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MEDICAL SCIENCES (1960 journals)                  1 2 3 4 5 6 7 8 | Last

Showing 1 - 200 of 3562 Journals sorted alphabetically
16 de Abril     Open Access  
3D Printing in Medicine     Open Access   (Followers: 1)
AADE in Practice     Hybrid Journal   (Followers: 5)
ABCS Health Sciences     Open Access   (Followers: 3)
Abia State University Medical Students' Association Journal     Full-text available via subscription  
ACIMED     Open Access   (Followers: 1)
ACS Medicinal Chemistry Letters     Hybrid Journal   (Followers: 41)
Acta Bio Medica     Full-text available via subscription   (Followers: 2)
Acta Bioethica     Open Access  
Acta Bioquimica Clinica Latinoamericana     Open Access   (Followers: 1)
Acta Facultatis Medicae Naissensis     Open Access  
Acta Informatica Medica     Open Access   (Followers: 1)
Acta Medica (Hradec Králové)     Open Access  
Acta Medica Bulgarica     Open Access  
Acta Medica Colombiana     Open Access   (Followers: 1)
Acta Médica Costarricense     Open Access   (Followers: 2)
Acta Medica Indonesiana     Open Access  
Acta Medica International     Open Access  
Acta medica Lituanica     Open Access  
Acta Medica Marisiensis     Open Access  
Acta Medica Martiniana     Open Access  
Acta Medica Nagasakiensia     Open Access  
Acta Medica Peruana     Open Access   (Followers: 2)
Acta Médica Portuguesa     Open Access  
Acta Medica Saliniana     Open Access  
Acta Scientiarum. Health Sciences     Open Access   (Followers: 1)
Acupuncture & Electro-Therapeutics Research     Full-text available via subscription   (Followers: 4)
Acupuncture and Natural Medicine     Open Access  
Addiction Science & Clinical Practice     Open Access   (Followers: 6)
Addictive Behaviors Reports     Open Access   (Followers: 8)
Adıyaman Üniversitesi Sağlık Bilimleri Dergisi / Health Sciences Journal of Adıyaman University     Open Access  
Adnan Menderes Üniversitesi Sağlık Bilimleri Fakültesi Dergisi     Open Access  
Advanced Biomedical Research     Open Access  
Advanced Health Care Technologies     Open Access   (Followers: 4)
Advanced Science, Engineering and Medicine     Partially Free   (Followers: 7)
Advances in Bioscience and Clinical Medicine     Open Access   (Followers: 5)
Advances in Clinical Chemistry     Full-text available via subscription   (Followers: 28)
Advances in Life Course Research     Hybrid Journal   (Followers: 8)
Advances in Lipobiology     Full-text available via subscription   (Followers: 1)
Advances in Medical Education and Practice     Open Access   (Followers: 26)
Advances in Medical Sciences     Hybrid Journal   (Followers: 6)
Advances in Medicinal Chemistry     Full-text available via subscription   (Followers: 5)
Advances in Medicine     Open Access   (Followers: 3)
Advances in Microbial Physiology     Full-text available via subscription   (Followers: 4)
Advances in Molecular Oncology     Open Access   (Followers: 2)
Advances in Molecular Toxicology     Full-text available via subscription   (Followers: 7)
Advances in Parkinson's Disease     Open Access  
Advances in Phytomedicine     Full-text available via subscription  
Advances in Preventive Medicine     Open Access   (Followers: 6)
Advances in Protein Chemistry and Structural Biology     Full-text available via subscription   (Followers: 20)
Advances in Regenerative Medicine     Open Access   (Followers: 2)
Advances in Skeletal Muscle Function Assessment     Open Access  
Advances in Therapy     Hybrid Journal   (Followers: 5)
Advances in Veterinary Science and Comparative Medicine     Full-text available via subscription   (Followers: 13)
Advances in Virus Research     Full-text available via subscription   (Followers: 5)
Advances in Wound Care     Hybrid Journal   (Followers: 10)
Aerospace Medicine and Human Performance     Full-text available via subscription   (Followers: 11)
African Health Sciences     Open Access   (Followers: 2)
African Journal of Biomedical Research     Open Access  
African Journal of Clinical and Experimental Microbiology     Open Access   (Followers: 1)
African Journal of Laboratory Medicine     Open Access   (Followers: 2)
African Journal of Medical and Health Sciences     Open Access   (Followers: 2)
African Journal of Trauma     Open Access   (Followers: 1)
Afrimedic Journal     Open Access   (Followers: 2)
Aggiornamenti CIO     Hybrid Journal   (Followers: 1)
AIDS Research and Human Retroviruses     Hybrid Journal   (Followers: 8)
AJOB Primary Research     Partially Free   (Followers: 3)
AJSP: Reviews & Reports     Hybrid Journal  
Aktuelle Ernährungsmedizin     Hybrid Journal   (Followers: 4)
Al-Azhar Assiut Medical Journal     Open Access  
Alexandria Journal of Medicine     Open Access   (Followers: 1)
Allgemeine Homöopathische Zeitung     Hybrid Journal   (Followers: 2)
Alpha Omegan     Full-text available via subscription  
ALTEX : Alternatives to Animal Experimentation     Open Access   (Followers: 3)
American Journal of Biomedical Engineering     Open Access   (Followers: 11)
American Journal of Biomedical Research     Open Access   (Followers: 2)
American Journal of Biomedicine     Full-text available via subscription   (Followers: 7)
American Journal of Chinese Medicine, The     Hybrid Journal   (Followers: 4)
American Journal of Clinical Medicine Research     Open Access   (Followers: 7)
American Journal of Family Therapy     Hybrid Journal   (Followers: 11)
American Journal of Law & Medicine     Full-text available via subscription   (Followers: 11)
American Journal of Lifestyle Medicine     Hybrid Journal   (Followers: 5)
American Journal of Managed Care     Full-text available via subscription   (Followers: 11)
American Journal of Medical Case Reports     Open Access   (Followers: 1)
American Journal of Medical Sciences and Medicine     Open Access   (Followers: 4)
American Journal of Medicine     Hybrid Journal   (Followers: 45)
American Journal of Medicine and Medical Sciences     Open Access   (Followers: 1)
American Journal of Medicine Studies     Open Access   (Followers: 1)
American Journal of Medicine Supplements     Full-text available via subscription   (Followers: 3)
American Journal of the Medical Sciences     Hybrid Journal   (Followers: 12)
