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4. Long-term safety and efficacy of anacetrapib in patients with atherosclerotic vascular disease

Author

Sammons, E, Hopewell, JC, Chen, F, Stevens, W, Wallendszus, K, Valdes-Marquez, E, Dayanandan, R, Knott, C, Murphy, K, Wincott, E, Baxter, A, Goodenough, R, Lay, M, Hill, M, Macdonnell, S, Fabbri, G, Lucci, D, Fajardo-Moser, M, Brenner, S, Hao, D, Zhang, H, Liu, J, Wuhan, B, Mosegaard, S, Herrington, W, Wanner, C, Angermann, C, Ertl, G, Maggioni, A, Barter, P, Mihaylova, B, Mitchel, Y, Blaustein, R, Goto, S, Tobert, J, DeLucca, P, Chen, Y, Chen, Z, Gray, A, Haynes, R, Armitage, J, Baigent, C, Wiviott, S, Cannon, C, Braunwald, E, Collins, R, Bowman, L, Landray, M, and Group, HPS3/TIMI55-REVEAL Collaborative

Subjects
Cardiology and Cardiovascular Medicine
Abstract

Aims REVEAL was the first randomized controlled trial to demonstrate that adding cholesteryl ester transfer protein inhibitor therapy to intensive statin therapy reduced the risk of major coronary events. We now report results from extended follow-up beyond the scheduled study treatment period. Methods and results A total of 30 449 adults with prior atherosclerotic vascular disease were randomly allocated to anacetrapib 100 mg daily or matching placebo, in addition to open-label atorvastatin therapy. After stopping the randomly allocated treatment, 26 129 survivors entered a post-trial follow-up period, blind to their original treatment allocation. The primary outcome was first post-randomization major coronary event (i.e. coronary death, myocardial infarction, or coronary revascularization) during the in-trial and post-trial treatment periods, with analysis by intention-to-treat. Allocation to anacetrapib conferred a 9% [95% confidence interval (CI) 3–15%; P = 0.004] proportional reduction in the incidence of major coronary events during the study treatment period (median 4.1 years). During extended follow-up (median 2.2 years), there was a further 20% (95% CI 10–29%; P Conclusion The beneficial effects of anacetrapib on major coronary events increased with longer follow-up, and no adverse effects emerged on non-vascular mortality or morbidity. These findings illustrate the importance of sufficiently long treatment and follow-up duration in randomized trials of lipid-modifying agents to assess their full benefits and potential harms. Trial registration International Standard Randomized Controlled Trial Number (ISRCTN) 48678192; ClinicalTrials.gov No. NCT01252953; EudraCT No. 2010-023467-18.

Published
2022

8. HPS2-THRIVE randomized placebo-controlled trial in 25 673 high-risk patients of ER niacin/laropiprant: trial design, pre-specified muscle and liver outcomes, and reasons for stopping study treatment

Author

Haynes, Richard, Jiang, Lixin, Hopewell, Jemma C, Li, Jing, Chen, Fang, Parish, Sarah, Landray, Martin J., Collins, Rory, Armitage, Jane, Collins, R., Armitage, J., Baigent, C., Chen, Z., Landray, M., Chen, Y., Jiang, L., Pedersen, T., Landray, M., Bowman, L., Chen, F., Hill, M., Haynes, R., Knott, C., Rahimi, K., Tobert, J., Sleight, P., Simpson, D., Parish, S., Baxter, A., Lay, M., Bray, C., Wincott, E., Leijenhorst, G., Skattebol, A., Moen, G., Mitchel, Y., Kuznetsova, O., MacMahon, S., Kjekshus, J., Hill, C., Lam, T.H., Sandercock, P., Peto, R., and Hopewell, J.C.

Published
2013
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9. The structural embeddedness of resistance among public managers

Author

Brower, Ralph S. and Abolafia, Mitchel Y.

Subjects
Government executives -- Research, Organizational behavior -- Research, Business, general, Business, Research
Abstract

In my first job after graduate school, it took me about a year to realize that, no matter what I did, it was impossible to please my supervisor. (But) there [...]

Published
1995

11. Narrative Construction as Sensemaking: How a Central Bank Thinks

Author

Mitchel Y. Abolafia

Subjects
Organizational Behavior and Human Resource Management, Operating model, business.industry, Process (engineering), Strategy and Management, Control (management), Sensemaking, Public relations, Selective retention, Management of Technology and Innovation, Elite, Narrative, Sociology, business, Legitimacy
Abstract

How do elite policy-making groups make sense of complex and ambiguous environments while remaining consistent with the group’s institutionalized operating model? This paper identifies a sensemaking process based in shared narrative construction. It is a social process of pattern recognition involving abduction, the comparison of culturally approved models to the current conditions to establish relevant facts and events; plotting, the reordering of those facts and events into a plausible narrative; and selective retention, the collective negotiation of a policy choice that fits the emerging narrative. This paper uses verbatim transcripts of meetings at the Federal Reserve to explore how policy makers use a logic of appropriateness to identify relevant cues and integrate them with existing models by weaving sensible plots. These plots are designed to control the supply of money and credit and maintain the legitimacy of the central bank.

