amlodipine--atorvastatin-drug-combination and Cardiovascular-Diseases

Amlodipine/atorvastatin (Caduet) is a single-tablet, fixed-dose combination of the dihydropyridine calcium channel antagonist amlodipine and the HMG-CoA reductase inhibitor atorvastatin. The bioavailability of amlodipine and atorvastatin with a single-tablet, fixed-dose amlodipine/atorvastatin combination was not significantly different to that with coadministered separate amlodipine and atorvastatin tablets. In well controlled clinical trials in patients with hypertension and dyslipidaemia, once-daily amlodipine and atorvastatin (administered as the single-tablet, fixed-dose combination or coadministered as two separate tablets) effectively reduced systolic BP (SBP) and low-density lipoprotein cholesterol (LDL-C) levels, and enabled more patients to achieve BP and LDL-C goals than single-agent or placebo therapy. There was no modification of the effect of amlodipine on SBP when administered in combination with atorvastatin and there was no modification of the effect of atorvastatin on LDL-C when administered in combination with amlodipine. In noncomparative, titration-to-goal, open-label 'real-world' trials, the single-tablet, fixed-dose combination of amlodipine/atorvastatin enabled patients with hypertension and dyslipidaemia to achieve both BP and LDL-C goals. Administration of a single tablet of amlodipine/atorvastatin, compared with coadministration of these agents as two separate tablets, improved patient adherence, according to a retrospective study that utilized prescription refill rates from a large US insurance database. Data from the large, randomized, double-blind, placebo-controlled ASCOT-LLA trial also demonstrated that the combination of amlodipine-based therapy and atorvastatin was effective in preventing cardiovascular (CV) endpoints in hypertensive patients at risk of CV disease (CVD). In summary, amlodipine/atorvastatin offers a convenient and effective approach to improving adherence and managing CV risk in hypertensive patients with dyslipidaemia or at risk of CVD.

Topics: Amlodipine; Anticholesteremic Agents; Antihypertensive Agents; Blood Pressure; Cardiovascular Diseases; Clinical Trials as Topic; Drug Combinations; Dyslipidemias; Heptanoic Acids; Humans; Hypertension; Lipoproteins, LDL; Patient Compliance; Pyrroles; Treatment Outcome

Atherosclerotic renal-artery stenosis is a common problem in the elderly. Despite two randomized trials that did not show a benefit of renal-artery stenting with respect to kidney function, the usefulness of stenting for the prevention of major adverse renal and cardiovascular events is uncertain.. We randomly assigned 947 participants who had atherosclerotic renal-artery stenosis and either systolic hypertension while taking two or more antihypertensive drugs or chronic kidney disease to medical therapy plus renal-artery stenting or medical therapy alone. Participants were followed for the occurrence of adverse cardiovascular and renal events (a composite end point of death from cardiovascular or renal causes, myocardial infarction, stroke, hospitalization for congestive heart failure, progressive renal insufficiency, or the need for renal-replacement therapy).. Over a median follow-up period of 43 months (interquartile range, 31 to 55), the rate of the primary composite end point did not differ significantly between participants who underwent stenting in addition to receiving medical therapy and those who received medical therapy alone (35.1% and 35.8%, respectively; hazard ratio with stenting, 0.94; 95% confidence interval [CI], 0.76 to 1.17; P=0.58). There were also no significant differences between the treatment groups in the rates of the individual components of the primary end point or in all-cause mortality. During follow-up, there was a consistent modest difference in systolic blood pressure favoring the stent group (-2.3 mm Hg; 95% CI, -4.4 to -0.2; P=0.03).. Renal-artery stenting did not confer a significant benefit with respect to the prevention of clinical events when added to comprehensive, multifactorial medical therapy in people with atherosclerotic renal-artery stenosis and hypertension or chronic kidney disease. (Funded by the National Heart, Lung and Blood Institute and others; ClinicalTrials.gov number, NCT00081731.).

