A comparison between intensive and conventional cabergoline treatment of newly diagnosed patients with macroprolactinoma. (2nd July 2013)

• Record Type: Journal Article
• Authors: Rastogi, Ashu; Bhansali, Anil; Dutta, Pinaki; Singh, Paramjit; Vijaivergiya, Rajesh; Gupta, Vaishali; Sachdeva, Naresh; Bhadada, Sanjay Kumar; Walia, Rama
• Is Part Of: Clinical endocrinology. Volume 79:Number 3(2013:Sep.)
• Page Start: 409
• Page End: 415
• Publication Date: 2013-07-02
• Subjects: Endocrinology -- Periodicals; 616.4005
• DOI: 10.1111/cen.12149
• Languages: English
• ISSNs: 0300-0664

Abstract

<abstract abstract-type="main" id="cen12149-abs-0001"> <title>Summary</title> <sec id="cen12149-sec-0001" sec-type="section"> <title>Context</title> <p>Intensive treatment with cabergoline may lead to earlier reduction in prolactin and tumour volume in comparison to conventional schedule.</p> </sec> <sec id="cen12149-sec-0002" sec-type="section"> <title>Objective</title> <p>To compare the efficacy and safety of two different dosing schedules of cabergoline in patients with macroprolactinoma.</p> </sec> <sec id="cen12149-sec-0003" sec-type="section"> <title>Design</title> <p>Prospective, randomized trial in drug naive patients assigned to conventional (4 weekly escalation by 0·5 mg per week, group A) or intensive (weekly increase by 1 mg per week followed by 4 weekly escalation, group B) treatment with cabergoline.</p> </sec> <sec id="cen12149-sec-0004" sec-type="section"> <title>Outcome measure</title> <p>The duration required to achieve normoprolactinemia and tumour shrinkage of >50% as a composite end‐point.</p> </sec> <sec id="cen12149-sec-0005" sec-type="section"> <title>Results</title> <p>38 patients (19 in each group) completed the study with a mean follow‐up of 64·3 ± 24·9 weeks. More subjects (22%) achieved the composite end‐point in group B (18/19) as compared to the group A (14/19) (<italic>P</italic> = 0·18). The duration of cabergoline treatment required to achieve the composite end‐point was 13·1 ± 9·5 weeks <italic>vs</italic> 19·3 ± 15·7 weeks (<italic>P</italic> = 0·34) in the group A and B, respectively. A reduction in prolactin of ≥90% by the fourth week of cabergoline therapy predicted subsequent normalization of prolactin (AUC 0·78; <italic>P</italic> = 0·04). A further increase in cabergoline dosage after normalization of prolactin in patients with tumour reduction of <50%, led to further tumour shrinkage by 31·2% in an additional 26·3% of patients.</p> </sec> <sec id="cen12149-sec-0006" sec-type="section"> <title>Conclusions</title> <p>Intensive treatment with cabergoline is not superior to the conventional recommended dosage schedule in respect to the time necessary to achieve normoprolactinemia and ≥50% tumour shrinkage. Clinical trial registry: NCT 01143584.</p> </sec> </abstract>