Blood pressure. Supplement最新文献

It is well documented that reducing blood pressure (BP) in hypertensive individuals reduces the risk of cardiovascular (CV) events. Despite this, many patients with hypertension remain untreated or inadequately treated, and fail to reach the recommended BP goals. Suboptimal BP control, whilst arising from multiple causes, is often due to poor patient compliance and/or persistence, and results in a significant health and economic burden on society. The use of fixed-dose combinations (FDCs) for the treatment of hypertension has the potential to increase patient compliance and persistence. When compared with antihypertensive monotherapies, FDCs may also offer equivalent or better efficacy, and the same or improved tolerability. As a result, FDCs have the potential to reduce both the CV event rates and the non-drug healthcare costs associated with hypertension. When FDCs are adopted for the treatment of hypertension, issues relating to copayment, formulary restrictions and therapeutic reference pricing must be addressed.

Background: To compare the tolerability and safety of telmisartan +/- hydrochlorothiazide (HCTZ).

Methods: This retrospective analysis was performed on all hypertensive patients that were enrolled in telmisartan studies. A total of 30 double-blind (n=8023) and 20 open-label (n=8393) studies were available at the time of this analysis, and were included. Treatments investigated were placebo, telmisartan 10-160 mg, or telmisartan 10-160 mg plus HCTZ 6.25-25 mg. The incidence and causality of all adverse events (AEs) and laboratory abnormalities occurring during treatment were recorded.

Results: The incidences of all-cause AEs in the double-blind studies were: 2.73 per patient-year (PY) (36.1%; placebo); 2.03/PY (37.4%; telmisartan monotherapy) and 2.09/PY (44.8%; telmisartan plus HCTZ). The respective numbers in the open-label studies were: 0.65/PY (49.6%; telmisartan monotherapy) and 0.70/PY (40.3%; telmisartan plus HCTZ). The most frequent suspected adverse reactions were dizziness and headache, which were comparable across groups and studies. The overall incidence of drug-related laboratory abnormalities was low in all treatment groups. Treatment-related hyperuricaemia and hypokalaemia occurred in less than 0.1% of patients, respectively, treated with telmisartan plus HCTZ. Incidences of discontinuation due to an AE were 4.6%, 4.5% and 4.7%, respectively, for the placebo, telmisartan and telmisartan plus HCTZ treatment groups.

Conclusion: The consolidated data show that telmisartan +/- HCTZ are well tolerated in patients of all ages and have placebo-like tolerabilities.

Angiotensin-converting enzyme inhibitors (ACEIs) are used in the management of a range of cardiovascular disorders and are well established in primary as well as secondary cardiovascular prevention programmes. Over the years, several second- and third-generation ACEIs have been introduced into the clinic. In a comparative study in patients with mild to moderate hypertension, the efficacy and safety of zofenopril 30 mg od (with an up-titration to 60 mg od after 4 weeks in non-responder patients) was compared with enalapril 20 mg od (with an up-titration to 40 mg od after 4 weeks in nonresponders) during 12 weeks of treatment. Both treatments significantly reduced systolic (SBP) and diastolic blood pressure (DBP). BP reduction was significantly greater with zofenopril (30 mg/day) during the initial 4 weeks of treatment compared with enalapril (20 mg/day). A larger proportion of patients needed dose up-titration with enalapril compared with zofenopril to reach preset BP goals. After 12 weeks of treatment and after appropriate dose up-titration, SBP and DBPs were lowered to similar extent in the two treatment groups, resulting in no differences between the groups in terms of response and control rates. A similar number of patients reported adverse events in the two study groups. However, the severity of adverse events were significantly milder with zofenopril compared with enalapril. In mild to moderate hypertensive patients, zofenopril treatment results in a more pronounced lowering of BP compared with enalapril at recommended dose levels. Additionally, at clinical and comparative antihypertensive doses, zofenopril presents a more beneficial adverse event profile compared with enalapril.

Angiotensin-converting enzyme inhibitors (ACEIs) and calcium antagonists are today extensively used as first-line monotherapy as well as appropriate combination therapy in mild to moderate hypertension. In a parallel-group study, using clinically recommended doses, the ACEI zofenopril was compared with the calcium antagonist amlodipine in respect of their antihypertensive properties. In the study, 303 hypertensive patients, aged 18-75 years, were compared in terms of antihypertensive response and adverse effects after treatment with zofenopril, 30-60 mg once daily or amlodipine 5-10 mg od. After receiving the lower starting dose, up-titration was optional at 4 weeks to the higher dose if diastolic pressure (DBP) was 90 mmHg or more or if a decrease from base line of < 10 mmHg was present. After 4 weeks and appropriate up-titration of dose in non-responder patients, there were significant and similar reductions of sitting DBP by -10.0 and -9.9 mmHg and systolic blood pressure (SBP) by -13.0 and -13.2 mmHg the in the zofenopril and amlodipine groups, respectively. After 12 weeks of therapy, there were further reductions in blood pressure (BP) by the respective therapies. Thus, the higher zofenopril dose lowered SBP/DBP by 15.7/12.0 mmHg and the higher amlodipine dose by 17.1/ 12.2 mmHg (ns). Also, at the end of the study, the percentage of patients controlled (with sitting DBP < 90 mmHg) was 61.4% in the amlodipine and 62.2% in the zofenopril group and the percentage controlled (with sitting DBP < 90 mmHg and/or a decrease of at least 10 mmHg) was 76.4 in the amlodipine and 70.1 in the zofenopril groups (both ns). We conclude that SBP as well as DBP were substantially reduced in mild to moderate hypertensive patients over 12 weeks treatment with zofenopril or amlodipine in monotherapy. Thus, given the size of the BP reduction, such treatments are likely to produce beneficial cardiovascular outcome effects in patients with mild to moderate hypertension.

