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Gines Sanz - One of the best experts on this subject based on the ideXlab platform.

  • a polypill strategy to improve adherence results from focus fixed dose Combination Drug for secondary cardiovascular prevention project
    Journal of the American College of Cardiology, 2014
    Co-Authors: Jose M Castellano, Gines Sanz, Jose L Penalvo, Luz Angela Alvarez, Luis A Guzman, Juan Carlos Linares, Fernando Garcia, Sameer Bansilal, Antonio Fernandezortiz, F Daniello
    Abstract:

    BACKGROUND Adherence to evidence-based cardiovascular (CV) medications after an acute myocardial infarction (AMI) is low after the first 6 months. The use of fixed-dose Combinations (FDC) has been shown to improve treatment adherence and risk factor control. However, no previous randomized trial has analyzed the impact of an FDC strategy on adherence in post-MI patients. OBJECTIVES The cross-sectional FOCUS study (Phase 1) aimed to elucidate factors that interfere with appropriate adherence to CV medications for secondary prevention after an AMI. Additionally, 695 patients from Phase 1 were randomized into a controlled trial (Phase 2) to test the effect of a polypill (containing aspirin 100 mg, simvastatin 40 mg and ramipril 2.5, 5, or 10 mg) compared to the 3 Drugs given separately on adherence, blood pressure (BP), and low-density lipoprotein cholesterol (LDL-C), as well as safety and tolerability over a period of 9 months of follow-up. METHODS In Phase 1, a 5-country cohort of 2,118 patients was analyzed. Patients were randomized to either the polypill or 3 Drugs separately for Phase 2. Primary endpoint was adherence to the treatment measured at the final visit by the self-reported Morisky-Green questionnaire (MAQ) and pill count (patients had to meet both criteria for adherence at the in-person visit to be considered adherent). RESULTS In Phase 1, overall CV medication adherence defined as a MAQ score of 20 was 45.5%. In a multivariable regression model, the risk of being non-adherent (MAQ <20) was associated with younger age, depression, being on a complex medication regimen, poorer health insurance coverage, and a lower level of social support, with consistent findings across countries. In Phase 2, the polypill group showed improved adherence compared to the group receiving separate medications after 9 months follow-up: 50.8% vs 41% (p=0.019; intention-to-treat population) and 65.7% vs 55.7% (p=0.012; per protocol population) when using the primary endpoint, attending the final visit with MAQ=20 and high pill count (80-110%) combined, to assess adherence. Adherence also was higher in the FDC group when measured by MAQ alone (68% vs. 59%, p=0.049). No treatment difference was found at follow-up in mean SBP (129.6 vs 128.6 mmHg), mean LDL-C levels (89.9 vs 91.7 mg/dL), serious adverse events (23 vs 21), or death (1, 0.2% in each group). CONCLUSIONS For secondary prevention following AMI, younger age, depression, and a complex Drug treatment plan are associated with lower medication adherence. Meanwhile, adherence is increased in patients with higher insurance coverage levels and social support. Compared with the 3 Drugs given separately, the use of a polypill strategy met the primary endpoint for adherence for secondary prevention following an AMI. CLINICAL TRIAL INFO NCT01321255.

  • a polypill strategy to improve adherence results from focus fixed dose Combination Drug for secondary cardiovascular prevention project
    2014
    Co-Authors: Jose M Castellano, Gines Sanz, Jose L Penalvo, Luz Angela Alvarez, Luis A Guzman, Juan Carlos Linares, Fernando Garcia, Sara Varea, Felipe Martinez, Alberto Lorenzatti
    Abstract:

