NCT04269629

The Effect of Antihypertensive Drugs on Severity of Anaphylaxis and Side-effects During Venom Immunotherapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,425 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

There is an ongoing debate whether antihypertensive treatment with beta-blockers and/or angiotensin converting Enzyme (ACE)-inhibitors comprises a risk factor for more severe and more frequent side-effects during venom immunotherapy (VIT). In the literature, data are controversial and originate from case reports or statistically underpowered studies; the number of included patients was usually high but the proportion of patients on antihypertensive treatment was low ranging from 2-11%. The study was conducted as a prospective, observational, European multicenter study. 1425 patients, aged from 35 to 85 years, with a history of an anaphylactic reaction due to bee or wasp stings, were included. The medical history was recorded as well as laboratory parameters and data of the VIT-updosing phase. One year after reaching the maintenance dose, possible side-effects during VIT as well as the outcome of field stings or sting challenges were documented.

Conditions

• Hymenoptera Venom Allergy
• Antihypertensive Treatment

Interventions

Type	Name	Description
DRUG	Insect Venom	Patients receive insect venom immunotherapy. The frequency of systemic side-effects is recorded and compared between patients under antihypertensive treatment and patients not taking antihypertensive drugs.

Timeline

• Start date: 2014-08-01
• Primary completion: 2018-01-01
• Completion: 2019-03-01
• First posted: 2020-02-17
• Last updated: 2020-11-20
• Results posted: 2020-11-20

Locations

1 site across 1 country: Austria