The Random, Double-blind, Parallel Positive Control And Unicentral Stage-Ⅱ Clinical Observation For The Ivabradine Tablet To Cure The Chronic Stable Angina Pectoris

Background: With the greater economic development, the incidence rate of thecardiovascular disease has beening growing year by year, and chronic stable angina pectorisis one of the most common and high-attack rate one. While epidemiologic study found thatarrhythmia was one of the vital risk factors of cardiovascular diseases, and that theincrease of the resting heart rate had positive correlation to the cardiovascular diseases, thusregulating the heart rate to certain extant is significant to improvement of the quality of life.In the late1990s,the scientists began to focus on the provocation and regulation ofpacemaker activity because of that the subunit of HCN family was successfully cloned andthat hyperpolarizationg-activated positive ion current was more profoundly understood; Ifchannel is properly a kind of HCN,while ivabradine is the first kind specific inhibitor for Ifcurrent of senatorial node, which has one fold action of slowing down the heart rate, as asignificant and ideal curative of stable angina pectoris and other cardiovascular diseases, ithas favorable perspective of clinical application.Objective: To evaluate the efficacy and safety of administering Ivabradine on thedosage of5/7.5mg bid and Atenolol on the dosage of12.5/25mg bid to the chronic stableangina pectoris patients. Method: The visiting chronic stable angina pectoris patients of our division betweenFebruary,2010to February,2011was strictly screened and grouped to carry out the random,double-blind, parallel positive control clinical trial for the drug of Ivabradine and Atenolol,who were received ETT, hemat-biochemical test, blood routine test, urine routine test anddodeca-lead surface electrocardiogram respectively before and after administering drug inthe4thand12thweek, then finally evaluated the efficacy and safety via the valid and intactcases from the Ivabradine group and Atenolol group.Result: Both Ivabradine and Atenolol showed a favorable clinical therapeutic effectwith respect to the main and secondary observed index, which could dramatically improvethe exercise tolerance of the subjects, that reflected by the enhanced time of ETT wasprolonged from352.47±131.62ms and394.32±127.12ms before dosage to528.14±109.19ms and528.14±109.19ms12weeks after dosage, respectively. Statisticanalysis showed that the intra-group discrepancy of the two groups had a significantdifference (p<0.0001), while that of the inter-group had no significant difference (p=0.862).After statistical analysis of the safety-related indices, we could not find the two groups ofdrug had obviously affection to the indices of hepatic function, renal function, uric acid,blood glucose, blood fat, white blood cells and neutrophils.Conclution: Ivabradine has therapeutic equivalence to Atenolol for chronic stableangina pectoris, which yet has few adverse effects, thus it is effective and safe for thetreatment of chronic stable angina pectoris.