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Table 3 Summary of overall safety and selected AEs *

From: Efficacy and safety of canagliflozin compared with placebo in older patients with type 2 diabetes mellitus: a pooled analysis of clinical studies

 

Patients <65 y, n (%)

Patients ≥65 y, n (%)

PBO

CANA 100 mg

CANA 300 mg

PBO

CANA 100 mg

CANA 300 mg

(n = 509)

(n = 674)

(n = 685)

(n = 137)

(n = 159)

(n = 149)

Any AE

300 (58.9)

404 (59.9)

404 (59.0)

84 (61.3)

97 (61.0)

90 (60.4)

AEs leading to discontinuation

14 (2.8)

22 (3.3)

22 (3.2)

6 (4.4)

14 (8.8)

8 (5.4)

AEs related to study drug†

66 (13.0)

136 (20.2)

155 (22.6)

19 (13.9)

35 (22.0)

36 (24.2)

Serious AEs

17 (3.3)

17 (2.5)

17 (2.5)

5 (3.6)

11 (6.9)

5 (3.4)

Deaths

1 (0.2)

1 (0.1)

1 (0.1)

1 (0.7)

0

0

Selected AEs

      

  UTI

20 (3.9)

41 (6.1)

29 (4.2)

6 (4.4)

8 (5.0)

7 (4.7)

  Genital mycotic infection

      

   Male‡,§

2 (0.8)

14 (4.3)

11 (3.4)

0

3 (3.7)

4 (5.2)

   Female||,¶

10 (4.1)

37 (10.7)

44 (12.3)

0

7 (9.0)

5 (6.9)

  Osmotic diuresis-related AEs#

4 (0.8)

44 (6.5)

39 (5.7)

1 (0.7)

12 (7.5)

8 (5.4)

  Volume depletion-related AEs**

5 (1.0)

6 (0.9)

8 (1.2)

2 (1.5)

4 (2.5)

3 (2.0)

  Renal-related AEs††

2 (0.4)

2 (0.3)

12 (1.8)

2 (1.5)

3 (1.9)

2 (1.3)

  1. AE, adverse event; PBO, placebo; CANA, canagliflozin; UTI, urinary tract infection.
  2. *All AEs are reported for regardless of rescue medication; hypoglycaemia episodes are reported for prior to rescue medication.
  3. †Possibly, probably, or very likely related to study drug, as assessed by investigators.
  4. ‡For patients <65 years: PBO, n = 263; CANA 100 mg, n = 327; CANA 300 mg, n = 327; for patients ≥65 years: PBO, n = 71; CANA 100 mg, n = 81; CANA 300 mg, n = 77.
  5. §Reported terms included balanitis, balanitis candida, balanoposthitis, and genital infection fungal in both age groups.
  6. ||For patients <65 years: PBO, n = 246; CANA 100 mg, n = 347; CANA 300 mg, n = 358; for patients ≥65 years: PBO, n = 66; CANA 100 mg, n = 78; CANA 300 mg, n = 72.
  7. Reported terms included vaginal infection, vulvovaginal candidiasis, vulvovaginal mycotic infection, and vulvovaginitis in both age groups, and genital infection fungal and vulvitis in patients aged <65 years.
  8. #Reported terms included micturition urgency, nocturia, pollakiuria, polyuria, dry mouth, polydipsia, and thirst in both age groups, and urine output increased in patients aged <65 years.
  9. **Reported terms included dizziness postural, hypotension, and orthostatic hypotension in both age groups, and dehydration and syncope in patients aged <65 years.
  10. ††Reported terms included blood creatinine increased, glomerular filtration rate decreased, and renal impairment in both age groups, and renal failure acute in patients aged <65 years.
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BMC Endocrine Disorders

ISSN: 1472-6823

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