amlodipine--atorvastatin-drug-combination and Hyperlipidemias

Topics: Amlodipine; Drug Combinations; Drug Costs; Heptanoic Acids; Humans; Hyperlipidemias; Hypertension; Patient Compliance; Patient Selection; Practice Guidelines as Topic; Pyrroles; United States

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

The DoUble-blind Atorvastatin AmLodipine (DUAAL) trial investigated whether atorvastatin decreases ischaemia by a vascular benefit, independent of low-density lipoprotein cholesterol lowering, in patients with coronary artery disease (CAD), both alone and in combination with the traditional anti-anginal therapy, amlodipine.. Randomized, double-blind, parallel-group, multicountry trial (2 weeks run-in and 24 weeks active therapy) comparing three treatments: amlodipine, atorvastatin, and amlodipine + atorvastatin; in 311 patients (78% male; mean age 62 years) with stable angina (≥ 2 attacks/week), CAD history, ≥ 3 transient myocardial ischaemia (TMI) episodes, and/or ≥ 15 min ischaemia on 48 h ambulatory electrocardiographic (AECG) monitoring. Efficacy variables were change in TMI by AECG, exercise ischaemia, angina diary data, and inflammatory biomarkers at Week 26. There was a comparable, highly significant decrease in TMI with amlodipine and atorvastatin, but no additional benefit for the combination. More than 50% of patients became TMI-free in all three groups and this was accompanied by a comparable, marked reduction in angina and nitroglycerin consumption. High-sensitivity C-reactive protein fell by 40% in patients receiving atorvastatin but there was no change with amlodipine. Adverse events were comparable among groups.. Atorvastatin was as potent an anti-ischaemic agent as amlodipine. Future studies of combination therapies will be instructive.. National clinical trial number: NCT00159718, protocol number A0531031 listed on http://clinicaltrials.gov/.

Topics: Aged, 80 and over; Amlodipine; Angina, Stable; Antihypertensive Agents; Atorvastatin; Chronic Disease; Double-Blind Method; Drug Combinations; Electrocardiography, Ambulatory; Exercise Test; Female; Heptanoic Acids; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hyperlipidemias; Hypertension; Hypolipidemic Agents; Male; Middle Aged; Myocardial Ischemia; Pyrroles; Young Adult

Topics: Amlodipine; Angina Pectoris; Atorvastatin; Clinical Trials as Topic; Dose-Response Relationship, Drug; Drug Combinations; Heptanoic Acids; Humans; Hyperlipidemias; Hypertension; Pyrroles

Topics: Amlodipine; Clinical Trials as Topic; Double-Blind Method; Drug Combinations; Heptanoic Acids; Humans; Hyperlipidemias; Hypertension; Practice Guidelines as Topic; Pyrroles; Risk Assessment; Risk Factors