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 different results of reported adverse events of interest (AEIs) by specified age strata and AEI type. We report the weekly incidence rates of AEIs within 7 days following seasonal influenza vaccination using passive and active surveillance. METHODS:AEIs were collected within 7 days of vaccination from ten general practices predominantly administering inactivated quadrivalent influenza vaccine (IIV4, Fluarix Tetra, GSK). Vaccinees completed an adverse drug reaction (ADR) card. ADR card and medically attended AEIs data were recorded in practice electronic health records. We report the outcome of the first 5 weeks of safety surveillance (September 12, 2016-October 16, 2016); in an exploratory analysis, rates of AEI for IIV4 are compared to those passively reported through a sentinel network. RESULTS:Practices vaccinated 13.1% (12,864/98,091) of their registered population; 5.6% (95% CI 5.20-6.00) of them reported AEIs, none serious. The most frequent were respiratory 2.60% (95% CI 2.33-2.88), musculoskeletal 1.82% (95% CI 1.59-2.05) and neurological 1.05% (95% CI 0.88-1.23). AEIs were more frequently reported for adults than for children; 5.91% (95% CI 5.49-6.34) compared to 1.49% (95% CI 0.69-2.29); 47.18% of the adults reported AEI using the ADR card, none were returned for subjects < 18 years old. The frequency of AEIs reporting was higher, 6.88% (95% CI 6.35-7.42) vs. 3.30% (95% CI 2.68-3.96, 100/3028, p < 0.000), through ESS than passive surveillance. CONCLUSION:The ESS did not reveal any safety signal and we demonstrated the feasibility of conducting ESS following EMA recommendations. The use of a customised ADR card led to a doubling of AEIs reports over passive surveillance in adults. FUNDING:GlaxoSmithKline Biologicals SA, Wavre, Belgium.
journal_name
Adv Therjournal_title
Advances in therapyauthors
de Lusignan S,Dos Santos G,Byford R,Schuind A,Damaso S,Shende V,McGee C,Yonova I,Ferreira Fdoi
10.1007/s12325-018-0747-4subject
Has Abstractpub_date
2018-08-01 00:00:00pages
1199-1214issue
8eissn
0741-238Xissn
1865-8652pii
10.1007/s12325-018-0747-4journal_volume
35pub_type
杂志文章abstract::Blood pressure lowering by all classes of antihypertensive drugs is accompanied by significant reductions of stroke and major cardiovascular (CV) events. Drugs acting on the renin-angiotensin-aldosterone system, such as angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), showed s...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-018-0859-x
更新日期:2019-02-01 00:00:00
abstract::The lipid-lowering effect of a carob pulp preparation rich in insoluble dietary fiber and polyphenols was investigated in a noncomparative, open-label pilot study. Over 8 weeks, 47 volunteers with moderate hypercholesterolemia (total cholesterol 232-302 mg/dL) consumed 15 g of carob per day in three products (breakfas...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02853169
更新日期:2001-09-01 00:00:00
abstract::Polycystic ovary syndrome (PCOS) affects 6-10% of women and could be considered one of the most common endocrine alterations in women of reproductive age. The syndrome is characterized by several hormonal and metabolic alterations, including insulin resistance and hyperandrogenism, which play a severe detrimental role...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-018-0810-1
更新日期:2018-11-01 00:00:00
abstract:INTRODUCTION:Wet age-related macular degeneration (AMD) is a chronic eye condition that causes severe deterioration of vision and even blindness. Current wet AMD treatment in the UK involves the vascular endothelial growth factor inhibitors ranibizumab and aflibercept. Patients with wet AMD require frequent and long-te...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-016-0367-9
更新日期:2016-09-01 00:00:00
abstract:INTRODUCTION:It is unclear whether patients and their loved ones appreciate that cardiovascular disease (CVD) is the major cause of morbidity and mortality in type 2 diabetes mellitus (T2DM). The purpose of this survey was to evaluate the degree of awareness regarding the link between T2DM and CVD. METHODS:An online s...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-019-0871-9
更新日期:2019-03-01 00:00:00
abstract::Bacterial translocation is the passage of bacteria or endotoxins from the gastrointestinal tract to extraintestinal sites, such as mesenteric lymph nodes, liver, spleen, and bloodstream. In this study, the investigators examined the effects of various enteral nutrients on bacterial translocation and intestinal morphol...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02849991
更新日期:2007-01-01 00:00:00
abstract:INTRODUCTION:To compare the 24-h intraocular pressure (IOP) control and tolerability of travoprost/timolol benzalkonium chloride (BAK)-free (TTFC) vs. latanoprost/timolol fixed combination preserved with BAK (LTFC) in open-angle glaucoma patients insufficiently controlled with latanoprost 0.005% monotherapy given once ...
