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Background Peramivir is an intravenously administered neuraminidase inhibitor for influenza. The clinical efficacy of peramivir remains unclear because it is used in a limited number of countries. We compared the clinical efficacy of peramivir with that of oseltamivir in influenza patients during the 2012-2013 season. Methods Thirty-two influenza patients who were hospitalized at Teikyo University Hospital, a teaching hospital in Tokyo, Japan, from October 2012 to March 2013 were enrolled. Among them, 23 and 9 were treated with peramivir and oseltamivir, respectively. The end points of this study were the time to defervescence and survival rate. Results There were no significant differences in the clinical backgrounds of the two groups. However, patients treated with peramivir tended to have a higher incidence of consciousness disturbance [34.8% (8/23) vs 0.00% (0/9), P = 0.064]. There were no significant differences between the peramivir and oseltamivir groups with respect to the time to defervescence (30.9 ± 18.7 h vs 34.7 ± 18.6 h) or survival rate [95.7% (22/23) vs 100% (9/9), respectively]. Conclusions The clinical efficacy of peramivir is non-inferior to that of oseltamivir, although peramivir tended to be used in patients with serious complications. Intravenous administration of peramivir may be useful for patients with serious complications, such as consciousness disturbances. [ABSTRACT FROM AUTHOR]

A survey on adult community-acquired pneumonia was conducted jointly by multiple centers nationwide to verify the Japanese Respiratory Society Guidelines for the Management of Community-Acquired Pneumonia in Adults (JRS2005). The efficacy and safety of piperacillin (PIPC) were investigated at the same time. PIPC is recommended as the initial treatment for patients with suspected bacterial pneumonia and pneumococcal pneumonia in JRS2005. Overall, 552 and 333 patients were registered for safety and efficacy analysis in this study, respectively. The majority of the cases in which PIPC was used had moderate disease (63.7 %), and the most common daily dosage was 4 g (73.6 %). The efficacy rate was 83.5 % overall, 81.1 % in patients with suspected bacterial pneumonia, and 92.8 % in patients with pneumococcal pneumonia. The efficacy rate with a daily dosage of 4 g was 84.9 %, and the efficacy rates achieved with a daily dosage of 4 g in patients who had mild and moderate suspected bacterial pneumonia were 90.0 and 82.6 %, respectively. The most commonly isolated causative organisms were Streptococcus pneumoniae ( S. pneumoniae) and Haemophilus influenzae ( H. influenzae), and the bacterial eradication rates were high (97.2 and 100 %, respectively). The incidence of adverse drug reactions was 5.62 %, among which the main events were hepatic dysfunction and decreased white blood cell count. In conclusion, this study showed that PIPC is safe and effective at 4 g/day for mild-to-moderate adult community-acquired pneumonia. [ABSTRACT FROM AUTHOR]

Objectives It is known that the efficacy of azithromycin, in animal infection models, is best correlated with AUC/MIC. The pharmacokinetic–pharmacodynamic (PK–PD) relationship for azithromycin, however, has not been previously confirmed with clinical data. The objectives of this PK–PD analysis were to characterize exposure–response relationships for the efficacy and safety of azithromycin extended release (ER) in Japanese patients, and to evaluate the effects of potential covariates on the prediction of response. Methods Sparse serum azithromycin concentration, MIC, efficacy and safety data were collected from three Japanese Phase 3 studies of a 2 g single dose of azithromycin-ER for respiratory tract infections. These sparse concentration data were combined with data from eight Phase 1 PK studies in Japanese and Western populations, to develop a robust population PK model using a non-linear mixed effects approach. The exposure–response relationships for efficacy and safety were evaluated using logistic regression. Results A two-compartment model with first-order absorption and first-order elimination with a lag time adequately described the PK of azithromycin-ER, without any significant ethnic differences in AUC. The percentage of bacteriological and clinical success in patients with AUC/MIC > 5 (95.8% and 100%, respectively) was much higher than in those with AUC/MIC ≤ 5 (60.0% and 83.3%, respectively). Conclusions As expected, the probabilities of success in the clinical and bacteriological responses were positively associated with AUC/MIC, but not with AUC. For the exposure–safety relationship, the incidence of treatment-related diarrhoea was inversely associated with azithromycin exposure. [ABSTRACT FROM PUBLISHER]

