Treatment of mild-to-moderate hypertension with calcium channel blockers: a multicentre comparison of once-daily nifedipine GITS with once-daily amlodipine

SUMMARY

Background: Hypertension is one of the most important causes of cardiovascular disease, and treatment of hypertension leads to a significant reduction in cardiovascular mortality and morbidity. Although calcium channel blockers are regarded as an important part of the therapeutic armamentarium against cardiovascular diseases, and are among the most frequently prescribed antihypertensive medications, concern has been aroused about these drugs, particularly the short-acting dihydropyridine derivatives. However, the value of nifedipine GITS (Adalat-Crono), the long-acting dihydropyridine, is in need of being re-established.

Objective:To compare the effectiveness, safety and tolerability of once-daily nifedipine and amlodipine treatment in patients with mild-to-moderate essential hypertension.

Design: Randomised multicentre trial with an open comparison of treatments for 12 weeks, with a preceding placebo run-in period of 2 weeks (patients on beta-blockers at the time of enrolment entered a mandatory 2-week wash-out period before being allowed in the placebo run-in period; this wash-out period was one week for patients using any antihypertensive medication other than beta-blockers).

Setting: Nine centres (all university hospitals) in Turkey.

Patients: 155 patients with essential hypertension (diastolicblood pressure 95-109?mmHg).

Interventions: Initial treatment (step 1) consisted of 30mg nifedipine GITS (n?=?76; (Adalat-Crono tablets), or 5mg amlodipine (n?=?79; Norvasc* 5-mg tablets), either administered once daily, as a morning dose, or if the blood pressure was not below 140/90?mmHg, or the reduction in diastolic blood pressure was lower than 10?mmHg after a treatment period of 6 weeks, the dose was increased (Step 2) to 60?mg once daily in the nifedipine group, or 10?mg once daily in the amlodipine group.

Main efficacy parameter: Diastolic blood pressure at trough after 12 weeks of active compound therapy adjusted to baseline.

Results: After 12 weeks of treatment, the mean diastolic blood pressure was 83.1 and 81.9?mmHg, in the nifedipine and amlodipine groups, respectively (p?=?0.436). The mean decrease in systolic blood pressure (28.5?±?11.9 and 28.2?±?11.2?mmHg in the nifedipine and amlodipine groups, respectively) and the mean decrease in diastolic blood pressure (16.4?±?7.0 and 17.5?±?6.9?mmHg in the nifedipine and amlodipine groups, respectively), as well as the responder rates (88.1% and 92.1%, in the nifedipine and amlodipine groups, respectively) were comparable at the end of the study. No significant differences between groups were detected in the efficacy parameters assessed in this study. Both drugs were well tolerated. The overall incidence of adverse events was 7.9% in the nifedipine group and 10.1% in the amlodipine group. However, more patients discontinued treatment prematurely in the amlodipine group (13 patients; 19.7%), than in the nifedipine group (four patients; 5.6%).

Conclusions: The results of this study demonstrated that once-daily nifedipine in GITS formulation and amlodipine are comparably safe and effective treatment options in patients with mild-to-moderate essential hypertensi on.     

Combination of lisinopril and nifedipine GITS increases blood pressure control compared with single drugs in essential hypertensive patients

The present study was designed to evaluate the effect of combination therapy using the angiotensin-converting enzyme-inhibitor lisinopril and the dihydropyridine calcium antagonist nifedipine GITS on the degree and homogeneity of 24-hour blood pressure reduction in essential hypertensive patients. After a 4-week placebo run-in period, 51 patients (mean age, 54.4 +/- 9.4 years) with essential hypertension and clinic diastolic blood pressure between 105 and 115 mm Hg were randomized to 4-week treatment with lisinopril (20 mg), nifedipine GITS (30 mg), or their combination according to a multicenter, randomized, double-blind, crossover study. Trough clinic blood pressure and 24-hour ambulatory blood pressure were measured at the end of the run-in period and after 4 weeks of treatment. In addition to clinic and 24-hour average blood pressure reduction, the trough-to-peak ratio and the smoothness index, a new measure for the homogeneity of blood pressure reduction, were also calculated. Although both lisinopril and nifedipine GITS produced a significant reduction in clinic and 24-hour average blood pressure values, the reduction obtained with the combination was significantly (P < 0.001) greater. Moreover, the combination therapy increased (P < 0.01) the smoothness index as compared with each single drug for both systolic (lisinopril, 1.02; nifedipine GITS, 1.1; combination, 1.76) and diastolic (lisinopril, 0.98; nifedipine GITS, 0.87; combination, 1.54) blood pressure values, whereas trough-to-peak ratio values (expressed as median) for systolic (lisinopril, 0.41; nifedipine GITS, 0.52; combination, 0.55) and diastolic (lisinopril, 0.35; nifedipine GITS, 0.40; combination, 0.49) blood pressure values were not significantly increased by the combination therapy. Thus, antihypertensive treatment with the combination of lisinopril and nifedipine GITS is more effective and balanced over the 24 hours than the combination components administered alone, confirming that the smoothness index is superior to the trough-to-peak ratio in assessing homogeneity of pharmacologic blood pressure reduction.     

