Benicar is used for treating high blood pressure, alone or with other medicines. It may also be used for other conditions.
Other names for this medication:
Also known as: Olmesartan.
Benicar is an angiotensin II receptor antagonist. It works by inhibiting the action of a chemical transmitter (angiotensin II) and allowing the blood vessels to dilate (widen) and the kidneys to eliminate extra sodium and fluids. These actions combine to help lower blood pressure.
Generic name of Benicar is Olmesartan.
Benicar is also known as Olmesartan, Olmetec, Olmezest, Olmecip.
Brand name of Benicar is Benicar.
Take Benicar orally with or without food.
If you want to achieve most effective results do not stop taking Benicar suddenly.
If you overdose Benicar and you don't feel good you should visit your doctor or health care provider immediately.
Store your medicine at room temperature between 15 and 30 degrees C (59 and 86 degrees F) away from moisture and heat. Throw away any unused medicine after the expiration date. Keep out of the reach of children and in a container that small children cannot open.
The most common side effects associated with Benicar are:
Side effect occurrence does not only depend on medication you are taking, but also on your overall health and other factors.
Do not take Benicar if you are allergic to Benicar components.
Do not take Benicar if you're pregnant or you plan to have a baby, or you are a nursing mother.
Avoid machine driving.
Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment.
Be careful if you use salt substitute or a product that has potassium in it.
Do not stop taking Benicar suddenly.
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To develop a population pharmacokinetic model for olmesartan (RNH-6270), the active metabolite of olmesartan medoxomil, in healthy volunteers and hypertensive patients, and to evaluate effects of covariates on the apparent oral clearance (CL/F), with particular emphasis on the effect of race.
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Participants were randomized to OM 40/AML 10 mg, OM 40/HCTZ 25 mg, AML 10/HCTZ 25 mg, or OM 40/AML 10/HCTZ 25 mg during the double-blind phase. During the open-label extension, all participants received OM 40/AML 5/HCTZ 12.5 mg; participants not reaching BP goal within 2 weeks were randomly titrated to OM 40/AML 10/HCTZ 12.5 mg or OM 40/AML 5/HCTZ 25 mg, then to OM 40/AML 10/ HCTZ 25 mg after another 2 weeks.
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The safety and efficacy of an amlodipine/olmesartan medoxomil (OM)-based titration regimen was assessed in patients with type 2 diabetes mellitus and hypertension. After a 2- to 3-week placebo run-in period, 207 patients received amlodipine 5 mg and were uptitrated to amlodipine/OM 5/20, 5/40, and 10/40 mg and then amlodipine/OM 10/40 mg plus hydrochlorothiazide 12.5 and 25 mg in a step-wise manner at 3-week intervals if the seated blood pressure (BP) remained ≥120/70 mm Hg. The primary end point was the change from baseline in the mean 24-hour ambulatory systolic BP after 12 weeks of treatment. The baseline mean ± SD seated cuff systolic/diastolic BP was 158.8 ± 13.1/89.1 ± 10.1 mm Hg and the mean ± SD 24-hour ambulatory systolic/diastolic BP was 144.4 ± 11.7/81.6 ± 9.8 mm Hg. At week 12, the change from baseline in the mean ± SEM 24-hour ambulatory systolic/diastolic BP was -19.9 ± 0.8/-11.2 ± 0.5 mm Hg (p<0.0001 vs baseline), and 70% of patients had achieved a 24-hour ambulatory BP target of <130/80 mm Hg. At the end of 18 weeks of active treatment in patients uptitrated to amlodipine/OM 10/40 mg plus hydrochlorothiazide 25 mg, the change from baseline in the mean ± SEM seated BP was -28.0 ± 1.5/-13.7 ± 1.0 mm Hg (p<0.0001 vs baseline), with 62% of patients reaching the guideline-recommended seated BP goal of <130/80 mm Hg. Drug-related treatment-emergent adverse events occurred in 19.3% of patients. The most frequent events were peripheral edema (6%), dizziness (3%), and hypotension (2%). In conclusion, this amlodipine/OM-based titration regimen was well tolerated and effectively lowered BP throughout the 24-hour dosing interval in patients with hypertension and type 2 diabetes.
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Angiotensin II type 1 (AT1) receptor antagonists (angiotensin receptor blockers [ARBs]) are widely used for the treatment of not only hypertension but also cardiac dysfunction. B-type natriuretic peptide (BNP) is secreted mainly by the cardiac ventricle and plays an important role in the regulation of blood pressure (BP) and body fluid. It has been established that the plasma level of BNP is increased in patients with chronic heart failure in proportion to the severity of cardiac dysfunction. Because cardiac dysfunction is closely associated with a high risk of mortality in patients with diabetes mellitus, early identification and prevention of cardiac dysfunction are important. The objective of this study was to determine the effects of olmesartan medoxomil, a novel ARB, on the plasma level of BNP in hypertensive patients with type 2 diabetes.
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Recently, a novel device for measuring the cardio-ankle vascular index (CAVI) as an arterial stiffness parameter has been developed. In this study, we evaluated the effect of angiotensin II receptor blocker (ARB) and calcium channel (Ca) blocker on CAVI in type 2 diabetic patients with hypertension.
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This study investigated an aggressive treatment program for stage 2 systolic hypertension (pretreatment systolic blood pressure [SBP] > or = 160 mm Hg) using the angiotensin receptor blocker olmesartan medoxomil (OM) and hydrochlorothiazide (HCTZ). In this open-label, 16-week trial, 170 subjects received OM 20 mg/d for 3 weeks. If seated SBP/diastolic BP remained > or = 120/80 mm Hg, subjects were advanced to successive 3-week courses of OM 40 mg/d, OM/HCTZ 40/12.5 mg/d, and OM/HCTZ 40/25 mg/d. OM 20 mg/d reduced mean SBP by 16.9 mm Hg (P<.001), and there were further dose-dependent decreases in mean SBP to a maximum of 34.5 mm Hg with OM/HCTZ 40/25 mg/d. At study end, 75.1% of subjects achieved SBP goal (<140 mm Hg) and 16.0% achieved SBP normalization (<120 mm Hg). Treatment was well tolerated at all doses. The addition of HCTZ did not change serum potassium levels but resulted in a dose-independent but not symptomatic increase in serum glucose and uric acid. The authors conclude that an OM-based regimen, with or without HCTZ in conventional doses, is effective in controlling and normalizing BP in stage 2 systolic hypertension.
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Synthesis of new ester prodrugs of olmesartan is described. Their in vitro stabilities in simulated gastric juice, rat plasma, and rat liver microsomes were tested. And the pharmacokinetic parameters for olmesartan after their oral administration were also estimated and compared with those in case of olmesartan medoxomil. Compounds 13 and 14 demonstrated high stability in simulated gastric juice and were rapidly metabolized to olmesartan in rat liver microsomes and rat plasma in vitro. In addition, C(max) and AUC(last) parameters were significantly increased in case of compounds 13 and 14 compared with olmesartan medoxomil. These results indicate that compounds 13 and 14 with cyclohexylcarboxyethyl and adamantylcarboxymethyl promoieties, respectively, are promising prodrugs of olmesartan with markedly increased oral bioavailability.
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Angiotensin II receptor blockers have shown widespread efficacy as antihypertensive medications. These agents bind selectively to angiotensin II type 1 (AT(1)) receptors, specifically blocking the renin-angiotensin system at the last step in its cascade. CS-866 is the most recently introduced drug in this class. This article presents integrated safety and efficacy data from 7 randomized, double-blind, placebo-controlled, parallel group studies in which once-daily CS-866 monotherapy was used in the treatment of patients with essential hypertension (sitting diastolic blood pressure > or =100 mm Hg and < or =115 mm Hg). Data from a total of 2,145 CS-866-treated patients were included in the efficacy analysis. Safety data were available from 2,540 CS-866-treated patients, with a cumulative exposure of 5,888 patient-months. The antihypertensive efficacy of the drug was assessed using both cuff blood pressure measurements and 24-hour ambulatory blood pressure monitoring. The data show that CS-866 is effective and safe for the treatment of hypertension. Dose-dependent reductions in both diastolic and systolic blood pressures occurred within 1 week of initiating treatment, and the response was almost maximal within 2 weeks. There was no difference in efficacy between younger (<65 years) and older (> or =65 years) groups of patients. Trough-to-peak ratios showed that CS-866 retains the majority of its peak effect 24 hours after treatment, and is therefore suitable for once-daily dosing. Dizziness was the only treatment-emergent adverse event with which CS-866 was associated.
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In patients with essential hypertension, 12 weeks of treatment reduced mean seDBP (primary efficacy parameter) by 17.9 mmHg; mean seSBP was also significantly reduced. At study end (week 52), the proportion of diastolic responders (seDBP < or =90 mmHg) was 93%. In patients with isolated systolic hypertension, mean seSBP was reduced by 30.0 mmHg at week 12 (primary efficacy parameter); mean seDBP was only slightly reduced. At study end (week 24), the proportion of systolic responders (seSBP < or =135 mmHg) was 62.5%. Reductions in blood pressure (BP) were maintained throughout treatment in both patient populations. In each study, doubling the olmesartan medoxomil dose from 20 to 40 mg/day or adding hydrochlorothiazide delivered additional BP-lowering efficacy without any tolerability concerns, and the Integrated Summary of Safety also showed that olmesartan medoxomil with or without hydrochlorothiazide was well tolerated. Efficacy and safety results were similar in elderly (65-74 years) and very elderly (> or =75 years) patients.
