion Despite differences in participant characteristics, dapagliflozin reduced the risk of kidney and cardiovascular endpoints and all-cause mortality in participants with CKD, with and without type 2 diabetes, to a similar extent across all pre-specified geographic regions. Baseline characteristics by region • Of 4304 randomized participants, 1346 (31.3%) were in Asia, 1233 (28.6%) in Europe, 912 (21.2%) in Latin America, and 813 (18.9%) in North America. • There were some variations in the participants from difference regions (Table 1): – The mean age was lower among participants in Asia, and higher among participants in North America. – BMI was lowest in Asia and highest in North America. – eGFR was similar across regions, but UACR was lowest in North America. – In North America there was a higher proportion with type 2 diabetes. – The proportion with cardiovascular disease at baseline was lowest in Asia. Primary and secondary outcomes • Dapagliflozin consistently reduced the risk of the primary composite endpoint across the four regions by 30 to 49% (Figure 1). – There was no significant heterogeneity between regions (p=0.77). • There was no evidence of differences in secondary outcomes between regions (Figure 1). Safety • Serious adverse events were numerically less frequent in the dapagliflozin group, compared to the placebo group, within each region (Table 2). Study design • DAPA-CKD was a randomized, double-blind, placebo-controlled trial. 1 • Adults with baseline estimated glomerular filtration rate (eGFR) 25–75 mL/min/1.73m 2 and urinary albumin-to-creatinine ratio (UACR) 200–5000 mg/g, and who were receiving a stable dose of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, were randomized 1:1 to receive dapagliflozin 10mg or placebo once daily. • The study was conducted at 386 study sites in 21 countries, categorized into four broad geographic regions. Outcomes • The primary endpoint was a composite of the following: – Sustained ≥50% decline in eGFR (confirmed by a second serum creatinine after at least 28 days). – Onset of end-stage kidney disease (defined as maintenance dialysis for more than 28 days, kidney transplantation, or eGFR <15 mL/min/1.73 m 2 confirmed by a second measurement after at least 28 days). – Death from a kidney or cardiovascular cause. • Pre-specified secondary outcomes were, in hierarchal order: – A composite kidney endpoint, the same as the primary endpoint, but excluding death from cardiovascular causes. – A cardiovascular composite of hospitalization for heart failure or cardiovascular death. – All-cause mortality. • Time-to-event analyses using Cox proportional hazards models stratified by randomization factors (diabetes status and UACR) and adjusting for baseline eGFR, were used for the primary and secondary endpoints. Results Background • The DAPA-CKD trial demonstrated that dapagliflozin reduced the risk of kidney and cardiovascular events, and prolonged survival, in patients with chronic kidney disease (CKD), with and without type 2 diabetes. 1 • Regional differences in patient characteristics, comorbidities, and medical practice may result in differences in the efficacy and safety profile of a drug across regions. 2,3 • Here, we examined whether the effects of dapagliflozin varied by pre-specified geographic region. eGFR, estimated glomerular filtration rate; ESKD, end-stage kidney disease. 