American Journal on Addictions     Hybrid Journal   (Followers: 8)
American medical news     Free   (Followers: 3)
American Medical Writers Association Journal     Full-text available via subscription   (Followers: 5)
Amyloid: The Journal of Protein Folding Disorders     Hybrid Journal   (Followers: 5)
Anales de la Facultad de Medicina     Open Access  
Anales de la Facultad de Medicina, Universidad de la República, Uruguay     Open Access  
Anales del Sistema Sanitario de Navarra     Open Access   (Followers: 1)
Analgesia & Resuscitation : Current Research     Hybrid Journal   (Followers: 5)
Anatolian Clinic the Journal of Medical Sciences     Open Access  
Anatomical Science International     Hybrid Journal   (Followers: 2)
Anatomical Sciences Education     Hybrid Journal   (Followers: 1)
Anatomy     Open Access  
Anatomy Research International     Open Access   (Followers: 2)
Angewandte Schmerztherapie und Palliativmedizin     Hybrid Journal  
Angiogenesis     Hybrid Journal   (Followers: 3)
Ankara Medical Journal     Open Access   (Followers: 2)
Ankara Üniversitesi Tıp Fakültesi Mecmuası     Open Access  
Annales de Pathologie     Full-text available via subscription  
Annales françaises d'Oto-rhino-laryngologie et de Pathologie Cervico-faciale     Full-text available via subscription   (Followers: 3)
Annals of African Medicine     Open Access   (Followers: 1)
Annals of Anatomy - Anatomischer Anzeiger     Hybrid Journal   (Followers: 2)
Annals of Bioanthropology     Open Access   (Followers: 4)
Annals of Biomedical Engineering     Hybrid Journal   (Followers: 18)
Annals of Biomedical Sciences     Full-text available via subscription   (Followers: 3)
Annals of Clinical Microbiology and Antimicrobials     Open Access   (Followers: 10)
Annals of Family Medicine     Open Access   (Followers: 12)
Annals of Ibadan Postgraduate Medicine     Open Access  
Annals of Medical and Health Sciences Research     Open Access   (Followers: 7)
Annals of Medicine     Hybrid Journal   (Followers: 12)
Annals of Medicine and Surgery     Open Access   (Followers: 7)
Annals of Microbiology     Hybrid Journal   (Followers: 11)
Annals of Nigerian Medicine     Open Access   (Followers: 1)
Annals of Saudi Medicine     Open Access  
Annals of the New York Academy of Sciences     Hybrid Journal   (Followers: 5)
Annals of The Royal College of Surgeons of England     Full-text available via subscription   (Followers: 3)
Annual Reports in Medicinal Chemistry     Full-text available via subscription   (Followers: 7)
Annual Reports on NMR Spectroscopy     Full-text available via subscription   (Followers: 4)
Annual Review of Medicine     Full-text available via subscription   (Followers: 16)
Anthropological Review     Open Access   (Followers: 23)
Anthropologie et santé     Open Access   (Followers: 5)
Antibiotics     Open Access   (Followers: 9)
Antibodies     Open Access   (Followers: 2)
Antibody Technology Journal     Open Access   (Followers: 1)
Anuradhapura Medical Journal     Open Access  
Anwer Khan Modern Medical College Journal     Open Access   (Followers: 2)
Apmis     Hybrid Journal   (Followers: 1)
Apparence(s)     Open Access   (Followers: 1)
Applied Clinical Research, Clinical Trials and Regulatory Affairs     Hybrid Journal  
Applied Medical Informatics     Open Access   (Followers: 10)
Arab Journal of Nephrology and Transplantation     Open Access   (Followers: 1)
Arak Medical University Journal     Open Access  
Archive of Clinical Medicine     Open Access   (Followers: 1)
Archive of Community Health     Open Access   (Followers: 1)
Archives Medical Review Journal / Arşiv Kaynak Tarama Dergisi     Open Access  
Archives of Medical and Biomedical Research     Open Access   (Followers: 3)
Archives of Medical Laboratory Sciences     Open Access   (Followers: 1)
Archives of Medicine and Health Sciences     Open Access   (Followers: 3)
Archives of Medicine and Surgery     Open Access  
Archives of Trauma Research     Open Access   (Followers: 3)
Archivos de Medicina (Manizales)     Open Access  
ArgoSpine News & Journal     Hybrid Journal  
Arquivos Brasileiros de Oftalmologia     Open Access  
Arquivos de Ciências da Saúde     Open Access  
Arquivos de Medicina     Open Access  
Ars Medica : Revista de Ciencias Médicas     Open Access  
ARS Medica Tomitana     Open Access   (Followers: 1)
Art Therapy: Journal of the American Art Therapy Association     Full-text available via subscription   (Followers: 12)
Arterial Hypertension     Open Access   (Followers: 1)
Artificial Intelligence in Medicine     Hybrid Journal   (Followers: 13)
Artificial Organs     Hybrid Journal   (Followers: 1)
ASHA Leader     Open Access  
Asia Pacific Family Medicine     Open Access   (Followers: 1)
Asia Pacific Journal of Clinical Nutrition     Full-text available via subscription   (Followers: 10)
Asia Pacific Journal of Clinical Trials : Nervous System Diseases     Open Access  
Asian Bioethics Review     Full-text available via subscription   (Followers: 3)
Asian Biomedicine     Open Access   (Followers: 2)
Asian Journal of Cell Biology     Open Access   (Followers: 5)
Asian Journal of Health     Open Access   (Followers: 3)
Asian Journal of Medical and Biological Research     Open Access   (Followers: 3)
Asian Journal of Medical and Pharmaceutical Researches     Open Access   (Followers: 1)
Asian Journal of Medical Sciences     Open Access   (Followers: 2)
Asian Journal of Scientific Research     Open Access   (Followers: 3)
Asian Journal of Transfusion Science     Open Access   (Followers: 1)
Asian Medicine     Hybrid Journal   (Followers: 5)
Asian Pacific Journal of Cancer Prevention     Open Access  
ASPIRATOR : Journal of Vector-borne Disease Studies     Open Access  
Astrocyte     Open Access  
Atención Familiar     Open Access  
Atención Primaria     Open Access   (Followers: 1)
Atti della Accademia Peloritana dei Pericolanti - Classe di Scienze Medico-Biologiche     Open Access  
Audiology - Communication Research     Open Access   (Followers: 9)
Auris Nasus Larynx     Full-text available via subscription  
Australian Coeliac     Full-text available via subscription   (Followers: 1)
Australian Family Physician     Full-text available via subscription   (Followers: 3)
Australian Journal of Medical Science     Full-text available via subscription   (Followers: 1)
Autopsy and Case Reports     Open Access  
Avicenna     Open Access   (Followers: 3)
Avicenna Journal of Clinical Medicine     Open Access  
Avicenna Journal of Medicine     Open Access   (Followers: 1)
Bangabandhu Sheikh Mujib Medical University Journal     Open Access   (Followers: 1)
Bangladesh Journal of Anatomy     Open Access   (Followers: 1)
Bangladesh Journal of Bioethics     Open Access  
Bangladesh Journal of Medical Biochemistry     Open Access   (Followers: 3)
Bangladesh Journal of Medical Education     Open Access   (Followers: 2)
Bangladesh Journal of Medical Microbiology     Open Access   (Followers: 3)
Bangladesh Journal of Medical Physics     Open Access  
Bangladesh Journal of Medical Science     Open Access  
Bangladesh Journal of Medicine     Open Access   (Followers: 1)
Bangladesh Journal of Physiology and Pharmacology     Open Access  
Bangladesh Journal of Scientific Research     Open Access   (Followers: 1)

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Journal Cover
Advances in Therapy
Journal Prestige (SJR): 1.075
Citation Impact (citeScore): 3
Number of Followers: 5  
  Hybrid Journal Hybrid journal (It can contain Open Access articles)
ISSN (Print) 1865-8652 - ISSN (Online) 0741-238X
Published by Springer-Verlag Homepage  [2348 journals]
  • Monitoring of Hematologic, Cardiac, and Hepatic Function in
           Post-Menopausal Women with HR+/HER2− Metastatic Breast Cancer
    • Authors: Annie Guérin; Debbie Goldschmidt; Tania Small; Patrick Gagnon-Sanschagrin; Hela Romdhani; Genevieve Gauthier; Sneha Kelkar; Eric Q. Wu; Polly Niravath; Anand A. Dalal
      Pages: 1251 - 1264
      Abstract: Introduction In the treatment of metastatic breast cancer (mBC), regular monitoring is key in helping physicians to make informed clinical decisions, managing treatment side effects, and maintaining patients’ quality of life. Therefore, we investigated the monitoring frequency in post-menopausal women with HR+/HER2− mBC stratified by first-line regimen. Methods Treatment monitoring was assessed using two complementary data sources: a medical chart review (chart review analysis) and a commercial claims database (claims analysis). Women with post-menopausal HR+/HER2− mBC who initiated first-line therapy for mBC were selected and classified under three cohorts, based on treatment received: cyclin-dependent kinase 4/6 (CDK4/6) inhibitor (i.e., palbociclib—the only CDK4/6 approved at the time of the study), endocrine therapy (ET), and chemotherapy. Frequency of monitoring [complete blood count (CBC), electrocardiogram (EKG), and liver function test (LFT)] and laboratory abnormalities detected during the first line of therapy were analyzed. Results In the chart review analysis, 64 US oncologists abstracted medical information on 401 eligible patients, including 210 CDK4/6 users, 121 ET users, 51 chemotherapy users; 19 patients used other regimens. All patients had ≥ 1 CBC; between 8.3% (ET users) and 39.5% (CDK4/6 users) had ≥ 1 EKG; and over 98% of patients had ≥ 1 LFT across all three cohorts. Among monitored patients, 64.6% had a CBC abnormality, with anemia (39.9%), leukopenia (27.4%), and neutropenia (26.7%) being the most common. Abnormal EKG readings were detected in 8.4, 0.0%, and 7.7% of CDK4/6, ET, and chemotherapy users, respectively. LFT abnormalities were detected in 14.1–26.0% of CDK4/6 and chemotherapy users, respectively. Similar frequency of monitoring was observed in the claims analysis, with the exception of EKG monitoring, for which the proportion of patients tested was higher. Conclusion Post-menopausal women with HR+/HER2− mBC receiving first-line therapy with CDK4/6, ET, or chemotherapy were regularly monitored regardless of the first-line regimen received. Funding Novartis Pharmaceuticals Corporation.
      PubDate: 2018-08-01
      DOI: 10.1007/s12325-018-0740-y
      Issue No: Vol. 35, No. 8 (2018)
  • Treatment and Monitoring Patterns Among Premenopausal Women with
           HR+/HER2− Advanced Breast Cancer
    • Authors: Anand A. Dalal; Geneviève Gauthier; Patrick Gagnon-Sanschagrin; Rebecca Burne; Annie Guérin; Polly Niravath; Tania Small
      Abstract: Introduction Premenopausal women with hormone receptor positive (HR+) and human epidermal growth factor receptor-2-negative (HER2−) advanced breast cancer (aBC) often present with aggressive tumor types that lead to poor prognosis, high rates of recurrence, and mortality. Although clinical guidelines provide evidence-based recommendations for optimal treatment and monitoring, there is a dearth of information regarding treatment and monitoring patterns in clinical practice. In this study, we describe treatment and monitoring patterns among premenopausal women with HR+/HER2− aBC in real-world practice. Methods A large US claims database was used to describe treatment patterns for patients in first, second, and third lines of therapy. Treatment monitoring included complete blood count (CBC), liver function test (LFT), and electrocardiogram (EKG) monitoring, described for the first three lines of therapy, and separately for patients receiving endocrine monotherapy (ET) and chemotherapy. Results Among 3203 patients, chemotherapy was the most common treatment used in first-line (63.6%) and second-line therapy (66.9%). ET was used in 34.4, 30.1, and 73.6% of patients in first, second, and third lines of therapy, respectively. The two most common treatment sequences were a single line of ET (27.3%), and two consecutive lines of chemotherapy followed by a line of ET (19.3%). Patients receiving chemotherapy were monitored with CBC on average more than two times per month, and for LFT one to two times per month. Patients receiving ET were monitored with CBC and LFT on average once every 2–3 months. Overall, approximately 20% of patients were monitored with an EKG at some point during each line of therapy. Conclusion A considerable proportion of premenopausal women with aBC received first- and second-line chemotherapy, which appears inconsistent with current clinical guidelines. The observed treatment heterogeneity points to a lack real-world consensus on the management of premenopausal women with HR+/HER2− aBC. Funding Novartis Pharmaceuticals Corporation.
