Effects of valsartan or ramipril addition to amlodipine/hydrochlorothiazide combination on left ventricular mass in diabetic hypertensive patients with left ventricular hypertrophy

Objective: The objective of this study was to compare valsartan or ramipril addition to amlodipine + hydrochlorothiazide (HCTZ) on blood pressure (BP) and left ventricular hypertrophy (LVH) in hypertensive diabetic patients with LVH.

Research design and methods: 293 patients were treated with amlodipine 10 mg + HCTZ 12.5 combination and then randomized to receive valsartan 160 mg or ramipril 5 mg, in addition to the previous therapy, for 1 year.

Main outcome measures: Clinic BP was measured every month; echocardiographic assessments were performed at the end of the placebo period, both before the randomization and after 1-year of triple combination therapy.

Results: Both triple regimens similarly reduced SBP/DBP values (-13.5/10.9 mm Hg in the valsartan group and -13.4/10.4 mm Hg in the ramipril group). Triple combination including valsartan better reduced LVMI (-20.1%, p < 0.001), interventricular septal thickness (IVST) (-20.3%, p < 0.001) and left ventricular posterior wall thickness (PWT) (-16.3%, p < 0.001), compared with triple combination including ramipril (-14%, p < 0.01; -16.2%, p < 0.001 and -9%, p < 0.01, respectively); the difference between treatments being statistically significant (p < 0.05). Triple combination with valsartan gave a greater increase of E/A ratio (p < 0.05 between groups).

Conclusions: Valsartan addition to dual therapy with amlodipine + HCTZ was more effective than ramipril addition in reducing LVH.     

Effects of valsartan compared with enalapril on blood pressure and cognitive function in elderly patients with essential hypertension

Objective This prospective, randomised, open-label, blinded-endpoint study was to compare the effects of the angiotensin II (Ang II) AT1 receptor antagonist valsartan with those of the ACE inhibitor enalapril on blood pressure (BP) and cognitive functions in elderly hypertensive patients.Methods One hundred and forty-four patients aged 61–80 years with mild to moderate essential hypertension (DBP 95 mmHg and 110 mmHg at the end of a 2-week placebo run-in period) were randomly assigned to once daily (o.d.) treatment with valsartan 160 mg (n=73) or enalapril 20 mg (n=71) for 16 weeks. The patients were examined every 4 weeks during the study, with pre-dose BP (standard mercury sphygmomanometer, Korotkoff I and V) and heart rate (pulse palpation) being recorded at each visit. Cognitive function was evaluated at the end of the wash-out period and after 16 weeks of active treatment by means of five tests (verbal fluency, the Boston naming test, word list memory, word list recall and word list recognition).Results Both valsartan and enalapril had a clear antihypertensive effect, but the former led to a slightly greater reduction in SBP/DBP at 16 weeks (18.6±4.6/13.7±4.0 mmHg vs 15.6±5.1/10.9±3.9 mmHg; P<0.01). Enalapril did not induce any significant changes in any of the cognitive function test scores; valsartan significantly increased the word list memory score (+11.8%; P<0.05 vs baseline and P<0.01 vs enalapril) and the word list recall score (+18.7%; P<0.05 vs baseline and P<0.01 vs enalapril), but not those of the other tests.Conclusion These findings indicate that, in elderly hypertensive patients, 16 weeks of treatment with valsartan 160 mg o.d. is more effective than enalapril 20 mg o.d. in reducing BP, and (unlike enalapril) improves some of the components of cognitive function, particularly episodic memory.     

Attaining United States and European Guideline LDL-C Levels with Simvastatin in Patients with Coronary Heart Disease (the GOALLS Study)

SUMMARY

Objectives: The primary objective was to assess the effects of rilmenidine monotherapy and in combination with perindopril on blood pressure (BP) in patients assessed with grade 1 or 2 essential hypertension. The study also examined the effects of 2-year rilmenidine monotherapy on left ventricular hypertrophy (LVH) and on diastolic function of the left ventricle, along with the effects of rilmenidine on left ventricular mass index in hypertensive patients with no LVH, and the relationship between BP reduction and any change in LVH.

