27 results on '"Real practice"'
Search Results
2. "الطبيعة القانونية لحماية حق التعليم في مدارس أمنه".
- Author
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ٕٖانتظار سعد حمد and هند علي محمد
- Abstract
Education is a fundamental right in safe schools, as it represents the cornerstone of individual, societal, and successful development. Constitutional and legal legislation has affirmed the right to education and provided the necessary constitutional and legal protections in various constitutional and legal texts. However, recognizing the right to education in a safe school environment for students does not mean they are secure from government intervention or negligence, necessitating effective guarantees to ensure the practical implementation of this right by providing protection against any attack or negligence and addressing the factors affecting this right through the provision of basic requirements for students. Additionally, it is important to protect this right from any assault or harm to students or those responsible for the educational process by providing constitutional and legal protection. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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- View/download PDF
3. The effectiveness and safety of vedolizumab induction for moderate to severe ulcerative colitis for Asia patient: A real practice observational study
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Chia-Jung Kuo, Puo-Hsien Le, Wei-Chen Tai, Keng-Liang Wu, Hsu-Heng Yen, Chih-Wei Yen, Shui-Yi Tung, Chen-Shuan Chung, Ming-Yao Su, and Cheng-Tang Chiu
- Subjects
Vedolizumab ,Ulcerative colitis ,Induction ,Real practice ,Medicine (General) ,R5-920 - Abstract
Background: The use of biologic agents has become the cornerstone of therapy for moderate to severe IBD. Few studies have investigated the efficacy of vedolizumab (VDZ) induction for ulcerative colitis (UC) in Asian patients in a real practice setting. Aims: To evaluate the efficacy and safety of VDZ induction therapy for moderate to severe UC in Taiwan. Methods: This was a retrospective and observational study. Selected moderate to severe UC patients received VZD 300 mg i.v. at weeks 0, 2, and 6 as induction therapy. Mayo scores were calculated to evaluate the efficacy. Results: A total of 37 patients with UC who received VDZ and completed the induction therapy at Chang Gung Memorial Hospital (2017/10–2021/5) were included. The mean age was 46.5 year-old and the male to female ratio was 1:1 (19/18). 81.8% of the patients were biologic-naive. At weeks 8–10, a clinical response, clinical remission and endoscopic remission with VDZ induction therapy were achieved in 56.8% (21/37), 32.4% (12/37) and 58.3% (7/12) of the patients, respectively. 54.1% (20/37) were able to taper off at week 8. Overall, only 10.8% (4/37) of the patients were primary non-responders during induction therapy. No obvious VDZ-related severe adverse events were noted. Overall, 58.9% (11/19) of the patients relapsed after stopping VDZ, and the relapse rate after VDZ discontinuation was 42.1% (8/19) within first 6 months and 52.6% (10/19) within the first year. Conclusion: In real-world experience, induction therapy with VDZ showed promising clinical benefits and safety profile for patients with UC.
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- 2022
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4. The effectiveness and safety of vedolizumab induction for moderate to severe ulcerative colitis for Asia patient: A real practice observational study.
- Author
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Kuo, Chia-Jung, Le, Puo-Hsien, Tai, Wei-Chen, Wu, Keng-Liang, Yen, Hsu-Heng, Yen, Chih-Wei, Tung, Shui-Yi, Chung, Chen-Shuan, Su, Ming-Yao, and Chiu, Cheng-Tang
- Subjects
ULCERATIVE colitis ,VEDOLIZUMAB ,DISEASE remission ,SCIENTIFIC observation ,DISEASE relapse - Abstract
Background: The use of biologic agents has become the cornerstone of therapy for moderate to severe IBD. Few studies have investigated the efficacy of vedolizumab (VDZ) induction for ulcerative colitis (UC) in Asian patients in a real practice setting.Aims: To evaluate the efficacy and safety of VDZ induction therapy for moderate to severe UC in Taiwan.Methods: This was a retrospective and observational study. Selected moderate to severe UC patients received VZD 300 mg i.v. at weeks 0, 2, and 6 as induction therapy. Mayo scores were calculated to evaluate the efficacy.Results: A total of 37 patients with UC who received VDZ and completed the induction therapy at Chang Gung Memorial Hospital (2017/10-2021/5) were included. The mean age was 46.5 year-old and the male to female ratio was 1:1 (19/18). 81.8% of the patients were biologic-naive. At weeks 8-10, a clinical response, clinical remission and endoscopic remission with VDZ induction therapy were achieved in 56.8% (21/37), 32.4% (12/37) and 58.3% (7/12) of the patients, respectively. 54.1% (20/37) were able to taper off at week 8. Overall, only 10.8% (4/37) of the patients were primary non-responders during induction therapy. No obvious VDZ-related severe adverse events were noted. Overall, 58.9% (11/19) of the patients relapsed after stopping VDZ, and the relapse rate after VDZ discontinuation was 42.1% (8/19) within first 6 months and 52.6% (10/19) within the first year.Conclusion: In real-world experience, induction therapy with VDZ showed promising clinical benefits and safety profile for patients with UC. [ABSTRACT FROM AUTHOR]- Published
- 2022
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- View/download PDF
5. Efficacy of long-term tenofovir disoproxil fumarate therapy in chronic hepatitis B patients with partial virologic response in real practice
- Author
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Jeong Eun Song, Chang Hyeong Lee, and Byung Seok Kim
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hepatitis b, chronic ,tenofovir ,partial virologic response ,real practice ,Medicine - Abstract
Background/Aims The optimal management of chronic hepatitis B (CHB) patients with partial virologic response (PVR) to tenofovir disoproxil fumarate (TDF) remains unclear. We aimed to evaluate the long-term efficacy of prolonged TDF therapy in treatment-naïve CHB patients with PVR to TDF therapy in real practice. Methods We retrospectively investigated the efficacy of prolonged TDF therapy in treatment-naïve CHB patients with PVR to TDF. PVR was defined as a decrease in serum hepatitis B virus (HBV) DNA over 2 log10 IU/mL from baseline, with detectable HBV DNA by real-time polymerase chain reaction at week 48. Results We included 232 patients who underwent TDF therapy for over 48 weeks. Forty-two patients (18.1%) showed PVR. In multivariate analysis, hepatitis B e antigen (HBeAg) positivity, and high levels of serum HBV DNA at baseline and week 12 were independent predictive factors for PVR during TDF therapy. Out of 42 patients with PVR, 39 (92.9%) achieved virologic response (VR) during continuous TDF treatment; the cumulative VR rates at 24, 36, and 48 months were 79.8%, 88.2%, and 95.6%, respectively. With an additional 12 months of therapy, VR was achieved in 28/31 (90.3%) patients with HBV DNA < 100 IU/mL, compared to 5/11 (45.5%) patients with HBV DNA ≥ 100 IU/mL, at week 48. Conclusions The vast majority of patients achieved VR through prolonged TDF therapy, thus TDF treatment can be maintained in nucleos(t)ide-naïve patients with PVR at week 48, especially in those with low viremia.
