title: New drugs and patient-centred end-points in old age: setting the wheels in motion.
abstract: Older patients with various degrees of frailty and disability, a key population target of pharmacological interventions in acute and chronic disease states, are virtually neglected in pre-marketing studies assessing the efficacy and safety of investigational drugs. Moreover, aggressively pursuing established therapeutic targets in old age, e.g. blood pressure, serum glucose or cholesterol concentrations, is not necessarily associated with the beneficial effects, and the acceptable safety, reported in younger patient cohorts. Measures of self-reported health and functional status might represent additional, more meaningful, therapeutic end-points in the older population, particularly in patients with significant frailty and relatively short life expectancy, e.g. in the presence of cancer and/or neurodegenerative disease conditions. Strategies enhancing early knowledge about key pharmacological characteristics of investigational drugs targeting older adults are discussed, together with the rationale for incorporating non-traditional, patient-centred, end-points in this ever-increasing group.
authors.affiliation: a Discipline of Clinical Pharmacology, School of Medicine , Flinders University and Flinders Medical Centre , Bedford Park , Australia.
authors.forename: Arduino A
authors.initials: AA
authors.lastname: Mangoni
authors.affiliation: b Department of Orthogeriatrics, Rehabilitation and Stabilization, Frailty Area , E.O. Galliera Hospital, National Relevance and High Specialization Hospital , Genova , Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Pilotto
mesh_terms: D000208:Acute Disease; D000367:Age Factors; D000368:Aged; D002908:Chronic Disease; D006233:Persons with Disabilities; D015507:Drugs, Investigational / Q000009:adverse effects / Q000627:therapeutic use*; D023381:Endpoint Determination; D016330:Frail Elderly; D006304:Health Status; D006801:Humans; D018802:Patient-Centered Care / Q000379:methods*
chemical_list: D015507:Drugs, Investigational
keywords: drug development; efficacy; frailty; functional status; older adults; pharmacodynamics; pharmacokinetics; safety; therapeutic goals