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Journal Cover The Lancet
  [SJR: 11.563]   [H-I: 514]   [1523 followers]  Follow
    
   Full-text available via subscription Subscription journal
   ISSN (Print) 0140-6736 - ISSN (Online) 1474-547X
   Published by Elsevier Homepage  [2817 journals]
  • Bipolar disorder
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Iria Grande, Michael Berk, Boris Birmaher, Eduard Vieta
      Bipolar disorder is a recurrent chronic disorder characterised by fluctuations in mood state and energy. It affects more than 1% of the world's population irrespective of nationality, ethnic origin, or socioeconomic status. Bipolar disorder is one of the main causes of disability among young people, leading to cognitive and functional impairment and raised mortality, particularly death by suicide. A high prevalence of psychiatric and medical comorbidities is typical in affected individuals. Accurate diagnosis of bipolar disorder is difficult in clinical practice because onset is most commonly a depressive episode and looks similar to unipolar depression. Moreover, there are currently no valid biomarkers for the disorder. Therefore, the role of clinical assessment remains key. Detection of hypomanic periods and longitudinal assessment are crucial to differentiate bipolar disorder from other conditions. Current knowledge of the evolving pharmacological and psychological strategies in bipolar disorder is of utmost importance.


      PubDate: 2016-04-09T08:32:19Z
       
  • Daratumumab in multiple myeloma
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): S Vincent Rajkumar



      PubDate: 2016-04-09T08:32:19Z
       
  • Beat diabetes: an urgent call for global action
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): The Lancet



      PubDate: 2016-04-09T08:32:19Z
       
  • UK PrEP decision re-ignites HIV activism
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): The Lancet



      PubDate: 2016-04-09T08:32:19Z
       
  • Ixmyelocel-T for patients with ischaemic heart failure: a prospective
           randomised double-blind trial
    • Abstract: Publication date: Available online 5 April 2016
      Source:The Lancet
      Author(s): Amit N Patel, Timothy D Henry, Arshed A Quyyumi, Gary L Schaer, R David Anderson, Catalin Toma, Cara East, Ann E Remmers, James Goodrich, Akshay S Desai, David Recker, Anthony DeMaria
      Background Ixmyelocel-T is an expanded, multicellular therapy produced from a patient's own bone marrow by selectively expanding two key types of bone marrow mononuclear cells: CD90+ mesenchymal stem cells and CD45+ CD14+ auto-fluorescent+ activated macrophages. Early phase clinical trials suggest that intramyocardial delivery of ixmyelocel-T might improve clinical, functional, symptomatic, and quality-of-life outcomes in patients with heart failure due to ischaemic dilated cardiomyopathy. We aimed to assess the safety and efficacy of catheter-based transendocardial injection of ixmyelocel-T cell therapy in patients with heart failure and reduced ejection fractions. Methods In this randomised, double-blind, placebo-controlled phase 2B trial (ixCELL-DCM), patients from 31 sites in North America with New York Heart Association class III or IV symptomatic heart failure due to ischaemic dilated cardiomyopathy, who had left ventricular ejection fraction 35% or less, an automatic implantable cardioverter defibrillator, and who were ineligible for revascularisation procedures were randomly assigned (1:1) to receive ixmyelocel-T or placebo at the time of bone marrow aspiration and followed for 12 months. Randomisation was done through an interactive (voice/web) response system. The pharmacist, treating physician, and coordinator at each site were unblinded, but the the follow-up team was completely blinded. The primary endpoint was a composite of all-cause death, cardiovascular admission to hospital, and unplanned clinic visits to treat acute decompensated heart failure based on the blinded adjudication of an independent clinical endpoint committee. Primary efficacy endpoint analyses and safety analyses were done by modified intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01670981. Findings Between April 2, 2013, and Jan 28, 2015, 126 participants were randomly assigned to receive either ixmyelocel-T (n=60) or placebo (n=66). 114 (90%) patients comprised the modified intention-to-treat population and 109 (87%) patients were included in the per-protocol primary efficacy analysis (58 in the ixmyelocel-T group and 51 in the placebo group). The primary efficacy endpoint was observed in 47 patients: 50 events in 25 (49%) of 51 patients in the placebo group and 38 events in 22 (38%) of 58 patients in the ixmyelocel-T group, which represents a 37% reduction in cardiac events compared with placebo (risk ratio 0·63 [95% CI 0·42–0·97]; p=0·0344). 41 (75%) of 51 participants in the placebo group had serious adverse events versus 31 (53%) of 58 in the ixmyelocel-T group (p=0·0197). Interpretation To the best of our knowledge, ixCELL-DCM is the largest cell therapy study done in patients with heart failure so far. The transendocardial delivery of ixmyelocel-T in patients with heart failure and reduced ejection fraction due to ischaemic dilated cardiomyopathy resulted in a significant reduction in adjudicated clinical cardiac events compared with placebo leading to improved patient outcomes. Funding Vericel Corporation.


