Clinical trial NCT04269629: The Effect of Antihypertensive Drugs on Severity of Anaphylaxis and Side-effects During Venom Immunotherapy
Official title: The Effect of Antihypertensive Drugs on Severity of Anaphylaxis and Side-effects During Venom Immunotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hymenoptera Venom Allergy
Antihypertensive Treatment
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 1425
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with a history of anaphylactic sting reaction

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.


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

Primary outcomes:
measure: Frequency of Side Effects (=Systemic Reaction, SR) During Venom Immunotherapy (VIT)
timeFrame: 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
Secondary outcomes:
measure: Severity of Sting Reactions
timeFrame: duration of first visit (~1hour)
measure: Correlation of the Prevalence of Cardiovascular Diseases and/or Hypertension With the Risk for More Severe Systemic Sting Reactions.
timeFrame: duration of first visit (~1hour)
measure: Association of Bee Venom With a Higher Frequency of Side-effects (=Systemic Reaction, SR).
timeFrame: 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
measure: Correlation of High Specific Immunoglobulin E (sIgE) Levels to a Higher Frequency of Side-effects (=Systemic Reaction, SR).
timeFrame: 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
measure: Correlation of High Tryptase Levels to a Higher Frequency of Side-effects (=Systemic Reaction, SR).
timeFrame: 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
measure: Correlation of Quicker Up-dosing Protocols to a Higher Frequency of Side-effects (=Systemic Reaction, SR).
timeFrame: depends on the protocol used for venom immunotherapy, a maximum of about 6 months
measure: Efficacy of VIT
timeFrame: 1 year after reaching the maintenance dose; duration of Visit ~1hour
measure: Correlation of the Prevalence of Cardiovascular Diseases and/or Hypertension With the Risk for More Frequent Side Effects (=Systemic Reaction, SR) Under VIT.
timeFrame: duration of Visit ~1hour
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Dermatology and Venerology, Medical University of Graz
Study officials:
References:
citation: Sturm GJ, Herzog SA, Aberer W, Alfaya Arias T, Antolin-Amerigo D, Bonadonna P, Boni E, Bozek A, Chelminska M, Ernst B, Frelih N, Gawlik R, Gelincik A, Hawranek T, Hoetzenecker W, Jimenez Blanco A, Kita K, Kendirlinan R, Kosnik M, Laipold K, Lang R, Marchi F, Mauro M, Nittner-Marszalska M, Poziomkowska-Gesicka I, Pravettoni V, Preziosi D, Quercia O, Reider N, Rosiek-Biegus M, Ruiz-Leon B, Schrautzer C, Serrano P, Sin A, Sin BA, Stoevesandt J, Trautmann A, Vachova M, Arzt-Gradwohl L. beta-blockers and ACE inhibitors are not a risk factor for severe systemic sting reactions and adverse events during venom immunotherapy. Allergy. 2021 Jul;76(7):2166-2176. doi: 10.1111/all.14785. Epub 2021 Mar 11.