      PubDate: 2018-08-13
      DOI: 10.1007/s12325-018-0764-3
  • Effectiveness and Tolerability of Micafungin in Chinese Patients with
           Invasive Fungal Infections: A Retrospective, Multicenter Study
    • Authors: Xiaoyun Zheng; Xiaobo Huang; Jianmin Luo; Juan Li; Wei Li; Qifa Liu; Ting Niu; Xiaodong Wang; Jianfeng Zhou; Xi Zhang; Jianda Hu; Kaiyan Liu
      Abstract: Introduction Invasive fungal infections (IFIs) are a significant health problem in immunocompromised patients, resulting in substantial morbidity, mortality, and healthcare costs. Micafungin is a broad-spectrum echinocandin with activity against Candida and Aspergillus spp. This was a multicenter, non-comparative, retrospective observational study that evaluated the effectiveness and tolerability of intravenously administered micafungin for treating IFIs caused by Candida and Aspergillus spp. Methods Adult patients in China who had received at least one dose of intravenously administered micafungin were eligible. Retrospective data (May 2008–April 2015) were extracted from patients’ medical files and recorded using electronic data capture. The primary endpoint was overall success rate (patients with complete or partial response). Subgroup analyses determined effectiveness according to diagnostic certainty, fungal species, type of IFI, duration of micafungin treatment, and daily dose of micafungin. Tolerability, including the incidence of adverse events (AEs), was also assessed. Results Overall, 2555 patients who received at least one dose of micafungin were identified. The mean duration of treatment and mean daily dose were 10.2 days and 133.0 mg, respectively. The overall success rate was 60.8%; this was significantly higher in patients who received treatment for at least 1 week (range 67.9–71.6% [mean 69.2%]) compared with less than 1 week (47.8%; P < 0.0001), and those who received 50–100 mg (65.7%) compared with other daily doses (range 42.9–60.1% [mean 59.0%]; P = 0.0011). Success rates in Candida- and Aspergillus-infected patients were similar (61.9% and 56.8%, respectively). AEs and adverse drug reactions were observed in 36.2% and 4.5% of patients, respectively. The majority of AEs were mild, while discontinuation due to AEs was low (2.3%). Conclusion Micafungin is effective and well tolerated for the treatment of patients with IFIs in China, as demonstrated in Candida- and Aspergillus-infected adults. Subgroup analyses highlighted the potential benefits of treating IFIs with micafungin for a minimum of 1 week. Trial registration identifier NCT02678598. Funding Astellas Pharma Inc.
      PubDate: 2018-08-13
      DOI: 10.1007/s12325-018-0762-5
  • Tailored Healthcare: Two Perspectives on the Development and Use of
           Patient Profiles
    • Authors: Tessa Dekkers; Dorijn F. L. Hertroijs
      Abstract: Abstract Calls for a more tailored approach to the management of cardiometabolic and musculoskeletal diseases have been increasing. Although tailored care is a centuries-old concept, it is still unclear how it should be best practised. The current paper introduces two phenotype-based Dutch approaches to support tailored care. One approach focuses on patients with type 2 diabetes, the other on patients undergoing total joint replacement. Using the patient profiling approach, both projects propose that care can be tailored by the assessment of biopsychosocial patient characteristics, stratification of patients into subgroups of patients with similar care needs, abilities, and preferences (so-called patient profiles) and tailoring of care in concordance with the common care preferences of these profiles. In this article, the advantages and disadvantages of the method are discussed to enable researchers or clinicians who want to extend the patient profiling approach to other patient populations to carefully evaluate these in relation to their project’s focus and available resources. Funding: Novo Nordisk B.V., the Netherlands Organisation for Scientific Research (NWO) (Grant 314-99-118) and Zimmer Biomet Inc.
      PubDate: 2018-08-13
      DOI: 10.1007/s12325-018-0765-2
  • Evaluating the Impact and Benefits of Fluticasone Furoate/Vilanterol in
           Individuals with Asthma or COPD: A Mixed-Methods Analysis of Patient
    • Authors: Henrik Svedsater; Helen A. Doll; Jake Macey; Gail Miles; Lisa Bradshaw; Magdalena Vanya
      Abstract: Introduction This study evaluated patients’ experiences with fluticasone furoate/vilanterol (FF/VI) combination therapy in UK patients with asthma or chronic obstructive pulmonary disease (COPD). Methods Participants aged ≥ 18 years, with self-reported, physician-diagnosed asthma or COPD (≥ 1 year) who had been receiving FF/VI (≥ 3 months) were recruited from UK primary care. This two-phase, mixed-methods study consisted of a semi-structured, telephone-interview phase (qualitative) and a self-completed online/paper-survey phase (quantitative). Results The telephone-interview phase included 50 individuals [asthma, n = 25; COPD, n = 25; mean age (SD) 56.7 years (13.3); 50% female]. Of these, 21 with asthma reported that their condition was stable/well controlled and 13 with COPD felt their condition was manageable. Most participants found FF/VI easy to use (asthma, 25; COPD, 23), easy to integrate into their daily routine (asthma, 25; COPD, 24), and able to control symptoms for ≥ 24 h (asthma, 14; COPD, 16). During the survey phase, 199 individuals were recruited [asthma, n = 100; COPD, n = 99; mean age (SD) 63.6 years (15.1); 59.3% female]. Most participants were satisfied/very satisfied with the efficacy of FF/VI in terms of all-day symptom relief (asthma, 84%; COPD, 75%) and found FF/VI easy/very easy to fit into their daily routine (asthma, 99%; COPD, 96%), easy/very easy to use (asthma, 97%; COPD, 92%), and convenient/very convenient to take as instructed (asthma, 95%; COPD, 93%). Significantly more individuals with asthma (87% versus 46%, P < 0.001) and numerically more individuals with COPD (84% versus 76%, P = 0.055) were satisfied/very satisfied with FF/VI compared with their most recent previous maintenance medication. Conclusion The majority of individuals in this study had confidence in FF/VI and were satisfied or very satisfied with various key attributes of the treatment. Trial Registration GSK study HO-15-15503/204888. Funding GSK.
      PubDate: 2018-08-13
      DOI: 10.1007/s12325-018-0760-7
  • Anti-Anginal Effectiveness and Tolerability of Trimetazidine Modified
           Release 80 Mg Once Daily in Stable Angina Patients in Real-World Practice
    • Authors: Maria G. Glezer; on behalf of ODA investigators; Vladimir A. Vygodin
      Abstract: Introduction Trimetazidine (TMZ) was shown to reduce angina symptoms and increase the exercise capacity in stable angina (SA) patients. A new formulation allowing a once-daily (od) dosage could improve patients’ satisfaction and adherence. Methods ODA was a 3-month, observational, multicenter, prospective Russian study in SA patients with persistent symptoms despite therapy. Angina attack frequency, short-acting nitrate (SAN) consumption, adherence to antianginal medications, and overall efficacy and tolerability of TMZ 80 mg od were assessed in a real-world setting. Results A total of 3066 patients were included (mean age 62.8, 48% male). After 3 months, TMZ 80 mg od treatment led to a significant (p < 0.001) decrease in angina attack frequency (from 4.7 ± 3.5 to 0.9 ± 1.3/week) and SAN use (from 4.5 ± 3.9 to 0.7 ± 1.3/week). Overall tolerability and effectiveness were rated as “very good” by the majority of physicians. Medication adherence improved significantly, with good adherence reported by 56% of patients (vs. 24% at baseline, p < 0.0001) and non-adherence by 3% (vs. 36% at baseline, p < 0.0001) at month 3. Patient satisfaction with TMZ od was 9.5 [on a scale of 1 to 10 (very satisfied)]. Patients reported improved physical activity: more patients reported no limitations (15% vs. 1% at baseline p < 0.01), slight limitation (46% vs. 5% at baseline, p < 0.001) or moderate limitation (30% vs. 23%, p < 0.01) and fewer patients reported substantial limitation (8% vs. 52% at baseline, p < 0.001) or very marked reduction (1% vs. 19% at baseline, p < 0.01) at month 3. Conclusion In this prospective, observational study, TMZ 80 mg od effectively reduced angina attacks and SAN consumption, improved physical activity and adherence and was well tolerated in chronic SA patients. Trial Registration ISRCTN registry Identifier, ISRCTN97780949. Funding Servier. Plain Language Summary Plain language summary available for this article.
