Abstract:
INTRODUCTION:The primary analysis of a global phase 3 study that evaluated the efficacy and safety of denosumab versus zoledronic acid for preventing skeletal-related events (SREs) in adults with newly diagnosed multiple myeloma (MM) indicated that denosumab was noninferior to zoledronic acid for time to first on-study SREs. Here we present a subgroup analysis to evaluate efficacy and safety in Asian patients. METHODS:Patients were randomized 1:1 to receive denosumab 120 mg subcutaneously or zoledronic acid intravenously 4 mg every 4 weeks in a double-blind, double-dummy fashion. All patients received standard-of-care first-line antimyeloma treatment. Each patient received either study drug until an estimated 676 patients experienced at least one on-study SRE and the primary efficacy and safety analyses were completed. RESULTS:Of 1718 total enrolled patients, 196 Asian patients (denosumab, n = 103; zoledronic acid, n = 93) were included in this subgroup analysis. Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group; the crude incidence of SREs at the primary analysis cutoff was 38.8% and 50.5%, respectively (HR [95% CI], 0.77 [0.48-1.26]). All 194 patients receiving at least one dose of study drug experienced at least one treatment-emergent AE. The most common AEs reported in either group (denosumab, zoledronic acid) were diarrhea (51.0%, 51.1%), nausea (42.2%, 46.7%), and pyrexia (38.2%, 41.3%). Treatment-emergent renal toxicity occurred in 9/102 (8.8%) and 20/92 (21.7%) patients, respectively. Similar rates of positively adjudicated osteonecrosis of the jaw (7 [6.9%] vs 5 [5.4%]) and treatment-emergent hypocalcemia (19 [18.6%] vs 17 [18.5%]) were reported in the denosumab and zoledronic acid groups, respectively. CONCLUSION:Efficacy and safety outcomes from this Asian subgroup were comparable to those of the full study population. Overall, this analysis supports denosumab as an additional treatment option for standard of care for Asian patients with newly diagnosed MM with lytic bone lesions. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov NCT01345019.
journal_name
Adv Therjournal_title
Advances in therapyauthors
Huang SY,Yoon SS,Shimizu K,Chng WJ,Chang CS,Wong RS,Gao S,Wang Y,Gordon SW,Glennane A,Min CKdoi
10.1007/s12325-020-01395-xsubject
Has Abstractpub_date
2020-07-01 00:00:00pages
3404-3416issue
7eissn
0741-238Xissn
1865-8652pii
10.1007/s12325-020-01395-xjournal_volume
37pub_type
杂志文章,随机对照试验abstract::As head and neck squamous cell carcinoma (HNSCC) patients with distant metastases (DM) were generally treated only palliatively, the value of screening for DM was usually limited to attempts to avoid extensive locoregional treatment when DM were present pretreatment. Recently, the concept of treating oligometastases, ...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-018-0662-8
更新日期:2018-02-01 00:00:00
abstract::Cardiovascular diseases (CVDs) are the leading cause of premature deaths globally and in Ukraine. Dyslipidemia is a recognized risk factor for the development of CVD. Therefore, early detection and appropriate management of dyslipidemia are essential for the primary prevention of CVDs. However, currently, there is a l...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-020-01490-z
更新日期:2020-11-01 00:00:00
abstract:BACKGROUND:It is hypothesized that diabetes mellitus (DM) and mood disorders share points of pathophysiological commonality in the central nervous system. METHODS:A PubMed search of all English-language articles published between 1966 and March 2009 was performed with the following search terms: depression, mood disor...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-010-0011-z
更新日期:2010-02-01 00:00:00
abstract::In the past 15 years, improvements in the treatment of HIV infection have dramatically reduced morbidity and mortality. Nucleoside reverse transcriptase inhibitors are the backbone of combination antiretroviral therapy for the treatment of HIV. One of the recommended and commonly used therapies in this class is the on...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-010-0006-9
更新日期:2010-01-01 00:00:00
abstract::Some patients with interstitial lung diseases (ILDs) other than idiopathic pulmonary fibrosis exhibit a progressive clinical phenotype. These chronic progressive fibrosing ILDs have a variety of underlying diseases, and their prevalence is currently unknown. Here we carry out the first systematic review of literature ...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-020-01578-6
更新日期:2020-12-14 00:00:00
abstract::Intensive postremission chemotherapy has produced disease-free survival comparable to that of bone marrow transplantation in patients with acute myelogenous leukemia (AML), but its efficacy was unknown in Taiwan. We assessed the efficacy of intensive postremission chemotherapy, consisting of high-dose arabinoside-C (H...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02852390
更新日期:2001-03-01 00:00:00
abstract:INTRODUCTION:Oxycodone is one of the most commonly used opioid analgesics in the clinical management of pain. The present retrospective analysis aimed to determine the dose of oxycodone that could achieve effective control of moderate pain when combined with a fixed dose of acetaminophen, and the time required to reach...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-016-0339-0
