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경희대학교 동서신의학병원 약품 정보지 NEWS LETTER 2008년 Vol 01. EAST-WEST NE MEDICAL CENTER DRUG INFRMATIN -contents신약 소개 02 Journal Review 03 Special Subject 03 의약품 안전성정보 06 약제부 알림 06 본 약품정보지는 경희대학교 동서신의학병원의 신약 및 최신 약물정보, 약물 상호작용, 철회 및 삭제약품, 의약품 안전성, 복약지도 등의 정보를 제공하기 위하여 연 4회 발행되는 정기간행물입니다. 약제부 약품정보실 제공

Certican tab. 0.25, 0.5, 0.75mg (Everolimus, Certican tab. 0.25, 0.5, 0.75mg Everolimus, N H H H Certican tab. 0.25mg Certican tab. 0.5mg Certican tab. 0.75mg > < > Very common cyclosporine microemulsion corticosteroid (> 1/10) Common (1/10 > >1/100) Uncommon (1/100 > >1/1000) _ 2

Journal Review Efficacy of single-agent bortezomib vs. single-agent thalidomide in patients with relapsed or refractory multiple myeloma: a systematic comparison BJECTIVE : To conduct a systematic review of the efficacy of singleagent bortezomib vs. single-agent thalidomide in patients with relapsed/refractory multiple myeloma. METHDS: Publications in English from 1966 to June 2005 (MEDLINE, EMBASE, Cochrane library), publication reference lists, Janssen-Cilag data-on-file and abstracts from recent multiple myeloma conferences were reviewed. Prospective studies containing at least a single arm of either treatment group with n> or =30 were included. Studies adding dexamethasone for nonresponders were excluded. Statistical pooling was performed for response rate and overall survival. RESULTS: ne bortezomib study (n = 333, NEJM 2005, 352; 2487-98) and 15 thalidomide (n = 1007) studies met these criteria and were included. Patient baseline characteristics including age, gender, IgG : IgA, disease duration and beta-2 microglobulin were well matched except that 48% of bortezomib patients had received prior thalidomide. Response rate, defined as serum M- protein reduction > or =50%, was 53% for patients receiving bortezomib vs. 32% for thalidomide (P < 0.001, n = 10 studies). Response rate determined by European Group for Blood and Marrow Transplantation (EBMT) criteria was 41% for patients receiving bortezomib vs. 22% for thalidomide (P < 0.001, n = 4 studies). CNCLUSIN: Bortezomib was associated with a significantly higher response rate and complete remission rate using both M-protein and EBMT criteria. Eur J Haematol. 2007 Aug;79(2):93-9 Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. BACKGRUND: Adding insulin to oral therapy in type 2 diabetes mellitus is customary when glycemic control is suboptimal, though evidence supporting specific insulin regimens is limited. METHDS: In an open-label, controlled, multicenter trial, we randomly assigned 708 patients with a suboptimal glycated hemoglobin level (7.0 to 10.0%) who were receiving maximally tolerated doses of metformin and sulfonylurea to receive biphasic insulin aspart twice daily, prandial insulin aspart three times daily, or basal insulin detemir once daily (twice if required). utcome measures at 1 year were the mean glycated hemoglobin level, the proportion of patients with a glycated hemoglobin level of 6.5% or less, the rate of hypoglycemia, and weight gain. RESULTS: At 1 year, mean glycated hemoglobin levels were similar in the biphasic group (7.3%) and the prandial group (7.2%) (P=0.08) but higher in the basal group (7.6%, P<0.001 for both comparisons). The respective proportions of patients with a glycated hemoglobin level of 6.5% or less were 17.0%, 23.9%, and 8.1%; respective mean numbers of hypoglycemic events per patient per year were 5.7, 12.0, and 2.3; and respective mean weight gains were 4.7 kg, 5.7 kg, and 1.9 kg. Rates of adverse events were similar among the three groups. CNCLUSINS: A single analogue-insulin formulation added to metformin and sulfonylurea resulted in a glycated hemoglobin level of 6.5% or less in a minority of patients at 1 year. The addition of biphasic or prandial insulin aspart reduced levels more than the addition of basal insulin detemir but was associated with greater risks of hypoglycemia and weight gain. N Engl J Med. 2007 ct 25;357(17):1716-30. Special Subject ( ) Detection and Evaluation of High Blood Cholesterol in ATP III (Adult Treatment Panel) & update 2004 LDL Cholesterol Goals and Cutpoints for TLC and Drug Therapy Risk Category LDL Goal LDL Therapeutic Lifestyle Change (TLC) LDL Drug Therapy Very High risk; *CHD or CHD risk equivalents < 70 mg/dl 100 mg/dl 100 mg/dl High risk; CHD or CHD risk equivalents 130 mg/dl High TG, low HDL: combination a fibrate or < 100 mg/dl 100 mg/dl :10-years risk>20% nicotinic acid with LDL lowering drug* Moderately high risk; *2+ Risk Factors :10-year risk 10-20% < 130 mg/dl 130 mg/dl 130 mg/dl(consider drug options if LDL-C 100-129 mg/dl)* Moderate risk; 2+ Risk Factors :10-year risk <10% < 130 mg/dl 130 mg/dl 160 mg/dl Low risk; 0-1 Risk Factor < 160 mg/dl 160 mg/dl 190 mg/dl(consider drug options if LDL-C 160-189 mg/dl) 2004 update, 0-1risk factor 10-year risk 10% 10-year risk assessment _ 3