Research design and methods: Mild-to-moderate hypertensive patients (n?=?500) were enrolled in a multicentre 2-year open study and treated with rilmenidine (1-2?mg per day) monotherapy or rilmenidine plus perindopril (2, 4 or 8?mg per day) if control of hypertension was not achieved with rilmenidine monotherapy within 12 weeks. Blood pressure was recorded at regular intervals by the investigators and LVH measured by centralised single-blind echocardiographic reading.

Results: Rilmenidine monotherapy (average dose 1.42?mg) produced a significant decrease in BPfrom the baseline of 163?±?10/100?±?5?mmHg to 134?±?10/86?±?7?mmHg at 1 year and to 136?±?10/84?±?7?mmHg at 2 years (p?2 at 2 years (p?Conclusions: Long-term rilmenidine monotherapy was shown to be efficient in controlling BP and in reducing LVH. The addition of perindopril to rilmenidine monotherapy proved to be effective and well tolerated in those patients who did not respond to rilmenidine alone.     

Efficacy and tolerability of combination therapy with valsartan/hydrochlorothiazide in the initial treatment of severe hypertension

ABSTRACT

Objective: Most patients with severe hypertension are at high risk for cardiovascular events and require prompt blood pressure (BP)-lowering and combination therapy to achieve BP goals. This study evaluated the therapeutic efficacy and tolerability of initial treatment with the combination of valsartan and hydrochlorothiazide (HCTZ) compared with valsartan monotherapy in patients with severe hypertension.

Research design and methods: This was a 6-week, randomized, double-blind, multicenter, forced titration study that compared initial therapy with the combination of valsartan/HCTZ 160/12.5?mg (force titrated to 160/25?mg after 2 weeks and to 320/25?mg after 4 weeks) to monotherapy with valsartan 160?mg (force titrated to 320?mg after 2 weeks and sham-titrated to 320?mg after 4 weeks). Eligible patients were 18–80 years old with severe essential hypertension (mean sitting diastolic BP?≥?110?mmHg and <120?mmHg and mean sitting systolic BP?≥?140?mmHg and <200?mmHg). The Clinical Trial Registry number was NCT00273299.

Main outcome measures: The primary efficacy variable was the rate of BP control (mean sitting BP?<?140/90?mmHg) at Week 4. Tolerability was evaluated by monitoring all adverse events, vital signs, and laboratory tests including hematology and biochemistry.

Results: A total of 608 patients were randomized to either valsartan/HCTZ (n?=?307) or valsartan monotherapy (n?=?301). Significantly more patients achieved overall BP control (<140/90?mmHg) with valsartan/HCTZ compared to monotherapy at Week 4 (primary efficacy variable and timepoint) (39.6% vs. 21.8%; p?<?0.0001) and Week 6 (48.2% vs. 27.2%; p?<?0.0001). Mean reductions in BP at Week 4 were significantly greater for valsartan/HCTZ (30.8/22.7?mmHg vs. 21.7/17.5?mmHg; p?<?0.0001), with further reductions at Week 6. BP control rates were greater with combination therapy as early as Week 2. The overall incidence of adverse events was comparable between the combination therapy (34.9%) and monotherapy (36.7%) treatment groups. A potential limitation of the forced-titration design is that some patients were titrated to higher doses despite having achieved goal BP. This may impact the interpretation of the incidence of dose-dependent adverse events.

Conclusions: Initial therapy with valsartan/HCTZ is effective and well tolerated in patients with severe hypertension.     

Dose-Dependent Antihypertensive Efficacy and Tolerability of Perindopril in a Large, Observational, 12-Week, General Practice-Based Study

Background

Current guidelines recommend the use of full therapeutic dosages of antihypertensive agents, or combination therapy, to improve BP control of hypertensive patients in primary healthcare.

Objective

The aim of this study was to assess the dose-dependent antihypertensive efficacy and safety of perindopril 4 and 8 mg/day in the clinical setting.

