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Trials in special populations
CURRENT THERAPEUTIC RESEARCH ® VOL. 58, NO. 10, OCTOBER 1997
Trials in Special Populations Editorial Comment This issue contains papers in two interesting special populations elderly patients with dysthymia and postpartum patients. The first study, by Bellino et al, describes an open-label, 6-month, randomized prospective comparison of sertrAline and amisulpride in elderly patients (mean age, 71 years) with dysthymic disorder. As in the general elderly population, the study population included far more women than men (32 vs 17). The authors were quick to point out the weakness of the study design, and no significant differences were found. More dropouts occurred in the sertraline group than in the amisulpride group (4 vs 1). The results of the study suggest that had the study continued, or had a greater number of patients been included, amisulpride might have proved to be superior in the management of dysthymic symptoms. This is an important and growing population, and perhaps the most important finding in the study is that this population can be successfully enroUed and retained in such prospective trials. The results of future similar, but double-masked, trials are eagerly awaited. The second paper, by Mikamo et al, describes the results of prophylactic antibiotic therapy with cefditoren in postpuerperal Japanese patients. The use of such prophylaxis is not routine in all countries, and the short- and long-term effects of such use remain unclear. Additional studies will be required to document the need for such prophylaxis in this or any other population and to assess the value of the investigators' observations. It is not clear what relationship, if any, exists between the ability to culture an organism from the birth canal and the outcome from, or incidence of, maternal infection. Such data are needed because of the growing incidence of antimicrobial resistance worldwide and because such use exposes another "special population"--breast-fed newborns--to antibiotics given to mothers. Unfortunately, the authors presented no data on the amount of cefditoren found in breast milk or any possible effects on breast-fed infants. Perhaps such studies should be mandatory for experimental studies of maternal medications. Clearly newborns are important, unintended recipients of many maternal medications. Philip D. Walson, M.D. Editor-in-Chief
797
0011-393x/97/$3.50
Trials in Special Populations Editorial Comment This issue contains papers in two interesting special populations elderly patients with dysthymia and postpartum patients. The first study, by Bellino et al, describes an open-label, 6-month, randomized prospective comparison of sertrAline and amisulpride in elderly patients (mean age, 71 years) with dysthymic disorder. As in the general elderly population, the study population included far more women than men (32 vs 17). The authors were quick to point out the weakness of the study design, and no significant differences were found. More dropouts occurred in the sertraline group than in the amisulpride group (4 vs 1). The results of the study suggest that had the study continued, or had a greater number of patients been included, amisulpride might have proved to be superior in the management of dysthymic symptoms. This is an important and growing population, and perhaps the most important finding in the study is that this population can be successfully enroUed and retained in such prospective trials. The results of future similar, but double-masked, trials are eagerly awaited. The second paper, by Mikamo et al, describes the results of prophylactic antibiotic therapy with cefditoren in postpuerperal Japanese patients. The use of such prophylaxis is not routine in all countries, and the short- and long-term effects of such use remain unclear. Additional studies will be required to document the need for such prophylaxis in this or any other population and to assess the value of the investigators' observations. It is not clear what relationship, if any, exists between the ability to culture an organism from the birth canal and the outcome from, or incidence of, maternal infection. Such data are needed because of the growing incidence of antimicrobial resistance worldwide and because such use exposes another "special population"--breast-fed newborns--to antibiotics given to mothers. Unfortunately, the authors presented no data on the amount of cefditoren found in breast milk or any possible effects on breast-fed infants. Perhaps such studies should be mandatory for experimental studies of maternal medications. Clearly newborns are important, unintended recipients of many maternal medications. Philip D. Walson, M.D. Editor-in-Chief
797
0011-393x/97/$3.50