Special Subject ( ) < > < < Nutrient Composition of the TLC Diet Nutrient Saturated fat Polyunsaturated fat Monounsaturated fat Total fat Carbohydrate Fiber Cholesterol Total calories (energy) Recommended Intake Less than 7% of total calories Up to 10% of total calories Up to 20% of total calories 25-35% of total calories 50-60% of total calories Approximately 15% of total calories Less than 200 mg/day Balance energy intake and expenditure to maintain desirable body weight/prevent weight gain A Model of Steps in Therapeutic Lifestyle Changes (TLC) Visit 1 Visit 2 Visit 3 F/U Visit _ 4 Drugs Affecting Lipoprotein Metabolism Drug Class HMG CoA reductase inhibitors (statins) Bile acid Sequestrants Nicotinic acid Fibric acids Visit 1 Agents and Daily Doses Lovastatin (20-80 mg), Pravastatin (20-40 mg), Simvastatin (20-80 mg), Fluvastatin (20-80 mg), Atorvastatin (10-80 mg), Cerivastatin (0.4-0.8 mg) Cholestyramine (4-16 g) Colestipol (5-20 g) Colesevelam (2.6-3.8 g) Immediate release (crystalline): nicotinic acid (1.5-3 gm), extended release nicotinic acid: (Niaspan ) (1-2 g), sustained release nicotinic acid (1-2 g) Gemfibrozil (600 mg BID) Fenofibrate (200 mg) Clofibrate (1000 mg BID) Lipid /Lipoprotein Side Effects Effects LDL-C - Myopathy HDL-C- TG - LDL-C - HDL-C - TG No change or increase LDL-C - HDL-C - TG - LDL-C - (may be increased in patients with high TG) HDL-C - TG - Increased liver enzymes Gastrointestinal distress Constipation Decreased absorption of other drugs Flushing Hyperglycemia Hyperuricemia (or gout) Upper GI distress Hepatotoxicity Dyspepsia Gallstones Myopathy Contraindications Absolute: - Active or chronic liver disease Relative: - Concomitant use of certain drugs* Absolute: - dysbetalipoproteinemia -TG >400 mg/dl Relative: -TG >200 mg/dl Absolute: - Chronic liver disease - Severe gout Relative: - Diabetes - Hyperuricemia - Peptic ulcer disease Absolute: - Severe renal disease - Severe hepatic disease Progression of Drug Therapy in Primary Prevention Visit 2 Visit 3 F/U Visit

Special Subject ( ) Clinical Identification of the Metabolic Syndrome Risk Category Defining Level Abdominal obesity (Waist circumference) Men >102 cm (>40 inch) Women >88 cm (>35 inch) TG 150 mg/dl Abdominal obesity (Waist circumference) Men <40 mg/dl Women <50 mg/dl Blood pressure 130 / 85 mm Hg Fasting glucose 110 mg/dl Comparison of LDL Cholesterol and Non-HDL Cholesterol Goals Risk Category LDL goal (mg/dl) Non - HDL goal (mg/dl) CHD and CHD risk equivalents < 100 < 130 Multiple (2+) Risk Factors < 130 < 160 Zero to one risk factor < 160 < 190 - - - < < > > _ 5

IIALXI Aloxi inj. 0.25mg/5ml (Palonosetron)/CJ IIAPV Apidra inj. 1000U/10ml/V (Insulin glulisine)/ IIAPP Apidra optiset pen inj. 300U/3ml (Insulin glulisine)/ IBN Bonviva inj. 3mg/3ml (Ibandronate)/ MBBN Bonviva tab. 150mg (Ibandronate)/ MBBPNY Buphenyl tab. 500mg (Phenylbutyrate)/ IFBAL2 CAPD2 Balence soln. (1.5%) 1.5L/FMC IFBAL3 CAPD3 Balence soln. (4.25%) 1.5L/FMC IFBAL4 CAPD4 Balence soln. (2.3%) 1.5L/FMC IACPM10 Cefamezin inj. 1g (Cefazolin)/ IACPM20 Cefamezin inj. 2g (Cefazolin)/ IACEF Cefoxitin sodium inj. 1g (Cefoxitin)/ MBCERA Certican tab. 0.25mg (Everolimus)/ MBCERB Certican tab. 0.5mg (Everolimus)/ MBCERC Certican tab. 0.75mg (Everolimus)/ IACTZ2 Cetrazole inj. 2g (Ceftezole)/ MYACET Children tylenol susp. 32mg/ml (Acetaminophen)/ Rhinapen elixir IACIPR4 Citopcin premix inj. 400mg/200ml (Ciprofloxacin)/CJ MBCVB Codiovan tab. 160/12.5mg (Valsartan, hydrochlorothiazide)/ MBCVA Codiovan tab. 80/12.5mg (Valsartan, hydrochlorothiazide)/ IIRT100 Curan inj. 100mg/4mL (Ranitidine)/ H2 MDIV Daivobet oint. 30g/tu (Betamethasone, calcipotriol)/ _ 6

