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  • 1
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    Starting point for benchmarking outcomes and reporting of pituitary adenoma surgery within the European Reference Network on Rare Endocrine Conditions (Endo-ERN): results from a meta-analysis and survey study
    Bioscientifica ; 2023
    In:  Endocrine Connections Vol. 12, No. 1 ( 2023-01-01)
    Details
    In: Endocrine Connections, Bioscientifica, Vol. 12, No. 1 ( 2023-01-01)
    Abstract: The European Reference Network on Rare Endocrine Conditions (Endo-ERN) aims to organize high-quality healthcare throughout Europe, including care for pituitary adenoma patients. As surgery is the mainstay of treatment, we aimed to describe the current surgical practice and published surgical outcomes of pituitary adenoma within Endo-ERN. Design and Methods Systematic review and meta-analysis of studies reporting surgical outcomes of pituitary adenoma patients within Endo-ERN MTG6 pituitary reference centers between 2010 and 2019. A survey was completed by reference centers on their current surgical practice. Results A total of 18 out of 43 (42%) reference centers located in 7 of the 20 (35%) MTG6-represented countries published 48 articles. Remission rates were 50% (95% CI: 42–59) for patients with acromegaly, 68% (95% CI: 60–75) for Cushing’s disease, and 53% (95% CI: 39–66%) for prolactinoma. Gross total resection was achieved in 49% (95% CI: 37–61%) of patients and visual improvement in 78% (95% CI: 68–87). Mortality, hemorrhage, and carotid injury occurred in less than 1% of patients. New-onset hypopituitarism occurred in 16% (95% CI: 11–23), transient diabetes insipidus in 12% (95% CI: 6–21), permanent diabetes insipidus in 4% (95% CI: 3–6), syndrome of inappropriate secretion of antidiuretic hormone (SIADH) in 9% (95% CI: 5–14), severe epistaxis in 2% (95% CI: 0–4), and cerebrospinal fluid leak in 4% (95% CI: 2–6). Thirty-five (81%) centers completed the survey: 54% were operated endoscopically and 57% were together with an ENT surgeon. Conclusion The results of this study could be used as a first benchmark for the outcomes of pituitary adenoma surgery within Endo-ERN. However, the heterogeneity between studies in the reporting of outcomes hampers comparability and warrants outcome collection through registries.
    Type of Medium: Online Resource
    ISSN: 2049-3614
    URL: Article
    DOI: 10.1530/EC-22-0349
    Language: Unknown
    Publisher: Bioscientifica
    Publication Date: 2023
    detail.hit.zdb_id: 2668428-7
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  • 2
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    Are there country-specific differences in the use of pegvisomant for acromegaly in clinical practice? An analysis from ACROSTUDY
    Springer Science and Business Media LLC ; 2022
    In:  Journal of Endocrinological Investigation Vol. 45, No. 8 ( 2022-08), p. 1535-1545
    Details
    In: Journal of Endocrinological Investigation, Springer Science and Business Media LLC, Vol. 45, No. 8 ( 2022-08), p. 1535-1545
    Abstract: A comprehensive picture of pegvisomant use for treating acromegaly in routine clinical practice in different countries is lacking. We aimed, therefore, to document country-specific behaviors in real-life pegvisomant use, and the main safety and effectiveness outcomes in the ACROSTUDY. Design ACROSTUDY is an open-label, non-interventional, post-marketing safety surveillance study. Methods A descriptive analysis was performed using data from the six top-recruiter ACROSTUDY countries, i.e., Germany ( n  = 548 patients), Italy ( n  = 466), France ( n  = 312), USA ( n  = 207), Spain ( n  = 200) and the Netherlands ( n  = 175). These nations accounted for  〉  85% of the ACROSTUDY cases. Results The mean pegvisomant dose at treatment start was lowest in the Netherlands (9.4 mg/day), whereas it ranged between 10.9 and 12.6 mg/day in the other countries. At year 5, the mean pegvisomant dose was around 15 mg/day in all countries, except France (18.1 mg/day). At starting pegvisomant, patients treated with monotherapy ranged between 15% in the Netherlands and 72% in Spain. Monotherapy remained lowest over time in the Netherlands. In all countries, the percentage of patients with normal IGF-1 increased steeply from  〈  20% at baseline to 43–58% at month 6 and 51–67% at year 1. After that, we observed minor changes in the rate of acromegaly control in all countries. The Netherlands peaked in disease control at year 2 (72%). The proportion of patients reporting changes in pituitary tumor size was generally low. Serious treatment-related adverse events were  〈  5% in all countries. Conclusions Our study provided a detailed summary of real-life use of pegvisomant in the six top-recruiter ACROSTUDY nations.