Published
2010

12. The Creation of Trust Through Interaction and Exchange

Author

Mitchel Y. Abolafia and Paul D. Nugent

Subjects
Organizational Behavior and Human Resource Management, business.industry, media_common.quotation_subject, 05 social sciences, 050301 education, 050109 social psychology, Context (language use), Network theory, Public relations, Social constructionism, Friendship, Interpersonal relationship, Arts and Humanities (miscellaneous), Economic sociology, Organizational behavior, 0501 psychology and cognitive sciences, business, Psychology, 0503 education, Social psychology, Applied Psychology, Social capital, media_common
Abstract

Scholars generally agree that highly effective organizations require the cultivation of personal relationships that are high in trust. However, although most conceptualizations of relational trust stress the roles of intention and choice, few explain how these are socially constructed in discrete interactions. To this end, the authors introduce the concept of consideration. Consideration entails a mode of interaction in which (a) a resource is bestowed to a recipient, (b) under a context of choice, (c) involving little sacrifice on the part of the giver, and (d) implying that the recipient’s situation is present in the giver’s thoughts and feelings. Consideration was observed to be central to trust formation and maintenance in a large defense company. Collegial relationships high in trust are characterized by the consistent application of consideration where there are perceived opportunities. These findings have useful implications for management, network theory, social capital, economic sociology, and friendship in the workplace.

Published
2006

15. On Improving Qualitative Methods in Public Administration Research

Author

Ralph S. Brower, Mitchel Y. Abolafia, and Jered B. Carr

Subjects
Marketing, Correctness, Public Administration, Sociology and Political Science, business.industry, media_common.quotation_subject, 05 social sciences, Public relations, Public administration, 0506 political science, Qualitative marketing research, 0502 economics and business, 050602 political science & public administration, sort, Sociology, Bureaucracy, business, Set (psychology), 050203 business & management, media_common, Qualitative research
Abstract

What do exemplary qualitative accounts look like, and how do they convince readers of their correctness? What sort of standards can be used to assess qualitative research accounts for public administration? To address these questions, the authors examined 72 recent qualitative research journal articles. Proceeding from a set of preliminary guidelines, they worked iteratively between articles and the emergent template to produce refined guidelines. In addition, they identified specific types of dilemmas for public bureaucracies and policies that trigger researchers’ strategies for persuading readers that their qualitative accounts are credible. They conclude with four actionable recommendations for improving the field’s qualitative research.

Published
2000

16. The creation of trust through interaction and exchange: the role of consideration in organizations

Author

Nugent, Paul D. and Abolafia, Mitchel Y.

Subjects
Associations, institutions, etc. -- Human resource management, Organizational communication -- Analysis, Interpersonal relations -- Analysis, Trust (Psychology) -- Analysis, Company personnel management, Business, Business, general
Abstract

This study examines the need for establishing trust and good work place relationships among employees of an organization through constant interactions.

Published
2006

18. Bureaucratic Politics: The View from Below

Author

Ralph S. Brower and Mitchel Y. Abolafia

Subjects
Marketing, Improvisation, Public Administration, Sociology and Political Science, business.industry, media_common.quotation_subject, Identity (social science), Public relations, Variety (cybernetics), Politics, Irrational number, Ethnography, Sociology, Bureaucracy, business, media_common
Abstract

From a broad ethnographic study of political activities among lower participants, the authors formulate a model of politics from below that contrasts with Graham Allison's model of bureaucratic politics among those at the top. They find that, because of their relatively less powerful hierarchical positions, lower participants engage in political activities that are primarily about the pursuit of identity rather than specific organizational outcomes. Because these are by their very nature out-of-bounds activities, they often prove highly improvisational. The authors conclude that these activities are not irrational, but they are embedded in local rationalities that admittedly countervail executives' intentions. These local rationalities reflect the variety of professional and subprofessional norms, conflicting processes, and multiple and conflicting goals that pervade public organizations.

