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.
Clinical Trials Related to Somavert (Pegvisomant)
Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects [Not yet recruiting]
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.
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 100µg 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.
Figitumumab Combined With Pegvisomant For Advanced Solid Tumors [Recruiting]
Tissue Biomarker for Pegvisomant Action [Recruiting]
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.
Acromegaly Combination Treatment Study [Recruiting]
In this study the investigators will evaluate whether combination low dose somatostatin
receptor ligand (SRL) and weekly or daily Pegvisomant will attain equivalent control of
serum IGF-1 levels, compared to combination high dose SRL and weekly Pegvisomant. Lower
doses of therapy will greatly reduce cost of acromegaly therapy.
Reports of Suspected Somavert (Pegvisomant) Side Effects
Weight Increased (8),
Blood Growth Hormone Increased (7),
Drug Ineffective (6),
Hypersensitivity (5), more >>