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- 2019
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6. HYPOLIPIDEMIC THERAPY IN STROKE PREVENTION: EXISTING STANDARDS, EVIDENCE-BASED MEDICINE DATA AND REAL PRACTICE
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O. V. Gaisenok, A. N. Rozhkov, and A. S. Lishuta
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stroke ,statins ,lipid-lowering therapy ,real practice ,evidence-based medicine ,Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Cardiovascular diseases occupy a leading position in morbidity, mortality and disability in most countries. Ischemic heart disease and stroke lead in the structure of mortality from cardiovascular diseases. The issues of lipid-lowering therapy with statins in the aspect of stroke prevention are discussed in the article. The main risk factors of atherosclerosis and their prevalence are presented. Topical standards for statin use, evidence-based medicine data obtained in randomized clinical trials, and evidence from actual clinical practice are covered. Possible promising areas of statin use for the prevention of acute cerebrovascular accident are also considered. Combination therapy together with other lipid-lowering drugs, as well as drugs of other pharmacological groups, the use of statins from earlier ages, the practical implementation of pleiotropic effects of statins can be attributed to the latter. The authors clearly demonstrate that the actual practice of using statins lags significantly behind the ideal, reflected in the recommendations and randomized clinical trials. Adherence to medical recommendations is one of the key factors in this. The main factors that can influence the increase of adherence of patients to taking statins and increase the effectiveness of their application in real clinical practice are presented.
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- 2018
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7. The Place of Art: Reflections on Art and Urban Regeneration in 1980s Britain
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Crehan, K., Clammer, John, editor, and Giri, Ananta Kumar, editor
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- 2017
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8. TREATMENT CHARACTERISTICS OF ACUTE CORONARY SYNDROME IN ELDERLY PATIENTS: PRACTICE OF N.I. PIROGOV CITY CLINICAL HOSPITAL №1
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M. Yu. Gilyarov, M. O. Zheltoukhova, E. V. Konstantinova, M. D. Muksinova, L. S. Muradova, A. P. Nesterov, and A. E. Udovichenko
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acute coronary syndrome ,elderly patients ,assessment of patient management ,real practice ,Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Aim. Assessment of compliance the management of elderly patients (≥75 years) with acute coronary syndrome (ACS) with existing guidelines and evaluation of ACS features during the last two years of working period of the Regional vascular center and compare the results with the data from Russian and foreign registries, randomized clinical studies (RCS) and recommendations. Material and methods. Analysis of diagnostic and treatment data of 999 patients, aged 75 years and over, who were taken by ambulance or made their own way to N. I. Pirogov City Clinical Hospital №1 (CCH №1) in Moscow and were hospitalized during the period between the 1st January 2014 and the 31st of December 2015 in the intensive care unit for patients with myocardial infarction with the initial diagnoses of ACS, myocardial infarction and unstable angina. Results. The elderly patients with ACS admitted to the CCH №1 in 2014 and 2015 were 41% and 54% of all patients with ACS, respectively; women prevailed in all age subgroups. There was no age difference between the subgroups of ACS in patients with elevation ST-segment and ACS in patients without ST-segment elevation. A high frequency of comorbidity in the elderly patients with ACS was observed; hypertension was the most common disease with an incidence rate of 95% without significant difference between the genders. The incidence of percutaneous coronary intervention (PCI) and coronary angiography (CAG) significantly increased in 2015 compared with 2014 (p
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- 2017
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9. Folfiri-Aflibercept vs. Folfiri-Bevacizumab as Second Line Treatment of RAS Mutated Metastatic Colorectal Cancer in Real Practice
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Alessandro Ottaiano, Monica Capozzi, Salvatore Tafuto, Alfonso De Stefano, Chiara De Divitiis, Carmela Romano, Antonio Avallone, and Guglielmo Nasti
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colorectal cancer ,chemotherapy ,bevacizumab ,aflibercept ,real practice ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Background: There are no clinical studies comparing the efficacy of bevacizumab vs.aflibercept in association with folfiri in RAS mutated (RAS-M) metastatic colorectal cancer patients (mCRC) pretreated with folfox and bevacizumab.Patients and Methods: Consecutive RAS-M unresectable mCRC patients progressing to first-line folfox/bevacizumab were treated with 12 cycles of folfiri/bevacizumab (arm A) or folfiri/aflibercept (arm B) at Oncologist discretion. Differences in overall survival between the two schedules were analyzed. Responses and toxicities were described with RECIST and NCI-CTC v4.0, respectively.Results: Seventy-four patients were treated from January 2014 to January 2018; 31 with arm A, 43 with arm B. Among clinical factors there was a predominance of more extended disease (>2 metastatic sites) in arm B (26/43 [60.5%] vs. 10/31 [32.2%] arm A; p = 0.0414). Fifty-nine patients were evaluable for response: arm A, 5 PR (Partial Response), 15 SD (Stable Disease), 8 PD (Progressive Disease); arm B, 5 PR, 16 SD, 10 PD. There were no grade 4 toxic events. Duration of first-line chemotherapy was significantly shorter in patients treated in arm B (12 pts
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- 2019
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10. THE IMARET OF SOFU MEHMED PAŞA IN SOFIA, 1548 - BEGINNING OF THE 19th CENTURY (COMPARATIVE NOTES BETWEEN THE FOUNDER'S WILL AND THE REALITIES).