      PubDate: 2018-08-13
      DOI: 10.1007/s12325-018-0756-3
  • Correction to: To See or NOsee: The Debate on the Nocebo Effect and
           Optimizing the Use of Biosimilars
    • Authors: Mourad F. Rezk; Burkhard Pieper
      Abstract: The article “To See or NOsee: The Debate on the Nocebo Effect and Optimizing the Use of Biosimilars”, written by Mourad F. Rezk and Burkhard Pieper was originally published electronically on the publisher’s internet portal (currently SpringerLink) on June 5, 2018 without open access.
      PubDate: 2018-08-10
      DOI: 10.1007/s12325-018-0768-z
  • Prostate Cancer in Primary Care
    • Authors: Samuel W. D. Merriel; Garth Funston; Willie Hamilton
      Abstract: Abstract Prostate cancer is a common malignancy seen worldwide. The incidence has risen in recent decades, mainly fuelled by more widespread use of prostate-specific antigen (PSA) testing, although prostate cancer mortality rates have remained relatively static over that time period. A man’s risk of prostate cancer is affected by his age and family history of the disease. Men with prostate cancer generally present symptomatically in primary care settings, although some diagnoses are made in asymptomatic men undergoing opportunistic PSA screening. Symptoms traditionally thought to correlate with prostate cancer include lower urinary tract symptoms (LUTS), such as nocturia and poor urinary stream, erectile dysfunction and visible haematuria. However, there is significant crossover in symptoms between prostate cancer and benign conditions affecting the prostate such as benign prostatic hypertrophy (BPH) and prostatitis, making it very challenging to distinguish between them on the basis of symptoms. The evidence for the performance of PSA in asymptomatic and symptomatic men for the diagnosis of prostate cancer is equivocal. PSA is subject to false positive and false negative results, affecting its clinical utility as a standalone test. Clinicians need to counsel men about the risks and benefits of PSA testing to inform their decision-making. Digital rectal examination (DRE) by primary care clinicians has some evidence to show discrimination between benign and malignant conditions affecting the prostate. Patients referred to secondary care for diagnostic testing for prostate cancer will typically undergo a transrectal or transperineal biopsy, where a number of samples are taken and sent for histological examination. These biopsies are invasive procedures with side effects and a risk of infection and sepsis, and alternative tests such as multiparametric magnetic resonance imaging (mpMRI) are currently being trialled for their accuracy and safety in diagnosing clinically significant prostate cancer.
      PubDate: 2018-08-10
      DOI: 10.1007/s12325-018-0766-1
  • Evaluation of 1294 Female Patients with Breast Pain: A Retrospective Study
    • Authors: Yasemin Altıntas; Mehmet Bayrak
      Abstract: Introduction Mastalgia, or breast pain, is one of the most important complaints referred to outpatient clinics. The objective of this study was to evaluate the factors causing mastalgia. All patients who presented to our clinic with complaints of mastalgia were assessed along with their type of mastalgia symptoms, menopausal status, and radiology results. Methods A total of 3157 patients with mastalgia complaints visited our clinic between January 2015 and February 2018. Only 1294 of them were retrospectively screened. Age, sex, menopausal (premenopausal, postmenopausal) status, mastalgia type (cyclic, non-cyclic), and imaging findings of the patients were examined. Results The mean age was 43.8 ± 11.8 (13–86) years, with 453 (35%) patients younger than 40 years and 841 (65%) older than 40. Cyclic mastalgia was found in 207 (16%) patients, and non-cyclic mastalgia was seen in 1087 (84%) patients. A total of 786 (60.7%) patients were premenopausal, and 508 (39.3%) were postmenopausal. Mammography was used in 545 (42.1%) patients; 1190 (92.0%) women had breast ultrasonography. Conclusion Although breast pain is a common symptom in women who are referred to breast outpatient clinics, we concluded that patients who complain of mastalgia should not be afraid of cancer. Despite this and for reassurance, clinical imaging may be necessary to alleviate these patients’ suspicions.
      PubDate: 2018-08-09
      DOI: 10.1007/s12325-018-0769-y
  • Non-medical Switching from Originator Tumor Necrosis Factor Inhibitors to
           Their Biosimilars: Systematic Review of Randomized Controlled Trials and
           Real-World Studies
    • Authors: Syed Numan; Freddy Faccin
      Abstract: Abstract Tumor necrosis factor (TNF) inhibitors are widely used biologics for the treatment of several chronic inflammatory diseases. The launch of anti-TNF biosimilars has introduced the possibility of non-medical switching between originator biologics and their biosimilars. However, the potential clinical and patient-reported consequences of non-medical switching remain largely unknown, as much of the evidence comes from poorly or uncontrolled real-world evidence (RWE) studies that often have an element of bias and nonstandardized outcome measures. To appropriately evaluate the safety, efficacy, and immunogenicity of non-medical switching from an originator to its biosimilar, we propose that seven key study design elements should be considered when assessing the existing evidence: studies should be (1) randomized and double-blind, (2) adequately controlled, and (3) adequately powered; include (4) multiple switching, (5) an assessment of immunogenicity, and (6) adequate follow-up duration; and (7) report individual patient-level outcomes. This systematic review assessed the robustness and consistency of the current non-medical switching evidence, with a focus on TNF inhibitors. A comprehensive literature search (January 2012–February 2018) identified 98 publications corresponding to 91 studies (17 randomized controlled trials and 74 RWE studies) describing non-medical switching from a TNF inhibitor originator to its biosimilar. When assessing the totality of this evidence, none of the non-medical switching studies conducted to date were found to use all seven of the key design elements, and the absence of these elements dilutes the robustness of the data. Furthermore, discontinuation rates varied widely among studies (0–87%), suggesting heterogeneity and inconclusiveness of the current efficacy, safety, and immunogenicity evidence, particularly at an individual patient level. Therefore, patients should not be indiscriminately switched from an originator TNF inhibitor to its biosimilar for non-medical reasons. Switching decisions should remain between the treating physicians and their patients and be made on a case-by-case basis, relying upon robust scientific evidence. Funding: AbbVie. Plain Language Summary: Plain language summary available for this article.
