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Michael P Busch - One of the best experts on this subject based on the ideXlab platform.

  • human immunodeficiency virus prevalence incidence and Residual Risk of transmission by transfusions at retrovirus epidemiology donor study ii blood centers in brazil
    Transfusion, 2012
    Co-Authors: Ester C Sabino, Brian Custer, Thelma T Goncalez, Nanci A Salles, David J Wright, Anna Barbara F Carneiroproietti, Moussa Sarr, Joao Eduardo Ferreira, Divaldo A Sampaio, Michael P Busch
    Abstract:

    BACKGROUND: In Brazil nationally representative donor data are limited on human immunodeficiency virus (HIV) prevalence incidence and Residual transfusion Risk. The objective of this study was to analyze HIV data obtained over 24 months by the Retrovirus Epidemiology Donor Study-II program in Brazil. STUDY DESIGN AND METHODS: Donations reactive to third- and fourth-generation immunoassays (IAs) were further confirmed by a less-sensitive (LS) IA algorithm and Western blot (WB). Incidence was calculated for first-time (FT) donors using the LS-EIA results and for repeat donors with a model developed to include all donors with a previous negative donation. Residual Risk was projected by multiplying composite FT and repeat donor incidence rates by HIV marker-negative infectious window periods. RESULTS: HIV prevalence among FT donors was 92.2/10(5) donations. FT and repeat donor and composite incidences were 38.5 (95% confidence interval [CI] 25.6-51.4) 22.5 (95% CI 17.6-28.0) and 27.5 (95% CI 22.0-33.0) per 100000 person-years respectively. Male and community donors had higher prevalence and incidence rates than female and replacement donors. The estimated Residual Risk of HIV transfusion transmission was 11.3 per 10(6) donations (95% CI 8.4-14.2) which could be reduced to 4.2 per 10(6) donations (95% CI 3.2-5.2) by use of individual-donation nucleic acid testing (NAT). CONCLUSION: The incidence and Residual transfusion Risk of HIV infection are relatively high in Brazil. Implementation of NAT will not be sufficient to decrease transmission rates to levels seen in the United States or Europe; therefore other measures focused on decreasing donations by at-Risk individuals are also necessary. (c) 2011 American Association of Blood Banks.

  • assessing the impact of hbv nat on window period reduction and Residual Risk
    Journal of Clinical Virology, 2006
    Co-Authors: Steven Kleinman, Michael P Busch
    Abstract:

    The incidence window period model for estimating Residual Risk was developed in the mid-1990s and in the last 5 years has been widely used internationally to estimate the Risk of transfusion-transmission of agents for which donor blood screening is in place (e.g. HIV, HCV, and HBV) (Schreiber et al., 1996; Kleinman et al., 1997; Glynn et al., 2002; Coste et al., 2005). The premise of the model is simple: the probability that a potentially infectious donation will be released into the blood supply (termed Residual Risk, to indicate that it is Risk persisting despite laboratory screening) is estimated by multiplying the incidence of new infection (seroconversion rate in a blood donor population over a specific time interval) by the average time interval that a seroconverting donor is capable of transmitting the infection (i.e., the length of the infectious pre-seroconversion window period). The model can also be used to project the yield of a new assay by multiplying incidence by the differential window period between the new and previously used donor screening assays. A basic assumption of the model is that a donor is equally likely to donate on any given day during the pre-seroconversion and post-seroconversion window periods, i.e. that donation behavior is not affected by the acquisition of acute infection. Incidence data are obtained from direct observation of blood donor populations and are measured as the number of newly infected (seroconverting) donors detected divided by the observed person-years at Risk; therefore this direct incidence measure applies only to repeat donors who made more than one donation during the study period. With the advent of minipool (MP) NAT testing for HIV and HCV,

  • prevalence incidence and Residual Risk of human immunodeficiency virus among community and replacement first time blood donors in sao paulo brazil
    Transfusion, 2005
    Co-Authors: Claudia C Barreto, Ester C Sabino, Thelma T Goncalez, Megan E Laycock, Brandee L Pappalardo, Nanci A Salles, David J Wright, Dalton De Alencar Fischer Chamone, Michael P Busch
    Abstract:

