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Purpose: To evaluate the diagnostic accuracy of the 131I-6β-iodomethyl-19-norcholesterol (NP-59) adrenal scintigraphy for the subtyping diagnosis of primary aldosteronism (PA), considering as gold standard for the diagnosis of unilateral PA (UPA), either the results of the adrenal venous sampling (AVS) or the outcome after adrenalectomy. Methods: A retrospective multicenter study was performed on PA patients from 14 Spanish tertiary hospitals who underwent NP-59 scintigraphy with an available subtyping diagnosis. Patients were classified as UPA if biochemical cure was achieved after adrenalectomy or/and if an AVS lateralization index > 4 with ACTH stimulation or >2 without ACTH stimulation was observed. Patients were classified as having bilateral PA (BPA) if the AVS lateralization index was ≤4 with ACTH or ≤2 without ACTH stimulation or if there was evidence of bilateral adrenal nodules >1 cm in each adrenal gland detected by CT/MRI. Results: A total of 86 patients with PA were included (70.9% (n = 61) with UPA and 29.1% (n = 25) with BPA). Based on the NP-59 scintigraphy results, 16 patients showed normal suppressed adrenal gland uptake, and in the other 70 cases, PA was considered unilateral in 49 patients (70%) and bilateral in 21 (30%). Based on 59-scintigraphy results, 10.4% of the patients with unilateral uptake had BPA, and 27.3% of the cases with bilateral uptake had UPA. The AUC of the ROC curve of the NP-59 scintigraphy for PA subtyping was 0.812 [0.707–0.916]. Based on the results of the CT/MRI and NP-59 scintigraphy, only 6.7% of the patients with unilateral uptake had BPA, and 24% of the cases with bilateral uptake had UPA. The AUC of the ROC curve of the model combining CT/MRI and 59-scintigraphy results for subtyping PA was 0.869 [0.782–0.957]. Conclusion: The results of NP-59 scintigraphy in association with the information provided by the CT/MRI may be useful for PA subtyping. However, their diagnostic accuracy is only moderate. Therefore, it should be considered a second-line diagnostic tool when AVS is not an option.

ObjectiveTo analyze the evolution of the cardiometabolic profile of patients with primary hyperaldosteronism (PA) after the treatment with surgery and with mineralocorticoid receptor antagonists (MRA).DesignRetrospective multicentric study of patients with PA on follow-up in twelve Spanish centers between 2018 and 2020.Results268 patients with PA treated by surgery (n = 100) or with MRA (n = 168) were included. At baseline, patients treated with surgery were more commonly women (54.6% vs 41.7%, P = 0.042), had a higher prevalence of hypokalemia (72.2% vs 58%, P = 0.022) and lower prevalence of obesity (37.4% vs 51.3%, P = 0.034) than patients treated with MRA. Adrenalectomy resulted in complete biochemical cure in 94.0% and clinical response in 83.0% (complete response in 41.0% and partial response in 42.0%). After a median follow-up of 23.6 (IQR 9.7–53.8) months, the reduction in blood pressure (BP) after treatment was similar between the group of surgery and MRA, but patients surgically treated reduced the number of antihypertensive pills for BP control more than those medically treated (∆antihypertensives: −1.3 ± 1.3 vs 0.0 ± 1.4, P < 0.0001) and experienced a higher increased in serum potassium levels (∆serum potassium: 0.9 ± 0.7 vs 0.6 ± 0.8mEq/ml, P = 0.003). However, no differences in the risk of the onset of new renal and cardiometabolic comorbidities was observed between the group of surgery and MRA (HR = 0.9 [0.5–1.5], P = 0.659).ConclusionIn patients with PA, MRA and surgery offer a similar short-term cardiovascular protection, but surgery improves biochemical control and reduces pill burden more commonly than MRA, and lead to hypertension cure or improvement in up to 83% of the patients.