- Author
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Andonova, Paulina
- Abstract
Like any other imaret in the Ottoman Empire that of Sofu Mehmed Paşa located in Sofia and designed by the great architect Mimar Sinan provided shelter, help andfree food for the waqf staff, the guests and travelers, the poor and the needy. The paper presents the menu and the recipes of the dishes, the beneficiaries and their portions provided by the soup kitchen whose capacity of work allowed approximately 250 people to be fed. However, the main purpose is not only to introduce data about the services of the imaret according to the founder's will, but also to establish the functioning of the imaret as revealed in contemporary sources both during the periods of financial stability and during the economic crisis or damages which interrupted and caused changes in the charitable practice of the foundation. [ABSTRACT FROM AUTHOR]
- Published
- 2019
11. Current practice in the management of branch retinal vein occlusion in Japan: Survey results of retina specialists in Japan.
- Author
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Ogura, Yuichiro, Kondo, Mineo, Kadonosono, Kazuaki, Shimura, Masahiko, Kamei, Motohiro, and Tsujikawa, Akitaka
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RETINAL vein occlusion , *ENDOTHELIAL growth factors , *RETINA , *OPTICAL coherence tomography , *PHYSICIAN practice patterns - Abstract
Purpose: To elucidate the current clinical practice patterns of branch retinal vein occlusion (BRVO) management by retina specialists in Japan in the era of anti-vascular endothelial growth factor (VEGF) therapy. Study design: A voting survey using an answer pad system. Methods: On May 28, 2017, forty-one retina specialists were surveyed on the pathology and clinical practice of BRVO management. Results: Most specialists (77.5%) use fundus examination and optical coherence tomography (OCT) for diagnosis of macular edema (ME) secondary to BRVO. All assess the condition of the ellipsoid zone (EZ) and external limiting membrane (ELM) and consider this a visual prognostic factor. For ME secondary to BRVO, anti-VEGF therapy is the first choice, and most specialists (82.4%) select initial injection followed by a pro re nata (PRN) regimen. For switching to other treatment options for persistent cases, combination therapy of anti-VEGF injections and laser therapy is the most common choice (35.9%), whereas 25.6% select vitreous surgery and 15.4% select adding steroid injections. Conclusions: Our survey presents the current opinions on the diagnosis and treatment of BRVO by retina specialists in Japan, and reveals the common views about damage to the EZ/ELM as a factor of poor prognosis and anti-VEGF therapy as the first line treatment, highlighting various opinions on initiation and switching of therapy. [ABSTRACT FROM AUTHOR]
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- 2019
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12. Folfiri-Aflibercept vs. Folfiri-Bevacizumab as Second Line Treatment of RAS Mutated Metastatic Colorectal Cancer in Real Practice.
- Author
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Ottaiano, Alessandro, Capozzi, Monica, Tafuto, Salvatore, De Stefano, Alfonso, De Divitiis, Chiara, Romano, Carmela, Avallone, Antonio, and Nasti, Guglielmo
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COLORECTAL cancer ,METASTASIS ,FOLINIC acid ,BEVACIZUMAB ,SURVIVAL analysis (Biometry) - Abstract
Background: There are no clinical studies comparing the efficacy of bevacizumab vs.aflibercept in association with folfiri in RAS mutated (RAS-M) metastatic colorectal cancer patients (mCRC) pretreated with folfox and bevacizumab. Patients and Methods: Consecutive RAS-M unresectable mCRC patients progressing to first-line folfox/bevacizumab were treated with 12 cycles of folfiri/bevacizumab (arm A) or folfiri/aflibercept (arm B) at Oncologist discretion. Differences in overall survival between the two schedules were analyzed. Responses and toxicities were described with RECIST and NCI-CTC v4.0, respectively. Results: Seventy-four patients were treated from January 2014 to January 2018; 31 with arm A, 43 with arm B. Among clinical factors there was a predominance of more extended disease (>2 metastatic sites) in arm B (26/43 [60.5%] vs. 10/31 [32.2%] arm A; p = 0.0414). Fifty-nine patients were evaluable for response: arm A, 5 PR (Partial Response), 15 SD (Stable Disease), 8 PD (Progressive Disease); arm B, 5 PR, 16 SD, 10 PD. There were no grade 4 toxic events. Duration of first-line chemotherapy was significantly shorter in patients treated in arm B (12 pts <6 months, 16 pts ≥6, and <12, 15 pts ≥12) vs. arm A (1 pts <6 months, 14 pts ≥6, and <12, 16 pts ≥12) (p = 0.0210); these patients were excluded from survival analysis to avoid prognostic interferences. No maintenance treatment with aflibercept was done in arm B while in arm A bevacizumab with or without fluorouracil and folinic acid were allowed. Median OS were 8.9 months in arm A vs. 12.1 months in arm B (+3.2 months; p = 0.9331, HR: 1.02; 95% CI: 0.57–1.84). Six-months survivals were 65% in arm A and 80% in arm B. Conclusions: Folfiri/bevacizumab and folfiri/aflibercept are equally effective second-line therapies in RAS-M mCRC patients. Although not significant, folfiri/aflibercept was associated with a lower risk of death particularly during the 6-months induction phase. [ABSTRACT FROM AUTHOR]
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- 2019
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13. Disease progression and health care resource consumption in patients affected by hepatitis C virus in real practice setting
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Perrone V, Sangiorgi D, Buda S, and Degli Esposti L
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Hepatitis C virus (HCV) ,hepatocellular carcinoma (HCC) ,cirrhosis ,real practice ,cost of illness. ,Medicine (General) ,R5-920 ,Therapeutics. Pharmacology ,RM1-950 - Abstract
