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Somavert (Pegvisomant) - Summary



SOMAVERT contains pegvisomant for injection, an analog of human growth hormone (GH) that has been structurally altered to act as a GH receptor antagonist.

SOMAVERT is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiation therapy and/or other medical therapies, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum IGF-I levels.

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Published Studies Related to Somavert (Pegvisomant)

Cotreatment with pegvisomant and a somatostatin analog (SA) in SA-responsive acromegalic patients. [2011.08]
CONTEXT: Cotreatment of acromegaly with pegvisomant and a somatostatin analog (SA) has proven feasible. Previous studies in the field have focused on patients with an insufficient response to SA monotherapy in whom pegvisomant was added without changing the SA dose. OBJECTIVE: The objective of the study was to study whether patients sufficiently controlled on SA monotherapy can be transferred to combination therapy with low-dose pegvisomant and a reduced SA dose... CONCLUSION: Acromegalic patients well controlled on SA monotherapy can maintain safe IGF-I levels during 24 wk of cotreatment with low-dose pegvisomant and a 50% reduced SA dose. This treatment modality, however, does not seem to provide significant benefits for the patients.

Comparison of pegvisomant and long-acting octreotide in patients with acromegaly naive to radiation and medical therapy. [2009.12]
CONCLUSIONS: Pegvisomant and octreotide LAR were equally effective in normalizing IGF-I in the overall population, and pegvisomant was more effective in patients with higher baseline IGF-I levels. Pegvisomant had a more favorable effect on parameters of glycemic control.

A randomized, controlled, multicentre trial comparing pegvisomant alone with combination therapy of pegvisomant and long-acting octreotide in patients with acromegaly. [2009.10]
OBJECTIVE: For patients with acromegaly who are suboptimally controlled on long-acting octreotide (LAR), treatment options are to switch to pegvisomant monotherapy (PM) or add pegvisomant to LAR (P-LAR). Our objective was to evaluate if the safety and efficacy of these regimens differ... CONCLUSIONS: In patients suboptimally controlled on LAR, PM and P-LAR were equally well tolerated and effective in normalizing IGF-I, and overall clinical improvement was observed with both regimens. Thus, pegvisomant monotherapy and adjunctive therapy are equally viable options for the treatment of LAR-resistant acromegaly.

Quality of life in acromegalic patients during long-term somatostatin analog treatment with and without pegvisomant. [2008.10]
OBJECTIVE: The objective of the study was to assess whether weekly administration of 40 mg pegvisomant (PEG-V) improves quality of life (QoL) and metabolic parameters in acromegalic patients with normal age-adjusted IGF-I concentrations during long-acting somatostatin analog (SSA) treatment... CONCLUSION: Improvement in quality of life was observed without significant change in IGF-I after the addition of 40 mg pegvisomant weekly to monthly SSA therapy in acromegalic patients who had normalized IGF-I on SSA monotherapy. These data question the current recommendations in how to assess disease activity in acromegaly. Moreover, the findings question the validity of the current approach of medical treatment in which pegvisomant is used only when SSA therapy has failed to normalize IGF-I.

Pegvisomant for the treatment of gsp-mediated growth hormone excess in patients with McCune-Albright syndrome. [2006.08]
CONCLUSIONS: Pegvisomant effectively reduced IGF-I and IGFBP-3 levels in gsp-mediated GH excess but had no effect on fibrous dysplasia.

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Clinical Trials Related to Somavert (Pegvisomant)

Pegvisomant With Glucagon Test to Assess for Adult Growth Hormone Deficiency [Recruiting]
Hypothesis: Pegvisomant combined with the glucagon stimulation test (GST) can improve the accuracy of this test when used to diagnose adult GH and cortisol (steroid hormone)insufficiency. Study aims: Diagnosing GH and cortisol deficiency in adults requires a special test. At present, the insulin tolerance test (ITT) is considered the test of choice. However, this test is difficult to perform as it involves giving insulin through the veins to decrease blood sugars to very low levels, and this can be unpleasant, and cannot be performed in elderly adults and in those with a history of heart disease, seizure disorders or stroke. For this reason there is an urgent need for an alternative reliable test. At present, the GST is considered the alternative test to the ITT but its accuracy in obese patients and in those with diabetes remains unclear. Pegvisomant is a medication that can increase GH production in the body. The purpose of this study is to find out if combining pegvisomant with the GST can help improve the accuracy of this test so that it is comparable with the ITT in diagnosing adult GH and cortisol insufficiency. Study design: Subjects will be recruited from the Oregon Health & Science University Dynamic Endocrine Testing Unit. A written informed consent will be obtained and a screening interview will be carried out. During the screening interview, the study will be explained to the subject in detail. For women of child-bearing age, a pregnancy test will be performed. The subjects will then take part in three studies on separate days: (1) GST; (2) pegvisomant (1 mg/kg) injection into the abdomen 3 days before the glucagon stimulation test (ii) insulin tolerance test. For the GST, glucagon will be injected into the muscle and blood draws will be performed every 30 mins for 240 mins. For the insulin tolerance test, a blood draw will be performed and insulin will be given into the vein followed by blood draws every 15 mins for 120 mins. The data from all three studies will be analyzed in the study where the peak growth hormone and cortisol levels for all three tests will be compared. A questionnaire will be used at the end of the study for the subjects to rank the level of preference of the three tests. The data of the study will be analyzed using a computer statistical program where the identity of the subjects will be coded to maintain confidentiality.

Acute Application of Pegvisomant and Octreotide in Acromegaly [Completed]
The purpose of the study is to investigate the efficacy of an acute additional application of the somatostatin analogue octreotide 100g s. c. or the dopamine agonist cabergoline 0. 5mg p. o. to the receptor antagonist pegvisomant during a 6 or 9 hour profile on reducing endogenous growth hormone in patients with acromegaly on stable pegvisomant therapy.

Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects [Completed]
The hypothesis to be tested is that the bioavailability of the new 30-mg vial is similar to

that of the current approved 15 - mg vials. In addition, the SC injection using the new 30-mg

vial is safe and well-tolerated.

Tissue Biomarker for Pegvisomant Action [Completed]
Acromegaly is a disease of the pituitary gland that involves the overproduction of growth hormone. The drug works by blocking the binding of growth hormone to growth hormone receptors found in tissues throughout the body. Human studies have evaluated the reduction of IGF-I levels in the blood following pegvisomant treatment, however, no studies have evaluated IGF-I levels in tissues following pegvisomant administration. In this study, we will test a novel tissue biomarker for pegvisomant action, distinct from measuring IGF-I levels in the blood. To this end, we will determine if administration of pegvisomant modifies the expression of IGF-I, IGF-I receptor, growth hormone receptor and GH- and IGF-i-dependent signaling molecules in the colon tissue of patients with acromegaly.

Change in Quality of Life After Addition of Weekly 40 mg Pegvisomant/Placebo in Controlled Acromegalic Patients [Completed]
Study Synopsis Study Title: Double blind, single centre, cross-over study on the effects of weekly subcutaneous administration of 40 mg pegvisomant or placebo on quality of life and insulin sensitivity in acromegalic patients with normal serum IGF-I concentrations during long-term treatment with long-acting somatostatin analogs Study Objectives: 1. To determine whether the addition of weekly pegvisomant administrations improves quality of life 2. To determine whether the addition of weekly pegvisomant administrations improves insulin sensitivity Study Population: Acromegalic patients, who have normalized their serum IGF-I levels down to the upper 25 centiles of normality during long-term treatment with monthly injections of a long-acting somatostatin analogue Number of Subjects: 20 Procedures:

- Patients on treatment with Sandostatin LAR (SL) 20 - 30 mg per months i. m. or patients

on treatment with Lanreotide autosolution (LA) 90 - 120 mg deep s. c. will be enrolled.

- For 4 months, all subjects will also receive weekly s. c. injections of either placebo

or a fixed dose of 40 mg pegvisomant

- After a 4 weeks wash-out period, patients will switch from either placebo to

pegvisomant or from pegvisomant to placebo

- Before, and after 2 and 4 months of each treatment period, serum efficacy parameters

and quality of life (AcroQol ™/ PASQ™) will be assessed.

- Before and after 4 months of each treatment period, pituitary tumor size and insulin

sensitivity (HOMA/SIGMA model) will be assessed. Duration of study: 9 months Hypothesis: •We postulate that co-administration of the growth hormone receptor antagonist pegvisomant will improve QoL and insulin sensitivity

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Reports of Suspected Somavert (Pegvisomant) Side Effects

Rash (10)Pruritus (8)Weight Increased (8)Blood Growth Hormone Increased (7)Urticaria (7)Drug Ineffective (6)Hepatitis (6)Fatigue (6)Depression (6)Hypersensitivity (5)more >>

Page last updated: 2011-12-09

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