Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes.

Abstract BACKGROUND: The cardiovascular effects of adding once-weekly treatment with exenatide to usual care in patients with type 2 diabetes are unknown. METHODS: We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly. The primary composite outcome was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The coprimary hypotheses were that exenatide, administered once weekly, would be noninferior to placebo with respect to safety and superior to placebo with respect to efficacy. RESULTS: In all, 14,752 patients (of whom 10,782 [73.1%] had previous cardiovascular disease) were followed for a median of 3.2 years (interquartile range, 2.2 to 4.4). A primary composite outcome event occurred in 839 of 7356 patients (11.4%; 3.7 events per 100 person-years) in the exenatide group and in 905 of 7396 patients (12.2%; 4.0 events per 100 person-years) in the placebo group (hazard ratio, 0.91; 95% confidence interval [CI], 0.83 to 1.00), with the intention-to-treat analysis indicating that exenatide, administered once weekly, was noninferior to placebo with respect to safety (P<0.001 for noninferiority) but was not superior to placebo with respect to efficacy (P=0.06 for superiority). The rates of death from cardiovascular causes, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, hospitalization for heart failure, and hospitalization for acute coronary syndrome, and the incidence of acute pancreatitis, pancreatic cancer, medullary thyroid carcinoma, and serious adverse events did not differ significantly between the two groups. CONCLUSIONS: Among patients with type 2 diabetes with or without previous cardiovascular disease, the incidence of major adverse cardiovascular events did not differ significantly between patients who received exenatide and those who received placebo. (Funded by Amylin Pharmaceuticals; EXSCEL ClinicalTrials.gov number, NCT01144338 .)

Book Reviews

THEY CALL IT JUSTICE: COMMAND INFLUENCE AND THE COURT-MARTIAL SYSTEM. By Luther C. West. New York: The Viking Press, 1977. Pp.xii, 302. $12.95. Reviewed by Daniel H. Benson In his book West is dealing with a subject that is difficult to discuss without generating hostility, misunderstanding, and, occasionally, incredulity. He is attacking the classic military understanding of the basic purpose of the court-martial system. He asks the reader to accept his word and assurances concerning the accuracy of the problems he describes, over the assurances of the military justice establishment that all is well. In doing all of this, West joins the ranks of a small but constantly growing group of individuals who have had the courage and the persistence to tell the unvarnished truth about the realities of the court-martial system. His work as a maverick within the system is not entirely without precedent in the history of American military justice, and one of the most valuable aspects of his book is its brief summary of the work of the early reformers and of the battles they had to fight in order to be heard. ======================== THE TRANSFORMATION OF AMERICAN LAW, 1780-1860. By Morton J.Horwitz. Cambridge, Mass. and London: Harvard University Press,1977. Pp. xvii, 356.$16.50. This study attempts to challenge certain features of the\u27consensus\u27 history that has continued to dominate American historiography since the Second World War, observes Morton Horwitz in his introduction.\u27 Specifically, Horwitz charges that historians sympathetic to the New Deal have been too uncritical in their assessments of earlier instances of governmental economic regulation.Eager to disprove the theory of an unbroken laissez-faire tradition,such figures as Louis Hartz and Oscar and Mary Handlin discovered in the early nineteenth century a pattern of governmental activism that seemed to them responsive to the needs of society at large. In fact, Horwitz argues, an interventionist legal policy grew out of conditions of social struggle in the antebellum years, and benefited men of commerce and industry at the expense of farmers,workers, consumers, and other less powerful groups within the society. To demonstrate this thesis, he focuses upon changes in private law-in such professedly neutral areas as contract, tort, property, and commercial law--by which economic wealth and political power were redistributed to a privileged minority during the eighty years that followed the American Revolution. Reviewed by Maxwell Bloomfield =============================== THE RULE OF REASON: A NEW APPROACH TO CORPORATE LITIGATION. By Milton R. Wessel. Reading, Mass.: Addison-Wesley Publishing Co., 1976. Pp. xviii, 221. $10.95. Reviewed by Donald E. Schwartz Milton Wessel is a respected New York trial lawyer, a partner in a major law firm, a part-time law professor, and a former government prosecutor. His background is well suited to provide him with a sensitivity to trends in the courts, and he perceives that the character and the stakes of litigation-especially corporate litigation-are changing drastically. The change, Wessel believes, requires that corporations adopt a new strategy, not only for their own sake, but for the sake of society as well. He implores corporations to pursue this new strategy, which he calls the rule of reason and which serves as the title of his book. Wessel deals with a phenomenon of which business persons,lawyers, and legal scholars increasingly have become aware: our society is more litigious than it used to be. Federal litigation alone has nearly doubled in fifteen years,\u27 and, more important, the nature of litigation affecting corporations has changed, especially since World War II. Issues of public policy, as distinct from merely private rights, are preoccupying the courts. Important questions concerning the environment, civil rights, consumer rights, and other areas previously left to legislatures now are resolved in the courts. These socioscientific disputes, as Wessel calls them, are the subject of his new approach to litigation.\u2

Alcohol consumption and attitudes towards restriction policies in European university students: Results from a cross-national students' health study (CNSHS)

Stock C, Maxwell A, Bloomfield K, et al. Alcohol consumption and attitudes towards restriction policies in European university students: Results from a cross-national students' health study (CNSHS). EUROPEAN JOURNAL OF PUBLIC HEALTH. 2007;17(Suppl. 2):100

Alcohol consumption and attitudes towards restriction policies in European university students: Results from a cross-national students' health study (CNSHS)

Stock C, Maxwell A, Bloomfield K, et al. Alcohol consumption and attitudes towards restriction policies in European university students: Results from a cross-national students' health study (CNSHS). EUROPEAN JOURNAL OF PUBLIC HEALTH. 2007;17(Suppl. 2):100

Alcohol consumption and attitudes towards banning alcohol sales on campus among European university students

Stock C, Mikolajczyk RT, Bloomfield K, et al. Alcohol consumption and attitudes towards banning alcohol sales on campus among European university students. Public Health. 2009;123(2):122-129.Objectives: The European Commission's new health strategy for improving health at the European Union (EU) level includes tackling alcohol consumption. This study aimed to assess the prevalence of alcohol consumption and problem drinking, as well as students' attitudes towards banning the sale of alcohol on campus. Study design: in total, 5826 students from universities in seven European countries (Denmark, Germany, Spain, Lithuania, Poland, Bulgaria and Turkey) took part in this cross-sectional study. Methods: A self-administered questionnaire assessed sociodemographic information, frequency of alcohol consumption, problem drinking and attitudes towards banning the sale of alcohol on campus. Results: The highest prevalence of drinking alcohol more than once per week was reported in Bulgarian (males 46%, females 64%) and Spanish students (males 59%, females 64%). Among those students who drank alcohol (n = 3170), problem drinking (CAGE score >1) was found in 24% of males and 13% of females. Male gender, depressive moods and a low importance of good grades at university were risk factors for drinking alcohol more than once per week as well as for problem drinking. There were substantial country differences in the proportion of students who would support a ban of alcohol sales on campus (23% in Denmark, 88% in Poland). Support for a ban was higher among female students and among students who drank alcohol once or less per week. Conclusions: Problem drinking is a concern among students in many European countries, especially among males. Students' support for banning the sale of alcohol on campus varies between countries and should be considered in developing EU policy. (C) 2008 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved