Safety and Tolerability of Fluvastatin XL, in the Treatment of Hypercholesterolemia : a Postmarketin Surveillance Conducted in Indonesia | Perpustakaan Badan Kebijakan Pembangunan Kesehatan

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Safety and Tolerability of Fluvastatin XL, in the Treatment of Hypercholesterolemia : a Postmarketin Surveillance Conducted in Indonesia

Arini Setiawati - Personal Name; Iwan Darmansjah - Personal Name;

Fluvastatin XL 80 mg tablet has been marketed in Indonesia since Desember 2002. This post-marketing surveillance (PMS) was conducted between May 2004 and April 2005 involving 98 general physicians to observe the sofety and tolerability of fluvastatin XL 80 mg once daily at bedtime for 8 weeks in the treatment of outpatiens with hypercholesterolemia. The afficacy of the drug inlowering LDL cholesterol and other lipid parameters was also observed in daily clinical practice in this PMS. A total of 740 patients were eligible for safety analyses. There were 32 patients (4.32%) with 39 adverse events that were conconsidered related to Fluvastatin XL therapy. The most common adverse rections were dizziness (2.02%, nausea (1.22%), and myalgia (0.68%). No serious adverse event (SAE) was found in this PMS, and no patient discontinued due to adverse event. According to physician’s globel evaluation, the safety and tolerability of treatment was good in 91.9% of patients. For efficacy analyses, only 566 patient were eligible. At week 8, fluvastatin XL caused decreases in LDL-cholesterol (LDL-C), total cholesterol (TC) and triglyceride (TG) levels by 28.6%, 30.2% and 24.5%, respectively and an increase in HDL-cholesterol (HDL-C) by 14.3%. In 74 patients with baseline TG≥300mg/dL, the decrease in TG was 38.1% and the increase in HDL-C was 18.1%. Reducation in LDL-C of ≥40% accurred in 19.6% of the patients. In conclusion, treatment with fluvastation XL 80 mg once daily for 8 weeks in this PMS was shown to be safe and wwell tolerated, and also effective in reducing LDL-C, TC abd TG, and raising HDL-C in daily clinical practice.

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Location name is not set Medical Joural of Indonesia, 17(2):88-95

A00002208

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Detail Information

Series Title: -
Call Number: Medical Joural of Indonesia, 17(2):88-95
Publisher: Jakarta : Fk. Universitas Indonesia., 2008
Collation: 5p.
Language: English
ISBN/ISSN: 0853-1773
Classification: -
Content Type: -
Media Type: -
Carrier Type: -
Edition: -
Subject(s): CHOLESTEROL,LDL
HYPERCHOLESTEROL
Specific Detail Info: -
Statement of Responsibility: -

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