Published
1997

20. The Structural Embeddedness of Resistance among Public Managers

Author

Ralph S. Brower and Mitchel Y. Abolafia

Subjects
Organizational Behavior and Human Resource Management, 060101 anthropology, Embeddedness, media_common.quotation_subject, 05 social sciences, Perspective (graphical), Resistance (psychoanalysis), 06 humanities and the arts, Variety (cybernetics), Antecedent (grammar), Arts and Humanities (miscellaneous), 050903 gender studies, Organizational behavior, 0601 history and archaeology, Bureaucracy, Sociology, 0509 other social sciences, Positive economics, Social psychology, Applied Psychology, Class conflict, media_common
Abstract

The study of resistance in organizations has been dominated by two perspectives. From a managerial perspective resistance is dysfunction that managers learn to "cope with." Most radical/critical perspectives see resistance as a weapon in the class struggle. Contrary to managerial characterizations we find that bureaucratic resistance is a common and varied mode of organizational behavior. Contrary to critical views it is often enacted to support, rather than undermine, the goals of the organization. Neither view adequately accounts for resistance by managers who are caught in conflicting role obligations. The many forms of resistance are largely unstudied, yet the informants in our ethnographic study have illuminated a variety of strategies and richly detailed accounts. We present a structural model of the relationships between resistors' strategies and antecedent conditions. Two cases from our research illustrate the model. We conclude with implications for managers, researchers, and recent prescriptions to "reinvent" government.

Published
1995

23. Lipid-altering efficacy and safety of simvastatin 80 mg/day: long-term experience in a large group of patients with hypercholesterolemia. World Wide Expanded Dose Simvastatin Study Group

Author

Ose, L., Davidson, M. H., Stein, E. A., Kastelein, J. J., Scott, R. S., Hunninghake, D. B., Campodonico, S., Insull, W., Escobar, I. D., Schrott, H. G., Stepanavage, M. E., Wu, M., Tate, A. C., Melino, M. R., Mercuri, M., Mitchel, Y. B., and Other departments

Subjects
lipids (amino acids, peptides, and proteins)
Abstract

Elevated levels of low-density lipoprotein (LDL) cholesterol promote the development of atherosclerosis and coronary heart disease. Simvastatin 80 mg/day will be more effective than simvastatin 40 mg/day at reducing LDL cholesterol and will be well tolerated. Two similar, randomized, multicenter, controlled, double-blind, parallel-group, 48-week studies were performed to evaluate the long-term lipid-altering efficacy and safety of simvastatin 80 mg/day in patients with hypercholesterolemia. One study conducted in the US enrolled patients meeting the National Cholesterol Education Program (NCEP) LDL cholesterol criteria for pharmacologic treatment. In the other multinational study, patients with LDL cholesterol levels > or = 4.2 mmol/l were enrolled. At 20 centers in the US and 19 countries world-wide, 1,105 hypercholesterolemic patients, while on a lipid-lowering diet, were randomly assigned at a ratio of 2:3 to receive simvastatin 40 mg (n = 436) or 80 mg (n = 669) once daily for 24 weeks. Those patients completing an initial 24-week base study were enrolled in a 24-week blinded extension. Patients who had started on the 80 mg dose in the base study continued on the same dose in the extension, while those who had started on the 40 mg dose were rerandomized at a 1:1 ratio to simvastatin 40 or 80 mg in the extension. There was a significant advantage in the LDL cholesterol-lowering effect of the 80 mg dose compared with that of the 40 mg dose, which was maintained over the 48 weeks of treatment. The mean percentage reductions (95% confidence intervals) from baseline in LDL cholesterol for the 40 and 80 mg groups were 41% (42, 39) and 47% (48, 46), respectively, for the 24-week base study, and 41% (43, 39) and 46% (47, 45), respectively, after 48 weeks of treatment (p < 0.001 between groups). Larger reductions in total cholesterol and triglycerides were also observed with the 80 mg dose compared with the 40 mg dose at Weeks 24 and 48. Both doses were well tolerated, with close to 95% of patients enrolled completing the entire 48 weeks of treatment. Myopathy (muscle symptoms plus creatine kinase increase > 10 fold upper limit of normal) and clinically significant hepatic transaminase increases (> 3 times the upper limit of normal) occurred infrequently with both doses. There was no significant difference between the groups in the number of patients with such increases, although there were more cases for both with the 80 mg dose. Compared with the 40 mg dose, simvastatin 80 mg produced greater reductions in LDL cholesterol, total cholesterol, and triglycerides. Both doses were well tolerated

Published
2000

26. Lipid-modifying efficacy and tolerability of extended-release niacin/laropiprant in patients with primary hypercholesterolaemia or mixed dyslipidaemia

Author

Maccubbin, D., Bays, H.E., Olsson, Anders, Elinoff, V., Elis, A., Mitchel, Y., Sirah, W., Betteridge, A., Reyes, R., Yu, Q., Kuznetsova, O., Sisk, C.M., Pasternak, R.C., Paolini, J.F., Maccubbin, D., Bays, H.E., Olsson, Anders, Elinoff, V., Elis, A., Mitchel, Y., Sirah, W., Betteridge, A., Reyes, R., Yu, Q., Kuznetsova, O., Sisk, C.M., Pasternak, R.C., and Paolini, J.F.

