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Hypertension is common side effect of Cushing Syndrome (CS): in patients with endogenous CS and those treated with glucocorticosteroids (GCs). The impact of the intravenous GCs therapy on blood pressure (BP) remains unclear. According to the European Group On Graves' Orbitopathy (EUGOGO), patients with active, severely symptomatic and sight-threatening Graves' orbitopathy (GO) should be treated with high dose intravenous methylprednisolone (IVMP) pulses. There are, however, reports of fatal side effects that may be associated with this therapy (e.g.: pulmonary embolism, myocardial infarction, severe cerebrovascular events, acute liver damage and sudden death). For this reason, the cumulative dose of IVMP should not exceed 8 g within each treatment course, and pulses should not be given on consecutive or alternate days, except for the case of dysthyroid optic neuropathy. A consensus on the monitoring of patients during and after IVMP pulse administration is not yet established. What is more, there is lack of paper regarding pattern of blood pressure at various time points during and after ivGCs administration. Thus, the investigators decided to evaluate acute changes of N-terminal pro-brain natriuretic peptide (NT-proBNP) as a marker of hemodynamic stress and to monitor BP before, during and after IVMP pulse administration. All of patients were treated routinely according to EUGOGO recommendations with standard doses of methylprednisolone with standard recommended schedule. Inclusion criterion for the therapy was according to EUGOGO guidelines active, moderate-to-severe and active GO (12 pulses of IVMP 6x0.5g followed by 6x0.25g every week).
Laboratory tests such as NT-proBNP, troponin I (TnI) and high - sensitivity C - reactive protein (hs-CRP) were performed before, 24 h and 48 h after IVMP during the following pulses: 1st, 6th and 12th. Patients underwent echocardiographic examination before 1st and after 12th pulse. 48-hours ambulatory blood pressure monitoring (ABPM) (for 24 hours before and 24 hours after IVMP) was done during the following pulses: 1st, 6th and 12th.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active, moderate-to-severe GO | Each participant received IVMP according to EUGOGO recommendations (cumulative dose of methylprednisolone 4.5 g, treatment duration 12 weeks in single weekly intravenous pulses, first 6 weeks 0.5g of IVMP, next 6 weeks 0.25g of IVMP). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| NT-proBNP 1-24h | Change in value of NT-proBNP from baseline (before administration of methylprednisolone) to 24 hours after first intravenous pulse | 24 hours |
| NT-proBNP 1-12w | Change in value of NT-proBNP from baseline (before administration of methylprednisolone) to the basic NT-proBNP before last pulse with methylprednisolone | 12 weeks |
| 48-hour ambulatory blood pressure monitoring (ABPM)- 1 mean BP | Analysis of changes in mean blood pressure in ABPM between day before methylprednisolone administration and second day after first pulse of methylprednisolone administration | 48 hours |
| 48-hour ambulatory blood pressure monitoring (ABPM)- 12 mean BP | Analysis of changes in mean blood pressure in ABPM between day before methylprednisolone administration and second day after 12th pulse of methylprednisolone administration | 12 weeks |
| 48-hour ambulatory blood pressure monitoring (ABPM)- 1 max systolic BP | Analysis of changes in maximal systolic blood pressure in ABPM between day before methylprednisolone administration and second day after first pulse of methylprednisolone administration | 48 hours |
| 48-hour ambulatory blood pressure monitoring (ABPM)- 12 max systolic BP | Analysis of changes in maximal systolic blood pressure in ABPM between day before methylprednisolone administration and second day after 12th pulse of methylprednisolone administration | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| hs-CRP | Change in value of hs-CRP from baseline (before administration of methylprednisolone) to 24 hours after first intravenous pulse | 24 hours |
| Biomarker of cardiomyocyte injury - TnI | Change in value of TnI from baseline (before administration of methylprednisolone) to 24 hours after first intravenous pulse |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to the clinic for routine treatment of active, moderate-to-severe GO
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| Name | Affiliation | Role |
|---|---|---|
| Piotr Miśkiewicz, MD, PhD | Department of Endocrinology Medical University of Warsaw | Principal Investigator |
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The collected data will be shared in a publication. It includes all laboratory results from all points of evaluation, results of 48 - hour ABPM and echocardiographic measurements
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The results of the study will be published in 2018
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| ID | Term |
|---|---|
| D006111 | Graves Disease |
| D049970 | Graves Ophthalmopathy |
| D006973 | Hypertension |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D006042 | Goiter |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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All assays were performed in sera obtained from venous blood samples and analysed immediately after blood sampling in The Central Laboratory in the hospital. NT-proBNP was measured using a Flex® Reagent Cartridge and Dimension®EXLTM integrated chemistry system with a LOCI® Module (Siemens HealthCare Diagnostics Ltd., Camberley, UK). The cutoff value of NT - proBNP typical for hemodynamic stress in the left ventricle was defined as ≥125 pg/ml. Measurements of TnI and hs-CRP were made. Analysis of TnI was performed on Siemens Dimension System (ExL LOCI TnI assay). TnI values ≥ 0.056 ng/mL as above the 99th percentile were reported as positive. Measurement of hs-CRP was performed in serum using an immunoturbidimetric method on Cobas 6000 Analyzer (Roche Diagnostics).
| echocardiographic examinations - median values of Ejection Fraction (EF) | Analysis of change in median values of EF between echocardiographic examinations before first methylprednisolone administration and after last pulse of methylprednisolone | 12 weeks |
| 24 hours |
| NT-proBNP 1-48h | Change in value of NT-proBNP from baseline (before administration of methylprednisolone) to 48 hours after first intravenous pulse | 48 hours |
| D013959 |
| Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D015785 | Eye Diseases, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |