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DisHpidemik hastalarda 4 haftalık kısa dönem günde tek doz 200 mg mikronize fenofibrat tedavisinin etkinlik ve güvenilirliği

Efficacy and Tolerability of Micronised Fenofibrat, in Dyslipidemic Patients.

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Abstract (2. Language): 
This study was conducted to evaluate the efficacy and safety of micronised fenofibrat 200 mg single-dose in dyslipidemic patients. It was an open study without a control group. Fourteen patients (range: 26 to 62 years; mean age: 44,9 10,5 years) in type IIa dyslipidemic group, 26 patients (range: 26 to 51 years; mean age: 40,5 7,4 years) in type IIb group and 6 patients (range: 24 to 57 years; mean age: 42 10,8 years) in type IV group includ¬ed in the study. 200 mg once-daily dose of micronised fenofibrat was given to patients after a four weeks stan¬dart diet without drug. Efficacy and safety parameters were assessed. After a four weeks short term treatment period, group type IIa showed a decrease of 17% in total cholesterol (TC), 22% in low density lipoprotein cholesterol (LDL-C), 28% in triglyceride (TG) and an increase of 18% in high density lipoprotein cholesterol (HDL-C) level. Type IIb dyslipidemic group showed a decrease of 14% in TC, 8% in LDL-C, 42% in TG and increase of 22% in HDL-C. All lipid variations were found statistically sig¬nificant (p = 0,001 and p < 0,001). Statistical analysis was not performed due to insufficient number in type IV group. No significant difference were detected in safety parameters (creatine kinaz, liver function tests, blood counts). No major side effect was observed. It was concluded that micronised fenofibrat is an effective and safe alternative for treatment of type IIa and IIb dyslipidemia.
Abstract (Original Language): 
Bu çalışma günde tek doz mikronize fenofibratın etkinlik ve güvenilirliğini araştırmak amacıyla yapıldı. Açık kontrol grubu olmayan bir çalışmadır. Çalışmaya tip IIa dislipidemi grubundan 14 (yaş aralığı: 26-62; yaş ortalaması: 44, 9 10,5) tip Iİb grubundan 26 (yaş aralığı: 26-51; yaş ortalaması: 40,5 7,4) ve tip IV grubundan 6 (yaş aralığı: 24-57; yaş ortalaması: 42 10,8) hasta alındı. Dört haftalık ilaçsız diyet tedavisi sonrası, dört hafta boyun¬ca günde tek doz 200 mg mikronize fenofibrat verildi. Etkinlik ve güvenilirlik parametreleri değerlendirildi. Dört haftalık kısa dönem tedavi sonunda tip IIa gubunda total kolesterol'de (TK) %17, düşük dansiteli lipoprotein kolesterol'de (LDL-K) %22, trigliserid'de (TG) %28 azalma ve yüksek dansiteli lipoprotein kolesterolde (HDL-K) ise %18 lik artış tespit edildi. Tip IIb grubunda ise TK'de %14 , LDL-K'de %8, TG vde %42 azalma ve HDL-K' de %22 lik artma tesbit edildi. Her iki gruptaki lipid değerlerindeki değişim istatistiksel açıdan anlam¬lı bulundu ( p = 0,001 ve p < 0,001). Tip IV grubunda sayı az olduğundan istatistik yapılmadı. Güvenilirlik parametrelerinde (kreatinine kinaz, karaciğer fonksiyon testleri, kan sayımı) anlamlı değişiklik saptanmadı. Önemli yan etki gözlenmedi. Mikronize fenofibratın tip IIa ve tip IIb dislipidemilerinde etkin ve güvenilir bir tedavi seçeneği olduğu kanısına varıldı.
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