Study Design and Setting

The CONFIDENCE study was a prospective, observational, multicenter trial. This was a real-world, clinic-based, outpatient study involving 880 general practitioners/primary-care clinics and 113 specialists in Canada.

Patients

The study included untreated or inadequately managed patients with hypertension (i.e. seated BP≥140/90 mmHg, or ≥130/80 mmHg in the presence of diabetes mellitus, renal disease, or proteinuria) without coronary artery disease (CAD).

Intervention

Treatment consisted of perindopril 4 mg/day, uptitrated to 8 mg/day as required for BP control at visit 2, for 12 weeks. Among the patients already being treated at baseline, perindopril either directly replaced all previous ACE inhibitors or angiotensin II type 1 receptor antagonists (angiotensin receptor blockers [ARBs]), or was added to antihypertensive treatment with calcium channel blockers (CCBs), diuretics, or β-adrenoceptor antagonists (β-blockers).

Main Outcomes Measures

The primary outcomes were the mean changes in BP from baseline following treatment with perindopril 4 and 8 mg/day as well as the proportion of patients achieving BP control (BP <140/90 mmHg, or <130/80 mmHg in diabetic patients) in the intent-to-treat (ITT) population. Secondary analyses included the incidence of adverse events and compliance.

Results

A total of 8298 hypertensive patients entered the study: 56% with newly diagnosed hypertension and 44% with uncontrolled hypertension. Mean SBP/DBP decreased significantly from baseline (152.5 ±10.8/89.5 ±9 mmHg) over 12 weeks (?18.5/?9.7 mmHg; p < 0.001). At visit 2, 23% of patients were uptitrated to perindopril 8 mg/day, which resulted in an additional mean 10.1/5.3 mmHg BP reduction; this reduction was even greater (15.1/5.7 mmHg) among a separate group of severely hypertensive patients (i.e. SBP >170 mmHg or DBP > 109 mmHg at baseline). Target BP was achieved in 54% of the ITT population. Both perindopril 4 mg/day and perindopril 8 mg/day were well tolerated and compliance was high throughout the study.

Conclusion

In the clinical outpatient setting, perindopril was found to be an effective dose-dependent and well tolerated antihypertensive treatment, with good compliance. Uptitration to the full therapeutic dosage of perindopril is an efficient approach for the management of a broad range of hypertensive patients without CAD.     

Metabolic syndrome and its components in relation to brachial-ankle pulse wave velocity in middle-aged Taiwanese males

To evaluate the association of The study is to evaluate the association of metabolic syndrome (MS) and its components on brachial-ankle pulse wave velocity (baPWV), an indirect marker of subclinical atherosclerosis, in middle-aged Taiwanese males. A total of 442 men aged 40 to 65 years were included in this cross-sectional survey. Arterial stiffness was measured using a non-invasive method by baPWV. MS is defined by the presence of ≥ 3 components using the modified National Cholesterol Education Program criteria. The mean baPWV was 1478.6 and 1520.3 cm/sec in normal-weight and overweight adults, respectively. Age, systolic blood pressure (BP), diastolic BP, and fasting blood glucose (FBG) correlated with baPWV levels in normal-weight and overweight males. In multiple logistic regression analysis, after adjusting for potential confounders, MS and its components (such as high BP and high FBG) were significantly associated with abnormal baPWV (≥1400 cm/sec) (p < 0.001). MS and its components are significantly associated with abnormal baPWV in Taiwanese middle-aged males and in addition, high BP was the component of MS most significantly associated with abnormal baPWV.     

