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This FDA laboratory study examines the impact of tablet splitting, the effect of tablet splitters, and the presence of a tablet score on the dose uniformity of two model drugs.
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The proportion of the elderly population in Nepal, though low, is steadily increasing. Studies on drug utilisation among geriatric patients in Western Nepal, a region with the highest proportion of the elderly in all of Nepal, are lacking. The present study was carried out at the Manipal Teaching Hospital, a 700-bed teaching hospital in Pokhara, Western Nepal.
The reduction in DBP at 8 weeks was significantly greater in patients treated with the combination therapies compared with the respective monotherapies for all specified comparisons except amlodipine camsylate/losartan 10 mg/100 mg versus amlodipine 10 mg. The incidence of adverse events in the group of patients treated with the amlodipine camsylate/losartan 10 mg/50 mg combination tended to be higher than for any other group (27.9%, 12/43); however, the effect was not statistically significant.
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Few data exist about the incidence of drug-induced acute pancreatitis in the general population. Although angiotensin-converting enzymes are generally well tolerated, acute pancreatitis has been reported in a few subjects treated with captopril, enalapril, and lisinopril. However, to our knowledge, there is no published data regarding recurrent pancreatitis secondary to lisinopril. Herein, we report the case of a 54-year-old man who developed recurrent acute pancreatitis after starting lisinopril.
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Successful treatment of hypertension entails not only normalizing high blood pressure, but also addressing the associated risk factors that increase the likelihood of cardiovascular morbidity and mortality. Hypertension often occurs in a setting of insulin resistance, hyperinsulinemia, dyslipidemia, and a prothrombotic state. A number of epidemiologic studies have shown that the clustering of these abnormalities is associated with increased risk of cardiovascular morbidity and mortality. Therefore, it is rational to direct therapy at moderating these risk factors as well as at lowering blood pressure in hypertensive patients. This is particularly important in patients with comorbidities such as diabetes, cardiovascular disease, or renal insufficiency. Many physicians prescribe only diuretics and beta-blockers, agents that have demonstrated efficacy in long-term randomized controlled trials. However, this approach does not consider the potential benefits of newer agents for which long-term outcome data are not yet available. The ongoing Valsartan Antihypertensive Long-term Use Evaluation (VALUE) trial, in which the angiotensin II subtype 1 receptor blocker valsartan is compared with the third-generation calcium channel blocker amlodipine, should provide important evidence on the long-term efficacy of these newer agents. A unique feature of VALUE is that it is specifically enrolling into the only current trial, now under way, hypertensive men and women at a relatively high risk for a cardiovascular event to determine the benefits of complete blockade of angiotensin II beyond those of the control of blood pressure.
A total of 14 (13 females) subjects were identified with a first diagnosis of TAK during 2000-05 in the UKGPRD. The median age was 51.0 years (interquartile range 28-66). The overall annual incidence of TAK was 0.8/million (95% CI 0.4, 1.3). The incidence was stable throughout the study period. The mean prevalence of TAK was 4.7/million. There were six patients (five females) aged <40 years presenting in 2000-05 with TAK. The annual incidence in those aged <40 years was 0.3/million. In the NORVASC population, one case was identified (0.4/million/year) with three prevalent cases (7.1/million).
Maxacalcitol in a dose of 30 but not 15 µg/kg/day induced reduction in DO index, non-voiding contractions frequency (FNVC), and amplitude (ANVC), while increasing volume threshold to elicit non-voiding contractions (VTNVC). The 14-day-long administration of maxacalcitol at a dose of 15 µg/kg/day to animals, followed by GSK 269962 at a single dose of 10 mg/kg, led to a statistically significant reduction of intercontraction interval and bladder compliance, and an increase in DO index, without any effect on ANVC, FNVC, and VTNVC. The assessment of the combined effect of maxacalcitol (15 µg/kg/day) and amlodipine besylate (0.25 mg/kg) demonstrated an increase in intercontraction interval, bladder compliance and VTNVC, with a decrease in FNVC. No statistically significant changes were found in DO index and ANVC. The combined outcome of administering maxacalcitol (15 µg/kg/day) and oxybutynin chloride (0.25 mg/kg) did not show any statistically significant value of the measured cystometric parameters.
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To estimate 8-year health and economic outcomes of the angiotensin II receptor blocker valsartan versus the calcium channel blocker amlodipine in therapy of patients with type 2 diabetes and microalbuminuria based on clinical endpoints from a 6-month randomized controlled clinical trial, the MicroAlbuminuria Reduction With VALsartan (MARVAL) study.
Amlodipine enhances nitric oxide synthesis in cytokine-stimulated cultured vascular smooth muscle cells by L-type calcium channel-independent mechanisms.
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While the incidence and prevalence of stroke is gradually decreasing in the western world, a parallel increase is seen in the developing world. It is a matter of special concern to us as approximately 20-30% of stroke occur in people younger than 45 years in India. Indians are prone to higher stroke risk because of urbanization, diabetes, cigarette smoking and high incidence of hypertension. Unfortunately, there is an inadequate awareness about the risk of stroke with hypertension among general public. Hypertension is considered to be the most important risk factor for stroke, and all forms of hypertension are associated with an increased risk of both ischemic and haemorrhagic stroke. The presence of hypertension also worsens mortality in stroke. Recently, it has been increasingly observed that controlling blood pressure variability (BPV) is equally important as achieving BP reduction, and an increased BPV has been shown to increase stroke risk. Thus, effective treatment option for stroke prevention should include drugs which can reduce BPV as well. The landmark ASCOT-BPLA trial reported that the calcium channel blocker amlodipine decreases stroke risk in hypertensive patients, and attributed this beneficial effect to its effective lowering of BPV. Such beneficial effects of amlodipine were replicated in other trials as well and thus it becomes an important drug from an Indian perspective. In this review, we analyse published literature and present a picture on the effect of amlodipine in the stroke prevention in hypertensive patients.
Patients who had completed the double-blind study were re-randomized to losartan or enalapril and followed for proteinuria and renal function for up to 3 years.
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Azelnidipine, a dihydropyridine calcium channel blocker unlike other dihydropyridine calcium channel blockers, does not increase but slightly decreases heart rate (HR) in clinical settings. In the present study, the mechanism for the HR-lowering action characteristic of azelnidipine was investigated in anesthetized dogs. In the in situ perfused sinus node preparation, the negative chronotropic action of azelnidipine was almost 5 times more potent than that of amlodipine. When injected intravenously in intact anesthetized dogs, both drugs produced a long-lasting blood pressure reduction, but the action of azelnidipine developed more slowly than that of amlodipine. Azelnidipine hardly affected HR at lower doses and decreased HR at higher doses. On the other hand, amlodipine consistently induced slight tachycardia. The HR-lowering effect of azelnidipine in autonomically blocked dogs was not much different from that in intact dogs, whereas tachycardia induced by amlodipine was eliminated in autonomically blocked dogs. However, neither drug affected the HR gain of baroreceptor reflex induced by changing carotid sinus pressure. These results suggest that compared with amlodipine, azelnidipine has a greater intrinsic negative chronotropic action and induces a lower level of reflex tachycardia most probably due to a slower development of blood pressure-lowering effects and that these characteristics of azelnidipine underlies its HR-lowering effects when administered systemically.
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Haemodynamic responses at rest and during exercise were studied in 18 patients with essential hypertension following long-term treatment with amlodipine. Patients underwent a 2-week placebo run-in period followed by a mean duration of 11 months' treatment with amlodipine 5-10 mg (mean dose 9 mg) once daily. Blood pressure was measured intra-arterially, cardiac output by dye dilution and heart rate by electrocardiogram. Amlodipine produced a mean reduction in systolic and diastolic arterial pressure of 27 and 16 mm Hg, respectively, at rest and after exercise. At rest sitting, mean systolic and diastolic arterial pressures were reduced by 16 and 14% (p less than 0.01), respectively, from initial mean values of 182.4/111.2 mm Hg. This reduction in blood pressure was associated with a marked reduction in the total peripheral resistance index of 19% (p less than 0.001). Similar responses were observed at rest supine and during exercise. No significant changes were seen in heart rate. Stroke index showed a small increase at rest and during exercise together with a trend towards an increase in cardiac index after treatment with amlodipine. Ambulatory blood pressure monitoring was carried out in 10 patients after the placebo run-in and at the end of the study. Amlodipine showed effective blood pressure control throughout the 24 h after one daily dose. The incidence of side effects was low (ankle oedema in 2 patients).
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The amlodipine-based regimen reduced the relative risk of cardiovascular events more effectively than the atenolol-based regimen in both older and younger patients. However, because event rates were higher among older patients, the absolute benefits were greater for older compared with younger patients.
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Preclinical models of cocaine dependence have shown favorable reductions in cocaine use using dihydropyridine calcium channel antagonists. This is one of the first reports testing the efficacy of the long-acting calcium channel antagonist, amlodipine, for the treatment of cocaine dependence. This was a 12-week, double-blind, randomized, placebo-controlled, parallel patient group trial of amlodipine vs. placebo for the treatment of cocaine dependence. One hundred and sixteen subjects participated in a 12-week medication trial in which 60 subjects received medication and 56 received placebo. Subjects in both groups received up to 12 standard manual-driven cognitive behavioral therapy sessions. Overall, drop-out rate for both groups was high, with only about 20% of subjects completing all 12 weeks of treatment. Both groups showed comparable levels of medication compliance and therapy attendance. In the end, amlodipine was no more effective than placebo in reducing craving or measured levels of cocaine use.
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Of 13,542 patients randomized, 13,080 (96.6%) completed the study: 6529 in Group A and 6551 in Group T. At endpoint, the BP levels were reduced by 27.4/14.3 mmHg in Group A and 27.1/14.5 mmHg in Group T. The BP control rates were similar for the two therapeutic regimens (87.5% vs 86.1%). Less than 4% of patients in each group discontinued their drugs during follow-up. Peripheral edema was one of the most common AEs, and occurred in only 24 patients in Group A and 19 in Group T.
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Telmisartan, an angiotensin II type 1 receptor blocker, and amlodipine, a calcium channel blocker, are antihypertensive agents clinically used as monotherapy or in combination. They exert beneficial cardiovascular effects independently of blood pressure lowering and classic mechanisms of action. In this study, we investigate molecular mechanisms responsible for the off-target effects of telmisartan and telmisartan-amlodipine in endothelial cells (ECs), using an unbiased genomic approach.
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Intoxication with 280 mg of amlodipine caused severe hypotension, third-degree heart block and hyperkalaemia in a 36-year-old female patient. The patient was initially treated with fluids, dopamine, calcium chloride, and epinephrine without effect. The patient was then given a bolus injection of insulin and glucose as a temporary mean to treat the hyperkalaemia. We observed a rise in blood pressure (BP) after insulin was given and the BP was subsequently responsive to epinephrine. A possible positive inotropic effect of insulin therapy in patients with calcium channel blocker intoxication is in accordance with previous findings. In conclusion, it is suggested that hyperinsulinaemia-euglycaemia therapy may be considered as a first-line therapy in calcium channel blocker intoxication.
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The effects of amlodipine and several other antioxidants on doxorubicin-induced oxidative stress and mitochondria-mediated apoptosis were examined.
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The purpose of the present study was to evaluate the effect of ion pairing on the skin permeation of amlodipine. Amlodipine base (AM) was first prepared from amlodipine besilate (AM-B), then amlodipine adipate (AM-A), amlodipine oxalate (AM-O) and amlodipine maleate (AM-M) were prepared using AM and the corresponding organic acids. Differential scanning calorimetry (DSC) thermogram studies demonstrated the formation of complexes between AM and the various acids. In vitro percutaneous absorption of AM and its complexes was evaluated through excised rat skin using 2-chamber diffusion cells. The results showed that AM had the greatest steady-state flux and lowest permeability coefficient of the five compounds from the El system (ethanol:isopropyl myristate (IPM)= 2:8), and its four complexes all exhibited a lower flux and higher permeability coefficient than AM.
