Pierwotna nadczynność przytarczyc o niewielkim nasileniu — porównanie leczenia farmakologicznego i obserwacji klinicznej w ramach trwającego pięć lat badania klinicznego

Introduction: Primary hyperparathyroidism (PHPT) is an increasingly common endocrine disorder. Most patients with PHPT do not have disease-specific symptoms. The management of these patients has been widely debated. Recent studies have shown the importance of following up asymptomatic patients in order to reduce co-morbidity. However, there are conflicting opinions as to medical management. The aim of our study was to compare the outcome of PHPT patients on antiresorptive therapy vs. observation only.Material and methods: We longitudinally evaluated 157 PHPT patients (126 females) aged 22–90 years. Patients who did not undergo surgery were divided into two groups: those on anti-resorptive therapy (N = 52), and those without any treatment (N = 37). Patients who were disease-free after surgery (N = 50) served as controls.Results: The values of serum calcium (S-Ca), parathyroid hormone (PTH) and indices of bone metabolism did not differ significantly among the three groups of subjects. No differences in 25(OH)-vitamin D levels were noted. Bone mineral density (BMD) was not significantly different at the spinal level. Finally, we found no evidence of an effect of medical treatment on quality of life (QoL). However, QoL significantly improved in the surgery group after parathyroidectomy (PTX).Conclusions: This study provided up-to-date information in terms of biochemical progression on the natural history of PHPT patients. No significant differences emerged between anti-resorptive therapy and observation only. It is not yet possible to assess the effect of pharmacological treatments on QoL in statistical terms. (Endokrynol Pol 2014; 65 (6): 456–463)Wstęp: Pierwotna nadczynność przytarczyc (PHPT) jest coraz częściej spotykanym zaburzeniem endokrynologicznym. Większość dotkniętych nim pacjentów nie ma szczególnych objawów podmiotowych, a metody leczenia schorzenia pozostają przedmiotem dyskusji. Najnowsze publikacje wskazują na konieczność obserwowania pacjentów bezobjawowych, co ma na celu zmniejszenie zapadalności na schorzenia współistniejące. Opinie na temat leczenia farmakologicznego są jednak podzielone. Celem niniejszego badania było porównanie przebiegu PHPT u pacjentów przyjmujących leki zmniejszające resorpcję kości i u pacjentów poddanych jedynie obserwacji.Materiał i metody: Przeanalizowano dane 157 pacjentów (w tym 126 kobiet) w wieku 22–90 lat chorujących na PHPT. Pacjentów nieleczonych chirurgicznie podzielono na dwie grupy: grupa leczonych preparatami hamującymi resorpcję kości (n = 52) i grupa nieleczona farmakologicznie (n = 37). W grupie kontrolnej znaleźli się pacjenci bez objawów choroby po zabiegu chirurgicznym (n = 50).Wyniki: Stężenia wapnia w surowicy (S-Ca), aktywność parathormonu (PTH) i wskaźniki metabolizmu kostnego nie różniły się istotnie w trzech badanych grupach pacjentów. Nie stwierdzono różnic pod względem stężenia witaminy 25-OH-D (hydroksycholekalcyferolu). Gęstość mineralna kości (BMD) w obrębie kręgosłupa nie różniła się istotnie pomiędzy grupami. Nie stwierdzono też wpływu farmakoterapii na jakość życia (QoL). Odnotowano jednak, że QoL poprawiła się istotnie po zabiegu paratyreoidektomii (PTX) w grupie operowanej.Wnioski: Niniejsze badanie przynosi informacje na temat naturalnego przebiegu i zmian biochemicznych u chorych na PHPT. Nie stwierdzono istotnych różnic pomiędzy grupą pacjentów leczonych preparatami hamującymi resorpcję kości a pacjentami nieleczonymi. Nie można jednak było ocenić statystycznie wpływu leczenia farmakologicznego na QoL. (Endokrynol Pol 2014; 65 (6): 456–463

five year longitudinal evaluation of mild primary hyperparathyroidism medical treatment versus clinical observation