The immune checkpoint inhibitor nivolumab inhibits the programmed death 1 receptor and suppresses the immune resistance of cancer cells. This is a long-term follow up of a single-arm, open-label, multicenter, phase II study of nivolumab in untreated Japanese patients with stage III/IV or recurrent melanoma. In addition, a post-hoc subgroup analysis stratified by melanoma types was performed. Nivolumab was administered intravenously at a dose of 3 mg/kg every 2 weeks. The primary endpoint was the overall response rate (ORR), and secondary endpoints included overall survival (OS), progression-free survival (PFS), best overall response, the disease control rate and change in tumor diameter. Safety was assessed by recording treatment-related adverse events (TRAE), including select immune-related adverse events. Of the 24 patients initially included in the primary phase II study, 10 survived for over 3 years (41.7%). The ORR was 34.8% (90% confidence interval [CI]: 20.8, 51.9) for all patients. When analyzing by melanoma type, the ORR was 66.7% (90% CI: 34.7, 88.3) for superficial spreading, 33.3% (90% CI: 11.7, 65.3) for mucosal, and 28.6% (90% CI: 10.0, 59.1) for acral lentiginous tumors. The median OS was 32.9 months, the 3-year OS rate was 43.5%, and the 3-year PFS rate was 17.2%. A long-term response was observed in all the tumor types. The most common TRAE included skin toxicity (45.8%) and endocrine disorders (29.2%). This study demonstrated the long-term efficacy and tolerability of nivolumab in patients with advanced or recurrent melanoma, irrespective of melanoma type., (© 2019 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.)

Background: Cedarcure ® for sublingual immunotherapy of cedar pollinosis was purchased in 2018. We studied clinical efficacy of Cedarcure ® in the first year., Methods: We compared 69 patients treated with Cedarcure ® (age, 18.0±13.5 years; male-to-female ratio, 40;29) and a control group of 97 patients treated with Cedartolen ® (age, 29.8±16.2 years; male-to-female ratio, 44;53) during the peak season of large amount of pollen dispersal (10933 grains/cm2/season) in 2019. The clinical efficacy was evaluated by assessing symptom scores by Japanese rhino-conjunctivitis quality of life questionnaire and visual analog scale (VAS)., Results: All the assessments except nasal congestion were slightly better in Cedarcure ® group, but they were not significant. There was no difference of concomitant medication in both groups. Because insurance coverage of Cedartolen ® is for patients over 12 years old in Japan, the efficacy in Cedarcure ® group enhanced better in all assessments if comparing the patients of over 12 years old. Percentage of adverse events was even in both over and under 12 years old., Conclusion: Cedarcure ® was treated in safe, and reduced symptoms as well as Cedartolen ® .

We performed a postmarketing surveillance study to determine the efficacy and safety of the oral quinolone antibacterial agent garenoxacin (Geninax(®) Tablets 200 mg) against atypical pneumonia. Between October 2009 and July 2011, patients with community-acquired pneumonia visited 26 facilities in Japan; we collected survey forms from 105 of these patients who were suspected of having atypical pneumonia based on the Japanese Respiratory Society Guidelines for the Management of Community-Acquired Pneumonia in Adults. We examined the safety in 105 patients and the efficacy in 71 patients. 1. The efficacy rates among patients suspected of having atypical pneumonia and those with a confirmed diagnosis of atypical pneumonia were 94.8% (55/58 patients) and 92.3% (12/13 patients), respectively. The efficacy rate was 4/4 for patients in whom Chlamydophila pneumoniae was detected (including 1 patient with a polymicrobial infection with another bacterial strain) and 90% (9/10 patients) for patients in whom Mycoplasma pneumoniae was detected (garenoxacin was ineffective in 1 of 2 patients with a polymicrobial infection with another bacterial strain). 2. The incidence of adverse drug reactions (including abnormal laboratory tests) was 4.8% (5/105 patients). Among the adverse drug reactions, gastrointestinal disorders, infection and infestation, nervous system disorder, and skin and subcutaneous tissue disorder were observed in 2.9% of patients (3/105), 1.0% (1/105), 1.0% (1/105), and 1.0% (1/105), respectively. In conclusion, garenoxacin showed an efficacy rate of greater than 90% for suspected atypical pneumonia and confirmed atypical pneumonia. Garenoxacin is considered to be useful in daily practice., (Copyright © 2014 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)

We performed a postmarketing surveillance study to determine the efficacy and safety of the oral quinolone antibacterial agent, garenoxacin (Geninax(®) Tablets 200 mg), against bacterial pneumonia. Between October 2009 and March 2011, patients with community-acquired pneumonia visited 174 facilities in Japan; we collected survey forms from 739 patients of these patients who were suspected with bacterial pneumonia on the basis of factors, e.g., the presence of purulent sputum or suspected presence of bacterial pathogens in clinical specimens. We examined the safety in 730 patients and the efficacy in 535 patients. The efficacy rate of garenoxacin for bacterial pneumonia was 92.8% (479/516 patients). The eradication rates for Streptococcus pneumoniae and Haemophilus influenzae, the major pathogens of bacterial pneumonia, were 98.5% (65/66 strains) and 100% (65/65 strains), respectively. The incidence of adverse drug reactions (including abnormal laboratory tests) was 7.9% (58/730 patients). Among the main adverse drug reactions, abnormal laboratory tests were observed in 2.1% patients (15/730), hepatobiliary disorders were observed in 1.8% patients (13/730), and skin and subcutaneous tissue disorders were observed in 1.6% patients (12/730). In conclusion, garenoxacin showed an efficacy rate of greater than 90% for bacterial pneumonia and is considered to be useful in daily practice., (Copyright © 2014 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)