BackgroundSignificant debate regarding the optimal anticoagulant therapy in the setting of primary PCI for STEMI patients is ongoing. Registry data and modest randomized trials support utilization of IV enoxaparin (ENOX) over unfractionated heparin (UFH). In the STrategic reperfusion Early After Myocardial infarction (STREAM) study, Canadian patients enrolled in the primary PCI arm underwent secondary randomization to IV ENOX or UFH administered pre-hospital.Methods/ResultsCanadian primary PCI patients in STREAM were randomized 1:1 to receive prehospital anticoagulation at the time of randomization with enoxaparin 0.5 mg/kg IV bolus with a provision for an additional 0.25 mg/kg IV bolus if two hours had elapsed between first dosing and completion of primary PCI or UFH 70 units/kg IV bolus with subsequent ACT guided IV dosing. The primary endpoint was the adequacy of anticoagulation measured as an anti-Xa level ≥ 0.5 with ENOX and an ACT ≥ 200 with UFH and glycoprotein IIb/IIIa inhibitors measured at sheath insertion. Patients from the ENOX (n=22) and UFH (n=23) arms were well balanced in baseline characteristics, time from symptom onset to randomization, and ECG metrics for baseline predicted risk (table 1). Glycoprotein IIb/IIIa was utilized in the majority of patients (ENOX 90.9% vs. UFH 82.6%). Post PCI ECG metrics of reperfusion favored ENOX including the worst lead ST-elevation resolution (ENOX 88% (78-100) vs UFH 67% (57-100)) and worst lead residual ST elevation ≥ 2 mm (Enox 18.2% vs UFH 34.8%). 30-day clinical endpoints were similar (table). The primary endpoint of ‘adequacy of anticoagulation’ favored ENOX. Specifically, in the ENOX arm the median pre-procedural anti-Xa was 0.76 (0.70-0.90) and post-procedural anti-Xa was 0.74 (0.52-1.12) and with UFH pre-procedural ACT was 199 (182-225) and post-procedure 226 (200-334). Individual patient pre and post procedure anticoagulant levels are shown in the figure.ConclusionView Large Image Figure ViewerDownload (PPT)Boehringer Ingehelheim, Sanofi Canada BackgroundSignificant debate regarding the optimal anticoagulant therapy in the setting of primary PCI for STEMI patients is ongoing. Registry data and modest randomized trials support utilization of IV enoxaparin (ENOX) over unfractionated heparin (UFH). In the STrategic reperfusion Early After Myocardial infarction (STREAM) study, Canadian patients enrolled in the primary PCI arm underwent secondary randomization to IV ENOX or UFH administered pre-hospital. Significant debate regarding the optimal anticoagulant therapy in the setting of primary PCI for STEMI patients is ongoing. Registry data and modest randomized trials support utilization of IV enoxaparin (ENOX) over unfractionated heparin (UFH). In the STrategic reperfusion Early After Myocardial infarction (STREAM) study, Canadian patients enrolled in the primary PCI arm underwent secondary randomization to IV ENOX or UFH administered pre-hospital. Methods/ResultsCanadian primary PCI patients in STREAM were randomized 1:1 to receive prehospital anticoagulation at the time of randomization with enoxaparin 0.5 mg/kg IV bolus with a provision for an additional 0.25 mg/kg IV bolus if two hours had elapsed between first dosing and completion of primary PCI or UFH 70 units/kg IV bolus with subsequent ACT guided IV dosing. The primary endpoint was the adequacy of anticoagulation measured as an anti-Xa level ≥ 0.5 with ENOX and an ACT ≥ 200 with UFH and glycoprotein IIb/IIIa inhibitors measured at sheath insertion. Patients from the ENOX (n=22) and UFH (n=23) arms were well balanced in baseline characteristics, time from symptom onset to randomization, and ECG metrics for baseline predicted risk (table 1). Glycoprotein IIb/IIIa was utilized in the majority of patients (ENOX 90.9% vs. UFH 82.6%). Post PCI ECG metrics of reperfusion favored ENOX including the worst lead ST-elevation resolution (ENOX 88% (78-100) vs UFH 67% (57-100)) and worst lead residual ST elevation ≥ 2 mm (Enox 18.2% vs UFH 34.8%). 30-day clinical endpoints were similar (table). The primary endpoint of ‘adequacy of anticoagulation’ favored ENOX. Specifically, in the ENOX arm the median pre-procedural anti-Xa was 0.76 (0.70-0.90) and post-procedural anti-Xa was 0.74 (0.52-1.12) and with UFH pre-procedural ACT was 199 (182-225) and post-procedure 226 (200-334). Individual patient pre and post procedure anticoagulant levels are shown in the figure. Canadian primary PCI patients in STREAM were randomized 1:1 to receive prehospital anticoagulation at the time of randomization with enoxaparin 0.5 mg/kg IV bolus with a provision for an additional 0.25 mg/kg IV bolus if two hours had elapsed between first dosing and completion of primary PCI or UFH 70 units/kg IV bolus with subsequent ACT guided IV dosing. The primary endpoint was the adequacy of anticoagulation measured as an anti-Xa level ≥ 0.5 with ENOX and an ACT ≥ 200 with UFH and glycoprotein IIb/IIIa inhibitors measured at sheath insertion. Patients from the ENOX (n=22) and UFH (n=23) arms were well balanced in baseline characteristics, time from symptom onset to randomization, and ECG metrics for baseline predicted risk (table 1). Glycoprotein IIb/IIIa was utilized in the majority of patients (ENOX 90.9% vs. UFH 82.6%). Post PCI ECG metrics of reperfusion favored ENOX including the worst lead ST-elevation resolution (ENOX 88% (78-100) vs UFH 67% (57-100)) and worst lead residual ST elevation ≥ 2 mm (Enox 18.2% vs UFH 34.8%). 30-day clinical endpoints were similar (table). The primary endpoint of ‘adequacy of anticoagulation’ favored ENOX. Specifically, in the ENOX arm the median pre-procedural anti-Xa was 0.76 (0.70-0.90) and post-procedural anti-Xa was 0.74 (0.52-1.12) and with UFH pre-procedural ACT was 199 (182-225) and post-procedure 226 (200-334). Individual patient pre and post procedure anticoagulant levels are shown in the figure. ConclusionBoehringer Ingehelheim, Sanofi Canada Boehringer Ingehelheim, Sanofi Canada
n engl j med 373;13 nejm.org september 24, 2015 1271 occurred at 137 centers throughout the world in the phase 3 trial, which suggests that the skills necessary to safely administer the combination therapy are widely available. Furthermore, and to Valsecchi’s point, among the 120 patients who discontinued combination therapy because of toxic effects, the response rate was 67.5%. To us, this supports the current guidelines for management of toxic effects and discontinuation of treatment, since it shows that high response rates can be observed in the context of no treatment-related deaths. Longer followup will be needed to assess the effect of treatment discontinuation on overall survival. James Larkin, M.D., Ph.D.
Administrative databases are commonly used for retrospective cohort studies and rely on diagnostic and procedure coding from inpatient and outpatient databases, for which accuracy is typically outdated or not known at all. Utilizing a registry of consecutive STEMI patients we evaluate the performance of administrative codes for a STEMI diagnosis and related in-hospital procedures. Vital Heart Response (VHR) is a comprehensive registry of over 3000 consecutive STEMI patients (2006 and 2011) within a defined health region (Edmonton, Alberta). Clinical information was acquired via chart review for all patients in VHR via trained data abstractors within a dedicated research centre (EPICORE). Using unique patient identifiers, the registry data was linked to administrative health data to obtain diagnostic and procedure codes from the discharge abstract database (DAD) and Ambulatory Care Classification System (ACCS). The DAD includes a most responsible diagnosis and up to 24 other diagnoses and 20 interventions/procedures, while the ACCS includes up to 10 diagnoses and 10 interventions/procedures. Both DAD and ACCS use the Canadian enhancement of International Statistical Classification of Diseases and Related Health Problems (ICD-10-CA) and the Canadian Classification of Health Interventions (CCI) during our time period to define diagnoses and procedures, respectively. Procedures in the administrative databases were defined using hospitalizations from DAD during the index hospitalization and ambulatory encounters during or immediately preceding the index hospitalization. Agreement of both primary STEMI diagnosis, and associated procedures of CABG, PCI, and Angiogram were compared between the two sources including calculation of sensitivity, specificity, positive predictive value and negative predictive value. Of 3049 unique patients in VHR that were successfully linked to the administrative databases, 2879 (94.4%) had a most responsible diagnosis of STEMI in their inpatient record corresponding to their index hospitalization. Of the 170 patients that had a most responsible diagnosis other than STEMI, the most frequent diagnoses were Non-ST elevation (NSTEMI) myocardial infarction (68.2%), AMI-Unspecified (18.8%), and Atherosclerotic heart disease of native coronary artery (8.8%). Coding accuracy for the CABG (n=122), PCI (n= 2510), and Angiogram (n=2895) was excellent, with sensitivity and specificity ranging from 95.0% to 99.3% and 83.8% to 100.0%, respectively (table). Within a registry of consecutive STEMI patients in Alberta, administrative coding for STEMI diagnosis and CABG, PCI and Angiogram procedures aligned very closely with the chart review registry data. This demonstrates the feasibility of using readily available administrative data to accurately define cohorts for research purposes.