Introduction: Primary hyperparathyroidism (PHPT) is an increasingly common endocrine disorder. Most patients with PHPT do not have disease-specific symptoms. The management of these patients has been widely debated. Recent studies have shown the importance of following up asymptomatic patients in order to reduce co-morbidity. However, there are conflicting opinions as to medical management. The aim of our study was to compare the outcome of PHPT patients on antiresorptive therapy vs. observation only. Material and methods: We longitudinally evaluated 157 PHPT patients (126 females) aged 22–90 years. Patients who did not undergo surgery were divided into two groups: those on anti-resorptive therapy (N = 52), and those without any treatment (N = 37). Patients who were disease-free after surgery (N = 50) served as controls. Results: The values of serum calcium (S-Ca), parathyroid hormone (PTH) and indices of bone metabolism did not differ significantly among the three groups of subjects. No differences in 25(OH)-vitamin D levels were noted. Bone mineral density (BMD) was not significantly different at the spinal level. Finally, we found no evidence of an effect of medical treatment on quality of life (QoL). However, QoL significantly improved in the surgery group after parathyroidectomy (PTX). Conclusions: This study provided up-to-date information in terms of biochemical progression on the natural history of PHPT patients. No significant differences emerged between anti-resorptive therapy and observation only. It is not yet possible to assess the effect of pharmacological treatments on QoL in statistical terms. (Endokrynol Pol 2014; 65 (6): 456–463

Primary hyperparathyroidism diagnosed after surgical ablation of a costal mass mistaken for giant-cell bone tumor: a case report

<p>Abstract</p> <p>Introduction</p> <p>Primary hyperparathyroidism is a common endocrine disorder characterized by elevated parathyroid hormone levels, which cause continuous osteoclastic bone resorption. Giant cell tumor of bone is an expansile osteolytic tumor that contains numerous osteoclast-like giant cells. There are many similarities in the radiological and histological features of giant cell tumor of bone and brown tumor. This is a rare benign focal osteolytic process most commonly caused by hyperparathyroidism.</p> <p>Case presentation</p> <p>We report the unusual case of a 40-year-old Caucasian woman in which primary hyperparathyroidism was diagnosed after surgical ablation of a costal mass. The mass was suspected of being neoplastic and histopathology was compatible with a giant cell tumor of bone. On the basis of the biochemical results (including serum calcium, phosphorous and intact parathyroid hormone levels) primary hyperparathyroidism was suspected and a brown tumor secondary to refractory hyperparathyroidism was diagnosed.</p> <p>Conclusions</p> <p>Since giant cell tumor is a bone neoplasm that has major implications for the patient, the standard laboratory tests in patients with bone lesions are important for a correct diagnosis.</p

Clinical Features, Cardiovascular Risk Profile, and Therapeutic Trajectories of Patients with Type 2 Diabetes Candidate for Oral Semaglutide Therapy in the Italian Specialist Care

Introduction: This study aimed to address therapeutic inertia in the management of type 2 diabetes (T2D) by investigating the potential of early treatment with oral semaglutide. Methods: A cross-sectional survey was conducted between October 2021 and April 2022 among specialists treating individuals with T2D. A scientific committee designed a data collection form covering demographics, cardiovascular risk, glucose control metrics, ongoing therapies, and physician judgments on treatment appropriateness. Participants completed anonymous patient questionnaires reflecting routine clinical encounters. The preferred therapeutic regimen for each patient was also identified. Results: The analysis was conducted on 4449 patients initiating oral semaglutide. The population had a relatively short disease duration (42%  60% of patients, and more often than sitagliptin or empagliflozin. Conclusion: The study supports the potential of early implementation of oral semaglutide as a strategy to overcome therapeutic inertia and enhance T2D management

Institutional experience of PTH evaluation on fine-needle washing after aspiration biopsy to locate hyperfunctioning parathyroid tissue#

