Underrepresentation of Elderly People in Randomised Controlled Trials. The Example of Trials of 4 Widely Prescribed Drugs

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. METHODS AND FINDINGS: 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

Changes in drug treatment in the elderly between 1971 and 2000

OBJECTIVE: To investigate changes in drug treatment among elderly men and women over a 29-year period between 1971 and 2000. METHODS: Drug consumption was investigated in five representative population samples of 70-year-olds born in 1901-1902 (n=973), 1906-1907 (n=1036), 1911-1912 (n=619), 1922 (n=449) and 1930 (n=506) and in three representative samples of 79- to 80-year-olds born in 1901-1902 (n=537), 1906-1907 (n=538) and 1915 (n=212). RESULTS: The proportion of 70-year-olds who used drugs increased from 60% to 79% in men and from 76% to 88% in women from 1972 to 2000. Among 80-year-olds, 21% of the men and 11% of the women were without drug treatment in 1980, compared with 7% in 1995. The average number of drugs among 70-year-olds on treatment increased during the observation period from 2.8 to 3.5 in men and from 2.8 to 4.0 in women. At age 79-80 years, the mean number of drugs was 3.3 in men and 4.0 in women in 1980 and 4.0 in men and 4.7 in women in 1995. The most common drugs were cardiovascular drugs, analgesics and drugs for diseases in the central nervous system. The most pronounced changes in the consumption of specific drugs were found for anti-ulcerative drugs (increased), digitalis (decreased), diuretics (decreased in women), anti-thrombotic drugs (increased), calcium/vitamin D (increased), insulin (increased in men aged 70 years), analgesics (increased), levaxin (increased in women), anti-depressants (increased in women aged 70 years) and oestrogen in women (increased). The treatment patterns for cardiovascular diseases changed during the observation period and the use of calcium antagonists, angiotensin converting enzyme inhibitors, beta-blockers and lipid-lowering drugs increased. CONCLUSION: The proportion of the population with drug treatment at ages 70 years and 79-80 years increased as did the average number of drugs among treated subjects between 1971 and 2000. Important differences in the treatment patterns for different diseases were observed

Changing prediction of mortality by systolic blood pressure with increasing age: the Rotterdam study

Item does not contain fulltextThere are indications that in persons of older age, systolic blood pressure (SBP) is no longer associated with mortality. This raises the question whether the predictive value of SBP changes from younger to older age groups. Analysis in the Rotterdam Study, a population-based prospective cohort study among 4,612 participants aged >/=55 years without previous cardiovascular disease and with a median follow-up of 14.9 (interquartile range, 11.1-15.8) years. Within four age groups (55-64, 65-74, 75-84, >/=85 years), the predictive value of baseline SBP for mortality was studied. From age 55 to >/=85 years, risk of all-cause mortality associated with SBP >/=160 mmHg decreased from HR 1.7 (95%CI 1.2-2.2) to HR 0.7 (95%CI 0.4-1.1), p for trend <0.001. For participants with SBP 140-159 mmHg, the risk decreased from HR 1.2 (95%CI 0.9-1.5) to HR 0.7 (95%CI 0.5-1.1), p for trend <0.001. Analyses in the 5-year age groups showed an increased risk with higher SBPs up to age 75 years. After 75 years, a trend towards SBP no longer being associated with an increased mortality risk was seen in our study. These findings need to be considered with recently reported beneficial effects of antihypertensive treatment in this age group