Valentina Perrone, Diego Sangiorgi, Stefano Buda, Luca Degli Esposti CliCon S.r.l. Health, Economics & Outcomes Research, Ravenna, Italy Introduction: Hepatitis C virus (HCV) infection represents serious health problems worldwide and is a major contributor to end-stage liver disease including cirrhosis and hepatocellular carcinoma (HCC). In Italy, ~2% of subjects are infected with HCV. The objective of this study was to describe treatment patterns, disease progression, and resource use in HCV.Methods: An observational retrospective cohort analysis based on four Local Health Units administrative and laboratory databases was conducted. HCV-positive patients between January 1, 2009 and December 31, 2010 were included and followed-up for 1 year. To explore which covariates were associated to disease progression (cirrhosis, HCC, death for any cause), Cox proportional hazards models were performed.Results: A total of 9,514 patients were analyzed of which 55.6% were male, aged 58.1±16.1, and prevalence 0.4%; 5.8% were positive to human immunodeficiency virus (HIV) infection, 3.0% to hepatitis B virus (HBV), and 1.6% to HCV+HBV+HIV; 26.1% had cirrhosis and 4.3% HCC. The majority of patients (76%) did not receive an antiviral treatment; the main factors affecting this decision were age, 44.1% of untreated patients being aged >65 years; 31% were affected by cirrhosis, 6.6% had ongoing substance or alcohol abuse, and 5.5% were affected by HCC. Disease progression in the observed timeframe was less frequent among treated patients (incidence rate per 100 patients/year: cirrhosis 2.1±0.7 vs 13.0±1.0, HCC 0.5±0.3 vs 3.6±0.5, death 0.5±0.3 vs 6.4±0.7). The annual expenditure for HCV management (drugs, hospitalizations, outpatient services) was €4,700 per patient.Conclusion: This observational, real-life study shows that only a small proportion of patients received antiviral therapy in the territorial services investigated; among patients who were not treated, this is reflected in a disease progression and cost of management higher than treated patients. These results suggest the importance of better defining the categories of patients who can really postpone treatment, and those who require immediate antiviral therapy. Keywords: hepatitis C virus, HCV, hepatocellular carcinoma, HCC, cirrhosis, real practice, cost of illness
- Published
- 2016
14. LIPID-LOWERING THERAPY IN OUTPATIENT PRACTICE (ACCORDING TO THE ARGO-2 STUDY)
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N. M. Akhmedzhanov, D. V. Nebieridze, A. S. Safaryan, V. A. Vygodin, A. Yu. Shuraev, A. N. Tkacheva, and A. S. Lishuta
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dyslipidemia ,total cholesterol ,real practice ,rosuvastatin ,Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Aim. To study the features of lipid-lowering therapy with rosuvastatin in high and very high cardiovascular risk patients in real outpatient practice.Material and methods. Patients ≥30 years, visited internists or cardiologists of district outpatient clinics in the period from October 2013 to July 2014 were included into the study. Each patient fill in questionnaire. Determination of total cholesterol (TC) level was performed without special preparation of the patient using a portable photometric blood analyzer. Doctors prescribed rosuvastatin therapy when indicated, in accordance with the Guidelines, choosing the dose on their own. Repeated TC level was determined after 1 month.Results. TC level was initially determined in 10547 patients. Rosuvastatin treatment was recommended for all patients. Repeated TC level determination was performed in 7897 patients in an average after 33 days. Baseline TC level in them was 6.37±0.89 mmol/l, and after 1 month while taking rosuvastatin – 4.89±0.81 mmol/l (p
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- 2016
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15. Clinical efficacy of adalimumab in Crohn's disease: a real practice observational study in Japan.
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Fuminao Takeshima, Daisuke Yoshikawa, Syuntaro Higashi, Tomohito Morisaki, Hidetoshi Oda, Maho Ikeda, Haruhisa Machida, Kayoko Matsushima, Hitomi Minami, Yuko Akazawa, Naoyuki Yamaguchi, Ken Ohnita, Hajime Isomoto, Masato Ueno, Kazuhiko Nakao, Takeshima, Fuminao, Yoshikawa, Daisuke, Higashi, Syuntaro, Morisaki, Tomohito, and Oda, Hidetoshi
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ADALIMUMAB , *INFLAMMATORY bowel disease treatment , *TREATMENT effectiveness , *PUBLIC health , *DISEASE remission , *THERAPEUTICS , *ANTI-inflammatory agents , *COMPARATIVE studies , *CROHN'S disease , *RESEARCH methodology , *MEDICAL cooperation , *RESEARCH , *EVALUATION research , *RETROSPECTIVE studies ,DISEASE relapse prevention - Abstract
Background: There are few reports of the efficacy of adalimumab (ADA) for clinical remission and preventing postoperative recurrence in Crohn's disease (CD) in Asian real practice settings. We conducted a Japanese multicenter retrospective observational study.Methods: We evaluated patients with CD who were treated with ADA at 11 medical institutions in Japan to investigate the clinical efficacy of remission up to 52 weeks and the associated factors to achieve remission with a CD Activity Index (CDAI) < 150. The effects of preventing postoperative recurrence were also evaluated.Results: In 62 patients, the remission rates were 33.9, 74.2, 75.8, 77.4, and 66.1 % at 0, 4, 12, 26, and 52 weeks, respectively. Although 10 patients discontinued treatment due to primary nonresponse, secondary nonresponse, or adverse events, the ongoing treatment rate at 52 weeks was 83.9 %. Comparison of remission and non-remission on univariate analysis identified colonic type and baseline CDAI value as significant associated factors (P < 0.05). In 16 patients who received ADA to prevent postoperative recurrence, the clinical remission maintenance rate was 93.8 % and the mucosal healing rate was 64.3 % during a mean postoperative follow-up period of 32.3 months.Conclusions: ADA effectively induced remission and prevented postoperative recurrence in patients with CD in a real practice setting. [ABSTRACT FROM AUTHOR]- Published
- 2016
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16. Efficacy of long-term tenofovir disoproxil fumarate therapy in chronic hepatitis B patients with partial virologic response in real practice
- Author
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Byung Seok Kim, Jeong Eun Song, and Chang Hyeong Lee