Felodipine extended release in mild to moderate hypertension

A multi-centre study was carried out to examine the antihypertensive effect and adverse event profile of felodipine in an extended-release (ER) formulation given once daily as monotherapy. Doses of 5 mg, 10 mg or 20 mg felodipine ER were compared with placebo in 183 patients with mild or moderate hypertension. All antihypertensive medication was discontinued on entering a 4-week placebo run-in period. If, at the end of the run-in period, supine diastolic blood pressure was in the range greater than 95 less than 120 mmHg, patients were randomly allocated to double-blind treatment with felodipine, 5 mg, 10 mg or 20 mg, or placebo, to be taken once daily for 4 weeks. Supine and standing blood pressure, heart rate and body weight were measured every 2 weeks during the trial. Assessments were made 24 hours after intake of the study drug. Adverse events were recorded at each review. Over the 4-week treatment period, a dose-related decrease in supine diastolic blood pressure was observed, this reduction occurring already during the first 2 weeks of active treatment. In the placebo group and the felodipine 5 mg, 10 mg and 20 mg groups, supine blood pressure (systolic/diastolic) decreased by 7/6 mmHg, 9/8 mmHg, 12/10 mmHg and 14/11 mmHg, respectively. Supine diastolic blood pressure reduction in the felodipine 10 mg group and both systolic and diastolic blood pressure reductions in the 20 mg group were significantly greater than with placebo. Standing diastolic blood pressure reduction was significantly greater in all three dose groups on felodipine compared with placebo.(ABSTRACT TRUNCATED AT 250 WORDS)     

Is initial dose titration of amlodipine worthwhile in patients with mild to moderate hypertension?

Amlodipine, a dihydropyrimidine calcium antagonist, is effective in the treatment of patients with mild to moderate hypertension at doses of 5-10 mg daily. The aim of the study reported here was to determine whether an early increase in dosage of amlodipine provided an advantage in terms of antihypertensive effect. This was a single-blind, randomised study in 115 patients with mild to moderate hypertension (diastolic blood pressure 95-114 mmHg) conducted at 10 centres with two parallel groups. Group I received amlodipine 5 mg once daily for the entire 10-week treatment period, while group II received amlodipine 5 mg once daily for two weeks, with the option to increase the dose to 10 mg once daily were the diastolic blood pressure to exceed 90 mmHg. The dose was increased in 40% of group II patients (20/50). Diastolic and systolic blood pressure decreased steadily until the end of the sixth week of treatment in both groups, with no statistically significant difference between the groups. The response rate (diastolic blood pressure < or = 90 mmHg) at the end of treatment was 84% in both groups. Because there is no advantage in an early increase in dosage of amlodipine in terms of antihypertensive effect, a dose increase should not be considered until after six weeks of treatment at 5 mg once daily.     

Comparison of doxazosin GITS and standard doxazosin in the treatment of high blood pressure

