ACE-inhibitor related angioedema is not sufficiently reported to the danish adverse drug reactions database

Johan Emil Lundbek Cornwall*, Cornwall Anette Bygum, Eva Rye Rasmussen

*Corresponding author for this work

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Abstract

Purpose: The primary objective of this study was to calculate the report rate of angiotensin-converting enzyme inhibitor-related angioedema (ACEi-AE). Secondary objectives were to determine factors suspected to affect the likelihood of ACEi-AE being reported and to investigate potential differences in angioedema risks between different ACEis. Patients and methods: Patient data from two cohorts comprising 176 patients with ACEi-AE were compared with report data from the Danish Adverse Drug Reactions Database, administered by the Danish Medicines Agency (DKMA). The study period was 1994–2015. Data were linked using unique personal identification numbers and birth dates. Cohort data and report data were compared with ACEi sales numbers from MedStat, an official database containing annual pharmaceutical drug sale data in Denmark. Results: ACEi-AE was reported in two out of 176 cases resulting in a report rate of 1.1%, meaning that 98.9% of the cases were not reported. Since 1994, a total of 417 ACEi-AE reports were made to the DKMA. Fifty-eight percent of these were made by general practitioners or physicians with unknown workplaces and 35% by hospital staff. Enalapril and ramipril were the most sold ACEi’s in the study period (40.3% and 42.6%, respectively). Enalapril was associated with 54.7% of ACEi-AE reports while ramipril was associated with 14.2%. ACEi substance received was known for 141 cohort patients, of which 53.9% were prescribed enalapril and 17.0% received ramipril. Conclusion: ACEi-AE was found to be severely underreported in Denmark, greatly limiting the available incidence data for this potentially life-threatening adverse reaction.

Original languageEnglish
JournalDrug, Healthcare and Patient Safety
Volume11
Pages (from-to)105-113
ISSN1179-1365
DOIs
Publication statusPublished - 30. Oct 2019

Fingerprint

Pharmaceutical Databases
Drug-Related Side Effects and Adverse Reactions
Ramipril
Enalapril
Denmark
Workplace
Pharmaceutical Preparations
General Practitioners
Databases
Physicians

Keywords

  • Adverse-effect
  • Agent
  • Antihypertensive
  • Edema
  • Pharmacovigilance
  • Side-effect

Cite this

@article{77ba22a44adc4f14ab48a1ded6ec5471,
title = "ACE-inhibitor related angioedema is not sufficiently reported to the danish adverse drug reactions database",
abstract = "Purpose: The primary objective of this study was to calculate the report rate of angiotensin-converting enzyme inhibitor-related angioedema (ACEi-AE). Secondary objectives were to determine factors suspected to affect the likelihood of ACEi-AE being reported and to investigate potential differences in angioedema risks between different ACEis. Patients and methods: Patient data from two cohorts comprising 176 patients with ACEi-AE were compared with report data from the Danish Adverse Drug Reactions Database, administered by the Danish Medicines Agency (DKMA). The study period was 1994–2015. Data were linked using unique personal identification numbers and birth dates. Cohort data and report data were compared with ACEi sales numbers from MedStat, an official database containing annual pharmaceutical drug sale data in Denmark. Results: ACEi-AE was reported in two out of 176 cases resulting in a report rate of 1.1{\%}, meaning that 98.9{\%} of the cases were not reported. Since 1994, a total of 417 ACEi-AE reports were made to the DKMA. Fifty-eight percent of these were made by general practitioners or physicians with unknown workplaces and 35{\%} by hospital staff. Enalapril and ramipril were the most sold ACEi’s in the study period (40.3{\%} and 42.6{\%}, respectively). Enalapril was associated with 54.7{\%} of ACEi-AE reports while ramipril was associated with 14.2{\%}. ACEi substance received was known for 141 cohort patients, of which 53.9{\%} were prescribed enalapril and 17.0{\%} received ramipril. Conclusion: ACEi-AE was found to be severely underreported in Denmark, greatly limiting the available incidence data for this potentially life-threatening adverse reaction.",
keywords = "Adverse-effect, Agent, Antihypertensive, Edema, Pharmacovigilance, Side-effect",
author = "{Lundbek Cornwall}, {Johan Emil} and Bygum, {Cornwall Anette} and Rasmussen, {Eva Rye}",
year = "2019",
month = "10",
day = "30",
doi = "10.2147/DHPS.S205119",
language = "English",
volume = "11",
pages = "105--113",
journal = "Drug, Healthcare and Patient Safety",
issn = "1179-1365",
publisher = "Dove Medical Press Ltd.(Dovepress)",

}

ACE-inhibitor related angioedema is not sufficiently reported to the danish adverse drug reactions database. / Lundbek Cornwall, Johan Emil; Bygum, Cornwall Anette; Rasmussen, Eva Rye.

In: Drug, Healthcare and Patient Safety, Vol. 11, 30.10.2019, p. 105-113.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - ACE-inhibitor related angioedema is not sufficiently reported to the danish adverse drug reactions database

AU - Lundbek Cornwall, Johan Emil

AU - Bygum, Cornwall Anette

AU - Rasmussen, Eva Rye

PY - 2019/10/30

Y1 - 2019/10/30

N2 - Purpose: The primary objective of this study was to calculate the report rate of angiotensin-converting enzyme inhibitor-related angioedema (ACEi-AE). Secondary objectives were to determine factors suspected to affect the likelihood of ACEi-AE being reported and to investigate potential differences in angioedema risks between different ACEis. Patients and methods: Patient data from two cohorts comprising 176 patients with ACEi-AE were compared with report data from the Danish Adverse Drug Reactions Database, administered by the Danish Medicines Agency (DKMA). The study period was 1994–2015. Data were linked using unique personal identification numbers and birth dates. Cohort data and report data were compared with ACEi sales numbers from MedStat, an official database containing annual pharmaceutical drug sale data in Denmark. Results: ACEi-AE was reported in two out of 176 cases resulting in a report rate of 1.1%, meaning that 98.9% of the cases were not reported. Since 1994, a total of 417 ACEi-AE reports were made to the DKMA. Fifty-eight percent of these were made by general practitioners or physicians with unknown workplaces and 35% by hospital staff. Enalapril and ramipril were the most sold ACEi’s in the study period (40.3% and 42.6%, respectively). Enalapril was associated with 54.7% of ACEi-AE reports while ramipril was associated with 14.2%. ACEi substance received was known for 141 cohort patients, of which 53.9% were prescribed enalapril and 17.0% received ramipril. Conclusion: ACEi-AE was found to be severely underreported in Denmark, greatly limiting the available incidence data for this potentially life-threatening adverse reaction.

AB - Purpose: The primary objective of this study was to calculate the report rate of angiotensin-converting enzyme inhibitor-related angioedema (ACEi-AE). Secondary objectives were to determine factors suspected to affect the likelihood of ACEi-AE being reported and to investigate potential differences in angioedema risks between different ACEis. Patients and methods: Patient data from two cohorts comprising 176 patients with ACEi-AE were compared with report data from the Danish Adverse Drug Reactions Database, administered by the Danish Medicines Agency (DKMA). The study period was 1994–2015. Data were linked using unique personal identification numbers and birth dates. Cohort data and report data were compared with ACEi sales numbers from MedStat, an official database containing annual pharmaceutical drug sale data in Denmark. Results: ACEi-AE was reported in two out of 176 cases resulting in a report rate of 1.1%, meaning that 98.9% of the cases were not reported. Since 1994, a total of 417 ACEi-AE reports were made to the DKMA. Fifty-eight percent of these were made by general practitioners or physicians with unknown workplaces and 35% by hospital staff. Enalapril and ramipril were the most sold ACEi’s in the study period (40.3% and 42.6%, respectively). Enalapril was associated with 54.7% of ACEi-AE reports while ramipril was associated with 14.2%. ACEi substance received was known for 141 cohort patients, of which 53.9% were prescribed enalapril and 17.0% received ramipril. Conclusion: ACEi-AE was found to be severely underreported in Denmark, greatly limiting the available incidence data for this potentially life-threatening adverse reaction.

KW - Adverse-effect

KW - Agent

KW - Antihypertensive

KW - Edema

KW - Pharmacovigilance

KW - Side-effect

U2 - 10.2147/DHPS.S205119

DO - 10.2147/DHPS.S205119

M3 - Journal article

C2 - 31908540

AN - SCOPUS:85077019866

VL - 11

SP - 105

EP - 113

JO - Drug, Healthcare and Patient Safety

JF - Drug, Healthcare and Patient Safety

SN - 1179-1365

ER -