Atorvastatin, Etidronate, or Both in Patients at High Risk for Atherosclerotic Aortic Plaques: A Randomized Controlled Trial
Background—Statins are not effective in reducing atherosclerotic plaques of the abdominal aorta, and accumulating evidence suggests that bisphosphonates have the potential to induce the regression of atherosclerotic plaques of the abdominal aorta.
Methods and Results—A prospective, randomized, open-label, blinded-endpoint trial, involving 108 participants with hypercholesterolemia was conducted, participants received either 20 mg of atorvastatin daily, 400 mg of etidronate daily, or both drugs daily. The primary endpoint was the percent change in maximal vessel wall thickness of atherosclerotic plaques in the thoracic and abdominal aortas as measured by magnetic resonance imaging, following 12 months of treatment. In both the combination-therapy and atorvastatin groups, maximal vessel wall thickness of the thoracic aorta was reduced by 13.8% [95% confidence interval [CI] -16.4 to -11.3] and 12.3% [95% CI -14.9 to -9.7], respectively. These reduction rates were comparable between both groups (p=0.61). Meanwhile, in the etidronate group, maximal vessel wall thickness of the thoracic aorta remained unchanged (2.2% [95% CI -0.3 to 4.8%]). Conversely, maximal vessel wall thickness of the abdominal aorta was reduced more effectively in the combination-therapy group (-11.4%) than those achieved in the atorvastatin group (-0.9%; p<0.001) and the etidronate group (-5.5%; p=0.006).
Conclusions—Atorvastatin plus etidronate combination-therapy for 12 months significantly reduced both thoracic and abdominal aortic plaques, while atorvastatin monotherapy reduced only thoracic aortic plaques, and etidronate monotherapy reduced only abdominal aortic plaques. The effectiveness of combination-therapy on reducing atherosclerotic plaques in the abdominal aorta was significantly greater than both atorvastatin and etidronate monotherapy.
Clinical Trial Registration Information—http://www.umin.ac.jp/ctr/. Identifier: UMIN 000002635.
- Received January 28, 2013.
- Revision received April 25, 2013.
- Accepted April 26, 2013.