Long-term improvement of arterial wall characteristics in patients with diabetes mellitus type 1 using cyclic, intermittent treatment with a low-dose fluvastatin and valsartan combination.

Improvement of arterial wall (AW) characteristics decreases cardiovascular risk. In a previous study, it was observed that AW characteristics in patients with diabetes mellitus type 1 are significantly improved by short-term treatment with a low-dose combination of fluvastatin and valsartan. Additionally, a unique phenomenon of prolonged effect after treatment discontinuation was suggested. The present study tested whether repeated treatm ent after a certain period results in the same beneficial effect, th ereby advancing the hypothesis that cyclic treatment can provide a long-term improvement of AW characteristics. A total of 44 patients with diabetes mellitus type 1 that participated in the previous study were recruited. Six months after the discontinuation of the initial treatment, the same treatment with a low-dose fluvastatin (10 mg daily) and valsartan (20 mg daily) combination (n=22) or placebo (n=22) was repeated. Brachial artery flow-mediated dilation (FMD), pulse wave velocity (PWV) and carotid artery β-stiffness were measured. It was found that the beneficial effect achieved with an initial 1-month treatment was completely regained following treatment repetition: FMD improved by 50.9% (P<0.01), PWV by 5.7% (P<0.001) and β-stiffness by 9.9% (P<0.001). In addition, a gradual decline of the obtained effects was observed, reaching the level of 9.6% for FM D, 6.3% for PWV and 9.5% for β-stiffness 6 months after treatm ent discontinuation. It was observed that repetition of treatment was similarly effective as the initial intervention. The benefits achieved by treatment steadily declined with time. Combining these findings, cyclic intermittent treatment with a low-dose fluvastatin and valsartan combination is proposed as a new cardiovascular preventive strategy in patients with DM1.

RCT Entities:   Population Interventions Outcomes