0.2 1 2 0.5 Dapagliflozin n/N Events/100 patient-years Placebo Hazard Ratio (95% CI) P Value for Interaction Primary outcome: eGFR decline ≥50%, ESKD, or kidney or cardiovascular death Overall Asia Europe Latin America North America 197/2152 50/692 57/610 55/449 35/401 312/2152 69/654 89/623 85/463 69/412 0.61 (0.51, 0.72) 0.70 (0.48, 1.00) 0.60 (0.43, 0.85) 0.61 (0.43, 0.86) 0.51 (0.34, 0.76) 0.77 4.6 4.2 4.4 5.8 4.2 7.5 6.3 6.7 9.0 8.5 Secondary outcome: eGFR decline ≥50%, ESKD, or kidney death Overall Asia Europe Latin America North America 142/2152 41/692 38/610 39/449 24/401 243/2152 62/654 61/623 70/463 50/412 0.56 (0.45, 0.68) 0.64 (0.43, 0.95) 0.55 (0.37, 0.83) 0.52 (0.35, 0.77) 0.48 (0.29, 0.78) 0.91 3.3 3.5 2.9 4.1 2.9 5.8 5.7 4.6 7.4 6.1 Secondary outcome: Heart failure hospitalization or cardiovascular death Overall Asia Europe Latin America North America 100/2152 14/692 33/610 25/449 28/401 138/2152 17/654 59/623 24/463 38/412 0.71 (0.55, 0.92) 0.77 (0.38, 1.57) 0.57 (0.37, 0.87) 1.04 (0.59, 1.82) 0.73 (0.45, 1.20) 0.39 2.2 1.1 2.4 2.4 3.0 3.0 1.4 4.2 2.3 4.2 Secondary outcome: All-cause mortality Overall Asia Europe Latin America North America 101/2152 16/692 32/610 30/449 23/401 146/2152 20/654 46/623 45/463 35/412 0.69 (0.53, 0.88) 0.75 (0.39, 1.46) 0.71 (0.45, 1.11) 0.67 (0.42, 1.07) 0.65 (0.38, 1.10) 0.99 2.2 1.2 2.3 2.9 2.5 3.1 1.7 3.2 4.2 3.7 Dapagliflozin Placebo Placebo better Dapagliflozin better *Reported by the investigator, “other” includes Native Hawaiian or other Pacific Islander, American Indian or Alaska Native, and other; † In patients with type 2 diabetes at baseline. ACE, angiotensin-converting enzyme; ARB, angiotensin receptor blocker; BMI, body mass index; CV, cardiovascular; DPP4, dipeptidylpeptidase-4; eGFR, estimated glomerular filtration rate; UACR, urinary albumin-to-creatinine ratio. *Includes death. Table 2. Safety Outcomes Figure 1. Pre-specified outcomes by region Table 1. Characteristics of the participants at baseline according to region and randomized treatment assignment Outcome, n/N (%) Dapagliflozin Placebo Discontinuation due to adverse event Asia 33/690 (4.8) 35/654 (5.3) Europe 35/609 (5.7) 36/620 (5.8) Latin America 23/449 (5.1) 29/463 (6.3) North America 27/401 (6.7) 23/412 (5.6) Any serious adverse event* Asia 151/690 (21.9) 175/654 (26.8) Europe 208/609 (34.1) 239/620 (38.6) Latin America 134/449 (29.8) 146/463 (31.5) North America 140/401 (34.9) 169/412 (41.0) Asia (N=1346) Europe (N=1233) Latin America (N=912) North America (N=813) Dapagliflozin Placebo Dapagliflozin Placebo Dapagliflozin Placebo Dapagliflozin Placebo (n=692) (n=654) (n=610) (n=623) (n=449) (n=463) (n=401) (n=412) Age, years, mean (SD) 59.0 (12.5) 59.1 (12.8) 61.8 (12.3) 62.1 (11.7) 62.6 (10.8) 63.1 (11.5) 65.8 (11.0) 64.6 (11.6) Female sex, n (%) 240 (34.7) 222 (33.9) 186 (30.5) 198 (31.8) 158 (35.2) 169 (36.5) 125 (31.2) 127 (30.8) Race,* n (%) White 0 0 594 (97.4) 610 (97.9) 249 (55.5) 265 (57.2) 281 (70.1) 291 (70.6) Black or African American 0 0 2 (0.3) 4 (0.6) 33 (7.3) 24 (5.2) 69 (17.2) 59 (14.3) Asian 692 (100) 654 (100) 12 (2.0) 7 (1.1) 4 (0.9) 7 (1.5) 41 (10.2) 50 (12.1) Other 0 0 2 (0.3) 2 (0.3) 163 (36.3) 167 (36.1) 10 (2.5) 12 (2.9) BMI, kg/m 2 , mean (SD) 25.7 (4.1) 25.5 (4.2) 30.8 (5.6) 31.5 (5.8) 29.8 (5.2) 29.9 (5.6) 33.2 (7.0) 33.2 (6.9) Current