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| __NOTOC__
| | #REDIRECT [[Pitavastatin#Clinical Studies]] |
| {{Pitavastatin}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Clinical Studies==
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| ===Primary [[hyperlipidemia]]or Mixed Dyslipidemia===
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| '''Dose-ranging study''': A multicenter, randomized, double-blind, placebo-controlled, dose-ranging study was performed to evaluate the efficacy of LIVALO compared with placebo in 251 patients with primary [[hyperlipidemia]](Table 4). LIVALO given as a single daily dose for 12 weeks significantly reduced plasma LDL-C, TC, TG, and Apo-B compared to placebo and was associated with variable increases in HDL-C across the dose range.
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| {|
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| |[[File:Pitavastatin04.jpg|thumb|800px]]
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| '''Active-controlled study with atorvastatin (NK-104-301)''': LIVALO was compared with the HMG-CoA reductase inhibitor atorvastatin in a randomized, multicenter, double-blind, double-dummy, active-controlled, non-inferiority Phase 3 study of 817 patients with primary [[hyperlipidemia]]or mixed [[dyslipidemia]]. Patients entered a 6- to 8-week wash-out/dietary lead-in period and then were randomized to a 12-week treatment with either LIVALO or atorvastatin (Table 5). Non-inferiority of pitavastatin to a given dose of atorvastatin was considered to be demonstrated if the lower bound of the 95% CI for the mean treatment difference was greater than 6% for the mean percent change in LDL-C.
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| Lipid results are shown in Table 5. For the percent change from baseline to endpoint in LDL-C, LIVALO was non-inferior to [[atorvastatin]] for the two pairwise comparisons: LIVALO 2 mg vs. [[atorvastatin]] 10 mg and LIVALO 4 mg vs. [[atorvastatin]] 20 mg. Mean treatment differences (95% CI) were 0% (-3%, 3%) and 1% (-2%, 4%), respectively.
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| {|
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| |[[File:Pitavastatin05.jpg|thumb|800px]]
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| '''Active-controlled study with simvastatin (NK-104-302)''': LIVALO was compared with the HMG-CoA reductase inhibitor [[simvastatin]] in a randomized, multicenter, double-blind, double-dummy, active-controlled, non-inferiority Phase 3 study of 843 patients with primary [[hyperlipidemia]]or mixed [[dyslipidemia]]. Patients entered a 6- to 8-week wash-out/dietary lead-in period and then were randomized to a 12 week treatment with either LIVALO or [[simvastatin]] (Table 6). Non-inferiority of pitavastatin to a given dose of [[simvastatin]] was considered to be demonstrated if the lower bound of the 95% CI for the mean treatment difference was greater than 6% for the mean percent change in LDL-C.
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| Lipid results are shown in Table 6. For the percent change from baseline to endpoint in LDL-C, LIVALO was non-inferior to [[simvastatin]] for the two pairwise comparisons: LIVALO 2 mg vs. [[simvastatin]] 20 mg and LIVALO 4 mg vs. [[simvastatin]] 40 mg. Mean treatment differences (95% CI) were 4% (1%, 7%) and 1% (-2%, 4%), respectively.
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| {|
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| |[[File:Pitavastatin06.jpg|thumb|800px]]
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| '''Active-controlled study with pravastatin in elderly (NK-104-306)''': LIVALO was compared with the HMG-CoA reductase inhibitor [[pravastatin]] in a randomized, multicenter, double-blind, double-dummy, parallel group, active-controlled non-inferiority Phase 3 study of 942 elderly patients (≥65 years) with primary [[hyperlipidemia]]or mixed [[dyslipidemia]]. Patients entered a 6- to 8-week wash-out/dietary lead-in period, and then were randomized to a once daily dose of LIVALO or [[pravastatin]] for 12 weeks (Table 7). Non-inferiority of LIVALO to a given dose of [[pravastatin]] was assumed if the lower bound of the 95% CI for the treatment difference was greater than -6% for the mean percent change in LDL-C.
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| Lipid results are shown in Table 7. LIVALO significantly reduced LDL-C compared to [[pravastatin]] as demonstrated by the following pairwise dose comparisons: LIVALO 1 mg vs. [[pravastatin]] 10 mg, LIVALO 2 mg vs. [[pravastatin]] 20 mg and LIVALO 4 mg vs. [[pravastatin]] 40 mg. Mean treatment differences (95% CI) were 9% (6%, 12%), 10% (7%, 13%) and 10% (7%, 13% ), respectively.
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| {|
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| |[[File:Pitavastatin07.jpg|thumb|800px]]
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| '''Active-controlled study with simvastatin in patients with ≥ 2 risk factors for coronary heart disease (NK-104-304)''': LIVALO was compared with the HMG-CoA reductase inhibitor [[simvastatin]] in a randomized, multicenter, double-blind, double-dummy, active-controlled, non-inferiority Phase 3 study of 351 patients with primary [[hyperlipidemia]]or mixed [[dyslipidemia]] with ≥2 risk factors for coronary heart disease. After a 6- to 8-week wash-out/dietary lead-in period, patients were randomized to a 12-week treatment with either LIVALO or [[simvastatin]] (Table 8). Non-inferiority of LIVALO to [[simvastatin]] was considered to be demonstrated if the lower bound of the 95% CI for the mean treatment difference was greater than -6% for the mean percent change in LDL-C.
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| Lipid results are shown in Table 8. LIVALO 4 mg was non-inferior to [[simvastatin]] 40 mg for percent change from baseline to endpoint in LDL-C. The mean treatment difference (95% CI) was 0% (-2%, 3%).
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| {|
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| |[[File:Pitavastatin08.jpg|thumb|800px]]
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| '''Active-controlled study with [[atorvastatin]] in patients with type II diabetes mellitus (NK-104-305)''': LIVALO was compared with the HMG-CoA reductase inhibitor [[atorvastatin]] in a randomized, multicenter, double-blind, double-dummy, parallel group, active-controlled, non-inferiority Phase 3 study of 410 subjects with type II diabetes mellitus and combined [[dyslipidemia]]. Patients entered a 6- to 8-week washout/dietary lead-in period and were randomized to a once daily dose of LIVALO or [[atorvastatin]] for 12 weeks. Non-inferiority of LIVALO was considered to be demonstrated if the lower bound of the 95% CI for the mean treatment difference was greater than -6% for the mean percent change in LDL-C.
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| Lipid results are shown in Table 9. The treatment difference (95% CI) for LDL-C percent change from baseline was -2% (-6.2%, 1.5%). The two treatment groups were not statistically different on LDL-C. However, the lower limit of the CI was -6.2%, slightly exceeding the -6% non-inferiority limit so that the non-inferiority objective was not achieved.
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| {|
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| |[[File:Pitavastatin09.jpg|thumb|800px]]
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| {|
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| |[[File:Pitavastatin10.jpg|thumb|800px]]
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| |}<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC. ] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2 | publisher = | date = | accessdate = 14 February 2014 }}</ref>
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| ==References==
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| {{Reflist|2}}
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| {{statins}}
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| [[Category:Statins]]
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| [[Category:Quinolines]]
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| [[Category:Diols]]
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| [[Category:Carboxylic acids]]
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| [[Category:Organofluorides]]
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| [[Category:Cyclopropanes]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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