Effective treatment of high blood pressure represents a key strategy for reducing the burden of hypertension-related cardiovascular diseases. In spite of these well-established concepts, hypertension remains poorly controlled worldwide. In addition, treated hypertensive patients often remain at higher risk compared with the normotensive population, even when a satisfactory blood pressure control is achieved, owing to a high or very high added cardiovascular risk profile. An emerging strategy to improve blood pressure control in hypertensive patients is a more extensive use of combination therapy than monotherapy in the daily clinical practice. Within the possible antihypertensive drug combinations currently available for the clinical management of hypertension, those based on the association of drugs inhibiting the renin-angiotensin system and thiazide diuretics or calcium channel-blockers have demonstrated to be effective and safe in lowering both systolic and diastolic blood pressure levels with a good tolerability profile. This article provides an overview of fixed-combination strategies, with a particular focus on the fixed-combination strategies based on olmesartan medoxomil.
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Reversal of left ventricular (LV) hypertrophy is an important goal of antihypertensive therapy. This phase 3b study compared the ability of the angiotensin receptor blocker olmesartan medoxomil with the calcium channel blocker amlodipine besylate to induce regression of LV hypertrophy and vascular hypertrophy after achieving blood pressure (BP) goal. After a washout phase, 102 patients with hypertension and LV hypertrophy were randomized to olmesartan medoxomil 20 mg/day, up titrated to 40 mg/day, or amlodipine 5 mg/day, up titrated to 10 mg/day, for up to 4 weeks until a BP goal of <140/90 mm Hg (<130/85 mm Hg for diabetes) was achieved (hydrochlorothiazide 25 mg/day and terazosin 1 to 5 mg/day 2 times/day could be added if needed). Upon achieving the BP goal or by week 8, and again at weeks 26 and 52, assessments of LV mass and compliance and arterial structure and function were performed by echocardiography, Doppler flow, and arterial ultrasonography, respectively. There was no statistically significant percent change in LV mass at 52 weeks in either treatment group (11.6% with olmesartan medoxomil vs 2.9% with amlodipine) and no statistically significant difference between treatment groups. There were no significant changes in LV compliance or carotid or femoral artery wall-to-lumen ratios in either treatment group at 52 weeks. In conclusion, there did not appear to be a clinically significant BP-independent effect with olmesartan medoxomil or amlodipine on LV mass decrease, diastolic function or vascular structure, and compliance in patients with hypertension and LV hypertrophy.
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We allocated 40 male Wistar rats with 2-kidney, 1-clip renovascular hypertension (2K1C-RVH) to 4 groups (each n = 10) that were dialyzed using various solutions for 42 days as follows: Group I-10 mL pH 3.5 dialysis solution containing 1.35% glucose Group II-10 mL pH 3.5 dialysis solution, plus oral administration of CS866 5 mg/kg daily Group III-10 mL pH 3.5 dialysis solution, plus oral administration of the calcium channel blocker (CCB) amlodipine 3 mg/kg daily Group IV-10 mL pH 7.0 dialysis solution Dialysis solution was injected every day for 42 days.
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In this study in Japanese patients with essential hypertension, the reductions in daytime, nighttime, and early-morning BP assessed using 24-hour ABPM were significantly greater with combination OLM/AZL than with either monotherapy, regardless of dipping pattern at baseline. Japan Pharmaceutical Information Center registration number: JapicCTI-060286.
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To investigate the neointima formation and the expression of monocyte chemoattractant protein-1 (MCP-1) and tumor necrosis factor-alpha (TNF-alpha) in cuff-induced vascular injury in mouse model, and to examine the effect of angiotensin II type 1 receptor (AT1) blocker, olmesartan, on MCP-1 and TNF-alpha expression and consequently vascular remodeling.
In conclusion, SLN show promising approaches as a vehicle for oral delivery of drugs like OLM.
