Details of a Researcher - HINOTSU Shiro

Papers - HINOTSU Shiro

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Approaches to the evaluation of safety warnings using claim database

KOYAMA Toshihiro, HINOTSU Shiro, OSHIMA Ayako, ZAMAMI Yoshito, SHIRAISHI Naoko, TATEBE Yasuhisa, SHINOMIYA Kazuaki, KANO Mitsunobu

Annual Meeting of the Japanese Society of Toxicology ( The Japanese Society of Toxicology ) 42 ( 0 ) S2 - 5 2015 [Refereed]

現在、医療に関わる大規模情報の利活用は、医薬品を安全に使用するために今後ますます重要性が高まるとされている。厚生労働省やPMDAはより効果的な安全性対策のため、さまざまな医療情報データベース構築事業を実施し、試行期間の終了とともに、順次、公益性の高い研究課題への利活用の推進に移行しつつある。これらの大規模医療情報は疫学的手法と情報技術によって抽出・解析され、医薬品等の安全対策とその効果検証や、医療の質向上にも広く役立てられつつある。また、我が国の課題解決のため、厚生労働科学研究の戦略研究においては、これまでの大規模介入研究とは異なる「健康医療分野における大規模データの分析及び基盤整備に関する研究」課題が採択され、国民や行政の大規模医療データの利活用に対する期待を映している。
現在、我々は健保組合の提供する診療報明細書情報を用いて、医療安全対策の効果について解析を行っており、その1例を紹介する。
炭酸リチウムは躁病や躁状態の治療に用いられるが、リチウムの血中濃度上昇によってリチウム中毒を引き起こすことが知られている。そのため、定期的なリチウム血中濃度の測定が求められている。しかし、PMDAが2005～2010年のレセプトデータをもとに調査した結果、炭酸リチウムの処方を受けた患者のうち、1度もリチウムの血中濃度測定を実施していない患者の割合が52 %である可能性が示された。この結果を受け、PMDAは2012年9月に炭酸リチウムの血中濃度測定遵守について通知を発出した。しかし、臨床で炭酸リチウムの適正使用が客観的に改善したのかは検証されていない。
そこで、本研究では、安全性対策が実施された効果について、炭酸リチウムの血中濃度測定実施割合を１つの指標として、安全対策前後での変化を明らかにすることにより、今後のさらに効果的な安全性対策に資するエビデンスを発信することを目的としている。

DOI CiNii

A systematic review and meta-analysis on the safety and efficacy of different strains of Mycobacterium bovis bacillus Calmette-Guérin for non-muscle invasive bladder cancer in Japan and US

Shiro Hinotsu, Naoyuki Kamatani, Timothy L Ratliff, Hideyuki Akaza

European Journal of Oncology Pharmacy ( Pharma Publishing and Media Europe ) 8 ( 4 ) 8 - 18 2015

Objective: To compare efficacy and safety of different strains of Mycobacterium bovis bacillus Calmette-Guérin (BCG) used in Japan and the US as intravesical therapeutics for non-muscle invasive bladder cancer. Materials and methods: Papers for review were selected from PubMed and Igakuchuozasshi databases, and meta-analysis was performed using the data obtained. Results: 352 papers from Japanese hospitals and 333 papers from US hospitals were reviewed. Strains used in Japan were Immunobladder®> (Tokyo 172) and ImmuCyst® (Connaught (JP)), while those used in the US were TICE® (TICE) and TheraCys® (Connaught (US)). CR (complete remission) rates for patients with CIS (carcinoma in situ) were 0.824 (n = 380, 95% CI 0.782–0.861), 0.868 (n = 38, 95% CI 0.719–0.956), 0.714 (n = 35, 95% CI 0.537–0.854) and 0.574 (n = 385, 95% CI 0.523–0.624) for Tokyo 172, Connaught (JP), TICE and Connaught (US), respectively. Non- recurrence survival (NRS) rates for non-CIS patients were 0.754 (n = 429, 95% CI 0.714–0.794), 0.790 (n = 83, 95% CI 0.702–0.878), 0.673 (n = 250, 95% CI 0.615–0.731) and 0.598 (n = 255, 95% CI 0.538–0.658) for Tokyo 172, Connaught (JP), TICE and Connaught (US), respectively. Conclusion: No significant differences were observed neither in efficacy nor in safety between two strains of BCG used Japan and the US. However, the rates of CR and NRS may be higher in Japan than the US, and the rates of severe adverse events may be higher in Japan than the US, although the data were not from controlled studies.

