scholarly journals Prospective observational study on Pazopanib in patients treated for advanced or metastatic renal cell carcinoma in countries in Asia Pacific, North Africa, and Middle East regions: PARACHUTE study

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Erman Mustafa ◽  
Biswas Bivas ◽  
Danchaivijitr Pongwut ◽  
Chen Lingwu ◽  
Yoke Fui Wong ◽  
...  
Keyword(s):  
Middle East ◽  
Observational Study ◽  
North Africa ◽  
Real World ◽  
Safety Data ◽  
Dose Intensity ◽  
Clinical Effectiveness ◽  
Asia Pacific ◽  
Observational Period ◽  
Middle East Countries

Abstract Background Clinical effectiveness and safety data of pazopanib in patients with advanced or mRCC in real-world setting from Asia Pacific, North Africa, and Middle East countries are lacking. Methods PARACHUTE is a phase IV, prospective, non-interventional, observational study. Primary endpoint was the proportion of patients remaining progression free at 12 months. Secondary endpoints were ORR, PFS, safety and tolerability, and relative dose intensity (RDI). Results Overall, 190 patients with a median age of 61 years (range: 22.0–96.0) were included. Most patients were Asian (70%), clear-cell type RCC was the most common (81%), with a favourable (9%), intermediate (47%), poor (10%), and unknown (34%) MSKCC risk score. At the end of the observational period, 78 patients completed the observational period and 112 discontinued the study; 60% of patients had the starting dose at 800 mg. Median RDI was 82%, with 52% of patients receiving < 85%. Of the 145 evaluable patients, 56 (39%) remained progression free at 12 months, and the median PFS was 10 months (95% CI: 8.48–11.83). 19% of patients (21/109) were long-term responders (on pazopanib for ≥18 months). The best response per RECIST 1.1 was CR/PR in 24%, stable disease in 44%, and PD in 31%. Most frequent (> 10%) TEAEs related to pazopanib included diarrhoea (30%), palmar-plantar erythrodysesthesia syndrome (15%), and hypertension (14%). Conclusions Results of the PARACHUTE study support the use of pazopanib in patients with advanced or mRCC who are naive to VEGF-TKI therapy. The safety profile is consistent with that previously reported by pivotal and real-world evidence studies.

scholarly journals Tuberculosis and viral hepatitis in patients treated with certolizumab pegol in Asia-Pacific countries and worldwide: real-world and clinical trial data

2020 ◽  
Author(s):  
Chak Sing Lau ◽  
Yi-Hsing Chen ◽  
Keith Lim ◽  
Marc de Longueville ◽  
Catherine Arendt ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Viral Hepatitis ◽  
Central Europe ◽  
Real World ◽  
Certolizumab Pegol ◽  
Safety Data ◽  
Asia Pacific ◽  
Hbv Reactivation ◽  
Post Marketing

Abstract Introduction/objectives To evaluate the incidence rate (IR) of tuberculosis (TB) and viral hepatitis B and C (HBV/HCV) during certolizumab pegol (CZP) treatment, worldwide and in Asia-Pacific countries, across clinical trials and post-marketing reports (non-interventional studies and real-world practice). Method CZP safety data were pooled across 49 clinical trials from 1998 to June 2017. Post-marketing reports were from initial commercialization until March 2015 (TB)/February 2017 (HBV/HCV). All suspected TB and HBV/HCV cases underwent centralized retrospective review by external experts. Incidence rates (IRs) were calculated per 100 patient-years (PY) of CZP exposure. Results Among 11,317 clinical trial patients (21,695 PY), 62 TB cases were confirmed (IR 0.29/100 PY) including 2 in Japan (0.10/100 PY) and 3 in other Asia-Pacific countries (0.58/100 PY). From > 238,000 PY estimated post-marketing CZP exposure, there were 31 confirmed TB cases (0.01/100 PY): 5 in Japan (0.05/100 PY), 1 in other Asia-Pacific countries (0.03/100 PY). Reported regional TB IRs were highest in eastern Europe (0.17/100 PY), central Europe (0.09/100 PY), and Mexico (0.16/100 PY). Across clinical trials, there was 1 confirmed HBV reactivation and no HCV cases. From > 420,000 PY estimated post-marketing CZP exposure, 5 HBV/HCV cases were confirmed (0.001/100 PY): 2 HCV reactivations; 1 new HCV; plus 2 HBV reactivations in Japan (0.008/100 PY). Conclusions CZP TB risk is aligned with nationwide TB rates, being slightly higher in Asia-Pacific countries excluding Japan. Overall, TB and HBV/HCV risk with CZP treatment is currently relatively low, as risk can be minimized with patient/physician education, screening, and vigilant treatment, according to international guidelines. Key Points:• TB rates were highest in eastern/central Europe, Mexico, and Asia-Pacific regions.• With the implementation of stricter TB screening and risk evaluations in 2007, especially in high TB incidence countries, there was a notable reduction TB occurrence.• Safety profile of biologics in real-world settings complements controlled studies.• TB and hepatitis (HBV/HCV) risk with certolizumab pegol (CZP) treatment is low.