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In human fibroblasts, HGF significantly increased the production of matrix metalloprotease-1 (MMP-1) and urokinase plasminogen activator, whereas HGF also significantly attenuated the reduction of MMP-1 activity induced by Ang II. In contrast, HGF significantly decreased transforming growth factor (TGF)-beta mRNA stimulated by Ang II, whereas HGF also decreased basal TGF-beta protein level without affecting growth. Similarly, in rat cardiac fibroblasts, HGF inhibited the expression and production of TGF-beta, whereas HGF upregulated its specific receptor, c-met. Conversely, in vivo experiments revealed that administration of temocapril and CS-866 to cardiomyopathic hamsters resulted in a significant decrease in fibrotic area and increase in cardiac HGF concentration and mRNA (P<0.01), whereas cardiac concentration and mRNA of HGF were significantly decreased in cardiomyopathic hamsters. In contrast, mRNA expression of collagen III was markedly decreased by treatment with temocapril and CS-866.
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Current hypertension guidelines recommend using two antihypertensive agents when blood pressure (BP) control is not achieved with one single agent.
Olmesartan medoxomil is an angiotensin type II receptor blocker, antihypertensive agent, administered orally. It is highly lipophilic (log P 5.5) and a poorly water-soluble drug with absolute bioavailability of 26%. The poor dissolution rate of water-insoluble drugs is still a major problem confronting the pharmaceutical industry. The objective of the present investigation was to develop liquisolid compacts for olmesartan medoxomil to improve the dissolution rate. Liquisolid compacts were prepared using Acrysol El 135 as a solvent, Avicel PH 102, Fujicalin and Neusilin as carrier materials, and Aerosil as coating material in different ratios. The interaction between drug and excipients was characterized by DSC and FT-IR studies, which showed that there is no interaction between drug and excipients. The powder characteristics were evaluated by different flow parameters to comply with pharmacopoeial limits. The dissolution studies for liquisolid compacts and conventional formulations were carried out, and it was found that liquisolid compacts with 80% w/w of Acrysol EL 135 to the drug showed significant higher drug release rates than conventional tablets. Amongst carriers used Fujicalin and Neusilin were found to be more effective carrier materials for liquid adsorption.
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Following cerebral ischemia, i.v. infusion of angiotensin II increases cerebral edema and mortality. Angiotensin type 1 receptor blockage should therefore improve acute cerebral ischemia. Left middle cerebral artery occlusion (120 min) followed by reperfusion was performed with the thread method under halothane anesthesia in Sprague-Dawley rats. Olmesartan (angiotensin type 1 receptor blocker; 0.01 or 0.1mumol/kg/h) was infused i.p. for 7 days following middle cerebral artery occlusion followed by reperfusion. Stroke index score, infarct volume, specific gravity, and brain angiotensin II and matrix metalloproteinases were quantified in the ischemic and non-ischemic hemispheres. Olmesartan treatment improved stroke index score, infarct volume, and cerebral edema in our cerebral ischemia model. In particular, stroke index score, infarct volume, and cerebral edema were reduced even with a low dose of olmesartan that did not decrease blood pressure. Paralleling these effects on cerebral ischemia, olmesartan treatment also reduced the reactive upregulation in brain angiotensin II, matrix metalloproteinase-2, matrix metalloproteinase-9, and membrane type 1-matrix metalloproteinase in the ischemic area. Angiotensin type 1 receptor stimulation may be one of the important factors that cause cerebral edema following cerebral ischemia, and that its inhibition may be of therapeutic advantage in cerebral ischemia.
The implication of advanced glycation end products (AGE) in the pathogenesis of atherosclerosis and of diabetic and uremic complications has stimulated a search for AGE inhibitors. This study evaluates the AGE inhibitory potential of several well-tolerated hypotensive drugs. Olmesartan, an angiotensin II type 1 receptor (AIIR) antagonist, as well as temocaprilat, an angiotensin-converting enzyme (ACE) inhibitor, unlike nifedipine, a calcium blocker, inhibit in vitro the formation of two AGE, pentosidine and N(epsilon)-carboxymethyllysine (CML), during incubation of nonuremic diabetic, nondiabetic uremic, or diabetic uremic plasma or of BSA fortified with arabinose. This effect is shared by all tested AIIR antagonists and ACE inhibitors. On an equimolar basis, they are more efficient than aminoguanidine or pyridoxamine. Unlike the latter two compounds, they do not trap reactive carbonyl precursors for AGE, but impact on the production of reactive carbonyl precursors for AGE by chelating transition metals and inhibiting various oxidative steps, including carbon-centered and hydroxyl radicals, at both the pre- and post-Amadori steps. Their effect is paralleled by a lowered production of reactive carbonyl precursors. Finally, they do not bind pyridoxal, unlike aminoguanidine. Altogether, this study demonstrates for the first time that widely used hypotensive agents, AIIR antagonists and ACE inhibitors, significantly attenuate AGE production. This study provides a new framework for the assessment of families of AGE-lowering compounds according to their mechanisms of action.