      PubDate: 2016-04-09T08:32:19Z
       
  • Teratogenic effects of the Zika virus and the role of the placenta
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Jennifer J Adibi, Ernesto T A Marques, Abigail Cartus, Richard H Beigi
      The mechanism by which the Zika virus can cause fetal microcephaly is not known. Reports indicate that Zika is able to evade the normal immunoprotective responses of the placenta. Microcephaly has genetic causes, some associated with maternal exposures including radiation, tobacco smoke, alcohol, and viruses. Two hypotheses regarding the role of the placenta are possible: one is that the placenta directly conveys the Zika virus to the early embryo or fetus. Alternatively, the placenta itself might be mounting a response to the exposure; this response might be contributing to or causing the brain defect. This distinction is crucial to the diagnosis of fetuses at risk and the design of therapeutic strategies to prevent Zika-induced teratogenesis.


      PubDate: 2016-04-09T08:32:19Z
       
  • An unexpected finding in an asymptomatic patient with atrial fibrillation:
           cardiac angiosarcoma
    • Abstract: Publication date: Available online 7 April 2016
      Source:The Lancet
      Author(s): Alfonso Campanile, Guido Tavazzi, Mohammed Harith Alam, Richard Paul, Susanna Price



      PubDate: 2016-04-09T08:32:19Z
       
  • Increasing value and reducing waste in biomedical research: who's
           listening'
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): David Moher, Paul Glasziou, Iain Chalmers, Mona Nasser, Patrick M M Bossuyt, Daniël A Korevaar, Ian D Graham, Philippe Ravaud, Isabelle Boutron
      The biomedical research complex has been estimated to consume almost a quarter of a trillion US dollars every year. Unfortunately, evidence suggests that a high proportion of this sum is avoidably wasted. In 2014, The Lancet published a series of five reviews showing how dividends from the investment in research might be increased from the relevance and priorities of the questions being asked, to how the research is designed, conducted, and reported. 17 recommendations were addressed to five main stakeholders—funders, regulators, journals, academic institutions, and researchers. This Review provides some initial observations on the possible effects of the Series, which seems to have provoked several important discussions and is on the agendas of several key players. Some examples of individual initiatives show ways to reduce waste and increase value in biomedical research. This momentum will probably move strongly across stakeholder groups, if collaborative relationships evolve between key players; further important work is needed to increase research value. A forthcoming meeting in Edinburgh, UK, will provide an initial forum within which to foster the collaboration needed.


      PubDate: 2016-04-09T08:32:19Z
       
  • Daratumumab monotherapy in patients with treatment-refractory multiple
           myeloma (SIRIUS): an open-label, randomised, phase 2 trial
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Sagar Lonial, Brendan M Weiss, Saad Z Usmani, Seema Singhal, Ajai Chari, Nizar J Bahlis, Andrew Belch, Amrita Krishnan, Robert A Vescio, Maria Victoria Mateos, Amitabha Mazumder, Robert Z Orlowski, Heather J Sutherland, Joan Bladé, Emma C Scott, Albert Oriol, Jesus Berdeja, Mecide Gharibo, Don A Stevens, Richard LeBlanc, Michael Sebag, Natalie Callander, Andrzej Jakubowiak, Darrell White, Javier de la Rubia, Paul G Richardson, Steen Lisby, Huaibao Feng, Clarissa M Uhlar, Imran Khan, Tahamtan Ahmadi, Peter M Voorhees
      Background New treatment options are needed for patients with multiple myeloma that is refractory to proteasome inhibitors and immunomodulatory drugs. We assessed daratumumab, a novel CD38-targeted monoclonal antibody, in patients with refractory multiple myeloma. Methods In this open-label, multicentre, phase 2 trial done in Canada, Spain, and the USA, patients (age ≥18 years) with multiple myeloma who were previously treated with at least three lines of therapy (including proteasome inhibitors and immunomodulatory drugs), or were refractory to both proteasome inhibitors and immunomodulatory drugs, were randomly allocated in a 1:1 ratio to receive intravenous daratumumab 8 mg/kg or 16 mg/kg in part 1 stage 1 of the study, to decide the dose for further assessment in part 2. Patients received 8 mg/kg every 4 weeks, or 16 mg/kg per week for 8 weeks (cycles 1 and 2), then every 2 weeks for 16 weeks (cycles 3–6), and then every 4 weeks thereafter (cycle 7 and higher). The allocation schedule was computer-generated and randomisation, with permuted blocks, was done centrally with an interactive web response system. In part 1 stage 2 and part 2, patients received 16 mg/kg dosed as in part 1 stage 1. The primary endpoint was overall response rate (partial response [PR] + very good PR + complete response [CR] + stringent CR). All patients who received at least one dose of daratumumab were included in the analysis. The trial is registered with ClinicalTrials.gov, number NCT01985126. Findings The study is ongoing. In part 1 stage 1 of the study, 18 patients were randomly allocated to the 8 mg/kg group and 16 to the 16 mg/kg group. Findings are reported for the 106 patients who received daratumumab 16 mg/kg in parts 1 and 2. Patients received a median of five previous lines of therapy (range 2–14). 85 (80%) patients had previously received autologous stem cell transplantation, 101 (95%) were refractory to the most recent proteasome inhibitors and immunomodulatory drugs used, and 103 (97%) were refractory to the last line of therapy. Overall responses were noted in 31 patients (29·2%, 95% CI 20·8–38·9)—three (2·8%, 0·6–8·0) had a stringent CR, ten (9·4%, 4·6–16·7) had a very good PR, and 18 (17·0%, 10·4–25·5) had a PR. The median time to first response was 1·0 month (range 0·9–5·6). Median duration of response was 7·4 months (95% CI 5·5–not estimable) and progression-free survival was 3·7 months (95% CI 2·8–4·6). The 12-month overall survival was 64·8% (95% CI 51·2–75·5) and, at a subsequent cutoff, median overall survival was 17·5 months (95% CI 13·7–not estimable). Daratumumab was well tolerated; fatigue (42 [40%] patients) and anaemia (35 [33%]) of any grade were the most common adverse events. No drug-related adverse events led to treatment discontinuation. Interpretation Daratumumab monotherapy showed encouraging efficacy in heavily pretreated and refractory patients with multiple myeloma, with a favourable safety profile in this population of patients. Funding Janssen Research & Development.