Abstract

Background: Improving lipids beyond low-density lipoprotein cholesterol (LDL-C) lowering with statin monotherapy may further reduce cardiovascular risk. Niacin has complementary lipid-modifying efficacy to statins and cardiovascular benefit, but is underutilised because of flushing, mediated primarily by prostaglandin D2 (PGD2). Laropiprant (LRPT), a PGD 2 receptor (DP1) antagonist that reduces niacin-induced flushing has been combined with extended-release niacin (ERN) into a fixed-dose tablet. Methods and results: Dyslipidaemic patients were randomised to ERN/LRPT 1 g (n = 800), ERN 1 g (n = 543) or placebo (n = 270) for 4 weeks. Doses were doubled (2 tablets/day, i.e. 2 g for active treatments) for 20 weeks. ERN/LRPT 2 g produced significant changes vs. placebo in LDL-C (-18.4%), high-density lipoprotein cholesterol (HDL-C, 20.0%), LDL-C:HDL-C (-31.2%), non-HDL-C (-19.8%), triglycerides (TG, -25.8%), apolipoprotein (Apo) B (-18.8%), Apo A-I (6.9%), total cholesterol (TC, -8.5%), TC:HDL-C (-23.1%) and lipoprotein(a) (-20.8%) across weeks 12-24. ERN/LRPT produced significantly less flushing than ERN during initiation (week 1) and maintenance (weeks 2-24) for all prespecified flushing end-points (incidence, intensity and discontinuation because of flushing). Except for flushing, ERN/LRPT had a safety/tolerability profile comparable with ERN. Conclusion: Extended-release niacin/LRPT 2 g produced significant, durable improvements in multiple lipid/lipoprotein parameters. The improved tolerability of ERN/LRPT supports a simplified 1 g?2 g dosing regimen of niacin, a therapy proven to reduce cardiovascular risk. © 2008 Merck & Co.

Published
2008
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28. Book Reviews

Author

Mitchel Y. Abolafia

Subjects
Public Administration, Sociology and Political Science, Arts and Humanities (miscellaneous), business.industry, Architecture, Telecommunications, business
Published
2002

38. Morality, Rationality, and Efficiency: New Perspectives on Socio-Economics

Author

Mitchel Y. Abolafia and Richard M. Coughlin

Subjects
Sociology and Political Science, Great Rationality Debate, media_common.quotation_subject, Economics, Principle of rationality, Rationality, Positive economics, Social science, Morality, Ecological rationality, media_common
Published
1993

39. Coordinating for the Collective Good

Author

Mitchel Y. Abolafia

Subjects
Marketing, Government, Public Administration, Sociology and Political Science, media_common.quotation_subject, 05 social sciences, Land-use planning, Resistance (psychoanalysis), Public administration, 0506 political science, Politics, State (polity), Political science, Coastal zone, 0502 economics and business, 050602 political science & public administration, Program development, Environmental planning, 050203 business & management, media_common
Abstract

This article investigates resistance to the implementation of a federal program of coastal zone planning. Interviews were conducted with officials in New York State and Washington, D.C., to explore the dynamics of state and local responses to a federal grant-in-aid. Resistance was found at every level of government, as well as in the environments of these levels. Segmentation of the program and the displacement of federal intention were found to be common state and local tactics. A comparison with the progressive program in California is used to indicate the significance of political and economic conditions for program development. The successful resistance to the federal program in New York is discussed in terms of its implications for the future of federal land use planning.

Published
1979

40. Extended-release niacin/laropiprant significantly improves lipid levels in type 2 diabetes mellitus irrespective of baseline glycemic control

Author

Bays HE, Brinton EA, Triscari J, Chen E, Maccubbin D, MacLean AA, Gibson KL, Ruck RA, Johnson-Levonas AO, O’Neill EA, and Mitchel YB

Subjects
Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Harold E Bays,1 Eliot A Brinton,2 Joseph Triscari,3 Erluo Chen,3 Darbie Maccubbin,3 Alexandra A MacLean,3 Kendra L Gibson,3 Rae Ann Ruck,3 Amy O Johnson-Levonas,3 Edward A O’Neill,3 Yale B Mitchel3 1Louisville Metabolic & Atherosclerosis Research Center (L-MARC), Louisville, KY, USA; 2Utah Foundation for Biomedical Research, Salt Lake City, UT, USA; 3Merck & Co, Inc., Whitehouse Station, NJ, USA Background: The degree of glycemic control in patients with type 2 diabetes mellitus (T2DM) may alter lipid levels and may alter the efficacy of lipid-modifying agents. Objective: Evaluate the lipid-modifying efficacy of extended-release niacin/laropiprant (ERN/LRPT) in subgroups of patients with T2DM with better or poorer glycemic control. Methods: Post hoc analysis of clinical trial data from patients with T2DM who were randomized 4:3 to double-blind ERN/LRPT or placebo (n=796), examining the lipid-modifying effects of ERN/LRPT in patients with glycosylated hemoglobin or fasting plasma glucose levels above and below median baseline levels. Results: At Week 12 of treatment, ERN/LRPT significantly improved low-density lipoprotein cholesterol, high-density lipoprotein cholesterol (HDL-C), non-high-density lipoprotein cholesterol, triglycerides, and lipoprotein (a), compared with placebo, with equal efficacy in patients above or below median baseline glycemic control. Compared with placebo, over 36 weeks of treatment more patients treated with ERN/LRPT had worsening of their diabetes and required intensification of antihyperglycemic medication, irrespective of baseline glycemic control. Incidences of other adverse experiences were generally low in all treatment groups. Conclusion: The lipid-modifying effects of ERN/LRPT are independent of the degree of baseline glycemic control in patients with T2DM (NCT00485758). Keywords: lipid-modifying agents, hyperglycemia, LDL, HDL, triglycerides