Long-term Survival of Extremely Advanced Prostate Cancer Patients Diagnosed with Prostate-specific Antigen over 500 ng/ml

Toru Sugihara, Changhong Yu, Michael W. Kattan, Hideo Yasunaga, Hiroyuki Ihara, Mizuki Onozawa, Shiro Hinotsu, Hideyuki Akaza

JAPANESE JOURNAL OF CLINICAL ONCOLOGY ( OXFORD UNIV PRESS ) 44 ( 12 ) 1227 - 1232 2014.12 [Refereed]

To investigate survival of hormone-na < ve prostate cancer patients diagnosed with prostate-specific antigen a parts per thousand yen500 ng/ml, stratified according to the prostate-specific antigen level and type of therapy. Data of prostate cancer patients with prostate-specific antigen a parts per thousand yen500 ng/ml diagnosed between 2001 and 2003 and receiving primary androgen deprivation therapy were extracted from the Japan Study Group of Prostate Cancer database. Cancer-specific survival and overall survival were assessed according to the prostate-specific antigen level (500-999, 1000-4999 and a parts per thousand yen5000 ng/ml) and type of therapy using Kaplan-Meier analyses and multivariate Cox proportional hazards models including age, Gleason score, oncological stage and comorbidity. The median follow-up was 27 months (interquartile range, 13-51) and a total of 1961 patients were included. Five-year cancer-specific and overall mortalities were 39.0 and 33.0%, respectively. There was a significant inverse relationship between overall survival and prostate-specific antigen magnitude among combination therapy patients, but not monotherapy patients (log-rank test, P = 0.034 and 0.558, respectively). The median overall survival in combination therapy patients with low-, intermediate- and high prostate-specific antigen and monotherapy patients with any prostate-specific antigen were 79, 59, 45 and 43 months, respectively. Multivariate analysis showed that combination therapy in patients with low- and intermediate prostate-specific antigen was significantly associated with a favorable overall survival compared with monotherapy (hazard ratios 0.66 and 0.75, respectively, both P < 0.001). Similar results were obtained for cancer-specific survival. There are major survival differences in extremely high prostate-specific antigen cases according to the prostate-specific antigen level and hormone therapy type and those patients would benefit notably from combination androgen blockade.

DOI PubMed

Recent Trends in the Initial Therapy for Newly Diagnosed Prostate Cancer in Japan

Mizuki Onozawa, Shiro Hinotsu, Taiji Tsukamoto, Mototsugu Oya, Osamu Ogawa, Tadaichi Kitamura, Kazuhiro Suzuki, Seiji Naito, Mikio Namiki, Kazuo Nishimura, Yoshihiko Hirao, Hideyuki Akaza

JAPANESE JOURNAL OF CLINICAL ONCOLOGY ( OXFORD UNIV PRESS ) 44 ( 10 ) 969 - 981 2014.10 [Refereed]

Objective: The objective of the present study was to investigate the trends over time in the initial treatment of prostate cancer in Japan. Methods: A total of 8291 patients with newly diagnosed prostate cancer whose treatment started in 2010 were registered in a multi-institutional observational study undertaken nationwide across Japan by the Japan Prostate Cancer Study Group. Each patient's background characteristics and initial treatment were recorded. Results: The median age at diagnosis was 71 years. The proportion of T1c disease was 40.5% and that of M1 disease was 10.4%. The prostate-specific antigen level was <10 ng/ml in 52.0% of the patients. High-, intermediate-and low-risk patients as determined by D'Amico's classification system made up 19.3, 29.8 and 25.9% of the cases, respectively. The initial treatment was androgen depletion therapy in 40.2%, radical prostatectomy in 32.0% (17.3% of these involved laparoscopic prostatectomy), radiation in 21.0% (46.4% of these involved brachytherapy). In cases of organ-confined disease, radical prostatectomy was selected in 39.5%, androgen depletion therapy in 28.0% and radiation in 23.9%. In D'Amico's low-risk group, the proportion treated with radiation was nearly equal to that treated with radical prostatectomy (30.2 and 32.7%, respectively); 73.2% of the radiation treatments involved brachytherapy. Conclusion: Compared with previous Japanese studies, radiation use was increased by similar to 10%. This increased proportion of radiation use was a typical trend in initial therapy for newly diagnosed prostate cancer cases in Japan. Although androgen depletion therapy use was decreased, it was selected in a high proportion of the patients irrespective of the disease stage.

