TY - JOUR
T1 - Renin angiotensin system blockers-associated angioedema in the Thai population: analysis from Thai National Pharmacovigilance Database
AU - Win, Thet Su Zin
AU - Chaiyakunapruk, Nathorn
AU - Suwankesawong, Wimon
AU - Dilokthornsakul, Piyameth
AU - Nathisuwan, Surakit
PY - 2015
Y1 - 2015
N2 - Background: Renin-angiotensin-aldosterone system (RAS) blockers are commonly used for cardiovascular diseases. Currently, little information exists for the Asian population on angioedema, a rare yet serious adverse event.
Objective: This study aimed to describe characteristics of RAS blockers-associated angioedema (RASBA) in Thai patients.
Methods: A retrospective study using the national pharmacovigilance database of Thailand was undertaken. Cases indicating the presence of angioedema with RAS blockers uses from 19842011 were identified. Patient demographics, co-morbidities, concomitant drugs, information for the RAS blockers and angioedema were obtained as well as causality assessment and quality of reports.
Results: A total of 895 cases were identified. Mean age was 59.9+/-12.8 years and 66.5 being female. Most angioedema events (48.6 ) occurred during the first week of treatment. Angiotensin converting enzyme inhibitors (87.7 ) were the most commonly implicated agents followed by angiotensin receptor blockers (10.5 ), aldosterone antagonist (2.1 ) and direct renin inhibitor (0.2 ). Out of the 895 cases incorporated in this study, 165 (18.4 ) were classified as serious events and resulted in hospitalization. The overall case fatality rate was 0.4 . Respiratory disturbance occurred in 46 cases (5.1 ). Patients with respiratory complications tended to be younger (53.4+/-13.9 vs 60.3+/-12.7 years old; p=0.002) and with higher frequency of allergy history (26.1 vs 14.7 ; p=0.032) compared to those without respiratory complications. Based on multivariate logistic regression, the adjusted OR for history of allergy was 2.23 (95 CI: 1.04 - 4.78,p = 0.041).
Conclusions: RASBA in Thai population occurred mostly in elderly female patients and often led to hospitalization. Since large number of patients is regularly exposed to RAS-blockers, a nationwide attempt to raise awareness of clinicians when prescribing RAS-blockers is prudent
AB - Background: Renin-angiotensin-aldosterone system (RAS) blockers are commonly used for cardiovascular diseases. Currently, little information exists for the Asian population on angioedema, a rare yet serious adverse event.
Objective: This study aimed to describe characteristics of RAS blockers-associated angioedema (RASBA) in Thai patients.
Methods: A retrospective study using the national pharmacovigilance database of Thailand was undertaken. Cases indicating the presence of angioedema with RAS blockers uses from 19842011 were identified. Patient demographics, co-morbidities, concomitant drugs, information for the RAS blockers and angioedema were obtained as well as causality assessment and quality of reports.
Results: A total of 895 cases were identified. Mean age was 59.9+/-12.8 years and 66.5 being female. Most angioedema events (48.6 ) occurred during the first week of treatment. Angiotensin converting enzyme inhibitors (87.7 ) were the most commonly implicated agents followed by angiotensin receptor blockers (10.5 ), aldosterone antagonist (2.1 ) and direct renin inhibitor (0.2 ). Out of the 895 cases incorporated in this study, 165 (18.4 ) were classified as serious events and resulted in hospitalization. The overall case fatality rate was 0.4 . Respiratory disturbance occurred in 46 cases (5.1 ). Patients with respiratory complications tended to be younger (53.4+/-13.9 vs 60.3+/-12.7 years old; p=0.002) and with higher frequency of allergy history (26.1 vs 14.7 ; p=0.032) compared to those without respiratory complications. Based on multivariate logistic regression, the adjusted OR for history of allergy was 2.23 (95 CI: 1.04 - 4.78,p = 0.041).
Conclusions: RASBA in Thai population occurred mostly in elderly female patients and often led to hospitalization. Since large number of patients is regularly exposed to RAS-blockers, a nationwide attempt to raise awareness of clinicians when prescribing RAS-blockers is prudent
UR - http://thailand.digitaljournals.org/index.php/APJAI/article/viewFile/27500/26702
U2 - 10.12932/AP0556.33.3.2015
DO - 10.12932/AP0556.33.3.2015
M3 - Article
SN - 0125-877X
VL - 33
SP - 227
EP - 235
JO - Asian Pacific Journal of Allergy and Immunology
JF - Asian Pacific Journal of Allergy and Immunology
IS - 3
ER -