Congenital diaphragmatic hernia (CDH) occurs in 1 of 4,000–5,000 live births. Despite advances in the care of these infants, pulmonary hypoplasia and resulting pulmonary hypertension (PH) carry significant morbidity and mortality. Thus, additional therapeutic strategies are needed. The use of continuous treprostinil for chronic pediatric pulmonary hypertensive disorders is increasing. However, its use for acute therapy is limited. We describe two 6-week-old infants with CDH and severe pulmonary hypertension treated with treprostinil. Rapid and dramatic clinical and hemodynamic improvement occurred in both cases. Both infants were weaned off the drug, representing the first reports of successful short-term treprostinil use in neonates with CDH. Case 1 was a female infant born at 37 weeks’ gestation, after a pregnancy complicated by late prenatal care, with left-sided, liver-up CDH. Patient underwent an uncomplicated hernia repair of DOL 3. Cardiac echo demonstrated suprasystemic RVp, requiring intubation with iNO. Patient was treated with PGE1 to maintain ductal patency with improvement in respiratory function and echo estimate of RVp. However, at 4 weeks of age, the child’s status deteriorated with a PH crises. At 6 weeks of age, cardiac catheterization measured suprasystemic PAp with severely elevated PVR of 13.5 Wood units; minimal PVR was 9.9 with vasodilators. Continuous IV epoprostenol was started, with transition to IV treprostinil after 48 hours. The dose was titrated over the next 4 weeks to a peak dose of 48 ng/kg/min, with minimal side effects. This resulted in significant clinical improvement and a decrease in BNP from 4,080 to 25 pg/mL. At 10 weeks, the patient was weaned off treprostinil, and treprostinil therapy was discontinued 30 days later. The infant was discharged at 5 months of age on bosentan and 0.5 LPM NC oxygen. Repeat cardiac catheterization at 7 months demonstrated a PVR of 3.7 Wood units. At 1-year follow-up, the infant was weaned off both oxygen and bosentan and continues to grow and develop well, with normal pulmonary pressures estimated by echo. Case 2 was a full-term female infant with prenatally diagnosed severe, left-sided, liver-up CDH. Echo on DOL 1 demonstrated suprasystemic RVp and decreased function. Patient underwent hernia repair with internal oblique muscle flap on DOL 2. Infant was supported on HFOV, FiO2 of 100%, 20-ppm iNO, and PGE. Patient was extubated to NCPAP at 2 weeks but continued on iNO, PGE, and milrinone. Repeat echo at 6 weeks was unchanged, with suprasystemic RVp and decreased function. At 6.5 weeks of age, cardiac catheterization measured systemic pulmonary pressures at baseline, with elevated PVR of 7.1 Wood units; minimal PVR was 5.8 with vasodilators. Continuous SC treprostinil was initiated and titrated up over the next 5 weeks to a peak dose of 52 ng/kg/min. This resulted in significant clinical improvement, including a successful weaning off PGE, milrinone, and iNO within 2 weeks. BNP decreased from 143 to 5 pg/mL. Patient was discharged home at 3.5 months of age on 0.5 L/min O2 and SC treprostinil. Bosentan was initiated at 6 months in anticipation of treprostinil weaning, and repeat cardiac catheterization at 8 months of age on room air demonstrated normal pulmonary pressures and a PVR of 4.3 Wood units. Patient was successfully weaned off treprostinil over the next 4 weeks and is maintained on bosentan, with excellent growth and development and normal pulmonary pressures estimated by echo. In conclusion, these 2 cases demonstrate the benefit of short-term treprostinil use initiated at 6–8 weeks of age in neonates with severe PH following CDH repair. These cases are consistent with our prior report demonstrating pulmonary vascular reactivity in infants with CDH at 2–3 months of age. Further, the successful use of SC treprostinil improves the safety of administration of prostacyclins in this vulnerable population, eliminating the need for a central line and its associated risks and allowing for outpatient therapy in a young infant.
