Anti-atherosclerotic effects between a combined treatment with simvastatin plus hirudin and single simvastatin therapy in patients with early type 2 diabetes mellitus

Abstract

Background: This study aimed to investigate the efficacy and safety of simvastatin plus hirudin in preventing atherosclerosis in the patients with early type 2 diabetes mellitus (T2DM). Methods: This was a 24-week, randomized, open-label and controlled study in which 150 outpatients initially diagnosed with T2DM were randomly assigned into either simvastatin (40 mg daily at night) plus hirudin (3 g thrice daily) group [combined group (CG) n=75] or simvastatin (40 mg once daily) group [monotherapy group (MG) n=75]. The therapeutic efficacy was evaluated by the score of carotid artery atherosclerosis, plaque size, peak systolic velocity (PSV) and end-diastolic velocity (EDV) on carotid ultrasonography at three and six months after treatment. Logistic regression analysis was used to investigate the correlation between treatment and carotid atherosclerosis. Results: One hundred and thirty-one patients completed this study, and there were no significant differences in the dropout rate in the CG (14.67%) and the MG (10.67%). Significant difference was found in the incidence of adverse events in the CG compared with the MG (37.50% vs. 17.91%, P<0.05) due to the higher risk of hemorrhage (12.50% vs. 1.49%, P<0.05), which did not affect the treatment compliance. The efficacy of combined treatment was better than monotherapy in the enhancement of carotid artery atherosclerosis scores (P<0.01), the plaque thickness (P<0.05) and the change of PSV (P<0.05) and EDV (P<0.05) since three months after treatment, which maintained to the end of observation. In addition, hirudin treatment was able to independently predict the carotid artery atherosclerosis scores (β=2.37, P<0.05), the plaque thickening (β=3.51, P<0.01) and the change of PSV (β=1.69, P<0.05) and EDV (β=1.79, P<0.05). Conclusions: Combined use of simvastatin and hirudin is well tolerated and possesses better antiatherosclerotic effects than simvastatin alone in patients with early T2DM.

The Anti-atherosclerotic Effects of Endothelin Receptor Antagonist, Bosentan, in Combination with Atorvastatin – an Experimental Study

“…Nevertheless, the beneficial effect of bosentan on plaque stability in an additive manner may encourage its use not as a standalone therapy but as a complementary regimen to established anti-atherosclerotic therapies, like statins. The use of pharmaceutical combinations has become a popular therapeutic approach in clinical practice of ASCVDs, since it promotes pharmaceutical synergy, inhibits a wider spectrum of atherosclerotic mechanisms and magnifies their effectiveness [31,32].…”

The Anti-Atherosclerotic Effects of Endothelin Receptor Antagonist, Bosentan, in Combination with Atorvastatin—An Experimental Study

“…Nevertheless, the beneficial effect of bosentan on plaque stability in an additive manner may encourage its use not as a stand-alone therapy but as a complementary regimen to established anti-atherosclerotic therapies, like statins. The use of pharmaceutical combinations has become a popular therapeutic approach in the clinical practice of ASCVDs, since it could inhibit a wider spectrum of atherosclerotic mechanisms and magnify their effectiveness [ 33 , 34 ]. This drug is currently available in clinical practice, but its use could be broadened if these effects on plaque stability were the same in people as those in mice [ 35 ].…”