Predictive factors and the management of hyperglycemia in patients with acromegaly and Cushing’s disease receiving pasireotide treatment: post hoc analyses from the SOM230B2219 study
IntroductionPasireotide, a somatostatin receptor ligand, is approved for treating acromegaly and Cushing’s disease (CD). Hyperglycemia during treatment can occur because of the drug’s mechanism of action, although treatment discontinuation is rarely required. The prospective, randomized, Phase IV SO...
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Frontiers Media S.A.
2024-03-01
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| Series: | Frontiers in Endocrinology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fendo.2024.1250822/full |
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| author | Ulla Feldt-Rasmussen Ulla Feldt-Rasmussen Marek Bolanowski Shao-Ling Zhang Yerong Yu Przemysław Witek Pramila Kalra Noppadol Kietsiriroje Andrea Piacentini Alberto M. Pedroncelli Susan L. Samson |
| author_facet | Ulla Feldt-Rasmussen Ulla Feldt-Rasmussen Marek Bolanowski Shao-Ling Zhang Yerong Yu Przemysław Witek Pramila Kalra Noppadol Kietsiriroje Andrea Piacentini Alberto M. Pedroncelli Susan L. Samson |
| author_sort | Ulla Feldt-Rasmussen |
| collection | DOAJ |
| description | IntroductionPasireotide, a somatostatin receptor ligand, is approved for treating acromegaly and Cushing’s disease (CD). Hyperglycemia during treatment can occur because of the drug’s mechanism of action, although treatment discontinuation is rarely required. The prospective, randomized, Phase IV SOM230B2219 (NCT02060383) trial was designed to assess optimal management of pasireotide-associated hyperglycemia. Here, we investigated predictive factors for requiring antihyperglycemic medication during pasireotide treatment.MethodsParticipants with acromegaly or CD initiated long-acting pasireotide 40 mg/28 days intramuscularly (acromegaly) or pasireotide 600 μg subcutaneously twice daily during pre-randomization (≤16 weeks). Those who did not need antihyperglycemic medication, were managed with metformin, or received insulin from baseline entered an observational arm ending at 16 weeks. Those who required additional/alternative antihyperglycemic medication to metformin were randomized to incretin-based therapy or insulin for an additional 16 weeks. Logistic-regression analyses evaluated quantitative and qualitative factors for requiring antihyperglycemic medication during pre-randomization.ResultsOf 190 participants with acromegaly and 59 with CD, 88 and 15, respectively, did not need antihyperglycemic medication; most were aged <40 years (acromegaly 62.5%, CD 86.7%), with baseline glycated hemoglobin (HbA1c) <6.5% (<48 mmol/mol; acromegaly 98.9%, CD 100%) and fasting plasma glucose (FPG) <100 mg/dL (<5.6 mmol/L; acromegaly 76.1%, CD 100%). By logistic regression, increasing baseline HbA1c (odds ratio [OR] 3.6; P=0.0162) and FPG (OR 1.0; P=0.0472) and history of diabetes/pre-diabetes (OR 3.0; P=0.0221) predicted receipt of antihyperglycemic medication in acromegaly participants; increasing baseline HbA1c (OR 12.6; P=0.0276) was also predictive in CD participants. Investigator-reported hyperglycemia-related adverse events were recorded in 47.9% and 54.2% of acromegaly and CD participants, respectively, mainly those with diabetes/pre-diabetes.ConclusionIncreasing age, HbA1c, and FPG and pre-diabetes/diabetes were associated with increased likelihood of requiring antihyperglycemic medication during pasireotide treatment. These risk factors may be used to identify those who need more vigilant monitoring to optimize outcomes during pasireotide treatment. |
| first_indexed | 2024-04-24T21:39:21Z |
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| issn | 1664-2392 |
| language | English |
| last_indexed | 2024-04-24T21:39:21Z |
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| series | Frontiers in Endocrinology |
| spelling | doaj.art-5afcf0fd8e6c4464b10108cdfc6742122024-03-21T10:13:34ZengFrontiers Media S.A.Frontiers in Endocrinology1664-23922024-03-011510.3389/fendo.2024.12508221250822Predictive factors and the management of hyperglycemia in patients with acromegaly and Cushing’s disease receiving pasireotide treatment: post hoc analyses from the SOM230B2219 studyUlla Feldt-Rasmussen0Ulla Feldt-Rasmussen1Marek Bolanowski2Shao-Ling Zhang3Yerong Yu4Przemysław Witek5Pramila Kalra6Noppadol Kietsiriroje7Andrea Piacentini8Alberto M. Pedroncelli9Susan L. Samson10Department of Medical Endocrinology and Metabolism, Copenhagen University Hospital Rigshospitalet, Copenhagen, DenmarkInstitute of Clinical Medicine, Faculty of Health and Medical Sciences, Copenhagen University, Copenhagen, DenmarkDepartment of Endocrinology, Diabetes and Isotope Therapy, Wroclaw Medical University, Wroclaw, PolandSun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, ChinaWest China Hospital, Sichuan University, Chengdu, ChinaDepartment of