A six-month, multicenter, open-label, noncomparative, prospective, observational study of the efficacy and tolerability of atorvastatin in the primary care setting(estudio del control de las hiperlipidemiasen atención primaria): the cheap study (original) (raw)
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Atherosclerosis, 2000
Hyperlipidemia is common in type 2 diabetic patients and is an independent risk factor for cardiovascular disease. The aim of this trial was to evaluate the efficacy and safety of once-daily atorvastatin 10 − 80 mg for the treatment of hyperlipidemia in type 2 diabetics with plasma low-density lipoprotein cholesterol (LDL-C) levels exceeding 3.4 mmol/l (130 mg/dl). One hundred and two patients met the study criteria and received 10 mg/day atorvastatin. Patients who reached the target LDL-C level of 52.6 mmol/l (100 mg/dl) maintained the same dosage regimen until they had completed 16 weeks of treatment. Patients not reaching the target LDL-C underwent dose titration to atorvastatin 20, 40 and 80 mg/day at Weeks 4, 8 and 12, respectively. All 88 patients who completed the study attained target LDL-C levels and 52 (59%) of patients achieved the target goal at the starting dose of atorvastatin 10 mg/day. In this group the differences between baseline and post-treatment values for LDL-C were 4.390.7 mmol/l (166 926 mg/dl) versus 2.2 90.4 mmol/l (87 914 mg/dl) (PB 0.0001), respectively, a decrease of 47%. Similar trends were observed for total cholesterol, triglycerides, very low-density lipoprotein cholesterol and apolipoprotein B levels. The safety profile of atorvastatin in these patients was highly favorable and similar to those reported with other statins. Only one patient withdrew due to a possible drug-related adverse event. These data confirm the marked efficacy and safety of atorvastatin in type 2 diabetic patients with hyperlipidemia and the efficacy of atorvastatin 10 mg in helping patients attain their LDL-C goal.
American Heart Journal, 2005
The 6-week efficacy and safety of atorvastatin versus simvastatin was determined during a 54-week, openlabel, multicenter, parallel-arm, treat-to-target study. In all, 1,424 patients with mixed dyslipidemia (triglyceride 200 to 600 mg/dl [2.26 to 6.77 mmol/L]) were stratified to 1 of 2 groups (diabetes or no diabetes). Patients were then randomized to receive either atorvastatin 10 mg/ day (n ؍ 730) or simvastatin 10 mg/day (n ؍ 694). Efficacy was determined by measuring changes from baseline in lipid parameters including low-density lipoprotein (LDL) cholesterol, total cholesterol, triglycerides, and apolipoprotein B. Compared with simvastatin, atorvastatin produced significantly greater (p <0.0001) reductions from baseline in LDL cholesterol (37.2% vs 29.6%), total cholesterol (27.6% vs 21.5%), triglycerides (22.1% vs 16.0%), the ratio of LDL cholesterol to highdensity lipoprotein (HDL) cholesterol (41.1% vs 33.7%), and apolipoprotein B (28.3% vs 21.2%), and a comparable increase from baseline in HDL cholesterol (7.4% vs 6.9%). Atorvastatin was also significantly (p <0.0001) more effective than simvastatin at treating the overall patient population to LDL cholesterol goals (55.6% vs 38.4%). Fewer than 6% of patients in either treatment group experienced drug-attributable adverse events, which were mostly mild to moderate in nature. Diabetic patients treated with either statin had safety characteristics similar to nondiabetics, with atorvastatin exhibiting superior efficacy to simvastatin. In conclusion, atorvastatin, at a dose of 10 mg/day, is more effective than simvastatin 10 mg/day at lowering lipids and reaching LDL cholesterol goals in patients with mixed dyslipidemia. Both statins are well tolerated with safety profiles similar to other members of the statin class. ᮊ2001 by Excerpta Medica, Inc.
A brief review paper of the efficacy and safety of atorvastatin in early clinical trials
Atherosclerosis, 1997
Preclinical and clinical data on atorvastatin, a new 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, indicate that it has superior activity in treating a variety of dyslipidemic disorders characterized by elevations in low-density lipoprotein cholesterol (LDL-C) and/or triglycerides. Results for patients randomized in early efficacy and safety studies were combined in one database and analyzed. This analysis included a total of 231 atorvastatin-treated patients (131 with hypercholesterolemia (HC), 63 with combined hyperlipidemia (CH), 36 with hypertriglyceridemia (HTG), and 1 with hyperchylomicronemia (Fredrickson Type V)). Patients were treated with a cholesterol-lowering diet (National Institutes of Health National Cholesterol Education Program Step 1 diet or a more rigorous diet) and either 2.5, 5, 10, 20, 40, or 80 mg/day of atorvastatin or placebo. Efficacy was based on percent change from baseline in total cholesterol, total triglycerides, LDL-C, very low-density lipoprotein cholesterol (VLDL-C), high-density lipoprotein cholesterol (HDL-C), apolipoprotein B (apo B), and non-HDL-C/HDL-C. Safety was assessed in all randomized patients. Atorvastatin seemed to preferentially lower those lipid and lipoprotein component(s) most elevated within each dyslipidemic state: LDL-C in patients with HC, triglycerides and VLDL-C in patients with HTG, or all 3 in patients with CH. Atorvastatin was well-tolerated with a safety profile similar to other drugs in its class.
Current Medical Research and Opinion, 2002
Atorvastatin is very effective in reducing plasma low-density lipoprotein cholesterol (LDL-C) levels. However, there is no long-term survival study that evaluated this statin. To assess the effect of atorvastatin on morbidity and mortality (total and coronary) of patients with established coronary heart disease (CHD), 1600 consecutive patients were randomised either to atorvastatin or to 'usual' medical care. The dose of atorvastatin was titrated from 10 to 80 mg/day, in order to reach the National Cholesterol Education Program (NCEP) goal of LDL-C <100 mg/dl (2.6 mmol/l). All patients were followed up for a mean period of 3 years. Primary endpoints of the study were defined as death, non-fatal myocardial infarction, unstable angina, congestive heart failure, revascularisation (coronary morbidity) and stroke. Secondary endpoints were the safety and efficacy of the hypolipidaemic drugs as well as the cost-effectiveness of atorvastatin. The mean dosage of atorvastatin was 24 mg/day. This statin reduced total chlesterol by 36%, LDL-C by 46%, triglycerides by 31%, and non-high-density lipoprotein cholesterol (non-HDL-C) by 44%, while it increased HDL-C by 7%; all these changes were significant. The NCEP LDL-C and non-HDL-C treatment goals were reached by 95% (n = 759) and 97% (n = 776), respectively, of patients on atorvastatin. Only 14% of the 'usual' care patients received any hypolipidaemic drugs throughout the study and 3% of them reached the NCEP LDL-C treatment goal. The cost per quaility-adjusted life-year gained with atorvastatin was estimated at $US 8350. During this study 196 (24.5%) CHD patients on 'usual' care had a CHD recurrent event or died vs. 96 (12%) CHD patients on atorvastatin; risk ratio (RR) 0.49, confidence interval (CI) 0.27-0.73, p < 0.0001. In detail, atorvastatin reduced, in comparison to 'usual' care, total mortality (RR 0.57, CI 0.39-0.78, p = 0.0021), coronary mortality (RR 0.53, CI 0.29-0.74, p = 0.0017), coronary morbidity (RR 0.46, CI 0.25-0.71, p < 0.0001), and stroke (RR 0.53, CI 0.30-0.82, p = 0.034). All subgroups of patients (women, those with diabetes mellitus, arterial hypertension, age 60 to 75 years, congestive heart failure, recent unstable angina or prior revascularisation) benefited from treatment with atorvastatin. Withdrawal of patients because of side-effects from the atorvastatin group was low (0.75%) and similar to that of the 'usual' care group (0.4%). Long-term treatment of CHD patients with atorvastatin to achieve NCEP lipid targets significantly reduces total and coronary mortality, coronary morbidity and stroke, in comparison to patients receiving 'usual' medical care. Treatment with atorvastatin is well tolerated and cost-effective.
