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1. Effects of statin therapy on diagnoses of new-onset diabetes and worsening glycaemia in large-scale randomised blinded statin trials: an individual participant data meta-analysis

Author

Reith, Christina, Preiss, David, Blackwell, Lisa, Emberson, Jonathan, Spata, Enti, Davies, Kelly, Halls, Heather, Harper, Charlie, Holland, Lisa, Wilson, Kate, Roddick, Alistair J, Cannon, Christopher P, Clarke, Robert, Colhoun, Helen M, Durrington, Paul N, Goto, Shinya, Hitman, Graham A, Hovingh, G Kees, Jukema, J Wouter, Koenig, Wolfgang, Marschner, Ian, Mihaylova, Borislava, Newman, Connie, Probsfield, Jeffrey L, Ridker, Paul M, Sabatine, Marc S, Sattar, Naveed, Schwartz, Gregory G, Tavazzi, Luigi, Tonkin, Andrew, Trompet, Stella, White, Harvey, Yusuf, Salim, Armitage, Jane, Keech, Anthony, Simes, John, Collins, Rory, Baigent, Colin, Barnes, Elizabeth, Fulcher, Jordan, Herrington, William G, Kirby, Adrienne, O'Connell, Rachel, Amarenco, Pierre, Arashi, Hiroyuki, Barter, Philip, Betteridge, D John, Blazing, Michael, Blauw, Gerard J, Bosch, Jackie, Bowman, Louise, Braunwald, Eugene, Bulbulia, Richard, Byington, Robert, Clearfield, Michael, Cobbe, Stuart, Dahlöf, Björn, Davis, Barry, de Lemos, James, Downs, John R, Fellström, Bengt, Flather, Marcus, Ford, Ian, Franzosi, Maria Grazia, Fuller, John, Furberg, Curt, Glynn, Robert, Goldbourt, Uri, Gordon, David, Gotto, Jr, Antonio, Grimm, Richard, Gupta, Ajay, Hawkins, C Morton, Haynes, Richard, Holdaas, Hallvard, Hopewell, Jemma, Jardine, Alan, Kastelein, John JP, Kean, Sharon, Kearney, Patricia, Kitas, George, Kjekshus, John, Knatterud, Genell, Knopp, Robert H, Koren, Michael, Krane, Vera, Landray, Martin, LaRosa, John, Latini, Roberto, Lonn, Eva, Lucci, Donata, MacFadyen, Jean, Macfarlane, Peter, MacMahon, Stephen, Maggioni, Aldo, Marchioli, Roberto, Moyé, Lemuel, Murphy, Sabina, Neil, Andrew, Nicolis, Enrico B, Packard, Chris, Parish, Sarah, Pedersen, Terje R, Peto, Richard, Pfeffer, Marc, Poulter, Neil, Pressel, Sara, Probstfield, Jeffrey, Rahman, Mahboob, Robertson, Michele, Sacks, Frank, Schmieder, Roland, Serruys, Patrick, Sever, Peter, Shaw, John, Shepherd, James, Simpson, Lara, Sleight, Peter, Smeeth, Liam, Tobert, Jonathan, Tognoni, Gianni, Varigos, John, Wanner, Christoph, Wedel, Hans, Weis, Stephen, Welch, K Michael, Wikstrand, John, Wilhelmsen, Lars, Wiviott, Stephen, Yamaguchi, Junichi, Young, Robin, and Zannad, Faiez

Published
2024
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2. Effect of statin therapy on muscle symptoms: an individual participant data meta-analysis of large-scale, randomised, double-blind trials

Author

Reith, Christina, Baigent, Colin, Blackwell, Lisa, Emberson, Jonathan, Spata, Enti, Davies, Kelly, Halls, Heather, Holland, Lisa, Wilson, Kate, Armitage, Jane, Harper, Charlie, Preiss, David, Roddick, Alistair, Keech, Anthony, Simes, John, Collins, Rory, Barnes, Elizabeth, Fulcher, Jordan, Herrington, William G, Kirby, Adrienne, Mihaylova, Borislava, O'Connell, Rachel, Amarenco, Pierre, Barter, Philip, Betteridge (deceased), D John, Blazing, Michael, Bosch, Jackie, Bowman, Louise, Braunwald, Eugene, Cannon, Christopher P, Clearfield, Michael, Cobbe, Stuart, Colhoun, Helen M, Dahlöf, Björn, Davis, Barry, de Lemos, James, Downs, John R, Durrington, Paul N, Fellström, Bengt, Ford, Ian, Franzosi, Maria Grazia, Fuller (deceased), John, Furberg, Curt, Glynn, Robert, Gordon, David, Gotto Jr, Antonio, Grimm, Richard, Gupta, Ajay, Hawkins, C Morton, Hitman, Graham A, Holdaas (deceased), Hallvard, Jardine, Alan, Jukema, J Wouter, Kastelein, John JP, Kean, Sharon, Kjekshus, John, Knatterud (deceased), Genell, Knopp (deceased), Robert H, Koenig, Wolfgang, Koren, Michael, Krane, Vera, Landray, Martin, LaRosa, John, Latini, Roberto, Lonn, Eva, Lucci, Donata, MacFadyen, Jean, Macfarlane, Peter, MacMahon, Stephen, Maggioni, Aldo, Marchioli, Roberto, Marschner, Ian, Moyé, Lemuel, Murphy, Sabina, Neil, Andrew, Nicolis, Enrico B, Packard, Chris, Parish, Sarah, Pedersen, Terje R, Peto, Richard, Pfeffer, Marc, Poulter, Neil, Pressel, Sara, Probstfield, Jeffrey, Rahman, Mahboob, Ridker, Paul M, Robertson, Michele, Sacks, Frank, Sattar, Naveed, Schmieder, Roland, Serruys, Patrick W, Sever, Peter, Shaw (deceased), John, Shepherd (deceased), James, Simpson, Lara, Sleight (deceased), Peter, Tavazzi, Luigi, Tognoni, Gianni, Tonkin, Andrew, Trompet, Stella, Wanner, Christoph, Wedel, Hans, Weis, Stephen, Welch, K Michael, White, Harvey, Wikstrand, John, Wilhelmsen, Lars, Wiviott, Stephen, Young, Robin, Yusuf, Salim, Zannad, Faiez, Arashi, Hiroyuki, Byington, Robert, Clarke, Robert, Flather, Marcus, Goldbourt, Uri, Goto, Shinya, Hopewell, Jemma, Hovingh, Kees, Kearney, Patricia, Kitas, George, Newman, Connie, Sabatine, Marc S, Schwartz, Greg, Smeeth, Liam, Tobert, Jonathan, Varigos, John, and Yamaguchi, Junichi

Published
2022
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3. The effect of statin therapy on heart failure events: a collaborative meta-analysis of unpublished data from major randomized trials

Author

Preiss, David, Campbell, Ross T, Murray, Heather M, Ford, Ian, Packard, Chris J, Sattar, Naveed, Rahimi, Kazem, Colhoun, Helen M, Waters, David D, LaRosa, John C, Amarenco, Pierre, Pedersen, Terje R, Tikkanen, Matti J, Koren, Michael J, Poulter, Neil R, Sever, Peter S, Ridker, Paul M, MacFadyen, Jean G, Solomon, Scott D, Davis, Barry R, Simpson, Lara M, Nakamura, Haruo, Mizuno, Kyoichi, Marfisi, Rosa M, Marchioli, Roberto, Tognoni, Gianni, Athyros, Vasilios G, Ray, Kausik K, Gotto, Antonio M, Clearfield, Michael B, Downs, John R, and McMurray, John J

Subjects
Clinical Trials and Supportive Activities, Cardiovascular, Clinical Research, Prevention, Heart Disease, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Female, Heart Failure, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Male, Middle Aged, Myocardial Infarction, Randomized Controlled Trials as Topic, Risk Factors, Secondary Prevention, Treatment Outcome, Statin, Heart failure, Randomized trial, Meta-analysis, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Cardiovascular System & Hematology
Abstract

AimsThe effect of statins on risk of heart failure (HF) hospitalization and HF death remains uncertain. We aimed to establish whether statins reduce major HF events.Methods and resultsWe searched Medline, EMBASE, and the Cochrane Central Register of Controlled Trials for randomized controlled endpoint statin trials from 1994 to 2014. Collaborating trialists provided unpublished data from adverse event reports. We included primary- and secondary-prevention statin trials with >1000 participants followed for >1 year. Outcomes consisted of first non-fatal HF hospitalization, HF death and a composite of first non-fatal HF hospitalization or HF death. HF events occurring