    Jose M. Castellano, MD, PhD Gines Sanz, MD, PhD Jose L. Penalvo, PhD Sameer Bansilal, MD, MS Antonio Fernandez-Ortiz, MD, PhD Luz Alvarez, BSc Luis Guzman, MD Juan Carlos Linares, MD Fernando Garcia, MD, PhD Fabiana D’Aniello, PhD Joan Albert Arnaiz, MD, PhD Sara Varea, BSc Felipe Martinez, MD Alberto Lorenzatti, MD Inaki Imaz, MD, PhD Luis M. Sanchez-Gomez, MD, MSc Maria Carla Roncaglioni, Biol Sci Dr Marta Baviera, Pharm Dr Sidney C. Smith Jr., MD Kathryn Taubert, PhD Stuart Pocock, PhD Carlos Brotons, MD, PhD Michael E. Farkouh, MD, MSc Valentin Fuster, MD, PhD

  • maximizing therapeutic envelope for prevention of cardiovascular disease role of polypill
    Mount Sinai Journal of Medicine, 2012
    Co-Authors: Gines Sanz, Valentin Fuster
    Abstract:

    Cardiovascular-disease prevention is often inadequate due to several factors. Lack of professional adherence to guidelines, unaffordable medication, and lack of patients' adherence to treatment are the most important. It has been suggested that an affordable, fixed-dose Combination Drug containing evidence-based active compounds could improve cardiovascular prevention by improving patients' adherence to treatment. The available evidence suggests that the polypill strategy can achieve this objective and it will gain a place in the therapeutic armamentarium for the prevention of cardiovascular events in patients at high risk. Mt Sinai J Med 79:683–688, 2012. © 2012 Mount Sinai School of Medicine

  • the fixed dose Combination Drug for secondary cardiovascular prevention project improving equitable access and adherence to secondary cardiovascular prevention with a fixed dose Combination Drug study design and objectives
    American Heart Journal, 2011
    Co-Authors: Gines Sanz, Luis A Guzman, Felipe Martinez, Valentin Fuster, Antonio Guglietta, Joan Albert Arnaiz, Antonio Sarria, Maria Carla Roncaglioni, Kathryn Taubert
    Abstract:

    In spite of advances in prevention and treatment, the burden of cardiovascular diseases is increasing. A fixed-dose Combination (FDC) pill, or “polypill,” composed of evidence-based Drugs has been proposed as a means of improving cardiovascular prevention by reducing cost and increasing patient adherence to treatment. The aim of the FOCUS project, funded by the 7th Framework Programme of the European Commission, is to characterize the factors that underlie inadequate secondary prevention and to test a new FDC. To achieve these goals, a 9-member consortium has been constituted, including institutions from Argentina, France, Italy, Spain, and Switzerland. FOCUS Phase-1 will examine factors potentially related to lack of adequate secondary prevention in 4,000 post–myocardial infarction (MI) patients and analyze the relationship between these factors and patient treatment adherence. Primary end points will be (1) the percentage of patients receiving aspirin, angiotensin-converting enzyme inhibitors, and statins and (2) adherence to treatment measured by the Morisky-Green test. FOCUS Phase-2 is a randomized trial that will compare adherence to treatment in 1,340 post–myocardial infarction patients either receiving an FDC comprising aspirin (100 mg), ramipril (2.5, 5, or 10 mg), and simvastatin (40 mg) or receiving the same 3 Drugs separately.

Valentin Fuster - One of the best experts on this subject based on the ideXlab platform.

  • maximizing therapeutic envelope for prevention of cardiovascular disease role of polypill
    Mount Sinai Journal of Medicine, 2012
    Co-Authors: Gines Sanz, Valentin Fuster
    Abstract:

    Cardiovascular-disease prevention is often inadequate due to several factors. Lack of professional adherence to guidelines, unaffordable medication, and lack of patients' adherence to treatment are the most important. It has been suggested that an affordable, fixed-dose Combination Drug containing evidence-based active compounds could improve cardiovascular prevention by improving patients' adherence to treatment. The available evidence suggests that the polypill strategy can achieve this objective and it will gain a place in the therapeutic armamentarium for the prevention of cardiovascular events in patients at high risk. Mt Sinai J Med 79:683–688, 2012. © 2012 Mount Sinai School of Medicine

