Assessment of real-world usage of lanreotide AUTOGEL 120 in Polish acromegalic patients - results from the prospective 12-month phase of Lanro-Study.

AIM OF THE STUDY: To assess resource utilization and costs of treatment with lanreotide AUTOGEL 120 mg (ATG120) administered as part of routine acromegaly care in Poland. MATERIAL AND METHODS: A multicentre, non-interventional, observational study on resource utilization in Polish acromegalic patients treated with ATG120 at 4 weeks or extended (> 4 weeks) dosing interval. The study recruited adult acromegalic patients treated medically for ≥ 1 year including at least 3 injections of ATG120. Data on dosing interval, aspects of administration, and resource utilization were collected prospectively during 12 months. Costs were calculated in PLN from the public health-care payer perspective for the year 2013. RESULTS: 139 patients were included in the analysis. Changes in dosing regimen were reported in 14 (9.4%) patients. Combined treatment was used in 11 (8%) patients. Seventy patients (50%) received ATG120 at an extended dosing interval; the mean number of days between injections was 35.56 (SD 8.4). ATG120 was predominantly administered in an out-patient setting (77%), by health-care professionals (94%). Mean time needed for preparation and administration was 4.33 and 1.58 min, respectively, mean product wastage - 0.13 mg. Patients were predominantly treated in an out-patient setting with 7.06 physician visits/patient/year. The most common control examinations were magnetic resonance imaging of brain and brain stem (1.36/patient/year), ultrasound of the neck (1.35/patient/year), GH (1.69/patient/year), glycaemia (1.12/patient/year), IGF-1 (0.84/patient/year), pituitary-thyroid axis hormone levels assessment (TSH-0.58/patient/year, T4-0.78/patient/year). There were 0.43 hospitalizations/patient/year. For direct medical costs estimated at PLN 50 692/patient/year the main item was the costs of ATG120 (PLN 4103.87/patient/month; 97%). The mean medical cost, excluding pharmacotherapy, was PLN 1445/patient/year (out-patient care - 49%, hospitalization - 23%, diagnostics/laboratory tests - 28%). CONCLUSIONS: These results represent the current use of ATG120 in the population of Polish acromegalic patients in a realistic clinical setting. Findings that 50% of patients could be treated with dose intervals of longer than 28 days support the potential of ATG120 to reduce the treatment burden.

[Lymphocytic hypophysitis and hypothalamitis-case report]. / Limfocytarne zapalenie podwzgórza i przysadki - opis przypadku.

Lymphocytic hypophysitis is an unusual disorder that nearly exclusively affects women. We present a case of 69 year-old female patient who developed the symptoms of diabetes insipidus and partial insufficiency of the anterior pituitary gland. Magnetic resonance imaging of the brain revealed a mass involving the sella and suprasellar region. After exclusion of other causes of infiltrate in this region and due to evident reaction to glucocorticoid treatment the diagnosis of lymphocytic hypophisitis and hypothalamitis was established.

The efficacy of octreotide LAR (long acting release) treatment in patients with somatotropinoma, and mixed pituitary tumours.

OBJECTIVE: The efficacy of somatostatin analogues in the treatment of acromegaly is not always equal and therefore we wanted to evaluate the efficacy of therapy with octreotide long acting release (LAR) in patients with monohormonal tumours (somatotropinomas) in comparison to individuals with mixed pituitary tumours secreting alpha-subunit. METHOD: The 35 acromegalic patients (18 males and 17 females), aged 41.8 +/- 8.8 years, were divided into 2 groups according to the secreted hormones: 1 with mixed pituitary tumours with elevated growth hormone and alpha-subunit concentrations, the other with isolated growth hormone hypersecretion and normal alpha-subunit levels. The groups included 19 patients (9 males and 10 females), aged 40.1 +/- 7.1 years (mean +/- SD), and 16 patients (9 males and 7 females) aged 43.8 +/- 8.8 years (mean +/- SD), respectively. RESULTS: The decrease of GH and IGF-I levels after octreotide LAR treatment were observed in both groups. However, the reduction of GH and IGF-I concentrations was not equal in both groups and the differences between both groups were statistically significant (P = 0.01 for GH levels, and P = 0.047 for IGF-I levels). CONCLUSIONS: After octreotide LAR treatment, the decrease of GH level and of mean IGF-I values was greater in patients with mixed pituitary tumours and high alpha-subunit concentrations than in patients with isolated GH hypersecretion and normal alpha-subunit levels.

Efficacy of procalcitonin measurement in patients after total thyroidectomy due to medullary thyroid carcinoma.