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Adult ,Male ,Hepatitis B virus ,medicine.medical_specialty ,Time Factors ,Sustained Virologic Response ,Tenofovir ,hepatitis b, chronic ,Phosphorous Acids ,Viremia ,medicine.disease_cause ,real practice ,Antiviral Agents ,Gastroenterology ,Drug Administration Schedule ,03 medical and health sciences ,0302 clinical medicine ,Chronic hepatitis ,Internal medicine ,medicine ,Humans ,Retrospective Studies ,business.industry ,Adenine ,Middle Aged ,Viral Load ,Hepatitis B ,medicine.disease ,Optimal management ,tenofovir ,Treatment Outcome ,HBeAg ,Virologic response ,Medicine ,Female ,Original Article ,030211 gastroenterology & hepatology ,business ,partial virologic response ,medicine.drug - Abstract
Background/Aims: The optimal management of chronic hepatitis B (CHB) pa tients with partial virologic response (PVR) to tenofovir disoproxil fumarate (TDF) remains unclear. We aimed to evaluate the long-term efficacy of prolonged TDF therapy in treatment-naive CHB patients with PVR to TDF therapy in real practice. Methods: We retrospectively investigated the efficacy of prolonged TDF ther apy in treatment-naive CHB patients with PVR to TDF. PVR was defined as a decrease in serum hepatitis B virus (HBV) DNA over 2 log10 IU/mL from base line, with detectable HBV DNA by real-time polymerase chain reaction at week 48. Results: We included 232 patients who underwent TDF therapy for over 48 weeks. Forty-two patients (18.1%) showed PVR. In multivariate analysis, hep atitis B e antigen (HBeAg) positivity, and high levels of serum HBV DNA at baseline and week 12 were independent predictive factors for PVR during TDF therapy. Out of 42 patients with PVR, 39 (92.9%) achieved virologic response (VR) during continuous TDF treatment; the cumulative VR rates at 24, 36, and 48 months were 79.8%, 88.2%, and 95.6%, respectively. With an additional 12 months of therapy, VR was achieved in 28/31 (90.3%) patients with HBV DNA < 100 IU/mL, compared to 5/11 (45.5%) patients with HBV DNA ≥ 100 IU/mL, at week 48. Conclusions: The vast majority of patients achieved VR through prolonged TDF therapy, thus TDF treatment can be maintained in nucleos(t)ide-naive pa tients with PVR at week 48, especially in those with low viremia.
- Published
- 2019
17. Onabotulinumtoxin A intravesical treatment in patients affected by overactive bladder syndrome: best practice in real-life management.
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Giannantoni, Antonella, Proietti, Silvia, Costantini, Elisabetta, Gubbiotti, Marilena, De Vermandois, Jacopo Rossi, and Porena, Massimo
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OVERACTIVE bladder , *BOTULINUM toxin , *MEDICAL protocols , *CATHETERIZATION , *INTRAOPERATIVE care , *PATIENTS , *THERAPEUTICS - Abstract
Purpose: We evaluated intradetrusorial OnabotulinumtoxinA (Onabot/A) treatment protocols in patients with idiopathic overactive bladder (OAB), in order to assess the care of patients before, during and after treatment. Methods: In 64 OAB patients injected with Onabot/A, we reviewed the length of the hospital stay, frequency of catheterization, frequency of intraoperative and postoperative complications, and patients' satisfaction to the proposed treatment protocol (as assessed by VAS). We also compared the results of the 3-day voiding diary, uroflowmetry with postvoid residual urine (PVR) and VAS to score the bother of urinary symptoms on quality of life (QoL) before and after treatment. Results: Twenty-one patients were firstly treated in an 'inpatient' setting. The mean ± SD duration of hospitalization and catheterization was 39.4 ±12.6 and 37.8 ± 10.6 h, respectively. The mean ± SD VAS values of treatment satisfaction and of bother of urinary symptoms on QoL were 6.3 ± 1.1 and 8.2 ± 1.3, respectively. The mean ± SD PVR value was 74.3 ± 15.2 ml. Frequency of UTIs was 2.4 ± 1.6. Forty-three patients were treated on an outpatient basis; the mean ± SD duration of catheterization, the 'outpatient' stay and the mean ± SD frequency of UTIs were lower than those of patients treated in an inpatient setting. The mean ± SD VAS value to score QoL was high. Conclusions: Intradetrusorial Onabot/A injection is a simple and fast procedure that can be easily carried on in an outpatient setting under local anesthesia, with low rates of intraoperative and postoperative complications. [ABSTRACT FROM AUTHOR]
- Published
- 2015
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18. HYPOLIPIDEMIC THERAPY IN STROKE PREVENTION: EXISTING STANDARDS, EVIDENCE-BASED MEDICINE DATA AND REAL PRACTICE
- Author
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A. S. Lishuta, O. V. Gaisenok, and A. N. Rozhkov
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medicine.medical_specialty ,Combination therapy ,Disease ,RM1-950 ,030204 cardiovascular system & hematology ,real practice ,law.invention ,statins ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,medicine ,Diseases of the circulatory (Cardiovascular) system ,Pharmacology (medical) ,cardiovascular diseases ,Intensive care medicine ,Stroke ,lipid-lowering therapy ,business.industry ,Evidence-based medicine ,Statin treatment ,medicine.disease ,stroke ,Stroke prevention ,RC666-701 ,Actual practice ,lipids (amino acids, peptides, and proteins) ,Therapeutics. Pharmacology ,Cardiology and Cardiovascular Medicine ,business ,evidence-based medicine ,030217 neurology & neurosurgery - Abstract
Cardiovascular diseases occupy a leading position in morbidity, mortality and disability in most countries. Ischemic heart disease and stroke lead in the structure of mortality from cardiovascular diseases. The issues of lipid-lowering therapy with statins in the aspect of stroke prevention are discussed in the article. The main risk factors of atherosclerosis and their prevalence are presented. Topical standards for statin use, evidence-based medicine data obtained in randomized clinical trials, and evidence from actual clinical practice are covered. Possible promising areas of statin use for the prevention of acute cerebrovascular accident are also considered. Combination therapy together with other lipid-lowering drugs, as well as drugs of other pharmacological groups, the use of statins from earlier ages, the practical implementation of pleiotropic effects of statins can be attributed to the latter. The authors clearly demonstrate that the actual practice of using statins lags significantly behind the ideal, reflected in the recommendations and randomized clinical trials. Adherence to medical recommendations is one of the key factors in this. The main factors that can influence the increase of adherence of patients to taking statins and increase the effectiveness of their application in real clinical practice are presented.