Published
2015

41. Effects of extended-release niacin/laropiprant, simvastatin, and the combination on correlations between apolipoprotein B, LDL cholesterol, and non-HDL cholesterol in patients with dyslipidemia

Author

Farnier M, Chen E, Johnson-Levonas AO, McCrary Sisk C, and Mitchel YB

Subjects
Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Michel Farnier,1 Erluo Chen,2 Amy O Johnson-Levonas,2 Christine McCrary Sisk,2 Yale B Mitchel21Point Médical, Dijon, France; 2Merck and Co, Inc., Whitehouse Station, NJ, USABackground: Statins modify correlations between apolipoprotein B (apoB) and low-density lipoprotein cholesterol (LDL-C) and apoB and non-high-density lipoprotein cholesterol (non-HDL-C); however, it is not known whether niacin-based therapies have similar effects.Objective: To evaluate the effects of extended-release niacin (ERN)/laropiprant (LRPT), simvastatin (SIMVA), and ERN/LRPT + SIMVA (pooled ERN/LRPT + SIMVA) on apoB:LDL-C and apoB:non-HDL-C correlations in dyslipidemic patients.Methods: This post-hoc analysis of a 12-week study evaluated the apoB:LDL-C and apoB:non-HDL-C correlations in dyslipidemic patients randomized equally to double-blind ERN/LRPT 1 g/20 mg, SIMVA 10, 20, or 40 mg, or ERN/LRPT 1 g/20 mg + SIMVA (10, 20, or 40 mg) once daily for 4 weeks. At week 5, doses were doubled in all groups except SIMVA 40 mg (unchanged) and ERN/LRPT 1 g/20 mg + SIMVA 40 mg (switched to ERN/LRPT 2 g/40 mg + SIMVA 40 mg). Simple linear regression analyses were used to calculate LDL-C and non-HDL-C levels corresponding to known apoB baseline values (ie, in untreated patients) and following treatment.Results: The apoB:LDL-C and apoB:non-HDL-C correlations were higher and the predicted LDL-C and non-HDL-C levels for a known apoB value were considerably lower following treatment with ERN/LRPT, SIMVA and ERN/LRPT + SIMVA compared with untreated patients at baseline.Conclusion: Greater dissociation of apoB, LDL-C, and non-HDL-C targets occur following treatment with ERN/LRPT, SIMVA, and ERN/LRPT + SIMVA in patients with dyslipidemia. The achievement of more aggressive LDL-C and non-HDL-C goals in patients receiving lipid-modifying therapy may further reduce coronary risk by normalizing apoB-containing atherogenic lipoproteins.Keywords: apoB, LDL-C, non-HDL-C

Published
2014

44. The Moral Dimension: Toward a New Economics

Author

Mitchel Y. Abolafia and Amitai Etzioni

Subjects
Public Administration, Sociology and Political Science, Arts and Humanities (miscellaneous), Philosophy and economics, Moral psychology, Economics, Social science, Positive economics, Dimension (data warehouse), Moral disengagement
Published
1989

45. Enacting Market Crisis: The Social Construction of a Speculative Bubble

Author

Mitchel Y. Abolafia and Martin Kilduff

Subjects
Solvency, Public Administration, Sociology and Political Science, Fluid ounce (US), Crisis management, Management, Market economy, Stern, Arts and Humanities (miscellaneous), Order (exchange), Business cycle, Economics, Market environment, Economic bubble
Abstract

The authors thank Steve Barley, John Forester, John Freeman, Mark Granovetter, Bob Stern, and Richard Thaler for their comments on earlier drafts of this paper. This study shows how the emotional phases that accompany market crisis can be related to an underlying cycle of actions, attributions, and regulatory reactions among participants in the market environment. The action-attribution-regulation process is here called "enactment," in order to focus on how market participants create the environment that then impinges on their activity. We illustrate this process with a case study of the 1980 crisis in the silver futures market, when prices soared from $10 per ounce to $50 per ounce and fell back to $10 per ounce in seven months. The traditional mania/distress/panic model of speculative bubbles is reframed as a cycle of organizing, focusing on the strategic actions of buyers, sellers, bankers, and government agencies. The paper shows how the crisis, enacted by market participants who created speculative opportunities, was resolved through the cooperation of powerful organizations that sought to protect the solvency of insiders and the integrity of the market. This view of market process suggests a cycle of action and institutional constraint that shapes the structure of market environments.'

