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Comparison of cabergoline versus raloxifene add-on therapy to long-acting somatostatin analogue in patients with inadequately controlled acromegaly: A randomized open label clinical trial

Imani, M. and Khamseh, M.E. and Asadi, P. and Ghorbani, M. and Akbari, H. and Alaei-Shahmiri, F. and Honardoost, M. and Kaynama, M.R. and Malek, M. (2018) Comparison of cabergoline versus raloxifene add-on therapy to long-acting somatostatin analogue in patients with inadequately controlled acromegaly: A randomized open label clinical trial. Endocrine Practice, 24 (6). pp. 542-547.

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Abstract

Objective: The present study aimed to evaluate the efficacy of add-on therapy of cabergoline versus raloxifene to long-acting somatostatin analogues (SAs) in patients with inadequately controlled acromegaly. Methods: This was a prospective, randomized open label clinical trial. Forty-four patients (22 per group) completed the study; where participants received either cabergoline (3 mg/week) or raloxifene (60 mg twice daily) add-on therapy for 12 weeks in a parallel manner. The primary outcome was the rate of reduction in serum insulin-like growth factor 1 (IGF-1) from baseline. Secondary outcomes comprised normalization of serum IGF-1 for age and sex. Results: Serum IGF-1 was significantly decreased in both the cabergoline (40.3 ± 25.6, P<.001) and raloxifene (31.5 ± 24.6, P<.001) groups, with no significant difference between arms (P>.05). Normalization in serum IGF-1 values occurred in 40.9 of patients who were on cabergoline compared to 45.5 of those receiving raloxi- fene (P = .76). The subsequent logistic regression analysis highlighted baseline IGF-1 as a significant predictor of IGF-1 normalization (odds ratio, 0.995; 95 confidence interval, 0.990-0.999; P = .02). Using the receiver operating characteristic (ROC) curve analysis for the entire group, the baseline IGF-1 value of 1.47 the upper limit of normal (ULN) was the best cut-off point to identify patients with normal IGF-1 at the end of the study (sensitivity: 52.6, specificity: 84.0, Yoden's index: 0.366). Full biochemical control of acromegaly was achieved in 22.7 of patients in the cabergoline group compared to 13.6 of those in the raloxifene group (P = .43). Conclusion: Cabergoline and raloxifene add-on therapy could effectively decrease serum IGF-1 level in patients with inadequately controlled acromegaly. The efficacy profiles of both drugs are comparable. Copyright © 2018 AACE.

Item Type: Article
Additional Information: cited By 0
Uncontrolled Keywords: cabergoline; estrogen receptor; glucose; growth hormone; insulin; prednisolone; prolactin; raloxifene; somatomedin C; somatostatin derivative; tamoxifen; testosterone; cabergoline; ergoline derivative; human growth hormone; IGF1 protein, human; raloxifene; selective estrogen receptor modulator; somatomedin C; somatostatin, acromegaly; add on therapy; adult; Article; body mass; chemiluminescence immunoassay; clinical article; controlled study; dizziness; drug efficacy; female; follow up; glucose blood level; hot flush; human; hypophysis adenoma; male; middle aged; nausea; prospective study; randomized controlled trial; receiver operating characteristic; sensitivity and specificity; acromegaly; analogs and derivatives; blood; blood pressure; comparative study; drug effect; pathophysiology; statistical model, Acromegaly; Adult; Blood Pressure; Ergolines; Female; Human Growth Hormone; Humans; Insulin-Like Growth Factor I; Logistic Models; Male; Middle Aged; Prospective Studies; Raloxifene Hydrochloride; Selective Estrogen Receptor Modulators; Somatostatin
Subjects: مقالات نمایه شده محققین دانشگاه در سایت ,Web of Science ,Scopus
Divisions: UNSPECIFIED
Depositing User: GOUMS
Date Deposited: 29 Sep 2018 08:49
Last Modified: 29 Sep 2018 08:49
URI: http://eprints.goums.ac.ir/id/eprint/9694

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