Smoker, n (%) 111 (16.0) 102 (15.6) 93 (15.2) 100 (16.0) 35 (7.8) 56 (12.1) 44 (11.0) 43 (10.4) Blood pressure, mmHg, mean (SD) Systolic 132.5 (16.5) 133.2 (15.7) 138.9 (16.1) 140 (16.7) 140.5 (19.2) 141.8 (19.7) 136.6 (17.7) 134.9 (15.8) Diastolic 77.1 (11.3) 77.8 (10.6) 79.1 (9.8) 78.8 (9.6) 78.4 (10.5) 78.3 (11.0) 74.8 (10.4) 74.2 (9.2) eGFR, mL/min/1.73m 2 , mean (SD) 42.4 (11.1) 41.9 (11.3) 43.7 (12.4) 44.1 (12.5) 44.3 (13.8) 43.7 (13.4) 42.7 (12.2) 42.2 (12.5) Median UACR, mg/g (IQR) 984 (493–1854) 930 (492–1895) 1043 (467–1821) 914 (488–1608) 1089 (499–2273) 1061 (496–2099) 770 (412–1554) 869 (449–1915) Type 2 diabetes, n (%) 438 (63.3) 403 (61.6) 367 (60.2) 404 (64.8) 342 (76.2) 329 (71.1) 308 (76.8) 315 (76.5) HbA1c, %, mean (SD) 6.9 (1.7) 6.8 (1.6) 6.8 (1.5) 6.9 (1.6) 7.6 (2.0) 7.4 (2.0) 7.3 (1.7) 7.2 (1.6) Duration of diabetes, years, median (IQR) 10.4 (5.7–17.3) 10.8 (5.6–19.1) 13.7 (7.3–19.3) 13.0 (7.4–20.4) 17.5 (9.7–24.7) 16.4 (9.4–22.9) 16.0 (8.2–22.5) 15.6 (8.9–22.1) Cardiovascular disease, n (%) 165 (23.8) 157 (24.0) 307 (50.3) 288 (46.2) 167 (37.2) 173 (37.4) 174 (43.4) 179 (43.4) Baseline medication, n (%) ACE inhibitor/ARB 678 (98.0) 637 (97.4) 606 (99.3) 614 (98.6) 44 (98.9) 459 (99.1) 384 (95.8) 387 (93.9) Diuretic 152 (22.0) 149 (22.8) 329 (53.9) 341 (54.7) 223 (49.7) 235 (50.8) 224 (55.9) 229 (55.6) Insulin † 205 (46.8) 183 (45.4) 194 (52.9) 213 (52.7) 227 (66.4) 186 (56.5) 188 (61.0) 202 (64.1) DPP4 inhibitor † 160 (36.5) 167 (41.4) 81 (22.1) 82 (20.3) 45 (13.2) 55 (16.7) 78 (25.3) 74 (23.5) Biguanides † 144 (32.9) 120 (29.8) 178 (48.5) 202 (50.0) 187 (54.7) 167 (50.8) 122 (39.6) 124 (39.4)
Transcript of DAPA-CKD: A regional analysis of kidney and cardiovascular ...
DAPA-CKD: A regional analysis of kidney and cardiovascular outcomesRicardo Correa-Rotter1, Priya Vart2, Niels Jongs2, Fan Fan Hou3, Glenn M. Chertow4, Anna Maria Langkilde5, John J. V. McMurray6, Peter Rossing7,8, C. David Sjöström5, Bergur V. Stefansson5, Robert D. Toto9, Walter Douthat10, Elizabeth Escudero11, Rey Isidto12, Dinesh Khullar13, Harpreet S. Bajaj14, David C. Wheeler15, Hiddo J. L. Heerspink2,16
1The National Medical Science and Nutrition Institute Salvador Zubiran, Mexico City, Mexico; 2University Medical Center Groningen, Groningen, Netherlands; 3Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China; 4Stanford University School of Medicine, Stanford, USA; 5Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; 6University of Glasgow, Glasgow, UK; 7Steno Diabetes Center Copenhagen, Gentofte, Denmark; 8University of Copenhagen, Copenhagen, Denmark; 9UT Southwestern Medical Center, Dallas, USA; 10Hospital Privado Universitario de Cordoba, Cordoba, Argentina; 11Hospital Arzobispo Loayza, Cayetano Heredia University, Lima, Peru; 12Healthlink Medical, Dental, Surgical Clinics and Diagnostics Center, Iloilo City, Philippines; 13Max Super Speciality Hospital, Saket, New Delhi, India; 14LMC Diabetes and Endocrinology, Brampton, Ontario, Canada; 15University College London, London, UK; 16The George Institute for Global Health, Sydney, Australia
Methods
PO2364
Presented at The American Society of Nephrology Kidney Week (ASN), Nov 4–7, 2021Supported by:
References1. Heerspink HJL, et al. N Engl J Med. 2020;383:1436-1446.2. Dewan P, et al. JACC Heart Fail. 2019;7:336-346.3. Ferreira JP, et al. Am Heart J. 2019;218:66-74.
