During the follow-up study the mean rate of GFR decline per month decreased from 0.44 (SD 0.54) mL/min per 1.73 m2 in the core study to 0.10 (0.50) mL/min per 1.73 m2 in patients originally randomised to ramipril (p=0.017), and from 0.81 (1.12) to 0.14 (0.87) mL/min per 1.73 m2 in those originally randomised to placebo plus conventional antihypertensive therapy (p=0.017). At the final visit, mean absolute GFR values were 12 mL/min per 1.73 m2 higher (33% better) in patients randomised to ramipril than in those assigned placebo (n=26 and 17, respectively: 35.5 [19.0] vs 23.8 [9.4] mL/min per 1.73 m2, p=0.01). 19 of the patients originally on ramipril versus 35 switched from placebo to ramipril progressed to ESRF (p=0.027) during the whole observation period; of these, six (8%) versus 14 (16%) reached that endpoint during the follow-up study; and the risk ratios were 1.86 (95% CI 1.07-3.26) over the whole observation period and 2.95 (1.13-7.68) during follow-up. Beyond follow-up at month 36, the incidence of ESRF was zero in patients originally randomised to ramipril but 30% in patients on placebo plus conventional antihypertensive therapy.
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We performed a descriptive gender-related analysis of regional safety data, obtained from the spontaneous reporting system.
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To investigate the effect of Shenqi Compound Formula (SCF) on peroxisome proliferators-activated receptor gamma (PPARgamma) in white adipose tissue of rats with macrovascular lesion in early stage of diabetes.
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Aldosterone (0.2 to 6 microg. mouse(-1) x d(-1)) was administered to E(0) mice alone or in combination with eplerenone (200 mg x kg(-1) x d(-1)), ramipril (5 mg x kg(-1) x d(-1)), or losartan (25 mg x kg(-1) x d(-1)). Mouse aortic atherosclerotic lesion area and macrophage and aortic oxidative status were evaluated. Aldosterone administration enhanced the mouse atherosclerotic lesion area by 32%. Mouse peritoneal macrophages and aortic segments from aldosterone-treated mice exhibited increased superoxide anion formation by up to 155% and 69%, respectively, and this effect was probably mediated by NADPH oxidase activation, because increased translocation of its cytosolic component p47phox to the macrophage plasma membrane was observed. THP-1 macrophages incubated in vitro with aldosterone (10 micromol/L) exhibited a higher capacity to release superoxide ions by 110% and increased ability to oxidize LDL by 74% compared with control cells. Aldosterone administration enhanced mouse peritoneal macrophage ACE activity and mRNA expression by 2.3-fold and 2.4-fold, respectively. Only cotreatment of eplerenone with ramipril or losartan completely blocked the oxidative effects of aldosterone.
In DIABHYCAR, the primary outcome and most of its components were not affected by the ACE insertion/deletion genotype. Only renal outcome was favored by the I allele (P = 0.03). The risk of myocardial infarction was not affected by ACE genotype, but the probability of fatal outcome increased with the number of D alleles (P < 0.03). In SURDIAGENE, the association between the ACE I allele and renal outcome was not replicated. In DIAB2NEPHROGENE, no association was found with nephropathy.
It is now clear that angiotensin-converting enzyme (ACE) inhibitor treatment after myocardial infarction (MI) reduces mortality and morbidity. However, the benefits of ACE inhibition are not homogeneous and are largely confined to high-risk patients who have subjective or objective evidence of left ventricular (LV) dysfunction. How long treatment should continue is a vexed question, which also arises with other agents, for example beta-blocker use after MI. The AIREX study assessed the long-term magnitude and duration of the survival benefits observed with ramipril in patients after MI who have clinically defined heart failure. The mortality status of all 603 patients recruited from the UK centres involved in the AIRE study was verified at an extended 5-year follow-up (3 years after the AIRE study closed). Ramipril assignation was associated with a 36% relative and a 11% absolute mortality risk reduction. These findings strongly support the view to select patients on the basis of impaired LV function and reinforce the previously reported conclusions of the "selective" ACE inhibition post-MI trials. Using this approach, the survival benefit is not only of large magnitude but also sustained over many years. These results also argue for life-long treatment with an ACE inhibitor, once a decision to treat an individual patient after MI has been made.
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In the Angiotensin-converting enzyme Post-Revascularization Study (APRES), 159 patients who underwent invasive revascularization for chronic angina and who had not had heart failure, acute myocardial infarction (AMI), or severe left ventricular dysfunction were randomized to receive 10 mg of ramipril or placebo. During the 12- to 46-month follow-up, the Specific Activity Scale class, exercise tests, and SF-36 quality of life scores were serially assessed.