Published
2015

4. HMG-coenzyme A reductase inhibition, type 2 diabetes, and bodyweight: evidence from genetic analysis and randomised trials

Author

Swerdlow, Daniel I, Preiss, David, Kuchenbaecker, Karoline B, Holmes, Michael V, Engmann, Jorgen EL, Shah, Tina, Sofat, Reecha, Stender, Stefan, Johnson, Paul CD, Scott, Robert A, Leusink, Maarten, Verweij, Niek, Sharp, Stephen J, Guo, Yiran, Giambartolomei, Claudia, Chung, Christina, Peasey, Anne, Amuzu, Antoinette, Li, KaWah, Palmen, Jutta, Howard, Philip, Cooper, Jackie A, Drenos, Fotios, Li, Yun R, Lowe, Gordon, Gallacher, John, Stewart, Marlene CW, Tzoulaki, Ioanna, Buxbaum, Sarah G, van der A, Daphne L, Forouhi, Nita G, Onland-Moret, N Charlotte, van der Schouw, Yvonne T, Schnabel, Renate B, Hubacek, Jaroslav A, Kubinova, Ruzena, Baceviciene, Migle, Tamosiunas, Abdonas, Pajak, Andrzej, Topor-Madry, Romanvan, Stepaniak, Urszula, Malyutina, Sofia, Baldassarre, Damiano, Sennblad, Bengt, Tremoli, Elena, de Faire, Ulf, Veglia, Fabrizio, Ford, Ian, Jukema, J Wouter, Westendorp, Rudi GJ, de Borst, Gert Jan, de Jong, Pim A, Algra, Ale, Spiering, Wilko, der Zee, Anke H Maitland-van, Klungel, Olaf H, de Boer, Anthonius, Doevendans, Pieter A, Eaton, Charles B, Robinson, Jennifer G, Duggan, David, DIAGRAM Consortium, MAGIC Consortium, Kjekshus, John, Downs, John R, Gotto, Antonio M, Keech, Anthony C, Marchioli, Roberto, Tognoni, Gianni, Sever, Peter S, Poulter, Neil R, Waters, David D, Pedersen, Terje R, Amarenco, Pierre, Nakamura, Haruo, McMurray, John JV, Lewsey, James D, Chasman, Daniel I, Ridker, Paul M, Maggioni, Aldo P, Tavazzi, Luigi, Ray, Kausik K, Seshasai, Sreenivasa Rao Kondapally, Manson, JoAnn E, Price, Jackie F, Whincup, Peter H, Morris, Richard W, Lawlor, Debbie A, Smith, George Davey, Ben-Shlomo, Yoav, Schreiner, Pamela J, Fornage, Myriam, Siscovick, David S, Cushman, Mary, Kumari, Meena, Wareham, Nick J, Verschuren, WM Monique, Redline, Susan, Patel, Sanjay R, Whittaker, John C, and Hamsten, Anders

Subjects
Epidemiology, Biomedical and Clinical Sciences, Health Sciences, Clinical Trials and Supportive Activities, Clinical Research, Genetics, Nutrition, Diabetes, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Metabolic and endocrine, Aged, Body Mass Index, Body Weight, Cholesterol, HDL, Cholesterol, LDL, Diabetes Mellitus, Type 2, Female, Genetic Testing, Humans, Hydroxymethylglutaryl CoA Reductases, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Male, Middle Aged, Polymorphism, Single Nucleotide, Randomized Controlled Trials as Topic, Risk Factors, DIAGRAM Consortium, MAGIC Consortium, InterAct Consortium, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundStatins increase the risk of new-onset type 2 diabetes mellitus. We aimed to assess whether this increase in risk is a consequence of inhibition of 3-hydroxy-3-methylglutaryl-CoA reductase (HMGCR), the intended drug target.MethodsWe used single nucleotide polymorphisms in the HMGCR gene, rs17238484 (for the main analysis) and rs12916 (for a subsidiary analysis) as proxies for HMGCR inhibition by statins. We examined associations of these variants with plasma lipid, glucose, and insulin concentrations; bodyweight; waist circumference; and prevalent and incident type 2 diabetes. Study-specific effect estimates per copy of each LDL-lowering allele were pooled by meta-analysis. These findings were compared with a meta-analysis of new-onset type 2 diabetes and bodyweight change data from randomised trials of statin drugs. The effects of statins in each randomised trial were assessed using meta-analysis.FindingsData were available for up to 223 463 individuals from 43 genetic studies. Each additional rs17238484-G allele was associated with a mean 0·06 mmol/L (95% CI 0·05-0·07) lower LDL cholesterol and higher body weight (0·30 kg, 0·18-0·43), waist circumference (0·32 cm, 0·16-0·47), plasma insulin concentration (1·62%, 0·53-2·72), and plasma glucose concentration (0·23%, 0·02-0·44). The rs12916 SNP had similar effects on LDL cholesterol, bodyweight, and waist circumference. The rs17238484-G allele seemed to be associated with higher risk of type 2 diabetes (odds ratio [OR] per allele 1·02, 95% CI 1·00-1·05); the rs12916-T allele association was consistent (1·06, 1·03-1·09). In 129 170 individuals in randomised trials, statins lowered LDL cholesterol by 0·92 mmol/L (95% CI 0·18-1·67) at 1-year of follow-up, increased bodyweight by 0·24 kg (95% CI 0·10-0·38 in all trials; 0·33 kg, 95% CI 0·24-0·42 in placebo or standard care controlled trials and -0·15 kg, 95% CI -0·39 to 0·08 in intensive-dose vs moderate-dose trials) at a mean of 4·2 years (range 1·9-6·7) of follow-up, and increased the odds of new-onset type 2 diabetes (OR 1·12, 95% CI 1·06-1·18 in all trials; 1·11, 95% CI 1·03-1·20 in placebo or standard care controlled trials and 1·12, 95% CI 1·04-1·22 in intensive-dose vs moderate dose trials).InterpretationThe increased risk of type 2 diabetes noted with statins is at least partially explained by HMGCR inhibition.FundingThe funding sources are cited at the end of the paper.

Published
2015

5. Very Low Levels of Atherogenic Lipoproteins and the Risk for Cardiovascular Events A Meta-Analysis of Statin Trials

Author

Boekholdt, S Matthijs, Hovingh, G Kees, Mora, Samia, Arsenault, Benoit J, Amarenco, Pierre, Pedersen, Terje R, LaRosa, John C, Waters, David D, DeMicco, David A, Simes, R John, Keech, Antony C, Colquhoun, David, Hitman, Graham A, Betteridge, D John, Clearfield, Michael B, Downs, John R, Colhoun, Helen M, Gotto, Antonio M, Ridker, Paul M, Grundy, Scott M, and Kastelein, John JP

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Atherosclerosis, Cardiovascular, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Biomarkers, Cardiovascular Diseases, Global Health, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Incidence, Lipoproteins, Randomized Controlled Trials as Topic, Risk Factors, apolipoprotein B, LDL-cholesterol, meta-analysis, non-HDL-cholesterol, non–HDL-cholesterol, Cardiorespiratory Medicine and Haematology, Public Health and Health Services, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

BackgroundLevels of atherogenic lipoproteins achieved with statin therapy are highly variable, but the consequence of this variability for cardiovascular disease risk is not well-documented.ObjectivesThe aim of this meta-analysis was to evaluate: 1) the interindividual variability of reductions in low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), or apolipoprotein B (apoB) levels achieved with statin therapy; 2) the proportion of patients not reaching guideline-recommended lipid levels on high-dose statin therapy; and 3) the association between very low levels of atherogenic lipoproteins achieved with statin therapy and cardiovascular disease risk.MethodsThis meta-analysis used individual patient data from 8 randomized controlled statin trials, in which conventional lipids and apolipoproteins were determined in all study participants at baseline and at 1-year follow-up.ResultsAmong 38,153 patients allocated to statin therapy, a total of 6,286 major cardiovascular events occurred in 5,387 study participants during follow-up. There was large interindividual variability in the reductions of LDL-C, non-HDL-C, and apoB achieved with a fixed statin dose. More than 40% of trial participants assigned to high-dose statin therapy did not reach an LDL-C target 175 mg/dl, those who reached an LDL-C 75 to 40% did not reach an LDL-C target

