The efficacy and safety of telmisartan compared to enalapril in patients with severe hypertension

This 8-week, open-label study compared the efficacy and safety of once-daily telmisartan, either alone or in combination with hydrochlorothiazide (HCTZ) and amlodipine, with a similar enalapril regimen in patients with severe hypertension. Clinically relevant reductions in supine systolic blood pressure/DBP were observed with telmisartan (14.6/13.2 mmHg) and enalapril (13.0/12.9 mmHg) monotherapy. Incremental reductions were seen with up-titration of monotherapy (telmisartan 8.1/7.4 and enalapril 9.2/7.7 mmHg), and the addition of HCTZ (telmisartan 14.9/8.7 and enalapril 8.0/6.7 mmHg), and amlodipine (telmisartan 8.0/6.5 and enalapril 10.5/6.4). After 8 weeks of treatment, supine DBP control was achieved in 55% and 35% of the patients on the telmisartan and enalapril regimens, respectively. Both treatment regimens were well tolerated. Telmisartan, a new angiotensin receptor blocker, is a safe and effective drug to use in combination for the treatment of patients with severe hypertension and proved at least as effective as the enalapril combination.     

An open-label, multi-dose efficacy and safety study of intramuscular tetrodotoxin in patients with severe cancer-related pain

Cancer pain is a prevalent and serious public health issue, and more effective treatments are needed. This study evaluates the analgesic activity of tetrodotoxin, a highly selective sodium channel blocker, in cancer pain. A Phase IIa, open-label, multicenter, dose-escalation study of intramuscular tetrodotoxin was conducted in patients with severe, unrelieved cancer pain. The study design called for six ascending dose levels of intramuscular tetrodotoxin, administered over a four-day treatment period in hospitalized patients, with six patients to be enrolled within each successive dose level. Twenty-four patients underwent 31 courses of treatment at doses ranging from 15 to 90 microg daily, administered in divided doses, over four days. Most patients described transient perioral tingling or other mild sensory phenomena within about an hour of each treatment. Nausea and other toxicities were generally mild, but two patients experienced a serious adverse event, truncal and gait ataxia, that resolved over days. Seventeen of 31 treatments resulted in clinically meaningful reductions in pain intensity, and relief of pain persisted for up to two weeks or longer. Two patients had opioids held due to narcosis concurrent with relief of pain. Somatic, visceral, or neuropathic pain could all respond, but it was not possible to predict which patients were more likely to have an analgesic effect. Tetrodotoxin was overall safe. It effectively relieved severe, treatment-resistant cancer pain in the majority of patients and often for prolonged periods after treatment. It may have a novel mechanism of analgesic effect. Further study is warranted.     

The efficacy of telmisartan compared with perindopril in patients with mild-to-moderate hypertension

In this study, efficacy of the angiotensin II type 1 receptor blocker telmisartan given as monotherapy was compared with that of perindopril monotherapy in patients with mild-to-moderate hypertension. After a 2-week, single-blind, placebo run-in period, 60 patients were randomised to double-blind, once-daily treatment with telmisartan 80 mg or perindopril 4 mg for 6 weeks. Clinic and ambulatory blood pressure measurements and clinical laboratory evaluation were performed at the end of the placebo run-in and active treatment phases. Both telmisartan and perindopril significantly (p < 0.0001) reduced clinic systolic blood pressure (SBP) and diastolic blood pressure (DBP) compared with baseline values. Also, both drugs significantly (p < 0.0001) reduced 24-h mean ambulatory SBP and DBP compared with baseline. Comparison of the mean hourly antihypertensive activities showed that the reduction in mean ambulatory DBP for the last 8 h of the dosing interval was significantly greater (p < 0.05) in telmisartan-treated patients. A 24-h mean DBP of <85 mmHg was observed in 66.6% of the telmisartan-treated patients but in only 46.6% of the perindopril-treated patients (p < 0.05). It is concluded that telmisartan and perindopril both produce significant reductions in clinic SBP and DBP, but the mean reduction in ambulatory DBP during the last 8 h of the dosing interval is greater in patients treated with telmisartan.     

