Table 9.
(Serious) treatment-emergent adverse events reported per treatment option
| Study | Angioedema subtype | Sample size | Therapy | SAEs | No. of patients with >1 TEAE | TEAEs |
|---|---|---|---|---|---|---|
| Lewis [4] | ACEi-induced | 58 + 18 | Ecallantide | 5 related SAEs (AE). One death in placebo group (respiratory compromise) | 30 (51.7 %) vs. 8 (44.4 %); 13/30 related | AE (20 cases); headache and hypoesthesia (2 cases each); abdominal pain, diarrhea, hematuria, injection site pain/swelling, muscle spasms, oropharyngeal pain, oral candidiasis, pain in extremity, and pruritic rash (1 each). |
| Bernstein [7] | ACEi-induced | 26 + 24 | Ecallantide | 2 (7.7 %) vs. 6 (25 %), none related | 18 (75 %) vs. 17 (65.4 %); none related | n.a. |
| Nanda [42] | Idiopathic | 1 | Ecallantide | 0 | 0 | n.a. |
| Bas [5] | ACEi-induced | 13 + 14 | Icatibant | 0 v.s. 1 (7 %) | 1 (7 %) vs. 4 (27 %); 1/1 related | Patient-reported injection site pain; additional investigator-assessed injection site reactions in >12 (80 %) |
| Bova [21] | ACEi-induced | 13 | Icatibant | n.r. | 1 | Injection site pain |
| Bas [6] | ACEi-induced | 8 | Icatibant | 0 | 8 | Injection site erythema and/or itching |
| Crooks [27] | ACEi-induced | 1 | Icatibant | 0 | 1 | Injection site erythema |
| Lleonart [46] | Idiopathic | 1 | Icatibant | 0 | 1 | Injection site pain |
| Mansi [19] | Idiopathic | 44 | TA | n.r. | 5 | Migraine, menstrual irregularities, dyspepsia, diarrhea |
| Wintenberger [55] | Idiopathic | 25 | TA | 0 | 11 | Abdominal pain, dizziness, weakness, pain in lower limbs, migraine |
| Du-Thanh [58] | Idiopathic | 25 | TA | n.r. | 1 | Digestive intolerance |
| Firinu [56] | Idiopathic | 16 | TA | n.r. | Uncleara | Abdominal discomfort and migraine (1 case), abdominal discomfort (unclear) |
| Cicardi [59] | Idiopathic | 15 | TA | 1 (myocardial infarction) | 2 | Laryngeal/pharyngeal dryness, self-limiting in months |
| Rijo Calderon [54] | AE with wheals | 10 | OMA | n.r. | 7a | Drowsiness (n = 7), digestive, cutaneous symptoms, and weight loss (5) |
| Azofra [60] | Idiopathic | 8 | OMA | 0 | 0 | n.a. |
| Rijo Calderon [54] | Idiopathic | 4 | OMA | n.r. | 7a | Drowsiness (n = 7), digestive, cutaneous symptoms, and weight loss (5) |
| vd Elzen [62] | AE with wheals | 3 | OMA | 0 | 2 | Headache in patient co-treated with cyclosporine, malaise (1 case each) |
| Buyukozturk [64] | Idiopathic | 2 | OMA | 0 | 0 | n.a. |
| Groffik [63] | AE with wheals | 2 | OMA | 0 | 3/9a | Headache, blood pressure decrease, fatigue; self-limiting 3–4 days after first 3 injections |
| Buyukozturk [64] | AE with wheals | 1 | OMA | 0 | 0 | n.a. |
| Ghazanfar [66] | AE with wheals | 1 | OMA | 0 | 0 | n.a. |
| Sanchez-Machin [70] | AE with wheals | 1 | OMA | 0 | 0 | n.a. |
| von Websky [72] | Idiopathic | 1 | OMA | 0 | 0 | n.a. |
| Suna [73] | Idiopathic | 1 | OMA | 0 | 0 | n.a. |
| Saule [57] | Idiopathic | 20 | Progestin | 0 | 17/55a | Weight gain (5 cases), oestrogenic deficiency (4), breakthrough bleeding (2), hyperandrogenia (2), n.r. (4) |
| Greve [22] | ACEi-induced | 10 | C1INH (B) | 0 | 0 | n.a. |
| Perez [65] | Idiopathic | 2 | MTX | 1, unrelated | Uncleara | Hair thinning and fatigue |
Related denote possibly, probably, or definately related to study drug, as described in the separate articles. The number of TEAEs may be higher than the number of patients reporting TEAEs since patients may have reported more than one TEAE. For RCTs, the sample size is shown as the number of treated patients + patients treated with placebo. SAE and TEAE are only shown as recorded for the treatment groups
n.a. not applicable since patients had reported no adverse effects or all adverse events were unrelated to the study medication
aTEAEs mentioned for the whole study population, which may be larger than the patients included in this review, e.g., in the case of chronic spontaneous urticaria with or without angioedema