更新日期:2016-06-01 00:00:00
abstract:INTRODUCTION:The 1100delC CHEK2 allele has been associated with a 1.4-to 4.7-fold increased risk of breast cancer in women carrying this mutation. Our study investigated the frequency of this allele in a Chinese population. METHODS:Using touchdown polymerase chain reaction, we sequenced the CHEK2.1100delC mutation in ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-008-0057-3
更新日期:2008-05-01 00:00:00
abstract::Pregnancy in adolescence has been and continues to be a problem in public health. The purpose of this study was to investigate obstetric outcomes of adolescent pregnancies in Samsun, Turkey. A cross-sectional study was conducted between January 1 and December 31, 2004, at 3 hospitals in Samsun, Turkey. Of the 10,100 w...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02849957
更新日期:2005-11-01 00:00:00
abstract:INTRODUCTION:The 21-gene breast cancer assay (Oncotype DX(®); Genomic Health, Inc.) is a validated diagnostic test that predicts the likelihood of adjuvant chemotherapy benefit and 10-year risk of distant recurrence in patients with hormone-receptor-positive, human epidermal growth receptor 2-negative, early-stage brea...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-015-0190-8
更新日期:2015-03-01 00:00:00
abstract:INTRODUCTION:Data regarding the prevalence of immune thrombocytopenia (ITP) is limited, and is derived from North American population-based analyses. Therefore, the authors conducted the first study outside the United States (US) using the United Kingdom (UK) General Practice Research Database (GPRD) to estimate the ad...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-011-0084-3
更新日期:2011-12-01 00:00:00
abstract::Complicated urinary tract infection (UTI), which often requires hospitalization or prolongs a hospital stay, presents numerous diagnostic and therapeutic challenges. Implementation of effective antimicrobial treatment is vital because of the risk of adverse sequelae due to persistence of infection, relapse, or reinfec...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:
更新日期:1995-07-01 00:00:00
abstract::Unfortunately, the fourteenth author's name was incorrectly published in the Original Article. The correct author name is Cen Hong. ...
journal_title:Advances in therapy
pub_type: 已发布勘误
doi:10.1007/s12325-019-01009-1
更新日期:2019-08-01 00:00:00
abstract::The article "A Relative Cost of Control Analysis of Once-Weekly Semaglutide Versus Exenatide Extended-Release and Dulaglutide for Bringing Patients to HbA1c and Weight Loss Treatment Targets in the USA", written by Pierre Johansen, Barnaby Hunt, Neeraj N. Iyer, Tam Dang-Tan, Richard F. Pollock was originally published...
journal_title:Advances in therapy
pub_type: 已发布勘误
doi:10.1007/s12325-019-00945-2
更新日期:2019-05-01 00:00:00
abstract:INTRODUCTION:Real-world data are sparse on longitudinal associations of opioid use with pain interference with activities (PIA) and daily function with osteoarthritis (OA) in the USA. METHODS:Data from the 2010-2015 Medical Expenditure Panel Surveys were analyzed for community-dwelling adults with OA. Opioid use patte...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-019-01200-4
更新日期:2020-02-01 00:00:00
abstract:INTRODUCTION:The purpose of the study was to conduct a cost-effectiveness analysis and budget impact analysis comparing lopinavir with ritonavir (LPV/r) and atazanavir plus ritonavir (ATV+RTV) for antiretroviral-naïve patients with a baseline CD4+ T-cell distribution and total cholesterol (TC) profile as reported in th...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-008-0141-8
更新日期:2009-02-01 00:00:00
abstract:INTRODUCTION:The European Medicines Agency (EMA) requires vaccine manufacturers to conduct enhanced safety surveillance (ESS) of seasonal influenza vaccines including a near real-time evaluation of collected data. The objective was to identify whether the use of passive surveillance or active surveillance provides diff...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-018-0747-4
更新日期:2018-08-01 00:00:00
abstract:INTRODUCTION:The traditional model of evaluating treatments based primarily on primary outcome measures has stumbled in its application to rare disease. Rare disease clinical trials face the methodological challenges of small, heterogeneous patient populations and relatively few validated, disease-specific outcome meas...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-019-00920-x
更新日期:2019-05-01 00:00:00
abstract:INTRODUCTION:Idiopathic pulmonary fibrosis (IPF) is the classic progressive fibrosing interstitial lung disease (ILD), but some patients with ILDs other than IPF also develop a progressive fibrosing phenotype (PF-ILD). Information on use and cost of healthcare resources in patients with PF-ILD is limited. METHODS:We u...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01380-4
更新日期:2020-07-01 00:00:00
abstract::The analgesic properties of 2 antiemetic agents--metoclopramide and ondansetron--were investigated in studies which showed that metoclopramide may decrease postoperative opioid requirements, but the analgesic effect of ondansetron is controversial. The postoperative effects of metoclopramide and ondansetron on pain in...