      PubDate: 2016-04-09T08:32:19Z
       
  • Can biomarkers balance stroke and bleeding risk'
    • Abstract: Publication date: Available online 4 April 2016
      Source:The Lancet
      Author(s): Paulus Kirchhof, Larissa Fabritz



      PubDate: 2016-04-09T08:32:19Z
       
  • Increases in general practice workload in England
    • Abstract: Publication date: Available online 5 April 2016
      Source:The Lancet
      Author(s): Matthew Thompson, Fiona Walter



      PubDate: 2016-04-09T08:32:19Z
       
  • Use of serological surveys to generate key insights into the changing
           global landscape of infectious disease
    • Abstract: Publication date: Available online 5 April 2016
      Source:The Lancet
      Author(s): C Jessica E Metcalf, Jeremy Farrar, Felicity T Cutts, Nicole E Basta, Andrea L Graham, Justin Lessler, Neil M Ferguson, Donald S Burke, Bryan T Grenfell



      PubDate: 2016-04-09T08:32:19Z
       
  • The novel biomarker-based ABC (age, biomarkers, clinical history)-bleeding
           risk score for patients with atrial fibrillation: a derivation and
           validation study
    • Abstract: Publication date: Available online 4 April 2016
      Source:The Lancet
      Author(s): Ziad Hijazi, Jonas Oldgren, Johan Lindbäck, John H Alexander, Stuart J Connolly, John W Eikelboom, Michael D Ezekowitz, Claes Held, Elaine M Hylek, Renato D Lopes, Agneta Siegbahn, Salim Yusuf, Christopher B Granger, Lars Wallentin
      Background The benefit of oral anticoagulation in atrial fibrillation is based on a balance between reduction in ischaemic stroke and increase in major bleeding. We aimed to develop and validate a new biomarker-based risk score to improve the prognostication of major bleeding in patients with atrial fibrillation. Methods We developed and internally validated a new biomarker-based risk score for major bleeding in 14 537 patients with atrial fibrillation randomised to apixaban versus warfarin in the ARISTOTLE trial and externally validated it in 8468 patients with atrial fibrillation randomised to dabigatran versus warfarin in the RE-LY trial. Plasma samples for determination of candidate biomarker concentrations were obtained at randomisation. Major bleeding events were centrally adjudicated. The predictive values of biomarkers and clinical variables were assessed with Cox regression models. The most important variables were included in the score with weights proportional to the model coefficients. The ARISTOTLE and RE-LY trials are registered with ClinicalTrials.gov, numbers NCT00412984 and NCT00262600, respectively. Findings The most important predictors for major bleeding were the concentrations of the biomarkers growth differentiation factor-15 (GDF-15), high-sensitivity cardiac troponin T (cTnT-hs) and haemoglobin, age, and previous bleeding. The ABC-bleeding score (age, biomarkers [GDF-15, cTnT-hs, and haemoglobin], and clinical history [previous bleeding]) score yielded a higher c-index than the conventional HAS-BLED and the newer ORBIT scores for major bleeding in both the derivation cohort (0·68 [95% CI 0·66–0·70] vs 0·61 [0·59–0·63] vs 0·65 [0·62–0·67], respectively; ABC-bleeding vs HAS-BLED p<0·0001 and ABC-bleeding vs ORBIT p=0·0008). ABC-bleeding score also yielded a higher c-index score in the the external validation cohort (0·71 [95% CI 0·68–0·73] vs 0·62 [0·59–0·64] for HAS-BLED vs 0·68 [0·65–0·70] for ORBIT; ABC-bleeding vs HAS-BLED p<0·0001 and ABC-bleeding vs ORBIT p=0·0016). A modified ABC-bleeding score using alternative biomarkers (haematocrit, cTnI-hs, cystatin C, or creatinine clearance) also outperformed the HAS-BLED and ORBIT scores. Interpretation The ABC-bleeding score, using age, history of bleeding, and three biomarkers (haemoglobin, cTn-hs, and GDF-15 or cystatin C/CKD-EPI) was internally and externally validated and calibrated in large cohorts of patients with atrial fibrillation receiving anticoagulation therapy. The ABC-bleeding score performed better than HAS-BLED and ORBIT scores and should be useful as decision support on anticoagulation treatment in patients with atrial fibrillation. Funding BMS, Pfizer, Boehringer Ingelheim, Roche Diagnostics.


