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Background: Hypertension guidelines recommend the use of 2 agents having complementary mechanisms of action when >1 agent is needed to achieve blood pressure (BP) goals. Objective: The aim of this study was to compare the efficacy and tolerability of combinations of olmesartan medoxomil (OM) and amlodipine besylate with those of the component monotherapies in patients with mild to severe hypertension. Methods: This was a multicenter, randomized, doubleblind, placebo-controlled, factorial study. Patients who were naive to antihypertensive therapy or who underwent a washout of previous antihypertensive therapy for up to 2 weeks and had a seated diastolic BP (SeDBP) of 95 to 120 mm Hg were randomized to receive 1 of the following for 8 weeks: OM 10, 20, or 40 mg; amlodipine (AML) 5 or 10 mg; each possible combination of OM and AML; or placebo. The primary end point was the change from baseline in SeDBP at week 8, with secondary end points including the change in seated systolic blood pressure (SeSBP), the proportion of patients reaching the BP goal (<140/90 mm Hg; <130/80 mm Hg for patients with diabetes), and the proportions of the intention-to-treat population reaching BP thresholds of <120/80, <130/80, <130/85, and <140/90 mm Hg. Safety and tolerability were also evaluated, with a particular focus on the incidence and severity of edema. Results: Of the 1940 randomized patients, 54.3% were male. The mean age of the study population was 54.0 years and 19.8% were aged ≥65 years. The mean baseline BP was 164/102 mm Hg, and 79.3% of patients had stage 2 hypertension. Combination therapy with OM and AML was associated with dose-dependent reductions in SeDBP (from −13.8 mm Hg with OM/AML 10/5 mg to −19.0 mm Hg with OM/AML 40/10 mg) and SeSBP (from −23.6 mm Hg with OM/AML 20/5 mg to −30.1 mm Hg with OM/AML 40/10 mg) that were significantly greater than the reductions with the corresponding component monotherapies ( P < 0.001). At week 8, the number of patients achieving the BP goal ranged from 57 of 163 (35.0%) to 84 of 158 (53.2%) in the combination-therapy groups, from 32 of 160 (20.0%) to 58 of 160 (36.3%) in the OM monotherapy groups, and from 34 of 161 (21.1%) to 53 of 163 (32.5%) in the AML monotherapy groups ( P < 0.005, combination therapies vs component monotherapies), compared with 14 of 160 (8.8%) in the placebo group. Achievement of the BP thresholds was highest in the combination-therapy groups, with 56.3% and 54.0% of patients achieving a BP <140/90 mm Hg with OM/AML 20/10 and 40/10 mg, respectively. Combination therapy was generally well tolerated, and no unexpected safety concerns emerged in the course of the study. The most common adverse events were edema (ranging from 9.9% [OM 20 mg] to 36.8% [AML 10 mg], compared with 12.3% with placebo) and headache (ranging from 2.5% [OM/AML 10/5 mg] to 8.7% [OM 20 mg], compared with 14.2% with placebo). Conclusion: The combination of OM and AML was effective and well tolerated in this adult population with hypertension.

Coffee is the most widely consumed beverage worldwide and is only second to water drinking and is consumed by 83% of adults in the United States. The long-held controversy regarding the association of coffee consumption with an increased incidence of cardiovascular diseases (CVDs) and hypertension has been reversed by several recent prospective cohort studies and meta-analyses, which have demonstrated that coffee consumption is not associated with increased incidence of CVDs and hypertension and instead it could have a beneficial effect. To get a better understanding of the effects of coffee consumption on cardiovascular health, a Medline search of the English language literature was conducted from 2010 to early 2015 and 25 pertinent reports with information on the effects of coffee drinking, the incidence of CVDs, and hypertension and its mechanism of action were selected for inclusion in this commentary. These studies have shown either a neutral or beneficial effect of coffee on cardiovascular health. In conclusion, coffee is safe to drink by both normal subjects and by those with preexisting CVDs and hypertension.

Cardiovascular disease (CVD) remains still the leading cause of death in the United States, and it is estimated to be the leading cause of death in the developing countries by 2020. In addition, the modifiable cardiovascular risk factors (CVRFs), hypertension, hypercholesterolemia, diabetes, and obesity, have increased significantly and by 2020 will account for 80% of all CVD deaths worldwide. Because the CVD and stroke risk increases significantly for subjects aged >50 years, it has been proposed to treat these subjects with a polypill containing 4 to 5 drugs, which is known to reduce the CVRFs for all subjects aged ≥55 years with an estimated reduction of CVD and stroke by 80%. However, this proposal is neither practical nor cost-effective, because it will involve a large number of subjects. Some investigators suggest to incorporate the coronary artery calcium score (CACS) with the Framingham Risk Score (FRS) to reduce the number of subjects who will benefit from the polypill. They have shown that patients with a CACS = 0 at age 50 years will derive no benefit from the polypill regardless of existing CVRFs, whereas those with a CACS of >100 will derive the best benefit. This strategy will reduce the number of qualified subjects for treatment with the polypill by 60%. Greater benefits will be derived with the combination of CACS and FRS. Additionally, other issues will have to be considered before approval of a polypill, and these issues will be discussed in this concise review. In conclusion, a polypill treatment strategy may be effective in the prevention of CVD and stroke, but, to be cost-effective, it may be reasonable to target patients with a high CACS and FRS.

