How are growth hormone and insulin-like growth factor-1 reported as markers for drug effectiveness in clinical acromegaly research? A comprehensive methodologic review.

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Term Occurence Count Dictionary
Pegvisomant 2 endocrinologydiseasesdrugs
acromegaly 29 endocrinologydiseases
Insulin 3 endocrinologydiseasesdrugs
Octreotide 6 endocrinologydiseasesdrugs
Pasireotide 5 endocrinologydiseasesdrugs

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Select Drug Character Offset Drug Term Instance
Insulin 4343 tolerance test (OGTT), further referred to in this article as the biomarkers of interest [[8], [9]]. Insulin -like growth factor-1In clinical practice, a main treatment goal is a reduction in IGF-1 concentrations
Insulin 24481 C0 apparent initial concentration, Ctrough apparent concentration before next dosing, t1/2 half-life Insulin -like growth factor-1The majority of studies that reported IGF-1 outcomes included one fasting or one/two
Insulin 28109 biochemically controlled, limiting the possibility to include the study results in a meta-analysis. Insulin -like growth factor-1To assess if IGF-1 concentrations decrease to ‘safe’ ranges after treatment,
Octreotide 10493 minimum of five acromegaly patients treated with the standard of treatment of somatostatin analogues ( Octreotide , Lanreotide or Pasireotide) or dopamine agonists (Bromocriptine, Cabergoline), and investigated the
Octreotide 11558 presented below, where CompoundName was replaced by the expanded names of Bromocriptine, Cabergoline, Octreotide , Lanreotide and Pasireotide. The full search term can be found in the Online Resource 1. Search results
Octreotide 22996 concentrations and mean of 2 individual serum concentrations versus IGF-1 concentrations, with linear regression Octreotide Gadelha et al. [[35]]25Octreotide implantPhase II, open-label, randomizedMean ± SD of Cmax, AUC0−6 months,
Octreotide 23029 concentrations versus IGF-1 concentrations, with linear regressionOctreotideGadelha et al. [[35]]25 Octreotide implantPhase II, open-label, randomizedMean ± SD of Cmax, AUC0−6 months, tmax. Graphical analysis
Octreotide 23206 AUC0−6 months, tmax. Graphical analysis of concentrations with mean ± SDChieffo et al. [[36]]16 Octreotide LAROctreotide implantPhase III, open-label, multicenter, randomizedGraphical analysis with mean ± SE
Octreotide 23220 tmax. Graphical analysis of concentrations with mean ± SDChieffo et al. [[36]]16Octreotide LAR Octreotide implantPhase III, open-label, multicenter, randomizedGraphical analysis with mean ± SE at sampled
Pasireotide 10519 patients treated with the standard of treatment of somatostatin analogues (Octreotide, Lanreotide or Pasireotide ) or dopamine agonists (Bromocriptine, Cabergoline), and investigated the effect of treatment on one
Pasireotide 11585 CompoundName was replaced by the expanded names of Bromocriptine, Cabergoline, Octreotide, Lanreotide and Pasireotide . The full search term can be found in the Online Resource 1. Search results were extracted from PubMed
Pasireotide 23529 dose-titrationMean ± SD for the C0, AUC and t1/2. Graphical analysis showing the mean ± SE Pasireotide Petersenn et al. [[46]]3 per scheduled visit, with ~ 20 visits per subjectPasireotideOpen-ended extension
Pasireotide 23616 mean ± SEPasireotidePetersenn et al. [[46]]3 per scheduled visit, with ~ 20 visits per subject Pasireotide Open-ended extension of a phase II studyIndividual dose normalized Ctrough concentration–time profilesPetersenn
Pasireotide 23756 phase II studyIndividual dose normalized Ctrough concentration–time profilesPetersenn et al. [[22]]16 Pasireotide LARPhase I, randomized, multicenter, open-labelGraphical analysis of mean ± SE Ctrough concentrations
Pegvisomant 24012 post-first injection day. Median and mean ± SD for the Cmax, Ctrough, AUC and accumulation ratio Pegvisomant Higham et al. [[66]]2PegvisomantProspective, multicenter, open-labelMean ± SD of concentrations
Pegvisomant 24044 and mean ± SD for the Cmax, Ctrough, AUC and accumulation ratioPegvisomantHigham et al. [[66]]2 Pegvisomant Prospective, multicenter, open-labelMean ± SD of concentrations at 2 time pointsPK pharmacokinetics,
Select Disease Character Offset Disease Term Instance
acromegaly 127 growth hormone and insulin-like growth factor-1 reported as markers for drug effectiveness in clinical acromegaly research? A comprehensive methodologic reviewMichiel J. van EsdonkEline J. M. van ZutphenFerdinand RoelfsemaAlberto
acromegaly 991 hormone (GH) and insulin-like growth factor-1 (IGF-1) as markers for drug effectiveness in clinical acromegaly research.Search strategyA systematic search of recent prospective and retrospective studies, published
acromegaly 1203 published between 2012 and 2017, that studied the effects of somatostatin analogues or dopamine agonists in acromegaly patients was performed. The markers of interest were GH, IGF-1, and the suppression of GH after an oral
acromegaly 1853 range of different cut-off values and sampling designs were used to determine biochemical control in acromegaly patients. The summary statistics were reported in various ways, with the percentage of biochemical control
acromegaly 2186 commonly performed on the available PK data.ConclusionsThe way GH and IGF-1 are measured and reported in acromegaly research varies considerably. A consensus on how to report study results would enable better comparisons
acromegaly 2393 comparisons between studies, thereby improving evidence based decision making to optimize treatment in acromegaly .Electronic supplementary materialThe online version of this article (10.1007/s11102-018-0884-4) contains
