amlodipine--atorvastatin-drug-combination and Hypertension

Hypertension (HTN) and dyslipemia (DYL) are two of the major modifiable cardiovascular (CV) risk factors, determinants in the development of cerebrovascular and coronary heart disease (CHD). Many patients have both risk factors which increase their total CV risk compared with patients with only one risk factor. Treatment guideline recommendations are poorly implemented in real practice, in part due to numerous and complicated drug regimes which hamper patient´s adherence.. In this article the authors describe the first combined fixed-dose pill of an antihypertensive and a lipid-lowering agent, the single-pill combination of amlodipine besylate and atorvastatin calcium (SPAA). They summarize the pharmacokinetic and pharmacodynamic properties of both compounds and the main randomized clinical studies, as well as real-world observational studies, made with the new combined formulation.. The use of the single-pill amlodipine and atorvastatin is an adequate option for the clinician to treat hypertensive patients with DYL or high CV risk burden, with proven efficacy, tolerability, cost-effectiveness, and the advantage of improving patient treatment compliance.

Topics: Amlodipine; Antihypertensive Agents; Atorvastatin; Calcium Channel Blockers; Drug Combinations; Dyslipidemias; Evidence-Based Medicine; Heptanoic Acids; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypertension; Pyrroles; Randomized Controlled Trials as Topic; Risk Factors

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

This review describes the clinical profile and rationale for the development of a single-pill formulation of the calcium channel blocker amlodipine besylate, a blood-pressure--lowering agent, and atorvastatin calcium, a statin with lipid-lowering antiatherosclerotic properties. Amlodipine and atorvastatin have been demonstrated in numerous clinical trials to be highly effective in lowering blood pressure and low-density lipoprotein cholesterol. Furthermore, both amlodipine and atorvastatin have been demonstrated to reduce cardiovascular events in a broad range of patients' in hypertensive patients with three concomitant cardiovascular risk factors but normal to mildly elevated cholesterol levels, amlodipine combined with atorvastatin demonstrated a reduction in cardiovascular events. The amlodipine/atorvastatin single pill has been shown to improve patients; achievement of national-guideline-recommended blood pressure and lipid target levels and exhibits a safety profile consistent with its parent compounds. The combination pill is now available in parts of Europe in formulations containing either 5 or 10 mg amlodipine and 10 mg atorvastatin. Amlodipine combined with atorvastatin has been demonstrated to reduce cardiovascular events in hypertensive patients at high cardiovascular risk, and the single-pill formulation has the potential to improve adherence and decrease prescription costs. These potential benefits are associated with important implications because hypertensive patients with additional risk factors represent a large proportion of those at risk for cardiovascular events.

Topics: Amlodipine; Antihypertensive Agents; Clinical Trials as Topic; Drug Combinations; Heptanoic Acids; Humans; Hypertension; Pyrroles

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

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

A proactive, multifactorial intervention strategy incorporating single-pill amlodipine/atorvastatin (SPAA) (5-10/10 mg up-titrated to 5-10/20 mg, where approved) is more effective than physician's usual care (UC) for reducing calculated 10 year coronary heart disease (CHD) risk, in patients with hypertension and additional risk factors (CRUCIAL trial: Curr Med Res Opin 2011;27:821--33). As SPAA combinations containing atorvastatin 20 mg are not approved in some countries, this post hoc analysis investigated the efficacy and safety of a proactive intervention strategy incorporating low-dose SPAA (5/10 or 10/10 mg) only (low-dose PI) versus UC.. Of 1461 CRUCIAL participants (35-79 years; hypertension and ≥3 additional risk factors; no CHD; total cholesterol ≤6.5 mmol/L), 105 were prescribed SPAA containing 20 mg atorvastatin and excluded. The primary endpoint was difference between treatment arms in Framingham 10 year CHD risk after 52 weeks; secondary assessments included difference in calculated CHD risk at Week 16; SCORE cardiovascular mortality (Week 16 and 52); blood pressure (BP)/lipid parameters; adverse events (AEs).. Baseline BP (149.2/89.2 vs. 144.3/86.5 mmHg) and calculated CHD risk (19.6% vs. 18.1%) were higher for low-dose PI (n = 655) versus UC (n = 657) patients. Least-squares mean treatment difference (low-dose PI vs. UC) in calculated 10 year CHD risk was -26.8 (95% CI: -31.7, -22.0; p < 0.001) after 52 weeks' follow-up and -24.8 (-29.8, -19.9; p < 0.001) after 16 weeks' follow-up. Treatment difference in SCORE mortality was -20.1 (-24.7, -15.6; p < 0.001) and -22.4 (-26.8, -18.0; p < 0.001) after 16 and 52 weeks' follow-up. Risk calculations are surrogate endpoints and may not translate into actual reductions in cardiovascular events. Overall, 49.1% (low-dose PI) and 44.0% (UC) reported AEs.. A proactive, multifactorial approach to cardiovascular management based on low-dose SPAA led to statistically significant improvements in calculated 10 year CHD risk versus physician's UC, comparable to that reported in the full CRUCIAL trial. These data will inform healthcare providers in countries where SPAA (5/10 or 10/10 mg) only are licensed.