  • the fixed dose Combination Drug for secondary cardiovascular prevention project improving equitable access and adherence to secondary cardiovascular prevention with a fixed dose Combination Drug study design and objectives
    American Heart Journal, 2011
    Co-Authors: Gines Sanz, Luis A Guzman, Felipe Martinez, Valentin Fuster, Antonio Guglietta, Joan Albert Arnaiz, Antonio Sarria, Maria Carla Roncaglioni, Kathryn Taubert
    Abstract:

    In spite of advances in prevention and treatment, the burden of cardiovascular diseases is increasing. A fixed-dose Combination (FDC) pill, or “polypill,” composed of evidence-based Drugs has been proposed as a means of improving cardiovascular prevention by reducing cost and increasing patient adherence to treatment. The aim of the FOCUS project, funded by the 7th Framework Programme of the European Commission, is to characterize the factors that underlie inadequate secondary prevention and to test a new FDC. To achieve these goals, a 9-member consortium has been constituted, including institutions from Argentina, France, Italy, Spain, and Switzerland. FOCUS Phase-1 will examine factors potentially related to lack of adequate secondary prevention in 4,000 post–myocardial infarction (MI) patients and analyze the relationship between these factors and patient treatment adherence. Primary end points will be (1) the percentage of patients receiving aspirin, angiotensin-converting enzyme inhibitors, and statins and (2) adherence to treatment measured by the Morisky-Green test. FOCUS Phase-2 is a randomized trial that will compare adherence to treatment in 1,340 post–myocardial infarction patients either receiving an FDC comprising aspirin (100 mg), ramipril (2.5, 5, or 10 mg), and simvastatin (40 mg) or receiving the same 3 Drugs separately.

Luis A Guzman - One of the best experts on this subject based on the ideXlab platform.

  • a polypill strategy to improve adherence results from focus fixed dose Combination Drug for secondary cardiovascular prevention project
    Journal of the American College of Cardiology, 2014
    Co-Authors: Jose M Castellano, Gines Sanz, Jose L Penalvo, Luz Angela Alvarez, Luis A Guzman, Juan Carlos Linares, Fernando Garcia, Sameer Bansilal, Antonio Fernandezortiz, F Daniello
    Abstract:

    BACKGROUND Adherence to evidence-based cardiovascular (CV) medications after an acute myocardial infarction (AMI) is low after the first 6 months. The use of fixed-dose Combinations (FDC) has been shown to improve treatment adherence and risk factor control. However, no previous randomized trial has analyzed the impact of an FDC strategy on adherence in post-MI patients. OBJECTIVES The cross-sectional FOCUS study (Phase 1) aimed to elucidate factors that interfere with appropriate adherence to CV medications for secondary prevention after an AMI. Additionally, 695 patients from Phase 1 were randomized into a controlled trial (Phase 2) to test the effect of a polypill (containing aspirin 100 mg, simvastatin 40 mg and ramipril 2.5, 5, or 10 mg) compared to the 3 Drugs given separately on adherence, blood pressure (BP), and low-density lipoprotein cholesterol (LDL-C), as well as safety and tolerability over a period of 9 months of follow-up. METHODS In Phase 1, a 5-country cohort of 2,118 patients was analyzed. Patients were randomized to either the polypill or 3 Drugs separately for Phase 2. Primary endpoint was adherence to the treatment measured at the final visit by the self-reported Morisky-Green questionnaire (MAQ) and pill count (patients had to meet both criteria for adherence at the in-person visit to be considered adherent). RESULTS In Phase 1, overall CV medication adherence defined as a MAQ score of 20 was 45.5%. In a multivariable regression model, the risk of being non-adherent (MAQ <20) was associated with younger age, depression, being on a complex medication regimen, poorer health insurance coverage, and a lower level of social support, with consistent findings across countries. In Phase 2, the polypill group showed improved adherence compared to the group receiving separate medications after 9 months follow-up: 50.8% vs 41% (p=0.019; intention-to-treat population) and 65.7% vs 55.7% (p=0.012; per protocol population) when using the primary endpoint, attending the final visit with MAQ=20 and high pill count (80-110%) combined, to assess adherence. Adherence also was higher in the FDC group when measured by MAQ alone (68% vs. 59%, p=0.049). No treatment difference was found at follow-up in mean SBP (129.6 vs 128.6 mmHg), mean LDL-C levels (89.9 vs 91.7 mg/dL), serious adverse events (23 vs 21), or death (1, 0.2% in each group). CONCLUSIONS For secondary prevention following AMI, younger age, depression, and a complex Drug treatment plan are associated with lower medication adherence. Meanwhile, adherence is increased in patients with higher insurance coverage levels and social support. Compared with the 3 Drugs given separately, the use of a polypill strategy met the primary endpoint for adherence for secondary prevention following an AMI. CLINICAL TRIAL INFO NCT01321255.