AcknowledgmentsThis study was funded by AstraZeneca. Editorial support was provided by Nicola Truss, inScience Communications, Springer Healthcare Ltd, UK, and was funded by AstraZeneca.
Presenting Author DisclosuresR Correa-Rotter is consultant and has received honoraria from AbbVie, AstraZeneca, GlaxoSmithKline, Medtronic, and Boehringer Ingelheim, and has lectured for Amgen, Janssen, Takeda, AstraZeneca, and Boehringer Ingelheim and has received research support from GlaxoSmithKline, Novo Nordisk and AstraZeneca.
Conclusion
Despite differences in participant characteristics, dapagliflozin reduced the risk of kidney and cardiovascular endpoints and all-cause mortality in participants with CKD, with and without type 2 diabetes, to a similar extent across all pre-specified geographic regions.
Baseline characteristics by region• Of 4304 randomized participants, 1346 (31.3%) were in Asia, 1233
(28.6%) in Europe, 912 (21.2%) in Latin America, and 813 (18.9%) in North America.
• There were some variations in the participants from difference regions (Table 1):
– The mean age was lower among participants in Asia, and higher among participants in North America.
– BMI was lowest in Asia and highest in North America. – eGFR was similar across regions, but UACR was lowest in
North America. – In North America there was a higher proportion with type 2 diabetes. – The proportion with cardiovascular disease at baseline was lowest
in Asia.
Primary and secondary outcomes• Dapagliflozin consistently reduced the risk of the primary
composite endpoint across the four regions by 30 to 49% (Figure 1).
– There was no significant heterogeneity between regions (p=0.77).
• There was no evidence of differences in secondary outcomes between regions (Figure 1).
Safety• Serious adverse events were numerically less frequent in the
dapagliflozin group, compared to the placebo group, within each region (Table 2).Study design
• DAPA-CKD was a randomized, double-blind, placebo-controlled trial.1
• Adults with baseline estimated glomerular filtration rate (eGFR) 25–75 mL/min/1.73m2 and urinary albumin-to-creatinine ratio (UACR) 200–5000 mg/g, and who were receiving a stable dose of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, were randomized 1:1 to receive dapagliflozin 10mg or placebo once daily.
• The study was conducted at 386 study sites in 21 countries, categorized into four broad geographic regions.
Outcomes• The primary endpoint was a composite of the following: – Sustained ≥50% decline in eGFR (confirmed by a second serum
creatinine after at least 28 days). – Onset of end-stage kidney disease (defined as maintenance
dialysis for more than 28 days, kidney transplantation, or eGFR <15 mL/min/1.73 m2 confirmed by a second measurement after at least 28 days).
– Death from a kidney or cardiovascular cause.
• Pre-specified secondary outcomes were, in hierarchal order: – A composite kidney endpoint, the same as the primary endpoint,
but excluding death from cardiovascular causes. – A cardiovascular composite of hospitalization for heart failure or
cardiovascular death. – All-cause mortality.
• Time-to-event analyses using Cox proportional hazards models stratified by randomization factors (diabetes status and UACR) and adjusting for baseline eGFR, were used for the primary and secondary endpoints.
ResultsBackground• The DAPA-CKD trial demonstrated that dapagliflozin reduced the risk
of kidney and cardiovascular events, and prolonged survival, in patients with chronic kidney disease (CKD), with and without type 2 diabetes.1
• Regional differences in patient characteristics, comorbidities, and medical practice may result in differences in the efficacy and safety profile of a drug across regions.2,3
• Here, we examined whether the effects of dapagliflozin varied by pre-specified geographic region.
eGFR, estimated glomerular filtration rate; ESKD, end-stage kidney disease.
0.2 1 20.5
Dapagliflozinn/N Events/100 patient-years
Placebo Hazard Ratio(95% CI)
P Valuefor Interaction
Primary outcome: eGFR decline ≥50%, ESKD, or kidney or cardiovascular deathOverall Asia Europe Latin America North America
197/215250/69257/61055/44935/401
312/215269/65489/62385/46369/412
0.61 (0.51, 0.72)0.70 (0.48, 1.00)0.60 (0.43, 0.85)0.61 (0.43, 0.86)0.51 (0.34, 0.76)
0.77
4.64.24.45.84.2
7.56.36.79.08.5
Secondary outcome: eGFR decline ≥50%, ESKD, or kidney deathOverall Asia Europe Latin America North America
142/215241/69238/61039/44924/401
243/215262/65461/62370/46350/412
0.56 (0.45, 0.68)0.64 (0.43, 0.95)0.55 (0.37, 0.83)0.52 (0.35, 0.77)0.48 (0.29, 0.78)
0.91
3.33.52.94.12.9
5.85.74.67.46.1
Secondary outcome: Heart failure hospitalization or cardiovascular death Overall Asia Europe Latin America North America
100/215214/69233/61025/44928/401
138/215217/65459/62324/46338/412
0.71 (0.55, 0.92)0.77 (0.38, 1.57)0.57 (0.37, 0.87)1.04 (0.59, 1.82)0.73 (0.45, 1.20)
0.39
2.21.12.42.43.0
3.01.44.22.34.2
Secondary outcome: All-cause mortalityOverall Asia Europe Latin America North America
101/215216/69232/61030/44923/401
146/215220/65446/62345/46335/412
0.69 (0.53, 0.88)0.75 (0.39, 1.46)0.71 (0.45, 1.11)0.67 (0.42, 1.07)0.65 (0.38, 1.10)
0.99
2.21.22.32.92.5
3.11.73.24.23.7
Dapagliflozin Placebo
Placebo betterDapagliflozin better
*Reported by the investigator, “other” includes Native Hawaiian or other Pacific Islander, American Indian or Alaska Native, and other; †In patients with type 2 diabetes at baseline.ACE, angiotensin-converting enzyme; ARB, angiotensin receptor blocker; BMI, body mass index; CV, cardiovascular; DPP4, dipeptidylpeptidase-4; eGFR, estimated glomerular filtration rate; UACR, urinary albumin-to-creatinine ratio.
*Includes death.
Table 2. Safety Outcomes
Figure 1. Pre-specified outcomes by region
Table 1. Characteristics of the participants at baseline according to region and randomized treatment assignment
Outcome, n/N (%) Dapagliflozin Placebo
Discontinuation due to adverse event
Asia 33/690 (4.8) 35/654 (5.3)
Europe 35/609 (5.7) 36/620 (5.8)
Latin America 23/449 (5.1) 29/463 (6.3)