脑心通胶囊对缬沙坦在大鼠体内药动学的影响

目的 研究脑心通胶囊对缬沙坦在大鼠体内药动学的影响。方法 建立液相色谱-串联质谱（LC-MS/MS）法检测缬沙坦血药浓度,并进行专属性考察、回收率试验、基质效应、稳定性试验等方法学验证;24只SD雄性大鼠,随机均分为3组,每组8只,分别为缬沙坦组（A组）,缬沙坦和脑心通胶囊单次给药组（B组）,脑心通胶囊给药7 d后,第8天ig给予缬沙坦和脑心通胶囊组（C组）,于给药前及给药后不同时间点由大鼠眼眶静脉丛采血,采用液相色谱-串联质谱（LC-MS/MS）法测定血浆中缬沙坦的质量浓度,DAS2.0软件统计分析,得到缬沙坦的药动学参数。结果 成功建立LC-MS/MS法检测缬沙坦血药浓度方法,方法学验证符合药动学相关规范要求。口服缬沙坦在大鼠体内的药动学属于一室模型。B组C_max明显低于A组,但差异无统计学差异;B组t_1/2显著高于A组（P<0.05）;C组t_max、t_1/2、AUC_0-tn、AUC_0-∞均显著高于A组（P<0.05、0.01）,K_e显著低于A组（P<0.05）;C组AUC_0-tn、AUC_0-∞显著高于B组（P<0.05）。结论 大鼠经连续ig给药脑心通胶囊后,可显著延缓缬沙坦在大鼠体内的达峰时间,并使缬沙坦在大鼠体内的生物利用度升高。     

Valsartan, a new angiotensin II antagonist for the treatment of essential hypertension: efficacy and safety compared to hydrochlorothiazide

Objective: To compare the antihypertensive efficacy of a new angiotensin II antagonist, valsartan, with a reference therapy, hydrochlorothiazide (HCTZ). Methods: In this double-blind study, 167 adult outpatients with mild-to-moderate essential hypertension were randomly allocated in equal number to receive valsartan 80 mg or HCTZ 25 mg for 12 weeks. In patients whose blood pressure (BP) remained uncontrolled after 8 weeks of monotherapy, atenolol 50 mg was added to the initial treatment. Patients were assessed at 4, 8 and 12 weeks. The primary efficacy variable was change from baseline in mean sitting diastolic BP (SDBP) at 8 weeks. Secondary variables included change in sitting systolic BP (SSBP) and responder rates (percentage of patients with SDBP <90 mmHg or drop ≥10 mmHg compared to baseline) at 8 weeks. Results: Valsartan and HCTZ were both effective at lowering diastolic and systolic blood pressure at all time points. Similar falls were seen in both groups with no significant differences between treatments. For the primary variable (decrease in SDBP) there was no significant difference between treatments. For SSBP there was also no significant difference observed. Responder rates at 8 weeks were 74% for valsartan and 62% for HCTZ (P = 0.10). Both treatments were well tolerated, both as monotherapy, and when combined with atenolol 50 mg per day. Conclusion: The data show valsartan 80 mg to be as effective as HCTZ in the treatment of mild-to-moderate hypertension. The results also show valsartan to be well tolerated when taken alone or in combination with atenolol. Received: 7 March 1996 / Accepted in revised form: 29 July 1996     

Efficacy and tolerability of the perindopril/indapamide combination therapy for hypertension: the PRIMUS study*

ABSTRACT

Background: Tight blood pressure (BP) control is required to reduce cardiovascular morbidity and mortality.

Objective: To evaluate the efficacy and tolerability of the first line combination perindopril/indapamide in hypertension in daily practice.

Design and methods: In this prospective, open-label, observational trial, 1892 general practitioners in Germany recruited patients with hypertension (?n = 8023; mean age 59.6 years, 48.1% males, body mass index 27.6?kg/m², systolic BP ≥ 140?mmHg and/or diastolic BP ≥ 90?mmHg) between October 2002 and December 2004. Patients received perindopril 2?mg/indapamide 0.625?mg for 12 weeks. BP measured in the general practice setting, safety, and tolerability were evaluated after 4 and 12 weeks.

