Inpharma 1227 - 4 Mar 2000 Itavastatin: dose dependent reduction of lipid levels The HMG CoA reductase inhibitor itavastatin reduces levels of total and LDL-cholesterol and triglycerides in a dose-dependent manner in patients with heterozygous familial hypercholesterolaemia, reports the Japan-based Horuriku NK-104 Study Group. In this study, 30 such patients received itavastatin [NK-104] 2mg once daily for 8 weeks, then 4 mg/day for 8 weeks. Significant reductions from baseline in levels of total, LDL- and non-HDL-cholesterol were seen over the course of the study; there were no significant changes from baseline in HDL-cholesterol levels [see table]. At week 8, there were significant increases from baseline in levels of apolipoprotein AI and AII; no further increases were seen at 16 weeks. At 8 weeks, there were significant decreases from baseline in levels of apolipoprotein B, CII and E; at 16 weeks, levels of apolipoprotein CIII had also decreased significantly from baseline and further significant decreases from the values at 8 weeks were seen in levels of apolipoprotein B and E. Table. Changes in lipid levels after 8 and 16 weeks of itavastatin therapy Baseline 8 weeks 16 weeks Total 8.8 6.11* 5.52*† cholesterol (mmol/L) LDL- 6.81 4.09* 3.55*† cholesterol (mmol/L) HDL- 1.31 1.31 1.35 cholesterol (mmol/L) Non-HDL- 7.49 4.81* 4.17*† cholesterol (mmol/L) Triglycerides 1.99 1.68 1.35*† (mmol/L) * significantly different from baseline † significantly different from value at 8 weeks Kajinami K, et al. Effects of NK-104, a new hydroxymethylglutaryl-coenzyme reductase inhibitor, on low-density lipoprotein cholesterol in heterozygous familial hypercholesterolemia. American Journal of Cardiology 85: 178-183, 15 Jan 2000 800813353 » Editorial comment: Itavastatin is undergoing joint development in Japan with Nissan Chemical and Kowa. The agent has been filed for regulatory approval in Japan for the treatment of hyperlipidaemia and it has been licensed to Sankyo for co-marketing in Japan. 1 Inpharma 4 Mar 2000 No. 1227 1173-8324/10/1227-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Itavastatin: dose dependent reduction of lipid levels

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Inpharma 1227 - 4 Mar 2000

Itavastatin: dose dependentreduction of lipid levels

The HMG CoA reductase inhibitor itavastatin reduceslevels of total and LDL-cholesterol and triglycerides in adose-dependent manner in patients with heterozygousfamilial hypercholesterolaemia, reports the Japan-basedHoruriku NK-104 Study Group.

In this study, 30 such patients received itavastatin[NK-104] 2mg once daily for 8 weeks, then 4 mg/day for8 weeks.

Significant reductions from baseline in levels of total,LDL- and non-HDL-cholesterol were seen over thecourse of the study; there were no significant changesfrom baseline in HDL-cholesterol levels [see table].

At week 8, there were significant increases frombaseline in levels of apolipoprotein AI and AII; no furtherincreases were seen at 16 weeks. At 8 weeks, there weresignificant decreases from baseline in levels ofapolipoprotein B, CII and E; at 16 weeks, levels ofapolipoprotein CIII had also decreased significantly frombaseline and further significant decreases from thevalues at 8 weeks were seen in levels of apolipoprotein Band E.

Table. Changes in lipid levels after 8 and 16 weeksof itavastatin therapy

Baseline 8 weeks 16 weeks

Total 8.8 6.11* 5.52*†cholesterol(mmol/L)

LDL- 6.81 4.09* 3.55*†cholesterol(mmol/L)

HDL- 1.31 1.31 1.35cholesterol(mmol/L)

Non-HDL- 7.49 4.81* 4.17*†cholesterol(mmol/L)

Triglycerides 1.99 1.68 1.35*†(mmol/L)

* significantly different from baseline† significantly different from value at 8 weeks

Kajinami K, et al. Effects of NK-104, a new hydroxymethylglutaryl-coenzymereductase inhibitor, on low-density lipoprotein cholesterol in heterozygous familialhypercholesterolemia. American Journal of Cardiology 85: 178-183, 15 Jan2000 800813353

» Editorial comment: Itavastatin is undergoing jointdevelopment in Japan with Nissan Chemical and Kowa. Theagent has been filed for regulatory approval in Japan for thetreatment of hyperlipidaemia and it has been licensed to Sankyofor co-marketing in Japan.