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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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4. 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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5. Effect of Pemafibrate on Diabetic Foot Ulceration and Gangrene: An Exploratory Analysis From PROMINENT

Author

Interne Geneeskunde Vasculaire, Circulatory Health, Marinho, Lucas L., Everett, Brendan M., Aday, Aaron W., Visseren, Frank L.J., MacFadyen, Jean G., Zaharris, Elaine, Plutzky, Jorge, Santos, Raul D., Libby, Peter, Fruchart, Jean Charles, Ridker, Paul M., Pradhan, Aruna Das, Interne Geneeskunde Vasculaire, Circulatory Health, Marinho, Lucas L., Everett, Brendan M., Aday, Aaron W., Visseren, Frank L.J., MacFadyen, Jean G., Zaharris, Elaine, Plutzky, Jorge, Santos, Raul D., Libby, Peter, Fruchart, Jean Charles, Ridker, Paul M., and Pradhan, Aruna Das

Published
2024

6. 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

7. Pharmacogenetic meta-analysis of genome-wide association studies of LDL cholesterol response to statins.

Author

Postmus, Iris, Trompet, Stella, Deshmukh, Harshal A, Barnes, Michael R, Li, Xiaohui, Warren, Helen R, Chasman, Daniel I, Zhou, Kaixin, Arsenault, Benoit J, Donnelly, Louise A, Wiggins, Kerri L, Avery, Christy L, Griffin, Paula, Feng, QiPing, Taylor, Kent D, Li, Guo, Evans, Daniel S, Smith, Albert V, de Keyser, Catherine E, Johnson, Andrew D, de Craen, Anton JM, Stott, David J, Buckley, Brendan M, Ford, Ian, Westendorp, Rudi GJ, Slagboom, P Eline, Sattar, Naveed, Munroe, Patricia B, Sever, Peter, Poulter, Neil, Stanton, Alice, Shields, Denis C, O'Brien, Eoin, Shaw-Hawkins, Sue, Chen, Y-D Ida, Nickerson, Deborah A, Smith, Joshua D, Dubé, Marie Pierre, Boekholdt, S Matthijs, Hovingh, G Kees, Kastelein, John JP, McKeigue, Paul M, Betteridge, John, Neil, Andrew, Durrington, Paul N, Doney, Alex, Carr, Fiona, Morris, Andrew, McCarthy, Mark I, Groop, Leif, Ahlqvist, Emma, Welcome Trust Case Control Consortium, Bis, Joshua C, Rice, Kenneth, Smith, Nicholas L, Lumley, Thomas, Whitsel, Eric A, Stürmer, Til, Boerwinkle, Eric, Ngwa, Julius S, O'Donnell, Christopher J, Vasan, Ramachandran S, Wei, Wei-Qi, Wilke, Russell A, Liu, Ching-Ti, Sun, Fangui, Guo, Xiuqing, Heckbert, Susan R, Post, Wendy, Sotoodehnia, Nona, Arnold, Alice M, Stafford, Jeanette M, Ding, Jingzhong, Herrington, David M, Kritchevsky, Stephen B, Eiriksdottir, Gudny, Launer, Leonore J, Harris, Tamara B, Chu, Audrey Y, Giulianini, Franco, MacFadyen, Jean G, Barratt, Bryan J, Nyberg, Fredrik, Stricker, Bruno H, Uitterlinden, André G, Hofman, Albert, Rivadeneira, Fernando, Emilsson, Valur, Franco, Oscar H, Ridker, Paul M, Gudnason, Vilmundur, Liu, Yongmei, Denny, Joshua C, Ballantyne, Christie M, Rotter, Jerome I, Adrienne Cupples, L, Psaty, Bruce M, Palmer, Colin NA, Tardif, Jean-Claude, and Colhoun, Helen M

Subjects
Welcome Trust Case Control Consortium, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Pharmacogenetics, Polymorphism, Single Nucleotide, Cholesterol, LDL, Genome-Wide Association Study, Cholesterol, LDL, Polymorphism, Single Nucleotide
Abstract

