27 th. Congress of the Federation of the International Danube Symposia on Diabetes Mellitus PROGRAMME. Zentraleuropäische diabetesgesellschaft

Átírás

1 27 th Congress of the Federation of the International Danube Symposia on Diabetes Mellitus PROGRAMME Zentraleuropäische diabetesgesellschaft, June 2012

2 Wörwag Neuropathy Specialist Thiogamma alpha-lipoic acid 600 mg Thiogamma 600 oral Active ingredient: alpha-lipoic acid 600 mg, Film-coated tablet Therapeutic Indication: Sensory disturbances in cases of diabetic polyneuropathy Dosage: Individual and Daily Doses: In the case of sensory disturbances associated with diabetic polyneuropathy, the following daily dose is recommended for adults: The daily dose is 1 Thiogamma 600 oral film-coated tablet (equivalent to 600 mg of alpha-lipoic acid), which is taken approximately 30 minutes before the first meal. In cases of severe sensory disturbances, infusion therapy with alpha-lipoic acid can be carried out initially. Properties: Alpha-Lipoic acid is a vitamin-like, but endogenously formed substance with a coenzyme function in the oxidative decarboxylation of alpha-keto acids. Contraindications: Thiogamma 600 oral is totally contraindicated in patients with known hypersensitivity to alpha-lipoic acid or any of the other constituents of Thiogamma 600 oral. Note: Children and adolescents should not be treated with Thiogamma 600 oral, as there is no clinical experience of this age group. Interactions: Loss of efficacy of cisplatin during simultaneous treatment with Thiogamma 600 oral.the blood-sugar lowering effect of insulin and oral anti-diabetics may be reinforced. For this reason, close monitoring of blood sugar levels is indicated, particularly during the initial phase of alpha-lipoic acid therapy. In order to avoid the symptoms of hypoglycaemia it may prove necessary in individual cases to reduce the insulin dose or the dose of the oral anti-diabetic. The regular consumption of alcohol represents a significant risk factor for the development and progression of neuropathic clinical pictures and may therefore prevent the success of treatment with Thiogamma 600 oral. Patients with diabetic polyneuropathy are therefore recommended as a matter of principle to avoid the consumption of alcohol as much as possible. Undesirable effects: Very rare: Change in taste sensations, nausea, vomiting, gastrointestinal pain and diarrhoea, Allergic reactions such as skin rash, hives (urticaria) and itching, Because of improved glucose utilization, a fall in blood sugar levels may occur. Symptoms similar to those of hypoglycaemia have been described such as vertigo, diaphoresis, headache and altered visual perception. Date of Revision of the Text: September 2009 Prescription Status: Only available from pharmacists Please refer to the complete summary of product characteristics for your country as variations may exist. Wörwag Pharma GmbH & Co. KG Calwer Strasse 7, Böblingen, Germany thio

3 Improved glycaemic control. The right partnership may get you there. BYETTA + basal insulin: a smart partnership. The addition of BYETTA is now approved for patients with type 2 diabetes inadequately controlled on an existing regimen of basal insulin. 1 BYETTA complements basal insulin s control of FPG with additional postprandial control. 2 Compared with titrated basal insulin alone, BYETTA + basal insulin resulted in greater HbA 1c reduction, no increased risk of hypoglycaemia, potential for weight loss* instead of weight gain, and less increase in insulin dose to achieve FPG <5.6 mmol/l. 2 * BYETTA is not indicated for the management of obesity, and weight change was a secondary endpoint in clinical trials. BYETTA 5μg and 10μg solution for injection, prefilled pen Abbreviated Summary of product characteristics Each dose contains 5 or 10 micrograms (μg) exenatide in 20 or 40 microlitres (μl) (respectively), (0.25 mg exenatide per ml). Each pre-filled pen contains 60 doses of sterile preserved solution. Therapeutic indications: BYETTA is indicated for treatment of type 2 diabetes mellitus in combination with metformin, sulphonylureas, thiazolidinediones, metformin and a sulphonylurea, metformin and a thiazolidinedione in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. BYETTA is also indicated as adjunctive therapy to basal insulin with or without metformin and/or pioglitazone in adults who have not achieved adequate glycaemic control with these agents. Posology and method of administration: BYETTA therapy should be initiated at 5 μg exenatide per dose administered twice daily (BID) for at least one month in order to improve tolerability. The dose of exenatide can then be increased to 10 μg BID to further improve glycaemic control. Doses higher than 10 μg BID are not recommended. BYETTA can be administered at any time within the 60-minute period before the morning and evening meal (or two main meals of the day, approximately 6 hours or more apart). BYETTA should not be administered after a meal. If an injection is missed, the treatment should be continued with the next scheduled dose. BYETTA is recommended for use in patients with type 2 diabetes mellitus who are already receiving metformin, a sulphonylurea, pioglitazone and/or a basal insulin. One can continue to use BYETTA when a basal insulin is added to existing therapy. When BYETTA is added to existing metformin and/or pioglitazone therapy, the current dose of metformin and/or pioglitazone can be continued as no increased risk of hypoglycaemia is anticipated, compared to metformin or pioglitazone alone. When BYETTA is added to sulphonylurea therapy, a reduction in the dose of sulphonylurea should be considered to reduce the risk of hypoglycaemia. When BYETTA is used in combination with basal insulin, the dose of basal insulin should be evaluated. In patients at increased risk of hypoglycaemia consider reducing the dose of basal insulin. The dose of BYETTA does not need to be adjusted on a day-by-day basis depending on selfmonitored glycaemia. However, blood glucose self-monitoring may become necessary to adjust the dose of sulphonylureas or the dose of basal insulin. BYETTA should be used with caution and dose escalation from 5 μg to 10 μg should proceed conservatively in patients >70 years. The clinical experience in patients >75 years is very limited. No dosage adjustment of BYETTA is necessary in patients with mild renal impairment creatinine clearance:50-80 ml/min). In patients with moderate renal impairment (creatinine clearance:30-50 ml/min), dose escalation from 5 μg to 10 μg should proceed conservatively. BYETTA is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance <30 ml/min). No dosage adjustment of BYETTA is necessary in patients with hepatic impairment. The safety and effectiveness of exenatide have not been established in patients under 18 years of age. Each dose should be administered as a subcutaneous injection in the thigh, abdomen, or upper arm. BYETTA and basal insulin must be administered as two separate injections. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Special warnings and precautions for use: BYETTA should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. BYETTA must not be administered by intravenous or intramuscular injection. BYETTA is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance <30 ml/min). BYETTA has not been studied in patients with severe gastrointestinal disease, including gastroparesis, therefore, the use of BYETTA is not recommended in patients with severe gastrointestinal disease. The concurrent use of BYETTA with D-phenylalanine derivatives (meglitinides), alpha-glucosidase inhibitors, dipeptidyl peptidase-4 inhibitors or other GLP-1 receptor agonists has not been studied and cannot be recommended. If pancreatitis is suspected, BYETTA and other potentially suspect medicinal products should be discontinued. Treatment with BYETTA should not be resumed after pancreatitis has been diagnosed. This medicinal product contains metacresol, which may cause allergic reactions. Interaction with other medicinal products: Gastroresistant formulations containing substances sensitive for degradation in the stomach, such as proton pump inhibitors, should be taken at least 1 hour before or more than 4 hours after BYETTA injection. INR should be closely monitored during initiation and dose increase of BYETTA therapy in patients on warfarin and/or cumarol derivatives. Fertility pregnancy and lactation: If a patient wishes to become pregnant, or pregnancy occurs, treatment with BYETTA should be discontinued. BYETTA should not be used during pregnancy or if breast feeding. Undesirable effects and Adverse reactions (Adverse reactions reported in long term phase 3 controlled studies and spontaneous adverse reactions) Patient frequencies are defined as: very common ( 1/10): Hypoglycaemia ( with sulphonylurea with or without metformin), Nausea, Vomiting, Diarrhoea; common ( 1/100 to <1/10): Decreased appetite, Headache, Dizziness, Dyspepsia, Abdominal pain, Gastroesophageal reflux disease, Abdominal distension, Hyperhidrosis, Feeling jittery, Asthenia, Injection site reactions; Weight decreased uncommon ( 1/1,000 to <1/100): Dysgeusia, Eructation, Constipation, Flatulence rare( 1/10,000 to <1/1,000): Dehydration, generally associated with nausea, vomiting and/or diarrhea, Somnolence, Acute pancreatitis, Alopecia, Macular and popular Rash, Pruritus, and/or urticaria, Angioneurotic oedema, Altered renal function, including acute renal failure, worsened chronic renal failure, renal impairment, increased serum creatinine. very rare (<1/10,000) Anaphylactic reaction, necrotising or hemorrhagic pancreatitis and/or death. Frequency not known: INR increased with concomitant warfarin, some reports associated with bleeding. In the three placebo-controlled trials 38 % of patients had low titre antiexenatide antibodies at 30 weeks. An additional 6 % of patients had higher titre antibodies at 30 weeks. About half of this 6 % had no apparent glycaemic response to BYETTA. Patients who develop antibodies to exenatide tend to have more injection site reactions (for example: redness of skin and itching), but otherwise similar rates and types of adverse events as those with no antiexenatide antibodies. When BYETTA was used in combination with basal insulin therapy the incidence and types of other adverse events observed were similar to those seen in the controlled clinical trials with exenatide as monotherapy, with metformin and/or sulphonylurea or a thiazolidinedione, with or without metformin. Pack size of 1 pen, injection needles are not included. Marketing Authorisation Number: EU/1/06/362/001-2, EU/1/06/362/003-4, date: 20 th of November Date of SmPC: 22. March In Hungary: Prescription only medicine by Internist/Diabetologist. In Hungary: Price: Ft, Patient co-pay with 70% reimbursement: 7498 Ft. For more information please read the Summary of Product Characteristic. Lilly Hungária Kft HUNGARY, Budapest, Madách u References: 1. BYETTA Summary of Product Characteristics. 2. Buse JB, Bergenstal RM, Glass LC, et al. Use of twice-daily exenatide in basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial. Ann Intern Med. 2011;154: HUDBT00068a, 12. June, 2012 Lilly Hungária Kft HUNGARY, Budapest, Madách u Tel.: +36-1/ ,

4 Novartis 1 Hirdetés Hatékony glikémiás kontroll, 1,2,3,4 kellô idôben 5 Glimepiridhez hasonló Glikémiás hatékonyság testsúlynövekedés nélkül és szignifikánsan kevesebb hipoglikémia elôfordulása mellett 1 pioglitazon kezeléshez hasonló Glikémiás hatékonyság 2, szívelégedetlenség, testsúlynövekedés és húgyhólyag carcinoma kismértékben fokozott kockázata nélkül 6, tôl érvényes árak 8 termelôi ár bruttó fogy. ár támogatás térítési díj Eucreas 50 mg/850 mg 60x Eucreas 50 mg/1000 mg 60x Irodalom: 1. Ferranini et al. Diabetes, Obesity and Metabolism, 11, 2009, Bolli G., et al. Diabetes, Obesity and Metabolism, 11: , Rosenstock J., et al. Diabetes Care 30: , Bosi et al. Diabetes Care 30: ; Eü pont. 6. Actos alkalmazási elôírás. 7. Competact alkalmazási elôírás Eucreas 50 mg / 850 mg filmtabletta Eucreas 50 mg / 1000 mg filmtabletta Vildagliptin / metformin-hidroklorid: 50 mg / 850 mg, 50 mg / 1000 mg filmtabletta. Terápiás javallatok: Azoknak a 2-es típusú cukorbetegségben szenvedô betegeknek a kezelésére javallt, akiknél a monoterápiában alkalmazott metformin maximális tolerált orális adagjával nem sikerült a vércukorszintet megfelelôen beállítani, vagy akiket már különálló tablettákban adott vildagliptin és metformin kombinációval kezelnek. Adagolás és alkalmazás: A 100 mg-nál magasabb vildagliptin adagok nem javasoltak. Az Eucreas-t vagy az 50 mg/850 mg-os vagy az 50 mg/1000 mg-os hatáserôsségû tabletta napi kétszeri szedésével lehet elkezdeni. A javasolt napi adag 100 mg vildagliptin és 2000 mg metformin-hidroklorid. A vildagliptint és metformint különálló tablettákban kapó betegek átállíthatók Eucreas-ra. Nincs klinikai tapasztalat vildagliptint és metformint, valamint más antidiabetikumot is tartalmazó hármas kombinációval. Az Eucreas nem javasolt 75 évnél idôsebb, vagy gyermekkorú (< 18 év) betegeknek. Ellenjavallatok: A készítmény hatóanyagaival vagy bármely segédanyagával szembeni túlérzékenység. Veseelégtelenség vagy vesemûködési zavar. Akut vagy krónikus metabolikus acidosis, beleértve a diabéteszes ketoacidózist kómával vagy annélkül. Olyan akut vagy krónikus kórképek, amelyek szöveti hipoxiát idézhetnek elô, mint például: keringési vagy légzési elégtelenség, friss szívinfarktus, sokk. Májkárosodás. Akut alkohol intoxikáció, alkoholizmus. Szoptatás. Különleges figyelmeztetések és az alkalmazással kapcsolatos óvintézkedések: Nem alkalmazható 1-es típusú cukorbetegségben szenvedô betegeknél. Fennállhat a laktát-acidózis kockázata. A vesemûködést ellenôrizni kell. Elôvigyázatosság szükséges olyan gyógyszerek együttadása esetén amelyek befolyásolhatják a vesemûködést vagy a metformin-hidroklorid hatását A májkárosodásban szenvedô betegeket beleértve azokat a betegeket is, akiknél a kezelés elôtt az ALT vagy az AST szintje meghaladja a normálérték felsô határának 3-szorosát nem szabad Eucreas-szal kezelni. A kezelés megkezdése elôtt májfunkciós vizsgálatokat kell végezni, majd a kezelés elsô évében háromhavonta, ezt követôen idôszakosan. Amennyiben az AST vagy az ALT értéke tartósan meghaladja a normálérték felsô határának háromszorosát, az Eucreas-kezelés megszakítása javasolt. Azoknál a betegeknél, akiknél sárgaság vagy májmûködési zavarra utaló egyéb tünet alakul ki, az Eucreas adását abba kell hagyni. Az Eucreas-kezelés abbahagyását és a májfunkciós vizsgálatok eredményeinek normalizálódását követôen az Eucreas-kezelést nem szabad újra elkezdeni. Nem javasolt gyermekek és serdülôk számára (< 18 év). A New York Heart Association (NYHA) I-II-es funkcionális stádiumú pangásos szívelégtelenségben szenvedô betegeknek fokozott óvatossággal alkalmazandó. NYHA III-as -IV-es stádiumú betegeknél alkalmazása nem ajánlott. Szívelégtelenségben szenvedô betegeknél ellenjavallt. A cukorbetegek rutinszerû gondozásával összhangban, a bôrbetegségek, mint például a hólyag-, vagy fekélyképzôdés ellenôrzése javasolt. A kezelést idôlegesen fel kell függeszteni: jódozott kontrasztanyagok intravaszkuláris alkalmazása, és mûtéti beavatkozás esetén. Az Eucreas-t a terhesség ideje alatt nem szabad alkalmazni. Vannak a forgalomba hozatalt követôen akut pancreatitisrôl szóló spontán beszámolók. Gyógyszerkölcsönhatások és egyéb interakciók: A vildagliptin esetében alacsony a gyógyszerkölcsönhatások valószínûsége. A vildagliptin nem mutatott klinikailag releváns farmakokinetikai interakciókat kombinációban adott orális antidiabetikumokkal (gliburid, pioglitazon, metformin), amlodipinnel, digoxinnal, ramiprillel, szimvasztatinnal, warfarinnal vagy valzartánnal. Más orális antidiabetikumokhoz hasonlóan, a vildagliptin hipoglikémiás hatását csökkenthetik bizonyos hatóanyagok, így pl. tiazidok, kortikoszteroidok, a pajzsmirigyre ható gyógyszerek és szimpatomimetikumok. Interakciók metformin hidrokloriddal - Nem javasolt kombinációk: alkohol, kationos hatóanyagok (pl. cimetidin), jódozott kontrasztanyagok. Elôvigyázatosságot igénylô kombinációk: a glükokortikoidok, béta-2-agonisták, diuretikumok, ACE inhibitorok. Nemkívánatos hatások, mellékhatások: A nemkívánatos események többsége enyhe és átmeneti volt, és nem igényelték a kezelés felfüggesztését. Vildagliptin: angioödémáról, májmûködési zavarról (beleértve a hepatitist is) ritkán számoltak be. Metforminnal kombinálva Gyakori: fejfájás, tremor, szédülés, hányinger Nem gyakori: fáradtság. Monoterápia esetén gyakori: szédülés, nem gyakori: fejfájás, székrekedés, arthralgia, perifériás ödéma. Nagyon ritka: nasopharyngitis, felsô légúti fertôzés. A metformin összetevô ismert mellékhatásai: nagyon gyakori: hányinger, hányás, hasmenés, hasi fájdalom és étvágytalanság, gyakori: fémes íz érzése, nagyon ritka: csökkent B12-vitamin felszívódás, laktát-acidózis, májfunkciós vizsgálatok kóros eredményei vagy hepatitis, bôrreakciók, mint például erythema, pruritus és urticaria. Megjegyzés: A forgalomba hozatali engedély kiadásának/megújításának dátuma, száma(i): ; EU/1/07/425/ A támogatásban, vagy az árakban bekövetkezô változások a honlapon, vagy az Egészségbiztosítási Közlönyben érhetôk el. Bôvebb információért kérjük, hogy olvassa el a gyógyszer alkalmazási elôírását (Eucreas-II-WS164, )! Forgalomba hozatali engedély jogosultjának magyarországi képviselôje: Novartis Hungária Kft., H-1114 Budapest, Bartók Béla u A dokumentum lezárásának dátuma: novartis hungária kft budapest, bartók béla út telefon: fax: EUC11/12MAR

