Effect Of Nifedipine GITS 60mg In Patients With Non-compliance Hypertension Under Monotherapy Of Initial Dose

Objective:Clinicians in China prefer to use initial dose of antihypertensive drugs,including CCB and other drugs,in consideration of safety.The treatment is not standardized.As a result,the current compliance rate of hypertension in China is only about 10%,which is relatively low and urgently needed to be improved.Although the guidelines recommend a combination of two standard-dose antihypertensive drugs,some patients require larger doses.CCB does not have absolute contraindications and is the most commonly used antihypertensive drug in China.The dose and effect of CCB have a good correlation.The common drug nifedipine GITS in CCB has 30mg and 60mg two dosage forms,there is evidence of 60mg dosage form efficacy and safety abroad,but the evidence in our country is still relatively small.The problem to be solved in this study is to assess the efficacy and safety of nifedipine GITS 60mg in the treatment of hypertensive patients who do not meet the threshold dose of monotherapy.Method:This trial is a prospective,open-label,single-group,8-week trial.In screening period of 1-2 weeks,we screened patients who had previously received antihypertensive monotherapy for at least 4 weeks with uncontrolled blood pressure by ABPM(Ambulatory Blood Pressure Monitoring)with the mean BP(blood pressure)set as baseline.The MSBP(mean sitting blood pressure)measured on the day before treatment was set as MSBP baseline.All the previous monotherapy of subjects discontinued,with the previous drug changed to nifedipine GITS 60 mg once daily at 9 o’clock in the morning for 8 weeks.Follow-ups are carried out in the screening period and the 1st,2nd,4th,8th week of the treatment period.Mean sitting blood pressure measuring,physical examination,and recording adverse events are made on every follow-up.The mean sitting blood pressure and ABPM acquired at the 0th week of the treatment period are set as the BP baseline.At the screening period and the 8th week,blood samples and urine samples were collected from the subjects for laboratory examination.Finally,the data were statistically analyzed to explore the effectiveness and safety of this drug:the change of MSSBP and MSDBP from the baseline at the 8th week,and the MSSBP compliance rate as the primary efficacy end point,and the MSSBP and MSDBP at the same time,the blood pressure response rate,and the MSSBP compliance time as the secondary Efficacy end point,to explore the effectiveness of drugs;the adverse reaction rate and severity,the heart rate,blood pressure coefficient of variation,laboratory test data and other changes relative to baseline at the 8th week as a safety indicator to explore drug safety.Results:A total of 60 subjects entered the trial through the screening period,and finally 56 people completed the trial.The completion rate was 93.33%.The mean sitting systolic pressure(MSSBP)decreased from(150.66±5.57)mmHg to(129.46± 10.53)mmHg,and the average sitting DBP from(88.29±7.36)mmHg to(79.52±7.68)mmHg after eight weeks of treatment.The difference was statistically significant(p<0.01).At the 8th week,there were 36 subjects with MSSBP declining≧10 mmHg and MSDBP declining≧ = 5 mmHg,with a BP response rate of 64.29%.The MSSBP compliance rate of 13 subjects with diabetes was 46.15%(MSSBP<130 mmHg)at the 8th week;and that of the other 43 subjects was 86.05%(MSSBP<140 mmHg);The total compliance rate was 76.79%.There were 45 subjects with MSDBP<90 mmHg(<80 mmHg for subjects with diabetes),accounting for 80.36%of the total.A total of 39 subjects having MSSBP and MSDBP met the target at the same time(for subjects with diabetes,MSSBP<130 mmHg and MSDBP<80 mmHg;for other subjects MSSBP<140 mmHg and MSDBP<90 mmHg),the compliance rate was 69.64%.At Week 8,the mean SBP and mean DBP were significantly reduced from baseline at 24 h,daytime(from 06:00 to 22:00),and at night(from 22:00 to 06:00)as assessed by ABPM(p<0.01).During the trial,four subjects developed edema of the lower extremities and withdrew from the trial,and the edema of the lower extremities naturally disappeared after discontinuation.The incidence of adverse reactions was 6.67%.All mild adverse reactions.At week 8,the drop of SBP and DBP at night,as well as coefficient of variation on 24h,daytime and night were assessed by ABPM,with no significant change from baseline(p>0.05).The number of subjects with dipper blood pressure(nighttime blood pressure decreased by 10%to 20%),non-dipper blood pressure(night blood pressure drop rate<10%),and anti-dipper blood pressure(night blood pressure decrease rate<-5%)have changed,without significant difference by chi-square test(p>0.05).In the 8th week,the office pulse rate was(77.54±6.95)beats/min,which was higher than the baseline pulse rate(73.25±7.47)beats/min.The difference was statistically significant(p<0.01).The mean value of pulse rate acquired from ABPM for 24 h,daytime and nighttime at week 8 was significantly higher than that at baseline(p<0.05).Conclusion:The blood pressure lowering effect of nifedipine GITS 60mg,especially for systolic blood pressure,is significant and stable.Monotherapy of this drug can make most hypertensive patients reach the BP target.Although there is no significant difference in the ability to reduce blood pressure in patients with or without diabetes,hypertensive patients with diabetes can hardly reach the BP target which is lower than others with monotherapy of this drug only.Except for a small number of peripheral edema and mildly elevated heart rate,there were no other adverse reactions.