Assessment of the Tolerance of Dobenox Forte® in Patients with Chronic Venous Disease.

This prospective, observational, multicenter study assessed the tolerance of Dobenox Forte®, the first approved over-the-counter product containing calcium dobesilate, in 1795 outpatients with chronic venous disease (CVD) in daily clinical practice. In addition, the effectiveness (decrease in circumferences of a more affected limb at the ankle and middle part of the calf, and changes in the severity of CVD signs) was assessed. No adverse events related to use of the preparation were reported in a period of 64 ± 20 days. Dobenox Forte® use was associated with a reduction in calf circumference by 13.1 mm (95%CI: 12.2-14.1) and in ankle circumference by 9.7 mm (95%CI: 9.2-11.0) in patients reporting swelling of the lower legs (60.0% of the cohort). A reduction in calf and ankle circumference by at least 1 cm was achieved in 34.9% and 24.9% of patients, respectively. The percentages of patients reporting moderate to very severe lower limb heaviness decreased from 96.6% to 56.0%, calf cramps decreased from 91.0% to 41.0%, calf pain decreased from 89.2% to 43.7%, swelling decreased from 86.1% to 38.8%, and burning sensation that worsens when standing decreased from 79.0% to 33.7%. The medicinal product Dobenox Forte® is well tolerated by patients and seems to effectively reduce the symptoms of CVD.

The assessment of effectiveness, tolerance, and patient satisfaction with the use of a new fixed-dose combination product, containing salmeterol and fluticasone propionate, Salflumix Easyhaler® in the treatment of asthma in the daily clinical practice.

BACKGROUND: The effectiveness of a fix-dose salmeterol/fluticasone combination therapy in asthma was previously shown for the original product. The study aim was to evaluate the clinical effectiveness and safety of a second entry DPI - dry powder inhaler (Salflumix Easyhaler) in patients with asthma in everyday clinical practice. PATIENTS AND METHODS: This multicenter Investigator-Initiated Study that enrolled 2,037 adult outpatients with asthma treated with Salflumix Easyhaler, was conducted by 220 pulmonologists across Poland. Asthma control was assessed during 3 visits with 6 ± 2 weeks intervals based on the Asthma Control Test (ACT). In addition, patient Satisfaction with Asthma Treatment Questionnaire (SATQ) and adherence and adverse events (AEs) were monitored. RESULTS: During the observation (86 ± 30 days) the percentage of patients with controlled asthma (ACT 20-25 pts) increased from 35.5% at the first visit to 86.5% at the third visit (p < 0.001). In the subgroup analysis, there were more patients not obtaining asthma control among patients that switched from the treatment with other devices than in naive ones. Global SATQ scores increased from 5.8 ± 0.7 to 6.2 ± 0.6 during the observation. Patients' satisfaction with the use of the Salflumix Easyhaler was high. Adherence exceeded 95%. Eight AEs were reported. CONCLUSIONS: Salflumix Easyhaler is highly effective and well-tolerated by naïve patients with asthma and those switching from another device. In general, patients show good compliance with medical product and are satisfied with the use of this new device, and not reporting difficulties and errors related to its' use. Their physicians' overall perception of Salflumix Easyhaler use is very positive.

Health status and its socio-economic covariates in the older population in Poland - the assumptions and methods of the nationwide, cross-sectional PolSenior2 survey.

INTRODUCTION: Population ageing constitutes an increasing medical, social, and economic burden worldwide. Optimal senior policy should be based on well-assessed knowledge on the prevalence and control of age-related diseases, multimorbidity, disabilities, and their social determinants. The objective of this paper is to describe the assumptions, methods, and sampling procedures of the PolSenior2 survey, which was aimed at characterising the health status of old and very-old adults in Poland. MATERIAL AND METHODS: The project was conducted in the period 2018-2019 as a cross-sectional survey of a representative sample of people aged 60 years and over. Subjects were selected using three-stage stratified and proportional random sampling in seven equally sized (n = 850) age groups. The study protocol consisted of face-to-face interviews, specific geriatric scales and tests, and anthropometric and blood pressure measurements performed by well-trained nurses at participants homes as well as blood and urine sample laboratory tests. RESULTS: In the Polsenior2 study a group of 5987 subjects underwent the questionnaire parts of the survey, and almost all (n = 5823) agreed to blood or urine sample collection. CONCLUSIONS: In recent decades several studies focused on various aspects of elderly health and life conditions had been carried out in Poland and Central and Eastern Europe. However, none of them is so complex and has covered so many issues as PolSenior2, which is the largest study devoted to the health status of older persons in Poland and one of the largest and the most comprehensive in Europe. The results of the study will help to improve health policy targeted at the elderly population in Poland.

