Our library of drug research abstracts drawn from the medical literature is updated on a regular schedule, and you can be assured that new amlodipine research articles will be listed here shortly after becoming available to us.
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Medical research on amlodipine
Olmesartan medoxomil : a review of its use in the management of hypertension.
Drugs. 2008; 68(9): 1239-72
Scott LJ, McCormack PL
Olmesartan medoxomil (Olmetec((R)), Benicar((R))) is an angiotensin II type 1 (AT(1)) receptor antagonist (angiotensin receptor blocker [ARB]) that inhibits the actions of angiotensin II on the renin-angiotensin-aldosterone system, which plays a key role in the pathogenesis of hypertension. Oral olmesartan medoxomil 10-40 mg once daily is recommended for the treatment of adult patients with hypertension. In those with inadequate BP control using monotherapy, fixed-dose olmesartan medoxomil/hydrochlorothiazide (HCTZ) [Olmetec plus((R)), Benicar-HCT((R))] combination therapy may be initiated.Extensive clinical evidence from several large well designed trials and the clinical practice setting has confirmed the antihypertensive efficacy and good tolerability profile of oral olmesartan medoxomil, as monotherapy or in combination with HCTZ, in patients with hypertension, including elderly patients with isolated systolic hypertension (ISH). Notably, BP control is sustained throughout the 24-hour dosage interval, including during the last 4 hours of this period. In clinical trials, olmesartan medoxomil monotherapy provided better antihypertensive efficacy than losartan, candesartan cilexetil or irbesartan monotherapy, and was at least as effective as valsartan treatment, with a faster onset of action than other ARBs in terms of reductions from baseline in diastolic BP (DBP) and, in most instances, systolic BP (SBP). Combination therapy with olmesartan medoxomil plus HCTZ was superior to that with benazepril plus amlodipine, as effective as that with losartan plus HCTZ, noninferior to that with atenolol plus HCTZ, but less effective than that with telmisartan plus HCTZ, in individual trials. Data from ongoing clinical outcome trials are required to more fully determine the relative position of olmesartan medoxomil therapy in the management of hypertension. In the meantime, the consistent antihypertensive efficacy during the entire 24-hour dosage interval and good tolerability profile of olmesartan medoxomil, with or without HCTZ, make it a valuable option for the treatment of adult patients with hypertension, including the elderly.
Electrophoresis. 2008 Jun 10;
Liu X, Chen X, Yue Y, Zhang J, Song Y
Flow injection (FI)-CE coupled with frontal analysis (FA) was applied to the study of stereoselectivity binding of amlodipine (AL) to HSA. Under protein-drug binding equilibrium, the unbound concentrations of drug enantiomers were measured by plateau height. The stereoselectivity of AL binding to HSA was proved by the different free fractions of two enantiomers. In physiological phosphate solution (pH 7.4, ionic strength 0.17) when 200 muM (+/-)AL was equilibrated with 300 muM HSA, the concentration of unbound R-AL was about 1.5 times higher than that of its antipode. The binding constants of two enantiomers, K(R-AL) and K(S-AL), were 9910-11200 and 90200-104000 M(-1), respectively. The results obtained by the method were compared with those determined by conventional equilibrium dialysis (ED)-CE and fluorescence spectra. Hydroxypropyl-beta-CD (HP-beta-CD) (10 mM) was used as a chiral selector in pH 3.7 phosphate buffer. L-Tryptophan (L-try) and ketoprofen (Ket) were used as displacement reagents to investigate the binding sites of AL to HSA. A binding synergism effect between hydrochlorothiazide (QL) and AL was observed and the results suggested that QL can destroy binding equilibrium of R-AL and S-AL toward HSA and they can occupy the same binding site of HSA (site I). The reproducibility was confirmed by RSD (RSD
Kardiologiia. 2008; 48(5): 16-22
Oleinikov VE, Matrosova IB, Gerasimova AS, Tomashevskaia IuA
Am J Cardiovasc Drugs. 2008; 8(3): 155-60
Hennekens CH
The obvious strengths of fixed-dose drug combinations include the potential advantages of increased compliance, convenience, and cost savings. In contrast, potential disadvantages include reduced flexibility in dosing, exposure of some patients to therapies they do not require, and possible increased risks of adverse effects without added benefits. With respect to fixed-dose drug combinations of HMG-CoA reductase inhibitors (statins), the totality of evidence is far less for the non-statin component leading to possible over utilization of two drugs when single-agent efficacy will suffice to maximize the benefit and minimize the risks.The current US FDA policy for fixed-dose drug combinations was established in 1971. The policy states that "two or more drugs may be combined in a single dosage form when each component makes a contribution to the claimed effects and the dosage of each component (amount, frequency, duration) is such that the combination is safe and effective for a significant patient population requiring such concurrent therapy as defined in the labeling for the drug."The FDA was concerned with several disadvantages associated with fixed-dose combination drugs, including the lack of flexibility in titration, exposure of patients to unnecessary drugs when one component alone would be effective, as well as the increased possibility of adverse reactions without increased efficacy.The FDA has considered novel fixed-dose combination drugs to be composed of component drugs at least one of which has not been previously approved, labeled for an indication that is new to at least one or more of the component drugs, or where no significant evidence exist to support concurrent use of the components in a patient population.Based on the current FDA regulatory approval process for fixed-dose drug combinations with statins, it was possible to gain regulatory approval with intermediate endpoints such as lipids for example niacin/lovastatin and ezetimibe/simvastatin and BP/lipids, for example, amlodipine/atorvastatin. Based on the more stringent criteria of additive benefits on clinical endpoints of myocardial infarction, stroke, and cardiovascular disease death, it was possible to gain regulatory approval for aspirin/pravastatin.In summary, the approvals of several fixed-dose drug combinations with statins have both strengths and limitations. The availability to the healthcare provider of many individual statins with varying potency on lipids as well as several fixed-dose drug combinations reinforces the fact that the final decision should be made on astute and individual clinical judgements based on randomized clinical trial data, guidelines and FDA approvals with evidence to do more good than harm to the patient.