      PubDate: 2016-04-09T08:32:19Z
       
  • Clinical workload in UK primary care: a retrospective analysis of 100
           million consultations in England, 2007–14
    • Abstract: Publication date: Available online 5 April 2016
      Source:The Lancet
      Author(s): F D Richard Hobbs, Clare Bankhead, Toqir Mukhtar, Sarah Stevens, Rafael Perera-Salazar, Tim Holt, Chris Salisbury
      Background Primary care is the main source of health care in many health systems, including the UK National Health Service (NHS), but few objective data exist for the volume and nature of primary care activity. With rising concerns that NHS primary care workload has increased substantially, we aimed to assess the direct clinical workload of general practitioners (GPs) and practice nurses in primary care in the UK. Methods We did a retrospective analysis of GP and nurse consultations of non-temporary patients registered at 398 English general practices between April, 2007, and March, 2014. We used data from electronic health records routinely entered in the Clinical Practice Research Datalink, and linked CPRD data to national datasets. Trends in age-standardised and sex-standardised consultation rates were modelled with joinpoint regression analysis. Findings The dataset comprised 101 818 352 consultations and 20 626 297 person-years of observation. The crude annual consultation rate per person increased by 10·51%, from 4·67 in 2007–08, to 5·16 in 2013–14. Consultation rates were highest in infants (age 0–4 years) and elderly people (≥85 years), and were higher for female patients than for male patients of all ages. The greatest increases in age-standardised and sex-standardised rates were in GPs, with a rise of 12·36% per 10 000 person-years, compared with 0·9% for practice nurses. GP telephone consultation rates doubled, compared with a 5·20% rise in surgery consultations, which accounted for 90% of all consultations. The mean duration of GP surgery consultations increased by 6·7%, from 8·65 min (95% CI 8·64–8·65) to 9·22 min (9·22–9·23), and overall workload increased by 16%. Interpretation Our findings show a substantial increase in practice consultation rates, average consultation duration, and total patient-facing clinical workload in English general practice. These results suggest that English primary care as currently delivered could be reaching saturation point. Notably, our data only explore direct clinical workload and not indirect activities and professional duties, which have probably also increased. This and additional research questions, including the outcomes of workload changes on other sectors of health care, need urgent answers for primary care provision internationally. Funding Department of Health Policy Research Programme.


      PubDate: 2016-04-09T08:32:19Z
       
  • IxCELL-DCM: rejuvenation for cardiac regenerative therapy'
    • Abstract: Publication date: Available online 5 April 2016
      Source:The Lancet
      Author(s): Thomas J Povsic, Andreas M Zeiher



      PubDate: 2016-04-09T08:32:19Z
       
  • Zika virus and Guillain-Barré syndrome: another viral cause to add to
           the list
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): David W Smith, John Mackenzie



      PubDate: 2016-04-09T08:32:19Z
       
  • Are we ready for immune checkpoint inhibitors for advanced non-small-cell
           lung cancer'
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Tony S K Mok, Herbert H Loong