      PubDate: 2018-08-06
      DOI: 10.1007/s12325-018-0742-9
  • A New Automatically Fixating Stone Basket (2.5 F) Prototype with a
           Nitinol Spring for Accurate Ureteroscopic Stone Size Measurement
    • Authors: Jens Cordes; Felix Nguyen; Wolfhard Pinkowski; Axel S. Merseburger; Tomasz Ozimek
      Abstract: Introduction Intraoperative assessment of stone size is crucial for the successful and safe extraction of stones. The first automatically fixating measuring stone basket prototype showed a mismatch between the steel spring and the nitinol basket; therefore, to improve this prototype, the steel spring was replaced with a nitinol spring and a modified scale was implemented on the basket handle for accurate intraoperative stone size measurement. Methods The proposed tipped basket was composed of nitinol. A standard handle with a spring-supported self-closing mechanism (2.5 F, Urotech®) was used, and a modified nonlinear millimeter scale was established on the handle. The grasping force was provided by the new nitinol spring mechanism in the handgrip. Various colors associated with the stone size were applied on the scale. Results The material difference between the basket and the spring was eliminated. The measuring scale ranged from 2 mm (green) through 5 mm (yellow) to 8 mm (red), and the scale was nonlinear because of the nonlinear relationship between the diameter of the stone and the distance marked on the scale. Conclusion The proposed automatically fixating stone basket with a nitinol spring has the potential to improve the safety and effectiveness of endourological stone retrieval. Further validation of this new scale and basket should follow.
      PubDate: 2018-08-04
      DOI: 10.1007/s12325-018-0761-6
  • 12-Month Outcomes of Goniotomy Performed Using the Kahook Dual Blade
           Combined with Cataract Surgery in Eyes with Medically Treated Glaucoma
    • Authors: Syril K. Dorairaj; Leonard K. Seibold; Nathan M. Radcliffe; Ahmad A. Aref; Jesús Jimenez-Román; Gabriel S. Lazcano-Gomez; Jason K. Darlington; Kaweh Mansouri; John P. Berdahl
      Abstract: Introduction To describe the 12-month efficacy and safety of goniotomy performed using the Kahook Dual Blade (KDB) in combination with cataract surgery in eyes with medically treated open-angle glaucoma (OAG). Methods This was a prospective, interventional case series conducted at seven centers in North America. Consecutive patients with medically treated OAG and visually significant cataract underwent phacoemulsification combined with goniotomy (PE + goniotomy) using KDB. Indications for glaucoma surgery included reduction of intraocular pressure (IOP) and reduction of IOP-lowering medications. De-identified data were collected and included pre-, intra-, and postoperative data on IOP, the use of IOP-lowering medications, and adverse events through 12 months of follow-up. Results Among 52 eyes undergoing surgery, mean IOP was reduced from 16.8 ± 0.6 mmHg at baseline to 12.4 ± 0.3 mmHg at month 12 (P < 0.001), a 26.2% reduction. Mean IOP across time points ranged from 12.4–13.3 mmHg during follow-up. The mean number of topical IOP-lowering medications was reduced from 1.6 ± 0.2 at baseline to 0.8 ± 0.1 at month 12 (P < 0.05), a 50.0% reduction. At month 12, 57.7% of eyes had IOP reduction ≥ 20% from baseline, and 63.5% were on ≥ 1 fewer IOP-lowering medications. In subgroup analysis, 84.6% of eyes with lower mean baseline IOP were using ≥ 1 fewer medications at month 12, and 100% of eyes with higher mean baseline IOP had IOP reductions ≥ 20%. The most common postoperative adverse events were pain/irritation (n = 4, 7.7%), opacification of the posterior lens capsule (n = 2, 3.8%), and IOP spike > 10 mmHg (n = 2, 3.8%). Conclusion PE + goniotomy using the KDB significantly lowers both IOP and dependence on IOP-lowering medications in eyes with OAG. Adverse events were not sight-threatening and typically resolved spontaneously. Funding New World Medical, Inc.
      PubDate: 2018-08-04
      DOI: 10.1007/s12325-018-0755-4
  • A Targeted Literature Review Examining Biologic Therapy Compliance and
           Persistence in Chronic Inflammatory Diseases to Identify the Associated
           Unmet Needs, Driving Factors, and Consequences
    • Authors: Nikos Maniadakis; Emese Toth; Michael Schiff; Xuan Wang; Maria Nassim; Boglarka Szegvari; Irina Mountian; Jeffrey R. Curtis
      Abstract: Chronic inflammatory diseases (CIDs) represent a substantial clinical and economic burden to patients, providers, payers and society overall. Biologics, such as tumor necrosis factor inhibitors (TNFi), have emerged as effective treatment options for patients with CIDs. However, the therapeutic potential of biologics is not always achieved in clinical practice, with results from studies examining the use of biologics in real-world settings suggesting lower levels of treatment effectiveness compared with clinical trial results. Using a targeted approach, this literature review demonstrates that compliance and persistence with biologic therapy is suboptimal and that this has implications for both clinical outcomes and treatment costs. The review identified a variety of predictors of treatment compliance and persistence, including increased age, female gender, presence of comorbidities, increased disease activity, longer disease duration, smoking, increased body mass index, higher biologic treatment dose, higher treatment cost and lower health-related quality-of-life scores. Patients often cited factors associated with medication delivery as a reason for non-compliance and non-persistence, and device-related improvements to treatment delivery were associated with higher rates of compliance and persistence. The articles identified in this review provide insights that have the potential to help guide the development of new solutions to improve disease management and optimize treatment regimens. This has the potential to benefit patients’ health by improving clinical outcomes and to reduce the burden to society by limiting the economic impact of patients’ disease. Funding UCB Pharma.
