Dataset Information

Efficacy and Safety of Esaxerenone in Hypertensive Patients with Diabetic Kidney Disease: A Multicenter, Open-Label, Prospective Study.

ABSTRACT:

Introduction

Clinical data of esaxerenone in hypertensive patients with diabetic kidney disease (DKD) are lacking. We evaluated the efficacy and safety of esaxerenone in patients with DKD and an inadequate response to blood pressure (BP)-lowering treatment.

Methods

In this multicenter, open-label, prospective study, patients were divided into urinary albumin-to-creatinine ratio subcohorts (UACR < 30, 30 to < 300, and 300 to < 1000 mg/gCr). Esaxerenone was initiated at 1.25 mg/day and followed by incremental dose escalation based on BP and serum potassium level monitoring. The treatment period was 12 weeks. The primary endpoint was change in morning home systolic BP/diastolic BP (SBP/DBP) from baseline to end of treatment (EOT). Secondary endpoints included achievement rate of target BP, change in UACR from baseline, and safety.

Results

In total, 113 patients were enrolled. Morning home SBP/DBP significantly decreased from baseline to EOT in the total population (- 11.6/- 5.2 mmHg, both p < 0.001) and in all UACR subcohorts (all p < 0.001). The target BP achievement rate was 38.5%. Significant reductions in bedtime home and office BPs were also shown in the total population and all UACR subcohorts. UACR significantly improved from baseline to EOT in the total (- 50.9%, p < 0.001) and all UACR subcohorts (all p < 0.001). Incidence of serum potassium elevation as drug-related treatment emergent adverse events was 2.7%. The change from baseline in estimated glomerular filtration rate (eGFR) was - 4.8 mL/min/1.73 m².

Conclusion

Esaxerenone demonstrated a BP-lowering effect and improved albuminuria. The effects were consistent regardless of the severity of albuminuria without clinically relevant serum potassium elevation and eGFR reduction.

Clinical trial registration

jRCTs06119002.

SUBMITTER: Uchida HA

PROVIDER: S-EPMC9449923 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Efficacy and Safety of Esaxerenone in Hypertensive Patients with Diabetic Kidney Disease: A Multicenter, Open-Label, Prospective Study.

Uchida Haruhito A HA Nakajima Hirofumi H Hashimoto Masami M Nakamura Akihiko A Nunoue Tomokazu T Murakami Kazuharu K Hosoya Takeshi T Komoto Kiichi K Taguchi Takashi T Akasaka Takaaki T Shiosakai Kazuhito K Sugimoto Kotaro K Wada Jun J

Advances in therapy 20220907 11

<h4>Introduction</h4>Clinical data of esaxerenone in hypertensive patients with diabetic kidney disease (DKD) are lacking. We evaluated the efficacy and safety of esaxerenone in patients with DKD and an inadequate response to blood pressure (BP)-lowering treatment.<h4>Methods</h4>In this multicenter, open-label, prospective study, patients were divided into urinary albumin-to-creatinine ratio subcohorts (UACR < 30, 30 to < 300, and 300 to < 1000 mg/gCr). Esaxerenone was initiated at 1.25 mg/day ...[more]

PMID: 36070133

Similar Datasets

Project description:AimsSevere acute respiratory syndrome coronavirus type 2 (SARS-COV-2) infection may increase the risk of developing dangerous symptoms among the elderly with underlying medical conditions. The aim of this study was to evaluate the safety and immunogenicity of the SARS-CoV-2 inactivated vaccine (Vero) in patients over 60 years of age with hypertension and/or diabetes.MethodsAn open-label, multi-center, prospective clinical trial was conducted at three medical sites in Fujian, China. Participants aged 60 years and above with hypertension, diabetes, and healthy controls were included in four groups: hypertension, diabetes, combined disease, and healthy controls. Volunteers received two doses of the inactivated SARS-COV-2 vaccine (BBIBP-CorV) on days 0 and 21. Adverse events were recorded for 21 days after each dose. Blood samples were taken before the first vaccination and 28 days after the second vaccination to detect the serum conversion rate and geometric mean titer (GMT) of neutralizing antibodies.ResultsA total of 480 participants (110 hypertension, 110 diabetes, 100 combined hypertension and diabetes, and 160 healthy controls) were recruited. The incidences of adverse events in the four groups were 10 (9.1%) in the hypertension group, 19 (17.3%) in the diabetes group, 11 (11.0%) in the combined disease group, and 11 (6.9%) in healthy controls, with no statistical significance (P > 0.05). At 28 days after the second vaccination, the positive conversion rates of serum neutralizing antibody in the four groups were 97.3%(107/110), 97.3% (107/110), 100.0% (99/99),and 98.7%(155/157), respectively, and the GMTs were 75.28 (95% CI 64.03-88.50), 69.4 (95% CI 59-81.63), 77.21 (95% CI 66.68-89.41), and 78.64 (95% CI 69.87-88.50), respectively. There was no significant difference in neutralizing antibody responses among the four groups (P > 0.05). Additionally, the GMT after immunization was higher in females than in males (OR = 2.59, 95% CI 1.31-5.12).ConclusionsThe BBIBP-CorV vaccine is safe and elicits an adequate antibody response in patients over 60 years of age with hypertension and/or diabetes.Trial registrationClinicalTrials.gov identifier, NCT05065879.

Dataset Information

Efficacy and Safety of Esaxerenone in Hypertensive Patients with Diabetic Kidney Disease: A Multicenter, Open-Label, Prospective Study.

Introduction

Methods

Results

Conclusion

Clinical trial registration

Publications

Efficacy and Safety of Esaxerenone in Hypertensive Patients with Diabetic Kidney Disease: A Multicenter, Open-Label, Prospective Study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets