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6. Cross-Reactivity of Anti-HIV-1 T Cell Immune Responses among the Major HIV-1 Clades in HIV-1-Positive Individuals from 4 Continents

Author

Coplan, Paul M., Gupta, Swati B., Dubey, Sheri A., Pitisuttithum, Punnee, Nikas, Alex, Mbewe, Bernard, Vardas, Efthyia, Schechter, Mauro, Kallas, Esper G., Freed, Dan C., Fu, Tong-Ming, Mast, Christopher T., Puthavathana, Pilaipan, Kublin, James, Brown Collins, Kelly, Chisi, John, Pendame, Richard, Thaler, Scott J., Gray, Glenda, Mcintyre, James, Straus, Walter L., Condra, Jon H., Mehrotra, Devan V., Guess, Harry A., Emini, Emilio A., and Shiver, John W.

Published
2005

8. Cross-clade reactivity of HIV-1-specific T-cell responses in HIV-1-infected individuals from Botswana and Cameroon

Author

Gupta, Swati B., Pitisuttithum, Punee, Burke, Donald, Mast, Christopher T., Vardas, Eftyhia, Freed, Dan, Wolfe, Nathan D., Mbewe, Bernard, Mogg, Robin, Novitsky, Vlad, Schechter, Mauro, Coplan, Paul M., Dubey, Sheri, A., Kallas, Esper G., Condra, Jon H., Long, Ronnie S., Anderson, Kiersten, Casimiro, Danilo R., Shiver, John W., and Straus, Walter L.

Subjects
HIV patients -- Health aspects, HIV infection -- Prognosis, T cells -- Research, Health
Abstract

Anti-HIV-1 T-cell immune responses among 363 unvaccinated adults infected with diverse HIV-1 clades is compared. It is revealed that the response rates to clade B Gag and/or clade B Nef in Botswana, with 95 percent and Cameroon, with 98 percent are similar.

Published
2006

9. Cost of illness of Alzheimer's disease: how useful are current estimates?

Author

Bloom, Bernard S., de Pouvourville, Nathalie, and Straus, Walter L.

Subjects
Alzheimer's disease -- Research, Alzheimer's disease -- Economic aspects, Mental illness -- Research, Mental illness -- Economic aspects, Health, Seniors
Abstract

Purpose: The goal of this literature review was to determine the validity and policy relevance of recent estimates from many countries of Alzheimer's disease (AD) costs. Design and Methods: We searched Medline and other databases for English-language peer-reviewed journals on total, direct, indirect, and per case cost of AD that used 1985-2000 data. We adjusted costs of U.S. studies for inflation. We adjusted non-U.S, studies by that country's medical cost inflation rate and purchasing power parity (PPP). Results: Of 71 studies identified, 21 met all criteria for inclusion. Annual inflation adjusted U.S. total costs of AD varied from $5.6 billion to $88.3 billion. AD total per case (direct and indirect) costs varied from $1,500 to $91,000; indirect/family costs varied from $3,700 to $21,000. Among non-U.S, studies, AD annual adjusted per case costs varied from PPP $2,300 to PPP $30,000. Cost variation was due to diverse study methods, data sources, services included, and lack of clear differentiation between cost of AD and cost of caring for people with AD. Implications: The cost of AD is high, although reliable estimates are not available. Costs are likely to rise given expected demographic shifts in all countries. The widely variable cost estimates call into question the real costs of Alzheimer's disease and their applicability to policy initiatives. Key Words: Alzheimer's disease, Dementia, Cost, Economics