      PubDate: 2016-04-09T08:32:19Z
       
  • Pembrolizumab versus docetaxel for previously treated, PD-L1-positive,
           advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled
           trial
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Roy S Herbst, Paul Baas, Dong-Wan Kim, Enriqueta Felip, José L Pérez-Gracia, Ji-Youn Han, Julian Molina, Joo-Hang Kim, Catherine Dubos Arvis, Myung-Ju Ahn, Margarita Majem, Mary J Fidler, Gilberto de Castro, Marcelo Garrido, Gregory M Lubiniecki, Yue Shentu, Ellie Im, Marisa Dolled-Filhart, Edward B Garon
      Background Despite recent advances in the treatment of advanced non-small-cell lung cancer, there remains a need for effective treatments for progressive disease. We assessed the efficacy of pembrolizumab for patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer. Methods We did this randomised, open-label, phase 2/3 study at 202 academic medical centres in 24 countries. Patients with previously treated non-small-cell lung cancer with PD-L1 expression on at least 1% of tumour cells were randomly assigned (1:1:1) in blocks of six per stratum with an interactive voice-response system to receive pembrolizumab 2 mg/kg, pembrolizumab 10 mg/kg, or docetaxel 75 mg/m2 every 3 weeks. The primary endpoints were overall survival and progression-free survival both in the total population and in patients with PD-L1 expression on at least 50% of tumour cells. We used a threshold for significance of p<0·00825 (one-sided) for the analysis of overall survival and a threshold of p<0·001 for progression-free survival. This trial is registered at ClinicalTrials.gov, number NCT01905657. Findings Between Aug 28, 2013, and Feb 27, 2015, we enrolled 1034 patients: 345 allocated to pembrolizumab 2 mg/kg, 346 allocated to pembrolizumab 10 mg/kg, and 343 allocated to docetaxel. By Sept 30, 2015, 521 patients had died. In the total population, median overall survival was 10·4 months with pembrolizumab 2 mg/kg, 12·7 months with pembrolizumab 10 mg/kg, and 8·5 months with docetaxel. Overall survival was significantly longer for pembrolizumab 2 mg/kg versus docetaxel (hazard ratio [HR] 0·71, 95% CI 0·58–0·88; p=0·0008) and for pembrolizumab 10 mg/kg versus docetaxel (0·61, 0·49–0·75; p<0·0001). Median progression-free survival was 3·9 months with pembrolizumab 2 mg/kg, 4·0 months with pembrolizumab 10 mg/kg, and 4·0 months with docetaxel, with no significant difference for pembrolizumab 2 mg/kg versus docetaxel (0·88, 0·74–1·05; p=0·07) or for pembrolizumab 10 mg/kg versus docetaxel (HR 0·79, 95% CI 0·66–0·94; p=0·004). Among patients with at least 50% of tumour cells expressing PD-L1, overall survival was significantly longer with pembrolizumab 2 mg/kg than with docetaxel (median 14·9 months vs 8·2 months; HR 0·54, 95% CI 0·38–0·77; p=0·0002) and with pembrolizumab 10 mg/kg than with docetaxel (17·3 months vs 8·2 months; 0·50, 0·36–0·70; p<0·0001). Likewise, for this patient population, progression-free survival was significantly longer with pembrolizumab 2 mg/kg than with docetaxel (median 5·0 months vs 4·1 months; HR 0·59, 95% CI 0·44–0·78; p=0·0001) and with pembrolizumab 10 mg/kg than with docetaxel (5·2 months vs 4·1 months; 0·59, 0·45–0·78; p<0·0001). Grade 3–5 treatment-related adverse events were less common with pembrolizumab than with docetaxel (43 [13%] of 339 patients given 2 mg/kg, 55 [16%] of 343 given 10 mg/kg, and 109 [35%] of 309 given docetaxel). Interpretation Pembrolizumab prolongs overall survival and has a favourable benefit-to-risk profile in patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer. These data establish pembrolizumab as a new treatment option for this population and validate the use of PD-L1 selection. Funding Merck & Co.


      PubDate: 2016-04-09T08:32:19Z
       
  • Guillain-Barré Syndrome outbreak associated with Zika virus infection
           in French Polynesia: a case-control study
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Van-Mai Cao-Lormeau, Alexandre Blake, Sandrine Mons, Stéphane Lastère, Claudine Roche, Jessica Vanhomwegen, Timothée Dub, Laure Baudouin, Anita Teissier, Philippe Larre, Anne-Laure Vial, Christophe Decam, Valérie Choumet, Susan K Halstead, Hugh J Willison, Lucile Musset, Jean-Claude Manuguerra, Philippe Despres, Emmanuel Fournier, Henri-Pierre Mallet, Didier Musso, Arnaud Fontanet, Jean Neil, Frédéric Ghawché
      Background Between October, 2013, and April, 2014, French Polynesia experienced the largest Zika virus outbreak ever described at that time. During the same period, an increase in Guillain-Barré syndrome was reported, suggesting a possible association between Zika virus and Guillain-Barré syndrome. We aimed to assess the role of Zika virus and dengue virus infection in developing Guillain-Barré syndrome. Methods In this case-control study, cases were patients with Guillain-Barré syndrome diagnosed at the Centre Hospitalier de Polynésie Française (Papeete, Tahiti, French Polynesia) during the outbreak period. Controls were age-matched, sex-matched, and residence-matched patients who presented at the hospital with a non-febrile illness (control group 1; n=98) and age-matched patients with acute Zika virus disease and no neurological symptoms (control group 2; n=70). Virological investigations included RT-PCR for Zika virus, and both microsphere immunofluorescent and seroneutralisation assays for Zika virus and dengue virus. Anti-glycolipid reactivity was studied in patients with Guillain-Barré syndrome using both ELISA and combinatorial microarrays. Findings 42 patients were diagnosed with Guillain-Barré syndrome during the study period. 41 (98%) patients with Guillain-Barré syndrome had anti-Zika virus IgM or IgG, and all (100%) had neutralising antibodies against Zika virus compared with 54 (56%) of 98 in control group 1 (p<0·0001). 39 (93%) patients with Guillain-Barré syndrome had Zika virus IgM and 37 (88%) had experienced a transient illness in a median of 6 days (IQR 4–10) before the onset of neurological symptoms, suggesting recent Zika virus infection. Patients with Guillain-Barré syndrome had electrophysiological findings compatible with acute motor axonal neuropathy (AMAN) type, and had rapid evolution of disease (median duration of the installation and plateau phases was 6 [IQR 4–9] and 4 days [3–10], respectively). 12 (29%) patients required respiratory assistance. No patients died. Anti-glycolipid antibody activity was found in 13 (31%) patients, and notably against GA1 in eight (19%) patients, by ELISA and 19 (46%) of 41 by glycoarray at admission. The typical AMAN-associated anti-ganglioside antibodies were rarely present. Past dengue virus history did not differ significantly between patients with Guillain-Barré syndrome and those in the two control groups (95%, 89%, and 83%, respectively). Interpretation This is the first study providing evidence for Zika virus infection causing Guillain-Barré syndrome. Because Zika virus is spreading rapidly across the Americas, at risk countries need to prepare for adequate intensive care beds capacity to manage patients with Guillain-Barré syndrome. Funding Labex Integrative Biology of Emerging Infectious Diseases, EU 7th framework program PREDEMICS. and Wellcome Trust.


