Pegvisomant Improves Glucose Metabolism in Acromegaly: A Meta-Analysis of Prospective Interventional Studies

Feola, Tiziana; Cozzolino, Alessia; Simonelli, Ilaria; Sbardella, Emilia; Pozza, Carlotta; Giannetta, Elisa; Gianfrilli, Daniele; Pasqualetti, Patrizio; Lenzi, Andrea; Isidori, Andrea M.

doi:10.1210/jc.2018-02281

Cited by 56 publications

(49 citation statements)

References 40 publications

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“…In our study, approximately 60% of patients treated with PEGV presented an improvement of their prediabetes/diabetes status, which is very relevant in comparison to other medications that are neutral or might even worsen glycemic control. A recent metaanalysis of prospective interventional studies have shown that PEGV, in monotherapy or combined with SRLs, improves glucose metabolism by reducing fasting plasma glucose and insulin levels, HbA1c, and insulin resistance, independently of disease control (33). In agreement with that, a consensus statement on acromegaly therapeutic outcomes has recommended PEGV as the best medical option for patients with impaired glucose tolerance unresponsive to firstgeneration of SRLs, due to its beneficial effect on insulin sensitivity and glucose tolerance (15).…”

Section: Discussionmentioning

confidence: 96%

Brazilian multicenter study on pegvisomant treatment in acromegaly

Boguszewski¹,

Huayllas²,

Vilar³

et al. 2019

Archives of Endocrinology and Metabolism

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Objective: Investigate the therapeutic response of acromegaly patients to pegvisomant (PEGV) in a real-life, Brazilian multicenter study. Subjects and methods: Characteristics of acromegaly patients treated with PEGV were reviewed at diagnosis, just before and during treatment. All patients with at least two IGF-I measurements on PEGV were included. Efficacy was defined as any normal IGF-I measurement during treatment. Safety data were reviewed. Predictors of response were determined by comparing controlled versus uncontrolled patients. Results: 109 patients [61 women; median age at diagnosis 34 years; 95.3% macroadenomas] from 10 Brazilian centers were studied. Previous treatment included surgery (89%), radiotherapy (34%), somatostatin receptor ligands (99%), and cabergoline (67%). Before PEGV, median levels of GH, IGF-I and IGF-I % of upper limit of normal were 4.3 µg/L, 613 ng/mL, and 209%, respectively. Pre-diabetes/diabetes was present in 48.6% and tumor remnant in 71% of patients. Initial dose was 10 mg/day in all except 4 cases, maximum dose was 30 mg/day, and median exposure time was 30.5 months. PEGV was used as monotherapy in 11% of cases. Normal IGF-I levels was obtained in 74.1% of patients. Glycemic control improved in 56.6% of patients with pre-diabetes/diabetes. Exposure time, pre-treatment GH and IGF-I levels were predictors of response. Tumor enlargement occurred in 6.5% and elevation of liver enzymes in 9.2%. PEGV was discontinued in 6 patients and 3 deaths unrelated to the drug were reported. Conclusions: In a real-life scenario, PEGV is a highly effective and safe treatment for acromegaly patients not controlled with other therapies.

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Section: Discussionmentioning

confidence: 96%

Brazilian multicenter study on pegvisomant treatment in acromegaly

Boguszewski¹,

Huayllas²,

Vilar³

et al. 2019

Archives of Endocrinology and Metabolism

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“…Indeed, HOMA-I also decreased −0.61 (95% CI; −1.2 to −0.04). This increase in glucose metabolism was not correlated to IGF1 level [36].…”

Section: Metabolicmentioning

confidence: 62%

Pegvisomant in Acromegaly and Gigantism

Briet¹,

Suteau²,

Rodien³

2020

Growth Disorders and Acromegaly

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Pegvisomant is a GH antagonist used in acromegaly in gigantism. Pegvisomant is a modified GH molecule with pegylation to increase half-life and nine amino acid substitutions to modify GH receptor affinity and dimerization. Pegvisomant leads to an IGF1 decrease. It is administered subcutaneously every day with a median dose of 15 mg/ day in meta-analysis. This treatment is indicated in acromegaly or gigantism in case of resistance to somatostatin analogs. This drug leads to a control of acromegaly in 90% of patients in phase III study and about 70% of patients in real-life study. In gigantism, only 50% of children are controlled with pegvisomant. It is a well-tolerated treatment with hepatic side effects in 3% of cases, headache in 2% of cases, and lipohypertrophy in 3% of cases. Pegvisomant does not act on adenoma size, and 6% of increasing tumour size is observed. Indeed, pegvisomant is an antagonist of GH receptor with a good efficacy which can be used alone or in association with somatostatin analog or cabergoline if acromegaly is not controlled by a somatostatin analog.

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“…Indeed, both treatments have differential effects in glucose homeostasis: pasireotide has been found to cause, compared to FG SSA, increased fasting plasma glucose (FPG) and glycated hemoglobin (HbA1c), thereby causing a higher incidence of drug-related hyperglycaemic adverse events [10]. In contrast, pegvisomant has favorable effects on glucose metabolism, since it improves insulin sensitivity, decreases FPG, improves glucose tolerance and decreases HbA1c levels [35].…”

Section: Discussionmentioning

confidence: 99%

Cost-effectiveness analysis of second-line pharmacological treatment of acromegaly in Spain

Peral

Cordido

Gimeno‐Ballester

et al. 2019

Expert Review of Pharmacoeconomics & Outcomes Research

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Objective: To estimate the cost-effectiveness of second-line pharmacological treatments in patients with acromegaly resistant to first-generation somatostatin analogues (FG SSA) from the Spanish National Health System (NHS) perspective. Methods: A Markov model was developed to analyze the cost-effectiveness of pegvisomant and pasireotide in FG SSA-resistant acromegaly, simulating a cohort of patients from the treatment beginning to death. Treatment with pegvisomant or pasireotide was compared to FG SSA retreatment. Efficacy data were obtained from clinical trials and utilities from the literature. Direct health costs were obtained from Spanish sources (€2018). Results: The Incremental Cost Effectiveness Ratio (ICER) of pegvisomant vs. FG SSA was €85,869/ Quality-adjusted life years (QALY). The ICER of pasireotide vs. FG SSA was €551,405/QALY. The ICER was mainly driven by the incremental efficacy (4.41 QALY for pegvisomant vs. FG SSA and 0.71 QALY for pasireotide vs. FG SSA), with a slightly lower increase in costs with pegvisomant (€378,597 vs. FG SSA) than with pasireotide (€393,151 vs. FG SSA). Conclusion: The ICER of pasireotide compared to FG SSA was six times higher than the ICER of pegvisomant vs. FG SSA. Pegvisomant is a more cost-effective alternative for the treatment of acromegaly in FG SSA-resistant patients in the Spanish NHS.

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Pegvisomant Improves Glucose Metabolism in Acromegaly: A Meta-Analysis of Prospective Interventional Studies

Cited by 56 publications

References 40 publications

Brazilian multicenter study on pegvisomant treatment in acromegaly

Brazilian multicenter study on pegvisomant treatment in acromegaly

Pegvisomant in Acromegaly and Gigantism

Cost-effectiveness analysis of second-line pharmacological treatment of acromegaly in Spain

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