8 results on '"Logoida P"'
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2. Правовий статус криптовалюти в країнах Азії
- Author
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V.M. Logoida
- Subjects
віртуальні активи ,цифрові активи ,об’єкт цивільних прав ,гроші ,платіжний засіб ,криптовалюта ,Law - Abstract
Стаття присвячена вивченню досвіду правового регулювання юридичного статусу криптовалют та операцій з ними в країнах Азії (крім Китайської Народної Республіки та азійських країн – членів Співдружності Незалежних Держав, оскільки їх автор розглядав у окремих своїх публікаціях). У статті автор, на основі вивчення нормативної бази, адміністративної та судової практики всіх основних країн цієї частини світу, наголошує на різноспрямованих тенденціях врегулювання операцій з криптовалютами в регіоні, коли окремі країни переходять від ліберального підходу до використання криптовалют до їх повної заборони і навпаки. Відзначається, що практично всі країни регіону дають юридичну оцінку платіжній функції криптовалют, використовуючи регуляторні або забороняючі підходи, залежно від обраної політики, що побічно підтверджує їх розуміння правової природи криптовалют насамперед як платіжного засобу. При цьому ці ж країни не тільки категорично розмежовують криптовалюти з фіатними грошима, що їх емітують центральні банки країн, але і переважно уникають офіційного визначення криптовалюти в якості приватних (децентралізованих) готівкових грошей, віддаючи перевагу кваліфікації їх в якості нематеріального активу, віртуального активу, цифрового активу, оборотної цінності і навіть товару чи послуги, що є наразі певним компромісом між політичною доцільністю та економічними реаліями. Автор також відзначає, що для азійського регіону характерними є досить активні спроби врегулювання правового статусу криптовалют саме на законодавчому рівні, а не лише адміністративне чи судове реагування на фактичні правовідносини, хоча прогрес різних країн у даному питанні є неоднаковим. В результаті автор робить висновок про те, що в країнах Азії, що розглядаються у статті, відсутній єдиний погляд як на правову сутність криптовалюти, її кваліфікацію в якості об’єкта цивільних прав, так і на шляхи врегулювання операцій з нею (лібертаріанський підхід, про-криптовалютний підхід, але з детальним державним регулюванням і контролем, або повністю рестриктивна політика у відношенні до криптовалютного ринку).
- Published
- 2021
- Full Text
- View/download PDF
3. Comparison of Two Diagnostic Methods for the Detection of Hepatitis B Virus Genotypes in the Slovak Republic
- Author
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Mariia Logoida, Pavol Kristian, Andrea Schreiberova, Patrícia Denisa Lenártová, Veronika Bednárová, Elena Hatalová, Ivana Hockicková, Sylvia Dražilová, Peter Jarčuška, Martin Janičko, Štefan Porhinčák, and Monika Halánová
- Subjects
hepatitis B virus ,HBV genotype ,genotyping methods ,sequencing ,Medicine - Abstract
The hepatitis B virus (HBV), belonging to the Hepadnaviridae family, is responsible for a global health concern still in the 21st century. The virus is divided into 10 genotypes, which differ in geographical distribution and in their effect on disease progression and transmission, susceptibility to mutations, and response to treatment. There are many methods for diagnostics of HBV and differentiating its genotypes. Various commercial kits based on real-time polymerase chain reaction (RT PCR) and hybridization available, as well as whole genome sequencing or the sequencing of only individual parts of the genomes. We compared a commercial kit AmpliSens HBV-genotype-FRT, based on RT PCR, with an adapted method of amplification of the surface genomic region combined with Sanger sequencing. In the examined samples we identified the A, B, C, D, and E genotypes. By PCR with Sanger sequencing, the genotypes were determined in all 103 samples, while by using the commercial kit we successfully genotyped only 95 samples, including combined genotypes, which we could not detect by sequencing.