AIMS AND OBJECTIVES : To Compare the Safety and Efficacy of Rosuvastatin (10 Mg) and Atorvastatin (30 Mg) in Cases of Dyslipidemia Over twelve Weeks of Treatment MATERIALS AND METHODS : Inclusion Criteria: Both male and female (Excluding Pregnancy) above 18 years of age with hypercholesterolemia, having LDL-C concentration of >159 and, 259 mg/dl and triglyceride concentration of <400mg/dl, who had failed to have achieved LDL-C goals laid down by the NECP ATP-III guidelines after therapeutic lifestyle change (TLC): HDL-C level: <40 mg/dl for men and, <50 mg/dl for women.60 cases of dyslipidemia were selected and 30 were treated with rosuv-astatin 10 mg (Study group 'A') and 30 of them were treated with atorvastatin 20 mg (study group 'B'). Exclusion Criteria : 1. Use of lipid lowering agents with in the past 6 months. 2. Any history of known familial hypercholesterolemia. 3. Any history of serious or hypersensivity reactions to other statins. 4. Uncontrolled hypothyroidism; uncontrolled hypertension. 5. Acute liver diseases or hepatic dysfunction. After estimation of total cholesterol,triglycerides,HDL-cholesterol and LDL-c in a basal state, 50 patients were put on rosuvastatin 10 mg and 50 patients were put on atorvastatin 30 mg daily after night meals.After taking drugs, lipid fractions were re-estimated at the end of 6 weeks and 12 weeks.Clinical examination and questions about occurrence of side effects were carried out at interval of 2 weeks.Present study was conducted in the department of Medicine and Pathology, of Katihar medical college, Katihar,B.N.Mandal University, Madhepura; Bihar. Approval of the institutional ethical committee was taken. Study conducted by " Keith C et al (2006) " showed 37.1±1.3%, improvementin patients treated with RSV (10) and 38.5±1%, with (ATV 20),(ARIES TRIAL), " Cheng J. W. et al(2004) " found 43% improvementin levels of LDL-C, with RSV(10) and " Herregod et al (2008) " found that RSV(10) significantly reducedLDL level up to 47% in his study. In the " SOLAR TRIAL " conducted by " Insull W Jr. et al (2007)1 " found that mean levels ofLDL-C in patients taking RSV(10) over six weeks reached their target <100 mg/dl, which were comparable 100.43±2.93 to our study.The most frequent adverse effect in both the groups were myalagia with incidence of 3.33% in study. Group' A' (RSV 10mg) and 6.66% incidence in study Group 'B' (ATV 30 mg), all adverse events were mild and had no action taken, and resolved spontaneously. SUMMARY AND CONCLUSION : The present study " Comparison of Safety and Efficacy of Rosuvastatin (10mg) and Atorvastatin (30mg) in cases of Dyslipidemia over 12 week Treatment " was conducted amongst 100 diagnosed patients of dyslipidemia. The result of this study shows that rosuvastatin 10 mg is only slightly more efficacious and safe in reducing the levels of TC, LDL, TC/HDL, TG and improving HDL levels as compared to Atorvastatin 30 mg.t KeywORds Atorvastatin, rosuvastatin, dyslipidemia improvement, efficacy.
Pakistan Journal of Medical and Health Sciences, 2022
Aim: The aim of this analysis was to compare the effectiveness of rosuvastatin in lowering cholesterol with that of atorvastatin in patients at high risk of dyslipidaemia. Place and Duration: In the Medicine department of Islam Medical College and Teaching Hospital Sialkot for six months duration from June 2021 to November 2021. Methods: This randomized, open-label study enrolled 90 patients with high-risk dyslipidaemia and diagnosed according to the international guidelines for the prevention of adult dyslipidaemia. These patients were randomized to rosuvastatin and atorvastatin to receive rosuvastatin 20 mg / day and atorvastatin 20 mg / day, respectively, for three months. In both groups, the efficacy of atorvastatin and rosuvastatin on the concentration of LDL-C, HDL-C, total cholesterol (TC) and triglycerides (TG) was assessed. In addition, the rates of achieving LDL-C or TC target levels were assessed in both groups. Results: Rosuvastatin caused a significantly greater reducti...
Pakistan Journal of Medical and Health Sciences
Hyperlipidaemia is the utmost important factors influencing coronary heart disease. Statins are supposed to be the 1st line of drug in clinical exercise for lowering low-density lipoprotein, total cholesterol and increasing HDL cholesterol. This study was held for the comparison of the safety and efficacy of atorvastatin and rosuvastatin in lowering hyperlipidaemia among hyperlipidemic patients. Study Design: A prospective observational study. Place and Duration: In the Medicine department of Mayo hospital, Lahore for three-months duration from 15th March 2021 to 15th June 2021. Methods: This study comprised 90 patients with newly diagnosed hyperlipidaemia divided into two groups containing equal number of patients in both. Patients prescribed 10 mg of atorvastatin in Group A and 5 mg of rosuvastatin in Group B once daily for 6 weeks by the treating doctor of medicine. The data was saved in a personalized proforma format, and the SPSS 20.0 was used for analysis. Results: Serum total...
The American journal of cardiology, 2002
The efficacy and safety of atorvastatin 10 mg versus simvastatin 20 mg and atorvastatin 80 mg versus simvastatin 80 mg was determined in a 6-week, prospective, randomized, open-label, blinded end-point trial of dyslipidemic patients with and without coronary heart disease. A total of 1,732 patients with hypercholesterolemia and triglycerides < or =600 mg/dl (6.8 mmol/L) were randomized to receive either atorvastatin 10 mg (n = 650), simvastatin 20 mg (n = 650), atorvastatin 80 mg (n = 216), or simvastatin 80 mg (n = 216). The primary efficacy parameter was the change in low-density lipoprotein (LDL) cholesterol from baseline to week 6. Secondary efficacy parameters included the percent change from baseline to week 6 in total cholesterol, triglyceride, high-density lipoprotein (HDL) cholesterol, very-low-density lipoprotein cholesterol, apolipoprotein B, and the percent of patients achieving their National Cholesterol Education Program (NCEP) LDL cholesterol goal at study end. Ato...