Background The EQ-5D-5L five-dimensional instrument, is one of the most widely used generic preference-based questionnaires to measure health-related quality of life and to estimate utility indices for use in economic evaluation. This study aimed to assess the psychometric properties of the Spanish EQ-5D-5L questionnaire in patients with Diabetes Mellitus (DM) assessing reliability, validity, and item-level properties such as item functioning. Methodology We included 133 patients with DM who completed the EQ-5D-5L, the Audit on Diabetes-Dependent Quality of Life (ADDQoL), the Hospital Anxiety and Depression Scale (HADS), one question about general health and sociodemographic, and clinical data. The reliability was assessed by Cronbach’s alpha, and the item functioning by the item response theory (IRT). Convergent validity was tested using the Spearman correlation coefficient between EQ-5D-5L, ADDQoL, HADS and the general health question. We examined known-groups validity by comparing the EQ-5D-5L scores between subgroups defined by age, gender, BMI, regular physical activity, disease duration, glycemic control by glycosylated blood hemoglobin (HbA1c) (%), type of DM, general health and anxiety and depression level using t -test, ANOVA, Wilcoxon or Kruskal-Wallis tests. Results The reliability was supported with a Cronbach’s alpha of 0.78. The IRT results supported the unidimensionality and showed adequate item functioning, except for the anxiety/depression dimension. The item with highest discriminatory power was usual activities dimension, followed by self-care and mobility dimensions. The EQ-5D-5L showed adequate convergent validity, with high correlation with the ADDQoL, HADS and general health. Older age, women, obese, no regular physical activity, ≥ 10 years of disease duration, poor glycemic control, poorer general health and higher anxiety and depression level linked with lower EQ-5D-5L scores. Conclusions These findings support the adequate psychometric properties of the EQ-5D-5L in patients with DM, supporting its use for clinicians and researchers as an outcome measure and for use in economic evaluation studies.

Objective: To evaluate the efficacy and safety of osilodrostat in patients with Cushing’s disease (CD). Methods: A retrospective, multicenter, real-world study of patients with CD. The main efficacy endpoint was the proportion of patients who were complete responders (urinary free cortisol [UFC] < the upper limit of normal and/or with adrenal insufficiency development). Results: Thirty-seven CD patients were enrolled. There were 33 patients who initially received osilodrostat in monotherapy and 4 in combination. However, 3 patients of the monotherapy group were switched to combination therapy. The median duration of osilodrostat treatment was 5 months (range 1–93). All the patients were classified as responders: 33 (89.2%) had complete response and 4 partial response. A positive correlation was detected between the percentage of UFC decrease and the maximum (r = 0.481, p = 0.006) and the maintenance doses (r = 0.440, p = 0.011). The initial doses of osilodrostat were a predictor of complete response (vs. partial) (Odds ratio [OR] 2.82, p = 0.030). The median time to UFC normalization in the group of complete responders was 4 weeks (range 1–20) and UFC normalized before or at month 1 in 67% (n = 20/30) of the patients. Osilodrostat led to a significant decrease in systolic and diastolic blood pressure in parallel with a reduction of antihypertensive medications. Conclusions: Osilodrostat leads to a complete UFC normalization in up to 90% of the patients with CD, in parallel with an improvement in the cardiometabolic profile. A proper titration of osilodrostat is important to achieve a complete response since a positive correlation between the doses and the UFC reduction was observed.

ObjectiveThe aim of this study was to evaluate the rate of adrenal venous sampling (AVS) performance in patients with primary aldosteronism (PA), the main reasons for its non-performance, and the success and complications rate of this procedure in Spain. Moreover, the concordance between CT/MRI and AVS for PA subtyping was evaluated.MethodsA retrospective multicenter study of PA patient follow-up in 20 Spanish tertiary hospitals between 2018–2021 was performed (SPAIN-ALDO Register).ResultsOf the 440 patients with PA included in the study, 153 underwent AVS (34.8%). The main reasons for not performing AVS were: patient rejection to the procedure, low catheterization rate in the center and unilateral disease based on CT/MRI. The overall success rate was 44.4% (the left adrenal vein was properly canulated in 77.8% and the right adrenal vein in 48.4%). Only 3 patients experienced minor complications. In the 45 patients with unilateral disease according to AVS, CT/MRI indicated bilateral disease or normal adrenal glands in 17. In the 23 patients with bilateral disease, CT/MRI indicated unilateral disease in 14. However, no significant differences were observed in biochemical response (P = 0.051) and hypertension resolution (P = 0.150) between patients who underwent surgery based on CT/MRI results and those who underwent surgery based on AVS results.ConclusionIn our setting, AVS is still an underused technique in patients with PA. The low experience and success rate in AVS partially justify these results. More training for providers and patients needs to be done to include appropriate well performed AVS in the diagnosis algorithm of PA.