Procalcitonin (PCT) is a protein synthetized by the thyroid C cells, inside which it is cut into calcitonin (CT) and catacalcin. It remains undetectable in serum in normal conditions. Its level increases during inflammation and in small cell lung cancer. There have been studies suggesting that the PCT level increases in medullary thyroid carcinoma (MTC). So far there have been no reports that would assess the usefulness of PCT detection in MTC. Our aim was to evaluate the usefulness of serum PCT assays in patients with MTC. We investigated 24 patients at 17-78 years of age, all after total thyroidectomy due to MTC. All patients had serum CT concentrations measured by radioimmune assay. The upper limit of the CT level was 60 pg/ml. The serum PCT was evaluated with an immunochromatographic kit. The reaction was considered positive when the PCT level exceeded 0.5 ng/ml. In all cases the C-reactive protein (CRP) serum level was measured. The statistical analysis was performed with Statistica 5.1G. The CT levels in all patients varied from 0 to 1410, mean 603.8 pg/ml. In 8 patients the CT level was within normal range, in 6 patients it was marginally, and in 10 patients markedly elevated. The PCT test was considered positive in 16 patients. There was correlation among serum PCT and CT concentrations (Spearman test, p<0.0001). The PCT levels varied considerably among patients with normal, marginally and markedly elevated CT levels (Kruskal-Wallis test, p=0.0013). All patients had normal CRP values. Fisher's exact test revealed a correlation between serum PCT and CT increase (p=0.04). Further studies on a larger group of patients should be considered; thus, the PCT assay can be considered useful in cases of unclear CT concentration.

[Usefulness of isotope diagnosis, ultrasound neck investigation and thyroglobulin assays in quantification of patients operated on for differentiated thyroid cancer and prepared for radioiodine treatment]. / Przydatnosc diagnostyki izotopowej, ultrasonografii szyi oraz oznaczen tyreoglobuliny w kwalifikacji chorych operowanych z powodu raka zróznicowanego tarczycy przygotowywanych do leczenia radiojodem (doswiadczenie wlasne).

UNLABELLED: The aim of the study was to assess the efficacy of surgical treatment of patients operated on differentiated thyroid carcinoma, using Tg serum assays and 131-I whole body scintigraphy. We investigated 208 patients aged from 15 to 78 yr. (mean 43.52, S.S. 16.37) including 182 females and 26 males. 183 cases of papillary cancer and 25 cases of follicular cancer were confirmed by pathologist. All the patients were investigated 6-8 weeks after thyreoidectomy. The following procedures were performed in all the patients: 1. ultrasound imaging. 2. 131 iodine uptake test, 24 hours after administration. 3. 131-I whole body scintigraphy (dose per patient 3 mCi, device Varicam). 4. TSH and Tg serum assay using FIA method. Moreover, all the tissue fragments obtained during surgery underwent histopathological assessment. RESULTS: The mean volume of the post-surgery thyroid tissue remains was 2.91 cc varying from 0 to 40. Volume was counted with Gutekunt's formula. Oncologically suspected lymph nodes were found in 8 cases. The mean TSH serum level was 79.31 (SD 59.59). The mean Tg serum level was 51.73 (SD 179). The mean value of an iodine uptake test was 6.96% (SD 6.69). Whole body scintigraphy discovered solitary thyroid site iodine uptake areas in 199 patients (95.7%). Additional uptake areas were observed in 4.3% 2 (0.9%) cases in cervical lymph nodes, 4 (1.9%) cases in lungs, 3 (1.5%) in bones. The correlation between investigations both laboratory and isotopic, and clinical state was observed in 207 cases (99.5%). The presence of high Tg serum level despite of absence of extracervical iodine uptake areas was observed in one case. We presume that the situation can be caused by the presence of multiple lung metastases not having possibility of iodine uptake. Ultrasound imaging, 131-I scintigraphy and Tg serum assays are essential methods in diagnosing and treatment process in the patients with differentiated thyroid carcinoma.

[Results of bone scintigraphy, densitometry and radiography in secondary hyperparathyroidism in patients with chronic renal failure]. / Wyniki scyntygrafii, densytometrii i radiografii kosci we wtórnej nadczynnosci przytarczyc u chorych na przewlekla niewydolnosc nerek.

UNLABELLED: Secondary hyperparathyroidism occurs frequently in patients with chronic renal failure (CRF). Cardinal manifestations in patients with secondary hyperparathyroidism involve also skeletal changes. Hence the aims of our studies were detailed investigations of bones using isotope scintigraphy (99mTc-MDP), densitometry (DEXA-Lunar) and radiography, in a group of 34 patients with advanced secondary hyperparathyroidism with very high PTH serum concentrations. Bone mineral density of radius amounted to 74.14 +/- 14%, and 29 cases had osteoporosis, and 5 cases osteopenia. Bone mineral density of vertebral bodies was 85.6 +/- 10.5% was within osteopenia range in 16 cases, osteoporosis in 11 cases and was normal in 6 cases. Bone scintigraphy revealed: excessive tracer uptake in cranial vault, mandible, spine and lateral parts of the sacral bone. Tracer accumulation was decreased in soft tissues and absent in kidneys. Roentgen studies revealed changes typical to secondary hyperparathyroidism: acroosteolysis in 60% of cases, subperiosteal resorption in 43% of cases, calcifications in 20% of cases, cortical fibrosis in 35% of cases and osteoporosis in 85% of cases. CONCLUSIONS: 1. Bone mineral density is markly decreased in the radius and to a lower extent in the vertebral bodies, hence DEXA studies of radius are most appropriate for evaluation of mineral bone density. The differences in BMD are characteristic of hyperparathyroidism, both primary and secondary. 2. In most patients bone scintigraphy shows characteristic abnormalities, thus scintigraphy is helpful in the diagnosis of advanced secondary hyperparathyroidism. 3. In x-ray studies osteoporosis is frequently observed, other signs of secondary hyperparathyroidism are not so common and appear in later stage of disease than decreased bone mineral density in densitometry.