Published
1988

46. Book Review

Author

Abolafia, Mitchel Y.

Published
1991

48. 40(th) EASD Annual Meeting of the European Association for the Study of Diabetes : Munich, Germany, 5-9 September 2004

Author

S. Artigas, A V Dreval, Mark I. McCarthy, C Watson, Peter H. Bennett, M Quint, Y Ikeda, E Alpert, F Schiele, H Sekihara, Erik Gylfe, P Lowe, J Kuhlmann, Alain Golay, V Longo, Shahidul Alam Khan Akm., L G Mantovani, M Zawodniak-Szalapska, G Winkler, T Harrity, L Virág, U Johne, Kuo S-W., Linda C Tapsell, J Rodriguez, Michel Komajda, K Kankova, Carole A. Cull, M Sporna, E Estilles, U Ribel, M C Spruce, E Buzzigoli, T Prazak, J K McLaughlin, M K Lingohr, M Lim, F Calara, A Siebenhofer, G Meregalli, Roberto Anichini, A D Baron, R Kurashvili, P C Butler, G I Fantus, T. E. De Gooyer, Park Y-M., R. Walther, S Heinrich, Agnieszka Zawiejska, S Mukherjee, Nikolaos Papanas, G Wong, Ian D. Caterson, David M. Maahs, Shuichi Kaneko, Alexandra E. Butler, Francisco Javier Ampudia-Blasco, O N Kong, Attali J-R., C A Hedman, K Oshinyemi, Nicolle Müller, I C Cranston, N Okumus, M V Vlaiculescu, Balasubramanian Ravikumar, W W Cheatham, K Mukasa, K B Biswas, Annunziata Lapolla, Phil McEwan, G Mader, Gilles Chassot, Dragi Anevski, Werner A. Scherbaum, M Donath, C Hesselmann, R A Gandhi, David E. Moller, Ezio Bonifacio, C Garcia, V Ifandi, P Hornnes, Nieuwenhoven Fav., C Puech, S Pérez-Del-Pulgar, Kim S-R., G Hines, C Rubio Terrés, Michael Gaster, N. Hosszufalusi, A Scholze, Andrew A. Young, Stavros Liatis, F Hariri, S Tan, Paul Valensi, Allan E. Karlsen, J Kim, E. Moberg, J Kaiser, L Berman, G Nelson, A Altkrüger, P Kothare, D B Cook, S Doran, G. van Dijk, Shahnaz Shahinfar, Kim C-S., P Stahl, M Manousaki, S Sigrist, S K Lim, M. P. Stern, A Guberti, C Rezzani, J McKenney, Karl Thomaseth, Sofia Carlsson, M Julia, R Brillante, I Rubesova, T Darkow, E Matsumoto, Wendy M. Macfarlane, M Di Martino, G Bardini, Rossella Menghini, D Duhot, E Farcasiu, Annalisa Natalicchio, I Lindner, J Buvat, Christian L. Brand, Harry Dorchy, Iwona Pietrzak, Z T Luo, P Home, M Ekelund, Jesper Gromada, Kristine Færch, F Piarulli, H Kim, R Mentel, Zsuzsanna K. Zsengellér, Dullaart Rpf., Anton Luger, Thomas A. Pearson, V Manicardi, P Rösen, Feng Y-M., R Morganti, Lars Hansen, Demuth H-U., Haruo Kasai, A Shostak, Rudi Steffensen, G Taylor, Markolf Hanefeld, C Santini, E Hamaguchi, Roberto Miccoli, F Storms, M Cooper, Y Lee, Allison E. Aiello, P Smith, T Suehiro, K Treece, M Waluś, Timothy A Welborn, Simone Baltrusch, E Kontela, S Chai, J Crean, H Yokoyama, Johan G. Eriksson, Rafael Hernández Hernández, J Rodríguez-Saldaña, M P Tornero, G Formoso, D. Lovell, E Bingham, A Mylonakis, M Manteghetti, D Fedele, Antonio Martín-Duce, Ralph A. DeFronzo, D Salcedo, Kurt Højlund, Antonio Petrone, Sheu Whh., C Gutierrez, Flavia Pricci, S Kurita, Z G Abbas, M M Benedetti, Philippe A. Halban, Daniel J. Cox, O Ljungkvist, Justine Davies, J Palsgaard, Lars Sjöström, E Bosi, L Janin-Manificat, W. F. Kelly, M. Fernandez, E Colak, O V Mulyarchik, B Kronshage, F Lang, M Erfurth, Takashi Kadowaki, N Jendrike, U Walter, J Wishart, Y. Neye, D Kim, N Furuhashi, M Barsotti, D Florow, L Ke, L Borgquist, N C Jackson, Ffolliott M. Fisher, V Baskar, K Yoshioka, Bryan A. Wolf, G Chabrier, R Skoumal, Livio Luzi, H Kose, I Pharisien, B. Klein, H Winiarska, M C Johnson, L Griffiths, Nonna Kravchun, C Combe, Baptist Gallwitz, J Zdychova, L Skorda, Jorma Ilonen, W Gao, I N Steen, A Terrinoni, P D Ambery, W Kern, C M Kusminski, Cho M-H., Paolo Pozzilli, Louise G. Grunnet, E Schönle, David R Matthews, Robert W. Taylor, Y Cohen, Kim H-S., M P Eccles, N B Tutuncu, D McDowell, Richard M. Bergenstal, K Takamatsu, T Steiner, Jaan Palgi, Valdemar Grill, N Niculescu, G Federici, S Lehto, P. M. McKeigue, M Barone, Michael E. 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Dell'Antonio, G, Maestroni, A, Ruggieri, D, Luzi, L, Piemonti, L, Zerbini, G, Anafaroglu, I, Tutuncu, N, Sultana, M, Siddiqua, N, Iwasaki, T, Nakajima, A, Yoneda, M, Mukasa, K, Tanaka, S, and Sekihara, H

