Safety And Effectiveness Of Combination Therapy Of Amlodipine Besylate And Telmisartan In Patients With Hypertension

Objective: The aim of this study was to evaluate safety and effectivenessof combination therapy of Amlodipine besylate and Telmisartan in Patientswith Hypertension.Method: This single-blind, randomized parallel trial was performed inpatients with hypertension. Amlodipine besylate was used as positive control.After6-week treatment with amlodipine besylate5mg once daily, the patients(mean sitting diastolic blood pressure [MSTDBP]≥90mmHg and＜120mmHg) were randomly divided into combination therapy group(Amlodipi-ne besylate and Telmisartan) and monotherapy group(Amlodipine besylate). The patients subsequently received treament ofAmlodipine besylate5mg plus Telmisartan80mg in combination therapygroup or Amlodipine besylate5mg in monotherapy group daily for8weeks.Periodic electrocardiograms, clinical laboratory tests, and physicalexaminations were performed at the beginning,4-week and the end oftreatment. The data was statistically analyzed.Results: A total of72patients completed the study and36patients foreach group. After the treatment for4weeks and8weeks, MSTDBP fell from (100.28±6.58)mmHg to (84.31±6.24) mmHg and (82.06±6.58) mmHg incombination therapy group, respectively, and fell from (98.58±6.03) mmHg to(90.81±6.71) mmHg and (87.89±7.95) mmHg in monotherapy group. There issignificant difference of MSTDBP reduction comparied with pre-treatment (p<0.01). Comparison of MSTDBP reduction between two groups werestatistically significant(p <0.01). Mean Seated Trough Systolic Blood Pressure(MSTSBP) fell from (155.42±9.43) mmHg to (134.47±7.12) mmHg and(132.00±9.52) mmHg in combination therapy group, respectively, and fell from(155.17±10.71) mmHg to (139.19±8.06) mmHg and (135.39±6.70) mmHg inmonotherapy group. There was significant difference of MSTSBP reductioncomparied with pre-treatment after4and8weeks of treatment (p<0.01).Comparison of MSTSBP reduction between two groups were statisticallysignificant after4weeks of treatment(p<0.01), but was not statisticallysignificant after8weeks of treatment(p＝0.085). After the treatment for8weeks, control rate and effective rate of the Diastolic Blood Pressure (DBP)were94.44%and97.22%in combination therapy group,63.89%and75.00%in monotherapy group, respectively. There was significant difference betweentwo groups (p <0.01). The control rate and effective rate of the Systolic BloodPressure (SBP) were83.33%and91.67%in combination therapy group,66.67%and72.22%in monotherapy group, respectively. There was significant difference of effective rate (p<0.05), but no significant difference of controlrate (p>0.05) between groups. After the treatment for8weeks, the Mean SeatedTrough Blood Pressure (MSTBP) target rate was91.67%in combinationtherapy group,58.33%in monotherapy group, respectively. There wassignificant difference between two groups (p<0.01). The incidence of adversereaction was5.56%in combination therapy group and was8.33%inmonotherapy group which there was no significant difference (p>0.05). Therewas also no significant differences in liver and kidney function, blood lipids,fasting blood-glucose, blood electrolytes and blood routine (p>0.05). But thetest group had greater efficacy than the control group in reducing urine protein.Conclusion:Comparing with the amlodipine besylate5mg, thecombination therapy of Amlodipine besylate5mg and Telmisartan amlodipine80mg can effectively reduce STBP, especially reduce MSTDBP and improvethe efficiency and target rate. Moreover, it can protect kidney function, andhas no incidence of peripheral oedema, with good safety and tolerability.