DOI PubMed

Antiemetic efficacy and safety of a combination of palonosetron, aprepitant, and dexamethasone in patients with testicular germ cell tumor receiving 5-day cisplatin-based combination chemotherapy

Shota Hamada, Shiro Hinotsu, Koji Kawai, Shigeyuki Yamada, Shintaro Narita, Tomomi Kamba, Hiroyuki Nishiyama, Yoichi Arai, Tomonori Habuchi, Osamu Ogawa, Koji Kawakami

SUPPORTIVE CARE IN CANCER ( SPRINGER ) 22 ( 8 ) 2161 - 2166 2014.08 [Refereed]

This study aimed to determine the antiemetic efficacy and safety of a combination of palonosetron, aprepitant, and dexamethasone in patients with testicular germ cell tumor (TGCT) receiving 5-day cisplatin-based combination chemotherapy. An open-label, single-arm, multicenter study was performed in patients with TGCT who were scheduled to receive 5-day cisplatin-based combination chemotherapy. The antiemetic therapy consisted of palonosetron 0.75 mg on day 1, aprepitant 125 mg on day 1 and 80 mg on days 2 to 5, and dexamethasone 9.9 mg on day 1 and 6.6 mg on days 2 to 8. The primary endpoint was complete response (CR) rate, which was defined as no vomiting and no rescue medication, in the overall period (0 to 216 h) in the first chemotherapy course. Incidence and severity of nausea were assessed based on the Common Terminology Criteria for Adverse Events (CTCAE) and a subjective rating scale completed by patients. Thirty patients were included in the analysis. CR was achieved in 90.0 % of the patients in the first chemotherapy course, and high CR rates were also observed in the second and third courses (82.1 and 78.3 %, respectively). The incidence of nausea peaked on days 4 to 6 in about 50 % of the patients. The reported adverse drug reactions were hiccups (13.3 %), anorexia (3.3 %), and stomach pain (3.3 %). None of these were unexpected and none were grade 3 or 4. The combination antiemetic therapy examined in this study was highly effective and well-tolerated in patients with TGCT receiving 5-day cisplatin-based combination chemotherapy.

DOI PubMed

Age at diagnosis on prostate cancer survival undergoing androgen deprivation therapy as primary treatment in daily practice: results from Japanese observational cohort

Teruo Inamoto, Haruhito Azuma, Shiro Hinotsu, Taiji Tsukamoto, Mototsugu Oya, Osamu Ogawa, Tadaichi Kitamura, Suzuki Kazuhiro, Seiji Naito, Mikio Namiki, Kazuo Nishimura, Yoshihiko Hirao, Michiyuki Usami, Masaru Murai, Hideyuki Akaza

JOURNAL OF CANCER RESEARCH AND CLINICAL ONCOLOGY ( SPRINGER ) 140 ( 7 ) 1197 - 1204 2014.07 [Refereed]

Primary androgen deprivation therapy (PADT) had been used extensively in Japan than in the USA and European countries regardless of the disease risk or patient's age. To illustrate the consequence of PADT from daily clinical practice, we evaluated the relationship among age, disease risk, and survival of patients with prostate cancer treated by PADT in largest Asian cohort. The 19,246 men subjected to PADT enrolled in the Japan Study Group of Prostate Cancer were enrolled for the present analysis. Patients were divided into four groups based on age at diagnosis: age < 66, 66-70, 71-75, and > 75. Risk was stratified according to the Japan Cancer of the Prostate Risk Assessment (J-CAPRA). Multivariate competing risks regression analysis was performed for OS and PFS. There was downward stage migration over age. Among men aged > 75 years, 34.1 % had nodal or distant metastatic disease. In contrast, 56.0 % of patients aged < 66 years presented with advanced disease. The modality of hormonal therapy varied with age across risk groups; the younger age group showed a higher proportion of maximal androgen blockade, while the proportion of monotherapy use was higher in older men. The likelihood of low-risk disease by J-CAPRA classification increased significantly with increasing age (p < 0.0001 by Pearson's chi-square test). The same as OS, the PFS rate increased with age until after the age of 75. Men aged 71-75 had better survival rates even after adjustments for treatment modality alone, or for treatment modality plus disease risk. Age cohorts do affect orientation toward favorable disease course after PADT with men aged 71-75 being benefiting more from PADT than other age groups.