OBJECTIVE: To examine (1) the relative therapeutic equivalence of 4 mg doxazosin gastrointestinal therapeutic system (DOX GITS) and 4 mg doxazosin standard (DOX-S4) and (2) the efficacy and safety of 4 mg DOX GITS versus 2 mg doxazosin standard (DOX-S2). PATIENTS: Male or female patients aged 18-80 diagnosed with mild-to-moderate essential hypertension (sitting diastolic blood pressure (DBP) 95-110 mmHg and systolic blood pressure (SBP) < 180 mmHg) were randomized into the study. METHODS: This double-blind, parallel, 9-week trial compared DOX-GITS with doxazosin standard (DOX-S) in 310 hypertensive patients. Following a 2-week placebo run-in phase, patients were randomized to receive DOX-GITS at 4 mg/d or DOX-S at 2 or 4 mg/d. DOX GITS dosage remained unchanged at 4 mg throughout the study. Titration in the DOX-S groups was initiated at Week 0 with 1 mg DOX-S and increased to 2 mg DOX-S at Week 1. Dosage in the DOX-S4 group was increased to 4 mg DOX-S at Week 3. Therapeutic equivalence was measured by the change from baseline in sitting diastolic BP (DBP). Efficacy was assessed using the change from baseline for all blood pressure measures. Safety analysis included evaluation of laboratory tests at clinic visits and adverse events (AEs). RESULTS: Therapeutic equivalences between DOX GITS and DOX-S4 and DOX-S2 were established at all study visits except for a significant difference in favor of DOX GITS at Week 1 (p = 0.019) when the dose of DOX-S was 1 mg. All groups had a significant decrease in BP at all study visits compared with baseline. The proportion of patients who reached goal sitting DBP (< 90 mmHg) was similar among the three treatment groups, except at Week 1, when more patients in the DOX GITS group had obtained the goal compared with those in the DOX-S2 group (40.6% vs. 22.3%; p = 0.005). The proportion of patients who reached sitting SBP (< 140 mmHg) goal was similar among groups. AE profiles among the groups were similar. CONCLUSION: DOX GITS was as effective as DOX-S in patients with mild-to-moderate hypertension. The improved pharmacokinetic profile of the GITS formulation compared with the standard formulation allows a therapeutic dose to be delivered earlier and without dose titration. Both formulations of doxazosin were well tolerated.     

Blood pressure reduction and tolerability of amlodipine versus nifedipine retard in Chinese patients with type 2 diabetes mellitus and hypertension: a randomized 1-year clinical trial

OBJECTIVE: In this 1-year clinical study, we compared the efficacy and tolerability of amlodipine and nifedipine retard in 64 Chinese Type 2 diabetic patients with hypertension. SUBJECTS AND METHODS: There were 25 (39.1%) men and 39 (60.9%) women with mean age 60.7+/-9.9 years. Thirty-four patients were randomized to receive amlodipine 5 mg daily and 30 to receive nifedipine retard 20 mg twice daily. The daily dose of amlodipine and nifedipine retard was increased from 5 mg to 10 mg daily and 20 mg to 40 mg twice daily, respectively, if sitting BP > 140/90 mmHg. RESULTS: Of the 64 patients, 9 dropped out early because they experienced adverse effects related to the drugs. If all treatment-related adverse effects were taken into account, 6 (19.4%) patients were from the amlodipine group and 14 (53.8%) from the nifedipine group (p = 0.011). After 1 year, 48 patients finished the study, 28 were on amlodipine and 20 were on nifedipine retard. Of the 28 patients from the amlodipine group, 11 (39.3%) required additional antihypertensive agents. Of the 20 patients from the nifedipine group, 5 (25%, p value: NS, comparing the 2 groups) required additional antihypertensive agents. Both groups showed similar and significant reduction in blood pressure from Week 6 to Week 52. CONCLUSION: Both amlodipine and nifedipine retard are relatively safe and useful in the treatment of hypertension in Chinese Type 2 diabetic patients. Nifedipine retard, when compared to amlodipine, showed significantly more adverse effects and these may hamper long-term compliance.     

Effects of the combination of low-dose nifedipine GITS 20 mg and losartan 50 mg in patients with mild to moderate hypertension

Most hypertensive patients require more than one medication to effectively control elevated blood pressure (BP) values. This multicenter, randomized, double-blind study was aimed at testing the efficacy and safety of the combination of low-dose nifedipine GITS 20 mg/ losartan 50 mg compared with either monotherapy in patients with grade 1 to 3 hypertension over an eight-week period. Of 352 patients enrolled in the study, 300 were randomized. All the three treatments lowered elevated BP without clinically relevant changes in heart rate. All the three treatments lowered mean 24-hour diastolic BP: nifedipine GITS/losartan -10.6 mm Hg, losartan -5.4 mm Hg, nifedipine GITS 20 mg -8.0 mm Hg. There was a statistically significant difference of diastolic BP change between patients receiving losartan compared with those receiving combination treatment (P < 0.05). Diastolic BP trough-to-peak ratio and smoothness index were highest in the patient group receiving combination therapy (70%). Nifedipine GITS monotherapy had the highest systolic BP trough-to-peak ratio of all treatment arms (78%) and higher diastolic BP trough-to-peak ratio and smoothness index than losartan monotherapy. All treatments were safe. These data provide evidence that in hypertensive patients combination of nifedipine GITS 20 mg and losartan 50 mg improves control of systolic and diastolic BP compared with either monotherapy.     

