The DOI matches its Crossref record; 24 of the 24 references it cites were found in a registry or an index.
Pasireotide Versus Octreotide in Acromegaly: A Head-to-Head Superiority Study
Open accessAbstract
CONTEXT: Biochemical control reduces morbidity and increases life expectancy in patients with acromegaly. With current medical therapies, including the gold standard octreotide long-acting-release (LAR), many patients do not achieve biochemical control. OBJECTIVE: Our objective was to demonstrate the superiority of pasireotide LAR over octreotide LAR in medically naive patients with acromegaly. DESIGN AND SETTING: We conducted a prospective, randomized, double-blind study at 84 sites in 27 countries. PATIENTS: A total of 358 patients with medically naive acromegaly (GH >5 μg/L or GH nadir ≥1 μg/L after an oral glucose tolerance test (OGTT) and IGF-1 above the upper limit of normal) were enrolled. Patients either had previous pituitary surgery but no medical treatment or were de novo with a visible pituitary adenoma on magnetic resonance imaging. INTERVENTIONS: Patients received pasireotide LAR 40 mg/28 days (n = 176) or octreotide LAR 20 mg/28 days (n = 182) for 12 months. At months 3 and 7, titration to pasireotide LAR 60 mg or octreotide LAR 30 mg was permitted, but not mandatory, if GH ≥2.5μg/L and/or IGF-1 was above the upper limit of normal. MAIN OUTCOME MEASURE: The main outcome measure was the proportion of patients in each treatment arm with biochemical control (GH <2.5 μg/L and normal IGF-1) at month 12. RESULTS: Biochemical control was achieved by significantly more pasireotide LAR patients than octreotide LAR patients (31.3% vs 19.2%; P = .007; 35.8% vs 20.9% when including patients with IGF-1 below the lower normal limit). In pasireotide LAR and octreotide LAR patients, respectively, 38.6% and 23.6% (P = .002) achieved normal IGF-1, and 48.3% and 51.6% achieved GH <2.5 μg/L. 31.0% of pasireotide LAR and 22.2% of octreotide LAR patients who did not achieve biochemical control did not receive the recommended dose increase. Hyperglycemia-related adverse events were more common with pasireotide LAR (57.3% vs 21.7%). CONCLUSIONS: Pasireotide LAR demonstrated superior efficacy over octreotide LAR and is a viable new treatment option for acromegaly.
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Cites
Diagnosis and Classification of Diabetes Mellitus
American Diabetes Association (2011) · Diabetes Care · doi:10.2337/dc11-s062 · Cited by 13,988
Diagnosis and classification of diabetes mellitus
American Diabetes Association (2010) · Diabetes Care · doi:10.2337/dc10-s062 · Cited by 5,491
A Consensus on Criteria for Cure of Acromegaly
Giustina, A., Chanson, P., Bronstein, M. D., Klibanski, A., Lamberts, S., Casanueva, F. F., Trainer, P., Ghigo, E., Ho, K., & Melmed, S. (2010) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2009-2670 · Cited by 783
Self-citationGuidelines for Acromegaly Management: An Update
Melmed, S., Colao, A., Barkan, A., Molitch, M., Grossman, A. B., Kleinberg, D., Clemmons, D., Chanson, P., Laws, E., Schlechte, J., et al. (2009) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2008-2421 · Cited by 764
Self-citationBruns, C., Lewis, I., Briner, U., Meno-Tetang, G., & Weckbecker, G. (2002) · European Journal of Endocrinology · doi:10.1530/eje.0.1460707 · Cited by 692
The outcome of surgery in 668 patients with acromegaly using current criteria of biochemical ‘cure’
Nomikos, P., Buchfelder, M., & Fahlbusch, R. (2005) · European Journal of Endocrinology · doi:10.1530/eje.1.01863 · Cited by 500
A meta-analysis of the effect of lowering serum levels of GH and IGF-I on mortality in acromegaly
Holdaway, I. M., Bolland, M. J., & Gamble, G. D. (2008) · European Journal of Endocrinology · doi:10.1530/eje-08-0267 · Cited by 462
Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
(2008) · Principles and Practice of Clinical Trial Medicine · doi:10.1016/b978-0-12-373695-6.00022-3 · Cited by 457
Hyperglycemia Associated With Pasireotide: Results From a Mechanistic Study in Healthy Volunteers
Henry, R. R., Ciaraldi, T. P., Armstrong, D., Burke, P., Ligueros-Saylan, M., & Mudaliar, S. (2013) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2013-1771 · Cited by 251
Predictors of morbidity and mortality in acromegaly: an Italian survey
Arosio, M., Reimondo, G., Malchiodi, E., Berchialla, P., Borraccino, A., De Marinis, L., Pivonello, R., Grottoli, S., Losa, M., Cannavò, S., et al. (2012) · European Journal of Endocrinology · doi:10.1530/eje-12-0084 · Cited by 219
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Diagnosis and Treatment of Pituitary Adenomas: A Review
Molitch, M. E. (2017) · JAMA · doi:10.1001/jama.2016.19699 · Cited by 933
A Consensus Statement on acromegaly therapeutic outcomes
Melmed, S., Bronstein, M. D., Chanson, P., Klibanski, A., Casanueva, F. F., Wass, J. A. H., Strasburger, C. J., Luger, A., Clemmons, D. R., & Giustina, A. (2018) · Nature Reviews Endocrinology · doi:10.1038/s41574-018-0058-5 · Cited by 561
Self-citationGadelha, M. R., Bronstein, M. D., Brue, T., Coculescu, M., Fleseriu, M., Guitelman, M., Pronin, V., Raverot, G., Shimon, I., Lievre, K. K., et al. (2014) · The Lancet Diabetes & Endocrinology · doi:10.1016/s2213-8587(14)70169-x · Cited by 396
Self-citationColao, A., Grasso, L. F. S., Giustina, A., Melmed, S., Chanson, P., Pereira, A. M., & Pivonello, R. (2019) · Nature Reviews Disease Primers · doi:10.1038/s41572-019-0071-6 · Cited by 396
Self-citationA Consensus on the Diagnosis and Treatment of Acromegaly Comorbidities: An Update
Giustina, A., Barkan, A., Beckers, A., Biermasz, N., Biller, B. M. K., Boguszewski, C., Bolanowski, M., Bonert, V., Bronstein, M. D., Casanueva, F. F., et al. (2020) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/clinem/dgz096 · Cited by 371
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Metadata
- Authors
- Colao, A., Bronstein, M. D., Freda, P., Gu, F., Shen, C.-C., Gadelha, M., Fleseriu, M., van der Lely, A. J., Farrall, A. J., Hermosillo Reséndiz, K., Ruffin, M., Chen, Y., Sheppard, M., & on behalf of the Pasireotide C2305 Study Group
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2014-03-01
- Volume
- 99
- Issue
- 3
- Pages
- 791-799
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- OpenAlex
- W1996943463
- Cited by
- 400
- References
- 24
- FWCI
- 33.51
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Colao, A., Bronstein, M. D., Freda, P., Gu, F., Shen, C.-C., Gadelha, M., Fleseriu, M., van der Lely, A. J., Farrall, A. J., Hermosillo Reséndiz, K., Ruffin, M., Chen, Y., Sheppard, M., & on behalf of the Pasireotide C2305 Study Group. (2014). Pasireotide Versus Octreotide in Acromegaly: A Head-to-Head Superiority Study. The Journal of Clinical Endocrinology & Metabolism. https://doi.org/10.1210/jc.2013-2480
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