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Table 1 Demographic and clinical characteristics of adults (< 75 years) and older adults (≥ 75 years) treated with SGLT2-inhibitors in the FAERS

From: The real-world safety profile of sodium-glucose co-transporter-2 inhibitors among older adults (≥ 75 years): a retrospective, pharmacovigilance study

 

ALL (24,253)

Adults (21,914)

Older adults (2339)

Region

 

Americasa

16,427/23,647 (69.4)

15,134/21,338 (70.9)

1,284/2,309 (55.3)

Europe

3,972/23,647 (16.7)

3,511/21,338 (16.4)

461/2,309 (19.9)

Asia

2,758/23,647 (11.7)

2,262/21,338 (10.6)

496/2,309(21.4)

Africa

61/23,647 (0.3)

59/21,338 (0.3)

2/2,309 (0.1)

Australia

438/23,647 (1.9)

372/21,338 (1.8)

66/2,309 (3.3)

Reporter

 

Health professional

12,882/23,100 (55.8)

11,412/20,878 (54.7)

1,470/2,222 (66.2)

Patient/lawyer

10,218/23,100 (44.2)

9,466/20,878 (43.2)

752/2,222 (33.8)

Year of report

 

2014b

652/24,253 (2.7)

603/21,914 (2.8)

49/2,339 (2.1)

2015

3,465/24,253 (14.3)

3,157/21,914 (14.4)

308/2,339 (13.2)

2016

2,747/24,253 (11.3)

2,490/21,914 (11.4)

257/2,339 (11.0)

2017

3,057/24,253 (12.6)

2,775/21,914 (12.7)

282/2,339 (12.1)

2018

5,426/24,253 (22.4)

5,044/21,914 (23.0)

382/2,339 (16.3)

2019

4,038/24,253 (16.6)

3,619/21,914 (16.5)

419/2,339 (17.9)

2020

3,201/24,253 (13.2)

2,790/21,914 (12.7)

411/2,339 (17.6)

2021

1,667/24,253 (6.9)

1,436/21,914 (6.6)

231/2,339 (9.9)

Medication

 

Canagliflozin

10,872/24,253 (44.8)

10,115/21,914 (46.2)

757/2,339 (32.4)

Dapagliflozin

5,099/24,253 (21.0)

4,560/21,914 (20.8)

539/2,339 (23.0)

Empagliflozin

8,112/24,253 (33.4)

7,078/21,914 (32.3)

1,034/2,339 (44.2)

Ertugliflozin

170/24,253 (0.7)

161/21,914 (0.7)

9/2,339 (0.4)

Age, years

 

Median (IQR)

60 (51–68)

58 (50–65)

79 (76–82)

Sex

 

Females

10,885/24,006 (45.3)

9,819/21,695 (45.3)

1,066/2,311 (46.1)

Males

13,121/24,006 (54.7)

11,876/21,695 (54.7)

1,245/2,311 (53.9)

Concomitant drugs

   

Metformin

9,480 (39.1)

8,655 (39.5)

825 (35.3)

GLP-1-agonists / DPP-4 inhibitors

4,895 (20.2)

4,274 (19.5)

621 (26.6)

Sulfonylureas

2,718 (11.2)

2,359 (10.8)

359 (15.4)

ACE inhibitors / ARBs

4,208 (17.4)

3,686 (16.8)

522 (22.3)

Diureticsc

1,529 (6.3)

1,280 (5.8)

249 (10.7)

Beta-blockers

1,697 (7.0)

1,422 (6.5)

275 (11.8)

Steroids

541 (2.2)

454 (2.1)

87 (3.7)

Stains

4,051 (16.7)

3,530 (16.1)

521 (22.3)

PPI

1,518 (6.3)

1,269 (5.8)

249 (10.7)

  1. Values are n/N (%) unless otherwise specified. a. Americas category includes north and south America; Out of 16,427 recipients of SGLT2-inhibitors from the Americas, 15,158 were from the United States (14,022 adults and 1,136 older adults). b. Only reports from July to December were included. c. Including loop diuretics, thiazides, and aldosterone antagonists. ACE inhibitors- angiotensin-converting enzyme inhibitors; ARBs- angiotensin II receptor blockers; DPP-4- dipeptidyl peptidase-4; FAERS- FDA adverse event reporting system; GLP1- glucagon-like peptide 1; IQR- interquartile range; PPI- proton pump inhibitors; SGLT2- sodium-glucose co-transporter-2
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Cardiovascular Diabetology

ISSN: 1475-2840