      PubDate: 2016-04-09T08:32:19Z
       
  • REGULATE-PCI trial – Author's reply
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): A Michael Lincoff, John H Alexander, Roxana Mehran



      PubDate: 2016-04-09T08:32:19Z
       
  • Organ donation during the financial crisis in Greece
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Demetrios Moris, Georgios Zavos, Georgia Menoudakou, Antreas Karampinis, John Boletis



      PubDate: 2016-04-09T08:32:19Z
       
  • Are doctors in training being trained'
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Matko Marlais, John Abraham Mathews, Ian Eardley



      PubDate: 2016-04-09T08:32:19Z
       
  • Worldwide trends in diabetes since 1980: a pooled analysis of 751
           population-based studies with 4·4 million participants
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): NCD Risk Factor Collaboration (NCD-RisC)
      Background One of the global targets for non-communicable diseases is to halt, by 2025, the rise in the age-standardised adult prevalence of diabetes at its 2010 levels. We aimed to estimate worldwide trends in diabetes, how likely it is for countries to achieve the global target, and how changes in prevalence, together with population growth and ageing, are affecting the number of adults with diabetes. Methods We pooled data from population-based studies that had collected data on diabetes through measurement of its biomarkers. We used a Bayesian hierarchical model to estimate trends in diabetes prevalence—defined as fasting plasma glucose of 7·0 mmol/L or higher, or history of diagnosis with diabetes, or use of insulin or oral hypoglycaemic drugs—in 200 countries and territories in 21 regions, by sex and from 1980 to 2014. We also calculated the posterior probability of meeting the global diabetes target if post-2000 trends continue. Findings We used data from 751 studies including 4 372 000 adults from 146 of the 200 countries we make estimates for. Global age-standardised diabetes prevalence increased from 4·3% (95% credible interval 2·4–7·0) in 1980 to 9·0% (7·2–11·1) in 2014 in men, and from 5·0% (2·9–7·9) to 7·9% (6·4–9·7) in women. The number of adults with diabetes in the world increased from 108 million in 1980 to 422 million in 2014 (28·5% due to the rise in prevalence, 39·7% due to population growth and ageing, and 31·8% due to interaction of these two factors). Age-standardised adult diabetes prevalence in 2014 was lowest in northwestern Europe, and highest in Polynesia and Micronesia, at nearly 25%, followed by Melanesia and the Middle East and north Africa. Between 1980 and 2014 there was little change in age-standardised diabetes prevalence in adult women in continental western Europe, although crude prevalence rose because of ageing of the population. By contrast, age-standardised adult prevalence rose by 15 percentage points in men and women in Polynesia and Micronesia. In 2014, American Samoa had the highest national prevalence of diabetes (>30% in both sexes), with age-standardised adult prevalence also higher than 25% in some other islands in Polynesia and Micronesia. If post-2000 trends continue, the probability of meeting the global target of halting the rise in the prevalence of diabetes by 2025 at the 2010 level worldwide is lower than 1% for men and is 1% for women. Only nine countries for men and 29 countries for women, mostly in western Europe, have a 50% or higher probability of meeting the global target. Interpretation Since 1980, age-standardised diabetes prevalence in adults has increased, or at best remained unchanged, in every country. Together with population growth and ageing, this rise has led to a near quadrupling of the number of adults with diabetes worldwide. The burden of diabetes, both in terms of prevalence and number of adults affected, has increased faster in low-income and middle-income countries than in high-income countries. Funding Wellcome Trust.


      PubDate: 2016-04-09T08:32:19Z
       
  • Bangladesh's rural water scandal
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): The Lancet



      PubDate: 2016-04-09T08:32:19Z
       
  • Trends in diabetes: sounding the alarm
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Etienne G Krug



      PubDate: 2016-04-09T08:32:19Z
       
  • Changes in the primary outcome in Ebola vaccine trial
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Yanyu Zhang, Shuo Feng, Benjamin J Cowling



      PubDate: 2016-04-09T08:32:19Z
       
  • Changes in the primary outcome in Ebola vaccine trial – Authors'
           reply
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Marie Paule Kieny, Ira M Longini, Ana Maria Henao-Restrepo, Conall H Watson, Matthias Egger, W John Edmunds



      PubDate: 2016-04-09T08:32:19Z
       
  • REGULATE-PCI trial
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Eirion Slade, Philip Hartley, Carl Heneghan



      PubDate: 2016-04-09T08:32:19Z
       
  • HIV moments and pre-exposure prophylaxis
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Robert M Grant, David V Glidden



