The DOI matches its Crossref record; 13 of the 13 references it cites were found in a registry or an index.
Long-Term Safety of Pegvisomant in Patients with Acromegaly: Comprehensive Review of 1288 Subjects in ACROSTUDY
Open accessAbstract
CONTEXT: Pegvisomant is a GH receptor antagonist. The ACROSTUDY is a global safety surveillance study of long-term treatment of acromegaly with pegvisomant. OBJECTIVE: The objective of the study was to monitor long-term safety and treatment outcomes. DESIGN: ACROSTUDY is open to all patients with acromegaly who are treated with pegvisomant. We report an interim analysis of data captured from 1288 subjects enrolled before a database freeze of December 31, 2009. SETTING: This was a global noninterventional surveillance study. MAIN OUTCOME MEASURE(S): Long-term monitoring of safety, including central magnetic resonance imaging (MRI) reading and treatment outcomes, was measured. RESULTS: Subjects (n = 1288) were treated with pegvisomant for a mean of 3.7 yr and followed up in ACROSTUDY for a mean of 2.1 yr. A total of 1147 adverse events (AE) were recorded in 477 subjects (37%), among which 192 AE in 124 subjects (9.6%) were considered to be related to pegvisomant. Serious AE were recorded in 159 subjects (12.3%), whereas pegvisomant-related Serious AE were recorded in 26 subjects (2%). No deaths (15 subjects; 1.2%) were attributed to pegvisomant use. The incidence of increase in pituitary tumor size in the subset with confirmed MRI increases on central reading represented 3.2% of the overall cohort with at least two available MRI (n = 936). Injection-site reactions were reported in 28 cases (2.2%). In 30 patients (2.5%), an elevated aspartate aminotransferase or alanine aminotransferase of more than 3 times the upper level of normality was reported. There were no reports of liver failure. After 5 yr of pegvisomant treatment, 63.2% of subjects had normal IGF-I levels at a mean dose of 18 mg/d. CONCLUSIONS: Data entered and evaluated in ACROSTUDY indicate that pegvisomant is an effective and safe medical treatment in patients with acromegaly. The reported low incidence of pituitary tumor size increase, liver enzyme elevations, and lipodystrophy at the injection site are reassuring.
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Cites
Treatment of Acromegaly with the Growth Hormone–Receptor Antagonist Pegvisomant
Trainer, P. J., Drake, W. M., Katznelson, L., Freda, P. U., Herman-Bonert, V., van der Lely, A. J., Dimaraki, E. V., Stewart, P. M., Friend, K. E., Vance, M. L., et al. (2000) · New England Journal of Medicine · doi:10.1056/nejm200004203421604 · Cited by 879
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
Acromegaly pathogenesis and treatment
Melmed, S. (2009) · Journal of Clinical Investigation · doi:10.1172/jci39375 · Cited by 687
Long-term treatment of acromegaly with pegvisomant, a growth hormone receptor antagonist
van der Lely, A. J., Hutson, R. K., Trainer, P. J., Besser, G. M., Barkan, A. L., Katznelson, L., Klibanski, A., Herman-Bonert, V., Melmed, S., Vance, M. L., et al. (2001) · The Lancet · doi:10.1016/s0140-6736(01)06844-1 · Cited by 645
Self-citationGrowth Hormone Receptor Antagonists: Discovery, Development, and Use in Patients with Acromegaly
Kopchick, J. J., Parkinson, C., Stevens, E. C., & Trainer, P. J. (2002) · Endocrine Reviews · doi:10.1210/er.2001-0022 · Cited by 352
Petersenn, S., Schopohl, J., Barkan, A., Mohideen, P., Colao, A., Abs, R., Buchelt, A., Ho, Y.-Y., Hu, K., Farrall, A. J., et al. (2010) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2009-2272 · Cited by 204
Self-citationSchreiber, I., Buchfelder, M., Droste, M., Forssmann, K., Mann, K., Saller, B., & Strasburger, C. J. (2007) · European Journal of Endocrinology · doi:10.1530/eje.1.02312 · Cited by 202
Self-citationColao, A., Pivonello, R., Auriemma, R. S., De Martino, M. C., Bidlingmaier, M., Briganti, F., Tortora, F., Burman, P., Kourides, I. A., Strasburger, C. J., et al. (2006) · European Journal of Endocrinology · doi:10.1530/eje.1.02112 · Cited by 167
Self-citationTrainer, P. J., Ezzat, S., D'Souza, G., Layton, G. R., & Strasburger, C. J. (2009) · Clinical Endocrinology · doi:10.1111/j.1365-2265.2009.03620.x · Cited by 140
Self-citationTrainer, P. J. (2009) · European Journal of Endocrinology · doi:10.1530/eje-09-0322 · Cited by 84
Cited by
Diagnosis and Treatment of Pituitary Adenomas: A Review
Molitch, M. E. (2017) · JAMA · doi:10.1001/jama.2016.19699 · Cited by 933
Interventions to slow aging in humans: are we ready?
Longo, V. D., Antebi, A., Bartke, A., Barzilai, N., Brown‐Borg, H. M., Caruso, C., Curiel, T. J., Cabo, R., Franceschi, C., Gems, D., et al. (2015) · Aging Cell · doi:10.1111/acel.12338 · Cited by 592
“Regarding adverse effects, van der Lely et al. (2012) reported that Long-term data on the efficacy and safety profile of pegvisomant are reassuring and few long-term serious adverse events have been reported but ongoing vigilance is required to monitor liver function and tumor size .”
The GH/IGF-1 axis in ageing and longevity
Junnila, R. K., List, E. O., Berryman, D. E., Murrey, J. W., & Kopchick, J. J. (2013) · Nature Reviews Endocrinology · doi:10.1038/nrendo.2013.67 · Cited by 574
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
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Metadata
- Authors
- van der Lely, A. J., Biller, B. M. K., Brue, T., Buchfelder, M., Ghigo, E., Gomez, R., Hey-Hadavi, J., Lundgren, F., Rajicic, N., Strasburger, C. J., Webb, S. M., & Kołtowska-Häggström, M.
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2012-05
- Volume
- 97
- Issue
- 5
- Pages
- 1589-1597
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- OpenAlex
- W1969427273
- Cited by
- 252
- References
- 13
- FWCI
- 21.86
- Type
- journal article
- Language
- en
- Open access
- green
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- van der Lely, A. J., Biller, B. M. K., Brue, T., Buchfelder, M., Ghigo, E., Gomez, R., Hey-Hadavi, J., Lundgren, F., Rajicic, N., Strasburger, C. J., Webb, S. M., & Kołtowska-Häggström, M. (2012). Long-Term Safety of Pegvisomant in Patients with Acromegaly: Comprehensive Review of 1288 Subjects in ACROSTUDY. The Journal of Clinical Endocrinology & Metabolism. https://doi.org/10.1210/jc.2011-2508
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