J Cardiovasc Pharmacol. 2008 May 29;
Ferguson JM, Minas J, Siapantas S, Komesaroff PA, Sudhir K
The ideal therapy for patients with isolated systolic hypertension remains unclear; diuretics, calcium channel blockers, and angiotensin-converting enzyme (ACE) inhibitors are all used in clinical practice. The aim of this study was to determine whether a fixed-dose ACE inhibitor/diuretic combination would reduce ambulatory blood pressures (BP) and arterial stiffness in isolated systolic hypertension more than antihypertensive monotherapy. In this randomized, double-blind study, 8 weeks of fosinopril/hydrochlorothiazide combination (10/12.5 mg titrated up to 20/12.5 mg) was compared with the calcium channel blocker (amlodipine, 5 mg titrated up to 10 mg) and diuretic (indapamide, 2.5 mg) monotherapy in 28 patients with isolated systolic hypertension. Each patient received all 3 therapies. Assessments included 24-hour ambulatory BP, clinic BP, and applanation tonometry-derived augmentation index. At 8 weeks, the fall in average 24-hour systolic BP and night time systolic BP were significantly greater in the fosinopril-hydrochlorothiazide group, compared to amlodipine and indapamide. The decrease in augmentation index and central aortic systolic BP was also greater in the fosinopril-hydrochlorothiazide group, compared to either amlodipine or indapamide. There was no difference between therapies in decrease in clinic systolic or diastolic BP, or diastolic ABP (average 24-h, diurnal, or nocturnal). Compared with either calcium channel blocker or diuretic therapy, a fixed-dose ACE inhibitor-diuretic combination induces greater reductions in systolic ABP, particularly at night, favorable effects that may be related to a decrease in the intensity of or delay in arterial wave reflections. ACE inhibitor-diuretic combination therapy is a useful approach to cardiovascular risk reduction in isolated systolic hypertension.
Aliskiren: new drug. Arterial hypertension: no evidence of clinical efficacy.
Prescrire Int. 2008 Apr; 17(94): 47-50
(1) Pharmacological management of arterial hypertension is based on antihypertensive drugs with proven efficacy on morbidity and/or mortality endpoints. (2) Aliskiren is the first renin inhibitor to reach the market. (3) There are no published trials of aliskiren with clinical endpoints. Five double-blind short-term (8 weeks) placebo-controlled trials showed a moderate effect on blood pressure. This effect was not superior to that of other antihypertensive drugs with which aliskiren was compared: hydrochlorothiazide, amlodipine, irbesartan, losartan, valsartan, lisinopril and rampiril. (4) When added to another antihypertensive drug, aliskiren had little or no additional effect on blood pressure. In particular, there is no firm evidence that adding aliskiren to amlodipine 5 mg/day is any more effective than doubling the dose of amlodipine. (5) Aliskiren has not been tested in patients with renovascular hypertension or severe hypertension, but pharmacological data suggest that aliskiren might be less effective in these individuals. (6) Overall, the adverse effect profile of aliskiren does not seem to be any better than that of other antihypertensive drugs. Aliskiren contributes to the onset of angioedema, cough, diarrhea and abdominal pain, hyperuricaemia, gout attacks, kidney stones and skin rash. Pharmacovigilance should focus specifically on certain adverse effects that are known to occur with other drugs acting on renin-angiotensin axis, such as angioedema, muscle disorders and anaemia, even though few such cases were observed with aliskiren during clinical trials. (7) Aliskiren is contraindicated during pregnancy, as are other antihypertensive drugs acting on the renin-angiotensin axis. (8) In practice, it is better not to use aliskiren to treat hypertensive patients because better-assessed antihypertensive drugs with longer follow-up are available.
Effect of amlodipine on cardiovascular events in hypertensive haemodialysis patients.