IIAPS Eglandin inj. 10mcg/2ml (Alprostadil)/ IALUCCA Ferbon inj. 100mg/10m (Leucovorin)/ Antidotes IAFNTA Fontiam inj. 0.5g (Cefotiam)/ IAFNTB Fontiam inj.1g (Cefotiam)/ IACL6 Fullgram inj. 600mg/4ml (Clindamycin)/ IIGADA Gadasil inj. 0.5ml/V ( Human papillomavirus)/sk MPGALA Galantase powd. 5,000 NPG/g ( -Galactosidase)/ IIA5 Hepamerz inj. 500mg/5mL (L-rnithine-L-aspartate)/ MBTRZ1 Hytrin tab. 1mg (Terazosin)/ TZC MBTRZ2 Hytrin tab. 2mg (Terazosin)/ Terapam MBTRZ5 Hytrin tab. 5mg (Terazosin)/ MBVER4 Isoptin tab.40mg(verapamil)/ Verapamil 40mg IACFTA Jetiam inj. 0.5g(Cefotiam)/ IILEVEF Levemir flexpen inj. 300U/3ml (Insulin detemir)/ IACMNX10 Meicelin inj. 1g (Cefminox)/ IITNA40 Metalyse inj. 40mg/Vial (Tenecteplase)/ metalyse 50mg IIMETA Metoject inj. 10mg/1ml (Methotrexate)/ IIMETB Metoject inj. 15mg/1.5ml (Methotrexate)/ MBMEVA20 Mevalotin tab. 20mg (Pravastatin)/CJ MBMEVA40 Mevalotin tab. 40mg (Pravastatin)/CJ MBNF10 Nifedipine soft cap. 10mg (Nifedipine)/ Adalat 10mg MBNIR Noiromin tab. 300mg (Hyperici dried extract)/ ther Antidepressants Jarsin MBMEGA macor cap. 1000mg (mega-3-acid ethyl esters 90)/ MBPAN20 Pantoloc tab. 20mg (Pantoprazole)/ IIGRAF Prograf inj. 5mg/ml (Tacrolimus)/ MBRFP45 Rifodex tab. 450mg (Rifampicin)/ MBRFP60 Rifodex tab. 600mg (Rifampicin)/ MBRPDB Riperidone tab. 0.5mg (Risperidone)/ Major MYRTA Rotateq soln. 2ml/Tu MSD MSEPI Sepidrin cream 30g (Doxepin)/ Doxederm MLSALF100 Seretide diskus 100 60dose (Fluticasone, salmeterol)/gsk MYSMETS Smecta susp. 150mg/ml (Dioctahedral smectite)/ IJTDPUR Td pur prefilled inj. 0.5ml/SK Td vaccine MBURK10 Urocitra K S.R. tab. 1080mg (Potassium citrate)/ Urocitra K 540mg MLVENE Ventolin nebules 2.5mg/2.5ml (Salbutamol)/GSK MBVES5 Vesicare tab. 5mg (Solifenacin succinate)/ MBVES10 Vesicare tab.10mg (Solifenacin succinate)/ IIZA40 Xanbon inj. 40mg (zagrel)/ MBXYZAL Xyzal tab. 5mg (Levocetirizine)/ _ 7

HGSH HMHJA HSBH HJRU HGS HMJS HSMSU HJJU HGT HMHR HSHY HCJG HGAJH HMY HSSJA HCGN HGY1 HMBD HSYB HCGNZ HGYM HMTS HSUJ HCSUG HGNB HBHN HSSG HCC1 HGPI HBNM HYY HCCH HGDC HBNBY HYSH HCHR HGCE HBJYN HYGS HCG HGJU HBBN HYUGN HCGM3 HGGJU HBGU HYG HCSK HGGJ3 HBDH HYJH HCS HGBE HBYS HYSC HCB HGBA HBPD HYYG HTSJ HGBN HBHS HYGU HTC HNM HBSG HYRJ HPGJ HND HBD HYSG HPG HNGSS HBYG HYB HPRP HNGD HBNB HYNG HPB HNGB HBD HYN HHSS HNEH HBM HYH HHGYE HNR HBYP HYJD HHBP HDJG HBJA HYM HHDE HDGG HSGAI HYHA HHBN HDDHG HSH HYJYU HHGA HDJS HSJG HDGA HHDR HDCT HSJM HJYD HHB HDHH HSJY HJHGY HHDN HDGAJ HSYG HJAS HHM HYDC HSGP HJAT HHDY HMHJ1 HSYH HJSJA HMSS HSYU HJSJ HMYA HSJYN HJYA HH011 HH233 HH331 HX003 HH043 HH235 HH338 HX004 HH089G HH236 HH342 HX005 HH094 HH257 HH345 HX009 HH095 HH266 HH348 HX014 HH103A HH277 HH349 HX015 HH104 HH278 HH353 HX016 HH113 HH280A HH356A AHX019 HH130 HH281 HH357 HX029 HH155 HH291 HH358 HX034 HH156 HH295A HHE157 HX036 HH165A HH300 HHE158 HX037 HH169 HH306 HHE160 HX038 HH169A HH307 HHE161 HX039 HH171 HH310 HHE207 HX044 HH176 HH313 HHE208 HX048 HH177 HH321 HHE234 HX052 HH189 HH322 HHE263 HX056 HH198 HH323 HHE351 HH230G HH328 HHE359B 500ML HH232 HH329 _ 8