Statins effectively lower LDL cholesterol levels in large studies and the observed interindividual response variability may be partially explained by genetic variation. Here we perform a pharmacogenetic meta-analysis of genome-wide association studies (GWAS) in studies addressing the LDL cholesterol response to statins, including up to 18,596 statin-treated subjects. We validate the most promising signals in a further 22,318 statin recipients and identify two loci, SORT1/CELSR2/PSRC1 and SLCO1B1, not previously identified in GWAS. Moreover, we confirm the previously described associations with APOE and LPA. Our findings advance the understanding of the pharmacogenetic architecture of statin response.

Published
2014

9. Relationship of C-reactive protein reduction to cardiovascular event reduction following treatment with canakinumab: a secondary analysis from the CANTOS randomised controlled trial

Author

Ridker, Paul M, MacFadyen, Jean G, Everett, Brendan M, Libby, Peter, Thuren, Tom, Glynn, Robert J, Kastelein, John, Koenig, Wolfgang, Genest, Jacques, Lorenzatti, Alberto, Varigos, John, Siostrzonek, Peter, Sinnaeve, Peter, Fonseca, Francisco, Nicolau, Jose, Gotcheva, Nina, Yong, Huo, Urina-Triana, Miguel, Milicic, Davor, Cifkova, Renata, Vettus, Riina, Anker, Stephan D, Manolis, Athanasios J, Wyss, Fernando, Forster, Tamas, Sigurdsson, Axel, Pais, Prem, Fucili, Alessandro, Ogawa, Hisao, Shimokawa, Hiroaki, Veze, Irina, Petrauskiene, Birute, Salvador, Leon, Cornel, Jan Hein, Klemsdal, Tor Ole, Medina, Felix, Budaj, Andrzej, Vida-Simiti, Luminita, Kobalava, Zhanna, Otasevic, Petar, Pella, Daniel, Lainscak, Mitja, Seung, Ki-Bae, Commerford, Patrick, Dellborg, Mikael, Donath, Marc, Hwang, Juey-Jen, Kultursay, Hakan, Flather, Marcus, Ballantyne, Christie, Bilazarian, Seth, Chang, William, East, Cara, Forgosh, Les, Harris, Barry, and Ligueros, Monica

Published
2018
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11. Exercise reduces inflammatory cell production and cardiovascular inflammation via instruction of hematopoietic progenitor cells

Author

Frodermann, Vanessa, Rohde, David, Courties, Gabriel, Severe, Nicolas, Schloss, Maximilian J., Amatullah, Hajera, McAlpine, Cameron S., Cremer, Sebastian, Hoyer, Friedrich F., Ji, Fei, van Koeverden, Ian D., Herisson, Fanny, Honold, Lisa, Masson, Gustavo Santos, Zhang, Shuang, Grune, Jana, Iwamoto, Yoshiko, Schmidt, Stephen P., Wojtkiewicz, Gregory R., Lee, I-Hsiu, Gustafsson, Karin, Pasterkamp, Gerard, de Jager, Saskia C. A., Sadreyev, Ruslan I., MacFadyen, Jean, Libby, Peter, Ridker, Paul, Scadden, David T., Naxerova, Kamila, Jeffrey, Kate L., Swirski, Filip K., and Nahrendorf, Matthias

Published
2019
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12. Effect of interleukin-1β inhibition with canakinumab on incident lung cancer in patients with atherosclerosis: exploratory results from a randomised, double-blind, placebo-controlled trial