5 Enabling patients to make the most of metformin s efficacy Extended Release Gold Standard Metformin 1 improves adherence 2 thanks to its: Once daily dosing Better tolerability 3 Flexible dose options (500 mg, 750 mg, 1000 mg) 1 - Campbell IW. Br J Diabetes Vasc Dis 2006;6: Donnelly LA et al. Diab Obes Metab 2009;11: Blonde L et al. Curr Med Res Opin 2004;20: metformin Merckformin Reshaping Efficacy Merck Serono CardioMetabolic Care MSME139/ Merckformin XR, Merckformin XR 500 mg retard tabletta, Merckformin XR 750 mg retard tabletta, Merckformin XR 1000 mg retard tabletta Hatóanyag: metformin-hidroklorid ATC: A10BA02 Terápiás javallatok: 2-es típusú diabetes mellitus kezelésére felnőttek esetén, különös tekintettel a túlsúlyos betegekre, amikor a diéta és a fokozott fizikai aktivitás nem eredményezi a szénhidrát-anyagcsere megfelelő kontrollját. A Merckformin XR alkalmazható monoterápiában, más orális antidiabetikummal vagy inzulinnal kombináltan. Túlsúlyos, 2-es típusú diabéteszes betegeknél a diéta sikertelenségét követő elsővonalbeli metformin-terápia esetén a diabéteszes szövődmények csökkenését mutatták ki. Adagolás: Monoterápia és kombináció más orális antidiabetikumokkal: Olyan betegek esetén, akiket metformin-hidrokloriddal most kezdenek el kezelni, a szokásos kezdő adag naponta egyszer egy Merckformin XR 500 mg retard tabletta az esti étkezéssel együtt bevéve nap után az adagolást a vércukormérések eredménye alapján kell módosítani. Az adagok fokozatos emelése javítja a gastrointestinalis toleranciát. A javasolt maximális dózis napi 4 tabletta a Merckformin XR 500 mg-os retard tabletta esetén, napi 2 tabletta a Merckformin XR 750 mg-os és 1000 mg-os tabletta esetén. Az adagolást heti 500 mg-mal javasolt emelni, legfeljebb napi 2000 mg-ig, a napi egyszeri, az esti étkezéssel együtt történő bevétellel. Amennyiben a beteg már metformint szed, a Merckformin XR kezdő dózisának azonosnak kell lennie az azonnali hatóanyag-leadású tabletta szedett napi mennyiségével. A Merckformin XR 1000 mg retard tabletta olyan betegek fenntartó kezelésére tervezett készítmény, akik jelenleg 1000 mg vagy 2000 mg metformin-hidroklorid terápiában részesülnek. Átálláskor a Merckformin XR 1000 mg retard tabletta napi dózisának azonosnak kell lennie a metformin-hidroklorid jelenlegi dózisával. Amennyiben a napi egyszeri Merckformin XR 750 mg retard tablettával nem érhető el a glikémiás kontroll, az adagolást maximum napi 3 retard tabletta egyszeri, az esti étkezéssel együtt történő bevételére lehet emelni. Amennyiben a Merckformin XR 1000 mg retard tabletta napi egyszeri adagolásával, 2000 mg maximális napi dózissal nem érhető el a glikémiás kontroll, akkor napi kétszeri adagolást kell betervezni, figyelembe véve mindkét dózis étellel együtt történő bevételét a reggeli és esti étkezés során. Ha a glikémiás kontroll még mindig nem érhető el, a betegeket standard metformin-hidroklorid tablettára kell átállítani 3000 mg maximális napi dózisig. A 2000 mg napi dózisnál nagyobb adaggal kezelt betegek esetén nem javasolt az átállítás Merckformin XR 1000 mg tablettára. Ha más orális antidiabetikumról tervezik az átállást, akkor abba kell hagyni a korábbi szer szedését és Merckformin XR adását kell elkezdeni a fenti javallat szerint. Kombináció inzulinnal: A metformin és az inzulin alkalmazható kombinált terápiaként a vércukorszint jobb beállítása érdekében. A Merckformin XR 500 mg és 750 mg retard tabletta szokásos kezdő adagja napi egyszer egy tabletta az esti étkezéssel bevéve, míg az inzulin mennyiségét a vércukormérések alapján kell megállapítani. Titrálás után Merckformin XR 1000 mg retard tablettára történő átállítás megfontolandó. Időskorúak: Csökkent vesefunkció lehetősége miatt a metformin adagolását a vesefunkció alapján kell meghatározni. Rendszeres vesefunkció-ellenőrzés szükséges. Gyermekkorúak: Adatok hiányában a Merckformin XR alkalmazása nem javasolt gyermekkorban. Ellenjavallatok: A készítmény hatóanyagával, a metformin-hidrokloriddal, vagy bármely segédanyagával szembeni túlérzékenység. Diabéteszes ketoacidózis, diabéteszes prekóma. Vesekárosodás vagy renális diszfunkció (kreatinin clearance < 60 ml/min). Akut állapotok, melyek megváltoztathatják a vesefunkciót, mint: dehidráció, súlyos fertőzés, sokk, jódtartalmú kontrasztanyag intravascularis adása. Akut vagy krónikus betegségek, melyek szöveti hypoxiát okozhatnak, mint: kardiális vagy respiratorikus elégtelenség, akut myocardialis infarctus, sokk. Májelégtelenség, akut alkoholos intoxikáció, alkoholizmus. Szoptatás, terhesség. Mellékhatások: Nagyon gyakori: gyomor-bél rendszeri zavarok, mint a hányinger, hányás, hasmenés, hasi fájdalom, étvágytalanság. Ezek a nemkívánatos mellékhatások leggyakrabban a terápia megkezdésekor jelentkeznek, és a legtöbb esetben spontán rendeződnek. Megelőzésükhöz a metformint napi 2-3 részre elosztott adagokban, étkezés közben vagy után javasolt bevenni. Az adag lassú emelése szintén javítja a gastrointestinalis tolerálhatóságot. Gyakori: megváltozott ízérzés. Rendszeres vesefunkció ellenőrzés szükséges! Tárolás: Különleges tárolást nem igényel. Megjegyzés: (egy kereszt) Kizárólag orvosi rendelvényhez kötött gyógyszer (V) Forgalomba hozatali eng. számai: OGYI-T-5157/13-14 (XR 500 mg), OGYI-T-5157/04-06 (XR 750 mg), OGYI-T-5157/15-16 (XR 1000 mg) Szöveg ellenőrzésének dátuma július 13. KÉRJÜK, OLVASSA EL A RÉSZLETES ALKALMAZÁSI ELŐÍRÁST! Rövídített alkalmazási előírás ellenőrzésének dátuma: Ár: OEP által nem támogatott termék. Merck Kft Budapest, Október huszonharmadika utca Telefon: Fax: Web: orvosinformacio@merck.hu

