Benefit-Risk Relationship

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W. M. Herrmann - One of the best experts on this subject based on the ideXlab platform.

  • The moral philosophical foundation of pharmaceutical medicine : basic ethical commodities and principles
    International Journal of Pharmaceutical Medicine, 2000
    Co-Authors: W. Wagner, W. M. Herrmann
    Abstract:

    1. In pharmaceutical medicine, benefit and risk are fundamental, intangible ethical commodities determined normatively in recourse to empirically proven preparation characteristics. As normative value judgements, benefit and risk cannot be offset against each other. For this reason it is proposed to replace the term ‘benefit/risk-balance’ by the term ‘benefit/risk-Relationship’. The logical gap left by the comparison of benefit and risk is closed by another normative determination: their Relationship is judged to be favourable, unfavourable, or unacceptable. 2. For the management of uncertainty, ethical principles are important decision-/action-guiding tools. As a general ethical model for pharmaceutical medicine, a three-tiered construction is proposed

  • The moral philosophical foundation of pharmaceutical medicine: basic ethical commodities and principles
    International Journal of Pharmaceutical Medicine, 2000
    Co-Authors: W. Wagner, W. M. Herrmann
    Abstract:

    1. In pharmaceutical medicine, benefit and risk are fundamental, intangible ethical commodities determined normatively in recourse to empirically proven preparation characteristics. As normative value judgements, benefit and risk cannot be offset against each other. For this reason it is proposed to replace the term ‘benefit/risk-balance’ by the term ‘benefit/risk-Relationship’. The logical gap left by the comparison of benefit and risk is closed by another normative determination: their Relationship is judged to be favourable, unfavourable, or unacceptable. 2. For the management of uncertainty, ethical principles are important decision-/action-guiding tools. As a general ethical model for pharmaceutical medicine, a three-tiered construction is proposed The justification tier forms the basis of the construction and contains the culture-defining principle of human dignity that should be viewed as an absolute, unrestrictable, transcendental and universal principle. Within the framework of ethical deliberation, the principle of human dignity systematically holds open the door to recourse and may be seen as a pragmatic substitute for metaphysics. The justification tier holds up the general action tier , which involves the implementation of actions once they have been decided upon. This second tier is characterized by the cardinal principle of responsibility — which is absolute and unrestrictable. As a primarily amoral principle, responsibility is initially ethically neutral, requiring a specific context to acquire its function as a moral philosophical ‘stabilizer’ for the consistent implementation and defence of decisions reached. The construction’s roof is the special action tier , at which morally relevant decisions to act are reached de facto . Ethical reflection draws here on the action-guiding principles of respect for beneficence, for non-maleficence, for autonomy and for justice. These traditional principles have a relative status; they are always valid prima facie and remain so provided that, in a specific situation, they are not forced to retire behind another, overriding principle or do not become restricted in an individual case. It is proposed to apply these principles only in the context of responsibility of the decision-maker, and this in turn should have its foundation in the principle of human dignity.

Joerg Hasford - One of the best experts on this subject based on the ideXlab platform.

  • Compliance and the benefit/risk Relationship of antihypertensive treatment
    Journal of Cardiovascular Pharmacology, 1992
    Co-Authors: Joerg Hasford
    Abstract:

    Compliance is defined as a patient's behavior in terms of taking prescribed medication, following diets, or executing medically recommended lifestyle changes. Furthermore, compliance measures the extent to which a person's behavior coincides with medical or health advice. The measurement of compliance over time is still a problem. The recently developed medication monitors, however, enable precise documentation of the taking of pills out of the container over long time periods. Long-term compliance with antihypertensive treatments is, referring to the literature, about 50%

  • Compliance and the benefit/risk Relationship of antihypertensive treatment.
    Journal of cardiovascular pharmacology, 1992
    Co-Authors: Joerg Hasford
    Abstract:

    Compliance is defined as a patient's behavior in terms of taking prescribed medication, following diets, or executing medically recommended lifestyle changes. Furthermore, compliance measures the extent to which a person's behavior coincides with medical or health advice. The measurement of compliance over time is still a problem. The recently developed medication monitors, however, enable precise documentation of the taking of pills out of the container over long time periods. Long-term compliance with antihypertensive treatments is, referring to the literature, about 50%. The causes of partial compliance are not yet well known. Partial compliance is often accompanied by reduced benefit, e.g., poor blood pressure control. There are even strong arguments that partial compliance increases the risks of treatment, especially with beta-blockers. Thus, the traditional physicians' nonperception of patients' partial compliance is no longer acceptable, as partial compliance has a negative impact on the benefit/risk ratio.

