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

NCT04269629 | Completed Results

• 1 other identifier: 26-422 ex13/14 (EADOAS)
• Study Type: observational
• Target: 1,425
• Locations: 1 country
• Sites: 1

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.

Conditions

Hymenoptera Venom Allergy; Antihypertensive Treatment

Outcome Measures

Primary Outcomes (1)

• Frequency of Side Effects (=Systemic Reaction, SR) During Venom Immunotherapy (VIT)

  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.

  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 (8)

• Severity of Sting Reactions

  duration of first visit (~1hour)

• Correlation of the Prevalence of Cardiovascular Diseases and/or Hypertension With the Risk for More Severe Systemic Sting Reactions.

  duration of first visit (~1hour)

• 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

• 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

• 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

Study Arms (1)

patients with a history of an anaphylactic sting reaction

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.

Drug: Insect Venom

Interventions

Insect Venom DRUG

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.

patients with a history of an anaphylactic sting reaction

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with a history of anaphylactic sting reaction

You may qualify if:

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

You may not qualify if:

• absolute contraindications for VIT
• pretreatment with Omalizumab

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Department of Dermatology and Venerology, Medical University of Graz

Graz, 8036, Austria

Location

Related Publications (1)

• 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.

  PMID: 33605465 DERIVED

MeSH Terms

Interventions

Arthropod Venoms

Intervention Hierarchy (Ancestors)

Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Assoz.-Prof. Dr. Gunter Sturm
• Organization: Department of Dermatology and Venerology

gunter.sturm@medunigraz.at

+4331638580318

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 17, 2020
• Study Start: August 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: March 1, 2019
• Last Updated: November 20, 2020
• Results First Posted: November 20, 2020

Record last verified: 2020-10

Locations

AU (1)