Author

Ridker, Paul, Lorenzatti, Alberto, Krum, Henry, Varigos, John, Siostrzonek, Peter, Sinnaeve, Peter, Fonseca, Francisco, Nicolau, Jose, Gotcheva, Nina, Genest, Jacques, Yong, Huo, Urina-Triana, Miguel, Milicic, Davor, Cifkova, Renata, Vettus, Riina, Koenig, Wolfgang, Anker, Stephan D, Manolis, Athanasios J, Wyss, Fernando, Forster, Tamas, Sigurdsson, Axel, Pais, Prem, Fucili, Alessandro, Ogawa, Hisao, Shimokawa, Hiroaki, Veze, Irina, Petrauskiene, Birute, Salvador, Leon, Kastelein, John, Cornel, Jan Hein, Klemsdal, Tor Ole, Medina, Felix, Budaj, Andrzej, Vida-Simiti, Luminita, Kobalava, Zhanna, Otasevic, Petar, Pella, Daniel, Lainscak, Mitja, Seung, Ki-Bae, Commerford, Patrick, Dellborg, Mikael, Donath, Marc, Hwang, Juey-Jen, Kultursay, Hakan, Flather, Marcus, Ballantyne, Christie, Bilazarian, Seth, Chang, William, East, Cara, Everett, Brendan, Forgosh, Les, Glynn, Robert, Harris, Barry, Libby, Peter, Ligueros, Monica, Thuren, Tom, Bohula, Erin, Charmarthi, Bindu, Cheng, Susan, Chou, Sherry, Danik, Jacqueline, McMahon, Graham, Maron, Bradley, Ning, MingMing, Olenchock, Benjamin, Pande, Reena, Perlstein, Todd, Pradhan, Aruna, Rost, Natalia, Singhal, Aneesh, Taqueti, Viviany, Wei, Nancy, Burris, Howard, Cioffi, Angela, Dalseg, Anne Marie, Ghosh, Nilanjan, Gralow, Julie, Mayer, Tina, Rugo, Hope, Fowler, Vance, Limaye, Ajit P, Cosgrove, Sara, Levine, Donald, Lopes, Renato, Scott, John, Hilkert, Robert, Tamesby, Georgia, Mickel, Carolyn, Manning, Brian, Woelcke, Julian, Tan, Monique, Manfreda, Sheryl, Ponce, Tom, Kam, Jane, Saini, Ravinder, Banker, Kehur, Salko, Thomas, Nandy, Panjat, Tawfik, Ronda, O'Neil, Greg, Manne, Shobha, Jirvankar, Pravin, Lal, Shankar, Nema, Deepak, Jose, Jaison, Collins, Rory, Bailey, Kent, Blumenthal, Roger, Colhoun, Helen, Gersh, Bernard, Glynn, Robert J, Ridker, Paul M, MacFadyen, Jean G, and Everett, Brendan M

Published
2017
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13. Effect of canakinumab on frailty: A post hoc analysis of the CANTOS trial.

Author

Orkaby, Ariela R., Thomson, Aerin, MacFadyen, Jean, Besdine, Richard, Forman, Daniel E., Travison, Thomas G., and Ridker, Paul M.

Subjects
FRAILTY, OLDER people, MONOCLONAL antibodies
Abstract

Although inflammation is strongly associated with frailty, whether medications that lower inflammation decrease frailty is unclear and randomized trial evidence is scant. We sought to test whether canakinumab, a therapeutic monoclonal antibody that inhibits IL‐1β and reduces C‐reactive protein (CRP), can lower frailty risk. This was a post hoc analysis of the Canakinumab ANti‐inflammatory Thrombosis Outcome Study (CANTOS), a randomized double‐blind placebo‐controlled trial of 10,061 stable postmyocardial infarction patients randomized to subcutaneous canakinumab once every 3 months. Incident frailty was measured using a 34‐item cumulative‐deficit Frailty Index (FI). Time‐to‐event analysis using intent to treat. A total of 9942 CANTOS participants had data to calculate a baseline FI. Median age was 61 (IQR 54–68); 74% were male, 12% Asian, 3% Black, 80% White, and 16% Hispanic/Latino. At baseline, mean FI score was 0.12 and 13% were frail using a cutoff of 0.2. Over 5 years, 1080 participants (12.5%) became frail and mean FI scores increased to 0.14. There was no effect on frailty incidence according to randomization to any canakinumab dose versus placebo over time, HR 1.03 (0.91–1.17), p = 0.63. Results were similar using phenotypic frailty. Additionally, the primary findings of CANTOS in terms of canakinumab‐associated cardiovascular event reduction were unchanged in analyses stratified by baseline frailty. In conclusion, among stable adult patients with atherosclerosis, random allocation to interleukin‐1b inhibition with canakinumab versus placebo did not lower risk of incident frailty over 5 years. More randomized data are needed to understand the role of targeted anti‐inflammatory medications for frailty prevention in older adults. [ABSTRACT FROM AUTHOR]

