Pitavastatin approved for treatment of primary hypercholesterolemia and combined dyslipidemia

Figures & data

Table 1 Lipid baselines, percent changes, and safety results of randomized clinical studies of pitavastatin compared with the other statin

Subject	Study	Lipid criteria (mg/dL)	Study drug	Duration	n	Percent change from baseline				Baseline level (mg/dL)				Safety
						LDL-C	TG	HDL-C	TC	LDL-C	TG	HDL-C	TC
Japan	Saito et al^Citation45	TC ≥ 220, TG < 400	PTV 2 mg	12 wks	120	−37.6		8.9	−28.0	194.2	158.0	56.8	279.7	Both treatments well tolerated
			PRV 10 mg		105	−18.4		9.8	−13.8	195.3	166.8	52.9	278.8
	CHIBA^Citation43	TC ≥ 220, TG < 400	PTV 2 mg	12 wks	93	−42.6	−17.3	3.2	−29.7	177.1	155.2	58.5	262.8	AST, ALT, γ-GTP elevated in ATV
			ATV 10 mg		98	−44.1	−10.7	1.7	−31.1	178.3	138.9	60.2	265.8
	PIAT^Citation39*	LDL-C ≥ 140, HDL-C < 80, TG < 500	PTV 2 mg	8 wks	88	−36.8		8.2		163.7	155.1	51.9	246.9	No significant differences
			ATV 10 mg		85	−37.9		3.4		161.9	171.9	51.6	246.7
Korea	Park et al^Citation46	LDL-C > 130, TG < 600	PTV 2 mg	8 wks	49	−38.2		8.3	−26.9	170.0	168.1	51.0	246.8	More incidence of ADRs in SMV
			SMV 20 mg		46	−39.4		3.6	−28.5	165.7	153.6	52.1	240.0
	Lee et al^Citation44	LDL-C > 130, TG < 400	PTV 2 mg	4 wks	110	−44.4	−13.4	4.6	−30.1	159	142	52	239	No significant differences
			ATV 10 mg		112	−43.2	−13.3	5.7	−29.3	160	136	52	239
Thailand	Sansanayudh et al^Citation42	Indicated for statin therapy by NCEP-ATP III	PTV 1 mg	8 wks	50	−37.4	−10.4	2.8	−27.6	176.0	145.2	53.4	258.4	Both treatments well tolerated
			ATV 10 mg		50	−45.8	−7.1	−0.4	−32.3	172.9	141.9	53.9	255.2
Europe	Budinski et al^Citation48	160 ≤ LDL-C ≤ 220, TG ≤ 400	PTV 2 mg	12 wks	315	−37.9	−14.1	4	−27.7	183.6	157.8	48.5	263.6	All treatments well tolerated
			ATV 10 mg		102	−37.8	−17.7	3	−28.1	179.8	156.8	50.2	261.3
			PTV 4 mg		298	−44.6	−19	5	−32.4	182	156.8	49.9	263.3
			ATV 20 mg		102	−43.5	−22.3	2.5	−32.7	181.9	161.9	48.4	262.7
	Ose et al^Citation47	160 ≤ LDL-C ≤ 220, TG ≤ 400	PTV 2 mg	12 wks	307	−39.0	−15.9	6.0	−27.9	183.6	163.8	51.3	267.6	All treatments well tolerated
			SMV 20 mg		107	−35.0	−15.6	5.5	−25.4	184.1	166.7	51.0	268.4
			PTV 4 mg		319	−44.0	−16.8	6.2	−31.5	184.1	155.4	52.8	268.0
			SMV 40 mg		110	−42.8	−16.1	6.8	−30.5	184.0	153.9	52.3	267.0
	Hounslow^Citation49	130 ≤ LDL-C ≤ 220	PTV 1 mg	12 wks		−31.4								All treatments well tolerated
			PRV 10 mg			−22.4
			PTV 2 mg			−39.0				162.8–
			PRV 20 mg			−28.8				166.6
			PTV 4 mg			−44.3
			PRV 40 mg			−34.0
Japan	JAPAN-ACS^Citation16,Citation40	TC ≥ 180, LDL-C ≥ 100	PTV 4 mg	8–12 mos	125	−36.2	16.2	9.9	−21.6	130.9	119.2	45.0	196.5	No significant differences
			ATV 20 mg		127	−35.8	21.2	8.0	−21.9	133.8	116.7	43.9	197.9
	Toi et al^Citation41	Unspecified	PTV 2 mg	2–3 wks	80	−31.0	−8.0	−2.6	−22.5	114.7	86.2	45.5	178.0	NA
			ATV 10 mg		80	−27.9	0.8	−5.1	−22.0	122.0	120.3	45.5	191.1

* Note: Patients with impaired glucose tolerance or Type 2 diabetes mellitus.

Abbreviations: ACS, acute coronary syndrome; n, number of patients; PTV, pitavastatin; PRV, pravastatin; ATV, atorvastatin; SMV, simvastatin; NA, data not available; ADRs, adverse drug reactions; TC, toal cholesterol; TG, triglycerides; LDL-C, low-density lipoprotein cholesterol; HDL-C, high-density lipoprotein cholesterol.

Figure 1 Time course of high-density lipoprotein cholesterol levels in long-term clinical studies of pitavastatin.

Note: Data are expressed as mean ± standard deviation. Reference ⁵² is subanalysis for patients whose baseline high-density lipoprotein cholesterol was <40 mg/dL.

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