  • a polypill strategy to improve adherence results from focus fixed dose Combination Drug for secondary cardiovascular prevention project
    2014
    Co-Authors: Jose M Castellano, Gines Sanz, Jose L Penalvo, Luz Angela Alvarez, Luis A Guzman, Juan Carlos Linares, Fernando Garcia, Sara Varea, Felipe Martinez, Alberto Lorenzatti
    Abstract:

    Jose M. Castellano, MD, PhD Gines Sanz, MD, PhD Jose L. Penalvo, PhD Sameer Bansilal, MD, MS Antonio Fernandez-Ortiz, MD, PhD Luz Alvarez, BSc Luis Guzman, MD Juan Carlos Linares, MD Fernando Garcia, MD, PhD Fabiana D’Aniello, PhD Joan Albert Arnaiz, MD, PhD Sara Varea, BSc Felipe Martinez, MD Alberto Lorenzatti, MD Inaki Imaz, MD, PhD Luis M. Sanchez-Gomez, MD, MSc Maria Carla Roncaglioni, Biol Sci Dr Marta Baviera, Pharm Dr Sidney C. Smith Jr., MD Kathryn Taubert, PhD Stuart Pocock, PhD Carlos Brotons, MD, PhD Michael E. Farkouh, MD, MSc Valentin Fuster, MD, PhD

  • the fixed dose Combination Drug for secondary cardiovascular prevention project improving equitable access and adherence to secondary cardiovascular prevention with a fixed dose Combination Drug study design and objectives
    American Heart Journal, 2011
    Co-Authors: Gines Sanz, Luis A Guzman, Felipe Martinez, Valentin Fuster, Antonio Guglietta, Joan Albert Arnaiz, Antonio Sarria, Maria Carla Roncaglioni, Kathryn Taubert
    Abstract:

    In spite of advances in prevention and treatment, the burden of cardiovascular diseases is increasing. A fixed-dose Combination (FDC) pill, or “polypill,” composed of evidence-based Drugs has been proposed as a means of improving cardiovascular prevention by reducing cost and increasing patient adherence to treatment. The aim of the FOCUS project, funded by the 7th Framework Programme of the European Commission, is to characterize the factors that underlie inadequate secondary prevention and to test a new FDC. To achieve these goals, a 9-member consortium has been constituted, including institutions from Argentina, France, Italy, Spain, and Switzerland. FOCUS Phase-1 will examine factors potentially related to lack of adequate secondary prevention in 4,000 post–myocardial infarction (MI) patients and analyze the relationship between these factors and patient treatment adherence. Primary end points will be (1) the percentage of patients receiving aspirin, angiotensin-converting enzyme inhibitors, and statins and (2) adherence to treatment measured by the Morisky-Green test. FOCUS Phase-2 is a randomized trial that will compare adherence to treatment in 1,340 post–myocardial infarction patients either receiving an FDC comprising aspirin (100 mg), ramipril (2.5, 5, or 10 mg), and simvastatin (40 mg) or receiving the same 3 Drugs separately.

Christopher R Chapple - One of the best experts on this subject based on the ideXlab platform.