Socioeconomic Risk Factors of Poor Nutritional Status in Polish Elderly Population: The Results of PolSenior2 Study.

Poor nutritional status (PNS) threatens successful aging. Identifying potentially modifiable predictors of PNS is essential for elaborating a preventive strategy for the population at risk. To assess the prevalence of PNS in the Polish elderly population and analyze its socioeconomic correlates based on the data from the nationwide PolSenior2 project. Special emphasis was put on potentially modifiable factors among the identified PNS predictors. Nutritional status was assessed in 5698 community-dwelling older adults with the Mini Nutritional Assessment-Short Form. We evaluated the effect of age, sex, level of education, marital status, place of residence, subjective loneliness, and self-reported poverty on the nutritional status of the studied subjects. PNS was found in 25.3% of studied subjects (27.7% women and 21.9% men; p < 0.001). Female sex, older age, unmarried status (in men), subjective loneliness, and self-reported poverty were independent correlates of PNS. The two last above-mentioned predictors were identified as potentially modifiable. Based on our results, we recommend preventive interventions (e.g., performing regular screening), particularly in unmarried (men), poorly educated individuals, self-reporting poverty, complaining of loneliness, and the oldest old. PNS preventive strategies should include social support (both emotional and instrumental) to reduce the effect of poverty and subjective loneliness.

Osteoprotegerin Assessment Improves Prediction of Mortality in Stroke Patients.

BACKGROUND: Elevated circulating osteoprotegerin (OPG) level is associated with an increased risk of hospitalization for ischemic stroke and coronary artery disease. The aim of the present study was to analyze whether OPG assessment may improve the prediction of mortality in patients with stroke. PATIENTS AND METHODS: Serum OPG, fetuin A, 25-OH-D3, intact parathyroid hormone levels were assessed in serum samples which were left over after routine tests in a hospital laboratory. This assessment was conducted in 240 consecutive patients with acute ischemic stroke, admitted within 24hours after the onset of symptoms to the Stroke Unit. Mortality data were obtained from the local registry office. RESULTS: The mean OPG serum level was 14.6 ± 6.0pmol/L (range: 3.7-43.4). There were no significant differences in the OPG values between men and women (13.9 ± 5.0 versus 15.1 ± 6.7 pmol/L; P = .12). Therefore, tertiles were calculated for the whole group. During the follow-up, 85 (35.4%) patients died and 92 (38.3%) died or had recurrent stroke. OPG level appeared a significant predictors of death and composite end-point (death/recurrent stroke), in addition to the well-established once (age, atrial fibrillation, diabetes RANKIN at admission and discharge, severity of stroke). In multivariable stepwise backward analyses, the OPG level persisted as a significant and independent predictor of death (hazard ratio [HR] = 1.084 (95% confidence intervals: 1.036-1.134)] and composite and point (HR = 1.082 [1.037-1.129]). CONCLUSIONS: OPG level may be considered as a predictor of mortality in stroke patients.

Utilization of medical rehabilitation services among older Poles: results of the PolSenior study.

