Maria Fleseriu, Rosario Pivonello, John Newell-Price, Mônica R Gadelha, Beverly M K Biller, Richard J Auchus, Richard A Feelders, Akira Shimatsu, Przemysław Witek, Marie Bex, Andrea Piacentini, Alberto M Pedroncelli, André Lacroix
{"title":"奥西洛他可改善库欣病患者的血压和血糖控制：linc3和linc4研究的汇总分析","authors":"Maria Fleseriu, Rosario Pivonello, John Newell-Price, Mônica R Gadelha, Beverly M K Biller, Richard J Auchus, Richard A Feelders, Akira Shimatsu, Przemysław Witek, Marie Bex, Andrea Piacentini, Alberto M Pedroncelli, André Lacroix","doi":"10.1007/s11102-024-01471-3","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the effect of osilodrostat and hypercortisolism control on blood pressure (BP) and glycemic control in patients with Cushing's disease.</p><p><strong>Methods: </strong>Pooled analysis of two Phase III osilodrostat studies (LINC 3 and LINC 4), both comprising a 48-week core phase and an optional open-label extension. Changes from baseline in systolic and diastolic BP (SBP and DBP), fasting plasma glucose (FPG), and glycated hemoglobin (HbA<sub>1c</sub>) were evaluated during osilodrostat treatment in patients with/without hypertension or diabetes at baseline.</p><p><strong>Results: </strong>Of 210 patients, 82.9% met criteria for hypertension and 40.0% for diabetes at baseline. In patients with hypertension, reductions in mean SBP/DBP were observed from week (W)12 to W72, and 49.1%/58.5% of patients with high SBP/DBP (> 130/>90 mmHg) at baseline had normotensive levels at W72. Antihypertensive medication dose was reduced/stopped in 26.8% of patients, and the proportion taking antihypertensive medication decreased from 54.3% at baseline to 47.3% at W72. In patients with diabetes, mean FPG and HbA<sub>1c</sub> decreased from W12 to W72, and 33.3%/61.5% with high FPG/HbA<sub>1c</sub> (≥ 100 mg/dL/≥6.5%) at baseline had normal levels at W72. Antihyperglycemic medication dose was reduced/stopped in 35.7% of patients, and the proportion taking antihyperglycemic medication decreased from 21.9% at baseline to 17.1% at W72; improvements in SBP/DBP and FPG/HbA<sub>1c</sub> were correlated with improvement in mean urinary free cortisol but not weight change. BP/glycemic parameters generally remained normal in patients without hypertension/diabetes at baseline.</p><p><strong>Conclusions: </strong>Patients with Cushing's disease and comorbid hypertension/diabetes receiving osilodrostat had rapid and sustained improvements in SBP/DBP and glycemic control, respectively.</p>","PeriodicalId":20202,"journal":{"name":"Pituitary","volume":"28 1","pages":"22"},"PeriodicalIF":3.3000,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11762609/pdf/","citationCount":"0","resultStr":"{\"title\":\"Osilodrostat improves blood pressure and glycemic control in patients with Cushing's disease: a pooled analysis of LINC 3 and LINC 4 studies.\",\"authors\":\"Maria Fleseriu, Rosario Pivonello, John Newell-Price, Mônica R Gadelha, Beverly M K Biller, Richard J Auchus, Richard A Feelders, Akira Shimatsu, Przemysław Witek, Marie Bex, Andrea Piacentini, Alberto M Pedroncelli, André Lacroix\",\"doi\":\"10.1007/s11102-024-01471-3\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>To evaluate the effect of osilodrostat and hypercortisolism control on blood pressure (BP) and glycemic control in patients with Cushing's disease.</p><p><strong>Methods: </strong>Pooled analysis of two Phase III osilodrostat studies (LINC 3 and LINC 4), both comprising a 48-week core phase and an optional open-label extension. Changes from baseline in systolic and diastolic BP (SBP and DBP), fasting plasma glucose (FPG), and glycated hemoglobin (HbA<sub>1c</sub>) were evaluated during osilodrostat treatment in patients with/without hypertension or diabetes at baseline.</p><p><strong>Results: </strong>Of 210 patients, 82.9% met criteria for hypertension and 40.0% for diabetes at baseline. In patients with hypertension, reductions in mean SBP/DBP were observed from week (W)12 to W72, and 49.1%/58.5% of patients with high SBP/DBP (> 130/>90 mmHg) at baseline had normotensive levels at W72. Antihypertensive medication dose was reduced/stopped in 26.8% of patients, and the proportion taking antihypertensive medication decreased from 54.3% at baseline to 47.3% at W72. In patients with diabetes, mean FPG and HbA<sub>1c</sub> decreased from W12 to W72, and 33.3%/61.5% with high FPG/HbA<sub>1c</sub> (≥ 100 mg/dL/≥6.5%) at baseline had normal levels at W72. Antihyperglycemic medication dose was reduced/stopped in 35.7% of patients, and the proportion taking antihyperglycemic medication decreased from 21.9% at baseline to 17.1% at W72; improvements in SBP/DBP and FPG/HbA<sub>1c</sub> were correlated with improvement in mean urinary free cortisol but not weight change. BP/glycemic parameters generally remained normal in patients without hypertension/diabetes at baseline.