Zusammenfassung
Kennzeichnend für das fortgeschrittene Lebensalter ist eine hohe Krankheitslast. Trotzdem sind ältere Patienten mit inneren Erkrankungen in klinischen Studien oft unterrepräsentiert; patienten-, arzt- und protokollbezogene Barrieren verhindern vor allem den Einschluss von alten Patienten mit eingeschränkter „medizinischer Fitness“ (Komorbidität, Komedikation, schlechter Performancestatus, kognitives Defizit etc.). Empfehlungen, die auf Studien an jüngeren Erwachsenen basieren, können meistens nicht pauschal für ältere Patienten übernommen werden. In der Versorgungspraxis und in klinischen Studien sollte nicht alters-, sondern fitnessadaptiert behandelt werden: Bei guter Fitness ist die Standardbehandlung in der Regel auch bei älteren Patienten wirksam und gut verträglich. Bei eingeschränkter Fitness können Therapiemodifikationen indiziert sein. An Studien, die neue Therapiemodalitäten an jüngeren Erwachsenen erproben, sollten auch ältere Patienten mit guter Fitness teilnehmen können. Nutzen und Risiko von Therapiemodifikationen müssen bei älteren Patienten mit reduzierter Fitness in gesonderten Studien erforscht werden.
Abstract
Advanced age is associated with a higher burden of illness. Nevertheless, elderly patients suffering from internal diseases are underrepresented in clinical trials; patient, physician and protocol-designed barriers in particular prevent the recruitment of older patients with impaired medical fitness (co-morbidity, co-medication, poor performance status, cognitive dysfunction etc.). Recommendations that are based on trials in younger subjects mostly cannot be generally adopted for the elderly. Treatment in clinical practice and clinical trials should be fitness-adapted rather than age-adjusted. Normally, standard regimens are effective and well tolerated in medically fit patients of advanced age. In contrast, it may be necessary to apply modified regimens for the medically unfit. Trials exploring novel treatment modalities in the young should always allow the inclusion of elderly patients with good medical fitness. The benefit of modifying a treatment regimen in medically unfit patients of advanced age has to be determined by separate trials.
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Goede, V., Hallek, M. Ältere Patienten in klinischen Studien. Internist 48, 1232–1238 (2007). https://doi.org/10.1007/s00108-007-1944-4
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DOI: https://doi.org/10.1007/s00108-007-1944-4