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Purpose: This study evaluated the long-term safety of roflumilast in patients with chronic obstructive pulmonary disease or chronic bronchitis using electronic healthcare databases from Germany, Norway, Sweden, and the United States (US)., Patients and Methods: The study population consisted of patients aged ≥40 years who had been exposed to roflumilast and a matched cohort unexposed to roflumilast. The matching was based on sex, age, calendar year of cohort entry date (2010-2011, 2012, or 2013), and a propensity score that included variables such as demographics, markers of chronic obstructive pulmonary disease (COPD) severity and morbidity, and comorbidities. In comparison to the unexposed matched cohort (never use), three exposure definitions were used for the exposed matched cohort: ever use, use status (current, recent, past use), and cumulative duration of use. The main outcome was 5-year all-cause mortality. Cox regression models were used to estimate crude and adjusted hazard ratios (HRs) and 95% confidence intervals (CI)., Results: 112,541 unexposed and 23,239 exposed patients across countries were included. Some variables remained unbalanced after matching, indicating higher COPD disease severity among the exposed patients. Adjusted HRs of 5-year all-cause mortality for "ever use" of roflumilast, compared to "never use", were 1.12 (95% CI, 1.08-1.17) in Germany, 1.00 (95% CI, 0.92-1.08) in Norway, 0.98 (95% CI, 0.92-1.04) in Sweden, and 1.16 (95% CI, 1.12-1.20) in the US. Compared to never users, there was a decrease in 5-year mortality risk observed among "current users" in Germany (HR: 0.93, 95% CI: 0.88-0.98), Norway (HR: 0.77, 95% CI: 0.67-0.87), and Sweden (HR: 0.80, 95% CI: 0.73-0.88)., Conclusion: There was no observed increase in 5-year mortality risk with the use of roflumilast in Sweden or Norway. A small increase in 5-year mortality risk was observed in Germany and the US in the ever versus never comparison, likely due to residual confounding by indication., Competing Interests: Edeltraut Garbe has been chairwoman of the Department of Clinical Epidemiology at the Leibniz Institute for Prevention Research and Epidemiology – BIPS and in this function occasionally performed studies for pharmaceutical industries. The pharmaceutical companies included Byk-Gulden, Nycomed, Bayer, Celgene, GlaxoSmithKline, Mundipharma, Novartis, Sanofi-Aventis, Sanofi Pasteur MSD, and STADA. She has been a consultant to Bayer-Schering, Nycomed, GlaxoSmithKline, Schwabe, Teva, and Novartis, as well as to AstraZeneca (including this study). Per Arkhammar, Marie Carlholm, Eileen O Dareng, Harald Fjällbrant, and Stefan Franzén are employees and shareholders of AstraZeneca. Atul Kumar is an employee of AstraZeneca. Tore Persson is an AstraZeneca contractor and shareholder. Cecilia Hedlund is an AstraZeneca contractor. Gunnar Johansson has served on advisory boards arranged by AstraZeneca, Novartis, and Teva. Bianca Kollhorst, Wiebke Schäfer, and Tania Schink are working at an independent, non-profit research institute, the Leibniz Institute for Prevention Research and Epidemiology – BIPS. Unrelated to this study, BIPS occasionally conducts studies financed by the pharmaceutical industry. These are post-authorization safety studies (PASS) requested by health authorities and performed in line with the ENCePP Code of Conduct. Fabian Hoti, Muriel Lobier, Aaro Salosensaari, Xu Qiao, and Vasili Mushnikov are employed by IQVIA, a contract research organization that conducts studies financed by the pharmaceutical industry. Nicholas Sicignano and Kristian Svendsen confirm that there are no known conflicts of interest associated with this publication and there has been no significant financial support for this work that could have influenced its outcome. The authors report no other conflicts of interest in this work., (© 2024 Garbe et al.)