6 27 th Congress of the Federation of the International Danube Symposia on Diabetes Mellitus General information ORGANIZATION FID President: Prof. Dr. Michael Roden Deutsches Diabetes - Zentrum DDZ Leibniz Zentrum für Diabetes Forschung an der Heinrich-Heine Universität Düsseldorf Auf m Hennekamp D Düsseldorf Germany michael.roden@ddz.uni-duesseldorf.de Phone: +49/ Fax: +49/ President of the Local Organizing Committee (Tagungspräsident): Prof. Dr. Peter Kempler 1 st Dept of Medicine Semmelweis University H 1083 Budapest, Korányi S. u. 2/a kempet@bel1.sote.hu Fax: +36/ Local Organizing Committee: Prof. Dr. László Barkai Dr. Zsolt Gaál Dr. Tibor Hidvégi Prof. Dr. György Jermendy Prof. Dr. Peter Kempler Dr. Győző Vándorfi Dr. Tamás Várkonyi Prof. Dr. Gábor Winkler P.C.O. Organizer Secretary and Congress Office: STAND-ART Agency Ltd., Dr. Erika Bernáth H 6723 Szeged, Tisza Palace B/2., Felső Tisza-part Phone: +36/ Fax : +36/ fid-office@t-online.hu URL: Phone No. of Registration Office: +36/

7 Official Website of the Congress: Official Congress Language: English and German Venue: Hotel Hilton Budapest, Buda Castle (H-1014 Budapest, Hess András sq. 1-3.) Period: Thursday 28 Saturday 30 June 2012 Registration Fees Registration fees for delegates include access to all scientific sessions and commercial exhibition, coffee and lunch. After 15 April 2012 and On-Site fid members 180 students* 120 Non-members 220 accompanying persons 140 Accompanying persons registration fee includes admission to the exhibition. One-Day Ticket includes admission to the scientific session and exhibition on the given day, daily coffee break and lunch. One-Day Ticket fid members 80 students* 50 Non-members 100 accompanying persons 60 *Student status should be confirmed by the tutor or head of the department. On-Site Registration Registration desk at Hotel Hilton Budapest will be open: 27 June 2012 (Wednesday) 16:00 21:00 28 June 2012 (Thursday) 09:00 21:00 29 June 2012 (Friday) 08:00 19:00 30 June 2012 (Saturday) 08:00 17:00 All documents regarding registration, including congress bag, name badge, program and abstract book will be handed out to registered participants during this time. 7

8 27 th Congress of the Federation of the International Danube Symposia on Diabetes Mellitus Poster Presentation Guidelines Place of the poster session: Hotel Hilton Corvina room The maximum size of poster presentation should not exceed 840 mm wide by 1200 mm high. Each poster board will be assigned a number corresponding to your abstract number in the program. Please use the board that corresponds with your abstract number. The Organizers will supply adhesive tape for affixing your presentation to the poster board. At least one of the authors must be present during poster session to answer questions. Please prepare your poster on the day of presentation before the start of the first session and please remove it on the same day at the end of the scientific sessions. Hotel Information Address Phone Hotel Hilton Budapest Buda Castle Fashion Hotel Hotel Castle Garden Budapest Art otel Budapest Carlton Hotel Budapest Hotel Victoria Hess A. sq / Úri u / Lovas út / Bem rakpart / hunbuart Apor Péter u / Bem rakpart / Internet Service (Hotel Hilton) Cable internet service is available in the rooms of Hotel Hilton at a special congress rate of 15/day. At the congress and exhibition area wireless broadband internet access is kindly provided free of charge for all congress participants by Lilly. User: LILLY Password: FID2012 Name Badges: Participants are requested to wear their name badges at all time. 8

9 Parking If you arrive by car to the Buda Castle district, there is a crossing bar at which you have to push the HOTEL HILTON button. Take the card showing and let it stamped at the Hotel Hilton reception. Parking is free near the conference venue for each FID 2012 participant. If you are staying in another hotel, a simple and pleasant way to reach the congress venue is to leave your car at your hotel and use the Budapest Castle Hill Funicular (starting from Clark Adam square, Chain Bridge, Buda side bridgehead). A return ticket costs HUF and you can use it the same day of your stay from 7.30 to in 5-10 minutes periods. Transportation Főtaxi ( is the official personal taxi company of the FID 2012 Congress. You can order a taxi by dialling +36/ Airport transfers have fixed tariffs, Budapest Airport Hotel Hilton travelling fare is 22. Health and Safety Emergency telephone numbers in Hungary: Ambulance: 104 Police: 107 Fire Department: 105 9

