Search

Background: Acute otitis media (AOM) remains a common infection in children despite the introduction of pneumococcal conjugate vaccines. This study estimated AOM incidence rates (IRs) over time in children < 16 years old in Germany following PCV13 introduction.Methods: AOM episodes were identified in the InGef healthcare claims database from 2014-2019 in children aged < 16 years. Each AOM episode was classified as either simple or recurrent. Recurrent AOM was defined as 3 or more episodes identified within a 6-month period; or 4 or more episodes within a 12-month period with at least one episode in the prior 6 months. AOM-related surgical procedures within 12 months and complications within 21 days of an AOM episode were also identified. Annual IRs were calculated as number of episodes/child-years (CY) at risk. 95% Confidence intervals (95%CI) were calculated using the Wilson method. The Mann-Kendall test was used to assess trends over time.Results: Between 2014 and 2019, the study population comprised 916,805 children with 327,726 AOM episodes, of which 15% (49,011) of all episodes were identified as recurrent AOM and 85% (278,715) as simple AOM. There were significant declines in AOM (p = 0.003) in the study population overall and in all age groups over the study period; from 101 (95%CI 101-102)/1000 CY to 79 (95%CI 78-80)/1000 CY in the total study population, from 209 (95%CI 206-212)/1000 CY to 147 (95%CI 145-150)/1000 CY in < 2-year-olds, from 239 (95%CI 237-242) to 179 (95%CI 177-182)/1000 CY in 2-4-year-olds, and from 50 (95%CI 49-50) to 38 (95%CI 37-39)/1000 CY in 5-15-year-olds. No significant trends were identified for AOM-related surgical procedures over the study period; however, AOM-related complications overall increased (p = 0.003).Conclusion: Between 2014 and 2019, AOM incidence overall declined in children aged 0-15 years in Germany. Over the study period, the incidence of complicated AOM cases increased, however the incidence of AOM-related surgical procedures remained constant. Despite the impact of PCV13, the burden associated with AOM in Germany remains substantial. [ABSTRACT FROM AUTHOR]

Aims: V114, a 15-valent pneumococcal conjugate vaccine (PCV15) currently approved in adults in the US, contains the 13 S. pneumoniae serotypes in PCV13 and two additional serotypes, 22 F and 33 F, which are important contributors to residual PD. This study quantified the health and economic burden of pediatric invasive pneumococcal disease (IPD) associated with V114 serotypes in eight countries in Europe. Materials and methods: A Markov model estimated V114-type IPD cases and costs in hypothetical unvaccinated birth cohorts from Denmark, France, Germany, Italy, Norway, Spain, Switzerland, and the UK over 20 years. Inputs were obtained from published literature. IPD cases and costs were calculated for three time periods using time-specific epidemiological data: (a) pre-PCV7; (b) pre-PCV13; and (c) post-PCV13. Costs were estimated from a societal perspective (2018 Euros) and discounted at 3%. Results: The model estimated that 4,649 IPD cases in the pre-PCV7 period, 3,248 cases in the pre-PCV13 period, and 958 cases in the post-PCV13 period were attributable to V114 serotypes. Total discounted costs associated with V114 serotypes were e109.1 million (pre-PCV7 period), e65.7 million (pre-PCV13 period), and e18.7 million (post-PCV13 period). Limitations: Post-meningitis sequelae, acute otitis media, and non-bacteremic pneumonia were not considered. Direct non-medical costs were not included. Conclusions on effectiveness of V114 or added value over existing infant vaccination programs cannot be drawn. Conclusions: IPD cases and costs were estimated in hypothetical birth cohorts in eight European countries followed for 20 years during three time periods. Serotypes included in V114 were associated with significant morbidity and costs in pre-PCV7, pre-PCV13, and post-PCV13 periods. Future pediatric pneumococcal vaccines should maintain protection against serotypes in licensed vaccines while extending coverage to additional serotypes to ensure reductions in IPD burden are maintained. [ABSTRACT FROM AUTHOR]