Comparison of once-daily nifedipine controlled-release with twice-daily nifedipine retard in the treatment of essential hypertension

AIMS: Nifedipine is a short-acting calcium antagonist formulated into several different oral preparations, each of which may have different effects on haemodynamics and autonomic nervous function. We compared the effects of nifedipine controlled-release (CR) and nifedipine retard on 24-h blood pressure, heart rate, rate-pressure product, and power spectral measures of heart rate variability in patients with essential hypertension. METHODS: After 4 weeks of a drug-free period, 25 patients were randomized to receive either once-daily treatment with nifedipine CR (20-40 mg daily; 12 patients) or twice-daily treatment with nifedipine retard (20-40 mg daily; 13 patients) for 12 weeks. The ambulatory blood pressure, heart rate, and ECG R-R intervals were measured during a 24-h period using a portable recorder (TM-2425) at the end of the drug-free and the treatment periods. A power-spectral analysis of R-R intervals was performed to obtain the low-frequency (LF) and high-frequency (HF) components. RESULTS: Nifedipine CR and nifedipine retard reduced 24-h blood pressure significantly by 15.9 +/- 3.2 (SE)/8.7 +/- 1.4 mmHg and by 10.9 +/- 2.8/9.4 +/- 1.7 mmHg, respectively, after the 12-week treatment. Nifedipine CR did not change the 24-h heart rate significantly, while nifedipine retard increased it significantly by 3.9 +/- 2.1 beats min(-1). Nifedipine CR produced a significant reduction in rate-pressure product throughout a 24-h period, while nifedipine retard did not change the rate-pressure product significantly. In addition, nifedipine retard significantly decreased the 24-h and daytime average values of the LF and HF components, while nifedipine CR affected the nighttime LF component alone and did not change the HF component throughout a 24-h period. CONCLUSIONS: These results demonstrate that both nifedipine CR and nifedipine retard are effective as antihypertensive agents, but nifedipine CR has less influence on the autonomic nervous system and heart rate than nifedipine retard.     

硝苯地平与氨氯地平分别联合阿托伐他汀钙治疗冠心病伴高血压的效果比较

目的:研究硝苯地平与氨氯地平分别联合阿托伐他汀钙治疗冠心病伴高血压的效果。方法:将2017年1月至2020年1月大余县人民医院收治的80例冠心病伴高血压患者依据随机数表法分为对照组和观察组,每组40例。对照组使用硝苯地平控释片联合阿托伐他汀钙片治疗,观察组使用苯磺酸氨氯地平片联合阿托伐他汀钙片治疗。对比分析两组患者治疗6周前后血压变化及血脂指标改善效果、心绞痛发作次数及持续时间。研究两组患者的不良反应发生情况。结果:治疗6周后,两组TC、LDL-C、TG、收缩压及舒张压水平均降低,且观察组低于对照组;两组HDL-C水平均升高,且观察组水平高于对照组,差异有统计学意义(P<0.05)。两组不良反应发生率对比,差异无统计学意义(P>0.05)。结论:冠心病伴高血压患者采用阿托伐他汀钙联合氨氯地平治疗能促进血压降低、血脂改善,对患者预后有积极影响,较使用硝苯地平联合阿托伐他汀钙治疗效果好。     