      PubDate: 2016-04-09T08:32:19Z
       
  • HIV moments and pre-exposure prophylaxis – Authors' reply
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): David T Dunn, Mitzy Gafos, Ellen White, Sheena McCormack



      PubDate: 2016-04-09T08:32:19Z
       
  • Refusal to provide health care to people with HIV in France
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Caroline Douay, Adeline Toullier, Sarah Benayoun, Daniela Rojas Castro, Pierre Chauvin



      PubDate: 2016-04-09T08:32:19Z
       
  • The world of yesterday
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Niall Boyce



      PubDate: 2016-04-09T08:32:19Z
       
  • Majid Ezzati: a positive enthusiasm for global health
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Geoff Watts



      PubDate: 2016-04-09T08:32:19Z
       
  • Willard Cates, Jr
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Alison Snyder



      PubDate: 2016-04-09T08:32:19Z
       
  • Medical education and regulation in the spotlight in India
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Dinesh C Sharma



      PubDate: 2016-04-09T08:32:19Z
       
  • Profile: Liverpool School of Tropical Medicine, UK
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Tony Kirby



      PubDate: 2016-04-09T08:32:19Z
       
  • Applause
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Sam Guglani



      PubDate: 2016-04-09T08:32:19Z
       
  • The Notes: encounters with medicine
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Sam Guglani



      PubDate: 2016-04-09T08:32:19Z
       
  • Offline: The Bedouin predicament
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Richard Horton



      PubDate: 2016-04-09T08:32:19Z
       
  • Recovery efforts in Flint slowly begin to take form
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Amy Lieberman



      PubDate: 2016-04-09T08:32:19Z
       
  • Bipolar disorders: key clinical considerations
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Gin S Malhi



      PubDate: 2016-04-09T08:32:19Z
       
  • Reducing global diabetes burden by implementing solutions and identifying
           gaps: a Lancet Commission
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Juliana C N Chan, Edward W Gregg, Jennifer Sargent, Richard Horton



      PubDate: 2016-04-09T08:32:19Z
       
  • First Liberal budget good for Canadian science, but what about global
           health'
    • Abstract: Publication date: 9–15 April 2016
      Source:The Lancet, Volume 387, Issue 10027
      Author(s): Jocalyn Clark



      PubDate: 2016-04-09T08:32:19Z
       
  • Primary angioplasty for STEMI: hard to improve upon
    • Abstract: Publication date: Available online 3 April 2016
      Source:The Lancet
      Author(s): Arnoud W J van 't Hof, Jan Paul Ottervanger



      PubDate: 2016-04-04T08:20:24Z
       
  • All over for valve surgery for intermediate-risk patients'
    • Abstract: Publication date: Available online 3 April 2016
      Source:The Lancet
      Author(s): Joachim Schofer



      PubDate: 2016-04-04T08:20:24Z
       
  • Transcatheter aortic valve replacement versus surgical valve replacement
           in intermediate-risk patients: a propensity score analysis
    • Abstract: Publication date: Available online 3 April 2016
      Source:The Lancet
      Author(s): Vinod H Thourani, Susheel Kodali, Raj R Makkar, Howard C Herrmann, Mathew Williams, Vasilis Babaliaros, Richard Smalling, Scott Lim, S Chris Malaisrie, Samir Kapadia, Wilson Y Szeto, Kevin L Greason, Dean Kereiakes, Gorav Ailawadi, Brian K Whisenant, Chandan Devireddy, Jonathon Leipsic, Rebecca T Hahn, Philippe Pibarot, Neil J Weissman, Wael A Jaber, David J Cohen, Rakesh Suri, E Murat Tuzcu, Lars G Svensson, John G Webb, Jeffrey W Moses, Michael J Mack, D Craig Miller, Craig R Smith, Maria C Alu, Rupa Parvataneni, Ralph B D'Agostino, Martin B Leon
      Background Transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve demonstrates good 30 day clinical outcomes in patients with severe aortic stenosis who are at intermediate risk of surgical mortality. Here we report longer-term data in intermediate-risk patients given SAPIEN 3 TAVR and compare outcomes to those of intermediate-risk patients given surgical aortic valve replacement. Methods In the SAPIEN 3 observational study, 1077 intermediate-risk patients at 51 sites in the USA and Canada were assigned to receive TAVR with the SAPIEN 3 valve [952 [88%] via transfemoral access) between Feb 17, 2014, and Sept 3, 2014. In this population we assessed all-cause mortality and incidence of strokes, re-intervention, and aortic valve regurgitation at 1 year after implantation. Then we compared 1 year outcomes in this population with those for intermediate-risk patients treated with surgical valve replacement in the PARTNER 2A trial between Dec 23, 2011, and Nov 6, 2013, using a prespecified propensity score analysis to account for between-trial differences in baseline characteristics. The clinical events committee and echocardiographic core laboratory methods were the same for both studies. The primary endpoint was the composite of death from any cause, all strokes, and incidence of moderate or severe aortic regurgitation. We did non-inferiority (margin 7·5%) and superiority analyses in propensity score quintiles to calculate pooled weighted proportion differences for outcomes. Findings At 1 year follow-up of the SAPIEN 3 observational study, 79 of 1077 patients who initiated the TAVR procedure had died (all-cause mortality 7·4%; 6·5% in the transfemoral access subgroup), and disabling strokes had occurred in 24 (2%), aortic valve re-intervention in six (1%), and moderate or severe paravalvular regurgitation in 13 (2%). In the propensity-score analysis we included 963 patients treated with SAPIEN 3 TAVR and 747 with surgical valve replacement. For the primary composite endpoint of mortality, strokes, and moderate or severe aortic regurgitation, TAVR was both non-inferior (pooled weighted proportion difference of −9·2%; 90% CI −12·4 to −6; p<0·0001) and superior (−9·2%, 95% CI −13·0 to −5·4; p<0·0001) to surgical valve replacement. Interpretation TAVR with SAPIEN 3 in intermediate-risk patients with severe aortic stenosis is associated with low mortality, strokes, and regurgitation at 1 year. The propensity score analysis indicates a significant superiority for our composite outcome with TAVR compared with surgery, suggesting that TAVR might be the preferred treatment alternative in intermediate-risk patients. Funding None.