BACKGROUND: Rehabilitation tailored to older adults' needs might improve their functional performance and quality of life, as well as increase social participation. The aim of the study was to evaluate the use of medical rehabilitation services among older Poles in relation to socio-economic and health-related determinants. MATERIALS AND METHODS: Data regarding medical rehabilitation were obtained from the nationwide, multidisciplinary PolSenior project (2007-2012) conducted on representative sample of 4813 respondents (48.3% women) aged 65+ years. Socio-economic status, physical functioning, falls, chronic pain, and formal disability occurrence, as well as self-rated health were accounted for. RESULTS: One in six respondents (18.9% women vs. 15.8% men, p < 0.005) underwent medical rehabilitation during 12 months prior to the survey. Respondents mostly received electrotherapy or light radiation therapy (61.3%). Multivariate logistic regression analysis revealed that women aged 80+ years and men aged 90+ years had a significantly lower chance of using rehabilitation services compared to the youngest study participants (65-69 y.o.). City dwellers used rehabilitation services nearly twice as frequently as rural dwellers. Respondents with university education level were most likely to take part in these services. Dependence in IADL decreased participation in medical rehabilitation, while formal disability and chronic pain promoted utilization of rehabilitation services. CONCLUSIONS: Younger age, city dwelling, higher education, functional independence, formal disability certificate, and chronic pain increased participation in medical rehabilitation. Such results of the study should be considered in planning actions towards reducing health inequalities at the national level and promoting health and well-being among older adults.

Clinical factors increasing discrepancies of renal function assessment with MDRD and Cockcroft-Gault equations in old individuals.

ABSTRACT: In a daily clinical practice, glomerular filtration rate (GFR) is still estimated on the basis of short MDRD formula, whereas medications' Summaries of Product Characteristics suggest that GFR used for the dosage adjustment should be estimated based on the Cockcroft-Gault (C-G) equation. The aim of the study was to compare eGFR values calculated on the basis of short and full MDRD and C-G equations in PolSenior study participants with decreased eGFR. METHODS: We have assessed differences in the estimation of GFR between short and full MDRD, as well as C-G formula, all equations utilizing non-isotope-dilution mass spectrometry-calibrated measurements of serum creatinine, in the community-based population of 760 persons aged 65 years or above (mean age 82 ± 8 years) with estimated GFR < 60 ml/min/1.73 m2 (according to short MDRD). In addition, in our analysis, we have included the detailed characteristics of comorbidities and different aspects of mobility and functional performance. RESULTS: The better concordance, precision, and accuracy with MDRD short formula were found for MDRDfull than C-G equation. In logistic regression analysis, female gender, activities in daily living (ADL) ≤ 4, and age > 80 years diminished, while visceral obesity improved accuracy (P30) of eGFR calculated according to C-G equation as compared to MDRDshort. Similar analysis did not found factors influencing P30 for MDRDfull equation. CONCLUSIONS: In very old subjects, especially females, dependent patients and those with visceral obesity, estimation of GFR based on short MDRD formula should not be used interchangeably with Cockcroft-Gault equation for the medicines dose tailoring.

Socio-economic determinants of vitamin D deficiency in the older Polish population: results from the PolSenior study.

OBJECTIVE: Numerous studies have reported an association between vitamin D (25-hydroxyvitamin D; 25(OH)D) deficiency and low economic status, lower educational level, drugs exposure, smoking and reduced physical activity. Our study analysed the association between sociodemographic factors and 25(OH)D status in Polish (Caucasian) seniors. DESIGN: Cross-sectional study (part of the PolSenior study). Serum 25(OH)D concentration was measured by a solid-phase ELISA method; a standardized questionnaire evaluated educational level, economic status, alcohol consumption, current or past cigarette smoking, physical activity, activities of daily living (ADL) and instrumental activities of daily living. SETTING: Community-dwelling randomly selected individuals aged 65 years or older, selected using three-stage stratified, proportional draw. SUBJECTS: Seniors (n 3472; 1658 women and 1814 men). RESULTS: Mean serum 25(OH)D concentration was 20·5 (sd 9·6) ng/ml. Values below the recommended level (30 ng/ml) were detected in 82·8 % of men and 90·4 % of women. Regression analysis revealed that the difference between sexes was associated with decreased walking activity in women, probably resulting in less sunlight exposure. There was a positive association between any disability in ADL and the presence of vitamin D deficiency/insufficiency. In the sex-adjusted analysis, older age, alcohol abstinence and lack of cycling and long-distance walking were explanatory variables for vitamin D deficiency. CONCLUSIONS: Vitamin D deficiency/insufficiency is frequent in the older Polish population and associated with functional disability and impaired mobility of seniors.

Assessment of renal function in geriatric palliative care patients - comparison of creatinine-based estimation equations.