Background Subclinical hypothyroidism (SCH) is an asymptomatic condition associated with increased thyroid‐stimulating hormone (TSH) >4 mIU/L with normal thyroxine (T4) and triidothyronine (T3) levels. It is more common in older subjects and especially in women with an overall incidence of 10%. Objective Because the normal TSH levels increase with age up to 7.5 mIU/L in older people, several studies have reported either no benefits whereas others have reported the benefits of treatment. These studies have caused a great debate over the treatment of SCH, especially in older subjects. Therefore, the objective of this study was to review the current evidence over this debate by reviewing the recent literature on the subject to discern whether treatment of SCH is necessary and under what circumstances. Methods To get a better perspective on the current debate over treatment of SCH, a focused Medline search of the English language literature was conducted from 2012 to 2019 using the terms, hypothyroidism, subclinical, dyslipidaemia, cardiovascular disease, heart failure and 38 papers with pertinent information were selected. Results The analysis of results from these papers indicated that the normal levels of TSH are increasing with the advancement of age from 4 mIU/L up to 7.5 mIU/L for patients ≥75 years of age. Also, several of reviewed studies have shown no benefits of treatment whereas, others have shown definite benefits of treatment with levothyroxine supplementation on the clinical and metabolic effects of SBH with reductions in CVD, HF and mortality. The treatment is more effective in younger persons and less so in older persons. Conclusions Based on the overall evidence, treatment of SCH is indicated in younger persons with a TSH level >4.0 mIU/L. In older subjects, treatment should be individualised and based on the presence of symptoms, the level of TSH, and initiated at TSH levels ≥10 mIU/L and at low doses to avoid adverse cardiovascular effects from overtreatment.

There is great interest lately, in the use of herbs for the treatment of hypertension and cardiovascular disease (CVD). Herbs and plants contain many phytochemicals that have been effective in the treatment of CVD and hypertension. Accumulating scientific evidence provides a reason for the use of herbs by health practitioners for treating their patients. The rationale for this expanding use of herbs is the belief of patients in a “holistic medicine” and that herbs are natural, safe, and effective. However, there are reasons of concern with the use of herbs, because they are not regulated or supervised carefully and their use could lead to serious complications or interactions with their combination with traditional medicines. In addition, their use is associated with significant out of pocket expenses, because their use is not compensated by health insurance providers. In this review, we present the scientific evidence for the use of herbs.

Phosphodiesterase 5 (PDE 5) inhibitors are selective inhibitors of the enzyme PDE 5, which catalyzes the hydrolysis of cyclic guanosine monophosphate (cGMP), a potent vasodilator and nitric oxide (NO) donor, to its corresponding metabolites (monophosphates). The enzyme PDE 5 is widely distributed in the body, including the heart and blood vessels. Because of its distribution, it was hypothesized that its inhibition could lead to significant coronary vasodilation, which would benefit patients with coronary artery disease (CAD). This hypothesis led to the development of PDE 5 inhibitors with the first being sildenafil citrate. Subsequent studies with sildenafil in patients with CAD demonstrated a modest cardiovascular effect, but a potent action on penile erection in men, resulting in sildenafil becoming a first-line therapy of erectile dysfunction (ED). Subsequently, two more PDE 5 inhibitors (vardenafil and tadalafil) were developed and approved by the Food and Drug Administration (FDA) for the treatment of ED. Recent studies have shown several pleiotropic beneficial effects of PDE 5 inhibitors in patients with CAD, hypertension, heart failure, pulmonary arterial hypertension, diabetes mellitus and Raynaud’s phenomenon. Side effects and interactions of PDE 5 inhibitors with other drugs have been minimal, with the exception of their coadministration with nitrates, which could lead to severe vasodilation and hypotension and therefore, their coadministration is prohibited. All these pleiotropic cardiovascular effects of PDE 5 inhibitors and their drug interactions will be discussed in this concise review in the context of the American College of Cardiology / American Heart Association guidelines and the recent developments in this field.

