Trial reportThe Journal of clinical endocrinology and metabolism2020
Maintenance of Acromegaly Control in Patients Switching From Injectable Somatostatin Receptor Ligands to Oral Octreotide.
Trial report in The Journal of clinical endocrinology and metabolism, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03252353 (A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of Octreotide Capsules in Patients Who Demonstrated Biochemical Control on Injectable Somatostatin Receptor Ligands), which is not on this map. Cited by 45 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of Octreotide Capsules in Patients Who Demonstrated Biochemical Control on Injectable Somatostatin Receptor Ligands (SRL) Treatment
Who cites it
45 citing papers in PubMed, 2 syntheses or guidelines pooled it, 99 citations in OpenAlex.
- Efficacy and safety of pharmacologic therapies in acromegaly: a systematic literature review and network meta-analysis.The Journal of clinical endocrinology and metabolism · 2026Pooled it
- Management of liver metastases from non-functional gastroenteropancreatic neuroendocrine tumors: a systematic review.Frontiers in endocrinology · 2025Pooled it
- Octreotide Subcutaneous Depot for Acromegaly: A Randomized, Double-blind, Placebo-controlled Phase 3 Trial, ACROINNOVA 1.The Journal of clinical endocrinology and metabolism · 2025Trial
- Acromegaly Disease Control Maintained After Switching From Injected Somatostatin Receptor Ligands to Oral Paltusotine.The Journal of clinical endocrinology and metabolism · 2024Trial
- MPOWERED Trial Open-Label Extension: Long-term Efficacy and Safety Data for Oral Octreotide Capsules in Acromegaly.The Journal of clinical endocrinology and metabolism · 2023Trial
- ACROBAT Edge: Safety and Efficacy of Switching Injected SRLs to Oral Paltusotine in Patients With Acromegaly.The Journal of clinical endocrinology and metabolism · 2023Trial
- Durable biochemical response and safety with oral octreotide capsules in acromegaly.European journal of endocrinology · 2022Trial
- Oral octreotide capsules for the treatment of acromegaly: comparison of 2 phase 3 trial results.Pituitary · 2021Trial
- Current treatment landscape of acromegaly.The Journal of clinical endocrinology and metabolism · 2026Review
- Acromegaly complications: an update.The Journal of clinical endocrinology and metabolism · 2026Review
- What is the future of acromegaly therapy?The Journal of clinical endocrinology and metabolism · 2026Review
- Current controversies in acromegaly care.The Journal of clinical endocrinology and metabolism · 2026Review
- Review
- Reappraisal of colorectal polyps in acromegaly: study on prevalence, recurrence and risk factors.Pituitary · 2026Article
- Association between vertebral fracture risk and bone mineral density in patients with acromegaly.Pituitary · 2025Article
- Consensus on acromegaly therapeutic outcomes: an update.Nature reviews. Endocrinology · 2025Review
- Ends of the spectrum best practices for early detection and multidisciplinary management of acromegaly.Journal of neuro-oncology · 2025Review
- Acromegaly: diagnostic challenges and individualized treatment.Expert review of endocrinology & metabolism · 2025Review
- IGF-I levels during standard Lanreotide dose predicts biochemical outcome of high-frequency regimen in acromegaly.Pituitary · 2024Article
- Novel approach to bone comorbidity in resistant acromegaly.Pituitary · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 14 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe 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).
methodsIn 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.
resultsMean 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 (< 2.5 ng/mL) in 77.7% for OOC vs 30.4% for placebo (P = .0007). Median time to loss of response (IGF-1 > 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.
conclusionsOOCs may be an effective therapy for patients with acromegaly who previously were treated with injectable SRLs.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.