BACKGROUND:The outcomes of acute cardiovascular symptom presentations are potentially modifiable with the use of biomarkers to accelerate accurate diagnosis. This randomized trial tested troponin and B-type natriuretic peptide before hospital guidance in patients with acute cardiovascular symptoms. METHODS:Patients with either chest pain or shortness of breath were randomized to usual care or biomarkers analyzed using a point-of-care device in the ambulance. The primary end point was time to final disposition (discharge from the emergency department or admission to hospital). The trial was stopped prematurely because of less than expected enrollment of patients of interest and no difference in the primary end point. RESULTS:We randomized 491 patients; 480 formed the final cohort. Patients were 49% male; median age 70 years; 42% had previous acute coronary syndrome; and 28% diabetes. The B-type natriuretic peptide level before hospital arrival was ≥ 100 pg/mL in 36.4%. Troponin was > 0.03 ng/mL in 13.4%; 3.6% had troponin > 0.1 ng/mL. After adjudication, 16% had acute coronary syndrome, 6.5% acute heart failure, 3.3% angina, and 74.2% another diagnosis. The primary end point was 9.2 (interquartile range, 7.3-11.1) hours in the biomarker group and 8.8 (interquartile range, 6.3-12.1) hours in the usual care group (P = 0.6). None died in the ambulance or in the emergency department: all-cause 30-day mortality was 2.1% (usual care) and 1.7% (biomarker). CONCLUSIONS:To our knowledge, this is the first randomized trial of biomarkers before hospital arrival to guide emergency management of suspected acute cardiovascular disease which showed no benefit and was terminated early because of futility. The results have important implications for the use of biomarkers in emergency management of heart disease and for the design of future randomized trials on this important topic.
Prehospital triage and diagnosis of patients with STEMI enhances treatment efficiency and improves patient outcomes. However it is unclear whether prehospital ECG and cardiac biomarkers hasten the triage process or enhance treatment outcomes in patients with acute chest discomfort or dyspnea (with STEMI excluded). Accordingly, we assessed dynamic ECG metrics, peak biomarkers and 30 day death and reassessment/readmission in pre-hospital patients with acute cardiovascular disease symptoms. The Providing Rapid Out of Hospital Acute Cardiovascular Treatment-3 (PROACT-3) trial enrolled pre-hospital patients with acute chest discomfort or dyspnea. We analysed 269 with paired prehospital (EMS) and first in-hospital (IH) ECGs in a core laboratory. Subjects were categorized according to adjudicated diagnosis into 4 groups: 9(3.3%) Angina, 42(15.6%) ACS, 12(4.5%) acute heart failure (AHF), and 206(76.6%) patients with other diagnoses. Dynamic ECG changes from EMS-ECGs to IH-ECGs were compared. We categorised total ST deviation resolution (DR) according to percentage change into 3 groups: and ST DR≥ 70%, ST DR≥30%-≤70% and ST DR <30% which also includes patients who experience an increase in ST deviation. Results are reported as medians with interquartile ranges. On the EMS ECG, ST deviation was: 1.0 (0.0-2.0) Angina, 3.5 (1.5-6.5) ACS, 1.5 (1.0-2.5) AHF, and other 2.0 (0.5-4.0). The median time in minutes from EMS-ECG to IH-ECG was 76.0 (44.0, 156.0) angina, 64.5 (48.0, 112.5) ACS, 78.0 (57.0, 103.0) AHF, and 76.5 (56.0-108.0) other. ECG metrics comparing EMS to IH ECG were as follows: 28(10.4%) had no ST deviation, 32(11.9%) had persistent ST deviation, 43(16%) developed ST DR≥70%, 54(20.1%) developed ST DR≥30%-≤70%, 112(41.6%) developed ST DR≤30% - including 81 patients with ST worsening. Among patients with improved ST change i.e. ST DR>70% diagnoses were: 0% angina, 18.6% ACS, 2.3% AHF and 79.1% in other. In those patients with ST DR≤30%, the peak cardiac biomarkers were elevated (BNP ≥400 and troponin I ≥0.3) in 12/68(17.6%) BNP (≥400) and 56/86(65.1%) troponin I (≥0.3). In the total cohort 30 day death occurred in 5/269: 1 with no ST deviation, 2 with persistent ST deviation, and 2 with ST DR≥30%-≤70%. 30 day rehospitalisation/emergency reassessment occurred in: 5/43(11.6%) ST DR≥70%, 16/54(29.6%) ST DR ≥30%-≤70% and 22/112(19.6%) ST DR≤30%. In prehospital patients with suspect acute cardiovascular disease, the EMS ECG frequently demonstrates ST deviation (89.6%). Furthermore, dynamic ECG changes are frequently observed as described above. Further analysis is required to determine the correlation of these dynamic ECG findings with clinical outcomes.