W. Wagner - One of the best experts on this subject based on the ideXlab platform.

  • The moral philosophical foundation of pharmaceutical medicine : basic ethical commodities and principles
    International Journal of Pharmaceutical Medicine, 2000
    Co-Authors: W. Wagner, W. M. Herrmann
    Abstract:

    1. In pharmaceutical medicine, benefit and risk are fundamental, intangible ethical commodities determined normatively in recourse to empirically proven preparation characteristics. As normative value judgements, benefit and risk cannot be offset against each other. For this reason it is proposed to replace the term ‘benefit/risk-balance’ by the term ‘benefit/risk-Relationship’. The logical gap left by the comparison of benefit and risk is closed by another normative determination: their Relationship is judged to be favourable, unfavourable, or unacceptable. 2. For the management of uncertainty, ethical principles are important decision-/action-guiding tools. As a general ethical model for pharmaceutical medicine, a three-tiered construction is proposed

  • The moral philosophical foundation of pharmaceutical medicine: basic ethical commodities and principles
    International Journal of Pharmaceutical Medicine, 2000
    Co-Authors: W. Wagner, W. M. Herrmann
    Abstract:

    1. In pharmaceutical medicine, benefit and risk are fundamental, intangible ethical commodities determined normatively in recourse to empirically proven preparation characteristics. As normative value judgements, benefit and risk cannot be offset against each other. For this reason it is proposed to replace the term ‘benefit/risk-balance’ by the term ‘benefit/risk-Relationship’. The logical gap left by the comparison of benefit and risk is closed by another normative determination: their Relationship is judged to be favourable, unfavourable, or unacceptable. 2. For the management of uncertainty, ethical principles are important decision-/action-guiding tools. As a general ethical model for pharmaceutical medicine, a three-tiered construction is proposed The justification tier forms the basis of the construction and contains the culture-defining principle of human dignity that should be viewed as an absolute, unrestrictable, transcendental and universal principle. Within the framework of ethical deliberation, the principle of human dignity systematically holds open the door to recourse and may be seen as a pragmatic substitute for metaphysics. The justification tier holds up the general action tier , which involves the implementation of actions once they have been decided upon. This second tier is characterized by the cardinal principle of responsibility — which is absolute and unrestrictable. As a primarily amoral principle, responsibility is initially ethically neutral, requiring a specific context to acquire its function as a moral philosophical ‘stabilizer’ for the consistent implementation and defence of decisions reached. The construction’s roof is the special action tier , at which morally relevant decisions to act are reached de facto . Ethical reflection draws here on the action-guiding principles of respect for beneficence, for non-maleficence, for autonomy and for justice. These traditional principles have a relative status; they are always valid prima facie and remain so provided that, in a specific situation, they are not forced to retire behind another, overriding principle or do not become restricted in an individual case. It is proposed to apply these principles only in the context of responsibility of the decision-maker, and this in turn should have its foundation in the principle of human dignity.

Richard L Wahl - One of the best experts on this subject based on the ideXlab platform.

  • Choosing an optimal radioimmunotherapy dose for clinical response.
    Cancer, 2002
    Co-Authors: Sally J Denardo, Lawrence E Williams, Bryan R Leigh, Richard L Wahl
    Abstract:

    Clinical trials have documented the single-agent efficacy of radioimmunotherapy (RIT) in lymphoma, and several combination therapy studies are now in progress. RIT agents are currently becoming generally available for clinical use in lymphoma therapy. Solid tumors, which are notoriously less responsive to any single agent, have demonstrated clinically useful responses, albeit temporary, and multimodality studies have been instituted. However, a sincere debate continues regarding the basic parameters to be used to define appropriate therapeutic dosing when using this modality in clinical cancer care. It is a good time to reevaluate relevant dose response information from preclinical and clinical RIT. Preclinical studies have demonstrated abundant evidence of dose response in tumor and normal tissue in homogenous model systems; however, substantive variation occurs between the dose responses of tumors with low and variable (or shed) antigen expression, as well as between histologically different tumor models. Clinical studies of various heavily pretreated patient populations given several very different RIT pharmaceuticals have led to disparate conclusions regarding patient dosing methods and dosimetric predictions of toxicity and efficacy. Single-study data on previously untreated lymphoma patients with similar histology has demonstrated a correlation of imaging dosimetry with toxicity and tumor response. High-dose therapy with bone marrow support has also demonstrated a high tumor response rate and nonmarrow normal organ toxicities that correlate with the calculated dose to those organs from imaging. In iodine-131 ((131)I)--anti-CD20 studies, (131)I was demonstrated to have variable excretion, and estimated total-body radiation dose from tracer study proved a predictive surrogate for marrow toxicity. Yttrium-90 ((90)Y)--anti-CD20, which has little (90)Y excretion from the body, demonstrated the injected dose per body weight to be more predictive of marrow toxicity than indium-111 ((111)In) tracer dosimetry methods in heavily pretreated patients, and showed maximal safety with standard mCi/kg therapy dosing. Variations in clinical RIT choices, dosing methods, and dosimetry methods emphasize the need to review the relevant information to date. Future clinical trial designs, the sophistication of dosimetry, treatment planning, and clinical treatment decisions should all be focused on achieving the best Benefit-Risk Relationship for each patient.