Published
2014

6. Adjusted* General Linear Model to Compare The Impact of Metformin on PSA, BMI and LDL between Race/Ethnicity Groups from Metformin for Reducing Racial/Ethnic Difference in Prostate Cancer Incidence for Men with Type II Diabetes

Author

Wang, Chen-Pin, primary, Lehman, Donna M., primary, Lam, Yui-Wing F., primary, Kuhn, John G., primary, Mahalingam, Devalingam, primary, Weitman, Steven, primary, Lorenzo, Carlos, primary, Downs, John R., primary, Stuart, Elizabeth A., primary, Hernandez, Javier, primary, Thompson, Ian M., primary, and Ramirez, Amelie G., primary

Published
2023
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7. Data from Metformin for Reducing Racial/Ethnic Difference in Prostate Cancer Incidence for Men with Type II Diabetes

Author

Wang, Chen-Pin, primary, Lehman, Donna M., primary, Lam, Yui-Wing F., primary, Kuhn, John G., primary, Mahalingam, Devalingam, primary, Weitman, Steven, primary, Lorenzo, Carlos, primary, Downs, John R., primary, Stuart, Elizabeth A., primary, Hernandez, Javier, primary, Thompson, Ian M., primary, and Ramirez, Amelie G., primary

Published
2023
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12. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials

Author

Sattar, Naveed, Preiss, David, Murray, Heather M, Welsh, Paul, Buckley, Brendan M, de Craen, Anton JM, Seshasai, Sreenivasa Rao Kondapally, McMurray, John J, Freeman, Dilys J, Jukema, J Wouter, Macfarlane, Peter W, Packard, Chris J, Stott, David J, Westendorp, Rudi G, Shepherd, James, Davis, Barry R, Pressel, Sara L, Marchioli, Roberto, Marfisi, Rosa Maria, Maggioni, Aldo P, Tavazzi, Luigi, Tognoni, Gianni, Kjekshus, John, Pedersen, Terje R, Cook, Thomas J, Gotto, Antonio M, Clearfield, Michael B, Downs, John R, Nakamura, Haruo, Ohashi, Yasuo, Mizuno, Kyoichi, Ray, Kausik K, and Ford, Ian

Published
2010
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17. Association of LDL Cholesterol, Non–HDL Cholesterol, and Apolipoprotein B Levels With Risk of Cardiovascular Events Among Patients Treated With Statins: A Meta-analysis

Author

Boekholdt, S. Matthijs, Arsenault, Benoit J., Mora, Samia, Pedersen, Terje R., LaRosa, John C., Nestel, Paul J., Simes, R. John, Durrington, Paul, Hitman, Graham A., Welch, K. M., DeMicco, David A., Zwinderman, Aeilko H., Clearfield, Michael B., Downs, John R., Tonkin, Andrew M., Colhoun, Helen M., Gotto, Antonio M., Jr, Ridker, Paul M, and Kastelein, John J.

Published
2012
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18. Measurement of C-reactive protein for the targeting of statin therapy in the primary prevention of acute coronary events

Author

Ridker, Paul M., Rifai, Nader, Clearfield, Michael, Downs, John R., Weis, Stephen E., Miles, J. Shawn, and Gotto, Antonio M., Jr.

Subjects
Lovastatin -- Physiological aspects, C-reactive protein, Heart attack -- Prevention
Abstract

Lovastatin can lower the risk of heart attack in people with high blood cholesterol, high C-reactive protein levels, or both. C-reactive protein is a marker of inflammation, and could be used to detect the early stages of heart disease in people who have no symptoms.

Published
2001

19. Management of Dyslipidemia for Cardiovascular Disease Risk Reduction: Synopsis of the 2020 Updated U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guideline

Author

O'Malley, Patrick G., primary, Arnold, Michael J., additional, Kelley, Cathy, additional, Spacek, Lance, additional, Buelt, Andrew, additional, Natarajan, Sundar, additional, Donahue, Mark P., additional, Vagichev, Elena, additional, Ballard-Hernandez, Jennifer, additional, Logan, Amanda, additional, Thomas, Lauren, additional, Ritter, Joan, additional, Neubauer, Brian E., additional, and Downs, John R., additional

Published
2020
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21. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS

Author

Downs, John R., Clearfield, Michael, Weis, Stephen, Whitney, Edwin, Shapiro, Deborah R., Beere, Polly A., Langendorfer, Alexandra, Stein, Evan A., Kruyer, William, and Gotto, Antonio M., Jr.

Subjects
Lovastatin -- Evaluation, Heart attack -- Prevention, Angina pectoris -- Prevention
Abstract

Lovastatin appears to lower the risk of heart attack, angina and the need for revascularization procedures in people without heart disease but with low levels of high-density lipoprotein (HDL) cholesterol. This type of cholesterol protects against heart disease. Researchers randomly assigned 5,608 men and 997 women to take lovastatin or placebo every day in addition to a low-fat diet. After an average follow-up of five years, lovastatin reduced the risk of heart attack, angina and other cardiovascular events by 25% to 40%. The need for revascularization procedures such as angioplasty was also reduced., Context.--Although cholesterol-reducing treatment has been shown to reduce fatal and nonfatal coronary disease in patients with coronary heart disease (CHD), it is unknown whether benefit from the reduction of low-density lipoprotein cholesterol (LDL-C) in patients without CHD extends to individuals with average serum cholesterol levels, women, and older persons. Objective.--To compare lovastatin with placebo for prevention of the first acute major coronary event in men and women without clinically evident atherosclerotic cardiovascular disease with average total cholesterol (TC) and LDL-C levels and below-average high-density lipoprotein cholesterol (HDL-C) levels. Design.--A randomized, double-blind, placebo-controlled trial. Setting.--Outpatient clinics in Texas. Participants.--A total of 5608 men and 997 women with average TC and LDL-C and below-average HDL-C (as characterized by lipid percentiles for an age- and sex-matched cohort without cardiovascular disease from the National Health and Nutrition Examination Survey [NHANES] III). Mean (SD) TC level was 5.71 (0.54) mmol/L (221 [21] mg/dL) (51st percentile), mean (SD) LDL-C level was 3.89 (0.43) mmol/L (150 [17] mg/dL) (60th percentile), mean (SD) HDL-C level was 0.94 (0.14) mmol/L (36 [5] mg/dL) for men and 1.03 (0.14) mmol/dL (40 [5] mg/dL) for women (25th and 16th percentiles, respectively), and median (SD) triglyceride levels were 1.78 (0.86) mmol/L (158 [76] mg/dL) (63rd percentile). Intervention.--Lovastatin (20-40 mg daily) or placebo in addition to a low-saturated fat, low-cholesterol diet. Main Outcome Measures.--First acute major coronary event defined as fatal or nonfatal myocardial infarction, unstable angina, or sudden cardiac death. Results.--After an average follow-up-of 5.2 years, lovastatin reduced the incidence of first acute major coronary events (183 vs 116 first events; relative risk [RR], 0.63; 95% confidence interval [Cl], 0.50-0.79; P [is less than] .001), myocardial infarction (95 vs 57 myocardial infarctions; RR, 0.60; 95% Cl, 0.43-0.83; P=.002), unstable angina (87 vs 60 first unstable angina events; RR, 0.68; 95% Cl, 0.49-0.95; P=.02), coronary revascularization procedures (157 vs 106 procedures; RR, 0.67; 95% Cl, 0.52-0.85; P=.001), coronary events (215 vs 163 coronary events; RR, 0.75; 95% Cl, 0.61 -0.92; P=.006), and cardiovascular events (255 vs 194 cardiovascular events; RR, 0.75; 95% Cl, 0.62-0.91; P=.003). Lovastatin (20-40 mg daily) reduced LDL-C by 25% to 2.96 mmol/L (115 mg/dL) and increased HDL-C by 6% to 1.02 mmol/L (39 mg/dL). There were no clinically relevant differences in safety parameters between treatment groups. Conclusions.--Lovastatin reduces the risk for the first acute major coronary event in men and women with average TC and LDL-C levels and below-average HDL-C levels. These findings support the inclusion of HDL-C in risk-factor assessment, confirm the benefit of LDL-C reduction to a target goal, and suggest the need for reassessment of the National Cholesterol Education Program guidelines regarding pharmacological intervention. JAMA. 1998;279:1615-1622

Published
1998

25. Efficacy and safety of statin therapy in older people: a meta-analysis of individual participant data from 28 randomised controlled trials

Author

Armitage, Jane, primary, Baigent, Colin, additional, Barnes, Elizabeth, additional, Betteridge, D John, additional, Blackwell, Lisa, additional, Blazing, Michael, additional, Bowman, Louise, additional, Braunwald, Eugene, additional, Byington, Robert, additional, Cannon, Christopher, additional, Clearfield, Michael, additional, Colhoun, Helen, additional, Collins, Rory, additional, Dahlöf, Björn, additional, Davies, Kelly, additional, Davis, Barry, additional, de Lemos, James, additional, Downs, John R, additional, Durrington, Paul, additional, Emberson, Jonathan, additional, Fellström, Bengt, additional, Flather, Marcus, additional, Ford, Ian, additional, Franzosi, Maria Grazia, additional, Fulcher, Jordan, additional, Fuller, John, additional, Furberg, Curt, additional, Gordon, David, additional, Goto, Shinya, additional, Gotto, Antonio, additional, Halls, Heather, additional, Harper, Charlie, additional, Hawkins, C Morton, additional, Herrington, Will, additional, Hitman, Graham, additional, Holdaas, Hallvard, additional, Holland, Lisa, additional, Jardine, Alan, additional, Jukema, J Wouter, additional, Kastelein, John, additional, Kean, Sharon, additional, Keech, Anthony, additional, Kirby, Adrienne, additional, Kjekshus, John, additional, Knatterud (deceased), Genell, additional, Knopp (deceased), Robert, additional, Koenig, Wolfgang, additional, Koren, Michael, additional, Krane, Vera, additional, Landray, Martin J, additional, LaRosa, John, additional, Lonn, Eva, additional, MacFarlane, Peter, additional, MacMahon, Stephen, additional, Maggioni, Aldo, additional, Marchioli, Roberto, additional, Marschner, Ian, additional, Mihaylova, Borislava, additional, Moyé, Lemuel, additional, Murphy, Sabina, additional, Nakamura, Haruo, additional, Neil, Andrew, additional, Newman, Connie, additional, O'Connell, Rachel, additional, Packard, Chris, additional, Parish, Sarah, additional, Pedersen, Terje, additional, Peto, Richard, additional, Pfeffer, Marc, additional, Poulter, Neil, additional, Preiss, David, additional, Reith, Christina, additional, Ridker, Paul, additional, Robertson, Michele, additional, Sacks, Frank, additional, Sattar, Naveed, additional, Schmieder, Roland, additional, Serruys, Patrick, additional, Sever, Peter, additional, Shaw, John, additional, Shear, Charles, additional, Simes, John, additional, Sleight, Peter, additional, Spata, Enti, additional, Tavazzi, Luigi, additional, Tobert, Jonathan, additional, Tognoni, Gianni, additional, Tonkin, Andrew, additional, Trompet, Stella, additional, Varigos, John, additional, Wanner, Christoph, additional, Wedel, Hans, additional, White, Harvey, additional, Wikstrand, John, additional, Wilhelmsen, Lars, additional, Wilson, Kate, additional, Young, Robin, additional, Yusuf, Salim, additional, and Zannad, Faiez, additional

Published
2019
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27. Editorials.

Author

Arnold, Michael J., O'Malley, Patrick G., and Downs, John R.

Subjects
CLINICAL trials monitoring, FAMILIAL hypercholesterolemia, DYSLIPIDEMIA, STUDENT health services
Abstract

11 Moderate-dose statins have fewer adverse effects than high-dose statins; therefore, we strongly recommend them as the first step in therapy to reduce cardiovascular risk. 6 Limited study of high-dose statins for primary prevention shows similar cardiovascular benefits as moderate-dose statins, with increased risks of diabetes and statin intolerance. 10 The ACC/AHA guidelines also recommend moderate-dose statins, although high-dose statins and additional medications are suggested for certain conditions despite lack of evidence of superior outcomes. 1 Switching to high-dose statins and adding ezetimibe or PCSK9 inhibitors to statins reduces nonfatal cardiovascular events more than moderate-dose statins alone, each to a similar extent. [Extracted from the article]

Published
2021

28. Management of Dyslipidemia for Cardiovascular Disease Risk Reduction: Synopsis of the 2020 Updated U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guideline.

Author

O’Malley, Patrick G., Arnold, Michael J., Kelley, Cathy, Spacek, Lance, Buelt, Andrew, Natarajan, Sundar, Donahue, Mark P., Vagichev, Elena, Ballard-Hernandez, Jennifer, Logan, Amanda, Thomas, Lauren, Ritter, Joan, Neubauer, Brian E., Downs, John R., and O'Malley, Patrick G

Subjects
DYSLIPIDEMIA, CARDIOVASCULAR diseases, VETERANS, GUIDELINES, PHYSICAL activity, TEAMS in the workplace
Abstract

Description: In June 2020, the U.S. Department of Veterans Affairs (VA) and U.S. Department of Defense (DoD) released a joint update of their clinical practice guideline for managing dyslipidemia to reduce cardiovascular disease risk in adults. This synopsis describes the major recommendations.Methods: On 6 August to 9 August 2019, the VA/DoD Evidence-Based Practice Work Group (EBPWG) convened a joint VA/DoD guideline development effort that included clinical stakeholders and conformed to the Institute of Medicine's tenets for trustworthy clinical practice guidelines. The guideline panel developed key questions, systematically searched and evaluated the literature (English-language publications from 1 December 2013 to 16 May 2019), and developed 27 recommendations and a simple 1-page algorithm. The recommendations were graded by using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system.Recommendations: This synopsis summarizes key features of the guideline in 7 crucial areas: targeting of statin dose (not low-density lipoprotein cholesterol goals), additional tests for risk prediction, primary and secondary prevention, laboratory testing, physical activity, and nutrition. [ABSTRACT FROM AUTHOR]

Published
2020
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30. Report of Sewage Works Practice Committee, September 15, 1945

Author

Cohn, Morris M., Brooks,, John H., Brown, Reuben, Downs, John R., Edwards, G. P., Gilcreas, F. W., Gray, Harold F., Hill, Kenneth V., Keefer, C. E., Mohlman, F. W., Niles, A. H., Pearse, Langdon, Rudolfs, Willem, Van Kleeck, L. W., Wirts, J. J., and Wisely, W. H.

Published
1946

32. The effect of statin therapy on heart failure events: a collaborative meta-analysis of unpublished data from major randomized trials

Author

Preiss, David, Campbell, Ross T., Murray, Heather M., Ford, Ian, Packard, Chris J., Sattar, Naveed, Rahimi, Kazem, Colhoun, Helen M., Waters, David D., LaRosa, John C., Amarenco, Pierre, Pedersen, Terje R., Tikkanen, Matti J., Koren, Michael J., Poulter, Neil R., Sever, Pete S., Ridker, Paul M., MacFadyen, Michael J., Solomon, Scott D., Davis, Barry R., Simpson, Lara M., Nakamura, Haruo, Mizuno, Kyoichi, Marfisi, Rosa M., Marchioli, Roberto, Tognoni, Gianni, Athyros, Vasilios G., Ray, Kausik K., Gotto, Antonio M., Clearfield, Michael B., Downs, John R., McMurray, John J., Clinicum, Department of Medicine, University of Helsinki, Medicum, Kardiologian yksikkö, Imperial College Healthcare NHS Trust- BRC Funding, and National Institute for Health Research

Subjects
Male, Cardiac & Cardiovascular Systems, Clinical Sciences, Myocardial Infarction, Cardiorespiratory Medicine and Haematology, PLACEBO-CONTROLLED TRIAL, 1102 Cardiovascular Medicine And Haematology, HYPERTENSIVE PATIENTS, Clinical Research, Risk Factors, AVERAGE CHOLESTEROL LEVELS, Secondary Prevention, Humans, HIGH-DOSE ATORVASTATIN, Randomized Controlled Trials as Topic, Heart Failure, Science & Technology, VASCULAR EVENTS, ACUTE CORONARY SYNDROMES, Prevention, Heart Failure/Cardiomyopathy, Statin, Middle Aged, Meta-analysis, Treatment Outcome, MYOCARDIAL-INFARCTION, Cardiovascular System & Hematology, CARDIOVASCULAR-DISEASE, 3121 General medicine, internal medicine and other clinical medicine, Cardiovascular System & Cardiology, Female, LDL CHOLESTEROL, Randomized trial, Hydroxymethylglutaryl-CoA Reductase Inhibitors, PRIMARY PREVENTION, Life Sciences & Biomedicine
Abstract

Aims The effect of statins on risk of heart failure (HF) hospitalization and HF death remains uncertain. We aimed to establish whether statins reduce major HF events.\ud Methods and results We searched Medline, EMBASE, and the Cochrane Central Register of Controlled Trials for randomized controlled endpoint statin trials from 1994 to 2014. Collaborating trialists provided unpublished data from adverse event reports. We included primary- and secondary-prevention statin trials with >1000 participants followed for

Published
2014

33. Metformin for Reducing Racial/Ethnic Difference in Prostate Cancer Incidence for Men with Type II Diabetes

Author

Wang, Chen-Pin, primary, Lehman, Donna M., additional, Lam, Yui-Wing F., additional, Kuhn, John G., additional, Mahalingam, Devalingam, additional, Weitman, Steven, additional, Lorenzo, Carlos, additional, Downs, John R., additional, Stuart, Elizabeth A., additional, Hernandez, Javier, additional, Thompson, Ian M., additional, and Ramirez, Amelie G., additional

Published
2016
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34. HMG-coenzyme A reductase inhibition, type 2 diabetes, and bodyweight : Evidence from genetic analysis and randomised trials

Author

Swerdlow, Daniel I., Preiss, David, Kuchenbaecker, Karoline B., Holmes, Michael V., Engmann, Jorgen E L, Shah, Tina, Sofat, Reecha, Stender, Stefan, Johnson, Paul C D, Scott, Robert A., Leusink, Maarten, Verweij, Niek, Sharp, Stephen J., Guo, Yiran, Giambartolomei, Claudia, Chung, Christina, Peasey, Anne, Amuzu, Antoinette, Li, Kawah, Palmen, Jutta, Howard, Philip, Cooper, Jackie A., Drenos, Fotios, Li, Yun R., Lowe, Gordon, Gallacher, John, Stewart, Marlene C W, Tzoulaki, Ioanna, Buxbaum, Sarah G., Van Der A, Daphne L., Forouhi, Nita G., Onland-Moret, N. Charlotte, Van Der Schouw, Yvonne T., Schnabel, Renate B., Hubacek, Jaroslav A., Kubinova, Ruzena, Baceviciene, Migle, Tamosiunas, Abdonas, Pajak, Andrzej, Topor-Madry, Romanvan, Stepaniak, Urszula, Malyutina, Sofia, Baldassarre, Damiano, Sennblad, Bengt, Tremoli, Elena, De Faire, Ulf, Veglia, Fabrizio, Ford, Ian, Jukema, J. Wouter, Westendorp, Rudi G J, De Borst, Gert Jan, De Jong, Pim A., Algra, Ale, Spiering, Wilko, Der Zee, Anke H Maitland Van, Klungel, Olaf H., De Boer, Anthonius, Doevendans, Pieter A., Eaton, Charles B., Robinson, Jennifer G., Duggan, David, Kjekshus, John, Downs, John R., Gotto, Antonio M., Keech, Anthony C., Marchioli, Roberto, Tognoni, Gianni, Sever, Peter S., Poulter, Neil R., Waters, David D., Pedersen, Terje R., Amarenco, Pierre, Nakamura, Haruo, McMurray, John J V, Lewsey, James D., Chasman, Daniel I., Ridker, Paul M., Maggioni, Aldo P., Tavazzi, Luigi, Ray, Kausik K., Seshasai, Sreenivasa Rao Kondapally, Manson, Joann E., Price, Jackie F., Whincup, Peter H., Morris, Richard W., Lawlor, Debbie A., Smith, George Davey, Ben-Shlomo, Yoav, Schreiner, Pamela J., Fornage, Myriam, Siscovick, David S., Cushman, Mary, Kumari, Meena, Wareham, Nick J., Verschuren, W. M Monique, Redline, Susan, Patel, Sanjay R., Whittaker, John C., Hamsten, Anders, Delaney, Joseph A., Dale, Caroline, Gaunt, Tom R., Wong, Andrew, Kuh, Diana, Hardy, Rebecca, Kathiresan, Sekar, Castillo, Berta A., Van Der Harst, Pim, Brunner, Eric J., Tybjaerg-Hansen, Anne, Marmot, Michael G., Krauss, Ronald M., Tsai, Michael, Coresh, Josef, Hoogeveen, Ronald C., Psaty, Bruce M., Lange, Leslie A., Hakonarson, Hakon, Dudbridge, Frank, Humphries, Steve E., Talmud, Philippa J., Kivimäki, Mika, Timpson, Nicholas J., Langenberg, Claudia, Asselbergs, Folkert W., Voevoda, Mikhail, Bobak, Martin, Pikhart, Hynek, Wilson, James G., Reiner, Alex P., Keating, Brendan J., Hingorani, Aroon D., Sattar, Naveed, Swerdlow, Daniel I., Preiss, David, Kuchenbaecker, Karoline B., Holmes, Michael V., Engmann, Jorgen E L, Shah, Tina, Sofat, Reecha, Stender, Stefan, Johnson, Paul C D, Scott, Robert A., Leusink, Maarten, Verweij, Niek, Sharp, Stephen J., Guo, Yiran, Giambartolomei, Claudia, Chung, Christina, Peasey, Anne, Amuzu, Antoinette, Li, Kawah, Palmen, Jutta, Howard, Philip, Cooper, Jackie A., Drenos, Fotios, Li, Yun R., Lowe, Gordon, Gallacher, John, Stewart, Marlene C W, Tzoulaki, Ioanna, Buxbaum, Sarah G., Van Der A, Daphne L., Forouhi, Nita G., Onland-Moret, N. Charlotte, Van Der Schouw, Yvonne T., Schnabel, Renate B., Hubacek, Jaroslav A., Kubinova, Ruzena, Baceviciene, Migle, Tamosiunas, Abdonas, Pajak, Andrzej, Topor-Madry, Romanvan, Stepaniak, Urszula, Malyutina, Sofia, Baldassarre, Damiano, Sennblad, Bengt, Tremoli, Elena, De Faire, Ulf, Veglia, Fabrizio, Ford, Ian, Jukema, J. Wouter, Westendorp, Rudi G J, De Borst, Gert Jan, De Jong, Pim A., Algra, Ale, Spiering, Wilko, Der Zee, Anke H Maitland Van, Klungel, Olaf H., De Boer, Anthonius, Doevendans, Pieter A., Eaton, Charles B., Robinson, Jennifer G., Duggan, David, Kjekshus, John, Downs, John R., Gotto, Antonio M., Keech, Anthony C., Marchioli, Roberto, Tognoni, Gianni, Sever, Peter S., Poulter, Neil R., Waters, David D., Pedersen, Terje R., Amarenco, Pierre, Nakamura, Haruo, McMurray, John J V, Lewsey, James D., Chasman, Daniel I., Ridker, Paul M., Maggioni, Aldo P., Tavazzi, Luigi, Ray, Kausik K., Seshasai, Sreenivasa Rao Kondapally, Manson, Joann E., Price, Jackie F., Whincup, Peter H., Morris, Richard W., Lawlor, Debbie A., Smith, George Davey, Ben-Shlomo, Yoav, Schreiner, Pamela J., Fornage, Myriam, Siscovick, David S., Cushman, Mary, Kumari, Meena, Wareham, Nick J., Verschuren, W. M Monique, Redline, Susan, Patel, Sanjay R., Whittaker, John C., Hamsten, Anders, Delaney, Joseph A., Dale, Caroline, Gaunt, Tom R., Wong, Andrew, Kuh, Diana, Hardy, Rebecca, Kathiresan, Sekar, Castillo, Berta A., Van Der Harst, Pim, Brunner, Eric J., Tybjaerg-Hansen, Anne, Marmot, Michael G., Krauss, Ronald M., Tsai, Michael, Coresh, Josef, Hoogeveen, Ronald C., Psaty, Bruce M., Lange, Leslie A., Hakonarson, Hakon, Dudbridge, Frank, Humphries, Steve E., Talmud, Philippa J., Kivimäki, Mika, Timpson, Nicholas J., Langenberg, Claudia, Asselbergs, Folkert W., Voevoda, Mikhail, Bobak, Martin, Pikhart, Hynek, Wilson, James G., Reiner, Alex P., Keating, Brendan J., Hingorani, Aroon D., and Sattar, Naveed

Published
2015

35. HMG-coenzyme A reductase inhibition, type 2 diabetes, and bodyweight: Evidence from genetic analysis and randomised trials

Author

Cardiovasculaire Epi Team 3, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, JC onderzoeksprogramma Kanker, Cardiovasculaire Epidemiologie, Circulatory Health, Zorgeenheid Vaatchirurgie Medisch, ZL Cerebrovasculaire Ziekten Medisch, MS Infectieziekten, Global Health, JC onderzoeksprogramma Methodologie, Cardiologie, Public Health Epidemiologie, Swerdlow, Daniel I., Preiss, David, Kuchenbaecker, Karoline B., Holmes, Michael V., Engmann, Jorgen E L, Shah, Tina, Sofat, Reecha, Stender, Stefan, Johnson, Paul C D, Scott, Robert A., Leusink, Maarten, Verweij, Niek, Sharp, Stephen J., Guo, Yiran, Giambartolomei, Claudia, Chung, Christina, Peasey, Anne, Amuzu, Antoinette, Li, Kawah, Palmen, Jutta, Howard, Philip, Cooper, Jackie A., Drenos, Fotios, Li, Yun R., Lowe, Gordon, Gallacher, John, Stewart, Marlene C W, Tzoulaki, Ioanna, Buxbaum, Sarah G., Van Der A, Daphne L., Forouhi, Nita G., Onland-Moret, N. Charlotte, Van Der Schouw, Yvonne T., Schnabel, Renate B., Hubacek, Jaroslav A., Kubinova, Ruzena, Baceviciene, Migle, Tamosiunas, Abdonas, Pajak, Andrzej, Topor-Madry, Romanvan, Stepaniak, Urszula, Malyutina, Sofia, Baldassarre, Damiano, Sennblad, Bengt, Tremoli, Elena, De Faire, Ulf, Veglia, Fabrizio, Ford, Ian, Jukema, J. Wouter, Westendorp, Rudi G J, De Borst, Gert Jan, De Jong, Pim A., Algra, Ale, Spiering, Wilko, Der Zee, Anke H Maitland Van, Klungel, Olaf H., De Boer, Anthonius, Doevendans, Pieter A., Eaton, Charles B., Robinson, Jennifer G., Duggan, David, Kjekshus, John, Downs, John R., Gotto, Antonio M., Keech, Anthony C., Marchioli, Roberto, Tognoni, Gianni, Sever, Peter S., Poulter, Neil R., Waters, David D., Pedersen, Terje R., Amarenco, Pierre, Nakamura, Haruo, McMurray, John J V, Lewsey, James D., Chasman, Daniel I., Ridker, Paul M., Maggioni, Aldo P., Tavazzi, Luigi, Ray, Kausik K., Seshasai, Sreenivasa Rao Kondapally, Manson, Joann E., Price, Jackie F., Whincup, Peter H., Morris, Richard W., Lawlor, Debbie A., Smith, George Davey, Ben-Shlomo, Yoav, Schreiner, Pamela J., Fornage, Myriam, Siscovick, David S., Cushman, Mary, Kumari, Meena, Wareham, Nick J., Verschuren, W. M Monique, Redline, Susan, Patel, Sanjay R., Whittaker, John C., Hamsten, Anders, Delaney, Joseph A., Dale, Caroline, Gaunt, Tom R., Wong, Andrew, Kuh, Diana, Hardy, Rebecca, Kathiresan, Sekar, Castillo, Berta A., Van Der Harst, Pim, Brunner, Eric J., Tybjaerg-Hansen, Anne, Marmot, Michael G., Krauss, Ronald M., Tsai, Michael, Coresh, Josef, Hoogeveen, Ronald C., Psaty, Bruce M., Lange, Leslie A., Hakonarson, Hakon, Dudbridge, Frank, Humphries, Steve E., Talmud, Philippa J., Kivimäki, Mika, Timpson, Nicholas J., Langenberg, Claudia, Asselbergs, Folkert W., Voevoda, Mikhail, Bobak, Martin, Pikhart, Hynek, Wilson, James G., Reiner, Alex P., Keating, Brendan J., Hingorani, Aroon D., Sattar, Naveed, Cardiovasculaire Epi Team 3, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, JC onderzoeksprogramma Kanker, Cardiovasculaire Epidemiologie, Circulatory Health, Zorgeenheid Vaatchirurgie Medisch, ZL Cerebrovasculaire Ziekten Medisch, MS Infectieziekten, Global Health, JC onderzoeksprogramma Methodologie, Cardiologie, Public Health Epidemiologie, Swerdlow, Daniel I., Preiss, David, Kuchenbaecker, Karoline B., Holmes, Michael V., Engmann, Jorgen E L, Shah, Tina, Sofat, Reecha, Stender, Stefan, Johnson, Paul C D, Scott, Robert A., Leusink, Maarten, Verweij, Niek, Sharp, Stephen J., Guo, Yiran, Giambartolomei, Claudia, Chung, Christina, Peasey, Anne, Amuzu, Antoinette, Li, Kawah, Palmen, Jutta, Howard, Philip, Cooper, Jackie A., Drenos, Fotios, Li, Yun R., Lowe, Gordon, Gallacher, John, Stewart, Marlene C W, Tzoulaki, Ioanna, Buxbaum, Sarah G., Van Der A, Daphne L., Forouhi, Nita G., Onland-Moret, N. Charlotte, Van Der Schouw, Yvonne T., Schnabel, Renate B., Hubacek, Jaroslav A., Kubinova, Ruzena, Baceviciene, Migle, Tamosiunas, Abdonas, Pajak, Andrzej, Topor-Madry, Romanvan, Stepaniak, Urszula, Malyutina, Sofia, Baldassarre, Damiano, Sennblad, Bengt, Tremoli, Elena, De Faire, Ulf, Veglia, Fabrizio, Ford, Ian, Jukema, J. Wouter, Westendorp, Rudi G J, De Borst, Gert Jan, De Jong, Pim A., Algra, Ale, Spiering, Wilko, Der Zee, Anke H Maitland Van, Klungel, Olaf H., De Boer, Anthonius, Doevendans, Pieter A., Eaton, Charles B., Robinson, Jennifer G., Duggan, David, Kjekshus, John, Downs, John R., Gotto, Antonio M., Keech, Anthony C., Marchioli, Roberto, Tognoni, Gianni, Sever, Peter S., Poulter, Neil R., Waters, David D., Pedersen, Terje R., Amarenco, Pierre, Nakamura, Haruo, McMurray, John J V, Lewsey, James D., Chasman, Daniel I., Ridker, Paul M., Maggioni, Aldo P., Tavazzi, Luigi, Ray, Kausik K., Seshasai, Sreenivasa Rao Kondapally, Manson, Joann E., Price, Jackie F., Whincup, Peter H., Morris, Richard W., Lawlor, Debbie A., Smith, George Davey, Ben-Shlomo, Yoav, Schreiner, Pamela J., Fornage, Myriam, Siscovick, David S., Cushman, Mary, Kumari, Meena, Wareham, Nick J., Verschuren, W. M Monique, Redline, Susan, Patel, Sanjay R., Whittaker, John C., Hamsten, Anders, Delaney, Joseph A., Dale, Caroline, Gaunt, Tom R., Wong, Andrew, Kuh, Diana, Hardy, Rebecca, Kathiresan, Sekar, Castillo, Berta A., Van Der Harst, Pim, Brunner, Eric J., Tybjaerg-Hansen, Anne, Marmot, Michael G., Krauss, Ronald M., Tsai, Michael, Coresh, Josef, Hoogeveen, Ronald C., Psaty, Bruce M., Lange, Leslie A., Hakonarson, Hakon, Dudbridge, Frank, Humphries, Steve E., Talmud, Philippa J., Kivimäki, Mika, Timpson, Nicholas J., Langenberg, Claudia, Asselbergs, Folkert W., Voevoda, Mikhail, Bobak, Martin, Pikhart, Hynek, Wilson, James G., Reiner, Alex P., Keating, Brendan J., Hingorani, Aroon D., and Sattar, Naveed

Published
2015

36. HMG-coenzyme A reductase inhibition, type 2 diabetes, and bodyweight:evidence from genetic analysis and randomised trials

Author

Swerdlow, Daniel I, Preiss, David, Kuchenbaecker, Karoline B, Holmes, Michael V, Engmann, Jorgen E L, Shah, Tina, Sofat, Reecha, Stender, Stefan, Johnson, Paul C D, Scott, Robert A, Leusink, Maarten, Verweij, Niek, Sharp, Stephen J, Guo, Yiran, Giambartolomei, Claudia, Chung, Christina, Peasey, Anne, Amuzu, Antoinette, Li, KaWah, Palmen, Jutta, Howard, Philip, Cooper, Jackie A, Drenos, Fotios, Li, Yun R, Lowe, Gordon, Gallacher, John, Stewart, Marlene C W, Tzoulaki, Ioanna, Buxbaum, Sarah G, van der A, Daphne L, Forouhi, Nita G, Onland-Moret, N Charlotte, van der Schouw, Yvonne T, Schnabel, Renate B, Hubacek, Jaroslav A, Kubinova, Ruzena, Baceviciene, Migle, Tamosiunas, Abdonas, Pajak, Andrzej, Topor-Madry, Roman, Stepaniak, Urszula, Malyutina, Sofia, Baldassarre, Damiano, Sennblad, Bengt, Tremoli, Elena, de Faire, Ulf, Veglia, Fabrizio, Ford, Ian, Jukema, J Wouter, Westendorp, Rudi GJ, de Borst, Gert Jan, de Jong, Pim A, Algra, Ale, Spiering, Wilko, Maitland-van der Zee, Anke H, Klungel, Olaf H, de Boer, Anthonius, Doevendans, Pieter A, Eaton, Charles B, Robinson, Jennifer G, Duggan, David, Kjekshus, John, Downs, John R, Gotto, Antonio M, Keech, Anthony C, Marchioli, Roberto, Tognoni, Gianni, Sever, Peter S, Poulter, Neil R, Waters, David D, Pedersen, Terje R, Amarenco, Pierre, Nakamura, Haruo, McMurray, John J V, Lewsey, James D, Chasman, Daniel I, Ridker, Paul M, Maggioni, Aldo P, Tavazzi, Luigi, Ray, Kausik K, Seshasai, Sreenivasa Rao Kondapally, Manson, JoAnn E, Price, Jackie F, Whincup, Peter H, Morris, Richard W, Lawlor, Debbie A, Smith, George Davey, Ben-Shlomo, Yoav, Schreiner, Pamela J, Fornage, Myriam, Siscovick, David S, Cushman, Mary, Kumari, Meena, Wareham, Nick J, Verschuren, W M Monique, Redline, Susan, Patel, Sanjay R, Whittaker, John C, Hamsten, Anders, Delaney, Joseph A, Dale, Caroline, Gaunt, Tom R, Wong, Andrew, Kuh, Diana, Hardy, Rebecca, Kathiresan, Sekar, Castillo, Berta A, van der Harst, Pim, Brunner, Eric J, Tybjaerg-Hansen, Anne, Marmot, Michael G, Krauss, Ronald M, Tsai, Michael, Coresh, Josef, Hoogeveen, Ronald C, Psaty, Bruce M, Lange, Leslie A, Hakonarson, Hakon, Dudbridge, Frank, Humphries, Steve E, Talmud, Philippa J, Kivimäki, Mika, Timpson, Nicholas J, Langenberg, Claudia, Asselbergs, Folkert W, Voevoda, Mikhail, Bobak, Martin, Pikhart, Hynek, Wilson, James G, Reiner, Alex P, Keating, Brendan J, Hingorani, Aroon D, Sattar, Naveed, Swerdlow, Daniel I, Preiss, David, Kuchenbaecker, Karoline B, Holmes, Michael V, Engmann, Jorgen E L, Shah, Tina, Sofat, Reecha, Stender, Stefan, Johnson, Paul C D, Scott, Robert A, Leusink, Maarten, Verweij, Niek, Sharp, Stephen J, Guo, Yiran, Giambartolomei, Claudia, Chung, Christina, Peasey, Anne, Amuzu, Antoinette, Li, KaWah, Palmen, Jutta, Howard, Philip, Cooper, Jackie A, Drenos, Fotios, Li, Yun R, Lowe, Gordon, Gallacher, John, Stewart, Marlene C W, Tzoulaki, Ioanna, Buxbaum, Sarah G, van der A, Daphne L, Forouhi, Nita G, Onland-Moret, N Charlotte, van der Schouw, Yvonne T, Schnabel, Renate B, Hubacek, Jaroslav A, Kubinova, Ruzena, Baceviciene, Migle, Tamosiunas, Abdonas, Pajak, Andrzej, Topor-Madry, Roman, Stepaniak, Urszula, Malyutina, Sofia, Baldassarre, Damiano, Sennblad, Bengt, Tremoli, Elena, de Faire, Ulf, Veglia, Fabrizio, Ford, Ian, Jukema, J Wouter, Westendorp, Rudi GJ, de Borst, Gert Jan, de Jong, Pim A, Algra, Ale, Spiering, Wilko, Maitland-van der Zee, Anke H, Klungel, Olaf H, de Boer, Anthonius, Doevendans, Pieter A, Eaton, Charles B, Robinson, Jennifer G, Duggan, David, Kjekshus, John, Downs, John R, Gotto, Antonio M, Keech, Anthony C, Marchioli, Roberto, Tognoni, Gianni, Sever, Peter S, Poulter, Neil R, Waters, David D, Pedersen, Terje R, Amarenco, Pierre, Nakamura, Haruo, McMurray, John J V, Lewsey, James D, Chasman, Daniel I, Ridker, Paul M, Maggioni, Aldo P, Tavazzi, Luigi, Ray, Kausik K, Seshasai, Sreenivasa Rao Kondapally, Manson, JoAnn E, Price, Jackie F, Whincup, Peter H, Morris, Richard W, Lawlor, Debbie A, Smith, George Davey, Ben-Shlomo, Yoav, Schreiner, Pamela J, Fornage, Myriam, Siscovick, David S, Cushman, Mary, Kumari, Meena, Wareham, Nick J, Verschuren, W M Monique, Redline, Susan, Patel, Sanjay R, Whittaker, John C, Hamsten, Anders, Delaney, Joseph A, Dale, Caroline, Gaunt, Tom R, Wong, Andrew, Kuh, Diana, Hardy, Rebecca, Kathiresan, Sekar, Castillo, Berta A, van der Harst, Pim, Brunner, Eric J, Tybjaerg-Hansen, Anne, Marmot, Michael G, Krauss, Ronald M, Tsai, Michael, Coresh, Josef, Hoogeveen, Ronald C, Psaty, Bruce M, Lange, Leslie A, Hakonarson, Hakon, Dudbridge, Frank, Humphries, Steve E, Talmud, Philippa J, Kivimäki, Mika, Timpson, Nicholas J, Langenberg, Claudia, Asselbergs, Folkert W, Voevoda, Mikhail, Bobak, Martin, Pikhart, Hynek, Wilson, James G, Reiner, Alex P, Keating, Brendan J, Hingorani, Aroon D, and Sattar, Naveed

Abstract

BACKGROUND: Statins increase the risk of new-onset type 2 diabetes mellitus. We aimed to assess whether this increase in risk is a consequence of inhibition of 3-hydroxy-3-methylglutaryl-CoA reductase (HMGCR), the intended drug target.METHODS: We used single nucleotide polymorphisms in the HMGCR gene, rs17238484 (for the main analysis) and rs12916 (for a subsidiary analysis) as proxies for HMGCR inhibition by statins. We examined associations of these variants with plasma lipid, glucose, and insulin concentrations; bodyweight; waist circumference; and prevalent and incident type 2 diabetes. Study-specific effect estimates per copy of each LDL-lowering allele were pooled by meta-analysis. These findings were compared with a meta-analysis of new-onset type 2 diabetes and bodyweight change data from randomised trials of statin drugs. The effects of statins in each randomised trial were assessed using meta-analysis.FINDINGS: Data were available for up to 223 463 individuals from 43 genetic studies. Each additional rs17238484-G allele was associated with a mean 0·06 mmol/L (95% CI 0·05-0·07) lower LDL cholesterol and higher body weight (0·30 kg, 0·18-0·43), waist circumference (0·32 cm, 0·16-0·47), plasma insulin concentration (1·62%, 0·53-2·72), and plasma glucose concentration (0·23%, 0·02-0·44). The rs12916 SNP had similar effects on LDL cholesterol, bodyweight, and waist circumference. The rs17238484-G allele seemed to be associated with higher risk of type 2 diabetes (odds ratio [OR] per allele 1·02, 95% CI 1·00-1·05); the rs12916-T allele association was consistent (1·06, 1·03-1·09). In 129 170 individuals in randomised trials, statins lowered LDL cholesterol by 0·92 mmol/L (95% CI 0·18-1·67) at 1-year of follow-up, increased bodyweight by 0·24 kg (95% CI 0·10-0·38 in all trials; 0·33 kg, 95% CI 0·24-0·42 in placebo or standard care controlled trials and -0·15 kg, 95% CI -0·39 to 0·08 in intensive-dose vs moderate-dose trials) at a mean of 4·2 year