DOI PubMed

Bilateral Wilms Tumors Treated According to the Japan Wilms Tumor Study Group Protocol

Takaharu Oue, Tsugumichi Koshinaga, Hajime Okita, Yasuhiko Kaneko, Shiro Hinotsu, Masahiro Fukuzawa

PEDIATRIC BLOOD & CANCER ( WILEY-BLACKWELL ) 61 ( 7 ) 1184 - 1189 2014.07 [Refereed]

Background Children with diffuse intrinsic pontine glioma (DIPG) continue to have poor outcomes, and radiotherapy (RT) is the only temporarily effective treatment. In this retrospective analysis, we studied the effect of time from diagnosis to start of RT on event-free survival (EFS) and overall survival (OS) in children with DIPG. Methods Records of children (n = 95) with DIPG treated with RT at a single institution between April 1999 and September 2009 were analyzed. RT was delivered at doses of 54.0-55.8 Gy at 1.8 Gy per fraction, and children were followed prospectively. The effect of gender, race, interruption during treatment course, age at diagnosis, duration of symptoms prior to diagnosis, use of protocol-based chemotherapy, and time from diagnosis to initiation of RT on EFS and OS was assessed by the Cox proportional hazards model. Results Time as a continuous variable from diagnosis to start of RT did not affect outcome. Time dichotomized to <= 14 days significantly affected OS (hazard ratio [HR] = 1.70, P = 0.014) and race other than white or black affected EFS (HR = 2.32, P = 0.017). The 95 patients had a 6-month EFS and OS of 60 +/- 5% and 94.7 +/- 2.3%, respectively, and a 12-month EFS and OS of 11.6 +/- 3.1% and 49.5 +/- 5%, respectively. Conclusions Time as a continuous variable did not affect OS or EFS in our cohort; however, children treated within 2 weeks of diagnosis had poor outcomes. Although rapid initiation of RT is desirable, our findings do not support intensive efforts aimed at shortening delays from diagnosis to start of RT. Pediatr Blood Cancer 2014;61:1180-1183. (c) 2014 Wiley Periodicals, Inc.

DOI PubMed

Prognostic impact of young age on stage IV prostate cancer treated with primary androgen deprivation therapy

Tomokazu Kimura, Mizuki Onozawa, Jun Miyazaki, Taeko Matsuoka, Akira Joraku, Koji Kawai, Hiroyuki Nishiyama, Shiro Hinotsu, Hideyuki Akaza

INTERNATIONAL JOURNAL OF UROLOGY ( WILEY-BLACKWELL ) 21 ( 6 ) 578 - 583 2014.06 [Refereed]

Objectives To elucidate whether the disease characteristics and prognosis of stageIV prostate cancer treated with primary androgen deprivation therapy differ between young and elderly patients. Methods A total of 3006 patients identified from the database of the Japan Study Group of Prostate Cancer were included in the analysis according to the following entry criteria: age of 75 years or less and stageIV disease. These patients were stratified into three groups: young (aged 55 years); middle-aged (aged 56 and 65 years); and elderly (aged 66 and 75 years). Their prognoses were analyzed both within age groups and according to whether or not there was metastasis. Results The proportion of lymph node metastasis was significantly higher in the young group than in the elderly group (P=0.007), and there were no significant differences in other factors among age groups. The overall survival rate at 5 years in the young group was significantly worse than that in the middle-aged and elderly groups (26.6%, 59.7% and 55.3%, respectively) in patients with stageIV disease with metastasis, although there was no difference among age groups in patients with stageIV disease without metastasis. Multivariate analysis showed that younger age was an independent strong prognostic factor in stageIV disease with metastasis. Conclusions Young men with metastatic prostate cancer have a poor prognosis. Young age is an independent prognostic factor in stageIV metastatic prostate cancer patients treated with primary androgen deprivation therapy.

DOI PubMed

Nadir prostate-specific antigen (PSA) level and time to PSA nadir following primary androgen deprivation therapy as independent prognostic factors in a Japanese large-scale prospective cohort study (J-CaP)

Yasuhide Kitagawa, Satoru Ueno, Kouji Izumi, Atsushi Mizokami, Shiro Hinotsu, Hideyuki Akaza, Mikio Namiki

JOURNAL OF CANCER RESEARCH AND CLINICAL ONCOLOGY ( SPRINGER ) 140 ( 4 ) 673 - 679 2014.04 [Refereed]

