Translating the dose response into risk and benefit.
Br J Clin Pharmacol
; 85(10): 2187-2193, 2019 10.
Article
em En
| MEDLINE
| ID: mdl-30945324
ABSTRACT
When choosing a medicine two aspects determine the balance between benefit and harm (risk-benefit), matching the medicine to the individual and the choice of dose. Knowing the relationship between dose and response allows a calculation of the dose that causes 50% of the maximal effect, the ED50 . Rational drug dosing depends on defining the ratio of the dose to the ED50 . The ED50 of each drug has two scales, whether the effect measured is for efficacy, or safety. Quantifying efficacy is comparatively straightforward. A fall in blood pressure, combined with a statistical and clinically significant reduction in cardiovascular events, might justify the efficacy of an antihypertensive. Measuring a drug's effect on safety is more complex, as this is so often a subjective assessment of a collection of adverse events. Though a science-based therapeutic window defined from in vitro efficacy and safety dose response curves is reassuring, this review discusses how to translate this into dose-dependent risk-benefit based on clinical trial data. Some of the limitations of our knowledge about the choice of dose that optimizes an individual's risk-benefit, or whether no drug is a better option, are discussed. It is important to define these limitations when educating the consumer/patient about the clinical pharmacology that justifies their treatment dose options.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Preparações Farmacêuticas
/
Medição de Risco
/
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
Tipo de estudo:
Clinical_trials
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Etiology_studies
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Risk_factors_studies
Limite:
Humans
Idioma:
En
Revista:
Br J Clin Pharmacol
Ano de publicação:
2019
Tipo de documento:
Article
País de afiliação:
Reino Unido