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2. Pasireotide versus continued treatment with octreotide or lanreotide in patients with inadequately controlled acromegaly (PAOLA): A randomised, phase 3 trial

Author

Gadelha, Mônica R, Bronstein, Marcello D, Brue, Thierry, Coculescu, Mihail, Fleseriu, Maria, Guitelman, Mirtha, Pronin, Vyacheslav, Raverot, Gérald, Shimon, Ilan, Lievre, Kayo Kodama, Fleck, Juergen, Aout, Mounir, Pedroncelli, Alberto M, Colao, Annamaria, Abreu, A, Abucham Filho JZ, Araujo, L, Barkan, A, Bender G, Bex M, Bolanowski, M, Bollerslev, J, Cannavo', Salvatore, Caron, P, Chanson, P, Çomlekçi, A, De Marinis, L, Deyneli, O, dos Santos Nunes, V, Drui, D, Faria, Ms, Ferone, D, Flanagan, D, Ghigo, E, Houde, G, Leonova, Nv, Mayberg, M, Mcphaul, Mj, Mendes, H, Montenegro, Rm, Nasser, T, Obiols Alfons, G, Pico Alfonso, A, Raef, H, Rozhinskaya, Ly, Sari, R, Schoefl, C, Schopohl, J, Sowinski, J, Suplotova, L, Sworczak, K, Tabarin, A, Tovar, H, Venegas Moreno, E, Verges, B., Gadelha, Mônica R, Bronstein, Marcello D, Brue, Thierry, Coculescu, Mihail, Fleseriu, Maria, Guitelman, Mirtha, Pronin, Vyacheslav, Raverot, Gérald, Shimon, Ilan, Lievre, Kayo Kodama, Fleck, Juergen, Aout, Mounir, Pedroncelli, Alberto M, and Colao, Annamaria

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Endocrinology, Diabetes and Metabolism, Octreotide, Lanreotide, Gastroenterology, Peptides, Cyclic, law.invention, chemistry.chemical_compound, Young Adult, Endocrinology, Randomized controlled trial, law, Internal medicine, Acromegaly, 80 and over, Internal Medicine, Medicine, Humans, Insulin-Like Growth Factor I, Aged, Aged, 80 and over, Cyclic, Intention-to-treat analysis, business.industry, Human Growth Hormone, Medicine (all), Middle Aged, medicine.disease, Pasireotide, Surgery, Somatostatin, Treatment Outcome, chemistry, Female, Pegvisomant, business, Peptides, medicine.drug
Abstract

BACKGROUND: Many patients with acromegaly do not achieve biochemical control despite receiving high doses of the first-generation somatostatin analogues octreotide or lanreotide. In the PAOLA trial, we aimed to assess the efficacy and safety of two different doses of the somatostatin analogue pasireotide long-acting release compared with active control (octreotide or lanreotide) in patients with inadequately controlled acromegaly. METHODS: In a multicentre, randomised, phase 3 trial, we enrolled eligible patients aged 18 years or older with acromegaly who were inadequately controlled (5-point, 2 h mean growth hormone concentration >2·5 μg/L and insulin-like growth factor 1 [IGF-1] concentration >1·3 times the upper normal limit) and had received 30 mg octreotide long-acting repeatable or 120 mg lanreotide (Somatuline Autogel; Ipsen, UK) as monotherapy for 6 months or longer. We randomly assigned patients in a 1:1:1 ratio with an interactive voice-web response system to receive 40 mg pasireotide long-acting release once every 28 days for 24 weeks, 60 mg pasireotide long-acting release once every 28 days for 24 weeks, or continued treatment with octreotide or lanreotide (active control). Patients were stratified according to previous treatment (octreotide or lanreotide) and growth hormone concentrations at screening (2·5-10 μg/L and >10 μg/L). Patients and study investigators were not masked to study drug assignment but were masked to pasireotide dose allocation. The primary endpoint was number of patients achieving biochemical control, defined as mean growth hormone concentration less than 2·5 μg/L and normalised IGF-1 concentration. Efficacy analyses were based on intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01137682. FINDINGS: Between Dec 17, 2010, and Aug 6, 2012, 198 patients were enrolled and randomly assigned to pasireotide 40 mg (n=65), pasireotide 60 mg (n=65), or active control (n=68) groups. At 24 weeks, ten (15%) patients in the pasireotide 40 mg group and 13 (20%) patients in the pasireotide 60 mg group achieved biochemical control, compared with no patients in the active control group (absolute difference from control group 15·4%, 95% CI 7·6-26·5, p=0·0006 for pasireotide 40 mg group, 20·0%, 11·1-31·8, p

Published
2014

3. Cabergoline versus bromocriptine in the treatment of hyperprolactinemia: a systematic review of randomized controlled trials and meta-analysis.

Author

dos Santos Nunes V, El Dib R, Boguszewski CL, and Nogueira CR

Subjects
Cabergoline, Dopamine Agonists therapeutic use, Humans, Randomized Controlled Trials as Topic, Bromocriptine therapeutic use, Ergolines therapeutic use, Hyperprolactinemia drug therapy
Abstract

Cabergoline and bromocriptine are the most used drugs in the treatment of hyperprolactinemia, they are able to normalize the prolactin levels, restore gonadal function and promote tumor reduction in the majority of patients. We undertake a systematic review and meta-analysis of randomized controlled trials to compare cabergoline versus bromocriptine in the treatment of patients with idiopathic hyperprolactinemia and prolactinomas. The data sources were: Embase, Pubmed, Lilacs and Cochrane Central. The outcome measures were: normalization of prolactin secretion, restoration of gonadal function, reduction of tumoral volume, quality of life and adverse drug effects. Were identified 418 references and after screening by title and abstract, we obtained complete copies of 34 articles potentially eligible for inclusion in the review. From this total, 19 were selected to be included, but fifteen of them were excluded due to the following reasons: one randomized study compared cabergoline versus placebo and other randomized study compared different doses of cabergoline; five references were cases series; four were only controlled studies; three were retrospectives series and; one was a cohort study. Therefore, four publications were included in the review and in the final analysis. The meta-analysis of normalization of serum prolactin levels and menstruation with return of ovulatory cycle showed a significant difference in favor of cabergoline group (RR 0.67 [CI 95% 0.57, 0.80]) e (RR 0.74 [CI 95% 0.67, 0.83]), respectively. The number of adverse effects was significantly higher in the bromocriptine number than in cabergoline group (RR 1.43 [CI 95% 1.03, 1.98]). The meta-analysis showed new evidence favoring the use of cabergoline in comparison with bromocriptine for the treatment of prolactinomas and idiopathic hyperprolactinemia.

Published
2011
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