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Table 1 Demographic parameters, comorbidities and reported seriousness criteria in younger adults, older adults and stratified age groups

From: Adverse drug reactions in older adults: a retrospective comparative analysis of spontaneous reports to the German Federal Institute for Drugs and Medical Devices

 

Younger adults (19–65)

(n = 111,463)

Older adults (>  65)

(n = 69,914)

OR older adults (>  65) vs. younger adults (19–65)

[+/− adj. CI]

Patients aged 66–75

(n = 37,370)

OR patients aged 66–75 vs. younger adults

[+/− adj. CI]

Patients aged 76–85

(n = 24,149)

OR patients aged 76–85 vs. younger adults [+/− adj. CI]

Patients aged ≥86

(n = 5649)

OR patients aged ≥86 vs. younger adults [+/− adj. CI]

Demographic parameters

 mean age (+/− SD) [years]b

46.4 (+/−  12.8)

75.4 (+/−7.2)

–

70.5 (+/−  2.8)

–

79.7 (+/−  2.7)

–

89.1 (+/−  2.9)

–

 median, [IQR] [years]b

48 [37–57]

75 [70–80]

–

70 [68–73]

–

79 [77–82]

–

88 [87–91]

–

 female

60.3% (67,249)

55.9% (39,065)

0.8 [0.8–0.9]a

52.8% (19,731)

0.7 [0.7–0.8]a

58.2% (14,049)

0.9 [0.9–0.9]a

68.3% (3861)

1.4 [1.3–1.5]a

 male

38.4% (42,824)

43.2% (30,230)

 

46.4% (17,355)

 

41.0% (9907)

 

30.9% (1744)

 

 unknown

1.2% (1390)

0.9% (619)

 

0.8% (284)

 

0.8% (193)

 

0.8% (44)

 

Reported patients’ history

 hypertensionc

9.2% (10,302)

24.5% (17,105)

3.2 [3.1–3.3]a

22.8% (8538)

2.9 [2.8–3.1]a

27.5% (6652)

3.7 [3.5–3.9]a

28.0% (1583)

3.8 [3.5–4.2]a

 cardiac disordersd

7.3% (8180)

24.5% (17,163)

4.1 [3.9–4.3]a

20.8% (7776)

3.3 [3.2–3.5]a

29.5% (7115)

5.3 [5.0–5.6]a

33.6% (1898)

6.4 [5.8–7.0]a

 diabetes e

4.3% (4830)

11.2% (7837)

2.8 [2.6–3.0]a

10.8% (4047)

2.7 [2.5–2.9]a

12.5% (3012)

3.2 [2.9–3.4]a

11.4% (643)

2.8 [2.5–3.3]a

 renal disordersf

2.8% (3138)

8.9% (6224)

3.4 [3.2–3.6]a

7.1% (2670)

2.7 [2.4–2.9]a

11.0% (2646)

4.3 [3.9–4.6]a

13.4% (759)

5.4 [4.7–6.1]a

 hepatic impairmentsg

3.3% (3669)

2.5% (1765)

0.8 [0.7–0.8]a

2.9% (1068)

0.9 [0.8–1.0]

2.4% (569)

0.7 [0.6–0.8]a

1.6% (90)

0.5 [0.3–0.7]a

Reported seriousness criteriah

 serious

78.9% (87,954)

83.9% (58,681)

1.4 [1.3–1.5]a

82.1% (30,669)

1.2 [1.2–1.3]a

84.8% (20,482)

1.5 [1.4–1.6]a

88.2% (4982)

2.0 [1.8–2.3]a

 death

3.4% (3755)

9.1% (6340)

2.9 [2.7–3.0]a

6.9% (2595)

2.1 [2.0–2.3]a

10.6% (2570)

3.4 [3.2–3.7]a

15.7% (886)

5.3 [4.7–6.0]a

 hospitalization

32.7% (36,460)

40.2% (28,094)

1.4 [1.3–1.4]a

37.8% (14,131)

1.3 [1.2–1.3]a

43.4% (10,490)

1.6 [1.5–1.7]a

46.1% (2603)

1.8 [1.6–1.9]a

 life-threatening

8.2% (9171)

11.9% (8332)

1.5 [1.4–1.6]a

11.3% (4223)

1.4 [1.3–1.5]a

13.1% (3172)

1.7 [1.6–1.8]a

14.6% (825)

1.9 [1.7–2.1]a

 disabling

2.7% (3020)

3.0% (2118)

1.1 [1.0–1.2]

3.2% (1179)

1.2 [1.1–1.3]a

3.0% (731)

1.1 [1.0–1.3]

2.7% (151)

1.0 [0.8–1.3]

  1. a: OR = 1 is not included; OR > 1 reported more often in older adults or the stratified age groups; OR < 1 reported more often in younger adults
  2. b in some cases only the age group (e.g. 7. decade; older adults (> 65)) and not the exact age of the patient was reported. If so, these patients were not included in the calculation of the average and median age for older adults, younger adults, and stratified age groups
  3. c) -g) suitable hierarchical levels of the MedDRA terminology were chosen for the analysis of the reported patients’ history [25]. c) High Level Group Term vascular hypertensive disorder; d) System organ class cardiac disorders; e) High level term diabetes mellitus including subtypes; f) High Level Group Term renal disorders exclusive nephropathies; g) High Level Group Term hepatic and hepatobiliary disorders
  4. h according to the legal definition an ADR was considered serious if it led to death, was life-threatening, required or prolonged hospitalisation, resulted in persistent or significant disabilities, and/or was a congenital anomaly/birth defect [42]
  5. Table 1 shows the absolute numbers of ADR reports and the calculated odds ratios with Bonferroni adjusted confidence intervals for the demographic parameters, the reported comorbidities and the reported seriousness criteria of the patients. The dataset younger adults served as a reference for the calculation of the odds ratios. One ADR report may inform about more than one comorbidity and seriousness criteria. Hence, the number of reported comorbidities and seriousness criteria may exceed the number of ADR reports
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BMC Pharmacology and Toxicology

ISSN: 2050-6511

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