North America 27/401 (6.7) 23/412 (5.6)
Any serious adverse event*
Asia 151/690 (21.9) 175/654 (26.8)
Europe 208/609 (34.1) 239/620 (38.6)
Latin America 134/449 (29.8) 146/463 (31.5)
North America 140/401 (34.9) 169/412 (41.0)
Asia (N=1346) Europe (N=1233) Latin America (N=912) North America (N=813)
Dapagliflozin Placebo Dapagliflozin Placebo Dapagliflozin Placebo Dapagliflozin Placebo (n=692) (n=654) (n=610) (n=623) (n=449) (n=463) (n=401) (n=412)
Age, years, mean (SD) 59.0 (12.5) 59.1 (12.8) 61.8 (12.3) 62.1 (11.7) 62.6 (10.8) 63.1 (11.5) 65.8 (11.0) 64.6 (11.6)
Female sex, n (%) 240 (34.7) 222 (33.9) 186 (30.5) 198 (31.8) 158 (35.2) 169 (36.5) 125 (31.2) 127 (30.8)
Race,* n (%)
White 0 0 594 (97.4) 610 (97.9) 249 (55.5) 265 (57.2) 281 (70.1) 291 (70.6)
Black or African American 0 0 2 (0.3) 4 (0.6) 33 (7.3) 24 (5.2) 69 (17.2) 59 (14.3)
Asian 692 (100) 654 (100) 12 (2.0) 7 (1.1) 4 (0.9) 7 (1.5) 41 (10.2) 50 (12.1)
Other 0 0 2 (0.3) 2 (0.3) 163 (36.3) 167 (36.1) 10 (2.5) 12 (2.9)
BMI, kg/m2, mean (SD) 25.7 (4.1) 25.5 (4.2) 30.8 (5.6) 31.5 (5.8) 29.8 (5.2) 29.9 (5.6) 33.2 (7.0) 33.2 (6.9)
Current Smoker, n (%) 111 (16.0) 102 (15.6) 93 (15.2) 100 (16.0) 35 (7.8) 56 (12.1) 44 (11.0) 43 (10.4)
Blood pressure, mmHg, mean (SD)
Systolic 132.5 (16.5) 133.2 (15.7) 138.9 (16.1) 140 (16.7) 140.5 (19.2) 141.8 (19.7) 136.6 (17.7) 134.9 (15.8)
Diastolic 77.1 (11.3) 77.8 (10.6) 79.1 (9.8) 78.8 (9.6) 78.4 (10.5) 78.3 (11.0) 74.8 (10.4) 74.2 (9.2)
eGFR, mL/min/1.73m2, mean (SD) 42.4 (11.1) 41.9 (11.3) 43.7 (12.4) 44.1 (12.5) 44.3 (13.8) 43.7 (13.4) 42.7 (12.2) 42.2 (12.5)
Median UACR, mg/g (IQR) 984 (493–1854) 930 (492–1895) 1043 (467–1821) 914 (488–1608) 1089 (499–2273) 1061 (496–2099) 770 (412–1554) 869 (449–1915)
Type 2 diabetes, n (%) 438 (63.3) 403 (61.6) 367 (60.2) 404 (64.8) 342 (76.2) 329 (71.1) 308 (76.8) 315 (76.5)
HbA1c, %, mean (SD) 6.9 (1.7) 6.8 (1.6) 6.8 (1.5) 6.9 (1.6) 7.6 (2.0) 7.4 (2.0) 7.3 (1.7) 7.2 (1.6)
Duration of diabetes, years, median (IQR) 10.4 (5.7–17.3) 10.8 (5.6–19.1) 13.7 (7.3–19.3) 13.0 (7.4–20.4) 17.5 (9.7–24.7) 16.4 (9.4–22.9) 16.0 (8.2–22.5) 15.6 (8.9–22.1)
Cardiovascular disease, n (%) 165 (23.8) 157 (24.0) 307 (50.3) 288 (46.2) 167 (37.2) 173 (37.4) 174 (43.4) 179 (43.4)
Baseline medication, n (%)
ACE inhibitor/ARB 678 (98.0) 637 (97.4) 606 (99.3) 614 (98.6) 44 (98.9) 459 (99.1) 384 (95.8) 387 (93.9)
Diuretic 152 (22.0) 149 (22.8) 329 (53.9) 341 (54.7) 223 (49.7) 235 (50.8) 224 (55.9) 229 (55.6)
Insulin† 205 (46.8) 183 (45.4) 194 (52.9) 213 (52.7) 227 (66.4) 186 (56.5) 188 (61.0) 202 (64.1)
DPP4 inhibitor† 160 (36.5) 167 (41.4) 81 (22.1) 82 (20.3) 45 (13.2) 55 (16.7) 78 (25.3) 74 (23.5)
Biguanides† 144 (32.9) 120 (29.8) 178 (48.5) 202 (50.0) 187 (54.7) 167 (50.8) 122 (39.6) 124 (39.4)