Purpose The aim of this study was to investigate whether nadir prostate-specific antigen (PSA) level and time to PSA nadir (TTN) are independent prognostic factors equivalent to the pretreatment factors in the data of the Japan Study Group of Prostate Cancer registry, which is a large, multicenter, population-based database of patients undergoing primary androgen deprivation therapy (PADT). Methods A total of 10,958 patients treated with PADT were enrolled into the present study. Univariate and multivariate Cox proportional hazards regression analysis and Kaplan-Meier analysis were used to evaluate the associations of PSA nadir level and TTN with progression-free survival (PFS) and overall survival (OS), adjusting for the pretreatment factors adopted in the Japan Cancer of the Prostate Risk Assessment (J-CAPRA) score. Results Of the 10,958 patients, 3,451 (31.5 %) had lymph node and/or distant metastases. The median PSA level was 27.0 ng/ml before treatment, and the nadir PSA level in 6,983 patients (63.7 %) reached below 0.2 ng/ml. Disease progression occurred in 4,736 cases, and 2,163 patients died during a mean follow-up period of 3.86 years. Nadir PSA level and TTN were independent prognostic factors, similar to the pretreatment factors adopted in the J-CAPRA score. The probabilities of PFS and OS showed significant differences among the groups categorized by the combination of nadir PSA level and TTN in all J-CAPRA risk stratifications. Conclusions The present study demonstrated that nadir PSA level and TTN are strong predictors in patients undergoing PADT in a large-scale prospective cohort study.

DOI PubMed

Application of a Self-Controlled Case Series Study to a Database Study in Children

Hanae Ueyama, Shiro Hinotsu, Shiro Tanaka, Hisashi Urushihara, Masaki Nakamura, Yuji Nakamura, Koji Kawakami

DRUG SAFETY ( ADIS INT LTD ) 37 ( 4 ) 259 - 268 2014.04 [Refereed]

Post-marketing surveillance activities are particularly important for safety issues in children, the elderly, and patients with severe comorbidities since these populations are usually excluded from clinical trials. In addition, using electronic databases for monitoring of safety of marketed products has been of considerable interest. This study aimed to clarify the advantages and difficulties of the self-controlled case series method relative to cohort studies in pharmacoepidemiological studies in children, using an administrative database, and to explore the impact on results of handling the period eligible for analysis and recurrent events in different ways. Datasets of only individuals who had the outcome of interest were derived from an anonymized hospital administrative database in Japan from April 2003 through August 2011. We calculated incidence rate ratios (IRRs) and their 95 % confidence intervals (CIs) for the risks of diarrhea, bronchitis, and eczema related to palivizumab treatment in young children. The analysis included 'first diagnosed' events or 'multiple' events during an eligible period. An eligible period was defined in two ways: first-time inpatient periods of more than 3 continuous days (EPA); and a continuous period in cases where the interval between visits was below the 75th percentile of the interval between visits for patients with the same diagnosis (EPB). We extracted data for 70,771 patients and identified 641 who were exposed to palivizumab. The age-adjusted IRRs for diarrhea, bronchitis, and eczema were 3.0 (95 % CI 1.7-5.4), 10.3 (95 % CI 8.0-13.2), and 16.9 (95 % CI 12-23), respectively, in multiple events and the EPB eligible period. The IRRs varied greatly between the two eligible periods. This method could be a useful tool in pharmacoepidemiological studies in children. Careful consideration in the handling of inpatient and outpatient periods, including sensitivity analyses, is necessary because this method is a within-individual comparison.

DOI PubMed

Multicenter phase II clinical trial of everolimus in Japanese patients with unresectable or metastatic renal cell carcinoma (mRCC) after failure of treatment with first-line tyrosine kinase inhibitor (TKI) therapy

Seiichiro Ozono, Masafumi Oyama, Masahiro Nozawa, Kiyohide Fujimoto, Ken Kishida, Noriaki Tokuda, Go Kimura, Kazuo Nishimura, Akio Matsubara, Hideyasu Matsuyama, Takayuki Sugiyama, Tomomi Kamba, Haruki Kume, Naoya Masumori, Mototsugu Oya, Hiro-Omi Kanayama, Seiji Naito, Shiro Hinotsu, Kojiro Shimozuma, Hideyuki Akaza

JOURNAL OF CLINICAL ONCOLOGY ( AMER SOC CLINICAL ONCOLOGY ) 32 ( 4 ) 2014.02 [Refereed]

DOI

Seventh Joint Meeting of K-J-CaP and CaPSURE: extending the global initiative to improve prostate cancer management.

Akaza H, Kim CS, Carroll P, Choi IY, Chung BH, Cooperberg MR, Hirao Y, Hinotsu S, Horie S, Lee JY, Namiki M, Ng CF, Onozawa M, Ozono S, Ueno S, Umbas R, Ye D, Zhu G

Prostate international 2 ( 2 ) 50 - 69 2014 [Refereed]

DOI PubMed

Selection of appropriate design in the development of interventional and observational research

Shiro Hinotsu

Japanese Journal of Cancer and Chemotherapy ( Japanese Journal of Cancer and Chemotherapy Publishers Inc. ) 41 ( 4 ) 405 - 409 2014 [Refereed]