Purpose To determine the prevalence of hyperparathyroidism (HPT), including primary, secondary and normocalcemic in a cohort of patients with PA of the SPAIN-ALDO registry. Methods A retrospective multicenter study of primary aldosteronism (PA) patients followed in 37 Spanish tertiary hospitals and with available information on serum calcium, phosphorus, iPTH, and vitamin D at the time of PA diagnosis. The diagnosis of normocalcemic HPT (n-HPT) associated with PA was based on a iPTH > 65pg/mL with normal corrected serum calcium after excluding the most common causes of secondary HPT, and HPT was classified as secondary (S-HPT) in the presence of chronic kidney disease or vitamin D deficiency, and as primary (PHPT) when iPTH levels >65 pg/mL were associated with high serum calcium levels. Results A total of 246 patients with PA were included, of whom 56% ( n  = 139) had PTH > 65 pg/mL. In the group of participants with HPT ( n  = 139) the proportion of PHPT was 7.2%, of n-HPT 11.5% and of S-HPT 81.3%. Patients with n-HPT had a higher prevalence of atrial fibrillation (7.9% vs. 1.9%, P  = 0.04) and hypokalemia (71.6% vs. 46.2%, P  < 0.001) and greater aldosterone (33.2 vs. 26.8 ng/dL, p  = 0.003) and 24 h urinary calcium excretion ( 243.5 vs. 160.5 mg/24 h, p  = 0.01) than patients without hyperparathyroidism. No differences in surgical outcomes (biochemical and clinical response) were detected between patients with and without hyperparathyroidism. Conclusions HPT is a frequent condition in patients with PA and S-HPT is the most common etiology. Patients with HPT have a higher prevalence of atrial fibrillation and hypokalemia and a more severe PA than those without HPT. However, no differences in surgical outcomes were reported between patients with and without HPT.

Purpose Studies focused on the effects of sellar and/or perisellar (S/PS) meningiomas on pituitary function are scarce. The primary objective of the present study was to determinate the effects that S/PS meningiomas and their treatments have on pituitary function. Also, we described the clinical characteristics and therapeutic outcomes of the cohort of adult Spanish patients. Methods A multicenter and retrospective study of patients with S/PS meningiomas attended in 20 tertiary Spanish centers. Results 165 patients, 123 (74.5%) females, with median age of 61.4 [51–71] years were analyzed. At presentation, 115 (69.7%) had visual disturbance, 62 (37.6%) headache, 46 (27.9%) cranial nerve palsy and 34 (26.2%) hypopituitarism. Median tumor diameter was 29.1 [22–35.5] mm and cavernous sinus infiltration was detected in 95 (59%). As initial treatment, 128 (77.6%) underwent surgery, 25 (15.2%) received radiotherapy and 12 (7.3%) were clinically and radiologically monitored. Among operated patients, gross total resection (GTR) was achieved in 44 (34.4%), whereas in 84 (65.6%) the tumor was incompletely removed. Overall median follow-up was 5.7 [2.9–9.2] years. After treatments, hypopituitarism was present in 86 (53.4%) patients at the last evaluation, and it was associated with surgery extension (subtotal or GTR) but not with tumor subtype, type of radiotherapy or radiation dose received. Conclusions S/PS meningiomas affect the pituitary function in 25% of the cases. However, after the implementation of treatments, hypopituitarism prevails in more than 50% of the cases. They are relatively large tumors and GTR is achieved in one third of the cases in whom hypopituitarism is more prevalent.

Abstract Purpose To assess the impact of body mass index (BMI) on disease severity, cardiac remodeling, and clinical and biochemical outcomes after surgical and medical treatment in patients with primary aldosteronism (PA). Methods This international retrospective study included patients diagnosed with PA in Germany, Italy, and Spain. Patients with available BMI, serum potassium, blood pressure, and basal plasma aldosterone concentration at diagnosis were included. PA severity was classified using the Primary Aldosteronism Severity Classification. Results A total of 1752 patients were analyzed at baseline; 604 (34.5%) had obesity (BMI ≥30 kg/m2). Patients with obesity were older, more frequently male, and had a higher prevalence of cardiometabolic comorbidities, including type 2 diabetes, cardiovascular disease, left ventricular hypertrophy, and obstructive sleep apnea. PA severity according to the Primary Aldosteronism Severity Classification did not differ significantly between patients with and without obesity; however, the prevalence of severe PA increased progressively across BMI categories (MH test for linear trend: χ2(1) = 3.70, P = .054). Following adrenalectomy, the probability of complete hypertension resolution decreased with increasing BMI, whereas biochemical cure rates were similar. Among patients treated with mineralocorticoid receptor antagonists, obesity was associated with a lower likelihood of complete clinical response, without significant differences in biochemical response. Conclusion In patients with PA, obesity is associated with a higher burden of cardiometabolic comorbidities and increased prevalence of left ventricular hypertrophy at baseline, as well as with less favorable clinical outcome after both surgical and medical treatment.