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The SHR failed to develop reparative angiogenesis in response to ischemia, thus having inadequate perfusion recovery. Ramipril reduced both tail-cuff systolic blood pressure (180 +/- 7 v 207 +/- 2 mm Hg in the vehicle group at 28 days, P < .05) and intra-arterial mean blood pressure (115 +/- 6 v 135 +/- 5 mm Hg in the vehicle group, P < .05). These effects were associated with increased responsiveness to endothelium-dependent vasodilatation by acetylcholine. Treatment with ramipril did not influence muscular capillary and arteriole density but accelerated the rate of perfusion recovery, leading to complete healing within 28 days after surgery.
A total of 1,192,082 ACE inhibitors and 175,668 losartan initiators were included. The risk of hospitalization for pneumonia was significantly higher for captopril (hazard ratio 1.94, 95% CI 1.82-2.07), enalapril (hazard ratio 1.14, 95% CI 1.07-1.22), fosinopril (hazard ratio 1.11, 95% CI 1.02-1.21), perindopril (hazard ratio 1.14, 95% CI 1.04-1.25), and ramipril (hazard ratio 1.11, 95% CI 1.02-1.22), as compared with losartan. Captopril was associated with a significantly increased risk of pneumonia mortality (hazard ratio 2.43, 95% CI 1.79-3.31).
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The estimated efficacy and associated C/E of ramipril in HOPE, MICRO-HOPE and the AIRE study is extremely sensitive to the selected time horizon. Economic analyses beyond the duration of randomized clinical trials are required to fully evaluate the potential costs and benefits of long-term preventive therapies.
Dual blockade with ramipril enhanced the antialbuminuric efficacy of telmisartan and further reduced blood pressure. The effect of dual blockade was more pronounced in the macroalbuminuric subjects and it was well tolerated. However, careful monitoring of serum potassium is required.
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Nonmodulating (NMHT) is a high-renin subtype of salt sensitive hypertension, which additionally develops insulin resistance and oxidative stress. Conversely, modulating hypertensives (MHT) normally regulates renal hemodynamics after high sodium intake without metabolic impairment. We postulate that telmisartan, an angiotensin receptor blocker with partial peroxisome proliferators-activated receptorgamma partial agonist, may improve insulin resistance compared with ramipril, an angiotensin-converting enzyme inhibitor (ACEI) in NMHT.
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The use of angiotensin-converting enzyme (ACE) inhibitors has increased markedly during the last decade. It has been claimed that doses of ACE inhibitors prescribed in clinical practice are considerably lower than the target doses used in randomized clinical trials. The aim of the study was to investigate dosing of ACE inhibitors in patients discharged from the hospital after an acute myocardial infarction (AMI) and, furthermore, to compare these doses with the doses actually reached in clinical trials.
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Angiotensin receptor blockers (ARB) and angiotensin converting enzyme (ACE) inhibitors are known to reduce proteinuria. Their combination might be more effective than either treatment alone, but long-term data for comparative changes in renal function are not available. We investigated the renal effects of ramipril (an ACE inhibitor), telmisartan (an ARB), and their combination in patients aged 55 years or older with established atherosclerotic vascular disease or with diabetes with end-organ damage.
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In the DREAM trial, involving more than 5000 patients with "impaired glucose tolerance", ramipril had no preventive effect, while rosiglitazone had cardiac adverse effects.
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20 patients with angiographically documented stable coronary artery disease (CAD) were prospectively treated with 5 mg of ramipril per day for 4 weeks. Before and weekly after the initiation of ramipril therapy, EPCs were isolated from peripheral blood and counted. Ramipril treatment of patients with stable CAD was associated with an approximately 1.5-fold increase in the number of circulating EPCs by 1 week after initiation of treatment; this was followed by sustained increased levels to approximately 2.5-fold throughout the 4-week study period. In addition, ramipril treatmen was associated with increases in the functional activity of EPCs, as assessed by their proliferation, migration, adhesion and in vitro vasculogenesis capacity.
ZDF rats showed increased renal accumulation of the AGE subtypes 3-deoxyglucosone-imidazolone, pentosidine and CML by about 40, 55 and 55%, respectively compared with heterozygous, non-diabetic control animals at the age of 37 weeks. AVE7688 but not ramipril attenuated the renal accumulation of 3-deoxyglucosone-imidazolone, pentosidine and CML and improved CML clearance in ZDF rats. During glycation reactions in vitro, AVE7688 also demonstrated potent chelating activity and inhibited metal-catalysed formation of pentosidine and CML.