10 Elsô lépés a hatékonyság felé HU.GLA Hosszú távon is egyensúlyban. 24 órás hatás, nap mint nap. RÖVIDÍTETT ALKALMAZÁSI ELÔÍRÁS: A GYÓGYSZER MEGNEVEZÉSE: Lantus 100 egység/ml oldatos injekció patronban. Lantus SoloStar 100 egység/ml oldatos injekció elôretöltött injekciós tollban. 100 egység glargin inzulin milliliterenként. A patronok és az elôretöltött injekciós tollak egyenként 3 ml oldatos injekciót tartalmaznak, ami 300 egységnek felel meg. Farmakoterápiás csoport: Diabetesben alkalmazott gyógyszerek. Hosszú hatástartamú inzulinok és analógjai, injekció formájában történô beadásra. ATC-kód: A10A E04. TERÁPIÁS JAVALLATOK: Felnôttek, serdülôk és 6 éven felüli gyermekek kezelése inzulinkezelést igénylô diabetes mellitus esetén. ADAGOLÁS ÉS ALKALMAZÁS: Naponta egyszer, bármikor a nap folyamán, de minden nap ugyanabban az idôpontban alkalmazandó. Idôs betegeknél ( 65 éves kor),vesekárosodás, májkárosodás esetén az inzulinszükséglet kisebb lehet. 6 év alatt csak gondos orvosi ellenôrzés mellett adható. A Lantus-t subcutan kell beadni, intravénásan nem adható. A Lantus nem keverhetô semmilyen más inzulinnal és nem hígítható. KLINIKAI JELLEMZÔK: Ellenjavallatok: A készítmény hatóanyagával vagy bármely segédanyagával szembeni túlérzékenység. Figyelmeztetések: Diabeteses ketoacidosis kezelésére reguláris inzulin intravénás alkalmazása javasolt. Az inzulin alkalmazása inzulinellenes antitestek képzôdését idézheti elô. A Lantus által biztosított, idôben elnyújtottabb bázisinzulin ellátás miatt kevesebb éjszakai, de több kora reggeli hypoglykaemia várható. A subcutan beadott glargin inzulin hosszú hatástartama késleltetheti a hypoglykaemia rendezôdését. A kezelés során fellépô betegségek idején az anyagcsere fokozott ellenôrzése szükséges. A Lantus patronokat kizárólag a következô injekciós tollakkal szabad használni: OptiPen, ClikSTAR, Tactipen és Autopen 24. A Lantus és pioglitazon kombinációs kezelés alkalmazásakor figyelni kell a betegeket a szívelégtelenség jelei és tünetei, súlygyarapodás és oedema kialakulása miatt. A szívpanaszok bármilyen romlása esetén a pioglitazont le kell állítani. Gyógyszerkölcsönhatások: A vércukorszint-csökkentô hatást és a hypoglykaemiára való hajlamot fokozzák: orális antidiabetikumok, ACE gátlók, dizopiramid, fibrátok, fluoxetin, MAO gátlók, pentoxifillin, propoxifen, szalicilátok és szulfonamidok. A vércukorszint-csökkentô hatást gátolhatják: a kortikoszteroidok, danazol, diazoxid, diuretikumok, glukagon, izoniazid, ösztrogének és progesztogének, fenotiazin származékok, szomatotropin, szimpatomimetikumok, pajzsmirigy hormonok, atípusos antipszichotikumok. A béta-blokkolók, a klonidin, a lítium sók és az alkohol fokozhatják, de akár gátolhatják is az inzulin vércukorszint-csökkentô hatását. A pentamidin hypoglykaemiát válthat ki, melyet esetenként hyperglykaemia követhet. A szimpatolítikumok így a béta-blokkolók, a klonidin, a guanetidin és a reszerpin alkalmazása során az adrenerg ellenreguláció jelei gyengülhetnek vagy hiányozhatnak. Terhesség és szoptatás: A Lantus alkalmazása szükség esetén megfontolható a terhesség alatt. Szoptatás idején szükségessé válhat az inzulinadag és a diéta módosítása. Mellékhatások: Nagyon gyakori: Hypoglykaemia az ellenreguláció tüneteivel. Gyakori: Lipohypertrophia, az injekció beadási helyén kialakuló reakciók. Ritkán diabeteses retinopathia fordulhat elô. A további mellékhatásokra vonatkozóan kérjük olvassa el az alkalmazási elôírást! Túladagolás: Súlyos hypoglykaemia esetén intramuscularis vagy subcutan glukagont vagy koncentrált iv. glükózt kell adni. A FORGALOMBA HOZATALI ENGEDÉLY SZÁMA(I): EU/1/00/134/ , EU/1/00/134/ , EU/1/00/134/ ALKALMAZÁSI ELÔÍRÁS AZONOSÍTÓJA: EMEA/H/C/284/II IB/65-67 C(2011)463 Bôvebb információért olvassa el a gyógyszer alkalmazási elôírását! Támogatás: EÜ 100% ( A támogatás alapjául szolgáló teljes ár: Ft/1500 NE. A támogatás mértéke: Ft/1500 NE. Beteg által fizetendô térítési díj: 300 Ft/1500 NE. EÜ 50% ( A támogatás alapjául szolgáló teljes ár: Ft/1500 NE. A támogatás mértéke: 7767 Ft/1500 NE. Beteg által fizetendô térítési díj: 7767 Ft/1500 NE. Az árak október 1-tôl érvényesek sanofi-aventis Zrt Budapest, tó u. 1-5., tel.: (+36 1) , fax: (+36 1) Gyógyszerinformációs szolgálat: (+36 1)

11 FOR YOUR PATIENTS WITH TYPE 2 DIABETES HU/TRJ/00024 Meaningful and durable efficacy 1,2 Effective HbA 1c reduction up to -1,2% in poorly controlled type 2 diabetes patients 1 Favourable safety and tolerability profile 3 Safety profile similar to placebo 3 Simple therapy: one dose, once daily 3 Regardless of patient s kidney function 3 Control and care matter film-coated tablets Trajenta 5 mg film-coated tablets Composition: each tablet contains 5 mg of linagliptin. Therapeutic indications: it is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults: 1.) as monotheraphy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment. 2.) as combination therapy: 2.1 with metformin - when diet and exercise plus metformin alone do not provide adequate glycaemic control. 2.2 with sulphonylurea and metformin - when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Posology and method of administration: The dose of linagliptin is 5 mg once daily. When linagliptin is added to metformin: the dose of metformin should be maintained, and linagliptin administered concomitantly. When it is added to sulphonylurea: a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia. No dose adjustment of linagliptin is required for patients with renal impairment or for elderly. However, clinical experience in patients > 75 years of age is limited. Pharmacokinetic studies suggest that no dose adjustment is required for patients with hepatic impairment but clinical experience is lacking. The safety and efficacy of linagliptin in children and adolescents has not yet been established. Method of administration: It can be taken with or without a meal at any time of the day. If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day. Contraindication: Hypersensitivity to the active substance or to any of the excipients. Special warnings: It should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Fertility, pregnancy and lactation: As a precautionary measure, it is preferable to avoid the use of Trajenta during pregnancy. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Trajenta therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. No studies on the effect on human fertility have been conducted for Trajenta. Effects on ability to drive and use machines: Patients should be alerted to the risk of hypoglycaemia especially when combined with sulphonylurea. Undesirable effects: In linagliptin monotherapy: uncommon: nasopharyngitis, cough. In linagtin + metformin therapy: uncommon: nasopharyngitis, hypersensitivity, cough. In linagliptin + metformin + sulphonylurea therapy: very common: hypoglycaemia. Pharmacotherapeutic group: Drugs used in diabetes, DPP-4 inhibitor, ATC code: A10BH05 Marketed pack sizes: 30 1 film-coated tablets in perforated unit-dose blisters in cartons. Marketing Authorisation Holder: Boehringer Ingelheim International GmbH. Marketing Authorisation Numbers: EU/1/11/707/ Date of the SmPC: Medicinal product subject to medical prescription (Sz). Detailed information on the medicine is available on web site. Please, read the Summary of Product Characteristics of the medicine for more information. Gross retail price: HUF, Patients copay: 3701 HUF. ( 70% reimbursement, see: Approval date of the document: REFERENCES: 1. Owens DR, et al: Efficacy and safety of linagliptin in persons with Type 2 diabetes inadequately controlled by a combination of metformin and sulphonylurea: a 24-week randomized study. Diabet. Med. 2011, 28, Schlosser, A: Long-term safety and efficacy of the DPP-4 inhibitor linagliptin: data from a large 2-year study in subjects with type 2 diabetes mellitus. Diabetologia, 2011, 54, Abstract 242 Suppl 1, S1-S Summary of product characteristics Trajenta. Boehringer Ingelheim RCV Magyarországi Fióktelepe 1095 Budapest, Lechner Ödön fasor 6. Tel.: (+36 1) ; Fax: (+36 1) Lilly Hungária Kft Budapest, Madách u Tel.: (+36 1) Fax: (+36 1)