      PubDate: 2018-08-04
      DOI: 10.1007/s12325-018-0759-0
  • Treatment of Rheumatoid Arthritis with Certolizumab Pegol: Results from
           PROACTIVE, a Non-Interventional Study in the UK and Ireland
    • Authors: Namita Kumar; Sophia Naz; Mark Quinn; John Ryan; Thomas Kumke; Tom Sheeran
      Abstract: Introduction The objective of this non-interventional study was to investigate the long-term safety and effectiveness of certolizumab pegol (CZP) in patients with rheumatoid arthritis (RA) in the UK and Ireland. Methods Patients were prescribed CZP at their physicians’ discretion and followed during routine clinical practice for up to 88 weeks. DAS28(ESR) response (defined as at least a 1.2-point reduction from baseline) was measured in the full analysis set (FAS) at week 12, and patients were categorized by week 12 responder status in all subsequent analyses. The primary outcome was DAS28(ESR) response at week 78. Secondary outcomes included change from baseline in DAS28(ESR), HAQ-DI, and RADAI scores at week 78, and EULAR response at week 78. Adverse drug reactions (ADRs) were recorded for all patients who received at least one dose of CZP. Results A total of 149 patients were enrolled, of whom 111 (74.5%) formed the FAS. At week 12, 80 patients (72.1%) were DAS28(ESR) responders and 31 (27.9%) non-responders. Compared to non-responders, a greater proportion of week 12 responders had a DAS28(ESR) response at week 78 (43.8% versus 22.6%). Improvements in DAS28(ESR), HAQ-DI, and RADAI scores were also greater on average among week 12 responders, as was the proportion of patients meeting EULAR criteria. Overall, 9 patients (6.1%) experienced 13 ADRs during the study. Conclusion These data demonstrate the safety and effectiveness of CZP in adult patients with RA treated during routine clinical practice in the UK and Ireland. Trial Registration identifier, NCT01288287. Funding UCB Pharma.
      PubDate: 2018-08-03
      DOI: 10.1007/s12325-018-0758-1
  • Clinical Effectiveness of Budesonide/Formoterol Fumarate Easyhaler ® for
           Patients with Poorly Controlled Obstructive Airway Disease: a Real-World
           Study of Patient-Reported Outcomes
    • Authors: Lilla Tamási; Maria Szilasi; Gabriella Gálffy
      Abstract: Introduction The effectiveness of inhaled therapies can be influenced by many factors, including the type of inhaler, which may have clinical implications. We report a real-world, multicenter, open-label, non-randomized, non-interventional study conducted by 200 pulmonologists across 200 centers in Hungary. The effectiveness of budesonide/formoterol inhalation therapy in daily clinical practice, delivered via the Bufomix Easyhaler®, was evaluated in patients with asthma, chronic obstructive pulmonary disease (COPD) and asthma-COPD overlap (ACO). Methods Effectiveness was assessed after 12 weeks of treatment by spirometry, the Asthma Control Test, mini-Asthma Quality of Life Questionnaire, COPD Assessment Test and modified Medical Research Council dyspnea scale. Patient satisfaction with the Bufomix Easyhaler® and physicians’ assessments (ease of use and time taken to learn the technique) were also assessed. Results A total of 1498 patients with obstructive airway disease were evaluated (asthma: n = 621; COPD: n = 778; ACO: n = 99), of whom 455 (30.4%) were newly diagnosed inhaler-naïve patients and 1043 (69.6%) were switching from other inhalers. Significant improvements in lung function, disease control and health-related quality of life measures (all p ≤ 0.002) were reported after 12 weeks of Bufomix Easyhaler® use. Improvements were observed in both inhaler-naïve patients and those who switched to a Bufomix Easyhaler® from other devices. After switching, 72.4% of patients regarded the Bufomix Easyhaler® as ‘very good’ and > 90.0% of physicians described the Bufomix Easyhaler® as easy to teach; 73.8% and 98.9% of patients learned the technique within 5 and 10 min of teaching, respectively. Conclusion Twelve weeks’ treatment with the Bufomix Easyhaler® resulted in significant improvements in disease control and quality of life. The Bufomix Easyhaler® was considered easy to use, and most patients were satisfied with the inhaler. Results confirm the real-world effectiveness of the Bufomix Easyhaler® in the treatment of adult outpatients with obstructive airway disease. Funding Orion Corp., Orion Pharma.
      PubDate: 2018-07-31
      DOI: 10.1007/s12325-018-0753-6
  • Pharmacokinetics of a Single Dose of Azilsartan in Pediatric Patients: A
           Phase 3, Open-Label, Multicenter Study
    • Authors: Kazuaki Enya; Ben T. Saji; Takuya Kato; Hiroyuki Okamoto; Emiko Koumura
      Abstract: Introduction Azilsartan is an angiotensin II receptor blocker indicated for the treatment of patients with hypertension. The efficacy and safety of azilsartan are established in adults, but have not been evaluated in pediatric patients, nor has its pharmacokinetic profile been determined in pediatric patients. Methods In this phase 3, open-label, multicenter study, we investigated the pharmacokinetics and safety of single doses of azilsartan in six Japanese patients with hypertension, aged 9–14 years. The dose of azilsartan was 5 mg for three patients weighing less than 50 kg, with mean body weight at baseline of 27.5 kg, and 10 mg for three patients weighing at least 50 kg, with mean body weight at baseline of 65.9 kg. Results Mean maximum plasma concentration (Cmax) of azilsartan was 888.3 and 831.3 ng/mL and median time to maximum concentration (Tmax) of unchanged azilsartan was 3.0 and 4.0 h, in the 5-mg and 10-mg groups, respectively. Mean areas under the plasma concentration–time curve (AUC) from 0–24 h post-dose (AUC0–24) and 0 h to infinity (AUC0–inf) were 6350.3 and 6635.7 ng h/mL, respectively, in the 5-mg group, and 6871.7 and 7433.3 ng h/mL, respectively, in the 10-mg group. Both doses were well tolerated; no treatment-emergent adverse events considered to be related to azilsartan occurred during the study. Conclusion Our data suggest that pediatric patients weighing less than 50 kg may have  approximately 2-fold greater exposure to azilsartan than those weighing at least 50 kg at the same dose. Exposure to azilsartan in children weighing at least 50 kg is comparable to that in healthy adults at the same dose. Trial Registration identifier, NCT02451150. Funding Takeda Pharmaceutical Co. Ltd.
