Evidence map›Paper›PMID 26553421›Full record

Observational studyPituitary2016

Safety of long-term treatment with Pegvisomant: analysis of Spanish patients included in global ACROSTUDY.

I Bernabeu, A Pico, E Venegas, J Aller, C Alvarez-Escolá, J A García-Arnés, M Marazuela, P Jonsson, N Mir, M García Vargas and 1 more

Erratum issuedAbstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Pituitary, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
2.7field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. Pooled it
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 2 countries.

I BernabeuComplejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.
A PicoHospital General Universitario de Alicante, Alicante, Spain. antonio.pico@goumh.umh.es.
E VenegasHospital Universitario Virgen del Rocío, Seville, Spain.
J AllerHospital Universitario Puerta de Hierro - Majadahonda, Madrid, Spain.
C Alvarez-EscoláHospital Universitario La Paz, Madrid, Spain.
J A García-ArnésHospital Regional Universitario de Málaga, Málaga, Spain.
M MarazuelaHospital Universitario de La Princesa, Madrid, Spain.
P JonssonPfizer Endocrine Care, Sollentuna, Sweden.
N MirPfizer Medical Department, Madrid, Spain.
M García VargasPfizer Medical Department, Madrid, Spain.
Spanish ACROSTUDY Group
Complejo Hospitalario Universitario de Santiago · ESHospital Universitario La Paz · ESPfizer (Spain) · ESPfizer (Sweden) · SEHospital General Universitario de Alicante Doctor Balmis · ESHospital Regional Universitario de Málaga · ESHospital Universitario Puerta de Hierro Majadahonda · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the long-term safety of Pegvisomant (PEG) in the Spanish cohort of ACROSTUDY.

methodsAs of July 2013, 199 Spanish patients were included in ACROSTUDY, a global non interventional safety PEG surveillance study. Patients were observed for safety, biochemical outcome and magnetic resonance imaging evaluations.

resultsPEG was administered during an average period of 6.7 ± 2.1 years and a mean daily dose of 15.5 ± 7.5 mg. 48.2% of patients received PEG monotherapy. 90.9% of patients had received other medical treatment before PEG start. 195 adverse events (AEs) were reported in 88 patients (44.2%), and serious AEs were described in 31 patients (15.6%). There were no cases of liver tests >10 ULN, or permanent liver damage. Tumor size changes were locally reported in 61 cases (33.5%), with increases observed in 11 patients (6%). In acromegalic patients with diabetes mellitus a decrease in fasting serum glucose value was reported, reaching statistical significance after 1 and 4 years of treatment (-24.6 and -25.9 mg/dl, p = 0.04). After 60 months, normal or lower limit of normal (LLN) IGF-I levels were found in 67.9% of patients. 85.5% of patients showed an IGF-I normal or <LLN at any time after PEG start. Most patients with uncontrolled IGF-I levels were on submaximal PEG doses.

conclusionsACROSTUDY carried out with the Spanish cohort confirmed that PEG has a favorable safety and efficacy profile. The percentage of patients considered under control was similar to data reported globally and in other local ACROSTUDY results.

Indexed as

AcromegalyAdultDrug-Related Side Effects and Adverse ReactionsFemaleFollow-Up StudiesHormone AntagonistsHuman Growth HormoneHumansMagnetic Resonance ImagingMaleMiddle AgedProduct Surveillance, PostmarketingRegistriesSpainTime FactorsHormone AntagonistsHuman Growth HormonepegvisomantAcromegalyACROSTUDYIGF-IPegvisomantSafety

Identifiers

PMID26553421
OpenAlexW2144350547

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.