12 Onglyza Abbreviated Prescribing Information Presentations. 2.5 mg and 5 mg film-coated tablets. Each tablet contains 2.5 mg or 5 mg saxagliptin (as hydrochloride). Therapeutic indications. Add-on combination therapy: Onglyza is indicated in adult patients with type 2 diabetes mellitus to improve glycaemic control: in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control; in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate; in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate; in combination with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control. Posology and method of administration. Add-on combination therapy: the recommended dose of Onglyza is 5 mg once daily as add-on combination therapy with metformin, a thiazolidinedione or a sulphonylurea. The safety and efficacy of saxagliptin as triple oral therapy in combination with metformin and a thiazolidinedione, or with metformin and a sulphonylurea, has not been established. Renal impairment: no dose adjustment is recommended for patients with mild renal impairment. The dose of Onglyza should be reduced to 2.5 mg once daily in patients with moderate or severe renal impairment. The experience in patients with severe renal impairment is very limited. Therefore, saxagliptin should be used with caution in this population. Onglyza is not recommended for patients with end-stage renal disease (ESRD) requiring haemodialysis (see section 4.4). Because the dose of Onglyza should be limited to 2.5 mg based upon renal function, assessment of renal function is recommended prior to initiation of Onglyza, and, in keeping with routine care, renal assessment should be done periodically thereafter (see sections 4.4 and 5.2). Hepatic impairment: no dose adjustment is necessary for patients with mild or moderate hepatic impairment (see section 5.2). Saxagliptin should be used with caution in patients with moderate hepatic impairment, and is not recommended for use in patients with severe hepatic impairment (see section 4.4). Elderly ( 65 years): no dose adjustment is recommended based solely on age. Experience in patients aged 75 years and older is very limited and caution should be exercised when treating this population (see also sections 4.4, 5.1 and 5.2). Paediatric population: Onglyza is not recommended for use in children and adolescents due to lack of data on safety and efficacy. Method of administration: Onglyza can be taken with or without a meal at any time of the day. If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day. Contraindications. Hypersensitivity to the active substance or to any of the excipients, or a history of hypersensitivity to any DPP-4 inhibitor. Warnings & Precautions. General: Onglyza should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Use with medicinal products known to cause hypoglycaemia such as sulphonylurea or insulin: a lower dose of sulphonylurea or insulin may be required to reduce the risk of hypoglycaemia when used in combination with Onglyza. Pancreatitis: from post-marketing experience there have been spontaneous reports of acute pancreatitis. Resolution has been observed after discontinuation of saxagliptin. Hypersensitivity reactions: from post-marketing experience, there have been spontaneously reported adverse reactions of serious hypersensitivity reactions (anaphylactic reaction, anaphylactic shock, and angioedema; see section 4.8). If these conditions are suspected, discontinue Onglyza, assess for other potential causes for the event, and institute alternative treatment for diabetes. Skin disorders: ulcerative and necrotic skin lesions have been reported in extremities of monkeys in non-clinical toxicology studies (see section 5.3). Although skin lesions were not observed at an increased incidence in clinical trials, there is limited experience in patients with diabetic skin complications. Post-marketing reports of rash have been described in the DPP-4 inhibitor class. Rash is also noted as an adverse event (AE) for Onglyza (section 4.8). Therefore, in keeping with routine care of the diabetic patient, monitoring for skin disorders, such as blistering, ulceration or rash, is recommended. Cardiac failure: experience in NYHA class I-II is limited, and there is no experience in clinical studies with saxagliptin in NYHA class III-IV. Immunocompromised patients: immunocompromised patients, such as patients who have undergone organ transplantation or patients diagnosed with human immunodefi ciency syndrome, have not been studied in the Onglyza clinical programme. Therefore, the effi cacy and safety profi le of saxagliptin in these patients has not been established. Use with potent CYP3A4 inducers: using CYP3A4 inducers like carbamazepine, dexamethasone, phenobarbital, phenytoin and rifampicin may reduce the glycaemiclowering effect of Onglyza (see section 4.5). Lactose: the tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Pregnancy and lactation. Pregnancy: there are no data from the use of saxagliptin in pregnant women. Studies in animals have shown reproductive toxicity at high doses (see section 5.3). The potential risk for humans is unknown. Onglyza should not be used during pregnancy unless clearly necessary. Lactation: it is unknown whether saxagliptin is excreted in human breast milk. Animal studies have shown excretion of saxagliptin and/or metabolite in milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue therapy taking into account the benefit of breast-feeding for the child and the benefi t of therapy to the woman. Undesirable effects. Please refer to section 4.8 of SPC for complete information on side effects. There were 4,148 patients with type 2 diabetes, including 3,021 patients treated with Onglyza, randomised in six double-blind, controlled clinical safety and effi cacy studies conducted to evaluate the effects of saxagliptin on glycaemic control. In a pooled analysis, the overall incidence of adverse events in patients treated with saxagliptin 5 mg was similar to placebo. Discontinuation of therapy due to adverse events was higher in patients who received saxagliptin 5 mg as compared with placebo (3.3% as compared with 1.8%). Adverse reactions reported (regardless of investigator assessment of causality) in 5% of patients treated with saxagliptin 5 mg and more commonly than in patients treated with placebo or that were reported in 2% of patients treated with saxagliptin 5 mg and 1% more frequently compared with placebo are listed below. Saxagliptin with metformin: common ( 1/100 to <1/10): upper respiratory infection, urinary tract infection, gastroenteritis, sinusitis, nasopharyngitis, headache, vomiting. Saxagliptin with a sulphonylurea (glibenclamide): very common ( 1/10): hypoglycaemia. There was no statistically signifi cant difference compared with placebo. The incidence of confirmed hypoglycaemia was uncommon for Onglyza 5 mg (0.8%) and placebo (0.7%); common ( 1/100 to <1/10): upper respiratory infection, urinary tract infection, gastroenteritis, sinusitis, headache, vomiting. Saxagliptin with a thiazolidinedione: common ( 1/100 to <1/10): upper respiratory infection, urinary tract infection, gastroenteritis, sinusitis, headache, vomiting, peripheral oedema. Saxagliptin with insulin (with or without metformin): common ( 1/100 to <1/10): hypoglycaemia. Laboratory tests: across clinical studies, the incidence of laboratory adverse events was similar in patients treated with saxagliptin 5 mg compared with patients treated with placebo. Legal classifi cation: on medical prescription. Marketing Authorisation Number: EU/1/09/545/ Marketing Authorisation Holder: Bristol- Myers Squibb/AstraZeneca EEIG, Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex, UB8 1DH, United Kingdom. For more information please read the summary of product characteristics. Onglyza 2,5 mg 30x1 fi lmtablet Onglyza 5 mg 30x1 filmtablet local price: HUF local price: HUF local copayment: HUF reimbursement: 70% HUF local copayment: 3592 HUF Date of SmPC: 22-Dec-2011 For more information please turn to Bristol-Myers Squibb Kft, 1024 Budapest Lövoház u. 39. Phone: Date of preparation: Bristol-Myers Squibb 422HU12PM040 ONGLYZA is a trademark of Bristol-Myers Squibb PEON0440HU