Topics: Amlodipine; Antihypertensive Agents; Atorvastatin; Blood Pressure; Coronary Disease; Drug Combinations; Female; Heptanoic Acids; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypertension; Male; Middle Aged; Pyrroles; Risk Factors

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

Patients with diabetes mellitus (DM) and additional cardiovascular (CV) risk factors are at very high risk for future CV events. This study investigated the efficacy and safety of a proactive, multifactorial CV risk factor-management strategy based on single-pill amlodipine/atorvastatin (SPAA) versus continuing physicians' usual care (UC) over 52 weeks in patients with and without DM. Patients with hypertension and ≥ 3 additional CV risk factors from the Cluster Randomized Usual Care vs Caduet Investigation Assessing Long-Term-Risk (CRUCIAL) trial--an open-label, cluster-randomized trial conducted in 19 countries--were enrolled and randomized to receive proactive intervention (based on SPAA 5/10 to 10/20 mg) or UC (based on investigators' best clinical judgment). Patients were analyzed according to baseline DM status. Six hundred patients had DM. Patients with DM in the SPAA and UC arms had mean ages of 61.8 and 61.5 years, respectively, and an absolute coronary heart disease (CHD) risk of 25.2% and 21.5%, respectively. Among non-DM patients, mean ages were 58.6 and 59.5 years, respectively, and CHD risk was 16.0% vs 15.7%, respectively. Least-squares mean treatment differences in percentage change from baseline in calculated 10-year Framingham CHD risk were -26.3% vs -27.3% among DM and non-DM patients (adjusted for respective baseline values) (both P < 0.0001). Among DM and non-DM patients, adverse events were reported in 52.8% versus 45.6% in the SPAA and 49.6% versus 41.6% in the UC arms, respectively. This global risk-management approach, simultaneously targeting blood pressure and lipids, was more effective for reducing calculated 10-year Framingham CHD risk than UC in patients with DM. While blood pressure changes were of smaller magnitude among patients with DM, this strategy reduced overall risk to an extent comparable with that observed in non-DM patients. Further studies are thus warranted to study this proactive risk factor intervention on CV or mortality endpoints in patients with and without DM.. www.ClinicalTrials.gov identifier NCT00407537.

Topics: Adult; Aged; Amlodipine; Blood Pressure; Diabetes Complications; Diabetes Mellitus; Drug Combinations; Female; Follow-Up Studies; Heptanoic Acids; Humans; Hypertension; Lipids; Male; Middle Aged; Pyrroles; Risk Factors; Risk Management; Treatment Outcome

In many countries, combination therapy with amlodipine and atorvastatin is indicated for the treatment of patients with hypertension and hypercholesterolemia. The aim of this study was to investigate the impact of this combination therapy on plasma adiponectin levels.. Combination therapy with amlodipine and atorvastatin would increase plasma adiponectin levels.. A total of 25 patients with coronary artery disease and concomitant hypertension and hypercholesterolemia were evaluated. The combination of amlodipine and atorvastatin in 8 different dosage strengths were flexibly titrated over a period of 14 weeks. Lipid profile and plasma adiponectin were measured. Brachial flow-mediated dilation (FMD) was determined by vascular ultrasound.. As compared with baseline, combination therapy with amlodipine and atorvastatin significantly reduced systolic and diastolic blood pressure, total cholesterol, and low-density lipoprotein cholesterol (all P < 0.05). Furthermore, there were significant increases in adiponectin levels (mean [95% confidence interval (CI)], 12.1 [10.7-13.7] vs 8.1 [6.5-10.0] μg/mL; P < 0.001) and brachial FMD (4.4 ± 0.6% vs 5.6 ± 0.5%; P = 0.046) over 14 weeks of treatment. The change in adiponectin levels correlated significantly with the changes in diastolic blood pressure (r = -0.49; P = 0.014) and FMD (r = 0.55; P = 0.007).. The results of this study indicate that along with its antihypertensive and cholesterol-lowering effects, combination therapy with amlodipine and atorvastatin appears to increase plasma adiponectin levels and improve endothelial function.