journal_title:Advances in therapy
pub_type: 杂志文章,随机对照试验
doi:10.1007/s12325-014-0125-9
更新日期:2014-06-01 00:00:00
abstract:INTRODUCTION:The aim of this study was to evaluate the effectiveness of re-education in the insulin injection technique for glycemic control. METHODS:A preliminary experimental study was performed with 87 insulin-treated diabetic outpatients (11 with type 1 diabetes, 76 with type 2 diabetes; 43 men, 44 women). All pat...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-013-0066-8
更新日期:2013-10-01 00:00:00
abstract:INTRODUCTION:To assess the impact of certolizumab pegol (CZP) treatment on clinical, patient-reported, and musculoskeletal ultrasound outcomes and to determine the treatment response time point most predictive of long-term outcomes in Italian patients with rheumatoid arthritis (RA). METHODS:CZP-SPEED (NCT01443364) was...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1007/s12325-018-0751-8
更新日期:2018-08-01 00:00:00
abstract:INTRODUCTION:Glucagon-like peptide 1 (GLP-1) receptor agonists (RAs) approved to date are administered by injection; therefore, patient perceptions of an oral GLP-1 RA are unknown. This discrete choice experiment explored preferences for (unbranded) oral and injectable GLP-1 RA profiles among Japanese patients with typ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01561-1
更新日期:2020-11-27 00:00:00
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-reporte...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-018-0742-9
更新日期:2018-09-01 00:00:00
abstract:INTRODUCTION:Osteoarthritis is a chronic rheumatoid disease mediated by metalloproteinases and inflammatory cytokines. Methylsulfonylmethane (MSM) and boswellic acids (BA) each show promise in the treatment of inflammatory processes, but the efficacy of combined treatment with these substances in the treatment of arthr...
journal_title:Advances in therapy
pub_type: 杂志文章,随机对照试验
doi:10.1007/s12325-011-0068-3
更新日期:2011-10-01 00:00:00
abstract:PURPOSE:To compare the efficacy and safety of combined cataract extraction and either excisional goniotomy performed with the Kahook Dual Blade (KDB; phaco-KDB group) or single iStent trabecular bypass implantation (phaco-iStent group) in eyes with mild to moderate glaucoma and visually significant cataract. METHODS:T...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-019-01025-1
更新日期:2019-09-01 00:00:00
abstract::Shock is a serious acute circulatory failure leading to inadequate oxygen delivery to the cells. Its treatment is mainly based on circulating fluid optimization, and vasopressors to provide an adequate mean arterial pressure and microcirculatory flow. Norepinephrine is the drug of choice, but high dosages may be respo...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-020-01422-x
更新日期:2020-09-01 00:00:00
abstract:INTRODUCTION:This study aims to evaluate the early predictive value for postoperative sepsis and 30-day mortality in liver transplant patients using sequential organ failure assessment (SOFA). METHODS:A total of 96 liver transplant patients were enrolled into this study from February 2015 to June 2018. The general inf...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-019-0889-z
更新日期:2019-03-01 00:00:00
abstract::X-linked hypophosphataemia (XLH) is the most prevalent form of hereditary rickets characterized by an alteration of phosphate metabolism which frequently leads to the appearance of fractures, bone deformities and growth delay. Although the mechanism of growth impairment in patients with XLH still needs to be clarified...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-019-01178-z
更新日期:2020-05-01 00:00:00
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 monoth...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-018-0748-3
更新日期:2018-08-01 00:00:00
abstract:INTRODUCTION:Randomized controlled trials and real-world data from the USA have shown similar glycemic control with insulin glargine 300 U/ml (Gla-300) and insulin glargine 100 U/ml (Gla-100) and reduced hypoglycemia risk with Gla-300. This real-world study describes the efficacy and safety of Gla-300 and Gla-100 in pa...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01436-5
更新日期:2020-09-01 00:00:00
abstract:PURPOSE:A recent successful clinical trial demonstrated that a less invasive cell-injection procedure is a viable medical modality for treating corneal endothelial dystrophy. This medical advance still relies on human corneal endothelial cell (HCEC) sources derived from rare cornea donations. The progenitor of the corn...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-020-01237-w
更新日期:2020-03-01 00:00:00
