Benefit: risk ratio

The pharmacoeconomics of the anxiety disorders has received litde attention. In the past drug costs were largely incurred by use of benzodiazepines, most of which are available in generic forms and are cheap. They are effective and acceptable in the short term. Long-term use is associated with the risk of physical dependence, with an adverse risk—benefit ratio and high cost terms to facilitate withdrawal. There is now a trend towards the use of antidepressants in the anxiety disorders. Clinical experience has been followed by formal trial evaluation. 

Long-term use of oral corticosteroids should be avoided due to an unfavorable risk/benefit ratio. The steroid myopathy that can result from long-term use of oral corticosteroids weakens muscles, further decreasing the respiratory drive in patients with advanced disease. 

The protective efficacy of Engerix B has been demonstrated in a number of trials, in the context of infants, children and adults. Seroprotection rates (measured as serum anti-hepatitis B antibody titres above a value of 10 mlU ml-1) of over 95 per cent were usually recorded. The product was found to be generally well tolerated. The most frequently reported adverse effects were local reactions at the injection sites, fever, headache and dizziness. Special consideration to risk benefit ratio should be given to MS patients, as exacerbations of this condition have been (rarely) reported following administration of hepatitis B and other vaccines. Engerix B is manufactured and marketed by GlaxoSmithKline. 

Hormone therapy has proven highly effective in controlling the menopausal syndrome, especially severe hot flushes (MacLennan et al. 2004), even at doses significantly lower than those used until now (Speroff et al. 2000 Utian et al. 2001). Women s Health Initiative studies found that hormone replacement therapy, when administered as a primary prevention intervention for CVD in older women, increases the risk of heart disease and breast cancer. Even if a protective effect on fracture and colon cancer was observed, the risk-benefit ratio led to a recommendation of this treatment only for the short-term relief of menopausal symptoms (Rossouw et al. 2002 Anderson et al. 2004). The role of early administration of ovarian hormones to young postmenopausal women in the prevention of cardiovascular disease or late dementia remains... 

Pharmaceuticals are intended to have human exposure. Furthermore, pharmaceuticals are intended to have biological effects on the people that receive them. Frequently, the interpretation of results and the formulation of decisions about the continued development and eventual use of a drug are based on an understanding of both the potential adverse effects of the agent and its likely benefits, as well as the dose separation between these two. This makes a clear understanding of dose-response relationship critical, so that the actual risk/benefit ratio can be identified. It... 

Postmarketing surveillance Risk-benefit ratio Safety... 

No drug is completely safe or without potential side effects. Before a drug is approved for marketing, tests that show a drug is "safe" under the conditions on the proposed label. "Safety," therefore, is determined case-by-case and reflects the risk-benefit ratio. 

The United States National Institutes of Health (NIH) has stipulated seven ethical requirements to ensure that, before a trial begins, there is proper consideration of ethical issues and the trial subjects are protected. The essential tenet is that the potential exploitation of human subjects must be minimized and the risk-benefit ratio must be favorable. There are seven ethical requirements ... 

Social value Scientific validity Fair subject selection Informed consent Favorable risk-benefit ratio Independent review Respect for human subjects... 

Normally, healthy volunteers are recruited for the Phase I trial. In many cases, volunteers are compensated financially for participation in the Phase I trial. However, in some situations, patients who are critically ill or have terminal disease are presented with the option to be included in the trial after due consideration of the risk-benefit ratio. Phase I trials are usually conducted... 

Schafer-Korting, M., Schmid, M. H. and Korting, H. C., Topical glucocorticoids with improved risk-benefit ratio rationale of a new concept. Drug Saf, 14, 375-85, 1996. Egbaria, K., Ramachandran, C. and Weiner, N., Topical application of liposomaUy entrapped cyclosporin evaluated by in vitro diffusion smdies with human skin. Skin Pharmacol., 4, 21-28, 1991. 

With every drug use, unwanted effects must be taken into account. Before prescribing a drug, the physician should therefore assess the risk benefit ratio. In this, knowledge of principal and adverse effects is a prerequisite. 

In assessing the risk benefit ratio, it is also necessary to consider the benefit for the child resulting from adequate therapeutic treatment of its mother. For instance, therapy with antiepileptic drugs is indispensable, because untreated epilepsy endangers the infant at least as much as does administration of anticonvulsants. 

The Medicines Act, together with the associated EU legislation and EU and ICH guidelines, should ensure that the safety of drugs made to the highest quality, the acceptability of their risk/benefit ratio and the promotion of correct information to the prescribers and consumers are the dominant features of the controls that operate today. 

Anticholinergic side-effects are dry mouth, urinary retention and constipation. Confusion and drowsiness occur especially in the elderly and because of their poor risk-benefit ratio old age is a relative but serious contraindication for the use of these agents. 

The therapy of atrial premature contractions (APC) depends on the patient s symptoms. Asymptomatic APC need not be treated. However, asymptomatic APC may be associated with an increased risk of atrial fibrillation. In such cases, suppression of APC may be useful in prolonging the time to the onset of atrial fibrillation. /3-blockers or Class la/Ic agents may be effective for suppression of APC. The use of Class Ic agents, such as fiecainide, may achieve almost complete suppression of APC, but the risk-benefit ratio of these agents has not been studied. 

Research has potential Risk/benefit ratio must be favor-... 

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