Table 3. BfArM’s ADR-database analysis: Stratified analysis of anatomical areas affected by ACEi-associated angioedemas.
| tongue a | lips a | face a | pharynx a | neck/throat a | cheek a | glottis a | eye/eyelid a | |
|---|---|---|---|---|---|---|---|---|
| 41.3% | 28.1% | 20.6% | 13.2% | 12.4% | 10.7% | 9.1% | 7.4% | |
| (n = 50) | (n = 34) | (n = 25) | (n = 16) | (n = 15) | (n = 13) | (n = 11) | (n = 9) | |
| patient demographics | ||||||||
| mean age (median) [years] | 66.0 (70) | 64.9 (68.5) | 65.7 (69) | 66.6 (68.5) | 66.1 (69) | 65.4 (69) | 65 (67) | 57.8 (61) |
| female | 46.0% (23) | 32.4% (11) | 64.0% (16) | 31.3% (5) | 40.0% (6) | 30.8% (4) | 36.4% (4) | 77.8% (7) |
| male | 54.0% (27) | 67.6% (23) | 36.0% (9) | 68.8% (11) | 60.0% (9) | 69.2% (9) | 63.6% (7) | 22.2% (2) |
| smoking habits, allergic conditions | ||||||||
| smoker b | 26.0% (13) | 5.9% (2) | 12.0% (3) | 12.5% (2) | 13.3% (2) | 7.7% (1) | 36.4% (4) | 11.1% (1) |
| allergy c | 8.0% (4) | 20.6% (7) | 16.0% (4) | 6.3% (1) | 13.3% (2) | 7.7% (1) | 0.0% (0) | 33.3% (3) |
| angioedema d | 16.0% (32) | 44.1% (15) | 32.0% (8) | 18.8% (3) | 33.3% (5) | 30.8% (4) | 45.5% (5) | 44.4% (4) |
| asthma/COPD e | 10.0% (5) | 14.7% (5) | 8.0% (2) | 6.3% (1) | 6.7% (1) | 7.7% (1) | 0.0% (0) | 22.2% (2) |
| comedication | ||||||||
| everolimus | 8.0% (4) | 8.8% (3) | 16.0% (4) | 6.3% (1) | 0.0% (0) | 15.4% (2) | 0.0% (0) | 11.1% (1) |
| alteplase | 2.0% (1) | 0.0% (0) | 0.0% (0) | 0.0% (0) | 0.0% (0) | 0.0% (0) | 0.0% (0) | 0.0% (0) |
| reported attendant reactions | ||||||||
| urticaria f | 0.0% (0) | 8.8% (3) | 4.0% (1) | 0.0% (0) | 0.0 (0) | 0.0 (0) | 18.2% (1) | 0.0 (0) |
| pruritus h | 0.0% (0) | 14.7% (5) | 16.0% (4) | 0.0% (0) | 6.7% (1) | 7.7% (1) | 0.0 (0) | 33.3% (3) |
| seriousness criteria i | ||||||||
| serious | 92.0% (46) | 91.2% (31) | 92.0% (23) | 100.0% (16) | 93.3% (14) | 92.3% (12) | 100.0% (11) | 77.8% (7) |
| death | 6.0% (3) | 2.9% (1) | 0.0% (0) | 12.5% (2) | 13.3% (2) | 0.0% (0) | 18.2% (1) | 0.0% (0) |
| life-threatening | 48.0% (24) | 8.8% (3) | 32.0% (8) | 43.8% (7) | 46.7% 7) | 23.1 (3) | 54.5% (6) | 11.1% (1) |
| hospitalization | 54.0% (27) | 32.4% (11) | 40.0% (10) | 68.8% (11) | 60.0% (9) | 30.8% (4) | 63.6% (7) | 11.1% (1) |
a one report can yield information about more than one anatomical area affected by the angioedema. Therefore, the total number of areas affected by the angioedema exceeds that of the ADR reports.
b refers to current smoking at the time of the reported ADR. Former smokers were classified as non-smokers.
c the term "allergy" refers to a reported allergy and the occurrence of any allergic and hypersensitivity reactions reported in the history of the patient.
d the term "angioedema" summarizes previous angioedema or swellings coded in the SMQ "angioedema (narrow)" reported in the history of the patient.
e the term "asthma/COPD" refers to asthma/COPD (chronic obstructive pulmonary disease) reported in the patients’ history or as a drug indication for one of the drugs used concomitantly.
f the term "urticaria" summarizes urticarias coded in the SMQ "angioedema (narrow)" reported as adverse drug reaction.
h the term "pruritus" summarizes PTs that included pruritus independent of the anatomical area affected by the ADR.
i one ADR report may yield information about more than one seriousness criterion. Thus, the number of reported seriousness criteria exceeds that of the ADR reports.