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Efficacy of a Single-Dose, Inactivated Oral Cholera Vaccine in Bangladesh
Massachusetts Medical Society 2016 The New England journal of medicine Vol.374 No.18
<P>BACKGROUND A single-dose regimen of the current killed oral cholera vaccines that have been prequalified by the World Health Organization would make them more attractive for use against endemic and epidemic cholera. We conducted an efficacy trial of a single dose of the killed oral cholera vaccine Shanchol, which is currently given in a two-dose schedule, in an urban area in which cholera is highly endemic. METHODS Nonpregnant residents of Dhaka, Bangladesh, who were 1 year of age or older were randomly assigned to receive a single dose of oral cholera vaccine or oral placebo. The primary outcome was vaccine protective efficacy against culture-confirmed cholera occurring 7 to 180 days after dosing. Prespecified secondary outcomes included protective efficacy against severely dehydrating culture-confirmed cholera during the same interval, against cholera and severe cholera occurring 7 to 90 versus 91 to 180 days after dosing, and against cholera and severe cholera according to age at baseline. RESULTS A total of 101 episodes of cholera, 37 associated with severe dehydration, were detected among the 204,700 persons who received one dose of vaccine or placebo. The vaccine protective efficacy was 40% (95% confidence interval [CI], 11 to 60%; 0.37 cases per 1000 vaccine recipients vs. 0.62 cases per 1000 placebo recipients) against all cholera episodes, 63% (95% CI, 24 to 82%; 0.10 vs. 0.26 cases per 1000 recipients) against severely dehydrating cholera episodes, and 63% (95% CI, -39 to 90%), 56% (95% CI, 16 to 77%), and 16% (95% CI, -49% to 53%) against all cholera episodes among persons vaccinated at the age of 5 to 14 years, 15 or more years, and 1 to 4 years, respectively, although the differences according to age were not significant (P = 0.25). Adverse events occurred at similar frequencies in the two groups. CONCLUSIONS A single dose of the oral cholera vaccine was efficacious in older children (= 5 years of age) and in adults in a setting with a high level of cholera endemicity.</P>
Prasugrel versus clopidogrel for acute coronary syndromes without revascularization.
Roe, Matthew T,Armstrong, Paul W,Fox, Keith A A,White, Harvey D,Prabhakaran, Dorairaj,Goodman, Shaun G,Cornel, Jan H,Bhatt, Deepak L,Clemmensen, Peter,Martinez, Felipe,Ardissino, Diego,Nicolau, Jose C Massachusetts Medical Society 2012 The New England journal of medicine Vol.367 No.14
<P>The effect of intensified platelet inhibition for patients with unstable angina or myocardial infarction without ST-segment elevation who do not undergo revascularization has not been delineated.</P>
A form of the metabolic syndrome associated with mutations in DYRK1B.
Keramati, Ali R,Fathzadeh, Mohsen,Go, Gwang-Woong,Singh, Rajvir,Choi, Murim,Faramarzi, Saeed,Mane, Shrikant,Kasaei, Mohammad,Sarajzadeh-Fard, Kazem,Hwa, John,Kidd, Kenneth K,Babaee Bigi, Mohammad A,Ma Massachusetts Medical Society 2014 The New England journal of medicine Vol.370 No.20
<P>Genetic analysis has been successful in identifying causative mutations for individual cardiovascular risk factors. Success has been more limited in mapping susceptibility genes for clusters of cardiovascular risk traits, such as those in the metabolic syndrome.</P>
Telmisartan to prevent recurrent stroke and cardiovascular events.