BACKGROUND: Renal function impairment is common in geriatric palliative care patients. Accurate assessment of renal function is necessary for appropriate drug dosage. Several equations are used to estimate kidney function. AIMS: 1) To investigate the differences (Δ) in kidney function assessed with simplified Modifi-cation of Diet in Renal Disease (MDRD), Berlin Initiative Study (BIS1), and Cockcroft-Gault (C-G) formulas in geriatric palliative care patients, and 2) to assess factors that may influence these differences. METHODS: A retrospective analysis of data of patients aged ≥70 years admitted to a palliative care in-patient unit. The agreement between C-G, MDRD, and BIS1 equations was assessed with Bland-Altman analysis. Partial correlation analysis was used to analyze factors influencing the discordance. RESULTS: A total of 174 patients (67 men; mean age 77.9±5.8 years) were enrolled. The mean Δ MDRD and C-G was 18.6 (95% limits of agreement 55.3 and -18.2). The mean Δ BIS1 and C-G was 6.1 (25.7 and -13.5), and the mean Δ MDRD and BIS1 was 12.5 (40.6 and -15.6). According to the National Kidney Foundation classification, 61 (35.1%) patients were differently staged using MDRD and C-G, whilê20% of patients were differently staged with BIS1 and C-G and MDRD and BIS1. Serum creatinine (SCr) and body mass index (BMI) had the most important influence on variability of Δ MDRD and C-G (partial R2 37.7% and 28.4%). Variability of Δ BIS1 and C-G was mostly influenced by BMI (34.8%) and variability of Δ MDRD and BIS1 by SCr (42.2%). Age had relatively low influence on differences between equations (3.1%-9.5%). CONCLUSION: There is a considerable disagreement between renal function estimation formulas, especially MDRD and C-G in geriatric palliative care patients, which may lead to errors in drug dosage adjustment. The magnitude of discrepancy increases with lower SCr, lower BMI, and higher age.

The influence of oral water load on energy expenditure and sympatho-vagal balance in obese and normal weight women.

INTRODUCTION: Oral water load may increase the energy expenditure (EE) by stimulation of sympathetic dependent thermogenesis. Thus, drinking of water may be helpful in weight reduction. The aim of the study is to assess the influence of water load on energy expenditure and sympathetic activity in obese and normal weight women. MATERIAL AND METHODS: Forty-five women were included. Energy expenditure was measured twice, in the morning and after oral water load, by the indirect calorimetric method. The heart rate variability parameters low frequency (LF), high frequency (HF), LF/HF index, standard deviation of normal RR intervals (SDNN) and root mean square difference among successive RR normal intervals (rMSSD) were used for the indirect assessment of the sympatho-vagal balance. RESULTS: Resting energy expenditure (REE) was significantly higher in obese than in normal weight women (1529 ±396 kcal/day vs. 1198 ±373 kcal/day; p = 0.02). In both study groups after water load EE increased significantly (by 20% and by 12%, corresponding to 8.6 kcal/h and 5.2 kcal/h respectively), while, LF/HF index increased simultaneously. The increase of energy expenditure (EE) did not exceed the energetic cost of water heating, from room to body temperature - 15 kcal/1000 ml. There was no correlation between changes of energy expenditure (EE) and heart rate variability (HRV) parameters. CONCLUSIONS: The increase of EE induced by water load is mostly related to the heating of the consumed water to body temperature. The assessment of autonomic balance by means of standard HRV indices had been found insufficient for detection of actually operating mechanisms.

Medical, psychological and socioeconomic aspects of aging in Poland: assumptions and objectives of the PolSenior project.