Published
2003

11. Contributors

Author

Alangaden, George J., primary, Aldape, Michael J., additional, Allardet-Servent, Jérôme, additional, Allen, Upton D., additional, Ammerlaan, Heidi S.M., additional, Angelakis, Emmanouil, additional, Artenstein, Andrew, additional, Asboe, David, additional, Asiedu, Kingsley B., additional, Atherton, John C., additional, Aw, Tar-Ching, additional, Baid-Agrawal, Seema, additional, Bailey, Robin, additional, Bandel, Christopher, additional, Barie, Philip S., additional, Barillo, David J., additional, Bart, Pierre-Alexandre, additional, Bayston, Roger, additional, Beard, C. Ben, additional, Beeching, Nick J., additional, Bégué, Rodolfo E., additional, Benhamou, Yves, additional, Benson, Constance A., additional, Berbari, Elie F., additional, Berendt, Anthony R., additional, Bhatta, Madhav P., additional, Bille, Jacques, additional, Bitnun, Ari, additional, Black, Finn T., additional, Blair, Iain, additional, Blanche, Stéphane, additional, Bleck, Thomas P., additional, Bleeker-Rovers, Chantal P., additional, Bleijenberg, Gijs, additional, Bloch, Karen C., additional, Bonten, Marc J.M., additional, Boucher, Charles A.B., additional, Bourayou, Rafik, additional, Bouza, Emilio S., additional, Bowie, William R., additional, Brause, Barry D., additional, Brisse, Sylvain, additional, Britton, Warwick, additional, Brook, Itzhak, additional, Brown, David W.G., additional, Brun-Buisson, Christian, additional, Brust, James C.M., additional, Bryant, Amy E., additional, Bryskier, André, additional, Buller, R. Mark L, additional, Bush, Karen, additional, Calandra, Thierry, additional, Cameron, D. William, additional, Caraël, Michel, additional, Carr, Michael J., additional, Casas, Inmaculada, additional, Chambers, Stephen T., additional, Chiller, Katarina G., additional, Chiller, Tom M., additional, Chiodini, Peter L., additional, Chopra, Ian, additional, Chu, Anthony C., additional, Chung, Kevin K., additional, Clark, Benjamin M., additional, Clumeck, Nathan, additional, Cockerell, Clay J., additional, Cohen, Jonathan, additional, Collinge, John, additional, Conlon, Christopher P., additional, Corey, G. Ralph, additional, Cross, Alan, additional, Cross, John H., additional, Currier, Judith, additional, Curtis, Carmel M., additional, Dallabetta, Gina, additional, Davidson, Robert N., additional, Davies, Jane, additional, Day, Jeremy, additional, Day, Nicholas P.J., additional, De Gascun, Cillian F., additional, de Wit, Stéphane, additional, Delmont, Jean, additional, Dennis, David T., additional, Diemert, David J., additional, Doganay, Mehmet, additional, Doherty, Tom, additional, Dolecek, Christiane, additional, Donati, Stéphane Y., additional, Dondorp, Arjen M., additional, Doudier, Barbara, additional, Drancourt, Michel, additional, Drekonja, Dimitri M., additional, Drew, Richard H., additional, Duker, Jay S., additional, Dummer, J. Stephen, additional, Edwards, Charles N., additional, Ekkelenkamp, Miquel B., additional, Enright, Mark C., additional, Epstein, Paul R., additional, Erard, Veronique, additional, Eziefula, Alice Chijioke, additional, Feinberg, Mark B., additional, Fenollar, Florence, additional, Fenwick, Alan, additional, Fernandez, Luis, additional, Fierer, Joshua, additional, Finch, Roger G., additional, Flexner, Charles W., additional, Fluit, Ad C., additional, Ford-Jones, Elizabeth Lee, additional, Fournier, Pierre-Edouard, additional, Fraser, Victoria, additional, French, Martyn A., additional, Friedland, Jon S., additional, Fritz, Joseph M., additional, Furuya, E. Yoko, additional, Gage, Kenneth L., additional, Garcia, Lynne S., additional, Gastañaduy, Arturo S., additional, Ghanem, Khalil G., additional, Giannella, Maddalena, additional, Glaser, Carol A., additional, Glesby, Marshall J., additional, Glover, Sarah, additional, Glupczynski, Youri, additional, Gnann, John W., additional, Goddard, Andrew F., additional, Goldstein, Ellie J.C., additional, González, Iveth J., additional, Gorbach, Sherwood L., additional, Gottstein, Bruno, additional, Gowda, Ravi, additional, Grabenstein, John