    Type of Medium: Online Resource
    ISSN: 1720-8386
    URL: Article
    DOI: 10.1007/s40618-022-01789-4
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
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  • 3
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    The prevalence of silent acromegaly in prolactinomas is very low
    Springer Science and Business Media LLC ; 2021
    In:  Journal of Endocrinological Investigation Vol. 44, No. 3 ( 2021-03), p. 531-539
    Details
    In: Journal of Endocrinological Investigation, Springer Science and Business Media LLC, Vol. 44, No. 3 ( 2021-03), p. 531-539
    Type of Medium: Online Resource
    ISSN: 1720-8386
    URL: Article
    DOI: 10.1007/s40618-020-01338-x
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
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  • 4
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    Neuroendocrine response to diclofenac in healthy subjects: a pilot study
    Springer Science and Business Media LLC ; 2023
    In:  Journal of Endocrinological Investigation
    Details
    In: Journal of Endocrinological Investigation, Springer Science and Business Media LLC
    Abstract: The precise effects of non-steroidal anti-inflammatory drugs on the neuroendocrine hydro-electrolytic regulation are not precisely understood. The aim of this pilot study was to evaluate, in healthy subjects, the neuroendocrine response of the antidiuretic system to intravenous diclofenac infusion. Methods For this single-blinded, cross-over study, we recruited 12 healthy subjects (50% women). Test sessions were divided into three observation times (pre-test; test; 48 h post-test), which were repeated equally on two different occasions, with the administration of diclofenac (75 mg in saline solution 0.9% 100 cc) on 1 day, or placebo (saline solution 0.9% 100 cc) on another day. The night before the test the subjects were asked to collect a salivary cortisol and cortisone sample, which was repeated on the night of the procedure session. Serial urine and blood samples were collected on the test day (for osmolality, electrolytes, ACTH, cortisol, copeptin, MR-proADM, MR-proANP; the last three represent more stable and analytically reliable molecules than their respective active peptides). Moreover, the subjects were evaluated with the bioimpedance vector analysis (BIVA) before and after the test. Forty-eight hours after the end of the procedure urine sodium, urine potassium, urine osmolality, serum sodium and copeptin were revaluated together with BIVA. Results No significant changes in circulating hormone levels were observed; anyway, 48 h after diclofenac, BIVA showed a significant water retention ( p   〈  0.00001), especially in extracellular fluid (ECF) (16.47 ± 1.65 vs 15.67 ± 1.84, p   〈  0.001). Salivary cortisol and cortisone tended to increase only the night after placebo administration ( p  = 0.054 cortisol; p  = 0.021 cortisone). Conclusion Diclofenac resulted in an increased ECF at 48 h, but this phenomenon seems to be associated with a greater renal sensibility to the action of vasopressin rather than with an increase in its secretion. Moreover, a partial inhibitory effect on cortisol secretion can be hypothesized.
