Rates of treatment withdrawal due to adverse events did not differ between the groups. The Valsartan in Elderly Isolated Systolic Hypertension (VALISH) study involved 3260 Japanese participants aged 70 to 84 years, with systolic BP Z160 mm Hg.394 this study did not demonstrate any differences in outcomes or adverse events between the strict-control group (systolic BP goal o140 mm Hg, achieved mean systolic BP was 136.6 mm Hg) and the moderate-control group (systolic BP goal 140 150 mm Hg, achieved mean systolic BP was 142.0 mm Hg) after a median follow-up period of 3.07 Although 43 of the 3260 patients had kidney insufficiency (undefined) at study entry, none had a SCr level Z2 mg/dl (177 mmol/l) since this was an exclusion criterion, as were many other co-morbidities. Doubling of the SCr, an increase in the SCr level to 2.0 mg/dl (177 mmol/l), or dialysis occurred in 5 and 2 patients, respectively (non-significant). The authors concluded that in relatively healthy elderly Japanese patients, a BP o140 mm Hg is safely achievable, but that the trial was underpowered to assess outcome benefits. No difference was seen between the two groups in terms of adverse event rates (18.2% with strict control and 17.9% with mild control, P 0.851). Thus BP targets in the elderly, with or without CKD, should be set only after consideration of co-morbidities and should be achieved gradually. 