TY - JOUR
T1 - Corrigendum to “Medical treatment of hypercortisolism with relacorilant
T2 - Final results of the phase 3 GRACE study” (American Heart Journal, (2024), 278, S, (10-11), (S0002870324002606), 10.1016/j.ahj.2024.09.027)
AU - Pivonello, Rosario
AU - Arnaldi, Giorgio
AU - Auchus, Richard J.
AU - Badiu, Corin
AU - Busch, Robert S.
AU - Cannavo, Salvatore
AU - Dischinger, Ulrich
AU - Dobri, Georgiana A.
AU - Donegan, Diane
AU - Elenkova, Atanaska
AU - Fazeli, Pouneh K.
AU - Feelders, Richard A.
AU - Garcia-Centeno, Rogelio
AU - Gilis-Januszewska, Aleksandra
AU - Hamidi, Oksana
AU - Hannoush, Zeina C.
AU - Miller, Harold J.
AU - Ranetti, Aurelian Emil
AU - Recasens, Monica
AU - Reincke, Martin
AU - Rovner, Sergio
AU - Salvatori, Roberto
AU - Silverstein, Julie
AU - Stigliano, Antonio
AU - Terzolo, Massimo
AU - Wang, Christina
AU - Yuen, Kevin C.J.
AU - Hand, Austin L.
AU - Tudor, Iulia Cristina
AU - Araque, Katherine A.
AU - Moraitis, Andreas G.
N1 - Publisher Copyright:
© 2025 .
PY - 2026/2
Y1 - 2026/2
N2 - The authors regret that the information in the abstract that was published was incorrect. It should have the correct abstract information below. The authors would like to apologize for any inconvenience caused. Medical Treatment of Hypercortisolism with Relacorilant: Final Results of the Phase 3 GRACE Study ABSTRACT The phase 3 GRACE study (NCT03697109) assessed the efficacy and safety of relacorilant, a selective glucocorticoid receptor modulator, in patients with hypercortisolism and hypertension and/or hyperglycemia (diabetes/impaired glucose tolerance). 152 patients were enrolled (n = 31 with hypertension; n = 50 with hyperglycemia; n = 71 with both). During the 22-week open-label (OL) phase, rapid and sustained improvements in hypertension and hyperglycemia were observed, along with improvements in several other cortisol-related comorbidities. Patients who achieved prespecified hypertension and/or hyperglycemia response criteria were eligible to enter the 12-week, double-blind, placebo-controlled randomized-withdrawal (RW) phase. The study met its primary endpoint (defined as loss of response in hypertension control between relacorilant and placebo), assessed at the end of the RW phase, with an odds ratio of 0.17 (95% confidence interval 0.04-0.77; P = .02) in favor of relacorilant. See table for hypertension and hyperglycemic results in the OL and RW phases of the study. Relacorilant was well-tolerated in both phases of GRACE with mostly mild-to-moderate adverse events and with little difference between relacorilant and placebo. The most common adverse events in the RW phase were back pain, headache, arthralgia, insomnia, and pain in extremity, similar to the OL phase. No cases of drug-induced irregular vaginal bleeding associated with endometrial hyperplasia, and no QT prolongation (independently confirmed) or adrenal insufficiency were reported.
AB - The authors regret that the information in the abstract that was published was incorrect. It should have the correct abstract information below. The authors would like to apologize for any inconvenience caused. Medical Treatment of Hypercortisolism with Relacorilant: Final Results of the Phase 3 GRACE Study ABSTRACT The phase 3 GRACE study (NCT03697109) assessed the efficacy and safety of relacorilant, a selective glucocorticoid receptor modulator, in patients with hypercortisolism and hypertension and/or hyperglycemia (diabetes/impaired glucose tolerance). 152 patients were enrolled (n = 31 with hypertension; n = 50 with hyperglycemia; n = 71 with both). During the 22-week open-label (OL) phase, rapid and sustained improvements in hypertension and hyperglycemia were observed, along with improvements in several other cortisol-related comorbidities. Patients who achieved prespecified hypertension and/or hyperglycemia response criteria were eligible to enter the 12-week, double-blind, placebo-controlled randomized-withdrawal (RW) phase. The study met its primary endpoint (defined as loss of response in hypertension control between relacorilant and placebo), assessed at the end of the RW phase, with an odds ratio of 0.17 (95% confidence interval 0.04-0.77; P = .02) in favor of relacorilant. See table for hypertension and hyperglycemic results in the OL and RW phases of the study. Relacorilant was well-tolerated in both phases of GRACE with mostly mild-to-moderate adverse events and with little difference between relacorilant and placebo. The most common adverse events in the RW phase were back pain, headache, arthralgia, insomnia, and pain in extremity, similar to the OL phase. No cases of drug-induced irregular vaginal bleeding associated with endometrial hyperplasia, and no QT prolongation (independently confirmed) or adrenal insufficiency were reported.
UR - https://www.scopus.com/pages/publications/105023847392
U2 - 10.1016/j.ahj.2025.107286
DO - 10.1016/j.ahj.2025.107286
M3 - Comment/debate
AN - SCOPUS:105023847392
SN - 0002-8703
VL - 292
JO - American heart journal
JF - American heart journal
M1 - 107286
ER -