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.

From open to laparoscopic adrenalectomy: thirty years' experience of one medical centre.

INTRODUCTION: Laparoscopic adrenalectomy (LA) has become the standardized treatment of benign adrenal lesions over the last two decades, making the indications to open adrenalectomy (OA) limited. The purpose of this study was to show the thirty years of experience in open (OA) and laparoscopic adrenalectomy (LA) gained in one medical centre as well as to compare the results of OA and LA performed for benign adrenal lesions. MATERIAL AND METHODS: Three hundred patients underwent 127 open and 173 laparoscopic adrenalectomies between 1979 and 2009 at M. Curie Hospital in Szczecin, Poland. Analyzed factors included patients demographic data, ASA score, indication for surgery, tumour size and side, characteristics of the removed tumours, intraoperative and postoperative outcome of LA and OA, postoperative pain sensation, intraoperative and postoperative complications, and conversion rate from LA to OA. Tumours with diameter exceeding 8 cm were excluded. RESULTS: There were no significant differences regarding the analyzed preoperative data in both groups of patients. The mean operative time was longer in the LA group (137 v. 82 min., p < 0.0001) and the blood loss was lower in LA group (110 v. 254 mL, p < 0.0001). The mean time until resumption of normal diet was shorter after LA (22 v. 44 h), as was the mean time until ambulation (17 v. 36 h), mean length of the hospital stay (4.6 v. 6.8 days), and mean time until return to normal activities (14 v. 23 days, p < 0.0001 for each difference). The analgesic requirement on the first and the second day postoperatively was lower in the LA group (p < 0.0001). The incidence of intraoperative and postoperative complications did not differ significantly between both analyzed groups. The rate of the conversion from LA to OA was 16%. The histopathological diagnosis was adenoma of the adrenal gland in the majority of cases. CONCLUSIONS: This study shows that LA is a safe, effective, and well-tolerated procedure. It may be recommended as a "gold standard" surgery in a case of benign functioning or non-functioning adrenal tumours with diameter less than 8 cm. (Pol J Endocrinol 2010; 61 (1): 94-101).

Bone mineral density and hip structural analysis in type 1 diabetic men.

OBJECTIVE: The risk of non-vertebral fractures is increased in men with type 1 diabetes (DM1) but studies have shown only moderately decreased or normal bone mineral density (BMD) in these patients. No previous studies have evaluated hip strength and geometry indices in DM1 patients. This study was therefore designed to characterize associations between BMD, dual X-ray absorptiometry (DXA)-based hip strength indices, metabolic control, and DM1chronic complications. DESIGN AND METHODS: The study was performed on 36 males aged 43.6 +/- 5.1 years with long-lasting DM1 and 36 healthy males matched for age, weight, and height. BMD in lumbar spine, total hip, upper and lower part of the femoral neck, hip axis length, cross-sectional area and moment of inertia (CSMI), and glycated hemoglobin (HbA1c) were measured. RESULTS: DM1 men had decreased spine BMD (P < 0.05) and normal total hip BMD in comparison with controls. Hip geometry and strength indices were comparable in both groups. However, M1 men had decreased CSMI and upper femur BMD but these differences did not reach statistical significance (P = 0.06). BMD changes and hip strength parameters did not correlate with HbA1c. CONCLUSIONS: Middle-aged DM1 men have decreased lumbar spine BMD, normal hip BMD and normal hip strength indices. These changes are not influenced by metabolic control and presence of chronic microvascular complications.

[The effect of one year of recombinant human growth hormone (rhGH) therapy on left ventricle structure and function in adults with severe growth hormone deficiency]. / Wplyw rocznego, substytucyjnego leczenia ludzkim rekombinowanym hormonem wzrostu (rhGH) na budowe i czynnosc lewej komory serca u doroslych z duzym niedoborem hormonu wzrostu.