Subjects
0303 health sciences, medicine.medical_specialty, business.industry, EASD, Endocrinology, Diabetes and Metabolism, Human physiology, medicine.disease, 03 medical and health sciences, 0302 clinical medicine, Diabetes mellitus, Family medicine, Internal Medicine, Medicine, business, 030217 neurology & neurosurgery, 030304 developmental biology
Published
2004

49. Phase 2b Randomized Trial of the Oral PCSK9 Inhibitor MK-0616.

Author

Ballantyne CM, Banka P, Mendez G, Garcia R, Rosenstock J, Rodgers A, Mendizabal G, Mitchel Y, and Catapano AL

Subjects
Adult, Female, Humans, Male, Middle Aged, Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal, Humanized therapeutic use, Cholesterol, LDL, Double-Blind Method, Proprotein Convertase 9, Proprotein Convertases therapeutic use, Serine Endopeptidases therapeutic use, Treatment Outcome, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Hypercholesterolemia drug therapy
Abstract

Background: MK-0616 is an oral macrocyclic peptide inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9) in development for the treatment of hypercholesterolemia., Objectives: This Phase 2b, randomized, double-blind, placebo-controlled, multicenter trial aimed to evaluate the efficacy and safety of MK-0616 in participants with hypercholesterolemia., Methods: This trial was planned to include 375 adult participants with a wide range of atherosclerotic cardiovascular disease risk. Participants were assigned randomly (1:1:1:1:1 ratio) to MK-0616 (6, 12, 18, or 30 mg once daily) or matching placebo. The primary endpoints included percentage change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 8 and the proportion of participants with adverse events (AEs) and study intervention discontinuations due to AEs; participants were monitored for AEs for an additional 8 weeks after the 8-week treatment period., Results: Of the 381 participants randomized, 49% were female, and the median age was 62 years. Among 380 treated participants, all doses of MK-0616 demonstrated statistically significant (P < 0.001) differences in least squares mean percentage change in LDL-C from baseline to Week 8 vs placebo: -41.2% (6 mg), -55.7% (12 mg), -59.1% (18 mg), and -60.9% (30 mg). AEs occurred in a similar proportion of participants in the MK-0616 arms (39.5% to 43.4%) as placebo (44.0%). Discontinuations due to AEs occurred in 2 or fewer participants in any treatment group., Conclusions: MK-0616 demonstrated statistically significant and robust, dose-dependent placebo-adjusted reductions in LDL-C at Week 8 of up to 60.9% from baseline and was well tolerated during 8 weeks of treatment and an additional 8 weeks of follow-up. (A Study of the Efficacy and Safety of MK-0616 [Oral PCSK9 Inhibitor] in Adults With Hypercholesterolemia [MK-0616-008]; NCT05261126)., Competing Interests: Funding Support and Author Disclosures Funding for this research was provided by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, New Jersey, USA. Academic advisors and representatives of the funder participated in the study design. Data collected by the investigators and their site personnel were analyzed and interpreted by senior academic authors and representatives of the funder. The funder provided results and methodologic details and participated in the preparation, review, and approval of the manuscript. Dr Ballantyne has received grant/research support through his institution from Abbott Diagnostic, Akcea, Amgen, Arrowhead, Esperion, Ionis, Merck, New Amsterdam, Novartis, Novo Nordisk, Regeneron, and Roche Diagnostic; and has been a consultant for 89Bio, Abbott Diagnostics, Alnylam Pharmaceuticals, Althera, Amarin, Amgen, Arrowhead, AstraZeneca, Denka Seiken, Esperion, Genentech, Gilead, Illumina, Ionis, Matinas BioPharma Inc, Merck, New Amsterdam, Novartis, Novo Nordisk, Pfizer, Regeneron, and Roche Diagnostic. Dr Mendez has received lecture fees or research grants from Amgen, MSD, Bayer, Merck, Novartis, Tricida, and Servier. Dr Rosenstock has served on scientific advisory boards and received honorarium or consulting fees from Applied Therapeutics, Boehringer Ingelheim, Eli Lilly, Hanmi, Novo Nordisk, Oramed, Sanofi, Structure Therapeutics, Terns Pharma, and Zealand; has received grants/research support from Applied Therapeutics, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hanmi, Merck, Oramed, Novartis, Novo Nordisk, Pfizer, and Sanofi; and has received honorarium for lectures sponsored by Boehringer Ingelheim, Eli Lilly, Novo Nordisk and Sanofi. Dr Catapano’s work is supported in part by Ministero della Salute Ricerca Corrente; and he has received honoraria, lecture fees, or research grants from Aegerion, Amgen, Amryt, AstraZeneca, Bayer, Daiichi-Sankyo, Eli Lilly, Genzyme, Ionis Pharmaceutical, Kowa, Mediolanum, Medscape, Menarini, Merck, Mylan, Novartis, PeerVoice, Pfizer, Recordati, Regeneron, Sanofi, Sigma-Tau, and The Corpus. Dr Banka, Mr Rodgers, Dr Mendizabal, and Dr Mitchel are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, New Jersey, USA and may own stock or stock options in Merck & Co, Inc, Rahway, New Jersey, USA. Dr Garcia has reported that he has no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Published
2023
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50. Long-term safety and efficacy of anacetrapib in patients with atherosclerotic vascular disease.

Author

Sammons E, Hopewell JC, Chen F, Stevens W, Wallendszus K, Valdes-Marquez E, Dayanandan R, Knott C, Murphy K, Wincott E, Baxter A, Goodenough R, Lay M, Hill M, Macdonnell S, Fabbri G, Lucci D, Fajardo-Moser M, Brenner S, Hao D, Zhang H, Liu J, Wuhan B, Mosegaard S, Herrington W, Wanner C, Angermann C, Ertl G, Maggioni A, Barter P, Mihaylova B, Mitchel Y, Blaustein R, Goto S, Tobert J, DeLucca P, Chen Y, Chen Z, Gray A, Haynes R, Armitage J, Baigent C, Wiviott S, Cannon C, Braunwald E, Collins R, Bowman L, and Landray M

Subjects
Adult, Atorvastatin therapeutic use, Double-Blind Method, Humans, Treatment Outcome, Atherosclerosis drug therapy, Myocardial Infarction drug therapy, Oxazolidinones adverse effects
Abstract

Aims: REVEAL was the first randomized controlled trial to demonstrate that adding cholesteryl ester transfer protein inhibitor therapy to intensive statin therapy reduced the risk of major coronary events. We now report results from extended follow-up beyond the scheduled study treatment period., Methods and Results: A total of 30 449 adults with prior atherosclerotic vascular disease were randomly allocated to anacetrapib 100 mg daily or matching placebo, in addition to open-label atorvastatin therapy. After stopping the randomly allocated treatment, 26 129 survivors entered a post-trial follow-up period, blind to their original treatment allocation. The primary outcome was first post-randomization major coronary event (i.e. coronary death, myocardial infarction, or coronary revascularization) during the in-trial and post-trial treatment periods, with analysis by intention-to-treat. Allocation to anacetrapib conferred a 9% [95% confidence interval (CI) 3-15%; P = 0.004] proportional reduction in the incidence of major coronary events during the study treatment period (median 4.1 years). During extended follow-up (median 2.2 years), there was a further 20% (95% CI 10-29%; P < 0.001) reduction. Overall, there was a 12% (95% CI 7-17%, P < 0.001) proportional reduction in major coronary events during the overall follow-up period (median 6.3 years), corresponding to a 1.8% (95% CI 1.0-2.6%) absolute reduction. There were no significant effects on non-vascular mortality, site-specific cancer, or other serious adverse events. Morbidity follow-up was obtained for 25 784 (99%) participants., Conclusion: The beneficial effects of anacetrapib on major coronary events increased with longer follow-up, and no adverse effects emerged on non-vascular mortality or morbidity. These findings illustrate the importance of sufficiently long treatment and follow-up duration in randomized trials of lipid-modifying agents to assess their full benefits and potential harms., Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 48678192; ClinicalTrials.gov No. NCT01252953; EudraCT No. 2010-023467-18., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Published
2022
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