    Type of Medium: Online Resource
    ISSN: 1720-8386
    URL: Article
    DOI: 10.1007/s40618-023-02118-z
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
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  • 5
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    FRI0499 ACROMEGALY ARTROPATHY: IS THERE SOMETHING MORE BEHIND THE PAIN? A CROSS-SECTIONAL STUDY TO EVALUATE RHEUMATIC DISEASE IN GROWTH HORMONE SECRETING TUMOR PATIENTS
    BMJ ; 2020
    In:  Annals of the Rheumatic Diseases Vol. 79, No. Suppl 1 ( 2020-06), p. 848.1-848
    Details
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 79, No. Suppl 1 ( 2020-06), p. 848.1-848
    Abstract: Acromegaly is a rare disease with a remarkable impact on patients, both in terms of life expectancy and quality of life. Osteo-articular complications are one of the most frequently reported bothers. The “acromegaly artropathy” characterizes more than 70% of patients at diagnosis. Artropathy affects both spine and peripheral joints. A recent prospective study documented progression of acromegalic arthropathy identified as a worsening of osteophytes and joint space narrowing in 72–74% of patients despite long-term biochemical control. In addiction the Literature has occasionally reported cases of simultaneous presence of rheumatic diseases (rheumatoid arthritis, polymyalgia rheumatica, undifferentiated connective tissue diseases) and acromegaly and in all these cases the treatment has been delayed, because of wrong symptoms attribution to acromegaly artropathy. Objectives: The primary goal of the study is to better characterize joint pain in acromegaly patients and to evaluate the prevalence of rheumatic disease in growth hormone (GH) secreting pituitary tumor patients. Methods: We enrolled 20 acromegaly subjects (AS) and 20 control subjects (CS). In each subject immunological pattern (rheumatoid factor – RF; antinuclear antibodies - ANA, ENA; anti-citrullinated protein antibodies - ACPA; erythrocyte sedimentation rate – ESR) has been evaluated; they, also, underwent bilateral joint ultrasound of hands and wrists and nail capillaroscopy. The Chi square test and the Fisher’s exact test were used to evaluate the association between binary variables, while the Spearman’s test to evaluate the correlation of continuous ones. A multiple or logistic regression model was calculated in order to define the association between the capillaroscopic alterations and other detected variables. Results: Articular pain emerged as significantly more frequent in AS (p = 0.0269). No statistically significant differences are detected regarding immunological pattern. ANA and ENA screening resulted positive in 10% in AS and in 5% in CS. No IgA ACPA were detected in AS or CS, while IgG ACPA were positive only in one AS subject. No significant differences were detected between IgM and IgG RFin the two groups (AS 5% and CS 0%). Three fold higher IgG FR in AS compared to CS were detected. ESR levels were significantly higher than CS (p = 0.0405), as well as increased power doppler (PWD) articular uptake (AS 30% vs CS 5% p 0.081). The capillaroscopic evaluation showed a significant difference in almost each parameter that has been evaluated (logistic regression: number of enlargement p 0.004, hemorragies p 0.01 and capillaries p 0.001), showing a moderate-severe microangiopathy in AS. Interestingly, analyzing only the acromegaly cohort, we noticed higher GH levels at the enrollment in patients which developed capillary enlargements (GH: 0.95 ng/ml IQ 0,6-1,6) compared to other ones (GH: 0.55 ng/ml IQ 0.4-0.7; p = 0.08) and a significant lower number of hemorrhages (p = 0.02) in patients treated with GH antagonist pegvisomant. Conclusion: Our results demonstrated that joint damage in acromegaly does not seem to have an autoimmune etiology. Therefore, articular damage is mechanical and increased ESR and PWD alterations seems to confirm the presence of an inflammatory component. In addition, acromegaly is characterized by a microvascular pattern of moderate-severe microangiopathy, without correlation to IGF-I, but GH levels. Although requiring further confirmatory studies, our preliminary results seem to indicate how the capillaroscopic examination could be useful to detect earlier microangiopathy and to identify patients with a greater risk of macroangiopathy development.. References: [1]Claessen KMJA et al. Bone and joint disorders in acromegaly. Neuroendocrinology. 2016;103(1):86-95. [2]Örük G et al. Is every joint symptom related to acromegaly? Endocrine. 2013 Apr;43(2):404-11. Disclosure of Interests: None declared
    Type of Medium: Online Resource
    ISSN: 0003-4967 , 1468-2060
    URL: Article
    DOI: 10.1136/annrheumdis-2020-eular.3134
    RVK:
    XA 10000
    Language: English
    Publisher: BMJ
    Publication Date: 2020
    detail.hit.zdb_id: 1481557-6
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  • 6
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    Acromegaly and joint pain: is there something more? A cross-sectional study to evaluate rheumatic disorders in growth hormone secreting tumor patients
    Springer Science and Business Media LLC ; 2020