    BACKGROUND: Concerted efforts have been directed toward recruitment of community rather than replacement donors in Brazil. Time trends and demographic correlates of human immunodeficiency (HIV) prevalence and incidence among first-time (FT) donors in Brazil were examined by donation type. HIV Residual Risk from FT-donor transfusions, and projected yield of p24 antigen and nucleic acid test (NAT) screening were estimated. STUDY DESIGN AND METHODS: HIV prevalence data and seroreactive specimens were obtained at Fundacao Pro-Sangue/Hemocentro-de-Sao Paulo from 1995 to 2001. To estimate incidence, confirmed-positive samples from July 1998 through December 2001 were tested with a less-sensitive (detuned) enzyme immunoassay to detect recent seroconversions. Incidence data were used to estimate Residual Risk and p24 and NAT yield based on published window periods (WPs). RESULTS: HIV prevalence was 22 percent higher among the FT community donors than replacement donors (19.6 vs. 16.1 per 10,000; p < 0.01) and 48 percent higher among men than women (19.1 vs. 12.9; p < 0.01). In the multivariable logistic regression, both variables remained significant predictors of HIV prevalence. HIV prevalence decreased from 20.4 (1995) to 13.1 per 10,000 FT donations (2001). HIV incidence was 2.7 per 10,000 person-years. The estimated rate of infected antibody-negative donations was 14.9 per 1,000,000 units (95% confidence interval, 9.8-20.0). It was estimated that addition of p24 antigen, minipool NAT, and individual-donation NAT assays would detect 3.9 (2.0-5.8), 8.3 (5.3-11.3), and 10.8 (7.1-14.5) WP units per 1,000,000 FT donations, respectively. CONCLUSION: HIV incidence and Residual transfusion Risk estimates are approximately 10 times higher in Brazil FT donors compared to US and European FT donors. Community FT donors had higher HIV prevalence than replacement FT donors. The yield of p24 antigen or RNA screening will be low in Brazilian donors, but substantially higher than in US donors.

Frank M. Sacks - One of the best experts on this subject based on the ideXlab platform.

  • estudio realist Residual Risk lipids and standard therapies un analisis del riesgo Residual dependiente del perfil lipidico en el sindrome coronario agudo
    Endocrinología y Nutrición, 2011
    Co-Authors: Jesus Millan Nunezcortes, Frank M. Sacks, Michel P. Hermans, Juan Pedro-botet Montoya, Xavier Pinto Salas, Antonio Hernandez Mijares, Vincent J Carey, Jean-charles Fruchart
    Abstract:

    La Fundacion R3i (Residual Risk Reduction initiative), una organizacion academica, multinacional e independiente, esta llevando a cabo el estudio REALIST (Residual Risk, LIpids and Standard Therapies) en mas de 40 centros de diferentes paises. Se trata de un estudio epidemiologico retrospectivo, que esta disenado para proporcionar nuevos datos referentes al riesgo Residual de episodios coronarios mayores atribuible a las alteraciones lipidicas en pacientes que reciben los tratamientos de referencia actuales. Sus resultados iniciales se esperan para mediados del ano 2010, y los resultados globales para finales del ano 2010.

  • contribution of high plasma triglycerides and low high density lipoprotein cholesterol to Residual Risk of coronary heart disease after establishment of low density lipoprotein cholesterol control
    American Journal of Cardiology, 2010
    Co-Authors: Vincent J Carey, Frank M. Sacks, Louise M Bishop, Nancy Laranjo, Benjamin J Harshfield, Carolyn Kwiat
    Abstract:

    To determine the relative contributions of triglycerides (TGs) and high-density lipoprotein (HDL) cholesterol in the Residual Risk of coronary heart disease (CHD) after the reduction of low-density lipoprotein (LDL) cholesterol to guideline-recommended levels, we conducted a hospital-based, case-control study with optimal matching in the strata of LDL cholesterol, gender, ethnicity, and age. The 170 cases and 175 controls were patients at Brigham and Women's Hospital (Boston, Massachusetts) from 2005 to 2008 who had an LDL cholesterol level

  • The Residual Risk Reduction Initiative: a call to action to reduce Residual vascular Risk in dyslipidaemic patients
    Diabetes & vascular disease research, 2008
    Co-Authors: Jean-charles Fruchart, Paul M. Dodson, Paola Fioretto, Frank M. Sacks, Michel P. Hermans, Gerd Assmann, W. Virgil Brown, Richard Ceska, M. John Chapman, Henry N. Ginsberg
    Abstract:

    Despite current standards of care aimed at achieving targets for low-density lipoprotein (LDL) cholesterol, blood pressure and glycaemia, dyslipidaemic patients remain at high Residual Risk of vascular events. Atherogenic dyslipidaemia, specifically elevated triglycerides and low levels of high-density lipoprotein (HDL) cholesterol, often with elevated apolipoprotein B and non-HDL cholesterol, is common in patients with established cardiovascular disease, type 2 diabetes, obesity or metabolic syndrome and is associated with macrovascular and microvascular Residual Risk. The Residual Risk Reduction Initiative (R(3)i) was established to address this important issue. This position paper aims to highlight evidence that atherogenic dyslipidaemia contributes to Residual macrovascular Risk and microvascular complications despite current standards of care for dyslipidaemia and diabetes, and to recommend therapeutic intervention for reducing this, supported by evidence and expert consensus. Lifestyle modification is an important first step. Additionally, pharmacotherapy is often required. Adding niacin, a fibrate or omega-3 fatty acids to statin therapy improves achievement of all lipid Risk factors. Outcomes studies are evaluating whether these strategies translate to greater clinical benefit than statin therapy alone. In conclusion, the R3i highlights the need to address with lifestyle and/or pharmacotherapy the high level of Residual vascular Risk among dyslipidaemic patients who are treated in accordance with current standards of care.

  • The Residual Risk Reduction Initiative: a call to action to reduce Residual vascular Risk in patients with dyslipidemia.
    The American Journal of Cardiology, 2008
    Co-Authors: Jean-charles Fruchart, Paul M. Dodson, Paola Fioretto, Frank M. Sacks, Michel P. Hermans, Gerd Assmann, W. Virgil Brown, Richard Ceska, M. John Chapman, Henry N. Ginsberg
    Abstract:

    Despite achieving targets for low-density lipoprotein (LDL) cholesterol, blood pressure, and glycemia in accordance with current standards of care, patients with dyslipidemia remain at high Residual Risk of vascular events. Atherogenic dyslipidemia, characterized by elevated triglycerides and low levels of high-density lipoprotein (HDL) cholesterol, often with elevated apolipoprotein B and non-HDL cholesterol, is common in patients with established cardiovascular disease (CVD), type 2 diabetes mellitus, or metabolic syndrome and contributes to both macrovascular and microvascular Residual Risk. However, atherogenic dyslipidemia is largely underdiagnosed and undertreated in clinical practice. The Residual Risk Reduction Initiative (R3i) was established to address this highly relevant clinical issue. The aims of this position paper are (1) to highlight evidence that atherogenic dyslipidemia is associated with Residual macrovascular and microvascular Risk in patients at high Risk for CVD, despite current standards of care for dyslipidemia and diabetes; and (2) to recommend therapeutic intervention for reducing this Residual vascular Risk supported by evidence and expert consensus. Lifestyle modification with nutrition and exercise is an important, effective, and underutilized first step in reducing Residual vascular Risk. Therapeutic intervention aimed at achievement of all lipid targets is also often required. Combination lipid-modifying therapy, with the addition of niacin, a fibrate, or omega-3 fatty acids to statin therapy, increases the probability of achieving all lipid goals. Outcomes studies are in progress to evaluate whether these combination treatment strategies translate to a clinical benefit greater than that achieved with statins alone. The R3i highlights the need to address with lifestyle and/or pharmacotherapy the high level of Residual Risk of CVD events and microvascular complications among patients with dyslipidemia receiving therapy for high levels of LDL cholesterol and for diabetes in accordance with current standards of care.

Clive R. Seed - One of the best experts on this subject based on the ideXlab platform.

  • HIV Residual Risk in Canada under a three-month deferral for men who have sex with men.
    Vox sanguinis, 2019
    Co-Authors: Sheila F. O'brien, Yves Grégoire, Josiane Pillonel, Whitney R. Steele, Brian Custer, K. L. Davison, Marc Germain, Antoine Lewin, Clive R. Seed
    Abstract:

    BACKGROUND AND OBJECTIVES In Canada, the deferral for men who have sex with men (MSM) was decreased from a permanent deferral to a 5-year then a 12-month deferral. Current HIV testing can detect an HIV infection in donated blood within 2 weeks of exposure; thus, a 12-month deferral may be unnecessarily restrictive. We aimed to estimate the Residual Risk of HIV if the deferral were further decreased to 3 months. MATERIALS AND METHODS Using a deterministic model with stochastic Monte Carlo simulation, Residual Risk of HIV was the sum of testing error, assay sensitivity and window-period Risks. Data inputs were estimated from donor surveillance, donor surveys and published data. Residual Risk was modelled at baseline and using three scenarios: (1) most likely - non-compliance, HIV prevalence and incidence rates of MSM are unchanged; (2) optimistic - non-compliance improves by 50%; and (3) pessimistic - non-compliance, HIV prevalence and incidence rates of MSM all double. RESULTS HIV Residual Risk at baseline was 1 in 36·0 million donations (95% CI 1 in 1 504 907 million, 10·5 million); in the most likely scenario 1 in 34·2 million (1 in 225 534 million, 8·7 million); in the optimistic scenario 1 in 36·0 million (1 in 282 618 million, 9·5 million); in the pessimistic scenario 1 in 16·7 million (1 in 39 469 million, 6·0 million). All confidence intervals overlapped. CONCLUSION With very low modelled Risk under a 12-month deferral, the additional Risk with a 3-month deferral is very low. This is true even with a pessimistic scenario.

  • The Residual Risk of transfusion-transmitted cytomegalovirus infection associated with leucodepleted blood components.
    Vox sanguinis, 2015
    Co-Authors: Clive R. Seed, Janet Yuen Ha Wong, Mark N. Polizzotto, Helen M. Faddy, Anthony J. Keller, Joanne Pink
    Abstract:

    Background and Objectives Cytomegalovirus poses a Risk to transfusion safety as its transmission to an immunocompromised recipient may lead to significant clinical sequelae. Once infection is established, it is lifelong and generally asymptomatic. Strategies to reduce the Risk of transfusion-transmitted CMV (TT-CMV) include donor serological testing and blood component leucodepletion to deplete the transmissible reservoir. We estimate the Residual Risk for non-CMV antibody screened, leucodepleted (LD-only) fresh blood components. Materials and Methods We established an approach to estimate the Risk of TT-CMV under various scenarios. We estimated the probability of an infectious component, for both red cells and platelets, as a function of the observed WBC filter failure rate and the probability that such a unit was also contaminated with infectious virus. Results Using this model, the estimated combined Residual Risk of LD-only red cell and platelet units was very low, 1 in 13 575 000 (95%CI:1 in 1 344 167 000–1 in 1 730 000) as was the individual Residual Risk estimate for LD-only red cells, 1 in 7 790 000 (95%CI: 1 in 771 307 000–1 in 993 000) and LD-only platelets, where a zero Risk was estimated (95%CI: 0–1 in 1 074 000). Conclusion We describe a novel approach to assess the Residual Risk of LD-only components. This can be applied generally using local data. Our Risk estimate for LD-only blood components in Australia is below the threshold of 1 in 1 million, generally considered negligible. This provides a useful indicator of the relative safety of LD-only components to assist clinical decisions when serologically screened inventory is unavailable.

  • Residual Risk of transfusion-transmitted viral infections in Shenzhen, China, 2001 through 2004.
    Transfusion, 2007
    Co-Authors: Guifang Shang, Clive R. Seed, Fei Wang, Dongmei Nie, Albert Farrugia
    Abstract:

    BACKGROUND: There are no current estimates of the Residual Risks of transmission by blood of hepatitis B virus (HBV) or hepatitis C virus (HCV) and human immunodeficiency virus (HIV) in China. Such estimates are an essential prerequisite to monitoring and improving transfusion safety as well as supporting evidence based assessment of the value of implementing new screening interventions. STUDY DESIGN AND METHODS: Viral screening data for donors from Shenzhen, China, for the period 2001 to 2004, were retrospectively analyzed. The data were applied to a published model to estimate the Residual Risk of transmitting HIV, HBV, and HCV by blood transfusion in Shenzhen, as well as to assess the Residual Risk reduction value of various new tests. RESULTS: The point estimates for the combined 2003 and 2004 period calculate as 1 in 17,501 for HBV, 1 in 59,588 for HCV, and 1 in 903,498 for HIV. The predicted yield for improved hepatitis B surface antigen (HBsAg) assays, minipool (MP) nucleic acid testing (NAT), and individual-donation (ID) NAT was 6.9, 9.5, and 28.3 per million donations, respectively. The predicted yield for implementing a fourth-generation HCV (antigen-antibody) or MP NAT assay was 13.4 or 14.7 per million donations, respectively. For HIV, the predicted yield for implementing a fourth-generation HIV (antigen-antibody) or MP NAT assay was markedly smaller, 0.25 or 0.65 per million donations, respectively. CONCLUSIONS: Relative to that reported for Western blood systems, the prevalence and the Residual Risk of HBV and HCV are high, whereas HIV is comparable. Pending a formal cost-effectiveness study for NAT, implementing improved HBsAg and combination HCV antibody-antigen assays in Shenzhen would markedly reduce the Residual Risk.

  • Residual Risk of transfusion transmitted human immunodeficiency virus hepatitis b virus hepatitis c virus and human t lymphotrophic virus
    Internal Medicine Journal, 2005
    Co-Authors: Clive R. Seed, Philip Kiely, And A J Keller
    Abstract:

    Abstract Background:  The Risk of transfusion transmitted viral infection is now so low that mathematical modelling is required to estimate the Residual Risk. The first national viral Risk estimates for hepatitis B virus (HBV), human immunodeficiency virus (HIV) and hepatitis C virus (HCV) were recently published by the Australian Red Cross Blood Service. Using several refinements to the original methodology, as well as an additional 2 years of data, new Risk estimates have been derived. Methods:  Viral screening data for Australian donors for 2000/2003 were retrospectively analysed. The data were applied to three published models to estimate the Residual Risk of transmitting HIV, HBV, HCV or human T lymphotrophic virus (HTLV) by blood transfusion in Australia. Results:  Applying the three models to HBV, HIV and HCV, three point estimates of the Residual Risk per unit were calculated for each virus. The median point estimates were 1 in 1 339 000 for HBV, 1 in 1 in 7 299 000 for HIV, and 1 in 3 636 000 for HCV. Although the HTLV Risk could not be equivalently calculated because of the lack of incident infection it was estimated to be considerably less than 1 in 1 000 000 using a separate method. Conclusions:   The most current and accurate estimate of Residual Risk of viral transmission in Australia has been provided in the present study. The Residual Risk in Australia is exceptionally small, continuing to decrease and is generally less than European or US Risk estimates. These new estimates demonstrate that for viral transmission the Australian blood supply is amongst the safest in the world, and provide a basis for evaluating the cost benefit of future viral testing methodologies. (Intern Med J 2005; 35: 592–598)

Roger Y. Dodd - One of the best experts on this subject based on the ideXlab platform.