Although the incidence of invasive pneumococcal disease (IPD) and acute otitis media (AOM) in young children has decreased since the introduction of pneumococcal conjugate vaccines (PCVs), the subsequent emergence of non-vaccine Streptococcus pneumoniae serotypes and the persistence of certain vaccine serotypes both contribute to substantial residual pneumococcal disease. There is a need for the development of new pneumococcal vaccines to address the clinical and economic burden presented by emerging non-vaccine serotypes, while maintaining suppression of serotypes in existing vaccines. To assess the full value of next-generation vaccines, public health evaluations must consider epidemiological and economic data across all vaccine serotypes, including those included in existing vaccines and those unique to the new product. This is supported by two recent analyses that estimated the health and economic burden of IPD (in the United States and Europe) and AOM (in the United States only) associated with the serotypes in V114, a 15-valent pneumococcal conjugate vaccine (PCV15), which contains all serotypes in the licensed 13-valent pneumococcal conjugate vaccine (PCV13) as well as the unique serotypes 22 F and 33 F and was recently approved for use in adults in the US. The analyses demonstrated considerable health and economic burden associated with PCV13 serotypes, as well as increasing burden associated with serotypes 22 F and 33 F. In addition to addressing the burden of non-vaccine serotypes, ability to maintain or improve protection against disease caused by serotypes in existing vaccines will be an important consideration for decision makers. [ABSTRACT FROM AUTHOR]

Objective: The comparative effectiveness of low-dose budesonide inhalation suspension (BIS) versus oral montelukast (MON) in managing asthma control among children with mild asthma was assessed in Korea. Methods: Claims from Korea's national health insurance database for children (2–17 years) with mild asthma (GINA 1 or 2) who initiated BIS or MON during 2015 were retrospectively analyzed. Pre- and post-index windows were 1 year each. Adherence, persistency, asthma control, asthma-related health-care resource utilization, and costs were evaluated using unadjusted descriptive statistics and propensity score-matched regression analyses. Results: The number of children identified was 26,052 for unmatched (n = 1,221 BIS; n = 24,831 MON) and 2,290 for matched populations (n = 1,145 per cohort). Medication adherence, measured by proportion of days covered, was low for both cohorts but significantly higher for MON versus BIS (13.8% vs. 4.5%; p <.001). Time to loss of persistency was longer for MON versus BIS (82.3 vs. 78.4 days, respectively; p <.001). Mean number of post-index asthma-related office visits was 6.6 for BIS versus 8.3 for MON (p <.001). However, a greater proportion of patients in the BIS cohort had an asthma exacerbation-related office visit than the MON cohort (78.3% vs. 56.1%; p <.001). Asthma-related total health-care costs were higher with MON versus BIS (₩ 190,185 vs. ₩ 167,432, respectively; p <.001), likely driven by higher pharmaceutical costs associated with MON (₩ 69,113 vs. ₩ 49,225; p <.001). Conclusions: Montelukast patients had better adherence, a longer time to loss of persistency, and were less likely to experience an exacerbation-related office visit in the post-index period than BIS patients. [ABSTRACT FROM AUTHOR]

Objectives The 23-valent pneumococcal polysaccharide vaccine (PPSV23) was included in Japan's national immunisation programme for older adults in 2014. While vaccination coverage has increased following the implementation of the national immunisation programme, little is known about the factors that have influenced changes in PPSV23 uptake in Japan. This study aimed to investigate the effects of municipality-level activities implemented to improve vaccine uptake during the fiscal year 2015 (April 2015-March 2016). Design Community-based national survey. A postal and web-based nationwide survey was sent to all municipalities in Japan in June 2016 (n=1741). The survey included questions regarding PPSV23 coverage, out-of-pocket costs by individuals for vaccination and community-level activities implemented to improve and promote PPSV23 uptake. Municipality-level and prefecture-level variables (eg, unemployment rates, average per capita income) retrieved from published sources were also incorporated to explore the impact of social determinants on vaccine uptake. Setting Japan. Participants Municipal vaccination officers. Primary and secondary outcome measures The primary study outcome was PPSV23 coverage among adults aged 65 years in Japanese municipalities. Results A total of 1010 municipalities (58.0%) responded to the survey. The median PPSV23 coverage among responding municipalities was 41.8%. Vaccine coverage increased by 18.7% (16.7%-20.7%)%) in municipalities that sent a direct mail notification to the target population of adults compared with municipalities that did not send any notification. Vaccine coverage decreased by 3.02% (2.4%-3.6%)%) for every 1000 JPY increase in out-ofpocket costs. Municipality-level unemployment rates and average per capita income were negatively associated with PPSV23 coverage. Conclusions This nationwide survey provides insight into factors that may influence PPSV23 coverage in Japanese municipalities. Reduced out-of-pocket costs and direct mail notifications to the target population were associated with higher PPSV23 coverage in Japanese municipalities. [ABSTRACT FROM AUTHOR]