acromegaly 2832 abnormal growth of extremities, high morbidity, and an increased mortality risk. In virtually all cases, acromegaly is the result of a GH secreting pituitary adenoma [[2]–[4]]. Under normal physiological conditions,
acromegaly 3674 [7]].Guideline recommendationsBoth the GH and IGF-1 plasma concentrations are typically increased in active acromegaly and will decrease during effective treatment. Both biomarkers are therefore used in clinical practice
acromegaly 3821 treatment. Both biomarkers are therefore used in clinical practice to monitor biochemical control in acromegaly and to determine treatment effectiveness. As a result of the biological mechanisms underlying acromegaly,
acromegaly 3926 acromegaly and to determine treatment effectiveness. As a result of the biological mechanisms underlying acromegaly , the most recent guidelines, by the Endocrine Society and the American Association of Clinical Endocrinologists
acromegaly 4103 American Association of Clinical Endocrinologists (AACE), for the diagnosis and treatment monitoring in acromegaly focus on three key biomarkers; (a) IGF-1, (b) (mean) GH and (c) level of suppression of GH concentrations
acromegaly 4759 surrogate for ‘safe’ IGF-1 levels which can be used to monitor the biochemical control of an individual acromegaly patient. This ULN is commonly defined by 2 × the standard deviation (SD) of normal values, for
acromegaly 5180 IGF-1 concentrations between individuals.Growth hormoneThe primarily pathologically affected hormone in acromegaly is GH. A random GH measurement is therefore performed to provide an indication of the actual endogenous
acromegaly 6396 testAn OGTT is performed as a test to differentiate between healthy individuals and patients with active acromegaly . Furthermore, an OGTT can be performed already 1 week after surgery to assess successful reduction
acromegaly 7030 for 2 h. At present, the recommended cut-off used both for biochemical control, and the diagnosis of acromegaly , is a nadir GH of < 1 ng/ml [[8]], which has been re-adapted in 2014 from a previously more sensitive
acromegaly 7395 assay.Study comparisonThere are limited prospective clinical trials that included large cohorts of acromegaly patients, due to the low prevalence of acromegaly. Therefore, systematic reviews and meta-analyses serve
acromegaly 7445 prospective clinical trials that included large cohorts of acromegaly patients, due to the low prevalence of acromegaly . Therefore, systematic reviews and meta-analyses serve as a powerful tool to combine study results,
acromegaly 9709 applied to measure and report GH and IGF-1 in studies that evaluated medical treatment efficacy in acromegaly patients in peer-reviewed journals, published between 2012 and 2017. It is assumed that this selection
acromegaly 10222 will provide a perspective on the consistencies in the used methodology and reporting of studies in acromegaly research and therewith in the comparability of study results.MethodsIn- and exclusion criteriaProspective
acromegaly 10407 and exclusion criteriaProspective and retrospective clinical studies, that included a minimum of five acromegaly patients treated with the standard of treatment of somatostatin analogues (Octreotide, Lanreotide or
acromegaly 22391 designAnalysis summaryLanreotideGarrido et al. [[20]]10Lanreotide autogelPhase II, multicenter, randomized in acromegaly patientsPopulation PK/PD model linking the PK to individual GH (mean of 7 measurements with 30 min
acromegaly 27691 studies.DiscussionThis review clearly demonstrates that many methods are applied to measure and report on biomarkers in acromegaly research. To improve comparability of results between studies and the determination of optimal treatment
acromegaly 27810 research. To improve comparability of results between studies and the determination of optimal treatment in acromegaly , protocols should be more uniform on the biochemical reporting. However, different cut-off values and
acromegaly 31374 influence the results, as was recently shown in a paper that suggested that in patients with active acromegaly , the mean of four samples, sampled with 4 h intervals, reflected an endogenous 24 h GH profile best
acromegaly 33074 glucose tolerance testThe OGTT is commonly performed at study initiation for the confirmation of active acromegaly or to assess surgery success multiple weeks after surgery. Unfortunately, there is limited use in performing
acromegaly 37105 response on both the individual mean GH and IGF-1 levels, allowing a more evidence based approach in acromegaly treatment.Summary statisticsThe most common way of reporting the biomarkers concentrations in the included
acromegaly 38256 Resource 4 contains an extensive checklist of the advised reporting of IGF-1, GH, OGTT and PK results in acromegaly studies.Study inclusion criteriaIn addition to the variability in the reported outcomes, a wide variability
acromegaly 39033 conclusion, supplementary to a consensus on the diagnosis and the monitoring of treatment effectiveness in acromegaly , a second consensus on reporting of the results of both prospective and retrospective trials is urgently
acromegaly 40045 recommendations will enhance the inter-study comparison and therewith improve evidence based decision making in acromegaly .Electronic supplementary materialBelow is the link to the electronic supplementary material.Supplementary

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