Yusuf, Salim,Diener, Hans-Christoph,Sacco, Ralph L,Cotton, Daniel,Ounpuu, Stephanie,Lawton, William A,Palesch, Yuko,Martin, Reneé,H,Albers, Gregory W,Bath, Philip,Bornstein, Natan,Chan, Bernard Massachusetts Medical Society 2008 The New England journal of medicine Vol.359 No.12
<P>BACKGROUND: Prolonged lowering of blood pressure after a stroke reduces the risk of recurrent stroke. In addition, inhibition of the renin-angiotensin system in high-risk patients reduces the rate of subsequent cardiovascular events, including stroke. However, the effect of lowering of blood pressure with a renin-angiotensin system inhibitor soon after a stroke has not been clearly established. We evaluated the effects of therapy with an angiotensin-receptor blocker, telmisartan, initiated early after a stroke. METHODS: In a multicenter trial involving 20,332 patients who recently had an ischemic stroke, we randomly assigned 10,146 to receive telmisartan (80 mg daily) and 10,186 to receive placebo. The primary outcome was recurrent stroke. Secondary outcomes were major cardiovascular events (death from cardiovascular causes, recurrent stroke, myocardial infarction, or new or worsening heart failure) and new-onset diabetes. RESULTS: The median interval from stroke to randomization was 15 days. During a mean follow-up of 2.5 years, the mean blood pressure was 3.8/2.0 mm Hg lower in the telmisartan group than in the placebo group. A total of 880 patients (8.7%) in the telmisartan group and 934 patients (9.2%) in the placebo group had a subsequent stroke (hazard ratio in the telmisartan group, 0.95; 95% confidence interval [CI], 0.86 to 1.04; P=0.23). Major cardiovascular events occurred in 1367 patients (13.5%) in the telmisartan group and 1463 patients (14.4%) in the placebo group (hazard ratio, 0.94; 95% CI, 0.87 to 1.01; P=0.11). New-onset diabetes occurred in 1.7% of the telmisartan group and 2.1% of the placebo group (hazard ratio, 0.82; 95% CI, 0.65 to 1.04; P=0.10). CONCLUSIONS: Therapy with telmisartan initiated soon after an ischemic stroke and continued for 2.5 years did not significantly lower the rate of recurrent stroke, major cardiovascular events, or diabetes. (ClinicalTrials.gov number, NCT00153062.)</P>
Stents versus coronary-artery bypass grafting for left main coronary artery disease.
Seung, Ki Bae,Park, Duk-Woo,Kim, Young-Hak,Lee, Seung-Whan,Lee, Cheol Whan,Hong, Myeong-Ki,Park, Seong-Wook,Yun, Sung-Cheol,Gwon, Hyeon-Cheol,Jeong, Myung-Ho,Jang, Yangsoo,Kim, Hyo-Soo,Kim, Pum Joon,S Massachusetts Medical Society 2008 The New England journal of medicine Vol.358 No.17
<P>BACKGROUND: Several studies have compared the treatment effects of coronary stenting and coronary-artery bypass grafting (CABG). However, there are limited data regarding the long-term outcomes of these two interventions for patients with unprotected left main coronary artery disease. METHODS: We evaluated 1102 patients with unprotected left main coronary artery disease who underwent stent implantation and 1138 patients who underwent CABG in Korea between January 2000 and June 2006. We compared adverse outcomes (death; a composite outcome of death, Q-wave myocardial infarction, or stroke; and target-vessel revascularization) with the use of propensity-score matching in the overall cohort and in separate subgroups according to type of stent. RESULTS: In the overall matched cohort, there was no significant difference between the stenting and CABG groups in the risk of death (hazard ratio for the stenting group, 1.18; 95% confidence interval [CI], 0.77 to 1.80) or the risk of the composite outcome (hazard ratio for the stenting group, 1.10; 95% CI, 0.75 to 1.62). The rates of target-vessel revascularization were significantly higher in the group that received stents than in the group that underwent CABG (hazard ratio, 4.76; 95% CI, 2.80 to 8.11). Comparisons of the group that received bare-metal stents with the group that underwent CABG and of the group that received drug-eluting stents with the group that underwent CABG produced similar results, although there was a trend toward higher rates of death and the composite end point in the group that received drug-eluting stents. CONCLUSIONS: In a cohort of patients with unprotected left main coronary artery disease, we found no significant difference in rates of death or of the composite end point of death, Q-wave myocardial infarction, or stroke between patients receiving stents and those undergoing CABG. However, stenting, even with drug-eluting stents, was associated with higher rates of target-vessel revascularization than was CABG.</P>
Trial of everolimus-eluting stents or bypass surgery for coronary disease.
Park, Seung-Jung,Ahn, Jung-Min,Kim, Young-Hak,Park, Duk-Woo,Yun, Sung-Cheol,Lee, Jong-Young,Kang, Soo-Jin,Lee, Seung-Whan,Lee, Cheol Whan,Park, Seong-Wook,Choo, Suk Jung,Chung, Cheol Hyun,Lee, Jae Won Massachusetts Medical Society 2015 The New England journal of medicine Vol.372 No.13
<P>Most trials comparing percutaneous coronary intervention (PCI) with coronary-artery bypass grafting (CABG) have not made use of second-generation drug-eluting stents.</P>
Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy
Massachusetts Medical Society 2017 The New England journal of medicine Vol.376 No.22
<P>After standard neoadjuvant chemotherapy containing anthracycline, taxane, or both, the addition of adjuvant capecitabine therapy was safe and effective in prolonging disease-free survival and overall survival among patients with HER2-negative breast cancer who had residual invasive disease on pathological testing. (Funded by the Advanced Clinical Research Organization and the Japan Breast Cancer Research Group; CREATE-X UMIN Clinical Trials Registry number, UMIN000000843.)</P>