    In:  Journal of Endocrinological Investigation Vol. 43, No. 11 ( 2020-11), p. 1661-1667
    Details
    In: Journal of Endocrinological Investigation, Springer Science and Business Media LLC, Vol. 43, No. 11 ( 2020-11), p. 1661-1667
    Type of Medium: Online Resource
    ISSN: 1720-8386
    URL: Article
    DOI: 10.1007/s40618-020-01268-8
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
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  • 7
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    Development and internal validation of a predictive score for the diagnosis of central adrenal insufficiency when morning cortisol is in the grey zone
    Springer Science and Business Media LLC ; 2022
    In:  Journal of Endocrinological Investigation Vol. 46, No. 3 ( 2022-09-26), p. 535-543
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    In: Journal of Endocrinological Investigation, Springer Science and Business Media LLC, Vol. 46, No. 3 ( 2022-09-26), p. 535-543
    Abstract: When evaluating a patient for central adrenal insufficiency (CAI), there is a wide range of morning cortisol values for which no definite conclusion on hypothalamus–pituitary–adrenal (HPA) axis function can be drawn; in these cases, a stimulation test is required. Aim of this study was to develop an integrated model for CAI prediction when morning cortisol is in the grey zone, here defined as 40.0–160.0 μg/L. Methods Overall, 119 patients with history of sellar tumour which underwent insulin tolerance test (ITT) for the evaluation of HPA axis were enrolled. Supervised regression techniques were used for model development. Results An integrated predictive model was developed and internally validated, and showed a significantly better diagnostic performance than morning cortisol alone (AUC 0.811 vs 0.699, p  = 0.003). A novel predictive score (CAI-score) was retrieved, on a 5.5-point scale, by considering morning cortisol (0 points if 130.1–160.0 μg/L, 1 point if 100.1–130.0 μg/L, 1.5 points if 70.1–100.0 μg/L, 2.5 points if 40.0–70.0 μg/L), other pituitary deficits (2 points if ≥ 3 deficits), and sex (1 point if male). A diagnostic algorithm integrating CAI-score and ITT was finally proposed, with an overall accuracy of 99%, and the possibility to avoid the execution of stimulation tests in 25% of patients. Conclusions This was the first study that proposed an integrated score for the prediction of CAI when morning cortisol is in the grey zone. This score might be helpful to reduce the number of patients who need a stimulation test for the assessment of HPA axis function.
    Type of Medium: Online Resource
    ISSN: 1720-8386
    URL: Article
    DOI: 10.1007/s40618-022-01926-z
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
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  • 8
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    Benefits of dual-release hydrocortisone treatment on central adiposity and health-related quality of life in secondary adrenal insufficiency
    Springer Science and Business Media LLC ; 2022
    In:  Journal of Endocrinological Investigation Vol. 46, No. 3 ( 2022-10-17), p. 587-597
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    In: Journal of Endocrinological Investigation, Springer Science and Business Media LLC, Vol. 46, No. 3 ( 2022-10-17), p. 587-597
    Abstract: Patients with secondary adrenal insufficiency (SAI) have an increased morbidity and an impaired health-related quality of life (HRQoL), which seems to primarily depend on the sub-optimal replacement of hypoadrenalism with standard glucocorticoid (GC) therapy, and on the inadequate correction of other associated pituitary deficiencies. A dual-release hydrocortisone (DR-HC) formulation has shown to exert positive effects on morbidity and HRQoL, mainly in patients with primary adrenal insufficiency. We assessed the variations of anthropometric and metabolic parameters and HRQoL in patients with SAI after switching from cortisone acetate (CA) or hydrocortisone (HC) to DR-HC. Methods Twenty-one patients (17 M, 4 F) treated with CA ( n  = 16; 25 mg/day twice a day) or HC ( n  = 5; 20 mg/day three times a day), were evaluated for waist circumference, BMI, fasting glucose, HbA1c, insulin, HOMA-IR index, serum lipids, electrolytes, blood pressure and HRQoL at baseline, at 3, 6 and 12 months after switching from CA/HC to DR-HC. Results The study showed a significant reduction of waist circumference and BMI ( p  = 0.04, for both), after 3 and 6months of DR-HC treatment, respectively. No significant changes were observed for fasting glucose, insulin, HOMA-IR index, HbA1c, total cholesterol, triglycerides, LDL cholesterol, electrolytes, and blood pressure. However, HDL cholesterol significantly decreased ( p  = 0.003). An improvement of AddiQoL total score was observed during DR-HC treatment ( p  = 0.01), mainly for the category “emotions”. No predictors resulted for these changes. Conclusion DR-HC treatment provides some benefits in patients with SAI, reducing central adiposity and improving HRQoL; however, worsening of HDL cholesterol is observed during treatment with DR-HC.