替米沙坦治疗122例高血压临床对照研究

目的探讨替米沙坦与氯沙坦治疗原发性高血压的疗效及安全性。方法将122例原发性高血压患者随机分为替米沙坦治疗组62例与氯沙坦治疗组60例,两组疗程均为8w。治疗前与疗程结束时分别采用美国产DP5000A动态血压监测系统进行24h动态血压监测分析。结果两组治疗前与治疗后24h、白昼与夜间平均血压均显著降低(P<0.01);治疗后替米沙坦组24h和夜间平均血压下降较氯沙坦组更显著(P<0.01);两组降压谷/峰比率分别为80.5±7.4%和62.8±4.3%,差异有极显著性(P<0.01)。结论替米沙坦是一种强效、安全、耐受性好的治疗高血压的良药。     

替米沙坦对高血压病患者血浆apelin-12水平的影响

目的探讨替米沙坦对高血压病(EH)患者血浆apelin-12浓度的影响及其临床意义。方法轻、中度EH患者(EH组)45例,替米沙坦治疗12周,酶联免疫法测定治疗前后血浆apelin-12浓度,健康体检者30例作为对照。同时对EH组患者进行治疗前、后超声心动图检测,包括平均动脉压、左室射血分数(LVEF)及射血分数缩短率(LVFS)、左心室舒张末期内径(LVDd)、二尖瓣前叶舒张中期斜率(EF斜率)及二尖瓣血流多普勒频谱早晚期流速峰比值(E/A)等心功能指标。结果EH患者血浆apelin-12降低,与正常人比较,差异有统计学意义[(3.14±0.40)μg/Lvs(3.61±0.30)μg/L,P=0.0001]。替米沙坦治疗后EH患者血浆apelin-12浓度升高,差异有统计学意义[(3.14±0.40)μg/Lvs(3.41±0.59)μg/L,P=0.013]。心功能指标无明显变化(均P>0.05)。结论EH患者血浆apelin-12浓度降低,apelin-12与平均动脉压(MAP)存在负相关(r=-0.410,P=0.005),提示apelin-12含量的变化在EH发生中起一定的作用。替米沙坦能升高轻、中度EH患者血浆apelin-12的水平,其降压作用部分与apelin-12的升高有关。     

奥美沙坦与替米沙坦治疗老年轻、中度原发性高血压患者8周的疗效比较

目的通过与替米沙坦比较评价奥美沙坦治疗老年轻、中度原发性高血压的安全性及临床效果。方法采用随机双盲对照平行分组的方法共入选150例老年轻中度高血压患者,按1∶1比例随机分为两组。分别接受奥美沙坦20 mg或替米沙坦80 mg,1次/天。连续用药4周后进行血压评价,如果患者舒张压(DBP)仍≥90 mm Hg(1 mm Hg=0.133 k Pa),则试验药物剂量加倍,直至8周试验结束;治疗4周后DBP90 mm Hg的患者则维持原剂量继续治疗至第8周。结果治疗4周后,奥美沙坦组坐位DBP谷值平均下降11.35mm Hg,替米沙坦组平均下降8.47 mm Hg,两组间差异有统计学意义(P0.05);治疗8周后,奥美沙坦组坐位DBP谷值平均下降13.01 mm Hg,替米沙坦组平均下降10.87 mm Hg,两组间差异有统计学意义(P0.05);治疗4周后,两组有效病例数和有效率相当,P0.05;治疗8周后,奥美沙坦组有效数为65例(86.7%),替米沙坦组有效数为54例(72.0%),两组间差异有统计学意义(P0.05);随着治疗的进展,肾小球滤过率、肌酐清除率较治疗前升高,尿素氮、血肌酐明显降低(P0.01),奥美沙坦组较替米沙坦组下降更显著(P0.01)。替米沙坦组不良反应总发生率10.7%显著高于奥美沙坦组的2.7%(P0.05)。结论奥美沙坦每日口服20~40 mg能够有效地治疗治疗老年轻、中度原发性高血压。较每日口服替米沙坦80~160 mg/d效果更值得肯定,可有效保护肾功能,且耐受性好,安全可靠。     