scholarly journals Prevalence trends in non-alcoholic fatty liver disease at the global, regional and national levels, 1990–2017: a population-based observational study

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e036663
Author(s):  
Xiaojun Ge ◽  
Limei Zheng ◽  
Mei Wang ◽  
Yuxuan Du ◽  
Junyao Jiang
Keyword(s):  
Liver Disease ◽  
Middle East ◽  
Observational Study ◽  
Fatty Liver ◽  
North Africa ◽  
Fatty Liver Disease ◽  
Population Based ◽  
Prevention Strategies ◽  
Alcoholic Fatty Liver ◽  
Alcoholic Fatty Liver Disease

ObjectiveNon-alcoholic fatty liver disease (NAFLD) is the leading cause of end-stage liver diseases worldwide. Understanding NAFLD prevalence and trends over time at the global, regional and national levels is critical to understanding the NAFLD disease burden and creating more tailored prevention strategies.DesignPopulation-based observational study.SettingThe study was global, including 21 regions and 195 countries or territories.Main outcomes measureThe estimated annual percentage change for NAFLD prevalence.ResultsWorldwide, cases of NAFLD have increased from 391.2 million in 1990 to 882.1 million in 2017, with the prevalence rate increasing from 8.2% to 10.9% during the same period. The increasing trends were consistent across sexes. Case numbers were highest in East Asia, followed by South Asia, then North Africa and the Middle East. The highest prevalence of NAFLD was observed in North Africa and the Middle East, while the greatest increase was detected in Western Europe, followed by Tropical Latin America, then high-income North America.ConclusionNearly all countries or territories worldwide have experienced a significant increase in NAFLD prevalence. The greatest increase was observed in Oman. Almost all countries showed a significant increasing trend in NAFLD prevalence over the past three decades. This drastic increase is alarming and suggests that NAFLD has emerged as a new public health concern worldwide. As such, more efficient prevention strategies are urgently needed.

Ipilimumab in real-world clinical practice: efficacy and safety data from a multicenter observational study

2017 ◽  
Vol 29 (4) ◽  
pp. 245-251 ◽  
Author(s):  
Alberto Russi ◽  
Vera Damuzzo ◽  
Marco Chiumente ◽  
Jacopo Pigozzo ◽  
Marco Cesca ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Observational Study ◽  
Real World ◽  
Safety Data ◽  
Efficacy And Safety ◽  
Multicenter Observational Study

ICT Diffusion and Foreign Direct Investment

2011 ◽  
pp. 294-320
Author(s):  
Farid Shirazi ◽  
Dolores Añón Higón ◽  
Roya Gholami
Keyword(s):  
Foreign Direct Investment ◽  
Middle East ◽  
Direct Investment ◽  
Middle Eastern ◽  
Asia Pacific ◽  
Outward Fdi ◽  
Middle East Countries ◽  
Inverse Effect ◽  
The Impact

This chapter investigates the impact of inward and outward FDI on ICT diffusion in the Asia-Pacific and Middle East regions for the period 1996-2008. The results indicate that while inward FDI has generally had a positive and significant impact on ICT diffusion in Asia-Pacific economies, its impact on the Middle Eastern countries has been detrimental. In contrast, the results of this study also show that outward FDI has had, in general, the inverse effect, it has been in general positive and significant for the Middle East countries but insignificant for Asia-Pacific economies.

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