Objectives To quantify the risk of pneumococcal pneumonia (PP) and invasive pneumococcal disease (IPD) in adults aged =19 years with underlying medical conditions compared with healthy adults of the same age in Japan. Design An observational, retrospective, cohort study using two healthcare claims databases in Japan: Japan Medical Data Center (JMDC) and Medical Data Vision (MDV) databases. Participants A total of 10.4 million individuals, representing 9.3 million person-years of follow-up, were included in the analysis. Eleven medical conditions as well as PP and IPD were identified by the International Statistical Classification of Diseases and Related Health Problems version 10 diagnostic codes and/or local disease codes used in Japan. Primary outcome measures Adjusted rate ratios (RRs) for PP and IPD in adults with a medical condition versus adults without any medical condition were calculated using multivariate Poisson regression models with age and/or sex as covariates. Results In the JMDC and MDV databases, respectively, adults =19 years with a medical condition (RRs for PP: 3.3 to 13.4, 1.7 to 5.2; RRs for IPD: 12.6 to 43.3, 4.4 to 7.1), adults with two or more medical conditions (PP: 11.6, 2.8; IPD: 18.7, 5.8) and high-risk adults (PP: 12.9, 1.8; IPD: 29.7, 4.0) were at greater risk of PP and IPD compared with their healthy counterparts. Adults aged 50-64 years with an underlying medical condition (PP rate: 38.6 to 212.1 per 100 000 person-years) had a higher rate of PP than those aged =65 years without any condition (PP rate: 13.2 to 93.0 per 100 000 person-years). Conclusions Adults of all ages with an underlying medical condition are at greater risk of PP and IPD compared with adults without any medical condition. This risk increases with the number of underlying medical conditions. Our results support extending pneumococcal vaccination to younger adults with an underlying medical condition, especially those aged 50-64 years. [ABSTRACT FROM AUTHOR]

Objective: Orally disintegrating tablets (ODTs) offer a valuable treatment option, particularly when swallowing solid tablets with water is difficult or inconvenient. Montelukast is an effective treatment for asthma and allergic rhinitis (AR), and an ODT formulation became available in Japan in 2015. This study investigated levels of satisfaction with this new formulation among adults with asthma and/or AR in Japan.Methods: Patients aged 20 years or older who were refilling a prescription for montelukast ODT in pharmacies across Japan completed questions on satisfaction with key features of montelukast ODT and the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9). Study variables were analyzed descriptively. Factors associated with TSQM-9 global satisfaction and convenience domain scores were examined using analysis of covariance.Results: Of the 201 patients who participated, 89.6% reported overall satisfaction with montelukast ODT. Overall satisfaction was highest in patients with AR only (94.7% satisfied) or with asthma and AR (90.2% satisfied), and in patients with treatment duration <4 weeks (98.5% satisfied). Mean TSQM-9 global satisfaction and convenience domain scores were 58.9 and 66.7, respectively; scores were higher for patients with both asthma and AR and for those with longer disease duration. Overall ease of taking and dissolving speed were most closely associated with TSQM-9 global satisfaction scores, and ability to take without water and taste were most closely associated with TSQM-9 convenience scores.Limitations: The generalizability of the findings was limited by the convenience sample and the descriptive, single-arm study design. The study was limited to adults with asthma and/or AR.Conclusion: Montelukast ODT may be an acceptable dosage formulation for adults with mild-to-moderate asthma and/or AR in Japan. Satisfaction was high, particularly with respect to tablet size, dissolving speed, taste, and ease of taking. [ABSTRACT FROM AUTHOR]