Objective: Alzheimer's disease patients with hypertension or other vascular risk factors have been shown to receive greater symptomatic benefits than patients with strictly Alzheimer's disease following short-term rivastigmine treatment. We evaluated the long-term efficacy of rivastigmine in Alzheimer's disease patients with or without hypertension.
Design: Subjects in a 26-week placebo-controlled trial of rivastigmine entered an open-label extension study, for a total duration of 104 weeks. In the open-label extension phase, all patients received rivastigmine, irrespective of the treatment they had received during the double-blind phase.
Materials and Methods: Efficacy measures included the AD Assessment Scale - cognitive subscale (ADAS-cog), Progressive Deterioration Scale (PDS) and Global Deterioration Scale (GDS). Subjects were stratified by presence/absence of hypertension at baseline.
Results: At 104 weeks, there was a trend for hypertensive patients from the original rivastigmine 6-12mg/day group ('early' starters, who received rivastigmine for the full 104 weeks) to have better ADAS-cog scores than the original placebo group (3.76-point difference, p=0.077). Significant treatment differences were observed in the hypertensive subgroup on the PDS (11.56 points, p<0.013) and GDS (0.84 points, p<0.019). In non-hypertensive patients, changes from baseline at week 104 were similar in 'early' and 'late' starters of rivastigmine treatment.
Conclusion: The additional apparent benefits on disease progression detected in patients with hypertension and Alzheimer’s disease may be linked to drug effects on ischaemic changes. Since most patients have mixed dementia, this may have important clinical implications. These findings may have an important influence on the way cholinesterase inhibitors are prescribed.
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