Published
2015

37. Very low levels of atherogenic lipoproteins and the risk for cardiovascular events: a meta-analysis of statin trials

Author

Boekholdt, S. Matthijs, Hovingh, G. Kees, Mora, Samia, Arsenault, Benoit J., Amarenco, Pierre, Pedersen, Terje R., LaRosa, John C., Waters, David D., Demicco, David A., Simes, R. John, Keech, Antony C., Colquhoun, David, Hitman, Graham A., Betteridge, D. John, Clearfield, Michael B., Downs, John R., Colhoun, Helen M., Gotto, Antonio M., Ridker, Paul M., Grundy, Scott M., Kastelein, John J. P., ACS - Amsterdam Cardiovascular Sciences, Cardiology, and Vascular Medicine

Subjects
Incidence, Lipoproteins, non-HDL-cholesterol, nutritional and metabolic diseases, Cardiorespiratory Medicine and Haematology, Atherosclerosis, Global Health, meta-analysis, Cardiovascular System & Hematology, Cardiovascular Diseases, Risk Factors, Public Health and Health Services, LDL-cholesterol, apolipoprotein B, non–HDL-cholesterol, Humans, lipids (amino acids, peptides, and proteins), Hydroxymethylglutaryl-CoA Reductase Inhibitors, Biomarkers, Randomized Controlled Trials as Topic
Abstract

Background Levels of atherogenic lipoproteins achieved with statin therapy are highly variable, but the consequence of this variability for cardiovascular disease risk is not well-documented. Objectives The aim of this meta-analysis was to evaluate: 1) the interindividual variability of reductions in low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), or apolipoprotein B (apoB) levels achieved with statin therapy; 2) the proportion of patients not reaching guideline-recommended lipid levels on high-dose statin therapy; and 3) the association between very low levels of atherogenic lipoproteins achieved with statin therapy and cardiovascular disease risk. Methods This meta-analysis used individual patient data from 8 randomized controlled statin trials, in which conventional lipids and apolipoproteins were determined in all study participants at baseline and at 1-year follow-up. Results Among 38,153 patients allocated to statin therapy, a total of 6,286 major cardiovascular events occurred in 5,387 study participants during follow-up. There was large interindividual variability in the reductions of LDL-C, non-HDL-C, and apoB achieved with a fixed statin dose. More than 40% of trial participants assigned to high-dose statin therapy did not reach an LDL-C target 175 mg/dl, those who reached an LDL-C 75 to 40% did not reach an LDL-C target

Published
2013

40. Levels and Changes of HDL Cholesterol and Apolipoprotein A-I in Relation to Risk of Cardiovascular Events Among Statin-Treated Patients

Author

Boekholdt, S. Matthijs, primary, Arsenault, Benoit J., additional, Hovingh, G. Kees, additional, Mora, Samia, additional, Pedersen, Terje R., additional, LaRosa, John C., additional, Welch, K.M.A., additional, Amarenco, Pierre, additional, DeMicco, David A., additional, Tonkin, Andrew M., additional, Sullivan, David R., additional, Kirby, Adrienne, additional, Colhoun, Helen M., additional, Hitman, Graham A., additional, Betteridge, D. John, additional, Durrington, Paul N., additional, Clearfield, Michael B., additional, Downs, John R., additional, Gotto, Antonio M., additional, Ridker, Paul M., additional, and Kastelein, John J.P., additional

Published
2013
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44. Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS): Efficacy and Tolerability of Long-Term Treatment with Lovastatin in Women

Author

Clearfield, Michael, primary, Downs, John R., additional, Weis, Stephen, additional, Whitney, Edwin J., additional, Kruyer, William, additional, Shapiro, Deborah R., additional, Stein, Evan A., additional, Langendorfer, Alexandra, additional, Beere, Polly A., additional, and Gotto, Antonio M., additional

Published
2001
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45. Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS): Baseline Characteristics and Comparison with USA Population

Author

Clearfield, Michael, primary, Whitney, Edwin J., additional, Weis, Stephen, additional, Downs, John R., additional, Shapiro, Deborah R., additional, Stein, Evan A., additional, Watson, Douglas J., additional, Langendörfer, Alexandra, additional, Beere, Polly A., additional, Stamler, Jeremiah, additional, and Gotto, Antonio M., additional

Published
2000
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46. Relation Between Baseline and On-Treatment Lipid Parameters and First Acute Major Coronary Events in the Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS)

Author

Gotto, Antonio M., primary, Whitney, Edwin, additional, Stein, Evan A., additional, Shapiro, Deborah R., additional, Clearfield, Michael, additional, Weis, Stephen, additional, Jou, Jesse Y., additional, Langendörfer, Alexandra, additional, Beere, Polly A., additional, Watson, Douglas J., additional, Downs, John R., additional, and de Cani, John S., additional

Published
2000
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47. Coronary Events With Lipid-Lowering Therapy: The AFCAPS/TexCAPS Trial

Author

Wallis, E. J., Haq, I. U., Yeo, W. W., Jackson, P. R., Ramsay, L. E., Krut, Louis H., Kandzari, David E., Goldschmidt-Clermont, Pascal J., Mason, James M., Freemantle, Nick, McDiarmid, Todd D., Hensel, William A., Papadakis, John A., Mikhailidis, Dimitri P., Walsh, Judith, Siegel, David, Swislocki, Arthur L. M., Downs, John R., Gotto, Antonio M., Jr, Clearfield, Michael, Weis, Stephen, Rosenson, Robert S., and Tangney, Christine C.

Subjects
Coronary heart disease -- Prevention, Hypercholesterolemia -- Drug therapy
Published
1999

50. Assessing appropriateness of lipid management among patients with diabetes mellitus: moving from target to treatment.

Author

Beard AJ, Hofer TP, Downs JR, Lucatorto M, Klamerus ML, Holleman R, Kerr EA, Diabetes Clinical Action Measures Workgroup, Beard, Ashley J, Hofer, Timothy P, Downs, John R, Lucatorto, Michelle, Klamerus, Mandi L, Holleman, Rob, and Kerr, Eve A

Abstract

Background: Performance measures that emphasize only a treat-to-target approach may motivate overtreatment with high-dose statins, potentially leading to adverse events and unnecessary costs. We developed a clinical action performance measure for lipid management in patients with diabetes mellitus that is designed to encourage appropriate treatment with moderate-dose statins while minimizing overtreatment.Methods and Results: We examined data from July 2010 to June 2011 for 964 818 active Veterans Affairs primary care patients ≥18 years of age with diabetes mellitus. We defined 3 conditions as successfully meeting the clinical action measure for patients 50 to 75 years old: (1) having a low-density lipoprotein (LDL) <100 mg/dL, (2) taking a moderate-dose statin regardless of LDL level or measurement, or (3) receiving appropriate clinical action (starting, switching, or intensifying statin therapy) if LDL is ≥100 mg/dL. We examined possible overtreatment for patients ≥18 years of age by examining the proportion of patients without ischemic heart disease who were on a high-dose statin. We then examined variability in measure attainment across 881 facilities using 2-level hierarchical multivariable logistic models. Of 668 209 patients with diabetes mellitus who were 50 to 75 years of age, 84.6% passed the clinical action measure: 67.2% with LDL <100 mg/dL, 13.0% with LDL ≥100 mg/dL and either on a moderate-dose statin (7.5%) or with appropriate clinical action (5.5%), and 4.4% with no index LDL on at least a moderate-dose statin. Of the entire cohort ≥18 years of age, 13.7% were potentially overtreated. Facilities with higher rates of meeting the current threshold measure (LDL <100 mg/dL) had higher rates of potential overtreatment (P<0.001).Conclusions: Use of a performance measure that credits appropriate clinical action indicates that almost 85% of diabetic veterans 50 to 75 years of age are receiving appropriate dyslipidemia management. However, many patients are potentially overtreated with high-dose statins. [ABSTRACT FROM AUTHOR]

Published
2013
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