Clinical efficacy and safety of telmisartan 80 mg once daily vs. atenolol 50 mg once daily in patients with mild-to-moderate hypertension

The objective of this open-label, parallel-group comparative study was to assess the clinical efficacy and safety of once-daily treatment for 8 weeks with telmisartan 80 mg in comparison with atenolol 50 mg on systolic blood pressure (SBP) and diastolic blood pressure (DBP) in patients with mild-to-moderate hypertension (morning supine SBP 141-199 mmHg, DBP 95-114 mmHg). A total of 58 patients were enrolled. The comparability of the two treatment groups was statistically documented at the beginning of the study. Telmisartan was more effective than atenolol, with a decrease in SBP of 21.7 mmHg vs. 11.8 mmHg (p = 0.03) and a non-significant decrease in DBP of 14.7 mmHg vs. 10.1 mmHg. The safety profiles of both drugs were very similar; both drugs were well tolerated. In conclusion, once-daily telmisartan 80 mg is more effective than once-daily atenolol 50 mg in lowering SBP with no negative chronotropism. Furthermore, telmisartan was as well tolerated as atenolol in the treatment of mild-to-moderate essential hypertension in adults.     

阿托伐他汀钙对老老年高血压合并高脂血症患者的降脂作用及安全性观察

目的 探讨阿托伐他汀钙在老老年高血压合并高脂血症患者中的降脂作用及安全性.方法 选择68例老老年患者,均服用阿托伐他汀钙20 mg(每晚1次),观察服药前后血脂、肝肾功能及肌酸激酶的变化情况.结果 与治疗前比较,治疗后患者的甘油三脂(TG)、总胆固醇(TCH)、低密度脂蛋白胆固醇(LDL-C)水平降低,高密度脂蛋白胆固醇(HDL-C)水平升高,患者的丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、肌酐(Cr)、尿素氮(BUN)、肌酸激酶(CK)无明显变化.结论 老老年高血压合并高脂血症患者应用阿托伐他汀钙降脂作用明显,且安全性较好.     

A randomized, open-label study to evaluate the efficacy and safety of pitavastatin compared with simvastatin in Korean patients with hypercholesterolemia

BACKGROUND: Pitavastatin is a 3-hydroxy-3-methyl-glutaryl coenzyme A (HMG-CoA) reductase inhibitor used to treat hypercholesterolemia. OBJECTIVE: The goal of this study was to compare the efficacy and safety of pitavastatin versus those of simvastatin in Korean patients with hypercholesterolemia. METHODS: This was an 8-week, multicenter, prospective, randomized, open-label, Phase III clinical trial. Male and female Korean patients with hypercholesterolemia who were between the ages of 20 and 75 years and who had a fasting triglyceride level <600 mg/dL and a low-density lipoprotein (LDL) cholesterol level >130 mg/dL after a 4-week dietary lead-in period were eligible for entry. Eligible patients were randomized into 2 groups in a 1:1 ratio. Patients received pitavastatin 2 mg once daily or simvastatin 20 mg once daily for 8 weeks. The medication was administered initially for 4 weeks, and an additional 4 weeks of study medication was prescribed at week 4. The final visit was conducted 8 weeks after randomization. RESULTS: Of the 104 patients randomized to treatment, 95 patients (59 women; 36 men) completed the study (49 in the pitavastatin group [mean age, 59.9 years] and 46 in the simvastatin group [mean age, 56.4 years]). No significant difference was found between groups with respect to patient age, sex, or body mass index. There was no significant difference in the percent decrease in LDL cholesterol levels (mean [SD], 38.2% [11.6%] decrease for the pitavastatin group vs 39.4% [12.9%] decrease for the simvastatin group [P = 0.648]). Also, there were no significant differences between the 2 study groups in the percent changes in total cholesterol, triglyceride, or high-density lipoprotein (HDL) cholesterol levels from baseline to study end. No significant difference was observed for the proportion of patients who achieved the LDL cholesterol goal of the National Cholesterol Education Program Adult Treatment Panel III: 93.9% (46/49) of patients in the pitavastatin group and 91.3% (42/46) of patients in the simvastatin group (P = 0.709) met the target level. At least 1 clinical adverse event and at least 1 adverse drug reaction were observed in 25.0% (13/52) and 11.5% (6/52), respectively, of patients in the pitavastatin group, and 37.3% (19/51) and 23.5% (12/51), respectively, in the simvastatin group; this difference was not statistically significant. The most common adverse event was an elevation in creatine kinase levels >2 times the upper limit of normal in 3.8% of pitavastatin-treated patients and 9.8% of simvastatin-treated patients (P = 0.269). There were no serious adverse drug reactions observed in either group. CONCLUSION: The HMG-CoA reductase inhibitor pitavastatin was found to be noninferior to simvastatin in terms of reducing LDL cholesterol, total cholesterol, and triglyceride levels, and increasing HDL cholesterol levels, in Korean patients with hypercholesterolemia after 8 weeks of treatment.     