journal_title:Advances in therapy
pub_type: 杂志文章,随机对照试验
doi:10.1007/BF02850080
更新日期:2005-07-01 00:00:00
abstract:INTRODUCTION:An 8-week trial of amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCTZ) for moderate or severe hypertension demonstrated more-pronounced blood pressure (BP)-lowering effects compared with dual-component therapies. To elucidate the effects of time and baseline BP on the observed responses, exploratory an...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1007/s12325-009-0077-7
更新日期:2009-11-01 00:00:00
abstract:INTRODUCTION:Infantile hemangiomas (IH) are the most common benign vascular tumors of childhood, with an incidence of 5-10% during the first year of age. Propranolol is considered the first-line treatment for this condition. Potentially there is a high probability of negative results to therapy, because in many countri...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-016-0391-9
更新日期:2016-10-01 00:00:00
abstract::This study was conducted to assess clinical and cost outcomes associated with the use of daptomycin. This objective was addressed through a consecutive patient chart review of the first 50 inpatients treated with daptomycin. Type of infection, identity of isolated pathogens, prior therapy, duration of therapy, length ...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
doi:10.1007/BF02848774
更新日期:2007-05-01 00:00:00
abstract::Two patients with thalassemia minor and end-stage renal failure on hemodialysis were treated with epoetin zeta (Silapo, Retacrit; STADA, Germany), a medicinal product that was developed and registered as biosimilar to epoetin alfa. Dosing was titrated individually for two patients to achieve a stable hemoglobin (Hb) c...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-008-0119-6
更新日期:2008-12-01 00:00:00
abstract:BACKGROUND:The OPTIMA© (MSD, Courbevoie, France) questionnaire was developed to promote shared decisions and the set-up of specific micro-objectives in clinical practice by optimizing communication between type 2 diabetes (T2DM) patients and their physicians. The present study aimed to assess OPTIMA in clinical practic...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
doi:10.1007/s12325-016-0341-6
更新日期:2016-06-01 00:00:00
abstract:INTRODUCTION:The healthcare sector contributes 5-8% of the global greenhouse gas emissions. Global and regional organizations and governments have started to design and implement measures to reduce global greenhouse gas emissions in the healthcare sector, e.g. by green public procurement policies and inclusion of ecolo...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-019-01114-1
更新日期:2019-12-01 00:00:00
abstract::Available data from comparative trials involving 483 patients were analyzed to determine the rate of infectious morbidity following the use of absorbable staples versus traditional incision and suturing of the vaginal cuff in abdominal hysterectomy. Infections occurred in 24 of 268 (9%) patients who received absorbab...
journal_title:Advances in therapy
pub_type: 杂志文章,meta分析
doi:
更新日期:1991-05-01 00:00:00
abstract:INTRODUCTION:A combination of magnetic resonance imaging (MRI) with real-time high-resolution ultrasound (US) known as fusion imaging may improve visualization of musculoskeletal (MSK) sports medicine injuries. The aim of this study was to evaluate the applicability of MRI-US fusion technology in MSK sports medicine. ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-015-0217-1
更新日期:2015-06-01 00:00:00
abstract:INTRODUCTION:The findings of many new cardiology clinical trials over the last year have been published or presented at major international meetings. This paper aims to describe and place in context a summary of the key clinical trials in cardiology presented between January and December 2016. METHODS:The authors revi...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-017-0560-5
更新日期:2017-07-01 00:00:00
abstract:INTRODUCTION:ARTOS was an international, prospective, non-interventional, non-controlled observational study designed to determine the effectiveness, safety, and tolerability of moxifloxacin under daily-life conditions in patients with complicated skin and skin structure infections (cSSSIs) treated in Europe, the Middl...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-013-0038-z
更新日期:2013-06-01 00:00:00