</p><p><strong>Conclusions: </strong>Patients with Cushing's disease and comorbid hypertension/diabetes receiving osilodrostat had rapid and sustained improvements in SBP/DBP and glycemic control, respectively.</p>\",\"PeriodicalId\":20202,\"journal\":{\"name\":\"Pituitary\",\"volume\":\"28 1\",\"pages\":\"22\"},\"PeriodicalIF\":3.3000,\"publicationDate\":\"2025-01-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11762609/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pituitary\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s11102-024-01471-3\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pituitary","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s11102-024-01471-3","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
Osilodrostat improves blood pressure and glycemic control in patients with Cushing's disease: a pooled analysis of LINC 3 and LINC 4 studies.
Purpose: To evaluate the effect of osilodrostat and hypercortisolism control on blood pressure (BP) and glycemic control in patients with Cushing's disease.
Methods: Pooled analysis of two Phase III osilodrostat studies (LINC 3 and LINC 4), both comprising a 48-week core phase and an optional open-label extension. Changes from baseline in systolic and diastolic BP (SBP and DBP), fasting plasma glucose (FPG), and glycated hemoglobin (HbA1c) were evaluated during osilodrostat treatment in patients with/without hypertension or diabetes at baseline.
Results: Of 210 patients, 82.9% met criteria for hypertension and 40.0% for diabetes at baseline. In patients with hypertension, reductions in mean SBP/DBP were observed from week (W)12 to W72, and 49.1%/58.5% of patients with high SBP/DBP (> 130/>90 mmHg) at baseline had normotensive levels at W72. Antihypertensive medication dose was reduced/stopped in 26.8% of patients, and the proportion taking antihypertensive medication decreased from 54.3% at baseline to 47.3% at W72. In patients with diabetes, mean FPG and HbA1c decreased from W12 to W72, and 33.3%/61.5% with high FPG/HbA1c (≥ 100 mg/dL/≥6.5%) at baseline had normal levels at W72. Antihyperglycemic medication dose was reduced/stopped in 35.7% of patients, and the proportion taking antihyperglycemic medication decreased from 21.9% at baseline to 17.1% at W72; improvements in SBP/DBP and FPG/HbA1c were correlated with improvement in mean urinary free cortisol but not weight change. BP/glycemic parameters generally remained normal in patients without hypertension/diabetes at baseline.
Conclusions: Patients with Cushing's disease and comorbid hypertension/diabetes receiving osilodrostat had rapid and sustained improvements in SBP/DBP and glycemic control, respectively.
期刊介绍：
Pituitary is an international publication devoted to basic and clinical aspects of the pituitary gland. It is designed to publish original, high quality research in both basic and pituitary function as well as clinical pituitary disease.
The journal considers:
Biology of Pituitary Tumors
Mechanisms of Pituitary Hormone Secretion
Regulation of Pituitary Function
Prospective Clinical Studies of Pituitary Disease
Critical Basic and Clinical Reviews
Pituitary is directed at basic investigators, physiologists, clinical adult and pediatric endocrinologists, neurosurgeons and reproductive endocrinologists interested in the broad field of the pituitary and its disorders. The Editorial Board has been drawn from international experts in basic and clinical endocrinology. The journal offers a rapid turnaround time for review of manuscripts, and the high standard of the journal is maintained by a selective peer-review process which aims to publish only the highest quality manuscripts. Pituitary will foster the publication of creative scholarship as it pertains to the pituitary and will provide a forum for basic scientists and clinicians to publish their high quality pituitary-related work.
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