Published
2024
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16. Triglyceride Lowering with Pemafibrate to Reduce Cardiovascular Risk

Author

Das Pradhan, Aruna, primary, Glynn, Robert J., additional, Fruchart, Jean-Charles, additional, MacFadyen, Jean G., additional, Zaharris, Elaine S., additional, Everett, Brendan M., additional, Campbell, Stuart E., additional, Oshima, Ryu, additional, Amarenco, Pierre, additional, Blom, Dirk J., additional, Brinton, Eliot A., additional, Eckel, Robert H., additional, Elam, Marshall B., additional, Felicio, João S., additional, Ginsberg, Henry N., additional, Goudev, Assen, additional, Ishibashi, Shun, additional, Joseph, Jacob, additional, Kodama, Tatsuhiko, additional, Koenig, Wolfgang, additional, Leiter, Lawrence A., additional, Lorenzatti, Alberto J., additional, Mankovsky, Boris, additional, Marx, Nikolaus, additional, Nordestgaard, Børge G., additional, Páll, Dénes, additional, Ray, Kausik K., additional, Santos, Raul D., additional, Soran, Handrean, additional, Susekov, Andrey, additional, Tendera, Michal, additional, Yokote, Koutaro, additional, Paynter, Nina P., additional, Buring, Julie E., additional, Libby, Peter, additional, and Ridker, Paul M, additional

Published
2022
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18. Effects of Randomized Treatment With Icosapent Ethyl and a Mineral Oil Comparator on Interleukin-1β, Interleukin-6, C-Reactive Protein, Oxidized Low-Density Lipoprotein Cholesterol, Homocysteine, Lipoprotein(a), and Lipoprotein-Associated Phospholipase A2: A REDUCE-IT Biomarker Substudy

Author

Ridker, Paul M, primary, Rifai, Nader, additional, MacFadyen, Jean, additional, Glynn, Robert J., additional, Jiao, Lixia, additional, Steg, Ph. Gabriel, additional, Miller, Michael, additional, Brinton, Eliot A., additional, Jacobson, Terry A., additional, Tardif, Jean-Claude, additional, Ballantyne, Christie M., additional, Mason, R. Preston, additional, and Bhatt, Deepak L., additional

Published
2022
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19. Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease

Author

Ridker, Paul M, Everett, Brendan M., Thuren, Tom, MacFadyen, Jean G., Chang, William H., Ballantyne, Christie, Fonseca, Francisco, Nicolau, Jose, Koenig, Wolfgang, Anker, Stefan D., Kastelein, John J.P., Cornel, Jan H., Pais, Prem, Pella, Daniel, Genest, Jacques, Cifkova, Renata, Lorenzatti, Alberto, Forster, Tamas, Kobalava, Zhanna, Vida-Simiti, Luminita, Flather, Marcus, Shimokawa, Hiroaki, Ogawa, Hisao, Dellborg, Mikael, Rossi, Paulo R.F., Troquay, Roland P.T., Libby, Peter, and Glynn, Robert J.

Published
2017
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20. Canakinumab's Effect Against Subsequent Gout Flares and High‐Sensitivity C‐Reactive Protein Levels: A Causal Mediation Analysis.

Author

Yoshida, Kazuki, Glynn, Robert J., Choi, Hyon K., Everett, Brendan M., Li, Yi, MacFadyen, Jean G., Ridker, Paul M., and Solomon, Daniel H.