UNLABELLED: The aim of the study was to analyze the functional and structural changes in the echocardiographic parameters of the left ventricle (LV) in adult patients (pts) with growth hormone deficiency (GHD) without any treatment in childhood before and after one year long somatropin treatment. MATERIAL AND METHODS: Twelve GHD pts (mean age 42 +/- 10 years; M/F: 6/6) before (group GHD-1) and after one year rhGH therapy (group GHD-2) were compared. The s.c. rhGH treatment with somatropin (Genotropin, Pharmacia) at a dose 0.125 U/kg/week up to 0.25 U/kg/week has been continued for 1 year. Both groups were examined with echocardiography Twelve GHD pts (mean age 42 +/- 10 years; M/F: 6/6): with indiopatic GHD (n = 10, age from 29 to 46 years; M/F: 6/4) and with Sheehan syndrome (n = 2, age from 46 to 61 years; M/F: 0/2) before (group GHD-1) and after one year rhGH therapy (group GHD-2) were compared. The s.c. rhGH treatment with somatropin (Genotropin, Pharmacia) at a dose 0.125 U/kg/week up to 0.25 U/kg/week (till 50 percentyl of blood IGF-1 concentration for age and sex norm ) has been continued for 1 year. Both groups were examined with echocardiography. RESULTS: On echocardiography, in the group GHD-1 pts compared to GHD-2 pts, had lower LVM and LVMI were lower (adequately (138.4 +/- 39.8 vs. 153.1 +/- 49.5, p < 0.036), lower and LVMI (87.3 +/- 19.7 vs. 96 +/- 23.7, p < 0.05). There was no Therapy had no significant therapy effect on systolic LV function. The diastolic function of LV did not differ between both GHD-1 and GHD-2 groups (E/A: 1.4 +/- 0.2 vs. 1.3 +/- 0.3 ; E: 79 +/- 17; A: 59 +/- 16 vs. 58 +/- 10, ns), but DT increased significantly from 132 +/- 21 vs. 147 +/- 30, p < 0.05). There was only significant correlation between LV systolic dimension after one year and IGF plasma basal concentration (r = 0.7, p < 0.01). CONCLUSIONS: One year medical therapy with rhGH (somatropin) is associated with a significant positive effect on LVM and LVMI but no significant effect on systolic LV function, as assessed by echocardiography in adults with GHD. Significant decrease of DT after therapy may suggest an influence of GH therapy on diastolic LV function. The level of IGF did correlate with LV systolic diameter after therapy.

[Serum leptin and adiponectin concentrations in patients infected with human immunodeficiency virus type 1 (HIV-1) on antiretroviral therapy]. / Stezenia leptyny i adiponektyny w surowicy chorych zakazonych ludzkim wirusem niedoboru odpornosci typu 1 (HIV-1) leczonych antyretrowirusowo.

UNLABELLED: The lipodystrophy syndrome with dyslipidaemia and insulin resistance is side-effect of combined antiretroviral therapy (CART). AIM OF THE STUDY: to describe the influence of CART on leptin and adiponectin concentration in connection with lipids levels in HIV-infected patients on antiretroviral therapy. BMI, serum leptin, adiponectin, triglycerides, total cholesterol, HDL- and LDL-cholesterol concentrations were measured in 56 HIV(+) patients before and on CART; average of treatment duration 38.4 +/-13.2 months. Significant increase of BMI (p=0.0268) of (22.6 +/- 3.3 before and 23.5 +/- 3.4 kg/m2 on therapy, respectively) and all analyzed lipids were found. Mean adiponectin concentration in treated patients was significantly (7.256 +/- 3.551 microg/ml) lower than mean value before treatment (8.395 +/- 3.568 microg/ml; p=0.0011). Mean values of leptin concentrations did not differ significantly (before therapy 3.721 +/- 0.347 log10; on therapy 3.1737 +/- 0.353 log10). Significant positive correlation between BMI and leptin concentrations was found before, as well as during CART (r=0.5333; p<0.0001), but negative correlation between adiponectin and leptin concentrations (r=-0.2677; p=0.042). Leptin and adiponectin concentrations did not revealed significant correlation with lipids levels before therapy. The decrease of adiponectin concentration on CART correlated negatively with total (r=-0.2912; p=0.0310) and LDL-cholesterol (r=-0.310; p=0.0225). CART lasting longer than 2 years resulted in the decrease of adiponectin concentration, with lack of influence on leptin concentration in analyzed group. The increase of total cholesterol and LDL-cholesterol in correlation with the decrease of adiponectin concentration confirms that CART induces metabolic disturbances related to higher risk of atherosclerosis and its sequel.

[Ophthalmological tests value in detection of the optic neuropathy associated with pituitary tumours]. / Znaczenie badan okulistycznych w wykrywaniu neuropatii nerwu wzrokowego towarzyszacej guzom przysadki mózgowej.