Nifedipine and telmisartan for the treatment of hypertension: the TALENT study

A combination of two drugs as initial treatment in patients with a high or very high cardiovascular risk profile is recommended. Nifedipine extended release (GITS) is a calcium-channel antagonist known to be metabolically neutral, to mildly slow the development of atherosclerosis in hypertensive subjects and to significantly decrease cardiovascular risk in diabetic patients. Telmisartan is highly selective for the angiotensin receptor 1, it gives a greater improvement in glycemic and lipid control compared with irbesartan, and it proved its superiority in improving insulin sensitivity compared with eprosartan. The TALENT study was aimed to determine whether combining low-dose nifedipine GITS at and telmisartan reduced ambulatory and clinic blood pressure more than the two components in monotherapy in hypertensive patients at high cardiovascular risk. The study shows that combination treatment with nifedipine GITS and telmisartan provides a greater and earlier blood pressure reduction than the combination components in monotherapy.     

Clinical efficacy and safety of telmisartan 80 mg once daily compared with enalapril 20 mg once daily in patients with mild-to-moderate hypertension: results of a multicentre study

The efficacy and safety of once-daily telmisartan 80 mg vs. once-daily enalapril 20 mg in the treatment of essential hypertension were evaluated in a multicentre, single-blind, placebo-controlled, randomised trial. In total, 68 patients (49 females, 19 males) with mild-to-moderate hypertension, defined as morning supine systolic blood pressure (SBP) 141-149 mmHg, diastolic blood pressure (DBP) 95-114 mmHg, were enrolled. After a 4-week placebo run-in phase, patients were randomly assigned to treatment with telmisartan or enalapril administered once daily in the morning for 8 weeks. No statistically significant differences were found in the baseline characteristics of patients in either group. Both SBP and DBP were decreased in both treatment groups, but the reductions were statistically different in favour of telmisartan (SBP, p = 0.013; DBP, p = 0.002). The incidence of adverse effects was lower in the telmisartan group, with the absence of cough. In conclusion, telmisartan is more effective and better tolerated than enalapril for the treatment of hypertension and has the advantage that it does not cause cough.     