13 milgamma protekt Pathogenetic-based therapy for diabetic complications Ameliorates the progression of diabetic complications 1,2,3 Blocks four pathways of hyperglycaemic damage 4,5 Prevents AGE-induced micro- and macrovascular endothelial dysfunction 1 Five times better bio-availability helps to reduce vitamin B1 deficiencies 6 mil Stracke H, Gaus W, Achenbach U, Federlin K, Bretzel RC. Benfotiamine in diabetic polyneuropathy (BENDIP): Results of a randomised, double blind, placebo-controlled clinical study. Exp Clin Endocrinol Diabetes (2008) 116: Haupt E, Ledermann H, Kopcke W: Benfotiamine in the treatment of diabetic polyneuropathy: a three-week randomized, controlled pilot study (BEDIP study). Int J Clin Pharmacol Ther 43:71 77, Pan Xiaoli et al. Powerful benef cial effects of benfotiamine on cognitive impairment and b-amyloid deposition in amyloid precursor protein/presenilin-1 transgenic mice, Brain J of Nero. 2010: 133; Berrone Elena, Beltramo Elena, Solimine Carmela, Ape U Alessandro, and Porta Massimo. Regulation of Intracellular Glucose and Polyol Pathway by Thiamine and Benfotiamine in Vascular Cells Cultured in High Glucose. J Bio. Chem. 281(14): , Hammes HP, Du X, Edelstein D, Taguchi T, Matsumura T, Ju Q, Lin J, Bierhaus A, Nawroth P, Hannak D, Neumaier M, Bergfeld R, Giardino I, Brownlee M: Benfotiamine blocks three major pathways of hyperglycemic damage and prevents experimental diabetic retinopathy. Nat Med 9: , Schreeb KH, Freudenthaler S, Vormfelde SV, Gundert-Remy U, Gleiter CH: Comparative bioavailability of two vitamin B1 preparations: benfotiamine and thiamine mononitrate (Letter). Eur J Clin Pharmacol 52: , milgamma protekt Active Ingredient: Benfotiamine. Qualitative and Quantitative Composition: 1 f lm-coated tablet contains 300 mg Benfotiamine. Excipients: Microcrystalline Cellulose, Talcum, Povidon (K30), highlly disp. Siliciumdioxide, Croscarmellose-Natrium, Partialglyceride, Hypromellose, Titandioxide, Polyethylenglycole, Saccharin-Natrium. Therapeutic indication: Therapy or prophylaxis of clinically manifested Vitamin B1 def ciencies that cannot be aleviated by normal nutrional means. Treatment of Neuropathies and cardiovascular dysfunctions which are caused by Vitamin B1 def ciencies. Contraindication: Hypersensitivity towards benfotiamine/thiamine or any of the other excipients. Side Effects: In rare cases, hypersensitive reactions, gastrointestional dysfunctions. Wörwag Pharma GmbH & Co.KG,71034 Böblingen. Subject to sale by pharmacists only: 10/2008

14 27 th Congress of the Federation of the International Danube Symposia on Diabetes Mellitus SCIENTIFIC PROGRAMME Thursday, 28 June :30 13:00 BUFFET LUNCH 13:00 14:00 WELCOME AND OPENING Chair: Michael Roden, Germany; Nanette Schloot, Germany prof. Michael Roden, President of FID prof. János Gál, Deputy Rector of the Semmelweis University prof. Peter Kempler, President of the Local Organizing Committee prof. László Barkai, President of the Hungarian Diabetes Association dr. Máté Kocsis, Member of the Hungarian Parliament, Mayor of Budapest Concert 14:00 14:30 OPENING LECTURE Chair: Michael Roden, Germany; László Barkai, Hungary the LAST 12 MONTHS IN DIABETES CARE & RESEARCH WHAT WE DID AND DID NOT LEARN Cees J. Tack (The Netherlands) 14:30 15:30 SCREENING AND EDUCATION OF DIABETES SELF- MONITORING OF BLOOD GLUCOSE Chair: Tamás Halmos, Hungary; László Madácsy, Hungary screening FOR AND PREVENTION OF TYPE 2 DIABETES MELLITUS 20 György Jermendy, Hungary results OF SCREENING IN HUNGARY IN ADULTS 20 Gábor Winkler, Hungary results OF SCREENING IN HUNGARY IN CHILDREN 10 László Barkai, Hungary 14 Discussion 10

15 15:30 15:45 BREAK 15:45 17:05 TARGET ORGANS OF DIABETES Chair: Eberhard Standl, Germany; Raimund Weitgasser, Austria diabetes AND LIVER 20 Michael Roden, Germany diabetes AND KIDNEY 20 István Wittmann, Hungary diabetic EYE DISEASE 20 Ágnes Borbándy, Hungary diabetes AND THE HEART 20 Christoph Säly, Austria; Heinz Drexel, Austria 17:05 17:20 BREAK 17:20 18:00 MONITORING AND EDUCATION Chair: Éva Baranyi, Hungary; Cees Tack, The Netherlands education AND SELF-MONITORING OF BLOOD GLUCOSE: CORNERSTONES OF DIABETES CARE 20 Tibor Hidvégi, Hungary the ROLE OF TELEMEDICINE IN DIABETES MANAGEMENT DREAM OR REALITY? 20 Ádám Gy. Tabák, Hungary; Gyula Tamás, Hungary 18:00 19:00 COFFEE BREAK AND GUIDED POSTER-SESSION 1. Neuropathy Posters 1-8 Chair: Svetlana Bolgarskaya, Ukraine; Csaba Lengyel, Hungary 1. Evaluation of cardiovascular autonomic nerve function in patients with prediabetes and newly-diagnosed type 2 diabetes R. Dimova, T. Tankova, N. Chakarova, L. Dakovska, G. Grozeva, Bulgaria 15

16 27 th Congress of the Federation of the International Danube Symposia on Diabetes Mellitus 2. Possibility of the pain syndrome relief in sensomotor diabetic neuropathy V. Lobashova, E. Kozlova, N. Karlovich, I. Bilodid, T. Mokhort, Belarus 3. Hypertension and sensory nerve dysfunction in longstanding and newly diagnosed type 1 diabetes mellitus: is there a relationship? A. Körei, K. Keresztes, I. Istenes, Zs. Putz, N. Németh, T. Martos, P. Kempler, Hungary 4. Higher fasting glucose even within the normal range is an independent risk factor for sensory neuropathy in patients with essential hypertension K. Keresztes, Zs. Putz, I. Istenes, T. Martos, N. Németh, A. Körei, P. Vargha, P. Kempler, Hungary 5. Impaired glucose tolerance associated neural dysfunction: are cardiovascular factors of importance? N. Németh, Zs. Putz, Á. G. Tabák, I. Istenes, T. Martos, A. Körei, G. Koncsek, Z. Hermányi, K. Keresztes, Gy. Jermendy, P. Kempler, Hungary 6. Development of the classic therapeutic paradigm for pain in diabetic polyneuropathy I. Koleva, R. Yoshinov, Z. Stoineva, Bulgaria 7. Development of the classical therapeutical paradigm in neuropathic pain: from drugs to physical analgesia I. Koleva, R. Yoshinov, Bulgaria 8. Neuropathic foot ulcer in an undiagnosed diabetic patient suffering from cancer and many risk factors for neuropathy (case study) T. Martos, N. Németh, Zs. Putz, I. Istenes, A. Körei, P. Kempler, Hungary Clinical sciences Posters 9-18 Chair: Viktória Ferencz, Hungary; Gábor Firneisz, Hungary 9. Diabetic eye and foot care project in Moldova N. Palarie, Moldova 16