abstract:INTRODUCTION:Sevelamer hydrochloride (SH) and lanthanum carbonate (LC) are calcium-free phosphate binders used for the management of hyperphosphatemia in patients with end-stage renal disease (ESRD). The objective of this analysis was to evaluate the real-world dose-relativity between SH and LC monotherapy in US patien...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
doi:10.1007/s12325-013-0077-5
更新日期:2013-12-01 00:00:00
abstract::Ambulatory monitoring was used to evaluate the antihypertensive efficacy and effect on circadian rhythms of blood pressure and heart rate of a single dose and long-term administration of ramipril in 20 patients with mild to moderate essential hypertension. Patients initially were randomized to receive either placebo o...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章,随机对照试验
doi:
更新日期:1995-01-01 00:00:00
abstract:INTRODUCTION:This study of UK patients examines clinical, health-related quality of life (HRQOL) and economic outcomes associated with iron chelation therapy (ICT). Desferrioxamine (DFO) (Desferal; Novartis, Switzerland) and Deferiprone (Ferriprox; Apotex, Canada) are ICTs used to treat iron overload. DFO requires 8-to...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-008-0085-z
更新日期:2008-08-01 00:00:00
abstract:INTRODUCTION:New inhalers propelled by hydrofluoroalkanes (HFAs) have improved plume characteristics: higher fine particle fraction, and warmer plumes with reduced force and velocity. Together, this may avoid reflex interruption of inhalation and improve lung deposition of the inhaled drugs. However, even with HFA-prop...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-015-0219-z
更新日期:2015-06-01 00:00:00
abstract::Treating hyperglycemia is a critical aspect of managing type 2 diabetes mellitus (T2DM), but can be especially challenging in patients from vulnerable groups such as those with chronic kidney disease, African Americans, and older people. The dipeptidyl peptidase (DPP)-4 inhibitors are relatively new oral antidiabetes ...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-013-0071-y
更新日期:2013-12-01 00:00:00
abstract:INTRODUCTION:To evaluate long-term outcomes following stand-alone implantation of two second-generation trabecular micro-bypass stents (iStent inject®, Glaukos Corp., San Clemente, CA, USA) in eyes with predominantly primary open-angle glaucoma (POAG) and considerable preoperative disease burden. METHODS:Eyes with POA...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-019-00984-9
更新日期:2019-07-01 00:00:00
abstract:INTRODUCTION:Prostate cancer (PC) is the second leading cause of cancer death among US men and accounts for considerable healthcare expenditures. We evaluated economic outcomes in men with chemotherapy-naïve metastatic castration-resistant PC (mCRPC) treated with enzalutamide or abiraterone acetate plus prednisone (abi...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01260-x
更新日期:2020-05-01 00:00:00
abstract:INTRODUCTION:The aim of this analysis was to characterize the safety and tolerability of empagliflozin in patients with type 2 diabetes mellitus (T2DM) who were randomized to empagliflozin (10/25 mg) or placebo in clinical trials. METHODS:Pooled data from 20 trials were analyzed for patients with T2DM treated with emp...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01329-7
更新日期:2020-08-01 00:00:00
abstract:INTRODUCTION:This retrospective study used data from a primary care database to compare two insulin products in routine clinical practice for the treatment of type 2 diabetes in the UK. PATIENTS AND METHODS:Records were analyzed for patients with type 2 diabetes who had been initiated on biphasic insulin aspart 30 (BI...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-010-0079-5
更新日期:2010-11-01 00:00:00
abstract::The improvement of glycemic control in patients with type 2 diabetes (T2D) is an urgent need in Asia. East Asian T2D patients have distinct characteristics, including relatively low body weight, early impairment of islet beta cell function with reduced insulin secretion and a marked increase in postprandial blood gluc...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-019-00914-9
更新日期:2019-04-01 00:00:00
abstract:INTRODUCTION:The aim of this study was to assess the efficacy and safety of esomeprazole 40 mg once daily (q.d.) in healing reflux oesophagitis at 4 and 8 weeks, and the efficacy of esomeprazole 20 mg q.d. for 12 weeks in the maintenance of remission. METHODS:A total of 235 patients with endoscopically proven reflux o...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1007/s12325-008-0071-5
更新日期:2008-06-01 00:00:00