lisinopril and Dyslipidemias

To evaluate the efficacy and safety of a fixed-dose combination of the angiotensin-converting enzyme inhibitor lisinopril 10 mg and the calcium antagonist amlodipine 5 mg (ekvator) in conjunction with rosuvastatin (mertenil).. The investigation enrolled 50 patients (mean age 57.9 years) with essential hypertension. All the patients received the fixed-dose antihypertensive combination. Stable Functional Class I or II exertional angina was in 46% of the patients. The remaining 54% were found to have brachiocephalic atherosclerosis. All the patients had dyslipidemia and were given rosuvastatin.. The mean systolic blood pressure (SBP) initially reached 164.26 mm Hg. During the whole follow-up, the reduction in mean SBP generally accounted for 22.6% (p = 0.000). At the study inclusion, the mean diastolic blood pressure (DBP) reached 99.38 mm Hg. The total decline in mean DBP was 19.3% (p = 0.000). The mean level of total cholesterol (TC) decreased significantly by 32.1% (p = 0.000); that of triglycerides (TG) also fell significantly by 31.8% (p = 0.04); that of high-density lipoproteins increased insignificantly by 11.1% (p = 0.599); that of low-density lipoproteins (LDL) dropped significantly by 47.5% (p = 0.000).. Being safe, the fixed-dose lisinopril and amlodipine combination is effective in lowering blood pressure in patients with hypertensive disease (HD) concurrent with coronary heart disease (CHD) or atherosclerotic changes in the carotid artery. The use of rosuvastatin in patients with HD concurrent with CHD during 2 months causes positive changes in the blood lipid composition as a significant reduction in the-levels of (TC), LDL, and TG.

Topics: Amlodipine; Antihypertensive Agents; Blood Pressure; Coronary Disease; Dose-Response Relationship, Drug; Drug Combinations; Drug Monitoring; Drug Therapy, Combination; Dyslipidemias; Essential Hypertension; Female; Fluorobenzenes; Humans; Hypertension; Hypolipidemic Agents; Lipid Metabolism; Lisinopril; Male; Middle Aged; Pyrimidines; Rosuvastatin Calcium; Sulfonamides; Treatment Outcome

In clinical practice, blood pressure (BP)-lowering agents are generally prescribed for use in the morning, whereas (short-acting) statins are recommended for use in the evening. There is evidence that the reduction in LDL cholesterol (LDL-c) achieved with short-acting statins is superior when taken in the evening and reported improvement in BP control when aspirin and BP-lowering agents are taken in the evening. However, it is unclear whether the additional reduction in LDL-c and BP is offset by a reduction in adherence, given that taking medication in the evening may be less typical or convenient. There is therefore uncertainty concerning the best timing of administration of a cardiovascular combination pill such as the polypill.. The aim of TEMPUS (NCT01506505), a prospective randomized open blinded endpoint (PROBE) crossover trial, is to evaluate whether there is a difference in LDL-c levels or 24-hour ambulatory BP in individuals at increased risk of cardiovascular disease when the cardiovascular polypill is taken in the evening compared to the morning. An additional aim is to assess the effect of the polypill on LDL-c and BP compared to the administration of separate pills of identically dosed components of the polypill.. In total 75 participants with established cardiovascular disease or an intermediate to high risk for cardiovascular disease are randomly allocated to the sequence of three different treatments of 6-8 weeks: (1) the cardiovascular polypill (aspirin 75 mg, simvastatin 40 mg, lisinopril 10 mg, and hydrochlorothiazide 12.5 mg) in the evening; (2) the polypill in the morning; and (3) the use of the identically dosed agents in separate pills taken at different time points during the day. The primary endpoint is the difference in LDL-c and mean 24-hour ambulatory systolic BP. Secondary outcomes are the difference in relative risk reduction, biochemistry, platelet function and pulse wave analysis, participants' adherence, and acceptability.. TEMPUS will evaluate the effect of timing of the administration of a cardiovascular polypill on LDL-c and BP measurements in patients with an intermediate or high risk for cardiovascular disease.

Topics: Administration, Oral; Antihypertensive Agents; Aspirin; Biomarkers; Blood Platelets; Blood Pressure; Cardiovascular Diseases; Cholesterol, LDL; Clinical Protocols; Cross-Over Studies; Drug Chronotherapy; Drug Combinations; Dyslipidemias; Humans; Hydrochlorothiazide; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypertension; Lisinopril; Netherlands; Platelet Aggregation Inhibitors; Primary Prevention; Prospective Studies; Research Design; Simvastatin; Tablets; Time Factors; Treatment Outcome

Solid clinical evidence supports the effectiveness and safety of multiple drugs in treating diabetes, dyslipidemia, and hypertension, and numerous fixed-dose combination products (FDCs) containing such drugs have been developed for patients with more severe forms of these diseases. We sought to evaluate the extent to which utilization of treatment combinations for these conditions corresponded to the availability of FDCs.. Using claims data from a large national commercial insurer, we identified 2 cohorts of patients: those who filled multiple single-agent drugs to treat diabetes, dyslipidemia, and hypertension in 2012, and those who used FDCs containing these products during the same period. We determined the fill rate of single-agent pairs and FDCs, availability of FDCs for the most frequently filled single-agent and drug class pairs, and the number of conditions treated by frequently filled single-agent pairs and FDCs.. During our study period, 848,082 patients filled prescriptions for 3,248 unique single-agent pairs (mean 4.7 per patient, standard deviation [SD] 5.0); and 568,923 patients received prescriptions for 43 unique FDCs (mean 1.1 per patient, SD 0.3). Three (15%) of the 20 most frequently filled single-agent pairs were available as FDCs, whereas 9 (45%) of the 20 most frequently filled drug class pairs were available as FDCs. Nearly all of the frequently filled FDCs had lower fill rates than the most frequently filled single-agent pairs.. Utilization of drug combinations to treat cardiovascular conditions does not correspond well with availability of FDCs containing these agents. A concerted set of strategies should be implemented to streamline the development of useful combination products, including expedited approval pathways and increased investment in formulation studies.

Topics: Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Diseases; Comorbidity; Diabetes Mellitus; Drug Combinations; Dyslipidemias; Humans; Hypertension; Hypoglycemic Agents; Hypolipidemic Agents; Lisinopril; Metformin; Practice Patterns, Physicians'; Simvastatin; United States; United States Food and Drug Administration