Trial reportEuropean journal of endocrinology2020
Pasireotide for acromegaly: long-term outcomes from an extension to the Phase III PAOLA study.
Trial report in European journal of endocrinology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01137682 (A Phase III, Multicenter, Randomized, Parallel-group Study to Assess the Efficacy and Safety of Double-blind Pasireotide LAR 40 mg and Pasireotide LAR 60 mg Versus Open-label Octreotide LAR or Lanreotide ATG in Patients With Inadequately Controlled Acromegaly), which is not on this map. Cited by 43 papers, 3 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 III, Multicenter, Randomized, Parallel-group Study to Assess the Efficacy and Safety of Double-blind Pasireotide LAR 40 mg and Pasireotide LAR 60 mg Versus Open-label Octreotide LAR or Lanreotide ATG in Patients With Inadequately Controlled Acromegaly
Who cites it
43 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Comparison of somatostatin analogues on glucose metabolism: A systematic review and network Meta-Analysis of randomized controlled trials.Endocrine · 2026Pooled it
- Impact of pasireotide on lipid and glucose metabolism in patients with acromegaly: a systematic review and meta-analysis.Journal of endocrinological investigation · 2025Pooled it
- Pasireotide-Induced Shrinkage in GH and ACTH Secreting Pituitary Adenoma: A Systematic Review and Meta-Analysis.Frontiers in endocrinology · 2022Pooled it
- Predictive factors and the management of hyperglycemia in patients with acromegaly and Cushing's disease receiving pasireotide treatment:Frontiers in endocrinology · 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
- Long-term efficacy and safety of subcutaneous pasireotide alone or in combination with cabergoline in Cushing's disease.Frontiers in endocrinology · 2023Trial
- Disease and Treatment-Related Burden in Patients With Acromegaly Who Are Biochemically Controlled on Injectable Somatostatin Receptor Ligands.Frontiers in endocrinology · 2021Trial
- Can acromegaly be controlled in all cases?Journal of neuroendocrinology · 2026Review
- The acromegaly patient experience: burden of treatment and quality of life.The Journal of clinical endocrinology and metabolism · 2026Review
- Current treatment landscape of acromegaly.The Journal of clinical endocrinology and metabolism · 2026Review
- Consensus on acromegaly complications: an update.Pituitary · 2026Article
- Anti-secretory and anti-proliferative actions of next-generation dual subtype 2 and 5 somatostatin receptor ligands in neuroendocrine tumor models.Frontiers in oncology · 2026Article
- Consensus on acromegaly therapeutic outcomes: an update.Nature reviews. Endocrinology · 2025Review
- The paradoxical GH response at OGTT does not predict Pasireotide efficacy but matters for glucose metabolism.Journal of endocrinological investigation · 2025Article
- Article
- Short- and long-term glycemic effects of pasireotide in patients with acromegaly: a comprehensive case study with review of literature.Endocrine journal · 2025Review
- The Spectrum of GH Excess in Carney Complex and Genotype-phenotype Correlations.The Journal of clinical endocrinology and metabolism · 2025Article
- Acromegaly: diagnostic challenges and individualized treatment.Expert review of endocrinology & metabolism · 2025Review
- Somatostatin receptors in pituitary somatotroph adenomas as predictors of response to somatostatin receptor ligands: A pathologist's perspective.Brain pathology (Zurich, Switzerland) · 2025Review
- Real-Life Data on the Safety of Pasireotide in Acromegaly: Insights from EudraVigilance.Pharmaceuticals (Basel, Switzerland) · 2024Article
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveIn the Phase III PAOLA study (clinicaltrials.gov: NCT01137682), enrolled patients had uncontrolled acromegaly despite ≥6 months of octreotide/lanreotide treatment before study start. More patients achieved biochemical control with long-acting pasireotide versus continued treatment with octreotide/lanreotide (active control) at month 6. The current work assessed the extent of comorbidities at baseline and outcomes during a long-term extension. DESIGN/
methodsPatients receiving pasireotide 40 or 60 mg at core study end could continue on the same dose in an extension phase if biochemically controlled or receive pasireotide 60 mg if uncontrolled. Uncontrolled patients on active control were switched to pasireotide 40 mg, with the dose increased at week 16 of the extension if still uncontrolled (crossover group). Efficacy and safety are reported to 304 weeks (~5.8 years) for patients randomized to pasireotide (core + extension), and 268 weeks for patients in the crossover group (extension only).
resultsAlmost half (49.5%; 98/198) of patients had ≥3 comorbidities at core baseline. During the extension, 173 patients received pasireotide. Pasireotide effectively and consistently reduced GH and IGF-I levels for up to 5.8 years' treatment; 37.0% of patients achieved GH <1.0 µg/L and normal IGF-I at some point during the core or extension. Improvements were observed in key symptoms. The long-term safety profile was similar to that in the core study; 23/173 patients discontinued treatment because of adverse events.
conclusionsIn this patient population with a high burden of comorbid illness, pasireotide was well tolerated and efficacious, providing prolonged maintenance of biochemical control and improving symptoms.
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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 Socratic graph.