  • Choosing an optimal radioimmunotherapy dose for clinical response
    Cancer, 2002
    Co-Authors: Sally J Denardo, Lawrence E Williams, Bryan R Leigh, Richard L Wahl
    Abstract:

    Clinical trials have documented the single-agent efficacy of radioimmunotherapy (RIT) in lymphoma, and several combination therapy studies are now in progress. RIT agents are currently becoming generally available for clinical use in lymphoma therapy. Solid tumors, which are notoriously less responsive to any single agent, have demonstrated clinically useful responses, albeit temporary, and multimodality studies have been instituted. However, a sincere debate continues regarding the basic parameters to be used to define appropriate therapeutic dosing when using this modality in clinical cancer care. It is a good time to reevaluate relevant dose response information from preclinical and clinical RIT. Preclinical studies have demonstrated abundant evidence of dose response in tumor and normal tissue in homogenous model systems; however, substantive variation occurs between the dose responses of tumors with low and variable (or shed) antigen expression, as well as between histologically different tumor models. Clinical studies of various heavily pretreated patient populations given several very different RIT pharmaceuticals have led to disparate conclusions regarding patient dosing methods and dosimetric predictions of toxicity and efficacy. Single-study data on previously untreated lymphoma patients with similar histology has demonstrated a correlation of imaging dosimetry with toxicity and tumor response. High-dose therapy with bone marrow support has also demonstrated a high tumor response rate and nonmarrow normal organ toxicities that correlate with the calculated dose to those organs from imaging. In iodine-131 (131I)–anti-CD20 studies, 131I was demonstrated to have variable excretion, and estimated total-body radiation dose from tracer study proved a predictive surrogate for marrow toxicity. Yttrium-90 (90Y)–anti-CD20, which has little 90Y excretion from the body, demonstrated the injected dose per body weight to be more predictive of marrow toxicity than indium-111 (111In) tracer dosimetry methods in heavily pretreated patients, and showed maximal safety with standard mCi/kg therapy dosing. Variations in clinical RIT choices, dosing methods, and dosimetry methods emphasize the need to review the relevant information to date. Future clinical trial designs, the sophistication of dosimetry, treatment planning, and clinical treatment decisions should all be focused on achieving the best Benefit-Risk Relationship for each patient. Cancer 2002;94:1275–86. © 2002 American Cancer Society. DOI 10.1002/cncr.10297

Matilde Otero-losada - One of the best experts on this subject based on the ideXlab platform.

  • Antioxidant Supplementation in Cardiovascular Disease and Hypertension
    Biochemistry of Oxidative Stress, 2016
    Co-Authors: José Milei, Francisco Azzato, Susana Vila, Giuseppe Ambrosio, Matilde Otero-losada
    Abstract:

    This chapter is organized in three topics. First, relevant aspects of oxidative stress and oxidative intermediaries that are essential for comprehension of the pathophysiological consequences of oxidative stress are briefly commented. Second, we share our experience concerning with antioxidant supplementation in elderly cardiovascular hypertensive patients. Supplementation with antioxidants and its Benefit-Risk Relationship have been largely discussed in the elderly population. Numerous studies have focused on the utility of antioxidant supplementation in the treatment of cardiovascular diseases. Yet, whether antioxidant supplementation has any preventive and/or therapeutic value in cardiovascular pathology is still a matter of debate because the evidence is inconclusive. Our results on the benefits of antioxidants supplementation in elderly cardiovascular hypertensive patients undertaking periodical cardiovascular checking, are discussed focusing on potential improvement of the biochemical profile associated with oxidative metabolism. Third, our findings on biochemical indicators and histological analysis in the oxidative stress and myocardial injury, following cardioplegic arrest/reperfusion in human cardiac surgery, along with the role of the antioxidant therapy in cardiac surgery, are discussed. Our above mentioned findings are discussed in the light of updated information.

  • Antioxidants Supplementation in Elderly Cardiovascular Patients
    Oxidative Medicine and Cellular Longevity, 2013
    Co-Authors: Matilde Otero-losada, Susana Vila, Francisco Azzato, José Milei
    Abstract:

    Supplementation with antioxidants and its Benefit-Risk Relationship have been largely discussed in the elderly population. We evaluated whether antioxidants supplementation improved the biochemical profile associated with oxidative metabolism in elderly cardiovascular patients. Patients () received daily supplementation with α-TP 400 mg, beta-carotene 40 mg, and vitamin C 1000 mg for 2 months (treatment). Plasma concentrations of alpha-tocopherol (α-TP), β-carotene (βC), ubiquinol-10 (QH-10), glutathione, and thiobarbituric acid reactive substances (TBARS) were determined before and after treatment. Response to treatment was dependent on pretreatment α-TP and βC levels. Increase in α-TP and βC levels was observed only in patients with basal levels