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To compare the efficacy of two strategies of blood pressure (BP) measurement-based follow-up in hypertension and albuminuria control.Multicentre, prospective, randomised, open trial with a parallel-group design. Nineteen primary care centres and a hospital clinic participated. Adult type 2 diabetics with systolic BP ≥140mmHg without relevant renal disease were randomised to one of two follow-up strategies: 1) standard follow up, with a clinic BP target140/90mmHg and 2) self-monitoring home BP (SMHBP)-based follow up, with a BP target135/85mmHg. Biochemical standard blood variables, albuminuria, and 24-h ambulatory BP monitoring were performed at entry, 12 and 24 months. The main outcome measurement was 24-h ambulatory systolic BP variation. Albuminuria change was analysed as a secondary outcome.116 patients were analysed (mean age: 66.8 years). Mean systolic ambulatory 24- h BP change in two years was 3.9mmHg (95% CI 1.8-6.1). We did not find significant differences between both groups (p=0.706). Similarly, no differences were found when we compared other ambulatory BP values. Initial albuminuria was similar in both groups and did not significantly changed throughout the follow-up period.In type 2 diabetics without relevant nephropathy a SMHBP- based follow up was equivalent to a standard clinic-based BP follow up in BP and albuminuria control.

Keywords: treatment indication, cut-off points, stratification, albumin excretion rate, microalbuminuria, Type 2 diabetes, irbesartan Abstract Hypothesis The efficacy of a treatment in a clinical trial depends in part on where the cut-off point is placed for the test result used to select patients for the trial, and this applies to irbesartan in the Irbesartan Microalbuminuria II (IRMA II) trial for preventing nephropathy. Patients and methods Patients in the IRMA II trial were stratified into different pre-treatment albumin excretion rate (AER) ranges to compare the proportion of patients starting in these different ranges (i) that progressed to develop nephropathy within 24 months and (ii) whose AER was over 40 µg/minute at three months. Results The proportion of patients with pre-treatment AER values between 20 and 40 µg/minute progressing to develop nephropathy was 1.25% in the placebo group and 0.78% in the irbesartan group, while for pre-treatment AER values between 41 and 200 µg/minute, 24.4% and 11.2% develop nephropathy respectively in the placebo and irbesartan groups. In patients with a pre-treatment AER of 20 to 30 µg/minute, 32.5% and 13.6% respectively in the placebo and irbesartan groups had a value exceeding 40 µg/minute at three months. Conclusions The data demonstrate that irbesartan is effective in reducing the onset of nephropathy within two years when the pre-treatment AER is above 40 µg/minute, but if the AER is below this level it progresses unusually to nephropathy within two years. Irbesartan also slows progression of AER to over 40 µg/minute for patients with pre-treatment AER values at or above 20 µg/minute and these patients should be treated.

A 38-year-old woman with systemic lupus erythematosus (SLE) and an acute neurological event was studied with computed tomography (CT) and magnetic resonance (MR). Marked intracranial calcification mimicking that seen in hypoparathyroid states was found. The clinical significance of this finding is not clear and the mechanism for cerebral calcification remains unknown.