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Both drugs lowered mean arterial pressure; the decrease was more pronounced with mibefradil (from 118 +/- 3 to 99 +/- 2 mmHg, compared to 118 +/- 3 to 104 +/- 2 mmHg for amlodipine, P < 0.01 between drugs). Mibefradil decreased heart rate (66 +/- 2 to 57 +/- 2 bpm), whereas amlodipine caused a slight increase (66 +/- 2 to 70 +/- 2 bpm; P < 0.001 between drugs) and tended to increase cardiac output. Noradrenaline spillover increased similarly with the two drugs, from 3.44 +/- 0.27 to 5.20 +/- 0.48 nmol/min per m2(P < 0.01) during mibefradil and to 5.72 +/- 0.49 nmol/min per m2 (P < 0.001) during amlodipine. There were minor effects on cardiac sympatho-vagal balance, but systolic and diastolic myocardial velocities were increased similarly by both drugs.
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ALLHAT was a double-blind, randomized, clinical trial in 33,357 high-risk hypertensive patients aged > or =55 years. Hospitalized/fatal HF outcomes were examined with proportional-hazards models. Relative risks (95% confidence intervals; P values) of amlodipine or lisinopril versus chlorthalidone were 1.35 (1.21 to 1.50; <0.001) and 1.11 (0.99 to 1.24; 0.09). The proportional hazards assumption of constant relative risk over time was not valid. A more appropriate model showed relative risks of amlodipine or lisinopril versus chlorthalidone during year 1 were 2.22 (1.69 to 2.91; <0.001) and 2.08 (1.58 to 2.74; <0.001), and after year 1, 1.22 (1.08 to 1.38; P=0.001) and 0.96 (0.85 to 1.10; 0.58). There was no significant interaction between prior medication use and treatment. Baseline blood pressures were equivalent (146/84 mm Hg) and at year 1 were 137/79, 139/79, and 140/80 mm Hg in those given chlorthalidone, amlodipine, and lisinopril. At 1 year, use of added open-label atenolol, diuretics, angiotensin-converting enzyme inhibitors, and calcium channel blockers in the treatment groups was similar.
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To identify factors predicting visit and medication adherence in settings designed to optimize adherence, we did a retrospective analysis of participants in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). ALLHAT recruited participants at 632 sites in North America, Puerto Rico, and the U.S. Virgin Islands for random assignment to antihypertensive treatment with amlodipine, chlorthalidone, or lisinopril. Site investigators reported clinic characteristics at the time they applied to participate in the study and research coordinators used standardized methods to measure patient characteristics. We defined adequate visit adherence as attending at least 80 % of scheduled visits; adequate medication adherence was defined as taking 80 % or more of the randomly assigned medication at all study visits.
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This was a randomized, controlled, double-blind study of 6 weeks' duration in 566 patients with stage 2 hypertension. The primary endpoint was 24-h systolic BP by ambulatory monitoring.
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Most patients with hypertension require two or more agents from different classes to achieve BP control. Several fixed-dose combinations are available, often combining agents that target the renin angiotensin system (angiotensin-converting enzyme [ACE] inhibitors or an angiotensin receptor blockers [ARBs]) plus either thiazide diuretics or calcium channel blockers (CCBs). At low doses, these combinations may have greater efficacy and better tolerability than the respective high dose monotherapies. Combining an ARB (instead of an ACE inhibitor) with the CCB amlodipine offers efficacy with improved tolerability. This review aims to highlight the simplicity, tolerability, and convenience of fixed-dose combinations targeting the renin-angiotensin system, which can lead to improved compliance and more patients achieving BP goals.
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Hip and pelvic fracture hospitalizations.
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Commercial health plan enrollees aged at least 18 years with index claim(s) for AML/OM, AML/BEN, or LDC AML/ARB were identified. Absence of study drug 6 months pre index, and continuous enrollment for at least 12 months post index were required. Descriptive analyses were executed to make comparisons between treatments, as well as multivariate models adjusting for baseline demographic and clinical characteristics, including propensity for assignment to study drug.
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To study the impact of educational intervention on the pattern and incidence of potential drug-drug interactions (DDIs).
In human and rat fecalase incubation samples, amlodipine was metabolized to yield a major pyridine metabolite. The remaining amlodipine decreased and the formation of pyridine metabolite increased with incubation time, indicating the involvement of gut microbiota in the metabolism of amlodipine. Pharmacokinetic analyses showed that systemic exposure of amlodipine was significantly elevated in antibiotic-treated rats compared with controls.