Subjects
C-reactive protein, GOUT, CONFIDENCE intervals
Abstract

Objective: The objective of this study was to quantify the value of early suppression of high‐sensitivity C‐reactive protein (hsCRP) levels as a biomarker of the protective role of canakinumab against future gout flares. Methods: We conducted a post hoc causal mediation analysis of the Canakinumab Anti‐Inflammatory Thrombosis Outcome Study for gout flares. The 3‐month change in the log hsCRP level was the mediator of interest. We used linear regression for the hsCRP level mediator and Cox or Weibull regression for gout‐flare outcomes, combining them in causal mediation analysis. We examined the cohort overall, as well as stratified by prevalent gout at baseline. Results: We analyzed 9,221 patients without prevalent gout and 747 with prevalent gout. The Cox regression hazard ratio (HR) for a gout flare was 0.50 (95% confidence interval [95% CI] 0.37–0.68) comparing canakinumab with placebo, of which 6% was explained by the mediated effect through hsCRP level reduction in the first 3 months. In the prevalent‐gout subgroup, the HR was 0.58 (95% CI 0.36–0.95), of which 31% was explained by the mediated effect through hsCRP level reduction. The Weibull analysis gave a proportion‐mediated estimate of 47%. The indirect effect via hsCRP level reductions was unclear in the subgroup without prevalent gout. Conclusion: The first 3‐month reduction in hsCRP level was not a good biomarker for canakinumab's protective effect on future gout flares in the overall cohort. Among patients with prevalent gout, there may be a potential role for early hsCRP level reduction as a biomarker for interleukin‐1β inhibitors' future gout‐flare benefit. [ABSTRACT FROM AUTHOR]

Published
2023
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28. A randomized trial of rosuvastatin in the prevention of venous thromboembolism

Author

Glynn, Robert J., Danielson, Eleanor, Francisco, M.I.A, Fonseca, A.H., Genest, Jacques, Gotto, Antonio M., Jr., Kastelein, John J.P., Koenig, Wolfgang, Libby, Peter, Lorenzatti, Alberto J., MacFadyen, Jean G., Nordestgaard, Borge C., Shepherd, James, Willerson, James T., and Ridker, Paul M.

Subjects
Thromboembolism -- Drug therapy, Thromboembolism -- Prevention, Rosuvastatin -- Usage, Rosuvastatin -- Health aspects
Abstract

The effects of the stain therapy and use of rosuvastatin on the prevention of venous thromboembolism are analyzed. The results indicate that venous thromboembolism can be easily prevented in healthy persons by an effective use of rosuvastatin.

Published
2009

29. Vitamins E and C in the prevention of prostate and total cancer in men: the Physician's Health Study II Randomized Controlled Trial

Author

Gaziano, J. Michael, Glynn, Robert J., Christen, William G., Kurth, Tobias, Belanger, Charlene, MacFadyen, Jean, Bubes, Vadim, Manson, JoAnn E., Sesso, Howard D., and Buring, Julie E.

Subjects
Vitamin E -- Dosage and administration, Vitamin C -- Dosage and administration, Prostate cancer -- Prevention, Men -- Health aspects, Men -- Research
Abstract

The study aims to evaluate the efficacy of long-term administration of vitamins E and C in helping to prevent prostate and total cancer in men. The results indicate that neither of the two is effective in reducing the risk of prostate or total cancer.

Published
2009

31. Vitamins E and C in the prevention of cardiovascular disease in men: the Physician's Health Study II randomized controlled trial

Author

Sesso, Howard D., Buring, Julie E., Christen, William G., Kurth, Tobias, Belanger, Charlene, MacFadyen, Jean, Bubes, Vadim, Manson, JoAnn E., Glynn, Robert J., and Gaziano, J. Michael

Subjects
Vitamin E -- Health aspects, Vitamin E -- Research, Vitamin C -- Research, Vitamin C -- Health aspects, Cardiovascular diseases -- Prevention, Men -- Health aspects
Abstract

A study was conducted to investigate whether the long term consumption of vitamins E and C helped in reducing the risk of cardiovascular disease among men. Results indicated that neither vitamins E nor C helped reducing the risk.

