N/A N=1,425

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

Hymenoptera Venom Allergy · Antihypertensive Treatment

Bottom Line

View on ClinicalTrials.gov: NCT04269629 ↗

Enrolled (actual)

1,425

Serious AEs

—

Results posted

Nov 2020

Primary outcome: Primary: Frequency of Side Effects (=Systemic Reaction, SR) During Venom Immunotherapy (VIT) — 19; 74 Participants — p=0.25

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Insect Venom (Drug)
Age: Adult, Older Adult · 35+ yrs
Sex: All
Sponsor: Medical University of Graz
Primary completion: Jan 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Frequency of Side Effects (=Systemic Reaction, SR) During Venom Immunotherapy (VIT)	19; 74	0.25
SECONDARY Severity of Sting Reactions	171; 432	0.29
SECONDARY Correlation of the Prevalence of Cardiovascular Diseases and/or Hypertension With the Risk for More Severe Systemic Sting Reactions.	258; 343	0.04 sig
SECONDARY Association of Bee Venom With a Higher Frequency of Side-effects (=Systemic Reaction, SR).	54; 39	<0.001 sig
SECONDARY Correlation of High Specific Immunoglobulin E (sIgE) Levels to a Higher Frequency of Side-effects (=Systemic Reaction, SR).	17; 17; 8; 17; 9; 4	0.99
SECONDARY Correlation of High Tryptase Levels to a Higher Frequency of Side-effects (=Systemic Reaction, SR).	74; 13	0.16
SECONDARY Correlation of Quicker Up-dosing Protocols to a Higher Frequency of Side-effects (=Systemic Reaction, SR).	5; 84	0.50
SECONDARY Efficacy of VIT	4; 15	0.72
SECONDARY Correlation of the Prevalence of Cardiovascular Diseases and/or Hypertension With the Risk for More Frequent Side Effects (=Systemic Reaction, SR) Under VIT.	30; 63	0.11

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.

Eligibility Criteria

Inclusion Criteria

History of systemic sting reaction (≥ grade I according the classification by Ring and Messmer)
age 35 to 85 years

Exclusion Criteria

absolute contraindications for VIT
pretreatment with Omalizumab

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04269629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.