Selecting the appropriate study design is crucial when developing clinical research. A fundamental decision is whether to collect data to address the research question using an observational study or to apply an intervention and measure outcomes in a clinical trial. There are two well-known types of observational studies: cohort studies and cross-sectional studies. In the former, a cohort of subjects is observed over time. In prospective cohort studies, observations begin in the present and follow subjects for a given time period. In retrospective cohort studies, information is collected at time intervals in the past. The third potential study design is the case-control study. In such studies, the researcher compares a group of subjects who have a disease or some other outcome with a group without that characteristic. Among clinical trial options, the randomized clinical trial is thought to be higher evidence level than other clinical trials. Developing clinical research begins with the research question, which specifies the primary endpoint, explanatory variables, and the target population. Then, the clinical question and study outline are expanded to the study protocol and case report form. In developing the study protocol, the investigators consider study design, study size, data quality, and feasibility.

PubMed

NCCN Asian Consensus Statement - Can Asian patients with cancer accept treatment modalities from NCCN guidelines?

Seiichiro Ozono, Shiro Hinotsu, Mikio Namiki, Hideyuki Akaza

Japanese Journal of Cancer and Chemotherapy ( Japanese Journal of Cancer and Chemotherapy Publishers Inc. ) 41 ( 6 ) 683 - 686 2014 [Refereed]

To spread the National Comprehensive Cancer Network (NCCN) guidelines widely in Asia, committee members from Asian countries have been preparing an Asia Consensus Statement (ACS) along the NCCN guidelines. The ACS for Kidney Cancer guidelines and Prostate Cancer guidelines were issued in 2009 and in 2011, respectively. In addition, second versions of both these guidelines were issued in 2011 and 2013, respectively. In this review, the process and contents of NCCN ACS have been described.

PubMed

Does late morning waking-up affect sleep during the following night in patients with primary insomnia?

Atsushi Ogawa, Shiro Hinotsu, Koji Kawakami

BIOLOGICAL RHYTHM RESEARCH ( TAYLOR & FRANCIS LTD ) 44 ( 6 ) 938 - 948 2013.12 [Refereed]

Night-to-night variability in sleep duration and schedule is common in patients with insomnia. Among the various sleep variables, waking-up time is focused upon as the important factor for cognitive behavioural therapy for insomnia. This study examined the effect of a single late waking-up episode on sleep in the immediate following night in patients with chronic insomnia, using data from a placebo group (380 patients) of a double-blind placebo-controlled study. Patients tended to wake up later and have a longer total sleep time on weekends than weekdays. It was suggested that patients who woke up late one morning (>= 60 min later than the individual's regular waking-up time) extended their sleep onset latency by 4.3min in the immediate following night. The effects of late waking-up on total sleep time and bedtime were not clear. The importance of keeping regular waking-up time is highlighted for better sleep in patients with insomnia.

DOI

Prescription patterns following first-line new generation antidepressants for depression in Japan: A naturalistic cohort study based on a large claims database

Toshi A. Furukawa, Yoshie Onishi, Shiro Hinotsu, Aran Tajika, Nozomi Takeshima, Kiyomi Shinohara, Yusuke Ogawa, Yu Hayasaka, Koji Kawakami

Journal of Affective Disorders ( Elsevier B.V. ) 150 ( 3 ) 916 - 922 2013.09 [Refereed]

Background: Several studies have described real-world prescription patterns of first-line antidepressants for depression but little is known about their fate in terms of duration, intensity and changes. Methods: An inception cohort of new onset non-psychotic depression initiating antidepressant treatment with a new generation antidpressive agent was identified in a large health insurance claims database in Japan between 2009 and 2010. The duration and intensity of first-line antidepressants, the timing and kind of second-line antidepressants and the total duration of antidepressant treatment were examined. Results: We identified 1592 patients. The starting dose and the maximum dose attained with the firstline agent appeared to be largely in line with the guideline recommendations although the latter tended toward the minimum of the recommended range. The continuity of the first-line antidepressant was far below the guideline recommendations, with 28%never returning after the initial prescription and 55%dropping out within 3 months. Of all the first-line antidepressants, 14%were subsequently augmented by another psychotropic agent while 17%were switched to another antidepressant after a median of 3 or 2 months, respectively. The choice of the second-line agents varied extremely widely. The total duration of antidepressant therapy was as short as a median of 4 months, with 68%stopping treatment by 6 months. Limitations: The diagnosis of non-psychotic unipolar depression in the claims database analyses remains approximate. Conclusions: The current guidelines are grossly out of touch with the clinical realities. On the one hand, guidelines need to reflect the real-world practices on the other hand clinicians should limit their treatment options and allow evidence-based comparative effectiveness research among them so that patients shall no longer be given less effective and more effective treatments without being able to distinguish among them. © 2013 Elsevier B.V. All rights reserved.