- Published
- 2018
19. Safety of subcutaneous immunotherapy with carbamylated allergoids based on data from a pharmacovigilance database.
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Franco F, Cristoforo I, Francesca S, Arianna P, Laura M, Carlo C, Simonetta M, and Enrico C
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- Allergens therapeutic use, Allergoids, Humans, Plant Extracts, Desensitization, Immunologic adverse effects, Desensitization, Immunologic methods, Pharmacovigilance
- Abstract
Aims: Allergen immunotherapy aims to induce tolerance, which persists after its discontinuation, to targeted allergens. However, concern exists regarding the use of subcutaneous immunotherapy with whole extracts due to frequently reported events of anaphylactic reactions. Materials & methods: In this pharmacovigilance study, the authors assessed the safety of subcutaneous immunotherapy with the monomeric allergoid Lais-in using a database of adverse reactions documented in real-world postmarketing reports from 2010 to 2020. Results & conclusion: The results showed that more than 171,916 doses of Lais-in were administered from 2010 to 2020, resulting in five adverse drug reactions. Nonserious adverse events, including hives, eye irritation and skin reactions, were reported. These data indicate that monomeric allergoids prevent serious reactions to subcutaneous immunotherapy.
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- 2022
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20. Adherence to Statin Treatment and Health Outcomes in an Italian Cohort of Newly Treated Patients: Results From an Administrative Database Analysis
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Degli Esposti, Luca, Saragoni, Stefania, Batacchi, Paolo, Benemei, Silvia, Geppetti, Pierangelo, Sturani, Alessandra, Buda, Stefano, and Degli Esposti, Ezio
- Subjects
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STATINS (Cardiovascular agents) , *STROKE prevention , *CHI-squared test , *CONFIDENCE intervals , *DATABASES , *EPIDEMIOLOGY , *MORTALITY , *MULTIVARIATE analysis , *HEALTH outcome assessment , *PATIENT compliance , *RESEARCH funding , *LOGISTIC regression analysis , *DATA analysis , *TREATMENT effectiveness , *PROPORTIONAL hazards models , *RETROSPECTIVE studies , *DATA analysis software , *DESCRIPTIVE statistics - Abstract
Abstract: Background: Adherence to statin treatment is expected to be associated with health outcomes. Much of the available evidence is derived from studies conducted on selected populations (eg, Medicaid population), on specific cohorts of patients (eg, patients with diabetes mellitus or those who have experienced acute myocardial infarction [AMI]), or with respect to a single outcome (eg, only death or only AMI). Objective: The aim of this study was to evaluate the association between adherence to statin therapy and all-cause mortality and cardiovascular morbidity (AMI and stroke) in an unselected cohort of newly treated patients. Methods: We performed a population-based retrospective cohort study that included adult patients with a first prescription of a statin from January 1, 2004, through December 31, 2006, using data from the administrative databases of the Local Health Unit of Florence in Italy. Adherence to statin treatment was estimated as the proportion of days covered (PDC) by filled prescriptions and classified as low (PDC, 21%–40%), intermediate-low (PDC, 41%–60%), intermediate-high (PDC, 61%–80%), and high (PDC, >80%). Cases with PDC ≤20% were excluded. A Cox regression model was used to investigate the association between adherence to treatment and all-cause mortality and hospitalization for AMI or stroke. Results: The cohort consisted of 19,232 patients (9823 men and 9409 women) aged 18 to 102 years (mean [SD], 66.5 [11.4] years): 20.1% had been previously hospitalized for cardiovascular events and 17.6% had been treated with hypoglycemic drugs. Adherence to statins was low in 4427 patients (23.0%), intermediate-low in 3117 (16.2%), intermediate-high in 3784 (19.7%), and high in 7904 (41.1%). Lower-adherent patients were younger and had fewer comorbidities compared with higher-adherent patients. In our multivariable analyses, high adherence was significantly associated with decreased risk of all-cause death, AMI, or stroke. Compared with low adherence (hazard ratio [HR] = 1), the risk was lower in intermediate-low adherence (HR = 0.83; 95% confidence interval [CI], 0.71–0.98; P < 0.05) and much lower in intermediate-high (HR = 0.60; 95% CI, 0.51–0.70; P < 0.001) and high adherence (HR = 0.61; 95% CI, 0.54–0.71; P < 0.001). Conclusions: In this Italian cohort of newly treated patients, suboptimal adherence to statins occurred in a substantial proportion of patients and was associated with increased risk of adverse health outcomes. [Copyright &y& Elsevier]
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- 2012
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21. Thromboprophylaxis in Patients with Atrial Fibrillation: A Real Practice Analysis: La Tromboprofilassi Nei Pazienti Con Fibrillazione Atriale: Analisi Di Real Practice
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Deambrosis, Paola, Bettiol, Alessandra, Bolcato, Jenny, Pirolo, Roberta, Franchin, Giulia, Themistoclakis, Sakis, Giusti, Pietro, Chinellato, Alessandro, Deambrosis, Paola, Bettiol, Alessandra, Bolcato, Jenny, Pirolo, Roberta, Franchin, Giulia, Themistoclakis, Sakis, Giusti, Pietro, and Chinellato, Alessandro
- Abstract
Background Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and a major preventable cause of stroke and hospitalizations, with an estimate prevalence of 2.5%. Current guidelines recommend oral anticoagulant therapy for AF patients at moderate or high risk of stroke. However, despite the effectiveness of oral anticoagulants in stroke prevention, such a therapy remains broadly underused. Purpose The aim of this study was to evaluate Vitamin K Antagonists (VKAs) treatment in patients with Non Vascular AF (NVAF) in everyday clinical practice in light of current treatment guidelines, and to analyze the costs associated with patient management. Methods This retrospective observational study was performed utilizing several databases of the Local Health Authority 9 of Treviso, Italy, from January 1, 2010 to December 31, 2013. The cohort of patients affected by NVAF was identified on the basis of Hospital Discharge Records of the years 2010-2013, considering ICD9-CM diagnosis codes for atrial fibrillation and atrial flutter. After the first diagnosis of NVAF, patients have been stratified according to the individual stroke risk (CHA2DS2-VASc score), therapeutic treatment with VKA and achievement of anticoagulation control (Time in Therapeutic Range, TTR). The cost analysis for the year 2013 was performed for naïve and prevalent patients, separately; for naïve patients, costs in the year 2014 were also evaluated, so that data available for each patient referred to a minimum period of 12 months. Results The cohort of patients with NVAF identified for the years 2010-2013 comprised 4855 patients, of which 53% were treated with oral VKAs. This percentage decreases to 29.6% considering only patients with at least 6 continuative months of therapy and at least 8 INR (International Normalized Ratio) controls. Furthermore, only 31% of VKA-treated patients reached the therapeutic target (TTR ≥65%). The cost analysis showed that naïve patients cost 1.4 times more