阿罗洛尔与氨氯地平治疗糖尿病高血压的随机对照研究

目的验证阿罗洛尔在治疗糖尿病合并高血压病人应用中临床有效性和安全性。方法18～75 a的糖尿病合并高血压者83例,随机分为阿罗洛尔组(n=41)和氨氯地平组(n=42),分别服用阿罗洛尔(5～15 mg,bid)或氨氯地平(5～10 mg,qd),观察12 wk。每4 wk随访一次,观察血压、空腹血糖,用药前后测定糖化血红蛋白(HbA1c)及各项安全性指标。结果治疗后,2组血压都明显下降,组间无明显差异(P>0.05)。高血压治疗前后,2组的空腹血糖及HhA1c均无统计学差异(P>0.05)。治疗12 wk后,阿罗洛尔组心率由(78±6)次·min~(-1)下降至(69±9)次·min~(-1),与氨氯地平组相比有统计学差异。阿罗洛尔组总有效率为85%,氨氯地平组为93%,无统计学差异(P>0.05)。结论阿罗洛尔能有效地降低糖尿病合并高血压痛病人的收缩压和舒张压,对糖代谢及脂代谢无不良影响,对糖尿病合并的高血压病人,尤其是对伴有交感神经兴奋者是一个安全有效的降压药物。     

Efficacy and tolerability of amlodipine in patients with mild-to-moderate hypertension.

Twenty-one subjects with mild or moderate systemic hypertension were treated for 12 weeks with amlodipine, a new calcium antagonist of the dihydropyridine group. Initial amlodipine dose was 5 mg once daily, but the dose could be increased after four or eight weeks to 10 mg once daily if diastolic blood pressure was not less than or equal to 90 mmHg (12.0 kPa). At the end of the study, a substantial reduction of systolic blood pressure (20 mmHg-2.7 kPa-from baseline) and diastolic blood pressure (14 mmHg-1.9 kPa-from baseline) was observed. Statistically significant changes in systolic and diastolic blood pressure were produced after four weeks of treatment. There were no statistically significant changes in heart rate throughout the study. Six patients with mild and five patients with moderate hypertension became normotensive after amlodipine treatment (64%). Two with mild hypertension finished the trial without change in hypertensive status, and four with initially moderate hypertension changed to mild at the end of the study. Only one patient dropped out due to an adverse reaction, two adverse events were rated severe, but did not require discontinuation. Overall impressions of efficacy were excellent or good in two-thirds of cases and poor in 10%; overall impressions of toleration were excellent or good in 71% of cases and poor in 10%. It is concluded that amlodipine is useful and well tolerated in patients with mild or moderate hypertension.     

Clinical evaluation of amlodipine, a new long-acting calcium antagonist, in mild and moderate hypertension.

The antihypertensive efficacy of amlodipine was studied in 22 patients (16 female, six male) with mild-to-moderate hypertension. Following an initial two-week placebo run in, patients with a sitting diastolic blood pressure in the range 95-115 mmHg (12.7-15.3 kPa) began the 12-week active treatment phase with amlodipine at a dose of 5 mg once daily. If the sitting diastolic blood pressure was not reduced to less than or equal to 90 mmHg (12.0 kPa) after four weeks' treatment, the amlodipine dose could be adjusted to 10 mg once daily. The final four weeks of active treatment comprised of a maintenance phase during which the dose, which had produced the desired therapeutic response in each patient, remained constant. At the end of the trial, 18 patients (85.7%) were classified as therapeutic successes (reduction in diastolic blood pressure to less than or equal to 90 mmHg [12.0 kPa] with a greater than or equal to 5 mmHg [0.7 kPa] from baseline values or a greater than or equal to 10 mmHg [1.3 kPa] decrease from baseline). Of these patients, 16 received the 5 mg dose throughout the study and only two required an increase to 10 mg once daily. Patients generally tolerated amlodipine treatment well.     

硝苯地平控释片与缓释片治疗高血压疗效比较

目的 探讨硝苯地平缓释剂(SR)与硝苯地平控释剂(GITS)治疗原发性高血压的临床疗效.方法 将160例原发性高血压2级患者随机分为SR组和GITS组.SR组给予硝苯地平缓释片20 mg,2次/d;GITS组给予硝苯地平控释片30 ng,1次/d.两组均治疗8周,并对所有患者进行动态血压监测(ABPM),观察治疗前后两组患者的24 h平均血压、心率、谷/峰(T/P)值的变化及不良反应等情况.结果 治疗后GITS组收缩压(SBP)、舒张压(DBP)的T/P比值分别为68.5％、74.6％,均高于SR组的57.2％、61.1％(x2=6.32、7.05,均P＜0.05);GITS组心率低于SR组(t=4.17,P＜0.05);两组不良反应差异无统计学意义(x2=0.16,P＞0.05).结论 SR与GITS均能有效降压,但GITS更高效、平稳、安全,对心率的影响小.     

