Maintenance of Acromegaly Control in Patients Switching From Injectable Somatostatin Receptor Ligands to Oral Octreotide
| Autor: | Laurence Kennedy, Andrea Giustina, Asi Haviv, Peter J Trainer, William H. Ludlam, Artak Labadzhyan, Gary Patou, Marek Bolanowski, Maria Fleseriu, Shlomo Melmed, Nienke R. Biermasz, Murray B. Gordon, Susan L. Samson, Lisa B. Nachtigall, Mark E. Molitch, Ehud Ur, Christian J. Strasburger |
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| Rok vydání: | 2020 |
| Předmět: |
Male
Endocrinology Diabetes and Metabolism Clinical Biochemistry Administration Oral Octreotide Growth hormone Biochemistry Gastroenterology Placebos 0302 clinical medicine Endocrinology Clinical endpoint Medicine Prospective Studies Insulin-Like Growth Factor I somatostatin analogues Drug Substitution Human Growth Hormone Somatostatin receptor Middle Aged Safety profile Treatment Outcome IGF-1 Female Somatostatin AcademicSubjects/MED00250 medicine.drug Adult medicine.medical_specialty 030209 endocrinology & metabolism Placebo Injections 03 medical and health sciences Double-Blind Method oral octreotide Internal medicine Acromegaly Humans In patient Clinical Research Articles Aged business.industry Biochemistry (medical) medicine.disease somatostatin receptor ligands growth hormone acromegaly business 030217 neurology & neurosurgery |
| Zdroj: | The Journal of Clinical Endocrinology and Metabolism Journal of Clinical Endocrinology and Metabolism, 105(10), e3785-e3797. ENDOCRINE SOC |
| ISSN: | 1945-7197 0021-972X 0325-2353 |
| DOI: | 10.1210/clinem/dgaa526 |
| Popis: | Purpose The phase 3 CHIASMA OPTIMAL trial (NCT03252353) evaluated efficacy and safety of oral octreotide capsules (OOCs) in patients with acromegaly who previously demonstrated biochemical control while receiving injectable somatostatin receptor ligands (SRLs). Methods In this double-blind study, patients (N = 56) stratified by prior SRL dose were randomly assigned 1:1 to OOC or placebo for 36 weeks. The primary end point was maintenance of biochemical control at the end of treatment (mean insulin-like growth factor 1 [IGF-1] ≤ 1.0 × upper limit of normal [ULN]; weeks 34 and 36). Time to loss of IGF-1 response and proportion requiring reversion to injectable SRLs were assessed as broader control measures. Results Mean IGF-1 measurements were 0.80 and 0.97 × ULN for OOC and 0.84 and 1.69 × ULN for placebo, at baseline and end of treatment, respectively. Mean growth hormone (GH) changed from 0.66 to 0.60 ng/mL for OOCs and 0.90 to 2.57 ng/mL for placebo. Normalization of IGF-1 levels (≤ 1.0 × ULN) was maintained in 58.2% for OOCs vs 19.4% for placebo (P = .008); GH levels were maintained ( 1.0 or ≥ 1.3 × ULN definitions) for patients receiving placebo was 16 weeks; for patients receiving OOCs, it was not reached for both definitions during the 36-week trial (P < .0001). Of the patients in the OOC group, 75% completed the trial on oral therapy. The OOC safety profile was consistent with previous SRL experience. Conclusions OOCs may be an effective therapy for patients with acromegaly who previously were treated with injectable SRLs. |
| Databáze: | OpenAIRE |
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