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These results provide the first direct evidence that the long-term vascular effects of ADMA are not solely mediated by simple inhibition of endothelial NO synthesis. Direct upregulation of ACE and increased oxidative stress through AT(1) receptor appear to be involved in the long-term vascular effects of ADMA in vivo. This study demonstrates that asymmetrical dimethylarginine (ADMA) causes arteriosclerotic coronary lesions in mice in vivo through mechanisms other than simple inhibition of endothelial NO synthesis. Our findings should contribute to a better understanding of the pathophysiological role of ADMA in arteriosclerosis.
Cerebrovascular and cardiac adverse events can be significantly reduced by effective antihypertensive therapy; however, BP control rates remain poor. The objective of this randomized, double-blind, parallel-group, multicentre study was to determine the efficacy and safety of olmesartan medoxomil/amlodipine combination therapy in patients with moderate to severe hypertension who had failed to respond to treatment with 8 weeks of open-label amlodipine.
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The pathophysiological role of oxidative stress (OxSt) in hypertension and target organ damage is recognized. Angiotensin II (Ang II) induces OxSt via NAD(P)H oxidase activation and production of proinflammatory cytokines/growth factors leading to cardiovascular-renal remodeling. Ang II stimulates the RhoA/Rho kinase (ROCK) pathway, which is deeply involved in the development of cardiovascular-renal remodeling via OxSt induction. Olmesartan, an Ang II type 1 receptor blocker, possesses antioxidant and activating nitric oxide system-related effects, which we have shown in terms of p22(phox) reduction, heme oxygenase-1 and calcitonin gene-related peptide increase. This study evaluates in 15 untreated hypertensive patients the effect of olmesartan treatment on p63RhoGEF, key in Ang II-induced ROCK activation, and MYPT-1 phosphorylation, a marker of ROCK activity.
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Hydrolysis plays an important role in metabolic activation of prodrugs. In the current study, species and in vitro system differences in hepatic and extrahepatic hydrolysis were investigated for 11 prodrugs. Ten prodrugs in the data set are predominantly hydrolyzed by carboxylesterases (CES), whereas olmesartan medoxomil is also metabolized by carboxymethylenebutenolidase (CMBL) and paraoxonase. Metabolic stabilities were assessed in cryopreserved hepatocytes, liver S9 (LS9), intestinal S9 (IS9), kidney S9 (KS9), and plasma from human, monkey, dog, and rat. Of all the preclinical species investigated, monkey intrinsic hydrolysis clearance obtained in hepatocytes (CLint,hepatocytes) were the most comparable to human hepatocyte data. Perindopril and candesartan cilexetil showed the lowest and highest CLint,hepatocytes, respectively, regardless of the species investigated. Scaled intrinsic hydrolysis clearance obtained in LS9 were generally higher than CLint,hepatocytes in all species investigated, with the exception of dog. In the case of human and dog intestinal S9, hydrolysis intrinsic clearance could not be obtained for CES1 substrates, but hydrolysis for CES2 and CMBL substrates was detected in IS9 and KS9 from all species. Pronounced species differences were observed in plasma; hydrolysis of CES substrates was only evident in rat. Predictability of human hepatic intrinsic clearance (CLint,h) was assessed for eight CES1 substrates using hepatocytes and LS9; extrahepatic hydrolysis was not considered due to high stability of these prodrugs in intestinal and kidney S9. On average, predicted oral CLint,h from hepatocyte data represented 20% of the observed value; the underprediction was pronounced for high-clearance prodrugs, consistent with the predictability of cytochrome P450/conjugation clearance from this system. Prediction bias was less apparent with LS9, in particular for high-clearance prodrugs, highlighting the application of this in vitro system for investigation of prodrugs.
(1) The mean trough reduction in SeDBP from baseline in olmesartan group was significantly greater than that in losartan group after 4 weeks (11.72 mm Hg vs 9.23 mm Hg, P=0.004) and 8 weeks treatment (12.94 mm Hg vs 11.01 mm Hg, P=0.035). (2) The number and percentage of responders in olmesartan group (81, 65.3%) were statistically higher than those (68, 52.7%) in losartan group (P=0.028) after 4 weeks treatment and were similar between the two groups after 8 weeks treatment (P>0.05). (3) Individual and overall trough/peak ratios of DBP and SBP in 24-hour ambulatory blood pressure monitoring were higher in olmesartan group than losartan group. The hypotensive effect of olmesartan was more durable than losartan at 24 hour interval. (4) The incidence of study drug-related adverse events (AEs) in olmesartan group (10.5%) was similar as that in losartan group (13.9%, P>0.05). Most of these AEs were mild and transient.
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