Both descriptive and longitudinal studies of aging are nowadays a subject of growing interest in different countries worldwide. However, in Poland and other Central-Eastern European countries, such comprehensive, nationally representative, multidimensional studies were never performed in the past in elderly population. The present paper describes the PolSenior project including its objectives, sample selection and structure, methods, fieldwork procedures and study flow. The aim of the project was to examine medical, psychological and socioeconomic aspects of aging in Poland. The research sample included 5695 respondents (2899 males and 2796 females) split into six equally sized age groups of elderly individuals (65-69 years, 70-74 years, 75-79 years, 80-84 years, 85-89 years, 90+years) and one group of subjects just about to enter old age (55-59 years). Subjects were recruited using three stage stratified, proportional draw. The response rate was 42% and ranged from 32% to 61% between provinces. The study consisted of three visits performed by trained nurses including questionnaire survey, comprehensive geriatric assessment and blood and urine sampling. The questionnaire consisted of medical and specific socioeconomic questions. The comprehensive geriatric assessment included blood pressure and anthropometric measurements, as well as selected scales and tests routinely used in the examination of elderly subjects. Blood and urine samples were collected from 4737 and 4526 individuals, respectively. More than 50 biochemical parameters were measured, and DNA was isolated and banked. In a selected group of 1018 subjects, a medical examination by a physician was performed. The self-rated health was lower in females than in males in age groups 70-84, but similar in individuals of both sexes aged 65-69 and 85 years. Besides providing data on health and functioning of elderly population, the PolSenior project aims to analyze interrelationships between different elements of health and social status, and between genetics and health status in advanced age. The results of the PolSenior project will facilitate prioritizing the state's public health and social policies in elderly population. Such a program provides also an excellent starting point for longitudinal studies and a basis for comparative analysis between Poland and other European countries or regions.

[Comparison of quantitative computerized angiography and intravascular ultrasound in assessment of renal artery stenosis in patients with renovascular hypertension treated with percutaneous transluminal angioplasty with concomitant intravascular brachytherapy]. / Porównanie ilosciowej angiografii i ultrasonografii wewnatrznaczyniowej w ocenie zwezenia resztkowego i restenozy u chorych z nadcisnieniem naczyniowo- nerkowym leczonych metoda przezskórnej angioplastyki tetnicy nerkowej i brachyterapii sródnaczyniowej.

UNLABELLED: Renal Angiography and IntraVascular UltraSonography (IVUS), are valuable diagnosis methods for assessment of renovascular hypertension (RVH). Endovascular techniques employing percutaneous transluminal renal angioplasty (PTRA) are effective for therapy of ischaemic nephropathy in patients with RVH. Success of PTRA is limited by a significant rate of restenosis. THE AIM OF STUDY was to compare the assessment of residual stenosis and restenosis with angiography and IVUS. MATERIAL AND METHODS: Residual stenosis after PTRA (combine with intravascular brachyterapy in 33 patients--group I) were assessed in 62 RVH patients with angiography and IVUS techniques. Both baseline and 9-month follow-up quantitative computerized angiography (QCA) and intravascular ultrasound (IVUS) analysis were performed to assess restenosis. RESULTS: Residual stenosis after PTRA of atherosclerotic lesions was slightly lower with QCA than IVUS (in group I 15.49 +/- 4.69% and 18.81 +/- 4.81% and in group II 15.36 +/- 4.68% and 18.43 +/- 4.69%, respectively). The loss of lumen area in QCA assessment was slightly greater than in IVUS measurement (1.2 +/- 0.7 mm vs. 0.9 +/- 0.8 mm in group I i 1.7 +/- 0.7 mm vs. 1.5 +/- 0.8 mm in group II). The angiographic measurements of late lumen loss, diameter stenosis, and minimal lumen diameter correlated well with IVUS measurements (r = 0.81, r = 0.89 and r = 0.89 respectively). CONCLUSIONS: Angiography and IVUS are equally effective methods for diagnosis and assessment of residual stenosis and restenosis after endovascular renal artery revascularisation.

Angiographic and intravascular ultrasound assessment of immediate and 9-month efficacy of percutaneous transluminal renal artery balloon angioplasty with subsequent brachytherapy in patients with renovascular hypertension.

