PMID- 19684052
OWN - NLM
STAT- MEDLINE
DCOM- 20091110
LR  - 20221207
IS  - 1479-683X (Electronic)
IS  - 0804-4643 (Linking)
VI  - 161 Suppl 1
DP  - 2009 Nov
TI  - ACROSTUDY: the first 5 years.
PG  - S19-24
LID - 10.1530/EJE-09-0322 [doi]
AB  - ACROSTUDY is an observational registry intended to collect safety and efficacy 
      data on pegvisomant therapy. A total of 792 patients have been enrolled, of whom 
      83% had commenced pegvisomant prior to recruitment. The mean follow-up is 1.66 
      years with the mean duration of pegvisomant therapy 3.31 years representing 2625 
      patient years of treatment. About 90% of patients were on once daily pegvisomant, 
      and 67% were on monotherapy. Disappointingly, IGF1 was normalised in <70% of 
      patients; furthermore, in 80% of patients with an elevated IGF1, the daily dose 
      of pegvisomant was 20 mg or less. A total of 56 serious adverse events (AEs) were 
      reported, of which 13 were related to pegvisomant. A total of 276 AEs were 
      reported, of which 56 were considered related to pegvisomant. The AEs most 
      frequently attributed to pegvisomant were disturbed liver function tests and 
      injection site reactions. Magnetic resonance imaging (MRI) was available in 684 
      patients. A total of 411 patients had at least one MRI on pegvisomant compared 
      with a baseline. In 31 patients, a decrease in tumour size has been reported, of 
      whom 20 had previously received radiotherapy. An increase in tumour size has been 
      reported and confirmed in 22 patients. In 11 patients, there was contradictory 
      data on tumour size, while, in six patients, central review of the films failed 
      to confirm increase in tumour size. In conclusion, the safety data are generally 
      reassuring, while the IGF1 normalisation rate is disappointing, which probably 
      reflects a failure of dose titration. Further effort is needed to understand the 
      reasons for the failure of dose titration.
FAU - Trainer, Peter J
AU  - Trainer PJ
AD  - Department of Endocrinology, Christie Hospital, Manchester, UK. 
      peter.trainer@manchester.ac.uk
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20090814
PL  - England
TA  - Eur J Endocrinol
JT  - European journal of endocrinology
JID - 9423848
RN  - 0 (Biomarkers)
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hormone Antagonists)
RN  - 0 (Receptors, Somatotropin)
RN  - 12629-01-5 (Human Growth Hormone)
RN  - 67763-96-6 (Insulin-Like Growth Factor I)
RN  - EC 2.6.1.1 (Aspartate Aminotransferases)
RN  - EC 2.6.1.2 (Alanine Transaminase)
RN  - N824AOU5XV (pegvisomant)
SB  - IM
MH  - Acromegaly/blood/*drug therapy/etiology/metabolism
MH  - Adolescent
MH  - Adult
MH  - Alanine Transaminase/blood
MH  - Aspartate Aminotransferases/blood
MH  - Biomarkers/blood
MH  - Blood Glucose/metabolism
MH  - Female
MH  - Follow-Up Studies
MH  - Glycated Hemoglobin/metabolism
MH  - Growth Hormone-Secreting Pituitary Adenoma/complications/metabolism/pathology
MH  - Hormone Antagonists/administration & dosage/adverse effects/*therapeutic use
MH  - Human Growth Hormone/administration & dosage/adverse effects/*analogs & 
      derivatives/therapeutic use
MH  - Humans
MH  - Insulin-Like Growth Factor I/*metabolism
MH  - Liver Function Tests
MH  - Magnetic Resonance Imaging
MH  - Male
MH  - Middle Aged
MH  - Pituitary Neoplasms/complications/metabolism/pathology
MH  - Receptors, Somatotropin/*antagonists & inhibitors
MH  - Registries
MH  - Young Adult
EDAT- 2009/08/18 09:00
MHDA- 2009/11/11 06:00
CRDT- 2009/08/18 09:00
PHST- 2009/08/18 09:00 [entrez]
PHST- 2009/08/18 09:00 [pubmed]
PHST- 2009/11/11 06:00 [medline]
AID - EJE-09-0322 [pii]
AID - 10.1530/EJE-09-0322 [doi]
PST - ppublish
SO  - Eur J Endocrinol. 2009 Nov;161 Suppl 1:S19-24. doi: 10.1530/EJE-09-0322. Epub 
      2009 Aug 14.