Topics: Adiponectin; Aged; Aged, 80 and over; Amlodipine; Anticholesteremic Agents; Antihypertensive Agents; Biomarkers; Blood Pressure; Brachial Artery; Cholesterol; Coronary Artery Disease; Dose-Response Relationship, Drug; Drug Combinations; Drug Therapy, Combination; Endothelium, Vascular; Female; Heptanoic Acids; Humans; Hypertension; Male; Middle Aged; Pyrroles; Triglycerides; Ultrasonography

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

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

- The aim was to evaluate the efficacy of a single-pill combination of atorvastatin/amlodipine in patients with arterial hypertension, dyslipidemia and moderate to high cardiovascular risk. This prospective study included 243 patients with arterial hypertension, dyslipidemia and moderate to high cardiovascular risk, mean age 63.3±9.8 years. All patients were prescribed a treatment with one of the following doses of a single-pill combination of atorvastatin/amlodipine: 10/5, 10/10, 20/5 or 20/10 mg daily. The follow-up period was 3 months. The mean baseline values of the systolic and diastolic blood pressure were 155.7±16.2 and 92.0±9.2 mm Hg, respectively. At month 3, the respective mean systolic and diastolic blood pressure values were 136.9±26.9 and 80.6±5.1 mm Hg. The mean baseline values of total cholesterol and low-density lipoprotein cholesterol were 6.6±1.2 and 4.4±1.1 mmol/L, respectively. At month 3, the respective mean values of total cholesterol and low-density lipoprotein cholesterol were 5.1±0.9 and 2.9±1.0 mmol/L. Treatment was discontinued in 9 (3.7%) patients due to adverse events. In conclusion, treatment with the single-pill combination of atorvastatin/amlodipine was effective and well tolerated by the patients with arterial hypertension, dyslipidemia and moderate to high cardiovascular risk.

Topics: Aged; Amlodipine; Anticholesteremic Agents; Antihypertensive Agents; Blood Pressure; Cholesterol; Cholesterol, LDL; Dose-Response Relationship, Drug; Drug Combinations; Drug Monitoring; Dyslipidemias; Female; Heptanoic Acids; Humans; Hypertension; Male; Middle Aged; Prospective Studies; Pyrroles; Treatment Outcome

We compared statin adherence in individuals initiating combined amlodipine/atorvastatin therapy as a fixed-dose (FDC) or free combination and identified subgroups benefiting most from FDCs.. We used a 10% sample of Australian Pharmaceutical Benefits Scheme dispensing data (2005-2015) to identify individuals initiating amlodipine and atorvastatin as an FDC (n = 3996) or free combination (n = 5434), with or without prior statin dispensing. We measured the proportion of days covered in each 30-day period over 24 months and classified patterns of statin adherence using group-based trajectory models. We identified predictors of adherence trajectories using logistic regression.. The median age was 71 years, and 53% were female. We identified 4 patterns of statin adherence: near-perfect adherence (n = 5383), good adherence (n = 1893), declining adherence (n = 1247), and early nonadherence (n = 907). Compared with the free combination, FDC initiators were more likely to have near-perfect adherence if they were previously statin adherent irrespective of amlodipine dose (amlodipine 5 mg: OR = 1.61, 95% CI 1.38-1.87; amlodipine 10 mg: OR = 2.39, 95% CI 1.63-3.51) or they were previously statin nonadherent and initiated on the 5 mg amlodipine dose (OR = 1.87, 95% CI 1.50-2.32). Statin-naïve individuals initiating on the FDC with 10 mg amlodipine were less likely to have near-perfect adherence (OR = 0.60, 95% CI 0.41-0.88) and more likely to have early nonadherence (OR = 1.73, 95% CI 1.17-2.55).. The amlodipine/atorvastatin FDC was associated with greater statin adherence among prevalent statin users, and individuals who initiated on lower amlodipine doses. The FDCs did not improve adherence in statin-naïve individuals and in some cases resulted in poorer adherence.

