title: Underrepresentation of elderly people in randomised controlled trials. The example of trials of 4 widely prescribed drugs.
abstract: BACKGROUND
  We aimed to determine the representation of elderly people in published reports of randomized controlled trials (RCTs). We focused on trials of 4 medications--pioglitazone, rosuvastatin, risedronate, and valsartan-frequently used by elderly patients with chronic medical conditions.
  
  
  RESULTS
  We selected all reports of RCTs indexed in PubMed from 1966 to April 2008 evaluating one of the 4 medications of interest. Estimates of the community-based "on-treatment" population were from a national health insurance database (SNIIR-AM) covering approximately 86% of the population in France. From this database, we evaluated data claims from January 2006 to December 2007 for 1,958,716 patients who received one of the medications of interest for more than 6 months. Of the 155 RCT reports selected, only 3 studies were exclusively of elderly patients (2 assessing valsartan; 1 risedronate). In only 4 of 37 reports (10.8%) for pioglitazone, 4 of 22 (18.2%) for risedronate, 3 of 29 (10.3%) for rosuvastatine and 9 of 67 (13.4%) for valsartan, the proportion of patients aged 65 or older was within or above that treated in clinical practice. In 62.2% of the reports for pioglitazone, 40.9% for risedronate, 37.9% for rosuvastatine, and 70.2% for valsartan, the proportion of patients aged 65 or older was lower than half that in the treated population. The representation of elderly people did not differ by publication date or sample size.
  
  
  CONCLUSIONS
  Elderly patients are poorly represented in RCTs of drugs they are likely to receive.
authors.affiliation: INSERM U738, Paris, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: Konrat
authors.forename: Isabelle
authors.initials: I
authors.lastname: Boutron
authors.forename: Ludovic
authors.initials: L
authors.lastname: Trinquart
authors.forename: Guy-Robert
authors.initials: GR
authors.lastname: Auleley
authors.forename: Philippe
authors.initials: P
authors.lastname: Ricordeau
authors.forename: Philippe
authors.initials: P
authors.lastname: Ravaud
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D002908:Chronic Disease / Q000188:drug therapy*; D012968:Etidronic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D005464:Fluorobenzenes / Q000627:therapeutic use; D005602:France; D006801:Humans; D008875:Middle Aged; D000077205:Pioglitazone; D055553:Prescription Drugs / Q000627:therapeutic use*; D011743:Pyrimidines / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic; D000068296:Risedronic Acid; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000627:therapeutic use; D013777:Tetrazoles / Q000627:therapeutic use; D045162:Thiazolidinediones / Q000627:therapeutic use; D014633:Valine / Q000031:analogs & derivatives / Q000627:therapeutic use; D000068756:Valsartan
chemical_list: D005464:Fluorobenzenes; D055553:Prescription Drugs; D011743:Pyrimidines; D013449:Sulfonamides; D013777:Tetrazoles; D045162:Thiazolidinediones; D000068756:Valsartan; D000068718:Rosuvastatin Calcium; D014633:Valine; D000068296:Risedronic Acid; D012968:Etidronic Acid; D000077205:Pioglitazone