Therapeutic anticoagulation for intra-aortic balloon pumps (IABP) in coronary care unit patients is commonly utilized. A more selective strategy for anticoagulation (i.e. only patients with another primary indication for systemic anticoagulation receive heparin) has been suggested to minimize bleeding. A current review of IABP practice with respect to anticoagulation, patient population and its associated risks is timely.
A risk treatment paradox (RT paradox) is prevalent in patients with non-ST elevation acute coronary syndromes (NSTE-ACS); wherein the highest risk patients are least likely to receive evidence based invasive management and medical therapy. The influence of gender on the RT paradox is unclear. Accordingly, we evaluated this issue across gender within a detailed registry of NSTE-ACS patients after accounting for GRACE risk score, biomarker positive status and prior revascularization. Within a defined health care region (Edmonton), two consecutive cohorts of NST-ACS patients (n=552) were studied retrospectively through chart review (Sept2008-Nov2008 & Mar2010-Jun2010). Selected baseline characteristics, in-hospital management, clinical events and discharge medications are shown in table. Despite similar times from symptom onset to first medical contact (males 2.0 vs. females 1.9 hours, p=0.5), higher risk characteristics and more frequent presentation by ambulance, females had a delay from first medical contact to CCU admission (males 11.9 vs. females 15.1 hours, p<0.001). Once admitted females were less likely to: undergo catheterization (CATH), receive revascularization (REVASC) and had higher in-hospital events. The apparent gender based RT paradox existed in those with the highest GRACE risk tertile (>140): CATH males 57.3% vs females 43.1% (p=0.057) and REVASC males 42.7% vs females 29.2% (p=0.061). Troponin positive males also had higher rates of CATH and REVASC than troponin positive females: CATH 81.5% vs 66.7% (p=0.0012) and REVASC 65.1% vs 38.3% (p<0.001). In those that had no prior REVASC, males were more likely to undergo CATH: 84.6% vs 68.9%, p<0.001.In hospital re-MI and heart failure were more common in females whereas they were less likely to be prescribed ASA and ACE inhibitors at discharge.Tabled 1 Female NSTE-ACS patients represent 30% of the NSTE-ACS cohort and when compared to their male counterparts, are older, have higher baseline risk and are more likely to present to hospital by ambulance. They are less likely to undergo CATH and REVASC. The lower rates of CATH and REVASC for females persist even in those with the highest GRACE risk scores, with positive troponin, and with or without prior revascularization. Additionally females are less likely to receive evidence based medical therapy at discharge. The RT paradox in NST-ACS is more prevalent in females and represents an unmet need that should be further investigated and addressed in clinical practice.
Histopathology of endomyocardial biopsies (EMB) is the standard rejection surveillance for heart transplants. However, ISHLT consensus criteria for interpreting biopsies are arbitrarily defined. Gene expression offers an independent re-evaluation of existing diagnostic systems. We performed histologic and microarray analysis on 105 EMB from 45 heart allograft recipients. Histologic lesions, diagnosis and transcripts were compared to one another, time posttransplantation, indication for biopsy and left ventricular ejection fraction (LVEF). Histologic lesions presented in two groups: myocyte-interstitial and microcirculation lesions. Expression of transcript sets reflecting T cell and macrophage infiltration, and γ-interferon effects correlated strongly with each other and with transcripts indicating tissue/myocardium injury. This molecular phenotype correlated with Quilty (p < 0.005), microcirculation lesions (p < 0.05) and decreased LVEF (p < 0.007), but not with the histologic diagnosis of rejection. In multivariate analysis, LVEF was associated (p < 0.03) with γ-interferon inducible transcripts, time posttransplantation, ischemic injury and clinically indicated biopsies, but not the diagnosis of rejection. The results indicate that (a) the current ISHLT system for diagnosing rejection does not reflect the molecular phenotype in EMB and lacks clinical relevance; (b) the interpretation of Quilty lesions has to be revisited; (c) the assessment of molecules in heart biopsy can guide improvements of current diagnostics.