Topics: Aged; Amlodipine; Angioplasty, Balloon; Angiotensin II Type 1 Receptor Blockers; Anticholesteremic Agents; Antihypertensive Agents; Cardiovascular Diseases; Combined Modality Therapy; Drug Combinations; Female; Follow-Up Studies; Heptanoic Acids; Humans; Hypertension; Kaplan-Meier Estimate; Male; Middle Aged; Pyrroles; Renal Artery; Renal Artery Obstruction; Renal Insufficiency, Chronic; Stents; Treatment Failure

Few trials have compared different approaches to cardiovascular disease prevention among Pacific Asian (PA) populations. The Cluster Randomized Usual Care versus Caduet Investigation Assessing Long-term-risk (CRUCIAL) trial demonstrated that a proactive multifactorial intervention (PMI) approach (based on single-pill amlodipine/atorvastatin) resulted in a greater reduction in calculated Framingham 10-year coronary heart disease (CHD) risk compared with usual care (UC) among hypertensive patients with additional risk factors. One-third of CRUCIAL patients resided in the PA region. The aim of this subanalysis was to compare two approaches to cardiovascular risk factor management (PMI versus UC) among patients residing in PA and non-PA regions.. This subanalysis of the CRUCIAL trial compared treatment-related changes in calculated CHD risk among patients residing in PA and non-PA regions. Sensitivity analyses were conducted among men and women and those with and without diabetes.. Overall, 448 patients (31.6%) resided in the PA region and 969 patients (68.4%) resided in non-PA regions. The PMI approach was more effective in reducing calculated CHD risk versus UC in both PA (-37.1% versus -3.5%; P<0.001) and non-PA regions (-31.1% versus -4.2%; P<0.001); region interaction P=0.131. PA patients had slightly greater reductions in total cholesterol compared with non-PA patients. PA patients without diabetes had slightly greater reductions in CHD risk compared with non-PA patients. Treatment effects were similar in men and women and those with diabetes.. The PMI approach was more effective in reducing calculated Framingham 10-year CHD risk compared with UC among men and women with and without diabetes residing in the PA and non-PA region.

Topics: Aged; Amlodipine; Antihypertensive Agents; Asia; Calcium Channel Blockers; Cardiovascular Diseases; Diabetes Mellitus; Drug Combinations; Dyslipidemias; Europe; Female; Heptanoic Acids; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypertension; Latin America; Male; Middle Aged; Middle East; Preventive Health Services; Prospective Studies; Pyrroles; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

The efficacy and safety of single-pill amlodipine/atorvastatin for reducing blood pressure (BP), low-density lipoprotein cholesterol (LDLC), and predicted 10-year cardiovascular (CV) risk have been demonstrated in low CV risk countries. The Slovak Trial on Cardiovascular Risk Reduction Following National Guidelines with CaDUET® (amlodipine besylate/atorvastatin calcium; Pfizer, Morrisville, PA, USA; STRONG DUET) study evaluated its clinical utility in Slovakia, one of the highest CV risk regions in Europe.. This was a two-phase study involving 100 outpatient cardiologist and internist departments in Slovakia. Phase 1 assessed BP control and CV risk profiles in adults with treated hypertension, and phase 2 was an open-label, multicenter, observational study. In the phase 2 study, patients with treated but uncontrolled hypertension and three or more coronary heart disease risk factors received single-pill amlodipine/atorvastatin (5/10 or 10/10 mg) for 12 weeks. Major outcomes were the percentage of patients achieving target BP (≤140/90 mmHg) and/or LDL-C (≤3 mmol/L) and reductions in predicted 10-year CV risk.. Of the 4,672 phase 1 patients, 80.8% had uncontrolled hypertension and 61.4% had dyslipidemia. Of the 1,406 phase 2 patients, 90.3% of patients achieved target BP at week 12, 66.3% achieved target LDL-C, and 60.7% achieved both. The mean 10-year CV risk was reduced by 49% (P < 0.0001); treatment was well-tolerated and safe.. Single-pill amlodipine/atorvastatin was associated with significant improvements in BP, LDL-C target attainment, and 10-year CV risk in patients with uncontrolled hypertension in Slovakia. The treatment was well-tolerated and safe. Use of single-pill amlodipine/atorvastatin in high CV-risk countries could lead to significant improvements in CV risk management.