Two first-line antihypertensive therapies for initiating treatment in hypertension were compared, the angiotensin-converting enzyme inhibitor (ACEI) zofenopril and the beta-blocker atenolol. The study was multi-centre and double-blind, and included 304 middle-aged to elderly patients with mild to moderate hypertension who were randomized to receive either zofenopril 30-60 mg once daily (od) or atenolol 50-100 mg od for 4 weeks with the possibility to an up-titration in non-responding patients. The higher dose level was then administered until 12 weeks after randomization. Blood pressures (BPs) were substantially reduced by either treatment, but after 4 weeks, the systolic and diastolic BP reductions were significantly greater (p < 0.05) with zofenopril (-15.6/-13.5 mmHg) compared with atenolol (-13.1/-11.8 mmHg). After 12 weeks and the possibility of dose up-titration, BP differences between treatments were no longer significant. However, control rates (sitting diastolic BP < 90 mmHg) for zofenopril remained significantly higher compared with atenolol. The number of subjects with adverse drug reactions possibly or probably related to the study medication was 14 (9.1%) in the zofenopril group and 30 (20.8%) in the atenolol group (p = 0.008). It is concluded that zofenopril as well as atenolol induces substantial reductions of diastolic BP in middle-aged to elderly patients with hypertension. However, the control rate when initiating antihypertensive therapy with zofenopril is higher than that for atenolol.

In a parallel double-blind multicentre study, 375 hypertensive patients were enrolled and treated with either the angiotensin-converting enzyme inhibitor (ACEI) zofenopril 30 mg once daily (titration 60 mg od) or the angiotensin II type 1 receptor (AT1) antagonist losartan 50 mg od (titration 100 mg od). Patients with mild to moderate hypertension, defined as a diastolic blood pressure (DBP) between 95 and 110 mmHg in the sitting position without other signs of cardiovascular disease were enrolled and treated for 12 weeks. BP was assessed in the clinic, and self-measured by the patients at home during a working day and a holiday, as well as before and at the clinic follow-ups. Systolic (SBP) and DBP were significantly reduced in both treatment groups to a similar extent at the end of the 12-week study. However, the immediate or early reduction of DBP as well as DBP reduction over the first month was significantly greater with zofenopril (p= 0 .01 and p= 0 .003, respectively) compared with losartan treatment. After 3 months of treatment and dose up-titration, clinic BP reductions were similar in both groups. However, more subjects with losartan had used a higher dose step (42.1%) compared with zofenopril (33.1%). Home BP assessments demonstrated that systolic and diastolic pressures were substantially lower than the BP measurements made by sphygmomanometer in the clinic. In particular, assessments 2-3 days before the clinic visits during working days and holidays were characteristically lower, while the measurements during the clinic visits were largely similar to the conventional BP measurements by the doctor. The number and the severity of adverse events, related to the study medications, were largely benign and similar in both groups. The present study demonstrates that zofenopril in clinically recommended doses is at least therapeutically equivalent to losartan treatment, when assessed by conventional sphygmomanometry at the doctor's office or at home by self-measured BP assessments by the patients. Zofenopril however, induces a more rapid initial lowering of BP over the first month of therapy.

Purpose: This post-marketing surveillance study assessed the efficacy, safety and tolerability of the treatment with nifedipine GITS (gastro-intestinal therapeutic system) in hypertensive patients under normal daily practice conditions in China.

Patients and methods: A total of 3003 patients were included in 174 outpatient clinics. Patients received 30 mg or 60 mg of nifedipine GITS. Data were collected at up to three follow-up visits.

Results: At the end of the observation period, mean treatment duration was 13.3 weeks. Mean blood pressure reduction was 27.6/13.6 mmHg, 62.1% of patients had a systolic blood pressure <140 mmHg, and 82.2% had a diastolic blood pressure <90 mmHg. Blood pressure control according to international guidelines was achieved in 45.0% of all patients. A total of 1515 patients received additional antihypertensive medications, of which angiotensin-converting enzyme (ACE) inhibitors were mostly used (42.2%) followed by beta-blockers (33.7%). Twenty-two patients (0.7%) experienced 27 adverse events. Physicians' assessments of efficacy, tolerability and patient acceptance had ratings of "very good" and "good" in 88.7% (efficacy), 92.8% (tolerability) and 89.1% (patient acceptance) of patients.

Conclusions: Nifedipine GITS proved to be effective and well tolerated for the treatment of hypertension in 3003 Chinese patients. The results confirm the findings of previously performed clinical studies.