Results: At baseline, most patients had moderate to severe hypertension (78%); initial BP was 164.6/95.8?mmHg. At inclusion, 38% of the patients were newly diagnosed hypertensives (mean BP 166.1/97.2?mmHg) and 58% of patients had uncontrolled BP despite preexisting antihypertensive treatment (163.5/94.9?mmHg). Previous treatment consisted of β‐blockers (49.5%), ACE inhibitors (36.4%), calcium-antagonists (29.3%), diuretics (28.8%), AT‐I receptor antagonists (7.1%), and other treatments (8.1%). In the entire study cohort, treatment with perindopril/indapamide significantly decreased systolic BP (27.9?mmHg), diastolic BP (13.7?mmHg), and pulse pressure (14.2?mmHg), compared with baseline (?p < 0.0001); 96% of patients responded to treatment and in 50% of patients BP was normalized (< 140/90?mmHg). Treatment dose was doubled in 9.5% of patients. Similar results were found in various subgroup analyses (newly diagnosed patients, the elderly, and patients with isolated systolic hypertension, additional cardiovascular risk factors, associated diseases, or target organ damage). The most frequent adverse events (< 1% of patients) were dry cough and nausea.

Conclusions: The open-label, observational study PRIMUS, extends the existing evidence that the first line combination treatment of hypertension with perindopril/indapamide is effective, safe, and well tolerated in a representative cross-section of patients with newly diagnosed or pretreated but uncontrolled hypertension in daily practice.     

Effectiveness of perindopril/amlodipine fixed dose combination in everyday clinical practice: results from the EMERALD study

Objective: The rates of blood pressure (BP) control worldwide are discouraging. This study had the purpose of assessing the effectiveness of perindopril/amlodipine fixed dose combination on BP-lowering efficacy, and recording adherence, safety and tolerability during a 4 month treatment period.

Research design and methods: In this multicenter, observational study 2269 hypertensive patients were prospectively enrolled. The data were recorded at 1 and 4 months of treatment.

Main outcome measures and results: Between the first and third visits mean BP values (systolic/diastolic) decreased from 158.4?±?13.6/89.9?±?8.7?mmHg to 130.0?±?7.9/77.7?±?6.3?mmHg (P?<?0.001). The magnitude of BP reduction depended on baseline blood pressure levels and total cardiovascular (CV) risk (P?<?0.001). Patients with grade 1, 2 and 3 showed a BP reduction of 21.9/10.0?mmHg, 34.4/14.2?mmHg and 51.4/21.2?mmHg, accordingly (P?<?0.001). Patients with very high, high, moderate and low added CV risk showed a BP reduction of 35.7/14.9?mmHg, 27.5/12.1?mmHg, 28.6/12.2?mmHg and 14.5/5.8?mmHg respectively (P?<?0.001). Adherence to treatment was high: 98.3% of the sample was taking the treatment “every day” or “quite often”, while only 15 patients (0.7% of the sample) prematurely discontinued treatment. Study interpretation may be limited by the fact that this is an observational study with no comparator and a short follow-up period.

Conclusions: A perindopril/amlodipine fixed dose combination significantly decreases BP levels. The degree of BP reduction is related to baseline BP levels and total CV risk.     

Effect of naproxen and acetaminophen on blood pressure lowering by ramipril,valsartan and aliskiren in hypertensive patients

Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are frequently used for reducing pain and other symptoms in osteoarthritis (OA). NSAIDs have been associated with an increase in blood pressure (BP) in both normotensive and hypertensive individuals and a blunting effect on various anti-hypertensive medications. Acetaminophen effects on anti-hypertensive treatment, instead, are still a matter of debate.

Objectives: To assess the effect of naproxen versus acetaminophen on ramipril, valsartan and aliskiren therapy in hypertensive patients with OA in a double-blind, cross-over study, by measuring clinic, ambulatory BP and heart rate (HR).

Results: One hundred seventy four patients were randomly treated with ramipril, valsartan or aliskiren for 8 weeks and 135 patients with normalized BP were randomized to receive naproxen or acetaminophen for 2 weeks. Naproxen significantly increased clinic and ambulatory systolic/diastolic BP (SBP/DBP) values in patients treated with ramipril (p < 0.01) or valsartan (p < 0.05), but did not affect aliskiren effects. Also acetaminophen slightly but significantly affected clinic and ambulatory SBP/DBP in all three groups and, surprisingly, it also produced a slight increase in HR (+3.1, +3.3 and +3.4 b/min day-time HR values, for ramipril, valsartan and aliskiren, respectively; p < 0.05).