Topics: Aged; Amlodipine; Anticholesteremic Agents; Antihypertensive Agents; Australia; Blood Pressure; Drug Combinations; Female; Heptanoic Acids; Humans; Hypercholesterolemia; Hypertension; Male; Medication Adherence; Middle Aged; Pyrroles

Hypertension and dyslipidemia are modifiable cardiovascular risk factors. In Hungary hypertension and dyslipidemia are quite frequent conditions. The patients' adherence is very important factor to reach the targets.. The aim of the authors was to investigate the one-year persistence of the atorvastatin therapy and atorvastatin and amlodipine fixed dose combination.. National Health Insurance Found prescriptions database of Hungary on pharmacy claims between October 1, 2012 and September 30, 2013 was analyzed. The authors identified patients who filled prescriptions for atorvastatin and amlodipine fixed dose combination and atorvastatin prescribed for the first time. Patients did not receive similar drugs for one year before the study. To model the persistence, the apparatus of survival analysis was used, where "survival" was the time to abandon the medication. As it was available to month precision, discrete time survival analysis was applied: a generalized linear model was estimated with complementary log-log link function with the kind of drug being the only explanatory variable.. During the trial period, atorvastatin and atorvastatin plus amlodipine fixed dose combination was started in 192,579 and 24,433 patients, respectively. One year persistence rate in patients with atorvastatin and amlodipine fixed dose combination was 43%, and 21% in patients with atorvastatin therapy. The 360-days-restricted study period, the mean duration of persistence was 221.4 (SE: 0.894) days in patients on atorvastatin and amlodipine fixed dose combination and 153.0 days (SE: 0.297) in those on atorvastatin regimen. The hazard of discontinuation was almost twofold higher during treatment with atorvastatin therapy compared with the use of the atorvastatin and amlodipine fixed dose combination (hazard ratio = 1.85, p<0.0001).. There is a significant difference between the one-year persistence of atorvastatin therapy and atorvastatin plus amlodipine fixed dose combination. The result demonstrate that atorvastatin and amlodipine fixed dose combination is favourable to reach double goals on blood pressure and LDL-cholesterol.

Topics: Adult; Aged; Amlodipine; Antihypertensive Agents; Atorvastatin; Blood Pressure; Cholesterol, LDL; Drug Combinations; Female; Heptanoic Acids; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypercholesterolemia; Hypertension; Linear Models; Male; Medication Adherence; Middle Aged; Pyrroles; Retrospective Studies; Treatment Outcome

BACKGROUND Is the timing of dosing for amlodipine and atorvastatin important with regard to therapeutic efficacy? To answer this question, we designed an outpatient, practice-based, case-control study lasting 8 weeks. MATERIAL AND METHODS Two hundred patients were divided into 2 groups: in Group I, patients were provided with a single pill containing amlodipine/atorvastatin (5/20 mg) to be taken each night at 10 pm, and in Group II, patients were taking amlodipine (5 mg) and atorvastatin (20 mg) each morning at 7 am. RESULTS Our results indicated no obvious difference in blood pressure control between the 2 groups. Taking amlodipine at night not only lowered blood pressure, but it also provided better control during the peak blood pressure in the morning. Hypercholesterolemia control in the 2 groups was also not significantly different, taking atorvastatin in the morning was as effective as dosing at night in patients with hypercholesterolemia. While the carotid IMT, hs-CRP, and LVMI were significantly lower after treatment, no differences were found between the 2 groups. Although no obvious difference was found in adverse drug reactions between the 2 groups, compliance was much better in the single-pill group than in patients taking the 2 medications separately. CONCLUSIONS In conclusion, single-pill amlodipine-atorvastatin taken at night can lower blood pressure and reduce the morning peak blood pressure levels the next day. Additionally, this dosing method could improve patient adherence to the therapy.

Topics: Adult; Aged; Amlodipine; Antihypertensive Agents; Atorvastatin; Blood Pressure; Case-Control Studies; Disease Management; Drug Administration Schedule; Drug Combinations; Female; Heptanoic Acids; Humans; Hypercholesterolemia; Hypertension; Male; Middle Aged; Patient Compliance; Pyrroles

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

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