17 10. Comparison of bone mineral density and ultrasound parameters in patients with polycystic ovarian syndrome and type 2 diabetic women Sz. Mészáros, V. Ferencz, E. Hosszú, E. Csupor, E. Tóth, K. Bors, A. Tabák, C. Horváth, Hungary 11. Obesity does not protect against bone fractures V. Ferencz, Sz. Mészáros, Á. Tabák, Cs. Horváth, Hungary 12. Assessment of the possible role of alpha- and beta defensins in the pathogenesis of diabetic complications T. Várkonyi, R. Laurentzi, B. Németh, F. Somogyvári, A. Szegedi, R. Takács, Cs. Lengyel, P. Kempler, Y. Mándi, T. Wittman, Hungary 13. Effect of home based exercise program with type 2 diabetes mellitus on the exercise capacity and quality of life Z. Kunduracilar, B. Acar, F. Gökay, S. Güler, F. I. S. Bicer, Turkey 14. Occurrence of micro- and macrovascular complications in type 2 diabetic patients on early insulin treatment G. Herczeg, B. Polocsányi, Zs. Gaál, Hungary 15. Diagnosis of the gestational diabetes mellitus: WHO vs. IADPSG criteria Z. Soós, M. F. Salamon, L. Sóvágó, M. Hazay, B. Pál, A. Polyák, Á. Baranyi, F. Lintner, G. Winkler, Hungary 16. Independent association between vitamin D levels and insulin sensitivity and ß-cell function among women with prior GDM T. Tänczer, Á. G. Tabák, R. Magenheim, A. Pálfy, E. Szabó, Gy. Tamás, Hungary 17. Acute nephritis accompanying metformin therapy M. Krizsán, O. Árkossy, G. Winkler, Hungary 18. Serum dipeptidyl peptidase-4 activity in insulin resistant patients with non-alcoholic fatty liver disease: a novel liver disease biomarker G. Firneisz, T. Varga, G. Lengyel, J. Fehér, D. Ghyczy, B. Wichmann, L. Selmeci, Zs. Tulassay, K. Rácz, A. Somogyi, Hungary 17

18 27 th Congress of the Federation of the International Danube Symposia on Diabetes Mellitus 19:00 20:00 DINNER EDUCATIONAL SYMPOSIUM (ELI LILLY) approaches AND OPPORTUNITIES: SENSITISING, STIMULATING AND REPLACING INSULIN ACTION Chair: Michael Roden, Germany pioglitazone ON THE SCALES Peter Kempler, Hungary dpp-4 INHIBITORS IN CLINICAL PRACTICE: OPPORTUNITIES AND BARRIERS Nóra Hosszúfalusi, Hungary the REVISED ROLE OF PREMIXED INSULINS IN THE THERAPY OF TYPE 2 DIABETES Tamás Várkonyi, Hungary 20:30 WELCOME RECEPTION Friday, 29 June :30 09:45 CLINICAL AND DIAGNOSTIC ASPECTS OF DIABETIC NEUROPATHY Chair: Nóra Hosszúfalusi, Hungary; Tamás Várkonyi, Hungary CONNECTION BETWEEN AUTONOMIC NEUROPATHY AND HYPERTENSION 15 Ildikó Istenes, Hungary NEUROPATHY AMONG PATIENTS WITH IMPAIRED GLUCOSE TOLERANCE 15 Zsuzsanna Putz, Hungary the USE OF THE INDICATOR PLASTER IN THE DIAGNOSIS OF AUTONOMIC AND SOMATIC DIABETIC NEUROPATHY 15 Nicholas Papanas, Greece CENTRAL MANIFESTATIONS OF DIABETIC NEUROPATHY 15 Tamás Várkonyi, Hungary 18

19 lower LEG AMPUTATIONS IN DIABETIC PATIENTS IN ROMANIA: A NATIONWIDE FIVE-YEARS-LONG STUDY 10 Ioan Andrei Veresiu, Romania 09:45 10:00 BREAK 10:00 11:20 THERAPY OF TYPE 2 DIABETES MELLITUS Chair: Anikó Somogyi, Hungary; Helmut Schatz, Germany NEW PERSPECTIVES OF AN OLD AGENT: THE USE OF METFORMIN IN DIABETES AND POLYCYSTIC OVARY SYNDROME 20 Gyula Petrányi, Hungary/Cyprus acarbose IN THE TREATMENT OF THE HYPE RGLYCEMIC AND CARDIOVASCULAR CONTINUUM 20 Oliver Schnell, Germany sulfonylureas: ARE ALL THE SAME? 20 Gábor Pogátsa, Hungary incretin-based THERAPIES 20 Jens Juul Holst, Denmark 11:25 11:55 COFFEE BREAK 11:55 13:10 novel ASPECTS OF THERAPY IN DIABETIC NEUROPATHY Chair: Tibor Hidvégi, Hungary; Peter Kempler, Hungary award ceremony: Honorary Membership of the Hungarian Diabetes Association presented to Prof. Dan Ziegler is THERE A NEED FOR PATHOGENETIC ORIENTED THERAPY OF NEUROPATHY IN DIABETES MELLITUS? 25 Peter Kempler, Hungary benfotiamin EFFECTS ON DIABETIC NEUROPATHY AND BEYOND 25 Alin Stirban, Germany/Romania 19

20 27 th Congress of the Federation of the International Danube Symposia on Diabetes Mellitus symptomatic THERAPY OF DIABETIC NEUROPATHY 25 Dan Ziegler, Germany 13:10 14:35 LUNCH 14:35 15:35 LUNCH EDUCATIONAL SYMPOSIUM (NOVARTIS) the DISCOVERY OF FIRST GLIPTIN AND IT S EFFECT ON INDIVIDUALIZED THERAPY OF T2DM Chair: Peter Kempler, Hungary introduction - THE RATIONALE OF INDIVIDUALIZED THERAPY STARTED IN TIME IN TYPE 2 DIABETES MELLITUS Peter Kempler, Hungary NOVARTIS: OUR JOURNEY TO THE DISCOVERY OF THE FIRST DPP-4 INHIBITOR Edwin B. Villhauer, USA the RATIONALE OF INDIVIDUALIZED THERAPY STARTED IN TIME IN TYPE 2 DIABETES MELLITUS Peter Kempler, Hungary 15:35 17:00 LADA, MODY AND INSULIN TREATMENT Chair: László Kautzky, Hungary; Giatgen Spinas, Switzerland update ON LADA 20 Nanette Schloot, Germany mody: DIAGNOSTIC AND THERAPEUTICAL IMPLICATIONS 20 Zsolt Gaál, Hungary CURRENT CONCEPTS OF INSULIN THERAPY 20 Roger Lehmann, Switzerland update ON INSULIN PUMP THERAPY 20 Thomas Pieber, Austria 20