DOI PubMed

Validation of the prognostic grouping of the seventh edition of the tumor-nodes-metastasis classification using a large-scale prospective cohort study database of prostate cancer treated with primary androgen deprivation therapy

Tomokazu Kimura, Mizuki Onozawa, Jun Miyazaki, Koji Kawai, Hiroyuki Nishiyama, Shiro Hinotsu, Hideyuki Akaza

INTERNATIONAL JOURNAL OF UROLOGY ( WILEY-BLACKWELL ) 20 ( 9 ) 880 - 888 2013.09 [Refereed]

Objective: In the TNM seventh edition, a prognostic grouping for prostate cancer incorporating prostate-specific antigen and Gleason score was advocated. The present study was carried out to evaluate and validate prognostic grouping in prostate cancer patients. Methods: The 15259 study patients treated with primary androgen deprivation therapy were enrolled in the Japan Study Group of Prostate Cancer. Overall survival was stratified by tumor-nodes-metastasis, Gleason score and prostate-specific antigen, and extensively analyzed. The accuracy of grouping systems was evaluated by the concordance index. Results: The 5-year overall survival in prognostic grouping-I, IIA, IIB, III and IV was 90.0%, 88.3%, 84.8%, 80.6% and 57.1%, respectively. When considering subgroup stratification, the 5-year overall survival of subgroups prognostic grouping-IIA, IIB, III and IV was 80.9 approximate to 90.5%, 75.4 approximate to 91.8%, 75.7 approximate to 89.0% and 46.9 approximate to 86.2%, respectively. When prognostic grouping-IIB was subclassified into IIB1 (except IIB2) and IIB2 (T1-2b, prostate-specific antigen >20, Gleason score 8, and T2c, Gleason score 8), the 5-year overall survival of IIB2 was significantly lower than that of IIB1 (79.4% and 87.3%, P<0.0001). Also, when prognostic grouping-IV was subclassified into IV1 (except IV2) and IV2 (M1, prostate-specific antigen >100 or Gleason score 8), the 5-year overall survival of prognostic grouping-IV1 was superior to that of IV2 (72.9% and 49.5%, P<0.0001). Prognostic groupings were reclassified into modified prognostic groupings, divided into modified prognostic grouping-A (prognostic grouping-I, IIA, and IIB1), modified prognostic grouping-B (prognostic grouping-IIB2 and III), modified prognostic grouping-C (prognostic grouping-IV1) and modified prognostic grouping-D (prognostic grouping-IV2). The concordance index of prognostic grouping and modified prognostic grouping for overall survival was 0.670 and 0.685, respectively. Conclusion: Prognostic grouping could stratify the prognosis of prostate cancer patients. However, there is considerable variation among the prognostic grouping subgroups. Thus, the use of a modified prognostic grouping for patients treated with primary androgen deprivation therapy is advisable.

DOI PubMed

Does late morning waking-up affect sleep during the following night in patients with primary insomnia?

Atsushi Ogawa, Shiro Hinotsu, Koji Kawakami

JOURNAL OF BIOLOGICAL EDUCATION ( ROUTLEDGE JOURNALS, TAYLOR & FRANCIS LTD ) 47 ( 3 ) 938 - 948 2013.09 [Refereed]

Night-to-night variability in sleep duration and schedule is common in patients with insomnia. Among the various sleep variables, waking-up time is focused upon as the important factor for cognitive behavioural therapy for insomnia. This study examined the effect of a single late waking-up episode on sleep in the immediate following night in patients with chronic insomnia, using data from a placebo group (380 patients) of a double-blind placebo-controlled study. Patients tended to wake up later and have a longer total sleep time on weekends than weekdays. It was suggested that patients who woke up late one morning ( <inline-graphic xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="nbrr_a_781329_o_ilm0001.gif"></inline-graphic> later than the individual's regular waking-up time) extended their sleep onset latency by 4.3min in the immediate following night. The effects of late waking-up on total sleep time and bedtime were not clear. The importance of keeping regular waking-up time is highlighted for better sleep in patients with insomnia.