  • systematic review of Combination Drug therapy for non neurogenic lower urinary tract symptoms
    European Urology, 2019
    Co-Authors: Maurizio Serati, Karlerik Andersson, Roger R Dmochowski, Enrico Finazzi Agro, John Heesakkers, Valerio Iacovelli, Giacomo Novara, Christopher R Chapple
    Abstract:

    Abstract Background Several Drugs are approved for the treatment of lower urinary tract symptoms (LUTS) in men, but these are mostly used by clinicians as monotherapies. The Combination of different compounds, each of which targets a different aspect of LUTS, seems appealing. However, only few clinical trials have evaluated the effects of Combination therapies. Objective This systematic review analyzes the efficacy and adverse events of Combination therapies for male LUTS. Evidence acquisition PubMed and Cochrane databases were used to identify clinical trials and meta-analyses on male LUTS Combination therapy. The search was restricted to studies of level of evidence ≥1b. A total of 49 papers published between January 1988 and March 2012 were identified. Evidence synthesis The α 1 -adrenoceptor antagonist (α 1 -blocker)/5α-reductase inhibitor (5-ARI) Combination provides the most data. This Combination seems to be more efficacious in terms of several outcome variables in patients whose prostate volume is between 30ml and 40ml when treatment is maintained for >1 yr; when given for 1 -blockers alone are just as effective. The Combination of α 1 -blocker/5-ARI shows a slightly increased rate of adverse events. It remains unknown whether its safety and superiority over either Drug as monotherapy are sustained after >6 yr. The α 1 -blocker/muscarinic receptor antagonist (antimuscarinic) Combination was most frequently assessed as an add-on therapy to already existing α 1 -blocker therapy. Inconsistent data derive from heterogeneous study populations and different study designs. Currently, the α 1 -blocker/antimuscarinic Combination appears to be a second-line add-on for patients with insufficient symptom relief after monotherapy. The Combination seems to be safe in men with postvoid residual 4 mo concerning safety and efficacy of this Combination. The α 1 -blocker/phosphodiesterase type 5 inhibitor Combination is a new treatment option with only preliminary reports. More studies are needed before definitive conclusions can be drawn. Conclusions An α 1 -blocker/5-ARI Combination is beneficial for patients whose prostate volume is between 30ml and 40ml when medical treatment is intended for >1 yr. Based on short-term follow-up studies, add-on of antimuscarinics to α 1 -blockers is an option when postvoid residual is

Kathryn Taubert - One of the best experts on this subject based on the ideXlab platform.

  • the fixed dose Combination Drug for secondary cardiovascular prevention project improving equitable access and adherence to secondary cardiovascular prevention with a fixed dose Combination Drug study design and objectives
    American Heart Journal, 2011
    Co-Authors: Gines Sanz, Luis A Guzman, Felipe Martinez, Valentin Fuster, Antonio Guglietta, Joan Albert Arnaiz, Antonio Sarria, Maria Carla Roncaglioni, Kathryn Taubert
    Abstract:

    In spite of advances in prevention and treatment, the burden of cardiovascular diseases is increasing. A fixed-dose Combination (FDC) pill, or “polypill,” composed of evidence-based Drugs has been proposed as a means of improving cardiovascular prevention by reducing cost and increasing patient adherence to treatment. The aim of the FOCUS project, funded by the 7th Framework Programme of the European Commission, is to characterize the factors that underlie inadequate secondary prevention and to test a new FDC. To achieve these goals, a 9-member consortium has been constituted, including institutions from Argentina, France, Italy, Spain, and Switzerland. FOCUS Phase-1 will examine factors potentially related to lack of adequate secondary prevention in 4,000 post–myocardial infarction (MI) patients and analyze the relationship between these factors and patient treatment adherence. Primary end points will be (1) the percentage of patients receiving aspirin, angiotensin-converting enzyme inhibitors, and statins and (2) adherence to treatment measured by the Morisky-Green test. FOCUS Phase-2 is a randomized trial that will compare adherence to treatment in 1,340 post–myocardial infarction patients either receiving an FDC comprising aspirin (100 mg), ramipril (2.5, 5, or 10 mg), and simvastatin (40 mg) or receiving the same 3 Drugs separately.