BACKGROUND/AIM: Scarce data exist concerning the long-term effect of renal balloon angioplasty (PTRA) enhanced by intravascular gamma-brachytherapy (IVBT) in patients with renovascular hypertension. The aim of this randomized study was to evaluate long-term outcome after PTRA with IVBT in patients with renal artery stenosis. PATIENTS AND METHODS: 71 patients with renovascular hypertension were randomized into group I (PTRA + IVBT) or group II (PTRA). 9 patients who required stent implantation were excluded. Both baseline and 9-month follow-up quantitative computerized angiography and intravascular ultrasound (IVUS) analysis were performed to assess restenosis. During the 9-month follow-up, 3 patients died - 2 from group I and 1 from group II. RESULTS: The restenosis rate was 16.1% in group I and 32.1% in group II. The 9-month lumen loss in angiography was 1.2 +/- 0.7 and 1.7 +/- 0.7 mm (p = 0.004) and the area loss (IVUS) was 6.5 +/- 4.8 and 10.1 +/- 5.6 mm(2) in groups I and II, respectively (p = 0.01). eGFR increased both in group I (from 75 +/- 22 to 84 +/- 31 ml/min/1.73 m(2); p < 0.001) and in group II (from 74 +/- 23 to 77 +/- 23 ml/min/1.73 m(2); p = 0.04). Only the diastolic blood pressure in group I decreased significantly (65 +/- 17 and 77 +/- 18 mm Hg; p = 0.048). The rate of blood pressure normalization was low in both groups (6.1 and 6.9%). CONCLUSIONS: IVBT after PTRA with a self-centering source is a safe and effective method for prevention of restenosis in patients with renovascular hypertension.

[Outcome assessment of kidney transplantation in Katowice in years 1983-2000]. / Ocena wyników przeszczepiania nerek w osrodku katowickim w latach 1983-2000.

The aim of this study was to analyze the 20 years experience of the Renal Transplantation Center in Katowice in which 681 kidney transplants in 678 patients were performed between March 1983 and December 2000. Several parameters have been analyzed in this group: HLA class I and class II antigens compatibility, the mean cold ischaemia time, time to restore renal function, recipient's mortality, the causes of recipients' death, the early post-transplant complications, and patients' and grafts' survival. In the analyzed period of time HLA matching improved significantly (the median number of matched antigens of class I and II increased from 1 to 3) and the mean cold ischaemia time decreased from 27 to 20 hours. The number of transplants with early graft function increased from 9.5 to 42% and the number of primary non-functioning grafts decreased from 16 to 9%. Also recipients' early mortality declined significantly (from 31 to 5.5%). Among early post-transplant complications cases with sepsis and gastrointestinal bleeding decreased significantly. Improvement of both one-year and five-years graft survival was observed. During the observation period the number of donors did not changed and the rate of living kidney donors remained very low (1.76% of all transplants).

[Assessment of hearing organ ability in high-frequency auditory in patients suffering from chronic renal failure treated by haemodialysis and human recombinant erythropoietin (rhPEO)]. / Ocena wydolnosci narzadu sluchu w rozszerzonym zakresie czestotliwosci wysokich u osób chorych na przewlekla niewydolnosc nerek leczonych hemodializa i ludzka erytropoetyna uzyskana metoda rekombinacji genetycznej (rhEPO).

The problem of hearing loss occurrence in the course of chronic renal failure (CRF) was investigated in numerous research studies, attempting to explain both the etiological factors and treatment possibilities. According to various authors, the percentage of hearing loss occurrence in patients suffering from CRF differs between 20% and 80%. The idea of this paper is based on an observation that if peripheral blood parameters such; haemoglobin, amount of red blood cells improve when influenced by rhEPO, then tissue oxidation improvement connected with it causes also better metabolism of cilliar's cells, what helps to improve hearing. The purpose of this study has been to assess the influence of treatment with human recombinant erythropoietin obtained through genetic recombination and by haemodialysis upon the condition of the hearing organ in patients with CRF (as a result of both a single procedure and long-term treatment). 65 haemodialysed patients with chronic renal failure were enrolled in this study. 31 of them (with haematocrit value below 28%) were treated with rhEPO for 4 months (3 times a week, 4000 units). The remaining 34 patients (with haematocrit values of above 28%) were not treated with rhEPO. Impairment of hearing was found in 87.1% of the CRF patients examined, while the hearing loss in high frequency range (9-18 kHz) was significantly more pronounced than those observed in the conventional range. In 70% of the patients the hearing loss was the cochlear type. Thus, combining haemodialysis with recombinant human erythropoietin in treatment of CRF patients results in significant improvement of hearing, correlated with positive results in fighting anaemia. The improved hearing found is, most surely, related to better oxygen supply of ciliated cells of internal ear, resulting from improved oxygen supply in peripheral blood and tissues of the body, and may also be related to the centric activity of erythropoietin, as the presence of receptors for EPO was found in the central nervous system (CNS) neurocytes, and it was also proven that EPO is produced in CNS, probably in astrocytes.