IntroductionPrimary aldosteronism (PA) is associated with several cardiometabolic comorbidities. Specific treatment by mineralocorticoid receptor antagonists (MRA) or adrenalectomy has been reported to reduce the cardiometabolic risk. However, the cardiovascular benefit could depend on plasma renin levels in patients on MRA.AimTo compare the development of cardiovascular, renal and metabolic complications between medically treated patients with PA and those who underwent adrenalectomy, taking the renin status during MRA treatment into account.MethodsA multicenter retrospective study (SPAIN-ALDO Register) of patients with PA treated at 35 Spanish tertiary hospitals. Patients on MRA were divided into two groups based on renin suppression (n = 90) or non-suppression (n = 70). Both groups were also compared to unilateral PA patients (n = 275) who achieved biochemical cure with adrenalectomy.ResultsAdrenalectomized patients were younger, had higher plasma aldosterone concentration, and lower potassium levels than MRA group. Patients on MRA had similar baseline characteristics when stratified into treatment groups with suppressed and unsuppressed renin. 97 (55.1%) of 176 patients without comorbidities at diagnosis, developed at least one comorbidity during follow-up (median 12 months vs. 12.5 months’ follow-up after starting MRA and surgery, respectively). Surgery group had a lower risk of developing new cardiovascular events (HR 0.40 [95% CI 0.18–0.90]) than MRA group. Surgical treatment improved glycemic and blood pressure control, increased serum potassium levels, and required fewer antihypertensive drugs than medical treatment. However, there were no differences in the cardiometabolic profile or the incidence of new comorbidities between the groups with suppressed and unsuppressed renin levels (HR 0.95 [95% CI 0.52–1.73]).ConclusionCardiovascular, renal, and metabolic events were comparable in MRA patients with unsuppressed and suppressed renin. Effective surgical treatment of PA was associated with a decreased incidence of new cardiovascular events when compared to MRA therapy.

Disclosure: M. Araujo-Castro: None. M. Paja Fano: None. M. González Boillos: None. B. Pla Peris: None. E. Pascual-Corrales: None. A. García Cano: None. P. Parra: None. P. Martín Rojas-Marcos: None. J. Ruiz-Sanchez: None. A. Vicente Delgado: None. E. Gómez Hoyos: None. R. Ferreira: None. I. García Sanz: None. M. Recasens Sala: None. R. Barahona San Millan: None. M. Picón César: None. P. Díaz Guardiola: None. J. García González: None. C.M. Perdomo: None. L. Manjón Miguélez: None. R. García Centeno: None. Á. Rebollo Román: None. P. Gracia Gimeno: None. C. Robles Lázaro: None. M. Morales-Ruiz: None. M. Calatayud Gutiérrez: None. S. Simone Andree Furio Collao: None. D. Meneses: None. M. Sampedro Nuñez: None. V. Escudero Quesada: None. E. Mena Ribas: None. A. Sanmartin Sánchez: None. C. Gonzalvo Diaz: None. C. Lamas: None. F. Hanzu: None. Purpose: To evaluate the prevalence of type 2 diabetes mellitus (T2DM) in patients with primary aldosteronism (PA) and the risk factors for its development. Methods: A retrospective multicenter study of PA patients in follow-up in 27 Spanish tertiary hospitals (SPAIN-ALDO Register). Adrenal venous sampling (AVS) was informative of laterality in 128 out of 226 patients and adrenalectomy was performed in 201 patients. Unilateral PA was defined as biochemical cure after adrenalectomy or as a lateralization index in AVS > 2 with ACTH or >3 without ACTH stimulation. Results: Overall, 649 patients with PA were included. Median age was 55.5 (range 27.3-81.6) years, 59.1% were female and 58.5% had hypokalemia at diagnosis. A total of 224 patients were classified as unilateral PA (142 based on biochemical cure after adrenalectomy and 82 based also on AVS results) and 49 as bilateral PA. At diagnosis, 21.2% (n=137) had T2DM and 25 of them had microvascular complications, being diabetic kidney disease the most common (n=19). We identified as risk factors of type 2 diabetes: male sex (OR 2.80 [1.81-4.34], P<0.001), older age (OR 1.05 [1.03-1.07], P<0.001), familiar history of T2DM (OR 4.64 [2.39-8.99]), P<0.001), dyslipidemia (OR 4.05 [2.67-6.14], P<0.001), cardiovascular (OR 1.30 [1.14-1.48], P<0.001) and cerebrovascular disease (OR 1.59 [0.92-2.74], P=0.003), sleep apnea syndrome (SAS) (OR 2.21 [1.34-3.63], P=0.003), higher BMI (OR 1.06 per unit [1.03-1.10], <0.001), hypertension duration (OR 1.04 per year [1.02-1.06], P<0.001) and the number of antihypertensive drugs (OR 1.50 [1.29-1.74], P<0.0001). In the multivariant analysis, all these variables were independent risk factors for T2DM except for SAS, hypertension duration, sex, and BMI. No association was observed with plasma aldosterone concentration, potassium levels, unilaterality of PA or other parameters. No significant differences in the evolution of the glycemic control (fasting plasma glucose and HBA1c) were observed between T2DM who underwent surgery and those medically treated (P>0.05). Conclusion: Type 2 diabetes affects about one quarter of patients with PA and risk factors for its development are common than to the general population. Medical and surgical treatment provide a similar benefit in terms of glucose control in patients with PA and T2DM. Presentation: Friday, June 16, 2023