      PubDate: 2018-07-19
      DOI: 10.1007/s12325-018-0754-5
  • Comparison of Characteristics of Benign Prostatic Hyperplasia (BPH)
           Patients Treated with Finasteride and Alpha Blocker Combination Therapy
           Versus Alpha Blocker Monotherapy in China: An Analysis of Electronic
           Medical Record Data
    • Authors: Yanyan Fu; Simeng Han; Li Wang; Wei Gao; Eric Wu; Xian Cao; Jianye Wang
      Abstract: Introduction Benign prostatic hyperplasia (BPH) is commonly treated with 5-alpha-reductase inhibitor/alpha blocker combination therapy or with alpha blocker monotherapy. However, in China, the characteristics of BPH patients receiving 5-alpha-reductase inhibitor/alpha blocker combination therapy or alpha blocker monotherapy remain largely unknown. Therefore, this study compared the characteristics of BPH patients receiving either the 5-alpha-reductase inhibitor finasteride in combination with an alpha blocker or an alpha blocker as monotherapy in clinical practice in China. Methods Data were obtained from a large electronic medical record database from four tertiary hospitals in major cities in China (2009–2016). BPH patients aged ≥ 50 years with ≥ 1 alpha blocker fill on/after the first BPH diagnosis were selected. Patients were further classified as receiving combination therapy (≥ 1 overlapping day of supply for finasteride and an alpha blocker) or alpha blocker monotherapy (did not receive any 5-alpha-reductase inhibitor). Patient characteristics, visit type (in- vs. outpatient) at treatment initiation, and comorbidities were evaluated during the 6-month baseline period and compared between the two groups using two sample t tests and chi-square tests/Fisher’s exact tests. Results A total of 2666 and 2738 patients received combination therapy and monotherapy, respectively. The combination group was older (70.3 vs. 67.3 years, p < 0.0001) and had more patients initiated in an inpatient setting (46.0% vs. 26.4%, p < 0.0001). Compared with the monotherapy group, the combination group had more comorbidities, such as hypertension (48.3% vs. 35.6%, p < 0.0001), cardiovascular disease (65.3% vs. 48.0%, p < 0.0001), and diabetes (21.1% vs. 15.7%, p < 0.0001), and a higher Charlson comorbidity index (0.9 vs. 0.7, p < 0.0001). Conclusion Chinese BPH patients using finasteride/alpha blocker combination therapy were older and had a higher comorbidity burden than those using alpha blocker monotherapy. These findings provide Chinese healthcare decision-makers with a better understanding of the patient characteristics generally associated with BPH combination therapy vs. alpha blocker monotherapy. Funding Merck Sharp and Dohme (China) Co., Ltd., Shanghai, China.
      PubDate: 2018-07-16
      DOI: 10.1007/s12325-018-0748-3
  • Total Joint Arthroplasty in Patients with Inflammatory Rheumatic Diseases
    • Authors: Riccardo Compagnoni; Roberta Gualtierotti; Pietro Randelli
      Abstract: Abstract Since its introduction, total joint arthroplasty (TJA) has improved the quality of life of patients with degenerative joint disorders. In the last decades, a number of conventional and biological disease-modifying antirheumatic drugs have become available for the treatment of patients with inflammatory rheumatic diseases (IRD), leading to a reduction in the need to undergo TJA. However, TJA is still frequently performed in IRD patients. Both rheumatologists and orthopedics should be aware that patients with IRD have a peculiar perioperative risk profile due to disease-related, patient-related, and surgery-related risk factors. On the basis of current evidence, TJA is a safe procedure for IRD patients as long as an accurate risk stratification and a multidisciplinary approach are applied. We here describe the current strategies for an appropriate surgical management of osteoarthritis in IRD patients and the fascinating opening perspectives that surgeons and clinicians may expect in the future.
      PubDate: 2018-07-11
      DOI: 10.1007/s12325-018-0750-9
  • Permacol™ Collagen Paste Injection in Anal Fistula Treatment: A
           Retrospective Study with One-Year Follow-Up
    • Authors: Mehmet Bayrak; Yasemin Altıntas
      Abstract: Introduction This study aimed to evaluate the applicability, safety, results, and functional performance of Permacol™ collagen paste injection in patients with an anal fistula. Methods Thirty-one patients with anal fistula underwent Permacol™ collagen paste injection between February 2015 and February 2017. The patients were followed up for a total of 12 months with recovery conditions monitored at intervals of 3, 6, and 12 months. Preoperative insertion of seton was performed in 15 patients for a period of 6–8 weeks and 2 patients for a period of 12 weeks. Results A trans-sphincteric anal fistula was present in 20 patients and an intersphincteric fistula was present in 11 patients. There was a recurrence in 7 patients (22.5%): 1 patient (3.2%) after 1-month follow-up, 3 patients (9.7%) after 3-month follow-up, 2 patients (6.5%) after 6-month follow-up, and 1 patient (3.2%) after 12-month follow-up. A complete recovery was observed in 24 (77.5%) patients after a 12-month follow-up. The mean Fecal Incontinence Severity Index score was 0.29 ± 0.64 preoperatively and 0.55 ± 1.03 after 12 months. Conclusion In this study, we show that treatment of patients with an anal fistula by injection of Permacol™ is a safe and successful method that does not compromise continence.
      PubDate: 2018-07-02
      DOI: 10.1007/s12325-018-0743-8
  • Pharmacokinetics and Safety of DS-8500a, an Antidiabetic Drug, in Japanese
           Subjects with Hepatic or Renal Impairment: A Single-Center, Open-Label,
           Single-Dose Study
    • Authors: Manabu Kato; Hitoshi Ishizuka; Takashi Taguchi; Kazuhito Shiosakai; Emi Kamiyama; Michio Sata; Takafumi Yoshida
      Abstract: Introduction The pharmacokinetics, safety, and tolerability of DS-8500a (a G protein receptor 119 agonist) up to 100 mg have been investigated in healthy Japanese adults. The objective of this study was to evaluate the effects of hepatic or renal impairment on the pharmacokinetics of a single 25-mg oral dose of DS-8500a. Methods This single-center, open-label study enrolled subjects into eight groups according to hepatic function (normal; mild or moderate impairment) and renal function [normal; mild, moderate, or severe impairment; and end-stage renal disease (ESRD)]. Drug concentrations were measured by liquid-chromatography tandem mass spectrometry. Pharmacokinetic parameters were evaluated by non-compartmental analysis. Adverse events (AEs) were evaluated for safety. Results The hepatic and renal groups enrolled 15 and 30 subjects, respectively. Pharmacokinetic parameters of DS-8500a were comparable between the normal hepatic function and mild hepatic impairment groups, but the mean area under the concentration–time curve (AUC) was 1.37-fold higher, and the half-life was longer in the moderate hepatic impairment group compared with the normal hepatic function group. The maximum concentration (Cmax) and AUC values were 0.704- and 0.609-fold lower, respectively, in the ESRD group compared with the values in the other renal impairment groups; no clear differences in AUC and time to Cmax were observed in the normal function and mild, moderate, and severe renal impairment groups. There was no relationship between apparent total body clearance and estimated glomerular filtration rate. The incidence of AEs was similar among all groups. Conclusion DS-8500a exposure in the mild hepatic impairment and mild to severe renal impairment groups was similar to that in the corresponding normal hepatic and renal function groups, but dose adjustments may be required in those with moderate hepatic impairment and ESRD. Trial registration Japic CTI-No. 163135. Funding Daiichi Sankyo Co. Ltd., Tokyo, Japan.
      PubDate: 2018-07-02
      DOI: 10.1007/s12325-018-0739-4
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