D., additional, Grange, John M., additional, Green, Michael D., additional, Green, Stephen T., additional, Greenblatt, Danielle T., additional, Greenwood, Brian, additional, Gregson, Aric L., additional, Groll, Andreas H., additional, Gupta, Aditya K., additional, Gwee, Kok-Ann, additional, Hall, William, additional, Hammer, Scott M., additional, Handa, Sajeev, additional, Hanfelt-Goade, Diane, additional, Harari, Alexandre, additional, Harris, Marianne, additional, Hartman, Barry J., additional, Hay, Roderick J., additional, Henderson, David K., additional, Hensley, Lisa E., additional, Herbert, Luke, additional, Hill, David R., additional, Hills, Timothy J., additional, Hinze, John David, additional, Hirsch, Hans H., additional, Hirschel, Bernard, additional, Hoepelman, Andy I.M., additional, Holland, Steven M., additional, Horgan, Mary M., additional, Howe, Robin, additional, Hughes, James M., additional, Hull, Mark W., additional, Inderlied, Clark B., additional, Ison, Michael G., additional, Jenks, Peter J., additional, Johnson, James R., additional, Jones, Theodore, additional, Kanno, Mettassebia, additional, Kauffman, Carol, additional, Kelly, Patrick, additional, Kendler, Jason S., additional, Keynan, Yoav, additional, Khan, Ali S., additional, Kho, Grace T., additional, Kinghorn, George R., additional, Klapper, Paul E., additional, Kluytmans, Jan AJW, additional, Kok, Menno, additional, Koné-Paut, Isabelle, additional, Krieger, John N., additional, Kroes, Aloys C.M., additional, Kroon, Frank P., additional, Kubin, Christine J., additional, La Rosa, Alberto M., additional, Lalani, Tahaniyat, additional, Lalloo, David G., additional, Lambert, Harold, additional, Landraud, Luce, additional, Lawn, Stephen D., additional, Pharm, Phillipe Lehours, additional, Leone, Marc, additional, Levi, Itzchak, additional, Levitt, Alexandra M., additional, Lindquist, H. D. Alan, additional, Lloyd, Graham, additional, Looney, David J., additional, Lowy, Franklin D., additional, Luft, Benjamin J., additional, Lynn, William A., additional, Macielag, Mark J., additional, Mackowiak, Philip A., additional, MacPherson, Paul A., additional, Maghraoui-Slim, Valérie, additional, Main, Janice, additional, Mallet, Vincent, additional, Mangino, Julie E., additional, Manuel, Oriol, additional, Marchetti, Oscar, additional, Marks, Kristen, additional, Marr, Kieren A., additional, Martin, Claude, additional, Martín-Rabadán, Pablo, additional, Martinez, Augusto Julio, additional, Mascini, Ellen M., additional, Mayer, Kenneth H., additional, McCormick, Joseph B., additional, McGready, Rose, additional, McKendrick, Michael W., additional, Mead, Simon, additional, Mégraud, Francis, additional, Meheus, André Z., additional, Meintjes, Graeme, additional, Michaels, Marian G., additional, Miles, Michael, additional, Miller, Alastair, additional, Mimiaga, Matthew J., additional, Mingeot-Leclercq, Marie-Paule, additional, Mitchell, Thomas G., additional, Moise, Pamela A., additional, Montaner, Julio, additional, Moore, Caroline B., additional, Moreillon, Philippe, additional, Morgan-Capner, Peter, additional, Montessori, Valentina, additional, Moss, Peter, additional, Muñoz, Patricia, additional, Naber, Kurt G., additional, Nakhla, Sammy, additional, Narain, Jai P., additional, Nathwani, Dilip, additional, Newton, Paul, additional, Nguyen, Chinh, additional, Nicolle, Lindsay E., additional, Niederman, Michael S., additional, Noel, Gary J., additional, Norrby, S. Ragnar, additional, Nosten, François, additional, Notarangelo, Luigi Daniele, additional, Nyirjesy, Paul, additional, O'Connell, P. Ronan, additional, Odorico, Jon S., additional, Ong, Edmund L.C., additional, Opal, Steven M., additional, Ormerod, L. Peter, additional, Osmon, Douglas R., additional, Ottesen, Eric A., additional, Palacios, Gustavo, additional, Pantaleo, Giuseppe, additional, Papazian, Laurent, additional, Parola, Philippe, additional, Pascual, Manuel A., additional, Patrozou, Eleni, additional, Paya, Carlos, additional, Peacock, Sharon J., additional, Pechère, Jean-Claude, additional, Perkins, Mark D., additional, Peters, Barry, additional, Pfyffer, Gaby E., additional, Pham, Paul A., additional, Piot, Peter, additional, Placko-Parola, Geraldine, additional, Pol, Stainslas, additional, Posfay-Barbe, Klara M., additional, Powderly, William G., additional, Pozniak, Anton, additional, Prod'hom, Guy, additional, Quinn, Thomas C., additional, Rahn, Daniel W., additional, Rana, Aadia I., additional, Raoult, Didier, additional, Raz, Raul, additional, Razonable, Raymund, additional, Read, Robert C., additional, Reynolds, Stephen J., additional, Richardson, Malcolm D., additional, Robinson, Christopher C., additional, Rooijakkers, Suzan H.M., additional, Rosenbluth, Daniel, additional, Rosenzweig, Sergio D., additional, Rovery, Clarisse, additional, Rubin, Robert H., additional, Rubinovitch, Bina, additional, Rubins, Kathleen H., additional, Rubinstein, Ethan, additional, Ryan, Greg, additional, Ryder, Stephen, additional, Safren, Steven, additional, Sahasrabuddhe, Vikrant V., additional, Saikku, Pekka A.I., additional, Sakoulas, George, additional, Salazar, Juan Carlos, additional, Salvaggio, Michelle R., additional, Schaffer, Kirsten, additional, Schmitz, Franz-Josef, additional, Schooley, Robert T., additional, Schumacher, Richard-Fabian, additional, Scrimgeour, Euan M., additional, Seddon, James, additional, Seifert, Harald, additional, Serjeant, Graham R., additional, Sha, Beverly E., additional, Shah, Keerti V., additional, Shapiro, Daniel S., additional, Sheehan, Gerard, additional, Shoham, Shmuel, additional, Simmons, Cameron P., additional, Simonsen, Kari A., additional, Singh, Neeraj, additional, Slack, Mary P.E., additional, Sobel, Jack D., additional, Sopirala, Madhuri M., additional, Spacek, Lisa A., additional, Sriskandan, Shiranee, additional, Stanley, Samuel L., additional, Steckelberg, James M., additional, Stephenson, Iain, additional, Stevens, Dennis L., additional, Straus, Walter L., additional, Sturm, Willem, additional, Summerbell, Richard C., additional, Susa, Joseph S., additional, Tabrizi, Sarah J., additional, Tack, Marc A., additional, Taplitz, Randy, additional, Tebas, Pablo, additional, Temmerman, Marleen, additional, Thijsen, Steven F.T., additional, Thomas, Lora D., additional, Thomson, Gail, additional, Thwaites, Guy E., additional, Tirelli, Umberto, additional, Tolkoff-Rubin, Nina E., additional, Tønjum, Tone, additional, Torriani, Francesca J., additional, Townsend, Gregory C., additional, Masó, Gloria Trallero, additional, Tulkens, Paul M., additional, Tunkel, Allan R., additional, Vaccher, Emanuela, additional, Vallet-Pichard, Anaïs, additional, Van Bambeke, Françoise, additional, van de Beek, Diederik, additional, van der Meer, Jos W.M., additional, van Loon, Anton M., additional, van Putten, Jos, additional, Vaudaux, Bernard P., additional, Vermund, Sten H., additional, Verstraelen, Hans, additional, Verweij, Paul, additional, Viscidi, Raphael P., additional, Visvanathan, Kumar, additional, Visvesvara, Govinda S., additional, von Seidlein, Lorenz, additional, Wagenlehner, Florian M.E., additional, Wahl-Jensen, Victoria, additional, Walsh, Thomas J., additional, Warhurst, David C., additional, Warnock, David W., additional, Warrell, David A., additional, Warrell, Mary J., additional, Warris, Adilia, additional, Weber, Rainer, additional, Weidner, Wolfgang, additional, Weston, Vivienne C., additional, Whimbey, Estella, additional, Whitby, Michael, additional, White, Peter J., additional, Whitty, Christopher J.M., additional, Willems, Rob J.L., additional, Williams, Emrys, additional, Wilson, Cara, additional, Wilson, Mary E., additional, Winn, Richard E., additional, Winthrop, Kevin L., additional, Wiselka, Martin J., additional, Wisplinghoff, Hilmar, additional, Wolfe, Cameron R., additional, Wood, Robin, additional, Wright, Natalie, additional, Yankaskas, James R., additional, Zaidi, Najam A., additional, Zenilman, Jonathan M., additional, Zhang, Yaobi, additional, Zuckerman, Arie J., additional, Zuckerman, Jane Nicola, additional, and Zumla, Alimuddin, additional