PURPOSE: To evaluate the value of ophthalmological tests in detection of the optic neuropathy associated with pituitary tumours. MATERIAL AND METHODS: 38 patients with pituitary tumours in 21-73 years old, were examined. Routine ophthalmological examination, kinetic and static perimetry (screening test, "white-on-white" and "blue-on-yellow") and PVEP were performed. RESULTS: In patients with recurrent tumours (group II) more changes was observed in routine ophthalmological examination, perimetry and PVEP compared to patients with early detected pituitary tumours (group I). No patient of group I present changes in routine ophthalmological examination, but they had visual field defects and/or abnormal PVEP. In group I in Ps B-Y more visual field defects was detected than in kinetic perimetry (p<0.025). In the same group hemifield PVEP was more often abnormal than full-field PVEP (p<0.01). In group II similar differences were not observed. CONCLUSIONS: In patients with pituitary tumours the most useful test in the optic neuropathy diagnosis are "blue-on-yellow" static perimetry and hemifield PVEP.

A comparison of the periodontal status in patients with type 2 diabetes based on glycated haemoglobin levels and other risk factors.

PURPOSE: The aim of this study was to compare the periodontal status in patients with type 2 diabetes based on glycated haemoglobin levels and other risk factors. MATERIAL/METHODS: 75 patients with DM2 were grouped according to glycemic control: 40 subjects with HbA1c<7.0% and 35 subjects with HbA1c≥7.0%. We performed measurements of HbA1c, C-reactive protein (CRP), Approximal Plaque Index (API), Gingival Severity Index (GSI), tooth mobility (TM) as well as periodontal parameters such as probing depth (PD) and clinical attachment level (CAL). Age, gender and duration of the disease were analyzed too. RESULTS: No significant differences in PD, CAL, API, GSI and TM were found between the analyzed groups. HbA1c positively correlated with CRP (p=0.046) and the duration of DM2 (p=0.012) but not with the periodontal parameters. Patients' age was positively correlated with both the duration of DM2 (p=0.002) and CAL (p=0.034). Regardless of HbA1c, men had significantly worse periodontal parameters compared to women (respectively: PD 2.73mm vs. 2.18mm, p=0.01; CAL 3.84mm vs. 2.54mm, p=0.005; proportion of deep pockets 9.06% vs. 2.97%, p=0.01; proportion of teeth with grade 2 mobility 9.14% vs. 2.8%, p=0.02). CONCLUSIONS: The selected group of patients attending the Diabetes Outpatient Clinic showed a similar periodontal status with regard to glycated haemoglobin levels and other risk factors except gender. Male gender turned out to be a significant risk factor for periodontal disease in patients with type 2 diabetes mellitus.

Laparoscopic adrenalectomy for functioning and non-functioning adrenal tumours.

BACKGROUND: The purpose of this study was a retrospective analysis of outcomes following laparoscopic adrenalectomy (LA) performed for benign adrenal tumours responsible for various endocrinological disorders. The patients were diagnosed with non-functioning (NFT) and functioning adrenal tumours (FT) including pheochromocytoma (PH), Conn's syndrome (CO) and Cushing's (CS) syndrome. MATERIAL AND METHODS: A total of 165 LAs were carried out between August 1995 and September 2009 via either the transperitoneal (n = 38) or retroperitoneal (n = 127) approach. The analysed factors included demographic data of patients, the American Association of Anaesthesiology score (ASA), indication for surgery, tumour size and side, intraoperative and postoperative outcome of LA including duration of surgery, blood loss, time until ambulation, length of hospital stay, time until return to normal activity, the complication rate, as well as the conversion rate to open adrenalectomy. RESULTS: There were 111 patients with NFT and 54 with FT. Patients with NFT were significantly older than those with CO (p < 0.05). The mean size of the lesion differed between CO and other adrenal tumours (p < 0.05) as well as between NFT and PH (p < 0.05). All the lesions except aldosteronomas were detected predominantly in the right adrenal gland (p < 0.05). However, despite the different characteristic and clinical disorders related to laparoscopically removed adrenal tumours, the intraoperative and postoperative outcomes did not significantly differ in most cases between the analysed groups of patients. CONCLUSION: This study shows that LA is a safe, effective, and well-tolerated procedure despite the hormonal activity of the removed lesions. Minimal invasive surgery may be recommended as the 'gold standard' in the treatment of both functioning and non-functioning benign tumours of the adrenal gland.