Assaying parathyroid hormone (PTH) in the washing liquid after fine-needle aspiration biopsy (FNAB) seems to be a valid approach to locate parathyroid tissue. PTH-FNAB was evaluated in 47 patients with a clinical picture of primary hyperparathyroidism (PHP) and ultrasonography (US) suggestive of parathyroid lesion. The patients were subdivided into two groups on the basis of the absence or presence of US thyroid alterations. The result of PTH-FNAB was compared with those of cytology, scintigraphy and, in 24 patients, surgical outcome. PTH-FNAB samples with a value higher than that recorded in the serum and higher than our institutional cut-off were deemed to be probable samples of parathyroid tissue. Cytology proved diagnostic for benign thyroid lesions, non-diagnostic for thyroid lesions, hyperplastic parathyroid tissue, undetermined or malignant thyroid lesions and other lesions in 45%, 30%, 17%, 4%, and 4% of cases, respectively. In 47% of cases, PTH-FNAB indicated that the sample had been taken in parathyroid tissue. In patients without US alterations, the diagnostic accuracy of PTH-FNAB was greater than that of scintigraphy. After surgery, comparison between the results of PTH-FNAB and scintigraphy, in terms of positive predictive value (PPV), revealed the superiority of PTH-FNAB; PPV was 94% for FNAB and 71% for scintigraphy, while sensitivity was 83% and 69%, respectively. PTH-FNAB evaluation after FNAB appears to be more diagnostic than cytology and scintigraphy. Of all the procedures used, PTH-FNAB appears to be the method of choice when the target is US suggestive and reachable. PTH-FNAB appears to be a useful method of guiding surgical intervention

Effects on the incidence of cardiovascular events of the addition of pioglitazone versus sulfonylureas in patients with type 2 diabetes inadequately controlled with metformin (TOSCA.IT): a randomised, multicentre trial

Background The best treatment option for patients with type 2 diabetes in whom treatment with metformin alone fails to achieve adequate glycaemic control is debated. We aimed to compare the long-term effects of pioglitazone versus sulfonylureas, given in addition to metformin, on cardiovascular events in patients with type 2 diabetes. Methods TOSCA.IT was a multicentre, randomised, pragmatic clinical trial, in which patients aged 50\ue2\u80\u9375 years with type 2 diabetes inadequately controlled with metformin monotherapy (2\ue2\u80\u933 g per day) were recruited from 57 diabetes clinics in Italy. Patients were randomly assigned (1:1), by permuted blocks randomisation (block size 10), stratified by site and previous cardiovascular events, to add-on pioglitazone (15\ue2\u80\u9345 mg) or a sulfonylurea (5\ue2\u80\u9315 mg glibenclamide, 2\ue2\u80\u936 mg glimepiride, or 30\ue2\u80\u93120 mg gliclazide, in accordance with local practice). The trial was unblinded, but event adjudicators were unaware of treatment assignment. The primary outcome, assessed with a Cox proportional-hazards model, was a composite of first occurrence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularisation, assessed in the modified intention-to-treat population (all randomly assigned participants with baseline data available and without any protocol violations in relation to inclusion or exclusion criteria). This study is registered with ClinicalTrials.gov, number NCT00700856. Findings Between Sept 18, 2008, and Jan 15, 2014, 3028 patients were randomly assigned and included in the analyses. 1535 were assigned to pioglitazone and 1493 to sulfonylureas (glibenclamide 24 [2%], glimepiride 723 [48%], gliclazide 745 [50%]). At baseline, 335 (11%) participants had a previous cardiovascular event. The study was stopped early on the basis of a futility analysis after a median follow-up of 57\uc2\ub73 months. The primary outcome occurred in 105 patients (1\uc2\ub75 per 100 person-years) who were given pioglitazone and 108 (1\uc2\ub75 per 100 person-years) who were given sulfonylureas (hazard ratio 0\uc2\ub796, 95% CI 0\uc2\ub774\ue2\u80\u931\uc2\ub726, p=0\uc2\ub779). Fewer patients had hypoglycaemias in the pioglitazone group than in the sulfonylureas group (148 [10%] vs 508 [34%], p&lt;0\uc2\ub70001). Moderate weight gain (less than 2 kg, on average) occurred in both groups. Rates of heart failure, bladder cancer, and fractures were not significantly different between treatment groups. Interpretation In this long-term, pragmatic trial, incidence of cardiovascular events was similar with sulfonylureas (mostly glimepiride and gliclazide) and pioglitazone as add-on treatments to metformin. Both of these widely available and affordable treatments are suitable options with respect to efficacy and adverse events, although pioglitazone was associated with fewer hypoglycaemia events. Funding Italian Medicines Agency, Diabete Ricerca, and Italian Diabetes Society