Published
2008

40. Adverse Effects of Low‐Dose Methotrexate in a Randomized Double‐Blind Placebo‐Controlled Trial: Adjudicated Hematologic and Skin Cancer Outcomes in the Cardiovascular Inflammation Reduction Trial

Author

Vanni, Kathleen M.M., primary, Berliner, Nancy, additional, Paynter, Nina P., additional, Glynn, Robert J., additional, MacFadyen, Jean, additional, Colls, Joshua, additional, Lu, Fengxin, additional, Xu, Chang, additional, Ridker, Paul M., additional, and Solomon, Daniel H., additional

Published
2020
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45. Adverse Effects of Low-Dose Methotrexate

Author

Solomon, Daniel H., primary, Glynn, Robert J., additional, Karlson, Elizabeth W., additional, Lu, Fengxin, additional, Corrigan, Cassandra, additional, Colls, Josh, additional, Xu, Chang, additional, MacFadyen, Jean, additional, Barbhaiya, Medha, additional, Berliner, Nancy, additional, Dellaripa, Paul F., additional, Everett, Brendan M., additional, Pradhan, Aruna D., additional, Hammond, Sarah P., additional, Murray, Meredith, additional, Rao, Deepak A., additional, Ritter, Susan Y., additional, Rutherford, Anna, additional, Sparks, Jeffrey A., additional, Stratton, Jackie, additional, Suh, Dong H., additional, Tedeschi, Sara K., additional, Vanni, Kathleen M.M., additional, Paynter, Nina P., additional, and Ridker, Paul M, additional

Published
2020
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48. Rosuvastatin for the prevention of venous thromboembolism: a pooled analysis of the HOPE-3 and JUPITER randomized controlled trials.

Author

Joseph, Philip, Glynn, Robert, Lonn, Eva, Ramasundarahettige, Chinthanie, Eikelboom, John, MacFadyen, Jean, Ridker, Paul, and Yusuf, Salim

Subjects
THROMBOEMBOLISM, VENOUS thrombosis, ROSUVASTATIN, CARDIOVASCULAR diseases, PULMONARY embolism, BLOOD pressure, C-reactive protein
Abstract

Aims To examine the association between rosuvastatin and VTE risk, and whether effects vary in different subpopulations stratified by key demographic, cardiovascular disease (CVD) risk factors, and other risk factors associated with VTE. Methods and results An individual participant data meta-analysis was conducted across two randomized controlled trials in 30 507 participants over a mean follow-up of 3.62 years, individuals had no prior history of vascular disease but were at intermediate CV risk. In both trials, participants were randomized to receive rosuvastatin or matching placebo. The primary outcome was VTE during follow-up, defined as either deep vein thrombosis or pulmonary embolism. Associations between rosuvastatin and VTE were examined in the overall pooled cohort, and subpopulations stratified by demographic risk factors (i.e. age and sex), CVD risk factors (i.e. obesity, smoking, lipid levels, blood pressure levels, and C-reactive protein level), and a history of cancer. Mean age was 65.96 (SD 7.19) years of age, and 17 832 (58.45%) were male and 5434 (17.82%) were smokers, median BMI was 27.6 [interquartile range (IQR) 24.7–31.1] kg/m2, and median CRP level was 3.4 (IQR 2.1–6.0) mg/L. There were 139 VTE events. In the pooled cohort, rosuvastatin was associated with a large proportional reduction in the risk of VTE (hazard ratio 0.53, 95% CI 0.37–0.75). No significant interactions were observed between treatment with rosuvastatin and the risk of VTE across subpopulations stratified by demographic, CVD risk factors, or a history of cancer (P -values for interactions >0.05 for all subgroups). Conclusion Rosuvastatin is associated with a 47% proportional reduction in the risk of VTE, and its effect is consistent both in the presence or absence of VTE-related clinical risk factors. [ABSTRACT FROM AUTHOR]

Published
2022
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