  • Transfusion‐transmitted infections: testing strategies and Residual Risk
    ISBT Science Series, 2014
    Co-Authors: Roger Y. Dodd
    Abstract:

    Testing blood donations for markers of infectious disease is critical to the maintenance of blood safety. The minimal expectation from WHO is that all donations should be tested for HIV, HBV, HCV and syphilis and that, in certain parts of the world, it may be appropriate to test for locally prevalent transfusion-transmissible infectious (TTI) agents. This article will review the rationale for selection of appropriate test methods and properties and will explain why there continues to be Residual Risk of transmission and how to estimate such Risk.

  • Donor Testing and Risk: Current Prevalence, Incidence, and Residual Risk of Transfusion-Transmissible Agents in US Allogeneic Donations
    Transfusion medicine reviews, 2011
    Co-Authors: Shimian Zou, Susan L. Stramer, Roger Y. Dodd
    Abstract:

    Over the past 20 years, there has been a major increase in the safety of the blood supply, as demonstrated by declining rates of posttransfusion infection and reductions in estimated Residual Risk for such infections. Reliable estimates of Residual Risk have been possible within the American Red Cross system because of the availability of a large amount of reliable and consistent data on donations and infectious disease testing results. Among allogeneic blood donations, the prevalence rates of infection markers for hepatitis C virus (HCV) and hepatitis B virus have decreased over time, although rates for markers of human immunodeficiency virus (HIV) and human T-cell lymphotropic virus did not. The incidence (/100 000 person-years) of HIV and HCV among repeat donors showed apparent increases from 1.55 and 1.89 in 2000 through 2001 to 2.16 and 2.98 in 2007 through 2008. These observed fluctuations confirm the need for continuous monitoring and evaluation. The Residual Risk of HIV, HCV, and human T-cell lymphotropic virus among all allogeneic donations is currently below 1 per 1 million donations, and that of hepatitis B surface antigen is close to 1 per 300 000 donations.

  • Current incidence and Residual Risk of hepatitis B infection among blood donors in the United States.
    Transfusion, 2009
    Co-Authors: Shimian Zou, Susan L. Stramer, Edward P. Notari, Mary C. Kuhns, David E. Krysztof, Fatemeh Musavi, Chyang T. Fang, Roger Y. Dodd
    Abstract:

    BACKGROUND: This study used two approaches to estimate the current incidence of hepatitis B virus (HBV) in a US donor population. METHODS: HBV incidence was estimated through the hepatitis B surface antigen (HBsAg) yield approach and the seroconversion method. Residual Risk was estimated by the incidence–window period model. HBsAg yield refers to an HBsAg confirmed-positive, antibody against hepatitis B core antigen (anti-HBc)–nonreactive donation, adjusted for false-positive neutralization results. The number of HBsAg-seroconverting repeat donors divided by total number of person-years of evaluation or the HBsAg yield rate divided by HBsAg yield window gave rise to incidence estimates. RESULTS: The seroconversion and the yield approach, respectively, gave an incidence estimate of 3.41 or 3.43 per 105 person-years. Using a revised infectious window period of 38 or 30 days for current HBsAg assays, the current Residual Risk for HBV was respectively estimated for 2006 to 2008 at 1 in 282,000 or 1 in 357,000 donations from the seroconversion approach and 1 in 280,000 or 1 in 355,000 donations from the yield approach. With the same database and methods, this is a decrease from 1 in 86,000 to 1 in 110,000 observed in 1997 to 1999. CONCLUSIONS: Current HBV incidence and Residual Risk are lower than earlier estimates, especially in the youngest donors, but remain higher in the absence of HBV nucleic acid test than those for human immunodeficiency virus or hepatitis C virus (HCV). In addition to the exclusion of HBsAg false-positive donors, the reduction could reflect shortened window periods and decreased incidence rates due to vaccination or other reasons.

Henry N. Ginsberg - One of the best experts on this subject based on the ideXlab platform.

