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

Completed

Conditions: Hymenoptera Venom Allergy
Antihypertensive Treatment

Interventions: Drug: Insect Venom

Registration Number: NCT04269629

Lead Sponsor: Medical University of Graz

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1425

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with a history of an anaphylactic sting reaction	Insect Venom	At Visit 1, patients will be included after carefully reviewing all inclusion and exclusion criteria. All data concerning the index sting, laboratory parameters like immunoglobulin E (IgE) and tryptase levels and skin test results will be recorded as well as the concomitant diseases and medication. Visit 2 will be performed after VIT updosing is finished. At this Visit data concerning the immunotherapy - premedication, preparation, updosing protocol, the outcome of possible large, local reactions (LLR) and systemic reactions (SR) and changes in diseases and medication will be recorded. One year after reaching the maintenance dose, Visit 3 will be performed. At this Visit data concerning the maintenance phase like premedication and possible side effects will be recorded as well as the outcome of insect stings.

Primary Outcome Measures

Name	Time	Method
Frequency of Side Effects (=Systemic Reaction, SR) During Venom Immunotherapy (VIT)	after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour	The primary objective of this study is to evaluate whether subjects under antihypertensive treatment with beta-blockers and/or angiotensin converting enzyme (ACE)-inhibitors show more side effects during VIT compared to subjects with no antihypertensive treatment.

Secondary Outcome Measures

Name	Time	Method
Correlation of High Tryptase Levels to a Higher Frequency of Side-effects (=Systemic Reaction, SR).	after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour	To evaluate whether high tryptase levels are correlated to a higher frequency of side-effects
Severity of Sting Reactions	duration of first visit (~1hour)	To evaluate whether subjects under antihypertensive treatment with beta-blockers and/or ACE-inhibitors have more severe sting reactions.
Correlation of the Prevalence of Cardiovascular Diseases and/or Hypertension With the Risk for More Severe Systemic Sting Reactions.	duration of first visit (~1hour)	To correlate the prevalence of cardiovascular diseases and/or hypertension with the risk for more severe systemic sting reactions.
Correlation of High Specific Immunoglobulin E (sIgE) Levels to a Higher Frequency of Side-effects (=Systemic Reaction, SR).	after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour	To evaluate whether high specific immunoglobulin E (sIgE) levels are correlated to a higher frequency of side-effects. sIgE levels are expressed in kilo units/liter \[kU/L\].
Association of Bee Venom With a Higher Frequency of Side-effects (=Systemic Reaction, SR).	after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour	To evaluate whether bee venom is associated with a higher frequency of side-effects.
Correlation of Quicker Up-dosing Protocols to a Higher Frequency of Side-effects (=Systemic Reaction, SR).	depends on the protocol used for venom immunotherapy, a maximum of about 6 months	To evaluate whether quicker up-dosing protocols are correlated to a higher frequency of side-effects.
Efficacy of VIT	1 year after reaching the maintenance dose; duration of Visit ~1hour	The outcome (systemic reaction to sting or not) of sting challenges and/or field stings will be recorded to identify patients who will not tolerate but react to future stings. These results will be compared between patients not taking antihypertensive (AHT) drugs and patients taking AHT drugs.
Correlation of the Prevalence of Cardiovascular Diseases and/or Hypertension With the Risk for More Frequent Side Effects (=Systemic Reaction, SR) Under VIT.	duration of Visit ~1hour	To correlate the prevalence of cardiovascular diseases and/or hypertension with the risk for more frequent side effects (=systemic reaction, SR) under VIT..