A rare coexistence of primary hyperparathyroidism and hyperthyroidism due to toxic nodular goiter--a case report.

The frequent association of thyroid and parathyroid disorders has been reported. Most commonly, hyperthyroidism may coexist with hypercalcemia, but the latter is successfully treated when euthyroidism is achieved. However, the concomitant hyperthyroidism with primary hyperparathyroidism is of a rare occurrence. Moreover, it may frequently go unrecognized. In this paper we report a case of a patient with hypercalcemia due to PTH--secreting parathyroid adenoma associated with hyperthyroidism due to toxic nodular goiter. This case demonstrates the dramatic outcome of those two coexisting disorders. We point out that in patients with primary hyperparathyroidism thyroid function test should always be carried out. A proper, first-line treatment of hyperthyroidism will prevent the deterioration of primary hyperparathyroidism course, and thus surgical parathyroid treatment may safely be introduced.

The assessment of cabergoline efficacy and tolerability in patients with pituitary prolactinoma type.

Prolactinoma is the most frequent type of secreting pituitary tumours. In the treatment, pharmacotherapy with dopamine agonists is considered the first-line option. For many years bromocriptine, a D1 and D2 dopamine receptor agonist, has been the standard medicine for hyperprolactinemic patients. However, the treatment is frequently associated with intolerance or resistance. Recently cabergoline, a long acting, ergoline-derived, selective D2 agonist has become available and has been promoted as the initial treatment. Therefore the object of four studies was to assess the efficacy and tolerability of cabergoline in patients with prolactin-secreting pituitary adenomas. 17 patients, 13 women at the age of 21-55 years (average 37.1) and 4 men at the age of 29-45 years (average 36.3), with pathological hyperprolactinemia due to pituitary tumours were involved in the study. In all patients the increased pretreatment concentration of PRL was observed, ranging from 1047 to 1678 mlU/ml (mean 1369 mlU/ml). MRI scans revealed microprolactinomas in 11 (64.7%) cases and macroadenomas in 6 (35.3%) cases. None of the patients had previously undergone pituitary surgery and all of them were newly diagnosed, previously untreated. The patients were treated with cabergoline for 6 months. Cabergoline therapy was started at a dose of 0.5 mg twice a week for the first two months, then the dose was decreased to a 0.25 mg twice a week and finally maintained at 0.25 mg a week. After 6 months of the therapy, the normalization of serum PRL concentrations (from mean 1358 mlU/ml to mean 420 mlU/ml; p < 0.001) was achieved in 13 (76.5%) patients (8 with microprolactinoma and 5 with macroprolactinoma). In the remaining 4 patients PRL levels remained elevated but were decreased from mean 1403 mIU/ml to mean 812 mIU/ml. There were no differences, regarding CAB efficacy in lowering PRL levels, between patients with micro- and macroadenomas (p > 0.05). About 90% women resumed menstrual cycles in our study. All the other clinical pretreatment symptoms disappear in the course of the therapy. The tumour shrinkage, confirmed by control MRI was noted in 2 patients (33%) with macroprolactinoma. Cabergoline was tolerated satisfactorily by all our patients. The results have confirmed a high efficacy and a very good tolerability of CAB in the treatment of patients with pituitary adenomas. Together with a very convenient administration, such therapy can provide a very good patient compliance thus should be considered the first line option in patients with prolactinomas.

[Is hyperthyroidism often present in patients with thyroid differentiated carcinoma?]. / Czy nadczynnosc tarczycy czesto wystepuje u chorych ze zróznicowanym rakiem tarczycy?

The coexistence of thyroid cancer and hyperthyroidism is confirmed by many authors. It appears that the frequency of both disease can be greater as a result of lack of proper and penetrating biopsy diagnosis and of qualification to surgery treatment patients with hyperfunctional goiter and Graves disease, especially coexisting with nodes. The aim of our study was estimation of occurrence of hyperthyroidism in the patients with thyroid differentiated cancer. We examined group of 217 patients with diagnosed thyroid differentiated cancer, 20 patients (9.1%) of them were earlier hyperthyroidism diagnosed. 17 of them were hyperfunctional nodular goiter diagnosed and three as Graves disease, confirmed by presence of anti-TSH receptor antibodies (TRAK). Before thyroidectomy ultrasonography showed nodular goiter in 17 patients and hypoechogenic goiter with nodules in 3 patients. After thyroidectomy at the hyperthyroid patients in 16 papillary thyroid cancer and in 4 follicular thyroid cancers were diagnosed. The frequency of coexistence of cancer and hyperthyroidism in our material amounted for 9.1%. The results of our observation do not diverge from facts given in world literature and is point out the need for precise analysis of patients with hyperthyroidism and of proper qualification to surgery treatments changes suspected to be malignant process.