Internal Medicine, Endocrinology and Diabetes, Medical University of Warsaw, Warsaw, PolandDepartment of Endocrinology, MS Ramaiah Medical College and Hospitals, Bengaluru, IndiaEndocrinology and Metabolism Unit, Internal Medicine Department, Faculty of Medicine, Prince of Songkla University, Songkhla, ThailandRecordati SpA, Milan, Italy0Recordati AG, Basel, Switzerland1Departments of Medicine and Neurologic Surgery, Mayo Clinic, Jacksonville, FL, United StatesIntroductionPasireotide, a somatostatin receptor ligand, is approved for treating acromegaly and Cushing’s disease (CD). Hyperglycemia during treatment can occur because of the drug’s mechanism of action, although treatment discontinuation is rarely required. The prospective, randomized, Phase IV SOM230B2219 (NCT02060383) trial was designed to assess optimal management of pasireotide-associated hyperglycemia. Here, we investigated predictive factors for requiring antihyperglycemic medication during pasireotide treatment.MethodsParticipants with acromegaly or CD initiated long-acting pasireotide 40 mg/28 days intramuscularly (acromegaly) or pasireotide 600 μg subcutaneously twice daily during pre-randomization (≤16 weeks). Those who did not need antihyperglycemic medication, were managed with metformin, or received insulin from baseline entered an observational arm ending at 16 weeks. Those who required additional/alternative antihyperglycemic medication to metformin were randomized to incretin-based therapy or insulin for an additional 16 weeks. Logistic-regression analyses evaluated quantitative and qualitative factors for requiring antihyperglycemic medication during pre-randomization.ResultsOf 190 participants with acromegaly and 59 with CD, 88 and 15, respectively, did not need antihyperglycemic medication; most were aged <40 years (acromegaly 62.5%, CD 86.7%), with baseline glycated hemoglobin (HbA1c) <6.5% (<48 mmol/mol; acromegaly 98.9%, CD 100%) and fasting plasma glucose (FPG) <100 mg/dL (<5.6 mmol/L; acromegaly 76.1%, CD 100%). By logistic regression, increasing baseline HbA1c (odds ratio [OR] 3.6; P=0.0162) and FPG (OR 1.0; P=0.0472) and history of diabetes/pre-diabetes (OR 3.0; P=0.0221) predicted receipt of antihyperglycemic medication in acromegaly participants; increasing baseline HbA1c (OR 12.6; P=0.0276) was also predictive in CD participants. Investigator-reported hyperglycemia-related adverse events were recorded in 47.9% and 54.2% of acromegaly and CD participants, respectively, mainly those with diabetes/pre-diabetes.ConclusionIncreasing age, HbA1c, and FPG and pre-diabetes/diabetes were associated with increased likelihood of requiring antihyperglycemic medication during pasireotide treatment. These risk factors may be used to identify those who need more vigilant monitoring to optimize outcomes during pasireotide treatment.https://www.frontiersin.org/articles/10.3389/fendo.2024.1250822/fullhyperglycemiaglucose intolerancediabetes mellituspasireotideacromegalyCushing’s disease |
| spellingShingle | Ulla Feldt-Rasmussen Ulla Feldt-Rasmussen Marek Bolanowski Shao-Ling Zhang Yerong Yu Przemysław Witek Pramila Kalra Noppadol Kietsiriroje Andrea Piacentini Alberto M. Pedroncelli Susan L. Samson Predictive factors and the management of hyperglycemia in patients with acromegaly and Cushing’s disease receiving pasireotide treatment: post hoc analyses from the SOM230B2219 study Frontiers in Endocrinology hyperglycemia glucose intolerance diabetes mellitus pasireotide acromegaly Cushing’s disease |
| title | Predictive factors and the management of hyperglycemia in patients with acromegaly and Cushing’s disease receiving pasireotide treatment: post hoc analyses from the SOM230B2219 study |
| title_full | Predictive factors and the management of hyperglycemia in patients with acromegaly and Cushing’s disease receiving pasireotide treatment: post hoc analyses from the SOM230B2219 study |
| title_fullStr | Predictive factors and the management of hyperglycemia in patients with acromegaly and Cushing’s disease receiving pasireotide treatment: post hoc analyses from the SOM230B2219 study |
| title_full_unstemmed | Predictive factors and the management of hyperglycemia in patients with acromegaly and Cushing’s disease receiving pasireotide treatment: post hoc analyses from the SOM230B2219 study |
| title_short | Predictive factors and the management of hyperglycemia in patients with acromegaly and Cushing’s disease receiving pasireotide treatment: post hoc analyses from the SOM230B2219 study |
| title_sort | predictive factors and the management of hyperglycemia in patients with acromegaly and cushing s disease receiving pasireotide treatment post hoc analyses from the som230b2219 study |
| topic | hyperglycemia glucose intolerance diabetes mellitus pasireotide acromegaly Cushing’s disease |
| url | https://www.frontiersin.org/articles/10.3389/fendo.2024.1250822/full |
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