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Solid lipid nanoparticles are typically spherical with an average diameter between 1 and 1000 nm. It is an alternative carrier system to tradition colloidal carriers, such as, emulsions, liposomes, and polymeric micro and nanoparticles. Ramipril is an antihypertensive agent used in the treatment of hypertension. Its oral bioavailability is 28% and it is rapidly excreted through the renal route. This drug has many side effects such as, postural hypotension, hyperkalemia, and angioedema, when given as an immediate dosage form. To overcome the side effects and to increase the bioavailability of ramipril, solid lipid nanoparticles of ramipril are prepared by using lipids (glyceryl monostearate and glyceryl monooleate) with stabilizers (tween 80, poloxamer 188, and span 20). The prepared formulations have been evaluated for entrapment efficiency, drug content, in-vitro drug release, particle size analysis, scanning electron spectroscopy, Fourier transform-infrared studies, and stability. A formulation containing glyceryl monooleate, stabilized with span 20 as surfactant showed prolonged drug release, smaller particle size, and narrow particle size distribution, as compared to other formulations with different surfactants and lipids.
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In the presence of indomethacin (10 microM) and without previous exposure to bradykinin, two angiotensin-converting enzyme (ACE) inhibitors, moexiprilat and ramiprilat (0.1 microM), elicited distinct relaxation responses from preconstricted endothelium-intact but not from denuded bovine coronary artery rings, and enhanced the relaxation response to bradykinin (3 nM). All of these responses were strongly reduced by the selective B2-kinin receptor antagonist Hoe 140 (0.1 microM). Bradykinin (30 nM), moexiprilat or ramiprilat (0.3 microM) also significantly increased the cyclic GMP content of these coronary segments, an effect which was abolished by the nitric oxide (NO) synthase inhibitor NG-nitro-L-arginine (L-NNA; 30 microM) or by removal of the endothelium. L-NNA also strongly reduced the relaxation response to moexiprilat but only partially inhibited that to bradykinin, demonstrating that the ACE inhibitor-induced relaxation was predominantly mediated by endothelial NO release, whereas bradykinin acted in part through another endothelium-dependent mechanism. These findings suggest that ACE inhibitors induce endothelium-dependent relaxation presumably by facilitating the accumulation of endothelium-derived vasoactive kinins in or at the vessel wall. This local mechanism may significantly contribute to the dilator action of these compounds in vivo.
The development and validation of a reversed-phase liquid chromatographic method for the determination of the related substances of 2-[N-[(S)-1-Ethoxycarbonyl-3-phenylpropyl]-L-alanyl]-(1S, 3S, 5S)-2-azabicyclo[3.3.0]octane-3-carboxylic acid (ramipril) in Altace capsules is described. The method utilizes an ion-pairing agent and a simple two-step gradient for the separation of ramipril and ten related substances from each other in a 40-min run time. Four of the related substances are ramipril diastereomers. To the best of our knowledge, no method described previously in the literature has demonstrated resolution of ramipril from this set of related substances. No method for the determination of the related substances of ramipril is currently described in the United States Pharmacopoeia or the European Pharmacopoeia. The proposed method was validated with respect to accuracy, precision, linearity, and specificity. Also, the method was determined to be robust with regards to the following parameters: mobile phase apparent pH: mobile phase organic content: mobile phase perchlorate concentration; detection wavelength and time dependence of sample and standard stability.
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The results of the HOPE ("Heart Outcomes Prevention Evaluation") study were presented at the XXIst Congress of the European Society of Cardiology in Barcelona (August 28-September 1, 1999). In addition, results obtained in the large diabetic sub-population (38% of the 9541 patients included in the trial) were reported at the XXXVth Congress of the European Association for the Study of Diabetes in Brussels (September 28-October 2, 1999). The HOPE trial was terminated early because of a reduction of the relative risk (-22%, p < 0.000002) of major cardiovascular events in the group treated with ramipiril compared to the group receiving placebo. Such a favourable effect of ramipril was observed in non-diabetic subjects in secondary prevention and in diabetic patients in secondary or primary prevention. In the latter population, a significant reduction in the incidence of microangiopathic complications (nephropathy and retinopathy) was also demonstrated.
Adult rat ventricular cardiomyocytes were isolated and cultured. mRNA expression of ACE was investigated by RT-PCR, AP-1 activation by gel mobility shift assays, and cardiac contractile performance by electrical pacing of isolated cells and analysis of cell shortening via a line-camera.
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Recurrent focal segmental glomerulosclerosis (FSGS) after renal transplantation with nephrotic syndrome is a serious problem with a high risk of graft loss. The therapeutic role of renin-angiotensin-system (RAS) blockers in recurrent FSGS is not clear. We present the safety and efficacy of an intensified triple RAS blockade with an ACE-inhibitor, an AT 1 receptor blocker and the direct renin inhibitor aliskiren in a 29-year-old renal transplant recipient with biopsy proven recurrence of FSGS and relapsing severe nephrotic syndrome. We subsequently used full dose ramipril, candesartan and aliskiren under a close monitoring of kidney function and electrolytes and examined the effect on proteinuria, clinical course and tolerability over 12 months. We found a significant and sustained antiproteinuric effect under triple RAS blockade. RAS blockade was generally well tolerated. This can offer a new therapeutic approach in selected hypertensive patients with recurrent FSGS.