Conclusions: Both naproxen and acetaminophen can affect anti-hypertensive therapy with ramipril, valsartan or aliskiren with a different extent. When acetaminophen is chosen for OA management in subjects with hypertension, patients should be evaluated as carefully as when traditional NSAIDs are given.     

Comparative effect of canrenone or hydrochlorothiazide addition to valsartan/amlodipine combination on urinary albumin excretion in well-controlled type 2 diabetic hypertensive patients with microalbuminuria

Objective: To compare the effect of adding canrenone or hydrochlorothiazide (HCTZ) to valsartan/amlodipine combination on urinary albumin excretion (UAE) in microalbuminuric type 2 diabetic hypertensives.

Research design and methods: After a 2-week placebo period and after 4 weeks of valsartan 160 mg plus amlodipine 5 mg combination, 120 patients whose blood pressure (BP) was not controlled (> 130/80 mmHg) were randomized to canrenone 25 mg or HCTZ 12.5 mg in addition to the previous therapy for 24 weeks. After the first 6 weeks of triple therapy, canrenone or HCTZ doses were doubled in the patients whose BP was yet uncontrolled. At the end of each period (placebo, dual combination and triple combination therapy), clinic and ambulatory BP measurements were recorded and 24 h UAE was evaluated.

Results: Both triple combinations produced greater clinical and ambulatory BP reduction than dual therapy, with no difference between the two groups. UAE was reduced by both regimens, but the decrease associated with canrenone add-on therapy was more pronounced. At week 24, UAE decreased by 45.3% in the canrenone group and by 20.3% in the HCTZ group (p < 0.01).

Conclusions: These findings indicate that, despite similar BP-lowering effect, the addition of canrenone to valsartan/amlodipine combination was more effective in reducing UAE than HCTZ addition.     

Value of rilmenidine therapy and its combination with perindopril on blood pressure and left ventricular hypertrophy in patients with essential hypertension (VERITAS)

OBJECTIVES: The primary objective was to assess the effects of rilmenidine monotherapy and in combination with perindopril on blood pressure (BP) in patients assessed with grade 1 or 2 essential hypertension. The study also examined the effects of 2-year rilmenidine monotherapy on left ventricular hypertrophy (LVH) and on diastolic function of the left ventricle, along with the effects of rilmenidine on left ventricular mass index in hypertensive patients with no LVH, and the relationship between BP reduction and any change in LVH. RESEARCH DESIGN AND METHODS: Mild-to-moderate hypertensive patients (n = 500) were enrolled in a multicentre 2-year open study and treated with rilmenidine (1-2 mg per day) monotherapy or rilmenidine plus perindopril (2, 4 or 8 mg per day) if control of hypertension was not achieved with rilmenidine monotherapy within 12 weeks. Blood pressure was recorded at regular intervals by the investigators and LVH measured by centralised single-blind echocardiographic reading. RESULTS: Rilmenidine monotherapy (average dose 1.42 mg) produced a significant decrease in BP from the baseline of 163 +/- 10/100 +/- 5 mmHg to 134 +/- 10/86 +/- 7 mmHg at 1 year and to 136 +/- 10/84 +/- 7 mmHg at 2 years (p < 0.001 for both). In 188 patients with LVH, the left ventricular mass index was significantly reduced from 161.4 +/- 30.5 to 131.3 +/- 26.5 at 1 year and to 134.1 +/- 26.0 g/m(2) at 2 years (p < 0.001 for both). Addition of perindopril to those patients whose BP was not normalised by rilmenidine monotherapy after 12 weeks further decreased BP significantly from 150 +/- 13/93 +/- 8 mmHg to 142 +/- 14/89 +/- 7 mmHg at the end of the 2nd year. CONCLUSIONS: Long-term rilmenidine monotherapy was shown to be efficient in controlling BP and in reducing LVH. The addition of perindopril to rilmenidine monotherapy proved to be effective and well tolerated in those patients who did not respond to rilmenidine alone.     

