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Assessment of Benefits of Drug Therapies: Memantine for Alzheimer's Disease as an Example
After the approval of a drug, which represents a first assessment, independent institutions and medical professional associations provide further evaluations. Here, the question is to be asked whether common or diverging evaluation methods exist that can have an impact on the result. In principle, two methods are used: meta-analyses and responder analyses. Meta-analyses and the resulting effect sizes have to be interpreted according to the field of application (for example, the type and severity degree of a disease) with medical expertise. Omitting this can lead to incorrect evaluations and to a discrepancy of evaluation results. In the case of memantine, the merely biometric evaluation of meta-analyses performed by the IQWiG led to a denial of the benefit, while the same data, considering clinical routine, led professional associations to recommend memantine for moderate to severe Alzheimer's disease. In contrast to meta-analyses, responder analyses directly show the benefit of a therapy option in the presence of significant group differences, as the selected responder criteria are based on the indication. The corresponding results of the responder analyses on memantine were also acknowledged by the IQWiG and led to a positive evaluation of memantine. This discrepancy of evaluation results illustrates the fact that statistical procedures are necessary when evaluating drug and non-drug therapy options but, that the interpretation of the results with medical expertise is essential
152.25 years of drug surveillance of psychiatry - The AMSP system, a multinational approach
Pontine myelinolysis and hyponatremia associated with carbamazepine treatment in patients with alcohol dependence
Additive therapy with antidepressives for schizophrenic patients - Comparison of two patient collectives in stationary area to different treatment time space
152.25 years of drug surveillance of psychiatry - The AMSP system, a multinational approach
Elevated cortisol secretion in patients suffering from both depression and sleep-related breathing disorders
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