Nifedipine and telmisartan for the treatment of hypertension: the TALENT study

A combination of two drugs as initial treatment in patients with a high or very high cardiovascular risk profile is recommended. Nifedipine extended release (GITS) is a calcium-channel antagonist known to be metabolically neutral, to mildly slow the development of atherosclerosis in hypertensive subjects and to significantly decrease cardiovascular risk in diabetic patients. Telmisartan is highly selective for the angiotensin receptor 1, it gives a greater improvement in glycemic and lipid control compared with irbesartan, and it proved its superiority in improving insulin sensitivity compared with eprosartan. The TALENT study was aimed to determine whether combining low-dose nifedipine GITS at and telmisartan reduced ambulatory and clinic blood pressure more than the two components in monotherapy in hypertensive patients at high cardiovascular risk. The study shows that combination treatment with nifedipine GITS and telmisartan provides a greater and earlier blood pressure reduction than the combination components in monotherapy.     

卡维地洛与美多心安对高血压患者治疗效果的比较研究

目的　评价国产卡维地洛的降压效应与安全性。方法　 90例原发性高血压患者随机分为观察组与对照组 ,分别口服国产卡维地洛 1片 (10mg)或美多心安 1片 (2 5mg) ,2次 /d ,4周为 1疗程。 结果　卡维地洛组服药 4周后收缩压 (SBP)及舒张压 (DBP)与治疗前比较分别下降 (18.92± 11.5 8)、(12 .34± 7.2 5 )mmHg(P <0 .0 1) ,美多心安组与治疗前比较分别下降 (19.13± 9.70 )、(13.5 0± 7.4 6 )mmHg(P <0 .0 1) ;观察组与对照组总有效率分别为 89.4 8%与 80 .4 3% ,两组比较无显著差异 (P >0 .0 5 )。两药的不良反应均轻微 ,发生率分别为 2 .7%和 4 .4 %。结论　卡维地洛是一种安全有效的抗高血压药物     

多沙唑嗪治疗轻中度高血压疗效和安全性的临床研究

目的 评价新一代α_1受体拮抗剂甲磺酸多沙唑嗪的降压疗效及安全性,并与盐酸特拉唑嗪相比较。方法 采用随机分组平行对照方法,将226例轻、中度高血压患者分成两组:多沙唑嗪组(111例)口服甲磺酸多沙唑嗪2mg/d;盐酸特拉唑嗪组(115例)口服盐酸特拉唑嗪2mg/d。疗程8周。每两周一次上午监测诊室谷值坐位舒张压、心率,立位舒张压,并观察不良反应。用药前及治疗第8周后检测血液生化指标。第2周末谷值坐位舒张压仍大于90mmHg者加量至4mg/d,第4周末谷值坐位舒张压仍大于90mmHg者加量至6mg/d,第6周末谷值坐位舒张压仍大于90mmHg者,终止试验,改服其它药物。结果 治疗8周后甲磺酸多沙唑嗪组与盐酸特拉唑嗪组治疗有效反应率分别为74.77％和76.52％,(P>0.05);治疗后两组平均谷值坐位舒张压均有明显降低(P<0.05)。两组均无严重不良反应发生。结论 甲磺酸多沙唑嗪与盐酸特拉唑嗪降压疗效相似,不良反应发生率均较低,是一种安全、有效的治疗轻、中度原发性高血压的药物。     

替米沙坦治疗糖尿病合并高血压的临床疗效分析

目的探讨替米沙坦治疗糖尿病合并高血压的临床疗效。方法选取2009年9月至2012年1月该院收治的90例糖尿病合并高血压患者,随机分成对照组和治疗组,每组各45例。对照组仅给予氨氯地平药物治疗,治疗组则在使用氨氯地平的基础上,使用替米沙坦药物。治疗结束后,比较治疗前后空腹血糖、总胆固醇以及三酰甘油的变化情况、两组患者的治疗总有效率以及不良反应。结果治疗后,与对照组比较,治疗组空腹血糖、总胆固醇、三酰甘油均较治疗前下降,差异有统计学意义（P〈0．05）;对照组总有效率为62．2％,治疗组总有效率为88．9％,两组比较差异有统计学意义（P〈0．05）,治疗组疗效明显比对照组好;对照组的不良反应发生率为15．6％,治疗组不良反应发生率为17．8％,两组差异无统计学意义（P〉0．05）。结论替米沙坦治疗糖尿病合并高血压可以明显改善患者的空腹血糖、总胆固醇以及三酰甘油等指标,改善患者临床症状,治疗效果显著,不增加不良反应,值得临床上推广应用。     

Postmarketing surveillance study of benazepril in chinese patients with hypertension: An open-label, experimental, epidemiologic study

Background

Benazepril hydrochloride is an angiotensin-converting enzyme inhibitor. Previous clinical trials show that antihypertensive treatment with benazepril provides effective blood pressure (BP) control and is generally well tolerated by patients with hypertension. However, the long-term antihypertensive effects and tolerability of benazepril remain to be established in Chinese patients with hypertension.

Objective

The aim of this study was to investigate the long-term efficacy and tolerability of benazepril in Chinese patients with essential hypertension.

Methods

This 36-month, community-based, open-label, postmarketing surveillance study was conducted in the Nanshi District (Shanghai, China). Chinese patients with essential hypertension were to receive 1 or more benazepril tablets PO QD in the morning for 36 months. Data for BP and pulse pressure (PP) were collected at baseline (month 0) and throughout the surveillance period. The rate of patients achieving BP targets (systolic BP [SBP]/diastolic BP [DBP], <140/<90 mm Hg) was determined, as was the rate of decrease in BP. Subanalyses by sex and age group also were conducted.

Results

A total of 1831 patients (1090 men, 741 women; mean [SD] age, 55.8 [10.1] years [range, 35-88 years]) entered the study. After the 36-month treatment period, 75.7% of patients receiving benazepril as prescribed (1289 patients) had achieved the SBP target, 87.4% achieved the DBP target, and 71.5% achieved both targets. After 36 months of treatment, the mean (SD) decreases in SBP, DBP, and PP were 15.1 (0.4) mm Hg, 11.0 (0.3) mm Hg, and 4.2 (0.4) mm Hg, respectively, among compliers. In general, the rate of BP decrease slowed over time. No serious adverse drug reactions (ADRs) were detected during the 36-month follow-up period. All ADRs except cough (19.9%) occurred at a relatively low incidence rate (<3.0%). The cumulative incidence of benazepril related cough was statistically significantly higher in women than in men (23.6% vs 18.8%, respectively; P = 0.007). Of the 1831 patients studied, 1360 patients (74.3%) persisted in taking benazepril and were considered optimally compliant at 36-month follow-up.

Conclusion

In this study of Chinese patients with hypertension, benazepril was associated with prolonged, stable efficacy in lowering BP and relatively low incidence of ADRs.     

Carteolol treatment of essential hypertension: a long-term study of safety and efficacy

The long-term safety and antihypertensive efficacy of carteolol were evaluated in an open-label, multicenter trial of 245 hypertensive patients. For those patients maintained on carteolol monotherapy, three months of treatment with once-daily oral doses of carteolol ranging from 2.5 to 60 mg reduced the mean recumbent blood pressure by 12/14 mm Hg from baseline values of 151/100. Blood pressure reductions observed at three months were maintained throughout the study. The final daily dose of carteolol for most patients was 10 mg or less. Carteolol was shown to be safe and well tolerated by most patients.     

Effects of simvastatin on blood pressure in hypercholesterolemic patients: An open-label study in patients with hypertension or normotension

Background

Simvastatin has been reported to improve endotheliumdependent vascular relaxation in patients with hypercholesterolemia. The consequent decrease in arterial stiffness might be associated with a decrease in blood pressure (BP).

Objective

The aim of this study was to determine whether simvastatin 20 and 40 mg/d have an effect on systolic and diastolic blood pressure (SBP and DBP, respectively) in patients with hypercholesterolemia, and, if so, whether the effect is dose dependent and/or is related to the changes in the serum lipid profile.