Nephrol Dial Transplant. 2008 May 29;
Tepel M, Hopfenmueller W, Scholze A, Maier A, Zidek W
BACKGROUND: Hypertensive haemodialysis patients may be at a high risk for cardiovascular events. This study was undertaken to ascertain whether the calcium channel blocker amlodipine reduces mortality and cardiovascular events in these high-risk patients. METHODS: We evaluated the effects of amlodipine on cardiovascular events in 251 hypertensive haemodialysis patients in an investigator-designed, prospective, randomized, double-blind, placebo-controlled, multicenter trial. One hundred and twenty-three patients were randomly assigned to amlodipine (10 mg once daily) and 128 to placebo. The primary endpoint was mortality from any cause. The secondary endpoint was a composite variable consisting of mortality from any cause or cardiovascular event. Analysis was by intention-to-treat. The trial was registered with ClinicalTrials.gov (number NCT00124969). RESULTS: The median age of patients was 61 years (25% percentile - 75% percentile, 47-69), and the median follow-up was 19 months (8-30). Fifteen (12%) of the 123 patients assigned to amlodipine and 22 (17%) of the 128 patients assigned to placebo had a primary endpoint [hazard ratio 0.65 (95% CI 0.34-1.23); P = 0.19]. Nineteen (15%) of the 123 haemodialysis patients assigned to amlodipine and 32 (25%) of the 128 haemodialysis patients assigned to placebo reached the secondary composite endpoint [hazard ratio 0.53 (95% CI 0.31-0.93); P = 0.03]. CONCLUSION: Amlodipine safely reduces systolic blood pressure and it may have a beneficial effect on cardiovascular outcomes in hypertensive haemodialysis patients.
Ethn Dis. 2008; 18(2): 204-9
Dickson M, Plauschinat CA
OBJECTIVE: To assess compliance with antihypertensive therapy and healthcare utilization among African American and White Medicaid recipients who are receiving fixed-dose combination amlodipine besylate/benazepril HCl or a dihydropyridine calcium channel blocker plus an angiotensin-converting enzyme inhibitor prescribed as separate agents (free-combination). DESIGN: Longitudinal, retrospective, cohort analysis of South Carolina Medicaid claims for the years 1997 through 2002. Followup was 12 months from the index date, defined as the first prescription dispensing date for a study drug. SETTING AND PARTICIPANTS: South Carolina Medicaid beneficiaries receiving fixed-dose (n=3363) and free-combination (n=713) therapy, including 3016 African Americans and 1060 White patients. MAIN OUTCOME MEASURES: Compliance was defined as the total days' supply of drug (excluding last prescription fill) divided by the length of followup; healthcare utilization included cost and number of claims associated with ambulatory services, hospital care, and prescription drugs. RESULTS: The cohort (N=4076) was 74.0% African American; mean age was 62.2 years. Compliance was significantly greater in patients who received fixed-dose therapy than in those who received free-combination therapy (58.6% vs 48.1%; P
Complete atrioventricular block associated with rivastigmine therapy.
Am J Health Syst Pharm. 2008 Jun 1; 65(11): 1051-3
Kayrak M, Yazici M, Ayhan SS, Koc F, Ulgen MS
PURPOSE: A case of complete atrioventricular block associated with rivastigmine use is presented. SUMMARY: A 67-year-old Turkish woman with Alzheimer's disease was admitted to the hospital because of dizziness and syncope. Her medical history included diagnoses of hypertension (treated with amlodipine 5 mg daily) and diabetes mellitus (treated with nateglinide 120 mg daily). She had been taking both drugs for over five years. She had also been taking rivastigmine 6 mg p.o. daily for five months for the treatment of Alzheimer's disease. She had experienced dizziness since the onset of rivastigmine therapy but had not reported it to any health care provider. On admission, she had a blood pressure measurement of 90/60 mm Hg and a pulse rate of 34 beats/min. A 12-lead electrocardiogram revealed complete atrioventricular block. Echocardiography results, blood electrolyte levels, and cardiac biochemical markers were normal. After initial evaluation, a temporary transvenous pacemaker was implanted via the right femoral vein. Amlodipine and rivastigmine were discontinued. On the first day of hospitalization, a coronary angiogram revealed normal coronary anatomy. Two days later, the complete atrioventricular block resolved spontaneously to sinus rhythm. Rivastigmine 6 mg p.o. daily was reinitiated, and complete atrioventricular block recurred on the fourth day of therapy. A VVI permanent pacemaker was implanted on the fifth day of hospitalization. Amlodipine and rivastigmine were reinitiated. The patient continued rivastigmine 6 mg p.o. daily after permanent pacemaker implantation. A three-month follow-up appointment revealed that no further syncope episodes or dizziness had occurred. CONCLUSION: A 67-year-old woman developed complete atrioventricular block after receiving rivastigmine for the treatment of Alzheimer's disease.
Clin Ther. 2008 Apr; 30(4): 587-604
Chrysant SG, Melino M, Karki S, Lee J, Heyrman R
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 (