MORTALITY STUDIES AND THE EFFECTIVENESS OF DRUGS IN LONG-TERM TREATMENT

In scientific observations on the utilization of drugs under routine t reatment conditions in patients with affective disorders, one of the m ain problems is the etablishment of criteria for measuring treatment e ffectiveness. As the mortality risk of such patients is considerable, the mortality rate is an important outcome criterion for determining t he long-term effectiveness of medication administered in routine treat ment settings. Mortality studies are typical phase IV studies: the res earcher does not interact with the treatment procedure, he only observ es the results of treatment with respect to death rates. As lithium tr eatment is of increasing importance and interest as a major prophylact ic agent in recurrent affective disorders and is by its nature a longt erm treatment, such a therapy provides an excel lent field for observa tions of effectiveness under long-term treatment conditions. Mortality studies can take into account Various factors, such as type of treatm ent setting, treatment regimen, drop-out analysis, and comparison betw een times on and off treatment. Results from several mortality studies on lithium-treated patients are reported in order to demonstrate the methodology and outcome of long-term observation of drug treatment. Mo rtality studies conducted within the framework of phase IV studies and particularly within the concept of pharmacoeconomics can help to demo nstrate the effectiveness of long-term treatment, and are an important methodological adjunct to controlled clinical trials.