  • The Residual Risk Reduction Initiative: a call to action to reduce Residual vascular Risk in dyslipidaemic patients
    Diabetes & vascular disease research, 2008
    Co-Authors: Jean-charles Fruchart, Paul M. Dodson, Paola Fioretto, Frank M. Sacks, Michel P. Hermans, Gerd Assmann, W. Virgil Brown, Richard Ceska, M. John Chapman, Henry N. Ginsberg
    Abstract:

    Despite current standards of care aimed at achieving targets for low-density lipoprotein (LDL) cholesterol, blood pressure and glycaemia, dyslipidaemic patients remain at high Residual Risk of vascular events. Atherogenic dyslipidaemia, specifically elevated triglycerides and low levels of high-density lipoprotein (HDL) cholesterol, often with elevated apolipoprotein B and non-HDL cholesterol, is common in patients with established cardiovascular disease, type 2 diabetes, obesity or metabolic syndrome and is associated with macrovascular and microvascular Residual Risk. The Residual Risk Reduction Initiative (R(3)i) was established to address this important issue. This position paper aims to highlight evidence that atherogenic dyslipidaemia contributes to Residual macrovascular Risk and microvascular complications despite current standards of care for dyslipidaemia and diabetes, and to recommend therapeutic intervention for reducing this, supported by evidence and expert consensus. Lifestyle modification is an important first step. Additionally, pharmacotherapy is often required. Adding niacin, a fibrate or omega-3 fatty acids to statin therapy improves achievement of all lipid Risk factors. Outcomes studies are evaluating whether these strategies translate to greater clinical benefit than statin therapy alone. In conclusion, the R3i highlights the need to address with lifestyle and/or pharmacotherapy the high level of Residual vascular Risk among dyslipidaemic patients who are treated in accordance with current standards of care.

  • The Residual Risk Reduction Initiative: a call to action to reduce Residual vascular Risk in patients with dyslipidemia.
    The American Journal of Cardiology, 2008
    Co-Authors: Jean-charles Fruchart, Paul M. Dodson, Paola Fioretto, Frank M. Sacks, Michel P. Hermans, Gerd Assmann, W. Virgil Brown, Richard Ceska, M. John Chapman, Henry N. Ginsberg
    Abstract:

    Despite achieving targets for low-density lipoprotein (LDL) cholesterol, blood pressure, and glycemia in accordance with current standards of care, patients with dyslipidemia remain at high Residual Risk of vascular events. Atherogenic dyslipidemia, characterized by elevated triglycerides and low levels of high-density lipoprotein (HDL) cholesterol, often with elevated apolipoprotein B and non-HDL cholesterol, is common in patients with established cardiovascular disease (CVD), type 2 diabetes mellitus, or metabolic syndrome and contributes to both macrovascular and microvascular Residual Risk. However, atherogenic dyslipidemia is largely underdiagnosed and undertreated in clinical practice. The Residual Risk Reduction Initiative (R3i) was established to address this highly relevant clinical issue. The aims of this position paper are (1) to highlight evidence that atherogenic dyslipidemia is associated with Residual macrovascular and microvascular Risk in patients at high Risk for CVD, despite current standards of care for dyslipidemia and diabetes; and (2) to recommend therapeutic intervention for reducing this Residual vascular Risk supported by evidence and expert consensus. Lifestyle modification with nutrition and exercise is an important, effective, and underutilized first step in reducing Residual vascular Risk. Therapeutic intervention aimed at achievement of all lipid targets is also often required. Combination lipid-modifying therapy, with the addition of niacin, a fibrate, or omega-3 fatty acids to statin therapy, increases the probability of achieving all lipid goals. Outcomes studies are in progress to evaluate whether these combination treatment strategies translate to a clinical benefit greater than that achieved with statins alone. The R3i highlights the need to address with lifestyle and/or pharmacotherapy the high level of Residual Risk of CVD events and microvascular complications among patients with dyslipidemia receiving therapy for high levels of LDL cholesterol and for diabetes in accordance with current standards of care.