Published
2010
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15. Preventing perinatal transmission of HIV - costs and effectiveness of a recommended intervention

Author

Gorsky, Robin D., Farnham, Paul G., Straus, Walter L., Caldwell, Blake, Holtgrove, David R., Simonds, R.J., Rogers, Martha F., and Guinan, Mary E.

Subjects
HIV infection in children -- Prevention, Maternal-fetal exchange -- Prevention, Medical care, Cost of -- Analysis
Abstract

In the United States, nearly all new human immunodeficiency virus (HIV) infections in children are acquired through perinatal (mother-to-infant) transmission. Each year, approximately 7000 infants are born to HIV-infected women […]

Published
1996

16. Benefit of primary prophylaxis before 18 months of age in reducing the incidence of Pneumocystis carinii pneumonia and early death in a cohort of 112 human immunodeficiency virus-infected infants

Author

Thea, Donald M., Lambert, Genevieve, Weedon, Jeremy, Matheson, Pamela B., Abrams, Elaine J., Bamji, Mahrukh, Straus, Walter L., Thomas, Pauline A., Krasinski, Keith, and Heagarty, Margaret

Subjects
HIV infection in children -- Complications, Pneumocystis carinii pneumonia -- Prevention
Abstract

Early intervention with treatment to prevent Pneumocystis carinii pneumonia (PCP) may reduce the incidence of this infection and prevent deaths in infants born with human immunodeficiency virus (HIV) infections. Researchers compared the PCP infection and death rates of 112 infants born with HIV who either did or did not receive preventive treatment for PCP. Twelve of the 42 infants (29%) who did not receive the treatment developed a PCP infection before 18 months of age while only 3 of the 70 infants (4%) receiving the treatment developed the infection. Doctors identified the PCP infections at a median age of 5 months. The risk for developing a PCP infection did not seem to change with differing levels of HIV disease, as indicated by CD4 cell counts. The most common cause of death in these infants was PCP infection (31%)., ABSTRACT. Objective. To determine the effectiveness of primary prophylaxis in preventing Pneumocystis carinii pneumonia (PCP) in children with perinatally acquired human immunodeficiency virus 1 (HIV-1) infection. Methods. We conducted a retrospective analysis of a cohort of infants followed from birth at six metropolitan hospitals and one outpatient clinic for pregnant, drug-using women in New York City. Outcomes measured were histologically confirmed PCP and/or death. The potential confounding effect of the infant's stage of illness, as determined by CD4 count, was controlled by including all CD4 determinations as time-dependant covariates in a Cox proportional hazards analysis. Cases were censored at PCP onset, death, loss to follow-up, and 18 months of age. Results. One hundred twelve HIV-infected children were enrolled at birth between 1986 and 1993. Sixty of these were tracked beyond 18 months of age; of the others, 21 died before this age, 4 were considered lost to follow-up, and 27 had not reached 18 months of age at the last visit. Only 3 cases (4%) of confirmed PCP occurred among the 70 children who received primary PCP prophylaxis before 18 months of age, compared with 12 cases (28%) among 42 children not receiving PCP prophylaxis at any point before 18 months of age. The Kaplan-Meier estimated incidence of PCP in the first year among children not receiving prophylaxis was 25% (95% confidence interval [CI], 12 to 39). Using Cox methods, the unadjusted