Methods

This 6-month, open-label study was conducted at the Lipid Clinics of the Department of Internal Medicine, University of Milan, Maggiore Hospital IRCCS, and of the Department of Internal Medicine 1, G. Salvini Hospital, Garbagnate Milanese (Milan, Italy). Patients aged 18 to 80 years with primary hypercholesterolemia who were following a low-fat, low-cholesterol diet for >2 months before the study were enrolled. Patients at high risk for cardiovascular disease (CVD), according to the National Cholesterol Education Program Adult Treatment Panel II guidelines, were given simvastatin 20 mg (tablet) QD for 3 months, and those at low risk for CVD continued with diet only for 3 months (controls). Efficacy variables included body weight, SBP, DBP, and serum lipid levels (total cholesterol [TC], low-density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C], and triglycerides [TG]). At 3 months, patients in the simvastatin + diet group who reached their therapeutic goal continued to receive simvastatin 20 mg/d for 3 additional months. In simvastatintreated patients who were normotensive at baseline or who became normotensive at 3 months but who did not reach the therapeutic goal, the simvastatin dosage was increased to 40 mg/d. Patients in both groups who remained hypertensive at 3 months were switched to hypotensive therapy. In the diet-only group, patients who were formerly normotensive or who became normotensive at 3 months but who did not reach their therapeutic goal continued with diet only or started lipid-lowering therapy. All other patients in the diet-only group continued to be treated with diet only, for 3 additional months. Efficacy variables were measured again at 6 months. Tolerability of simvastatin was assessed at each visit using patient interview and measurement of serum aminotransferase and creatine phosphokinase levels.

Results

The study population comprised 222 patients (132 women, 90 men; mean [SEM] age, 53.9 [0.95] years [range, 23-76 years]); 115 high-risk patients (57 with untreated stage 1 hypertension) were assigned to the simvastatin + diet group, and 107 low-risk patients (29 with untreated stage 1 hypertension) were assigned to the diet-only group. In the simvastatin group, after 3 months of therapy, mean SBP was decreased by 3.9 (1.49) mm Hg (change, −2.9%), mean DBP decreased by 3.0 (0.87) mm Hg (change, −3.7%), mean TC decreased by 90.6 (3.98) mg/dL (change, −27.0%), mean LDL-C decreased by 88.9 (3.88) mg/dL (change, −35.6%), and mean TG decreased by 26.3 (7.34) mg/dL (change, −15.8%) (all, P < 0.001). Mean HDL-C increased by 3.6 (1.16) mg/dL (change, 6.9%; P < 0.001). The BP-lowering effect was found only in patients with hypertension at baseline (n = 57); in these patients, mean SBP decreased by 7.2 (2.44) mm Hg (change, −4.8%; P < 0.005 vs baseline) and DBP decreased by 4.8 (1.29) mm Hg (change, −5.6%; P < 0.001 vs baseline). Also in the simvastatin group, 26 patients (22.6%) achieved their target SBP/DBP. In patients with normotension at baseline (n = 58), neither SBP nor DBP was changed significantly (changes, −0.8 [1.65] and −1.4 [1.15] mm Hg, respectively [−0.6% and −1.8%, respectively]). The changes in serum lipid levels were similar between hypertensive and normotensive patients in the simvastatin group. Forty-one patients (18 hypertensive and 23 normotensive at baseline) were treated with simvastatin 40 mg/d plus diet between months 3 and 6. At 6 months, no further significant decrease was observed in mean BP. In contrast, the expected dose-dependent response was observed for TC and LDL-C levels. In the diet-only group, no significant changes occurred in BP or serum lipid levels. Changes in BP, TC, LDL-C, TG, and HDL-C were significantly greater in the simvastatin + diet group than in the diet-only group (all, P < 0.001). Body weight did not change significantly in either group.

Conclusions

In this group of patients with hypercholesterolemia, the starting dosage of simvastatin (20 mg/d) was associated with reductions in SBP and DBP within 3 months of treatment in patients with hypertension, and this effect was independent of the lipid-lowering properties of the drug. Although the decrease in BP was modest, it is likely clinically relevant. Further studies on this topic are advisable.