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- 2018
22. Disease progression and health care resource consumption in patients affected by hepatitis C virus in real practice setting
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Diego Sangiorgi, Luca Degli Esposti, Valentina Perrone, and Stefano Buda
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hepatitis C virus ,Pathology ,medicine.medical_specialty ,Cirrhosis ,Hepatitis C virus ,Economics, Econometrics and Finance (miscellaneous) ,cost of illness ,Alcohol abuse ,medicine.disease_cause ,real practice ,03 medical and health sciences ,Liver disease ,0302 clinical medicine ,Internal medicine ,medicine ,030212 general & internal medicine ,HCC ,Original Research ,Hepatitis B virus ,business.industry ,Proportional hazards model ,Health Policy ,cirrhosis ,Retrospective cohort study ,hepatocellular carcinoma ,medicine.disease ,Hepatocellular carcinoma ,HCV ,030211 gastroenterology & hepatology ,business - Abstract
Introduction Hepatitis C virus (HCV) infection represents serious health problems worldwide and is a major contributor to end-stage liver disease including cirrhosis and hepatocellular carcinoma (HCC). In Italy, ~2% of subjects are infected with HCV. The objective of this study was to describe treatment patterns, disease progression, and resource use in HCV. Methods An observational retrospective cohort analysis based on four Local Health Units administrative and laboratory databases was conducted. HCV-positive patients between January 1, 2009 and December 31, 2010 were included and followed-up for 1 year. To explore which covariates were associated to disease progression (cirrhosis, HCC, death for any cause), Cox proportional hazards models were performed. Results A total of 9,514 patients were analyzed of which 55.6% were male, aged 58.1±16.1, and prevalence 0.4%; 5.8% were positive to human immunodeficiency virus (HIV) infection, 3.0% to hepatitis B virus (HBV), and 1.6% to HCV+HBV+HIV; 26.1% had cirrhosis and 4.3% HCC. The majority of patients (76%) did not receive an antiviral treatment; the main factors affecting this decision were age, 44.1% of untreated patients being aged >65 years; 31% were affected by cirrhosis, 6.6% had ongoing substance or alcohol abuse, and 5.5% were affected by HCC. Disease progression in the observed timeframe was less frequent among treated patients (incidence rate per 100 patients/year: cirrhosis 2.1±0.7 vs 13.0±1.0, HCC 0.5±0.3 vs 3.6±0.5, death 0.5±0.3 vs 6.4±0.7). The annual expenditure for HCV management (drugs, hospitalizations, outpatient services) was €4,700 per patient. Conclusion This observational, real-life study shows that only a small proportion of patients received antiviral therapy in the territorial services investigated; among patients who were not treated, this is reflected in a disease progression and cost of management higher than treated patients. These results suggest the importance of better defining the categories of patients who can really postpone treatment, and those who require immediate antiviral therapy.
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- 2016
23. Clinical efficacy of adalimumab in Crohn’s disease: a real practice observational study in Japan
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Takeshima, Fuminao, Yoshikawa, Daisuke, Higashi, Syuntaro, Morisaki, Tomohito, Oda, Hidetoshi, Ikeda, Maho, Machida, Haruhisa, Matsushima, Kayoko, Minami, Hitomi, Akazawa, Yuko, Yamaguchi, Naoyuki, Ohnita, Ken, Isomoto, Hajime, Ueno, Masato, Nakao, Kazuhiko, Takeshima, Fuminao, Yoshikawa, Daisuke, Higashi, Syuntaro, Morisaki, Tomohito, Oda, Hidetoshi, Ikeda, Maho, Machida, Haruhisa, Matsushima, Kayoko, Minami, Hitomi, Akazawa, Yuko, Yamaguchi, Naoyuki, Ohnita, Ken, Isomoto, Hajime, Ueno, Masato, and Nakao, Kazuhiko
- Abstract
Background: There are few reports of the efficacy of adalimumab (ADA) for clinical remission and preventing postoperative recurrence in Crohn's disease (CD) in Asian real practice settings. We conducted a Japanese multicenter retrospective observational study. Methods: We evaluated patients with CD who were treated with ADA at 11 medical institutions in Japan to investigate the clinical efficacy of remission up to 52 weeks and the associated factors to achieve remission with a CD Activity Index (CDAI) < 150. The effects of preventing postoperative recurrence were also evaluated. Results: In 62 patients, the remission rates were 33.9, 74.2, 75.8, 77.4, and 66.1 % at 0, 4, 12, 26, and 52 weeks, respectively. Although 10 patients discontinued treatment due to primary nonresponse, secondary nonresponse, or adverse events, the ongoing treatment rate at 52 weeks was 83.9 %. Comparison of remission and non-remission on univariate analysis identified colonic type and baseline CDAI value as significant associated factors (P < 0.05). In 16 patients who received ADA to prevent postoperative recurrence, the clinical remission maintenance rate was 93.8 % and the mucosal healing rate was 64.3 % during a mean postoperative follow-up period of 32.3 months. Conclusions: ADA effectively induced remission and prevented postoperative recurrence in patients with CD in a real practice setting., BMC Gastroenterology, 16, 82; 2016
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- 2016
24. Analysis of disease patterns and cost of treatments for prevention of deep venous thrombosis after total knee or hip replacement: results from the Practice Analysis of THromboprophylaxis after Orthopaedic Surgery (PATHOS) study
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Luca Degli Esposti, Guido Didoni, Diego Sangiorgi, Ezio Degli Esposti, Teresa Simon, and Stefano Buda