DOI

Adverse reactions related to treatment compliance during BCG maintenance therapy for non-muscle-invasive bladder cancer

Jun Miyazaki, Shiro Hinotsu, Naoki Ishizuka, Seiji Naito, Seiichiro Ozono, Hideyuki Akaza, Hiroyuki Nishiyama

Japanese Journal of Clinical Oncology 43 ( 8 ) 827 - 834 2013.08 [Refereed]

Objective: The aim of the study was to investigate the factor of adverse reactions related to compliance with Mycobacterium bovis bacillus Calmette-Gué rin maintenance therapy in patients with high-risk non-muscle-invasive bladder cancer. Methods: This study was a post hoc analysis using the database of a randomized controlled trial that examined the efficacy of bacillus Calmette-Gué rin (Connaught strain) maintenance therapy. Among the 42 patients assigned to the bacillus Calmette-Gué rin maintenance therapy group, six patients dropped out or withdrew consent before the bacillus Calmette- Gué rin maintenance therapy. The adverse reactions and clinical backgrounds of the remaining 36 patients who underwent bacillus Calmette-Gué rin maintenance therapy were compared between the two groups: the patients who completed the bacillus Calmette-Gué rin maintenance therapy (the Completed group), and those who discontinued the bacillus Calmette- Gué rin maintenance therapy (the Discontinued group). Results: Of the 36 patients who underwent bacillus Calmette-Gué rin maintenance therapy, 15 (41.7%) were in the Completed group and 21 (58.3%) were in the Discontinued group. Local adverse reactions (≥G2) were observed during maintenance therapy in 86.7% of the Completed group and 95.2% of the Discontinued group. As for adverse reactions during the induction therapy (bacillus Calmette-Gué rin induction therapy), the frequencies of gross hematuria and systemic adverse reactions (any grade) tended to be higher in the Discontinued group than in the Completed group, although not significantly so. In the Cochran-Armitage trend test, the linear T trend (i.e. the trend in the risk of an increased rate of discontinuation according to gross hematuria and systemic adverse reactions with bacillus Calmette-Gué rin induction therapy) was statistically significant (P = 0.0179). Conclusions: Most patients who completed bacillus Calmette-Gué rin maintenance therapy experienced local adverse reactions (≥G2) during the maintenance therapy. Gross hematuria and systemic adverse reactions during bacillus Calmette-Gué rin induction therapy might be related to the discontinuation of bacillus Calmette-Gué rin maintenance therapy because of severe adverse reactions. © The Author 2013. Published by Oxford University Press. All rights reserved.

DOI PubMed

Japan Cancer of the Prostate Risk Assessment for combined androgen blockade including bicalutamide: Clinical application and validation

Yasuhide Kitagawa, Shiro Hinotsu, Kazuyoshi Shigehara, Kazufumi Nakashima, Shohei Kawaguchi, Hiroshi Yaegashi, Atsushi Mizokami, Hideyuki Akaza, Mikio Namiki

INTERNATIONAL JOURNAL OF UROLOGY ( WILEY-BLACKWELL ) 20 ( 7 ) 708 - 714 2013.07 [Refereed]

Objectives: The Japan Cancer of the Prostate Risk Assessment was developed as a risk stratification instrument for patients undergoing primary androgen deprivation therapy. However, there have been no studies to validate the accuracy of the Japan Cancer of the Prostate Risk Assessment in predicting clinical outcomes. We examined whether the clinical outcomes of patients treated with combined androgen blockade could be stratified using the Japan Cancer of the Prostate Risk Assessment. Methods: A total of 319 patients with prostate cancer treated with luteinizing hormone-releasing hormone agonist plus bicalutamide were included in this analysis. Progression-free survival, cause-specific survival and overall survival were compared among patients divided according to the prostate-specific antigen level at diagnosis, Gleason score on biopsy specimens, tumor-nodes-metastasis classification and Japan Cancer of the Prostate Risk Assessment score. Results: The median age of the patients was 75years, and the median prostate-specific antigen at diagnosis was 25.4ng/mL. A total of 102 patients (32.0%) had lymph node and/or distant metastases. On univariate analysis, the factors adopted in the Japan Cancer of the Prostate Risk Assessment points were significant predictors of progression-free survival. On multivariate analysis, clinical T stage and M stage were significant predictors of progression-free survival. The probabilities of progression-free survival and cause-specific survival were significantly different among the groups categorized according to the Japan Cancer of the Prostate Risk Assessment risk strata. The probability of overall survival in the low-risk group was higher than in the other groups. Conclusions: The progression-free survival, cause-specific survival and overall survival of prostate cancer patients treated by combined androgen blockade with bicalutamide were stratified by the Japan Cancer of the Prostate Risk Assessment. The Japan Cancer of the Prostate Risk Assessment score is clinically useful as a predictor of the prognosis of prostate cancer treated with combined androgen blockade.

DOI PubMed

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