Topics: Aged; Amlodipine; Antihypertensive Agents; Cardiovascular Diseases; Drug Combinations; Female; Heptanoic Acids; Humans; Hyperlipidemias; Hypertension; Hypolipidemic Agents; Male; Middle Aged; Pyrroles; Risk Factors; Slovakia; Treatment Outcome

TOGETHER investigated whether targeting multiple cardiovascular (CV) risk factors using single-pill amlodipine/atorvastatin (AML/ATO) and therapeutic lifestyle changes (TLC) results in greater blood pressure (BP)/lipid control and additional reduction in estimated cardiovascular disease (CVD) risk compared with blood pressure intervention only using amlodipine (AML) + TLC. TOGETHER was a 6-week, randomized, double-blind, double-dummy trial using hypertensive participants with additional CV risk factors without CVD/diabetes. Participants were randomized to either AML/ATO (5 to 10/20 mg) + TLC or AML (5 to 10 mg) + TLC. The primary end point was the difference in proportion of participants attaining both BP (<140/90 mm Hg) and low-density lipoprotein cholesterol (LDL-C) (<100 mg/dL) goals at week 6. At week 6, 67.8% of participants receiving AML/ATO + TLC attained the combined BP/LDL-C goal versus 9.6% with AML + TLC (RD [A-B]: 58.2; 95% CI [48.1 to 68.4] P < 0.001; OR: 19.0; 95% CI 9.1 to 39.6; P < 0.001). Significant reductions from baseline in LDL-C, total cholesterol and triglycerides and estimated 10-year Framingham risk were also observed. Treatment with AML/ATO was well tolerated. In conclusion, a multifactorial CV management approach is more effective in achieving combined BP/LDL-C targets as well as CV risk reduction compared with BP intervention only in this patient population.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Amlodipine; Antihypertensive Agents; Biomarkers; Blood Pressure; Calcium Channel Blockers; Cardiovascular Diseases; Double-Blind Method; Drug Combinations; Dyslipidemias; Female; Heptanoic Acids; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypertension; Lipids; Male; Middle Aged; Odds Ratio; Prospective Studies; Pyrroles; Risk Assessment; Risk Factors; Risk Reduction Behavior; Tablets; Time Factors; Treatment Outcome; United States; Young Adult

Topics: Age Factors; Amlodipine; Antihypertensive Agents; Atherosclerosis; Cardiovascular Diseases; Cholesterol, LDL; Drug Combinations; Fatty Liver; Heptanoic Acids; Humans; Metabolic Diseases; Non-alcoholic Fatty Liver Disease; Patient Compliance; Pyrroles; Risk; Risk Reduction Behavior

Cardiovascular diseases are the leading cause of death worldwide. Risk factors are rarely seen individually, and the 2 most common and most frequently associated risk factors are hypertension and dyslipidemia (DL). Studies conducted in different parts of the world uniquely point out insufficient efficacy of hypertension and DL treatment, which is reflected in blood pressure and low-density lipoprotein levels higher than target values. A reason of this therapeutic failure is the reduced adherence, which is mainly caused by multidrug therapy. A possible solution for this problem is the use of fixed combinations. The main advantages of amlodipine/atorvastatin fixed combination are synergistic effect of these 2 components, a single-dose treatment, high safety profile, and good tolerance.

Topics: Amlodipine; Anticholesteremic Agents; Calcium Channel Blockers; Cardiovascular Diseases; Drug Combinations; Drug Synergism; Dyslipidemias; Heptanoic Acids; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypertension; Medication Adherence; Pyrroles; Risk Factors