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medicine.medical_specialty ,Economics, Econometrics and Finance (miscellaneous) ,venous thromboembolism ,cost of illness ,antithrombotic therapy ,Review ,Fondaparinux ,real practice ,THR ,Hip replacement ,Antithrombotic ,medicine ,total knee replacement ,business.industry ,Health Policy ,Heparin ,medicine.disease ,Surgery ,total hip replacement ,Venous thrombosis ,Orthopedic surgery ,TKR ,VTE ,business ,Complication ,medicine.drug ,Cohort study - Abstract
INTRODUCTION Venous thromboembolism (VTE) is a well-known complication of total hip replacement (THR) and total knee replacement (TKR). Various drugs have been introduced in an attempt to reduce the mortality as well as the short-term and long-term morbidity associated with the development of VTE. The aim of this study was to analyze drug utilization for thromboprophylaxis and the cost of illness in real clinical practice in patients with THR or TKR. MATERIALS AND METHODS A multicenter, retrospective, observational cohort study based on local health unit administrative databases was conducted. All patients (≥18 years old) discharged for THR/TKR procedures between January 1, 2007 and December 31, 2008 were included in the study. The date of first hospital discharge was the index date; patients were followed up for a period of 12 months. RESULTS A total of 10,389 patients were included: 3516 males (33.8%, 69.4 ± 10.4 years) and 6873 females (66.2%, 71.7 ± 9.0 years), of which 5483 (52.8%) were discharged for THR and 4906 (47.2%) for TKR. First antithrombotic treatments after discharge were enoxaparin (3937, 37.9%), heparin (3752, 36.1%), antiplatelet agents (658, 6.3%), vitamin K antagonists (276, 2.7%), fondaparinux (136, 1.3%), combinations (185, 1.8%), and no therapy (1445, 13.9%). Overall, we observed 2347 (22.6%) treatment changes; median duration of antithrombotic treatment was 23 days (range 11-47) for THR and 22 days (range 11-46) for TKR. During the follow-up period, we observed 129 cases of VTE (120 per 10,000 patients), five post-thrombotic syndrome (4.8 per 10,000 patients), and three heparin-induced thrombocytopenia (2.9 per 10,000 patients). Median cost for both THR and TKR was €9052.00 (range €8063.00-€9084.96), with a median length of stay of 9.0 days (range 6.0-12.0).
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- 2013
25. Real practice studies in oncology: A positive perspective.
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Ottaiano A
- Abstract
In the majority of phase III clinical trials, patients are generally excluded on the basis of specific comorbidities, performance status Eastern Cooperative Oncology Group ≥ 2, age ≥ 65 years, previous malignancies, brain metastases, active infections, psychiatric disorders, non-measurable disease, number and type of previous lines of chemotherapies or biologic therapies. A question is raised: Can results of phase IIIstudies be extended to the general population? There is increasing attention to and a resurgence of some terms as "real world" or "real practice" which are wrongly viewed as contrary to clinical trial protocols. In fact, the general perception is that a contraposition exists between "wrong" (retrospective and biased) and "right" (prospective, randomized, well statistically designed) clinical research. We have to change this perspective. Real practice studies, generally retrospective in their nature, deserve to be reevaluated; biases are physiologically present but their punctual and rigorous description and analysis can help the interpretation of and in some cases reinforce results and their hypothesis-generating power. The correct and balanced interaction between clinical trials and real practice reports can help the scientific community to improve the knowledge on anti-cancer drug efficacy., Competing Interests: Conflict-of-interest statement: The author has no conflict of interest to declare.
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- 2018
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26. Analysis of disease patterns and cost of treatments for prevention of deep venous thrombosis after total knee or hip replacement: results from the Practice Analysis of THromboprophylaxis after Orthopaedic Surgery (PATHOS) study.
- Author
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Degli Esposti L, Didoni G, Simon T, Buda S, Sangiorgi D, and Degli Esposti E
- Abstract
Introduction: Venous thromboembolism (VTE) is a well-known complication of total hip replacement (THR) and total knee replacement (TKR). Various drugs have been introduced in an attempt to reduce the mortality as well as the short-term and long-term morbidity associated with the development of VTE. The aim of this study was to analyze drug utilization for thromboprophylaxis and the cost of illness in real clinical practice in patients with THR or TKR., Materials and Methods: A multicenter, retrospective, observational cohort study based on local health unit administrative databases was conducted. All patients (≥18 years old) discharged for THR/TKR procedures between January 1, 2007 and December 31, 2008 were included in the study. The date of first hospital discharge was the index date; patients were followed up for a period of 12 months., Results: A total of 10,389 patients were included: 3516 males (33.8%, 69.4 ± 10.4 years) and 6873 females (66.2%, 71.7 ± 9.0 years), of which 5483 (52.8%) were discharged for THR and 4906 (47.2%) for TKR. First antithrombotic treatments after discharge were enoxaparin (3937, 37.9%), heparin (3752, 36.1%), antiplatelet agents (658, 6.3%), vitamin K antagonists (276, 2.7%), fondaparinux (136, 1.3%), combinations (185, 1.8%), and no therapy (1445, 13.9%). Overall, we observed 2347 (22.6%) treatment changes; median duration of antithrombotic treatment was 23 days (range 11-47) for THR and 22 days (range 11-46) for TKR. During the follow-up period, we observed 129 cases of VTE (120 per 10,000 patients), five post-thrombotic syndrome (4.8 per 10,000 patients), and three heparin-induced thrombocytopenia (2.9 per 10,000 patients). Median cost for both THR and TKR was €9052.00 (range €8063.00-€9084.96), with a median length of stay of 9.0 days (range 6.0-12.0).
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- 2013
- Full Text
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27. EFFICIENCY OF TREATMENT OF PATIENTS WITH ARTERIAL HYPERTENSION AND COMORBID STATES IN REAL CLINICAL PRACTICE
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Tykhonova, S. A., Shtanko, V. A., Tykhonova, S. A., and Shtanko, V. A.
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