Long-Term Safety of Pegvisomant in Patients with Acromegaly: Comprehensive Review of 1288 Subjects in ACROSTUDY

Lely, Aart Jan van der; Biller, Beverly M. K.; Brue, Thierry; Buchfelder, Michael; Ghigo, Ezio; Gomez, Roy; Hey-Hadavi, Judith; Lundgren, Frida; Rajicic, Natasa; Strasburger, Christian J.; Webb, Susan M.; Kołtowska-Häggström, Maria

doi:10.1210/jc.2011-2508

Cited by 227 publications

(232 citation statements)

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“…31,32 GH receptor antagonist The efficacy of the GHRA pegvisomant in normalizing IGF-I levels in acromegaly is well established (HQ). 33 At the appropriate dose, pegvisomant normalizes IGF-I levels in most patients (MQ). Long-term data on the efficacy and safety profile of pegvisomant are reassuring and few long-term serious adverse events have been reported (MQ), 33 but ongoing vigilance is required to monitor liver function and tumour size (SR).…”

Section: Dopamine Agonistmentioning

confidence: 99%

“…33 At the appropriate dose, pegvisomant normalizes IGF-I levels in most patients (MQ). Long-term data on the efficacy and safety profile of pegvisomant are reassuring and few long-term serious adverse events have been reported (MQ), 33 but ongoing vigilance is required to monitor liver function and tumour size (SR). 33 Lipodystrophy can occur at the injection site (LQ).…”

Section: Dopamine Agonistmentioning

confidence: 99%

“…Long-term data on the efficacy and safety profile of pegvisomant are reassuring and few long-term serious adverse events have been reported (MQ), 33 but ongoing vigilance is required to monitor liver function and tumour size (SR). 33 Lipodystrophy can occur at the injection site (LQ). 34 A discrepancy exists between the proportion of patients achieving normal IGF-I levels during treatment with pegvisomant in randomized controlled trials and community-based databases, suggesting differences in participant selection, dose titration, patient compliance, history of earlier irradiation, and occurrence of adverse events (LQ).…”

Section: Dopamine Agonistmentioning

confidence: 99%

“…34 A discrepancy exists between the proportion of patients achieving normal IGF-I levels during treatment with pegvisomant in randomized controlled trials and community-based databases, suggesting differences in participant selection, dose titration, patient compliance, history of earlier irradiation, and occurrence of adverse events (LQ). 33,[35][36][37] If long-term control of acromegaly is achieved with pegvisomant, down-titration of the dose or decreasing the frequency of administration might be possible (DR).…”

Section: Dopamine Agonistmentioning

confidence: 99%

“…31 Current data show that pegvisomant therapy rarely leads to GH-producing pituita ry tumour growth (MQ). 33,[55][56][57] Recommendation for medical therapy…”

Section: Comorbiditiesmentioning

confidence: 99%

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Expert consensus document: A consensus on the medical treatment of acromegaly

et al. 2014

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| In March 2013, the Acromegaly Consensus Group met to revise and update guidelines for the medical treatment of acromegaly. The meeting comprised experts skilled in the medical management of acromegaly. The group considered treatment goals covering biochemical, clinical and tumour volume outcomes, and the place in guidelines of somatostatin receptor ligands, growth hormone receptor antagonists and dopamine agonists, and alternative modalities for treatment including combination therapy and novel treatments. This document represents the conclusions of the workshop consensus.

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Section: Dopamine Agonistmentioning

confidence: 99%

Section: Dopamine Agonistmentioning

confidence: 99%

Section: Dopamine Agonistmentioning

confidence: 99%

Section: Dopamine Agonistmentioning

confidence: 99%

“…31 Current data show that pegvisomant therapy rarely leads to GH-producing pituita ry tumour growth (MQ). 33,[55][56][57] Recommendation for medical therapy…”

Section: Comorbiditiesmentioning

confidence: 99%

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Expert consensus document: A consensus on the medical treatment of acromegaly

et al. 2014

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Diagnosis and Treatment of Pituitary Adenomas

Molitch

2017

JAMA

782

578

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pproximately 10% of unselected pituitaries (meaning those from individuals without known pituitary disease) examined at autopsy contain pituitary adenomas. 1 Magnetic resonance imaging (MRI) scans of normal volunteers also show a 10% prevalence, 2 but other pathologic entities may have a similar appearance, such as Rathke cleft cysts and metastatic tumors. 3 Not all patients with pituitary tumors develop symptoms because most tumors remain small and most do not secrete hormones in excessive amounts. Clinical case-finding studies, in which all hospitals and practices in a geographic area were queried about cases with pituitary tumors over a defined period, have suggested a prevalence of pituitary adenoma ranging from 1 in 865 persons to 1 in 2688 persons (Table 1). 4,[6][7][8][9][10][11] Pituitary adenomas are classified into microadenomas (<10 mm), macroadenomas (Ն10 mm), and giant adenomas (Ն40 mm) (Figure 1). 12,13 Pituitary carcinomas with distant metastases are rare, occurring in 0.1% to 0.2% of cases. 12 If an MRI shows the tumor impinging on the optic chiasm, then formal visual field testing is indicated. 13 An evaluation for hypopituitarism should be carried out in all patients with macroadenomas and even large (6-9 mm) microadenomas. 1 Diabetes insipidus is rarely seen with pituitary adenomas. 1 About two-thirds of pituitary adenomas may secrete excess hormones. In the studies 4,6-11 that included 1718 patients, about 50% of cases were macroadenomas and 32% to 66% of tumors were secreting prolactin, 14% to 54% were clinically nonfunction-IMPORTANCE Pituitary adenomas may hypersecrete hormones or cause mass effects. Therefore, early diagnosis and treatment are important.OBSERVATIONS Prevalence of pituitary adenomas ranges from 1 in 865 adults to 1 in 2688 adults. Approximately 50% are microadenomas (<10 mm); the remainder are macroadenomas (Ն10 mm). Mass effects cause headache, hypopituitarism, and visual field defects. Treatments include transsphenoidal surgery, medical therapies, and radiotherapy. Prolactinomas account for 32% to 66% of adenomas and present with amenorrhea, loss of libido, galactorrhea, and infertility in women and loss of libido, erectile dysfunction, and infertility in men; they are generally treated with the dopamine agonists cabergoline and bromocriptine. Growth hormone-secreting tumors account for 8% to 16% of tumors and usually present with enlargement of the lips, tongue, nose, hands, and feet and are diagnosed by elevated insulin-like growth factor 1 levels and growth hormone levels; initial treatment is surgical. Medical therapy with somatostatin analogues, cabergoline, and pegvisomant is often also needed. Adrenocorticotropic hormone (ACTH)-secreting tumors account for 2% to 6% of adenomas and are associated with obesity, hypertension, diabetes, and other morbidity. Measurement of a late-night salivary cortisol level is the best screening test but petrosal sinus sampling for ACTH may be necessary to distinguish a pituitary from an ectopic source. The primary treatment of Cushin...

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