Approximately 80-90% of protocol biopsies (PB) from heart allografts show no clinically relevant histopathological abnormalities according to current ISHLT consensus. But >10% of the heart allografts show loss in LVEF indicating that current diagnostic criteria are potentially not adequate for detecting relevant disease processes. Aim was therefore to correlate gene expression data and detailed histopathological lesions with LVEF.
The aim of this study was to examine the effects of 12 weeks of supervised aerobic and strength training (SET) versus no-training (NT) on peak aerobic power (VO(2peak)), submaximal exercise left ventricular (LV) systolic function, peripheral vascular function, lean tissue mass and maximal strength in clinically stable heart transplant recipients (HTR). Forty-three HTR were randomly assigned to 12 weeks of SET (n = 22; age: 57 +/- 10 years; time posttransplant: 5.4 +/- 4.9 years) or NT (n = 21; age: 59 +/- 11 years; time posttransplant: 4.4 +/- 3.3 years). The change in VO(2peak) (3.11 mL/kg/min, 95% CI: 1.2-5.0 mL/kg/min), leg and total lean tissue mass (0.78 kg, 95% CI: 0.31-1.3 kg and 1.34 kg, 95% CI: 0.34-2.3 kg, respectively), chest-press (10.4 kg, 95% CI: 5.2-15.5 kg) and leg-press strength (34.7 kg, 95% CI: 3.7-65.6 kg) were significantly higher after SET versus NT. No significant change was found for submaximal exercise LV systolic function or brachial artery endothelial-dependent or -independent vasodilation. Supervised exercise training is an effective intervention to improve VO(2peak), lean tissue mass and muscle strength in HTR. This training regimen did not improve exercise LV systolic function or brachial artery endothelial function.
T2 weighted imaging on magnetic resonance imaging (MRI) has been shown to predict ISHLT grading of allograft rejection. We sought to determine if MRI measures also correlated with transcript gene expression in cardiac allografts undergoing biopsy.
The increasing number of heart transplant survivors is leading to growing numbers of patients being considered for retransplantation. Due to the constant shortage of donor organs and the previously known worse results with repeat cardiac transplantation, some centres have been reluctant to offer this option. Nonetheless, methods and therapies utilized have continued to improve in all aspects of cardiac transplantation. We therefore re-examined our centre's experience with cardiac retransplantation.
Objective: Craniopharyngiomas (CPs) are benign brain tumors presenting frequently in childhood and are treated by surgery with or without radiotherapy. About 50% of cured patients suffer from eating disorders and obesity due to hypothalamic damage, as well as hypopituitarism, necessitating subsequent hormone substitution therapy. Gastric bypass surgery has been reported to be an efficient treatment strategy for morbid hypothalamic obesity. However, so far it is unknown whether oral hormone substitution is affected by impaired intestinal drug absorption, potentially leading to severe hypopituitarism or pituitary crisis.Methods: Four morbidly obese CP patients with panhypopituitarism treated by gastric bypass surgery were included in this retrospective analysis. Dosages of hormone substitution therapy, blood concentrations of hormones, potential complications of impaired drug absorption, and anthropometric characteristics were investigated pre- and postoperatively after 6 to 14 months and 13 to 65 months.Results: In all CP patients (3 female/1 male; baseline body mass index, 49 ± 7 kg/m2), gastric bypass resulted in distinct weight loss (-35 ± 27 kg). In follow-up examinations, mean daily dosage of thyroid hormone (levothyroxinebaseline 156 ± 44 μg/day versus levothyroxinefollow-up 150 ± 30 μg/day), hydrocortisone (hydrocortisonebaseline 29 ± 12 mg/day versus hydrocortisonefollow-up 26 ± 2 mg/day), growth-hormone (somatotropinbaseline 0.9 ± 0.5 mg/day versus somatotropinfollow-up 1.0 ± 0.4 mg/day), and desmopressin (desmopressinbaseline 222 ± 96 μg/day versus desmopressinfollow-up 222 ± 96 μg/day) substitution was unchanged. No patient developed adrenal insufficiency. Oral thyroid/hydrocortisone absorption testing performed in 1 patient indicated sufficient gastrointestinal drug absorption after bariatric surgery.Conclusion: Our preliminary results suggest that oral hormone substitution therapy is not impaired following gastric bypass operation in CP patients with morbid obesity, indicating that it might be a safe and effective treatment strategy.Abbreviations:BMI = body mass indexCP = craniopharyngiomafT4 = free thyroxineGH = growth hormoneIGF-1 = insulin-like growth factor 1