risk of PCP among infants not receiving prophylaxis, relative to those receiving it, was 4.1 (95% CI, 1.1 to 15); the relative risk was 4.4 (95% CI, 1.2 to 17) adjusting for the percentage of CD4-positive lymphocytes and 5.1 (95% CI, 1.3 to 20) adjusting for the absolute number of CD4-positive cells. Eight of 26 deaths were caused by PCP, and the likelihood of early death was significantly diminished if PCP prophylaxis was given (relative risk controlling for absolute CD4 cells, 2.57; 95% CI, 1.1 to 6.1). Conclusions. We report evidence that primary antimicrobial PCP prophylaxis is highly effective in decreasing the frequency of PCP and early death in infants with perinatal HIV infection. These findings support the revised National Pediatric HIV Resource Center and Centers for Disease Control and Prevention guidelines for PCP prophylaxis in children. Pediatrics 1996;97:59-64; perinatal human immunodeficiency virus infection, pediatric acquired immunodeficiency syndrome, Pneumocystis carinii pneumonia, primary prophylaxis, trimethoprimsulfamethoxazole., ABBREVIATIONS. HW, human immunodeficiency virus; PCP, Pneumocystis carinii.pneumonia; AIDS, acquired immunodeficiency syndrome; CDC, Centers for Disease Control and Prevention; NYC, New York City; PCR, polymerase chain reaction; TMP-SMX, trimethoprim-sulfamethoxazole; IVIG, [...]

Published
1996

26. Risk for domestic acquisition of Legionnaires disease

Author

Straus, Walter L., Plouffe, Joseph F., File, Thomas M., Jr., Lipman, Harvey B., Hackman, Barbara H., Salstrom, Sara-Jane, Benson, Robert F., and Breiman, Robert F.

Subjects
Legionnaires' disease -- Risk factors, Health
Published
1996

31. [Note to AZT Meeting Participants from Walter L. Straus]

Author

Straus, Walter L., Straus, Walter L., Straus, Walter L., and Straus, Walter L.

Abstract

(DLPS) 5571095.0283.008, http://name.umdl.umich.edu/5571095.0283.008, http://quod.lib.umich.edu/t/text/accesspolicy.html, Where applicable, subject to copyright. Other restrictions on distribution may apply. Please go to http://www.umdl.umich.edu/ for more information.

Published
1994

33. International epidemiology of human pre-existing adenovirus (Ad) type-5, type-6, type-26 and type-36 neutralizing antibodies: Correlates of high Ad5 titers and implications for potential HIV vaccine trials

Author

Mast, T. Christopher, primary, Kierstead, Lisa, additional, Gupta, Swati B., additional, Nikas, Alexander A., additional, Kallas, Esper G., additional, Novitsky, Vladimir, additional, Mbewe, Bernard, additional, Pitisuttithum, Punee, additional, Schechter, Mauro, additional, Vardas, Eftyhia, additional, Wolfe, Nathan D., additional, Aste-Amezaga, Miguel, additional, Casimiro, Danilo R., additional, Coplan, Paul, additional, Straus, Walter L., additional, and Shiver, John W., additional

Published
2010
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34. Incidence of and Preoperative Risk Factors forStaphylococcus aureusBacteremia and Chest Wound Infection After Cardiac Surgery

Author

Kanafani, Zeina A., primary, Arduino, Jean Marie, additional, Muhlbaier, Lawrence H., additional, Kaye, Keith S., additional, Allen, Keith B., additional, Carmeli, Yehuda, additional, Corey, G. Ralph, additional, Cosgrove, Sara E., additional, Fraser, Thomas G., additional, Harris, Anthony D., additional, Karchmer, Adolf W., additional, Lautenbach, Ebbing, additional, Rupp, Mark E., additional, Peterson, Eric D., additional, Straus, Walter L., additional, and Fowler, Vance G., additional

Published
2009
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35. Predicting Nursing Home Admission

Author

Banaszak-Holl, Jane, primary, Fendrick, A Mark, additional, Foster, Norman L, additional, Herzog, A Regula, additional, Kabeto, Mohammed U, additional, Kent, David M, additional, Straus, Walter L, additional, and Langa, Kenneth M, additional

Published
2004
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43. Metaanalysis of dyspepsia and nonsteroidal antiinflammatory drugs

Author

Ofman, Joshua J., Maclean, Catherine H., Straus, Walter L., Morton, Sally C., Berger, Marc L., Roth, Elizabeth A., and Shekelle, Paul G.

Abstract

ObjectiveNonsteroidal antiinflammatory drug NSAID use is a known risk factor for gastrointestinal GI perforations, ulcers, and bleeds, but there are limited data on its association with the very common symptom of dyspepsia. Using published and unpublished data sources, we sought to determine estimates of the risks of dyspepsia associated with NSAIDs.MethodsWe searched computerized databases 1966–1998 for primary studies of NSAIDs reporting on GI complications. We also obtained Food and Drug Administration FDA new drug application reviews for the 5 most common NSAIDs. We included studies reporting defined upper GI outcomes among subjects >17 years old who used oral NSAIDs for more than 4 days. Two reviewers evaluated 4,881 published titles, identifying 55 NSAID versus placebo randomized controlled trials RCTs, 37 unpublished FDA data placebocontrolled RCTs; 86 NSAID versus NSAID RCTs sample size ≥50; and 103 observational studies.ResultsThe majority of clinical trials were of good quality. Metaregression identified an increased risk of dyspepsia for users of specific NSAIDs adjusted odds ratio OR of indomethacin, meclofenamate, piroxicam 2.8, and for high dosages of other NSAIDs OR 3.1, but not for other NSAIDs regardless of dosage OR 1.1. Dyspepsia was not reported as an outcome in the case control or cohort studies.ConclusionsClinical trial data indicate that high dosages of any NSAID along with any dosage of indomethacin, meclofenamate, or piroxicam increase the risk of dyspepsia by about 3fold. Other NSAIDs at lower dosages were not associated with an increased risk of dyspepsia.

Published
2003
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44. A metaanalysis of severe upper gastrointestinal complications of nonsteroidal antiinflammatory drugs.

Author

Ofman, Joshua J, MacLean, Catherine H, Straus, Walter L, Morton, Sally C, Berger, Marc L, Roth, Elizabeth A, and Shekelle, Paul

Abstract

OBJECTIVE: Prior metaanalyses of the risk of upper gastrointestinal (GI) complications associated with nonsteroidal antiinflammatory drugs (NSAID) have focused on the published English language epidemiologic literature and/or only a portion of the relevant evidence, restrictions that are now known to be associated with bias in metaanalysis. We synthesized the published and unpublished evidence to determine the least biased estimates of the risks of perforations, ulcers, and bleeds (PUB) associated with NSAID use from all study designs and all languages. METHODS: Data sources: Using MEDLINE, EMBASE, HEALTHSTAR, and BIOSIS, we searched for English and non-English language studies of NSAID from 1966-1998 reporting primary data on GI complications. We obtained unpublished data from the US Food and Drug Administration (FDA) new drug application (NDA) reviews. NDA were hand searched to identify unpublished studies with inclusion criteria identical to those used for published reports. Study selection: Studies had to assess the use of oral NSAID for more than 4 days duration in subjects > 18 years of age and report on the clinically relevant upper GI outcomes of PUB. RESULTS: Two reviewers evaluated 4881 published titles and identified 13 NSAID versus placebo randomized clinical trials and 3 previously unpublished FDA placebo controlled randomized controlled trials, 9 cohort studies, and 23 case control studies sufficiently clinically homogeneous to pool. Two reviewers extracted data about study characteristics and study quality. Data synthesis: The majority of clinical trials were of good quality, but observational studies had methodologic limitations. The pooled odds ratio (OR) from 16 NSAID versus placebo clinical trials, comprising 4431 patients, was 5.36 (95% CI: 1.79, 16.1). The pooled relative risk of PUB from 9 cohort studies comprising over 750,000 person-years of exposure was 2.7 (95% CI: 2.1, 3.5). The pooled OR of PUB from 23 case control studies using age and sex matching, representing 25,732 patients, was 3.0 (95% CI: 2.5, 3.7). Data were insufficient to justify subgroup analyses stratified by age, comorbid conditions, drug, or dose. CONCLUSION: These data support an association between the use of NSAID and serious upper GI complications, including estimates from different study designs. Prior pooled estimates about the effect of patient and drug variables on increased risk must be viewed with caution.

Published
2002

50. Contributors

Author

Alangaden, George J., Aldape, Michael J., Allardet-Servent, Jérôme, Allen, Upton D., Ammerlaan, Heidi S.M., Angelakis, Emmanouil, Artenstein, Andrew, Asboe, David, Asiedu, Kingsley B., Atherton, John C., Aw, Tar-Ching, Baid-Agrawal, Seema, Bailey, Robin, Bandel, Christopher, Barie, Philip S., Barillo, David J., Bart, Pierre-Alexandre, Bayston, Roger, Beard, C. Ben, Beeching, Nick J., Bégué, Rodolfo E., Benhamou, Yves, Benson, Constance A., Berbari, Elie F., Berendt, Anthony R., Bhatta, Madhav P., Bille, Jacques, Bitnun, Ari, Black, Finn T., Blair, Iain, Blanche, Stéphane, Bleck, Thomas P., Bleeker-Rovers, Chantal P., Bleijenberg, Gijs, Bloch, Karen C., Bonten, Marc J.M., Boucher, Charles A.B., Bourayou, Rafik, Bouza, Emilio S., Bowie, William R., Brause, Barry D., Brisse, Sylvain, Britton, Warwick, Brook, Itzhak, Brown, David W.G., Brun-Buisson, Christian, Brust, James C.M., Bryant, Amy E., Bryskier, André, Buller, R. Mark L, Bush, Karen, Calandra, Thierry, Cameron, D. William, Caraël, Michel, Carr, Michael J., Casas, Inmaculada, Chambers, Stephen T., Chiller, Katarina G., Chiller, Tom M., Chiodini, Peter L., Chopra, Ian, Chu, Anthony C., Chung, Kevin K., Clark, Benjamin M., Clumeck, Nathan, Cockerell, Clay J., Cohen, Jonathan, Collinge, John, Conlon, Christopher P., Corey, G. Ralph, Cross, Alan, Cross, John H., Currier, Judith, Curtis, Carmel M., Dallabetta, Gina, Davidson, Robert N., Davies, Jane, Day, Jeremy, Day, Nicholas P.J., De Gascun, Cillian F., de Wit, Stéphane, Delmont, Jean, Dennis, David T., Diemert, David J., Doganay, Mehmet, Doherty, Tom, Dolecek, Christiane, Donati, Stéphane Y., Dondorp, Arjen M., Doudier, Barbara, Drancourt, Michel, Drekonja, Dimitri M., Drew, Richard H., Duker, Jay S., Dummer, J. Stephen, Edwards, Charles N., Ekkelenkamp, Miquel B., Enright, Mark C., Epstein, Paul R., Erard, Veronique, Eziefula, Alice Chijioke, Feinberg, Mark B., Fenollar, Florence, Fenwick, Alan, Fernandez, Luis, Fierer, Joshua, Finch, Roger G., Flexner, Charles W., Fluit, Ad C., Ford-Jones, Elizabeth Lee, Fournier, Pierre-Edouard, Fraser, Victoria, French, Martyn A., Friedland, Jon S., Fritz, Joseph M., Furuya, E. 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