骨化三醇治疗轻中度高血压伴维生素D缺乏患者的临床观察

目的观察骨化三醇对轻中度原发性高血压伴维生素D缺乏患者干预治疗的有效性和安全性。方法选取2012年9月至2013年3月在新疆医科大学第一附属医院高血压科初诊的103例轻中度原发性高血压伴维生素D缺乏患者,随机分为骨化三醇联合硝苯地平控释片治疗组(观察组n=53例)和硝苯地平控释片治疗组(对照组n=50例),监测患者治疗前、治疗后4周、12周和24周血清25-羟维生素D、血压、心率和肾素-血管紧张素-醛固酮水平、血钙、血磷、尿素、肌酐的变化。结果治疗后,两组患者25-羟维生素D水平较基线水平明显升高(P<0.01),收缩压和舒张压明显下降(P<0.01),观察组肾素较基线水平降低明显(P<0.05)。与对照组比较,观察组治疗后12周、24周25羟-维生素D水平明显升高,肾素、血管紧张素水平则明显降低(均P<0.05);另外,观察组治疗后24周收缩压下降较对照组明显,差异有统计学意义(P<0.05)。结论补充骨化三醇可以有效降低轻中度原发性高血压伴维生素D缺乏患者血压,尤其收缩压下降更明显,可能与维生素D水平升高抑制RAS系统活性有关。     

Comparison of monotherapy with irbesartan 150 mg or amlodipine 5 mg for treatment of mild-to-moderate hypertension.

OBJECTIVE. The primary objective of this study was to compare the antihypertensive efficacy of the angiotensin II receptor blocker irbesartan 150 mg and the calcium channel blocker amlodipine 5 mg in the treatment of patients with seated diastolic blood pressure (DBP) 95-110 mmHg. DESIGN. Multicentre, randomised, double-blind, comparative pilot study. METHODS. Subjects were 18-65 years of age, with DBP 95-110 mmHg, and of non-African American origin. Following a three week, single-blind, placebo lead-in period, 181 subjects were randomised in a 1:1 ratio to receive once-daily irbesartan 150 mg (n=89) or amlodipine 5 mg (n=92) for four weeks. Trough (24+/-3 hours post-dosing) BP measurements were obtained at baseline and at Weeks 2 and 4 under standardised, controlled conditions. Response was defined as DBP <90 mmHg or a reduction from baseline of 10 mmHg. RESULTS. After four weeks of treatment, the mean (+/-SE) decrease from baseline in DBP was 9.4+/-0.6 mmHg in the irbesartan group vs. 9.6+/-0.6 mmHg in the amlodipine group (p=0.806). The mean decrease from baseline in seated systolic BP was 12.2+/-1.0 mmHg in the irbesartan group vs. 12.0+/-1.0 mmHg in the amlodipine group (p=0.885). Overall, 62% of subjects in the irbesartan group and 63% in the amlodipine group had a response (p=0.609), and 54% and 56% of patients (p=0.596), respectively, had their DBP normalised (<90 mmHg). Adverse events were reported by 21.3% of patients receiving irbesartan and 20.7% receiving amlodipine. Conclusions. Irbesartan 150 mg demonstrated comparable efficacy to amlodipine 5 mg, thereby confirming its value as an antihypertensive treatment option in non-African American patients with DBP 95-110 mmHg.     

盐酸马尼地平片治疗轻中度原发性高血压的疗效和安全性

目的评价盐酸马尼地平片治疗轻中度原发性高血压的疗效和安全性。方法用随机双盲对照研究,设苯磺酸氨氯地平片为对照药物。随机入选病人共60例但脱落1例完成59例,马尼地平组30例,苯磺酸氨氯地平组29例。2组每天分别服用盐酸马尼地平片10～20 mg和苯磺酸氨氯地平片5～10 mg,两药均为每日1次,共8周。结果治疗8周后,盐酸马尼地平片组收缩压和舒张压分别下降(8.70±13.11)mmHg和(7.90±5.54)mmHg,苯磺酸氨氯地平片组分别下降为(13.28±13.40)mmHg和(11.66±7.66)mmHg,与治疗前相比均有统计学意义(均P<0.05)。2组均无严重不良事件发生。结论盐酸马尼地平片每日服用1次,可显著地、平稳地降低血压,患者耐受性较好。     

