TY - JOUR
T1 - Efficacy of High-Dose Dexamethasone in Reducing the Symptoms of Postembolization Syndrome Following Prostatic Artery Embolization
T2 - Results of a Double-Blind Randomized Controlled Trial
AU - Svarc, Petra
AU - Stroomberg, Hein Vincent
AU - Taudorf, Mikkel
AU - Brasso, Klaus
AU - Lonn, Lars
AU - Røder, Andreas
N1 - © 2024. The Author(s).
PY - 2024/5
Y1 - 2024/5
N2 - PURPOSE: To evaluate the efficacy of a single perioperative dose of dexamethasone in reducing postembolization syndrome following prostatic artery embolization.MATERIALS AND METHODS: We conducted a single-center double-blind randomized controlled trial from March 2021 to May 2022 (NCT04588857). Participants were randomized to receive either i.v. 24 mg dexamethasone or saline. The primary outcome measures were temperature, pain, and quality of life in the first 5 days following prostatic artery embolization. Sample size of 60 patients was needed for the assessment of primary outcomes. Participants were followed for 6 months and assessed for a variety of secondary outcome measures including inflammatory markers and lower urinary tract symptoms severity.RESULTS: Due to lack of clinical effect and mild symptoms in the control group, the trial was terminated early. 31 participants (16 dexamethasone vs. 15 control) were enrolled and analyzed. A difference in mean temperature was observed on day 1 (37.23 ± 0.64 °C control vs 36.74 ± 0.41 °C dexamethasone, p = 0.02, 95% CI 0.09-0.89). Difference in pain (score out of 10) was seen only on day 5 (1.48 ± 1.2 control vs. 2.9 ± 2.24 dexamethasone, p = 0.04, 95% CI - 2.78-- 0.04). A difference in C-reactive protein values was observed on day 2 (108 [54-161] mg/l control vs 10 [5-33] mg/l dexamethasone, p < 0.01). No significant differences in other outcomes were observed. No side effects were recorded.CONCLUSIONS: Twenty-four milligrams of dexamethasone bolus is safe but does not reduce postembolization syndrome following prostatic artery embolization.
AB - PURPOSE: To evaluate the efficacy of a single perioperative dose of dexamethasone in reducing postembolization syndrome following prostatic artery embolization.MATERIALS AND METHODS: We conducted a single-center double-blind randomized controlled trial from March 2021 to May 2022 (NCT04588857). Participants were randomized to receive either i.v. 24 mg dexamethasone or saline. The primary outcome measures were temperature, pain, and quality of life in the first 5 days following prostatic artery embolization. Sample size of 60 patients was needed for the assessment of primary outcomes. Participants were followed for 6 months and assessed for a variety of secondary outcome measures including inflammatory markers and lower urinary tract symptoms severity.RESULTS: Due to lack of clinical effect and mild symptoms in the control group, the trial was terminated early. 31 participants (16 dexamethasone vs. 15 control) were enrolled and analyzed. A difference in mean temperature was observed on day 1 (37.23 ± 0.64 °C control vs 36.74 ± 0.41 °C dexamethasone, p = 0.02, 95% CI 0.09-0.89). Difference in pain (score out of 10) was seen only on day 5 (1.48 ± 1.2 control vs. 2.9 ± 2.24 dexamethasone, p = 0.04, 95% CI - 2.78-- 0.04). A difference in C-reactive protein values was observed on day 2 (108 [54-161] mg/l control vs 10 [5-33] mg/l dexamethasone, p < 0.01). No significant differences in other outcomes were observed. No side effects were recorded.CONCLUSIONS: Twenty-four milligrams of dexamethasone bolus is safe but does not reduce postembolization syndrome following prostatic artery embolization.
KW - Aged
KW - Anti-Inflammatory Agents/administration & dosage
KW - Dexamethasone/administration & dosage
KW - Double-Blind Method
KW - Embolization, Therapeutic/methods
KW - Humans
KW - Lower Urinary Tract Symptoms/etiology
KW - Male
KW - Middle Aged
KW - Prostate/blood supply
KW - Prostatic Hyperplasia/therapy
KW - Quality of Life
KW - Syndrome
KW - Treatment Outcome
KW - Dexamethasone
KW - Embolization, Therapeutic
KW - Prostate
UR - http://www.scopus.com/inward/record.url?scp=85182408943&partnerID=8YFLogxK
U2 - 10.1007/s00270-023-03650-4
DO - 10.1007/s00270-023-03650-4
M3 - Journal article
C2 - 38233575
SN - 0174-1551
VL - 47
SP - 632
EP - 639
JO - Cardiovascular and Interventional Radiology
JF - Cardiovascular and Interventional Radiology
IS - 5
ER -