冠心病患者脉搏波传导速度与血浆脑钠肽水平的相关性研究

目的探讨冠心病患者脉搏波传导速度（PWV）与血浆脑钠肽（BNP）水平的关系。方法 100例符合入选标准的冠心病用VP1000动脉硬化测定仪测量患者脉搏波传导速度及用荧光免疫法定量测定患者血浆中BNP水平。结果对可能影响PWV的因素进行多元线性回归分析,PWV与BNP正相关（r=0.376P〈0.01）。结论对于冠心病患者PWV是BNP的独立影响因素。     

非洛地平缓释片对原发性高血压左室肥厚的影响

目的：观察非洛地平缓释片对高血压左室肥厚的逆转作用。方法：应用动脉血压及彩色多普勒超声心动图测定26例高血压并左室肥厚患者口服非洛地平缓释片（5～10mg/d),24周后血压及左室形态结构变化。结果：治疗后血压明显下降（P＜0．01）,舒张期室间隔厚度及左室后壁厚度,左室重量指数均明显减少（P＜0．01）。结论：非洛地平缓释片不但能有效降低血压,而且能逆转左室肥厚。     

Long-term safety,tolerability and efficacy of aliskiren in combination with valsartan in patients with hypertension: a 6-month interim analysis

ABSTRACT

Background: Renin–angiotensin system (RAS) blockade with ACE inhibitor and/or angiotensin receptor blocker therapy can lead to increased potassium levels, hence the need to assess dual blockade involving a direct renin inhibitor. Here we report the results of a pre-planned 6-month interim analysis of a long-term, open-label study examining the safety, tolerability and efficacy of the aliskiren/valsartan 300/320-mg combination in patients with hyper­tension.

Methods: A total of 601 patients with hyper­tension (msDBP ≥?90 and <?110?mmHg) received a combination of aliskiren/valsartan 150/160?mg for 2 weeks followed by forced titration to aliskiren/valsartan 300/320?mg once daily for a targeted duration of 52 weeks. Optional hydrochlorothiazide (HCTZ) addition was allowed from week 8 for inadequate BP control (≥?140/90?mmHg). The primary objective was to assess the safety of combination therapy; potassium elevations were a pre-defined safety outcome. BP was measured at regular intervals during the study.

Results: At the 6-month cut-off date, 512 patients (85.2%) were still ongoing with study treatment, and 192 patients had received at least one dose of HCTZ add-on during this period. Combination therapy was generally well-tolerated; the most commonly reported adverse events were headache (7.5%), dizziness (7.3%) and nasopharyngitis (7.2%). Ten patients (2.5%) receiving aliskiren/valsartan and two patients (1.0%) receiving aliskiren/valsartan/HCTZ had serum potassium elevations >?5.5?mmol/L. Only one patient (0.2%) exhibited potassium levels ≥?6.0?mmol/L during this period and the patient was treated with aliskiren/valsartan. Mean msSBP/DBP reductions of 22.3/14.4?mmHg were observed at 6-month endpoint (LOCF analysis) and 73.4% of patients achieved BP control (<?140/90?mmHg; LOCF).

Conclusions: Although lack of an active comparator group is a limitation of the study, our findings show that long-term treatment with the aliskiren/valsartan 300/320-mg combin­ation provided clinically significant BP lowering, was well-tolerated and was associated with a very low rate of potassium elevations in patients with hyper­tension.     

阿托伐他汀和缬沙坦联合治疗对老年高血压患者左心室肥厚的逆转

目的:探讨阿托伐他汀和缬沙坦联合治疗对老年原发性高血压(EH)患者左心室肥厚(LVH)的逆转。方法:将135例伴LVH的老年EH患者随机分成缬沙坦组和缬沙坦加阿托伐他汀治疗组,设定血压达标值为收缩压(SBP)<140mmHg(1mmHg=0.133kPa)和舒张压(DBP)<90mmHg。2组患者分别口服起始剂量缬沙坦80mg/d和阿托伐他汀20mg/d加缬沙坦8Omg/d。随访周期为2周,若血压未能达标,则增加缬沙坦剂量至160mg/d。2组患者均口服氢氯噻嗪25mg/d。总疗程24周。检测治疗前后24h动态血压、左室质量指数(LVMI)。结果:2组治疗后LVMI分别较治疗前显著性降低(均P<0.01)。缬沙坦和阿托伐他汀治疗组治疗前后LVMI的降低幅度大于单独缬沙坦治疗组,差别均具有统计学意义(P<0.05)。结论:阿托伐他汀加缬沙坦联合治疗在逆转LVH和抑制心脏交感活性方面较缬沙坦单药治疗具有更加显著的作用,且这些作用独立于降压疗效之外。     