The prevalence of hypertension is high in patients with diabetes mellitus (DM), chronic kidney disease (CKD) and chronic cardiovascular disease (CVD), as well as in black and elderly subjects. In addition, these subjects have the lowest control of blood pressure (BP) among the hypertensive population, and also the risk of having a morbid or fatal cardiovascular event >20% in 10 years. For these reasons, aggressive control of BP to <130/80 mm Hg for these subjects is strongly recommended by National and International guidelines. To accomplish this goal, combination therapy with two or more antihypertensive drugs with a complementary mechanism of action is necessary. Drugs that block the renin-angiotensin system (RAS) in combination with a calcium channel blocker (CCB) and a diuretic have been shown to be the most effective combinations to accomplish this goal. However, this will require the administration of multiple drugs given separately, which will decrease the patient compliance and adherence to treatment. Poor patient compliance and adherence to treatment is a major factor for poor BP control. Several studies have shown that patient compliance is inversely related to the number of drugs being administered. To overcome this problem, several dual and triple-drug, fixed-dose combinations with a RAS blocker, a CCB and a diuretic have been developed and marketed, which are easier to administer, and have been shown to increase patient compliance and adherence to treatment. In this concise review, the effectiveness and safety of the fixed-dose, triple-combination of the RAS blocker olmesartan medoxomil, the CCB amlodipine besylate and the diuretic hydrochlorothiazide, as well as other similar combinations for the treatment of hypertension, will be discussed. These drug combinations have been shown to be effective, safe and well tolerated by most patients.

Background: The cardiovascular disease (CVD) continuum is a chain of events that begins with a host of risk factors, including dyslipidemia, hypertension, diabetes, visceral obesity, and smoking. If left untreated, it might progress to atherosclerosis, left ventricular hypertrophy, coronary artery disease, myocardial infarction, left ventricular remodeling, left ventricular enlargement, and eventually endstage heart disease and death. Initiation of treatment, at any stage in its course, might prevent or delay its further progression. Objective: This review discusses data from doubleblind, randomized controlled trials (RCTs) that have investigated the effects of angiotensin II receptor blockers (ARBs) on various stages of the CVD continuum. Methods: PubMed/MEDLINE was searched for relevant English-language double-blind RCTs using the years 1995 to 2008 and the terms angiotensin type II receptor blocker, renin-angiotensin system, hypertension, heart failure, left ventricular hypertropby, renal disease, stroke, and cerebrovascular disease. Results: A total of 13 studies were included in this review. The results suggest that ARB-based therapy has cardioprotective, cerebroprotective, and renoprotective effects, including regression of left ventricular hypertrophy, reduction in the risk of stroke, and slowing of the progression of renal disease. Conclusions: Treatment of CVD risk factors, including hypertension, is increasingly recognized as a way to interrupt the CVD continuum. Activation of the renin-angiotensin system (RAS) contributes to the development and progression of CVD, and RAS blockade has been reported to be beneficial at all stages of the CVD continuum.

Background Patients with hypertension and cardiovascular disease (CVD), diabetes, or chronic kidney disease (CKD) usually require two or more antihypertensive agents to achieve blood pressure (BP) goals. Methods The efficacy/safety of olmesartan (OM) 40 mg, amlodipine besylate (AML) 10 mg, and hydrochlorothiazide (HCTZ) 25 mg versus the component dual-combinations (OM 40/AML 10 mg, OM 40/HCTZ 25 mg, and AML 10/HCTZ 25 mg) was evaluated in participants with diabetes, CKD, or chronic CVD in the Triple Therapy with Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide in Hypertensive Patients Study (TRINITY). The primary efficacy end point was least squares (LS) mean reduction from baseline in seated diastolic BP (SeDBP) at week 12. Secondary end points included LS mean reduction in SeSBP and proportion of participants achieving BP goal (<130/80 mm Hg) at week 12 (double-blind randomized period), and LS mean reduction in SeBP and BP goal achievement at week 52/early termination (open-label period). Results At week 12, OM 40/AML 10/HCTZ 25 mg resulted in significantly greater SeBP reductions in participants with diabetes (−37.9/22.0 mm Hg vs −28.0/17.6 mm Hg for OM 40/AML 10 mg, −26.4/14.7 mm Hg for OM 40/HCTZ 25 mg, and −27.6/14.8 mm Hg for AML 10/HCTZ 25 mg), CKD (−44.3/25.5 mm Hg vs −39.5/23.8 mm Hg for OM 40/AML 10 mg, −25.3/17.0 mm Hg for OM 40/HCTZ 25 mg, and −33.4/20.6 mm Hg for AML 10/HCTZ 25 mg), and chronic CVD (−37.8/20.6 mm Hg vs −31.7/18.2 mm Hg for OM 40/AML 10 mg, −30.9/17.1 mm Hg for OM 40/HCTZ 25 mg, and −27.5/16.1 mm Hg for AML 10/HCTZ 25 mg) ( P <0.05 for all subgroups vs dual-component treatments). BP goal achievement was greater for participants receiving triple-combination treatment compared with the dual-combination treatments, and was achieved in 41.1%, 55.0%, and 38.9% of participants with diabetes, CKD, and chronic CVD on OM 40/AML 10/HCTZ 25 mg, respectively. At week 52, there was sustained BP lowering with the OM/AML/HCTZ regimen. Overall, the triple combination was well tolerated. Conclusions In patients with diabetes, CKD, or chronic CVD, short-term (12 weeks) and long-term treatment with OM 40/AML 10/HCTZ 25 mg was well tolerated, lowered BP more effectively, and enabled more participants to reach BP goal than the corresponding 2-component regimens. Trial Identification Number NCT00649389