贝那普利／氨氯地平复方制剂治疗轻中度高血压临床疗效分析

目的通过实际使用氨氯地平与贝那普利复方制剂治疗轻中度高血压,探讨该复方制剂的有效性以及不良反应情况。方法将中度高血压患者分为A、B两组,A组给予贝那普利／氨氯地平复方制剂5mg,每日1次;B组给予氨氯地平5mg,每日1次。结果两组患者治疗4周及8周后收缩压、舒张压均较治疗前显著下降（P〈0．05或〈0．01）,但治疗8周后A组收缩压、舒张压下降程度较B组更明显（P〈0．05）。结论使用贝那普N／氨氯地平复方制剂治疗轻中度高血压是可行的,而且临床效果显著,具有不良反应少等优点,利大于弊。     

血管紧张素Ⅱ受体拮抗剂、血管紧张素转换酶抑制剂、钙拮抗剂对原发性高血压患者血尿酸水平的影响

目的观察血管紧张素Ⅱ受体拮抗剂(AngiotensinⅡreceptor antagonist,ARB)、血管紧张素转换酶抑制剂(Angiotensin converting enzyme inhibitor,ACEI)与钙离子通道拮抗剂(Calcium antagonist,CCB)对高血压患者血尿酸水平的影响。方法入选原发性高血压患者582例,随机分为氯沙坦钾组、替米沙坦组、硝苯地平控释片组、苯磺酸氨氯地平组、培哚普利组、盐酸贝那普利组及对照组,观察患者治疗前及治疗后血尿酸及血压的变化。结果经过8周治疗,与对照组相比,氯沙坦钾组、替米沙坦组、硝苯地平控释片组、培哚普利组、盐酸贝那普利组血尿酸水平均明显下降(P<0.05);与用药前相比,各组患者血压均得到明显控制(P<0.05)。结论对于原发性1~2级高血压患者,ARB类的氯沙坦钾、替米沙坦、ACEI类培哚普利、盐酸贝那普利、CCB类硝苯地平控释片均能降低患者血尿酸水平。     

硝苯地平控释片联合贝那普利治疗老年高血压疗效观察

目的观察硝苯地平控释片联合贝那普利治疗老年高血压临床疗效。方法老年高血压患者80例给予硝苯地平控释片及贝那普利口服治疗。治疗8周后比较治疗前后血压指标,评估其临床疗效。结果治疗4周后总有效率为73.75%,治疗8周后总有效率为85.00%。治疗4、8周后,血压下降情况与治疗前比较差异均有统计学意义(P<0.05或P<0.01)。80例患者发生刺激性干咳3例,头痛2例,踝关节水肿3例。结论硝苯地平控释片联合贝那普利治疗老年高血压疗效确切、安全性高、不良反应少,值得推广应用。     

Effect of doxazosin gastrointestinal therapeutic system on patients with uncontrolled hypertension: the ASOCIA Study

OBJECTIVE: To evaluate extended-release doxazosin gastrointestinal therapeutic system (GITS) as add-on therapy in patients with treated, but uncontrolled hypertension. METHODS: A 16-week, open, noncomparative, multicenter, prospective study of patients with hypertension (> or = 140/> or = 90 mm Hg). Doxazosin GITS 4 mg/d was added to entry medication and increased to 8 mg/d at Week 4 in cases of inadequate blood pressure (BP) control. RESULTS: A total of 3631 patients (40% women) with mean age of 62.4 +/- 0.2 years were included. Proportion of patients reaching goal (< 140/< 90 mm Hg) after 4 weeks of add-on therapy with doxazosin GITS was 39% and increased to 61% at Week 16. Systolic and diastolic BP (mean +/- SEM) decreased, respectively, from 161.6 +/- 0.2 and 95.1 +/- 0.1 mm Hg at baseline to 142.2 +/- 0.2 and 84.1 +/- 0.1 mm Hg at Week 4 (P < 0.0001) and 136.8 +/- 0.2 and 80.6 +/- 0.2 mm Hg at Week 16 (P < 0.0001). Adverse events occurred in 108 patients (3.0%), with 57 (1.6%) related to the study treatment. In 17 patients (0.5%), serious adverse events were described, but only one was related to the study drug. CONCLUSIONS: Doxazosin GITS as add-on therapy achieved target blood pressure and was well tolerated in patients with hypertension uncontrolled by previous regimens. Doxazosin GITS efficacy and tolerability was achieved in combination with all classes of antihypertensives tested.