参附注射液联合布美他尼治疗慢性充血性心力衰竭的临床研究

目的 研究参附注射液联合布美他尼注射液治疗慢性充血性心力衰竭的临床疗效。方法 选取2018年1月—2022年10月无锡市中医医院收治的90例充血性心力衰竭患者,通过随机数字表法将所有患者分为对照组和治疗组,每组各45例。对照组静脉滴注布美他尼注射液,2 mg置于250 mL 0.9%氯化钠注射液中稀释,滴注时间30～60 min,1次/d。治疗组在对照组基础上静脉滴注参附注射液,40 mL置于250 mL 5%葡萄糖注射液中稀释,滴注时间30～60 min,1次/d。两组患者均连续治疗10 d。观察两组的临床疗效,比较两组患者呼吸机辅助通气时间、心功能指标和血清脑钠肽（BNP）、N末端B型利尿钠肽原（NT-proBNP）。结果 治疗后,治疗组的总有效率95.56%显著高于对照组的总有效率82.22%（P＜0.05）。治疗后,治疗组无创呼吸辅助通气时间明显短于对照组,差异有统计学意义（P＜0.05）。治疗后,两组左心室收缩末期内径（LVESD）、左心室收缩末期容积（LVESV）均较治疗前显著降低,左心室射血分数（LVEF）较治疗前明显升高（P＜0.05）,且治疗组LVESD、LVESV低于对照组,LVEF高于对照组,两组比较差异有统计学意义（P＜0.05）。治疗后,两组血清BNP、NT-proBNP水平均较治疗前明显降低（P＜0.05）,且治疗组血清BNP、NT-proBNP水平明显低于对照组,两组比较差异有统计学意义（P＜0.05）。结论 参附注射液联合布美他尼注射液治疗充血性心力衰竭的疗效确切,可改善患者心功能,降低血清BNP、NT-proBNP水平,安全性良好。     

Effects of valsartan versus olmesartan addition to amlodipine/hydrochlorothiazide combination in treating stage 2 hypertensive patients

Objective: The objective of this study was to assess the effects of valsartan or olmesartan addition to dual therapy with amlodipine + hydrochlorothiazide (HCTZ) in the treatment of stage 2 hypertension.

Research design and methods: 180 patients with diastolic blood pressure (DBP) ≥ 99 and < 110 mm Hg were treated with amlodipine 5 mg + HCTZ 12.5 mg combination. After 4 weeks, 149 patients whose blood pressure (BP) was not controlled, were randomized to the combination of valsartan 160 mg + amlodipine 5 mg + HCTZ 12.5 mg or olmesartan 20 mg + amlodipine 5 mg + HCTZ 12.5 mg for 4 weeks.

Main outcome measures: At the end of each period, clinical and ambulatory BP measurements were recorded.

Results: Both triple combinations produced greater ambulatory and clinical SBP/DBP reduction than dual therapy. However, mean reduction from baseline in the valsartan + amlodipine + HCTZ-treated patients was significantly greater than in the olmesartan + amlodipine + HCTZ-treated patients. Compared with dual therapy, the add-on effect of valsartan was significantly greater than that of olmesartan, the difference being more evident for nighttime SBP/DBP values (-3.3 (95% CI 0.44 – 3.51)/3.0 (95% CI 0.59 – 3.34) mm Hg, p < 0.01).

Conclusions: The addition of valsartan to amlodipine + HCTZ produced greater BP reduction than the addition of olmesartan.