    Type of Medium: Online Resource
    ISSN: 1720-8386
    URL: Article
    DOI: 10.1007/s40618-022-01940-1
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
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  • 9
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    First but not second postoperative day growth hormone assessments as early predictive tests for long-term acromegaly persistence
    Springer Science and Business Media LLC ; 2021
    In:  Journal of Endocrinological Investigation Vol. 44, No. 11 ( 2021-11), p. 2427-2433
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    In: Journal of Endocrinological Investigation, Springer Science and Business Media LLC, Vol. 44, No. 11 ( 2021-11), p. 2427-2433
    Abstract: Postoperative assessment of acromegaly activity is typically performed at least 3 months after neurosurgery (NS). Few studies have evaluated the use of early postoperative growth hormone (GH) levels as a test to predict short- and long-term remission of acromegaly. Our objective was to evaluate the diagnostic performance of serum random GH on a postoperative day one (D1-rGH) and two (D2-rGH), particularly in predicting long-term disease persistence. Materials and methods Forty-one subjects with acromegaly who were undergoing NS were enrolled (mean age ± SD 47.4 ± 13.1 years at diagnosis; women 54%; macroadenomas 71%). The final assessment of disease activity was performed one year after NS. ROC curves were used to evaluate the diagnostic performance of D1-rGH and D2-rGH. Results After a 1-year follow-up, the overall remission rate was 55%. ROC analysis identified an optimal D1-rGH cut-off value of 2.1 ng/mL for diagnosing long-term disease persistence (55.6% SE; 90.9% SP). The cut-off point became 2.5 ng/mL after maximizing specificity for disease persistence (yielding a 100% positive predictive value) and 0.3 ng/mL after maximizing sensitivity for disease remission. The optimal D2-rGH cut-off value was 0.6 ng/mL (81.8% SE; 50% SP); the cut-off point became 2.9 ng/mL after maximizing specificity and 0.1 ng/mL after maximizing sensitivity, with no clinical utility. Conclusions D1-rGH could be a highly specific test for the early diagnosis of long-term acromegaly persistence, which is predicted by a value  〉  2.5 ng/mL with a great degree of certainty. The diagnostic performance of D2-rGH was insufficient. Further research is required to validate these preliminary results prior to modifying the postoperative management of acromegaly.
    Type of Medium: Online Resource
    ISSN: 1720-8386
    URL: Article
    DOI: 10.1007/s40618-021-01553-0
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
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  • 10
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    Mean GH profile is more accurate than single fasting GH in the evaluation of acromegaly disease control during somatostatin receptor ligands therapy
    Springer Science and Business Media LLC ; 2022
    In:  Journal of Endocrinological Investigation Vol. 45, No. 10 ( 2022-06-24), p. 1955-1965
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    In: Journal of Endocrinological Investigation, Springer Science and Business Media LLC, Vol. 45, No. 10 ( 2022-06-24), p. 1955-1965
    Abstract: This study aims to compare the accuracy of mean GH profile (GHP) 〈  2.5 ng/ml and single fasting GH (SGH) 〈  1 ng/ml in the evaluation of disease control in acromegaly patients during somatostatin receptor ligands (SRLs) therapy. Methods We retrospectively enrolled 100 acromegaly patients, 68 responder, and 32 partial responder to SRLs. Controlled disease has been defined as IGF-I levels within age-related normal limits, while partial response as pathological IGF-I values despite a reduction ≥ 50%. In all patients, GHP, SGH, IGF-I, and IGFBP-3 were evaluated. Results Median GHP levels (1.2 ng/ml, IQR 0.5–2.3 ng/ml) were lower ( p  = 0.001) than SGH (1.9 ng/ml, IQR 1.0–3.6 ng/ml). Accuracy of GHP was 81%, whereas that of SGH was 55%, with a Kappa index of 0.520 and 0.237, respectively. In multivariable analysis GHP ( p  = 0.002) and IGFBP-3 ( p  = 0.004), but not SGH, were independently associated with normal IGF-I levels. At receiver–operator characteristic curve (ROC) analysis GHP cut-off sensitivity and specificity were 94.1% and 50.0%, respectively, while SGH sensitivity and specificity were 35.3% and 93.7%, respectively. Finally, in obese patients the GH cut-off level (both as SGH and GHP) associated to good disease control was significantly different with respect to not obese ones. Conclusions GHP associates with IGF-I (and therefore with appropriate control of disease) with higher accuracy than SGH. When GH evaluation is needed, the measurement of mean GHP should be preferred and use of BMI-related cut-offs is suggested.
    Type of Medium: Online Resource
    ISSN: 1720-8386
    URL: Article
    DOI: 10.1007/s40618-022-01830-6
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
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