      PubDate: 2016-04-04T08:20:24Z
       
  • Deferred versus conventional stent implantation in patients with
           ST-segment elevation myocardial infarction (DANAMI 3-DEFER): an
           open-label, randomised controlled trial
    • Abstract: Publication date: Available online 3 April 2016
      Source:The Lancet
      Author(s): Henning Kelbæk, Dan Eik Høfsten, Lars Køber, Steffen Helqvist, Lene Kløvgaard, Lene Holmvang, Erik Jørgensen, Frants Pedersen, Kari Saunamäki, Ole De Backer, Lia E Bang, Klaus F Kofoed, Jacob Lønborg, Kiril Ahtarovski, Niels Vejlstrup, Hans E Bøtker, Christian J Terkelsen, Evald H Christiansen, Jan Ravkilde, Hans-Henrik Tilsted, Anton B Villadsen, Jens Aarøe, Svend E Jensen, Bent Raungaard, Lisette O Jensen, Peter Clemmensen, Peer Grande, Jan K Madsen, Christian Torp-Pedersen, Thomas Engstrøm
      Background Despite successful treatment of the culprit artery lesion by primary percutaneous coronary intervention (PCI) with stent implantation, thrombotic embolisation occurs in some cases, which impairs the prognosis of patients with ST-segment elevation myocardial infarction (STEMI). We aimed to assess the clinical outcomes of deferred stent implantation versus standard PCI in patients with STEMI. Methods We did this open-label, randomised controlled trial at four primary PCI centres in Denmark. Eligible patients (aged >18 years) had acute onset symptoms lasting 12 h or less, and ST-segment elevation of 0·1 mV or more in at least two or more contiguous electrocardiographic leads or newly developed left bundle branch block. Patients were randomly assigned (1:1), via an electronic web-based system with permuted block sizes of two to six, to receive either standard primary PCI with immediate stent implantation or deferred stent implantation 48 h after the index procedure if a stabilised flow could be obtained in the infarct-related artery. The primary endpoint was a composite of all-cause mortality, hospital admission for heart failure, recurrent infarction, and any unplanned revascularisation of the target vessel within 2 years' follow-up. Patients, investigators, and treating clinicians were not masked to treatment allocation. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01435408. Findings Between March 1, 2011, and Feb 28, 2014, we randomly assigned 1215 patients to receive either standard PCI (n=612) or deferred stent implantation (n=603). Median follow-up time was 42 months (IQR 33–49). Events comprising the primary endpoint occurred in 109 (18%) patients who had standard PCI and in 105 (17%) patients who had deferred stent implantation (hazard ratio 0·99, 95% CI 0·76–1·29; p=0·92). Procedure-related myocardial infarction, bleeding requiring transfusion or surgery, contrast-induced nephopathy, or stroke occurred in 28 (5%) patients in the conventional PCI group versus 27 (4%) patients in the deferred stent implantation group, with no significant differences between groups. Interpretation In patients with STEMI, routine deferred stent implantation did not reduce the occurrence of death, heart failure, myocardial infarction, or repeat revascularisation compared with conventional PCI. Results from ongoing randomised trials might shed further light on the concept of deferred stenting in this patient population. Funding Danish Agency for Science, Technology and Innovation, and Danish Council for Strategic Research.


      PubDate: 2016-04-04T08:20:24Z
       
  • Reforming international drug policy
    • Abstract: Publication date: 2–8 April 2016
      Source:The Lancet, Volume 387, Issue 10026
      Author(s): The Lancet



      PubDate: 2016-04-03T08:20:06Z
       
  • Yellow fever: a global reckoning
    • Abstract: Publication date: 2–8 April 2016
      Source:The Lancet, Volume 387, Issue 10026
      Author(s): The Lancet



      PubDate: 2016-04-03T08:20:06Z
       
  • The perfect storm: climate change and its health consequences
    • Abstract: Publication date: 2–8 April 2016
      Source:The Lancet, Volume 387, Issue 10026
      Author(s): The Lancet



      PubDate: 2016-04-03T08:20:06Z
       
 
 
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