Background: An Infectious Disease vaccine specialist joined our institution's Cochlear Implant Team in 2010 in order to address the high percentage of non-compliance to immunization prior to surgery identified previously from an internal review. The purpose of this study was to (1) review the immunization status of cochlear implant recipients in 2010-2014, (2) assess if introducing a vaccine specialist made a significant change in vaccination compliance and (3) elucidate any barriers to vaccination compliance., Methods: Retrospective chart review and a telephone survey. Medical records of 116 cochlear implant recipients between 2010 and 2014 were reviewed. A telephone survey was conducted to obtain the current vaccination status in children who required post-operative vaccinations with incomplete records on chart review and, if applicable, the reason for non-compliance., Results: Between 2010 and 2014, 98% of children were up-to-date at the time of surgery, compared to 67% up-to-date at the time of surgery between 2002 and 2007. 27 children were included in our post-operative immunization analysis. 29.6% (8/27) failed to receive necessary vaccinations post-surgery. Pneumovax-23, a vaccine for high-risk patients (such as cochlear implant candidates) was missed in all cases., Conclusion: Pre-operative vaccination for cochlear implant recipients improved dramatically with the addition of a vaccine specialist. However, a significant proportion of patients requiring vaccinations post-surgery did not receive them. The main reason for non-compliance was due to parents being unaware that their children required this vaccine postoperatively by being "high-risk". Although improvement was demonstrated, a communication gap continued to impede the adequacy of vaccination uptake in pediatric cochlear implant recipients following surgery at age 2 when the high-risk vaccine was due.

Background: In order to most appropriately allocate healthcare and research funding for cancer, it is important to have accurate population-based incidence data. The Saudi Cancer Registry (SCR) provides such information, covering the time period from 1994 to the present day. The current report concerns an overview of cancer incidence statistics for Saudi Arabia in 2012. Methods: The SCR collects data from healthcare facilities throughout the Kingdom of Saudi Arabia. All newly diagnosed cases of cancer are recorded, with information on site and histology. For the present report, age-standardised and age-specific incidence rates (ASR, AIR, respectively) were calculated, with attention to gender-specific and regional differences. Results: The total number of incident cases of cancer identified by the SCR in 2012 was 14,336, with 6,791 (47.5%) among males and 7,545 (52.6%) among females. Of this total, 11,034 cases (76.9%) occurred in patients of Saudi origin. For Saudi males, the overall ASR (inc. all cancer sites) was 78.1 per 100,000 people, while that for females was 86.7. Incidence varied by region, with the Eastern region and Riyadh displaying the highest ASRs for both males and females, and Hail and Jazan displaying the lowest. Incidence varied by gender, with colorectal cancer (13.3%), non-Hodgkin lymphoma (NHL; 8.4%), and leukaemia (8.2%) being the most common types in males, and breast (25.8%), thyroid (11.7%), and colorectal cancers (9.3%) being the most common in females. Conclusions: This analysis of cancer incidence in Saudi Arabia demonstrated significant differences according to gender, age, and region of the Kingdom. The data should help ensure the most appropriate allocation of resources, with the aim of minimising the healthcare burden associated with cancer., (Creative Commons Attribution License)

Background: The risk of tuberculosis is increased in solid organ transplantation. Rates remain high in developed and developing countries. We developed protocols to better identify transplant recipients at risk of tuberculosis and initiate interventions to prevent tuberculosis., Objectives: Report tuberculosis incidence in solid-organ transplant recipients and the results of expanded isoniazid prophylaxis in deceased-donor renal transplantation., Design: Retrospective cohort study, comparing two time periods., Setting: Large transplantation center in a WHO-medium endemicity country for tuberculosis., Methods: In a cohort of all solid-organ transplant recipients performed between 2003 and 2012, tuberculosis-free transplantation follow-up is used for incidence calculation. Rates of tuberculosis in renal transplant recipients are compared before and after implementation of expanded isoniazid prophylaxis., Main Outcome Measure(s): Active tuberculosis post-transplantation., Results: Of 1966 solid-organ transplant recipients (kidney: 1391, liver: 426, heart: 114, lung: 35), 20 recipients (1.02%) developed tuberculosis. Twelve cases (60%) developed tuberculosis within one year of transplantation. The incidence was 248 cases per 100 000 transplant-years. The proportion of transplant recipients (incidence of tuberculosis per 100 000 transplant-years) for specific organs were kidney 0.58% (127), liver 1.88% (594), heart: 1.75% (570), and lung 5.71% (4750). In the survival analysis, lung transplant recipients had significantly higher rates of tuberculosis compared to recipients of kidneys from living donors (P=.0001) with a rate ratio of 45.3 (95% CI: 7-313). Mortality was 5% among tuberculosis patients. After implementing expanded isoniazid prophylaxis among deceased-donor kidney recipients, no tuberculosis occurred in 177 recipients, compared to 3 out of 155 (2%) recipients before implementation., Conclusions: Rates of tuberculosis among our solid transplant recipients are decreasing. Universal iso-niazid prophylaxis in transplant recipients could reduce transplant-associated tuberculosis in endemic areas., Limitations: Donor data on tuberculosis exposure and prevention and tuberculosis prevention efforts before referral to our center are not available for all patients.