Pitavastatin and Atorvastatin Double-Blind Randomized ComPArative Study among HiGh-Risk Patients, Including ThOse with Type 2 Diabetes Mellitus, in Taiwan (PAPAGO-T Study)
Journal
PLoS ONE
Journal Volume
8
Journal Issue
10
Date Issued
2013
Author(s)
Liu P.-Y.
Lin L.-Y.
Hsia C.-H.
Hung Y.-R.
Yeh H.-I.
Wu T.-C.
Chen J.-Y.
Chen J.-W.
Abstract
Background:Evidence about the efficacy and safety of statin treatment in high-risk patients with hypercholesterolemia is available for some populations, but not for ethnic Chinese. To test the hypothesis that treatment with pitavastatin (2 mg/day) is not inferior to treatment with atorvastatin (10 mg/day) for reducing low-density lipoprotein cholesterol (LDL-C), a 12-week multicenter collaborative randomized parallel-group comparative study of high-risk ethnic Chinese patients with hypercholesterolemia was conducted in Taiwan. In addition, the effects on other lipid parameters, inflammatory markers, insulin-resistance-associated biomarkers and safety were evaluated.Methods and Results:Between July 2011 and April 2012, 251 patients were screened, 225 (mean age: 58.7 ± 8.6; women 38.2% [86/225]) were randomized and treated with pitavastatin (n = 112) or atorvastatin (n = 113) for 12 weeks. Baseline characteristics in both groups were similar, but after 12 weeks of treatment, LDL-C levels were significantly lower: pitavastatin group = -35.0 ± 14.1% and atorvastatin group = -38.4 ± 12.8% (both: p < 0.001). For the subgroup with diabetes mellitus (DM) (n = 125), LDL-C levels (-37.1 ± 12.9% vs. -38.0 ± 13.1%, p = 0.62) were similarly lowered after either pitavastatin (n = 63) or atorvastatin (n = 62) treatment. Triglycerides, non-high density lipoprotein cholesterol, and apoprotein B were similarly and significantly lower in both treatment groups. In non-lipid profiles, HOMA-IR and insulin levels were higher to a similar degree in both statin groups. Hemoglobin A1C was significantly (p = 0.001) higher in the atorvastatin group but not in the pitavastatin group. Both statins were well tolerated, and both groups had a similar low incidence of treatment-emergent adverse events.Conclusion:Both pitavastatin (2 mg/day) and atorvastatin (10 mg/day) were well tolerated, lowered LDL-C, and improved the lipid profile to a comparable degree in high-risk Taiwanese patients with hypercholesterolemia.Trial Registration: clinicaltrials.gov NCT01386853 http://clinicaltrials.gov/ct2/show/NCT01386853?term=NCT01386853&rank=1. ? 2013 Liu et al.
SDGs
Other Subjects
apolipoprotein A1; apolipoprotein B; atorvastatin; fatty acid; glucose; hemoglobin A1c; high density lipoprotein cholesterol; insulin; low density lipoprotein cholesterol; n(g),n(g) dimethylarginine; pitavastatin; triacylglycerol; adult; anxiety; article; backache; Chinese; cholesterol blood level; comorbidity; comparative study; controlled study; coughing; creatinine blood level; double blind procedure; drug efficacy; drug safety; drug tolerability; female; high risk patient; human; hypercholesterolemia; insulin resistance; major clinical study; male; multicenter study; myalgia; non insulin dependent diabetes mellitus; parallel design; randomized controlled trial; rash; rhabdomyolysis; rhinopharyngitis; side effect; sleep disorder; Taiwan; upper respiratory tract infection; urea nitrogen blood level; Aged; Anticholesteremic Agents; Cholesterol; Coronary Artery Disease; Diabetes Mellitus, Type 2; Female; Heptanoic Acids; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypercholesterolemia; Hypertension; Lipoproteins; Male; Middle Aged; Pyrroles; Quinolines; Risk Factors; Treatment Outcome; Triglycerides
Publisher
Public Library of Science
Type
journal article