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- 2021
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4. Seroprevalence of Bartonella henselae and Bartonella quintana Infection and Impact of Related Risk Factors in People from Eastern Slovakia
- Author
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Katarína Petríková, Monika Halánová, Ingrid Babinská, Mariia Logoida, Karin Kaliariková, Peter Jarčuška, Sylvia Dražilová, Vladimíra Sobolová, and Martin Janičko
- Subjects
Bartonella henselae ,Bartonella quintana ,IgG antibodies ,seroprevalence ,risk factors ,Slovakia ,Medicine - Abstract
The genus Bartonella is a rapidly expanding group of ubiquitous bacteria that occur mainly in different animal species, but some can also be transmitted to humans. Three species, B. henselae, B. bacilliformis, and B. quintana, are responsible for the majority of human cases. The severity of the clinical symptoms often depends on the immune status of the patient, but others factors such as the species of the pathogen, virulence factors, and bacterial load also can play an important role. As the information on the occurrence of bartonellosis in the human population in Slovakia is absent, the aim of our pilot study was to determine the seroprevalence against B. henselae and B. quintana in the population of people living in Eastern Slovakia, and to identify the impact of related risk factors. Of 536 people included in the study, 126 (23.5%) showed positivity for anti-B. henselae antibodies and 133 (24.8%) against B. quintana. A statistically higher prevalence was confirmed only in the case of B. quintana in women regardless of the risk group. In analyzing the risk factors, we found significant differences between B. henselae seropositive and seronegative groups only in uric acid levels and serum creatinine, both, however, clinically irrelevant. Significant, but clinically irrelevant differences were observed also in alanine aminotransferase (ALT) levels and creatinine in people seropositive to B. quintana.
- Published
- 2021
- Full Text
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5. THE DEVELOPMENT AND VALIDATION OF IDENTIFICATION METHODS OF LORATADINE TABLETS
- Author
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D. B. Korobko, O. B. Poliak, L. S. Logoida, N. O. Zarіvna, and O. V. Sem’ianіv
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identification ,validation ,spectrophotometry ,TLH ,loratadine ,tablets ,Pharmacy and materia medica ,RS1-441 - Abstract
Methods of identification of loratadine in tablets by absorption spectrophotometry, TLC and qualitative reaction (based on hydroxamic reaction) have been developed and validated. The development of scientifically based standardized procedures for the validation of analytical methods for identification and quantitative tests of determination the active ingredients and other components in drugs is very important. The selected object of the study was loratadine (Claritin) – second generation antihistaminic drugs. According to the chemical structure loratadine is ethyl 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridine-11-ylidene)-1-piperidine carboxylate. The purpose of our work is the development and validation of methods for identification of loratadine in tablets. When developing methods of identification of loratadine in tablets we used UV-spectrophotometry and TLC. We have studied the behavior of loratadine in the UV region of the spectrum in different solvents (ethanol, 0.1 mol/l solution of hydrochloric acid). Optical density of solutions was measured at 2 nm in the cell with a thickness of10 mm. The behavior of loratadine in the UV region of spectrum in different solvents shows that in all investigated solvents drugs have characteristic absorption bands in the wavelength range at 220-310 nm. Thus different maximum absorptions of loratadine has been observed in various solvents: ethanol – at 248 ± 2 nm, in 0.1 mol/l hydrochloric acid solution there are two absorptions maxima – at 248 ± 2 nm and 274 ± 2 nm. UV spectra of loratadine in all investigated solvents are characterized by the same absorption maximum at 248 ± 2 nm, this makes possible to use UV-spectrophotometry for identification of loratadine in tablets. We have investigated various mobile phases (solvent system) in order to identify the optimal choice of loratadine in tablets by TLC. For the purpose of methods for loratadine identification in other solvent systems, we have investigated the sensitivity detection of loratadine in them. Therefore, to identify loratadine in tablets TLC method can be used. It was established that the most optimal values of the coefficient of mobility are observed when using mobile phase: chloroform-acetone, 8:2. The detection limit for loratadine in the solvent system is 1.0 mg, which is not inferior to other mobile phases. According to the SPU and Notes of guidance on validation of analytical procedures: text and methodology (CPMP/ICH/381/95) for "Identification" must be validated to determine such characteristics as specificity and suitability of chromatographic system. When checking the stability of solution in time we used chromatography method in order to prepare fresh loratadine test solution and sustained test solution of loratadine. The solutions are stable over time, new areas have been identified. So, explored validation characteristics, namely specificity and suitability of the chromatographic system, meet the eligibility criteria established by the SPU. Also the known qualitative reaction for hydroxamic group with hydroxylamine and iron (III) chloride has been investigated and can be used to identify loratadine in tablets. Conclusions 1. We proposed and developed UV-spectrophotometry methods, TLC and hydroxamic reaction to identify loratadine in tablets. 2. Validation characteristics, namely specificity and suitability of the chromatographic system have been studied. It has been established that they meet the eligibility criteria required by SPU.
- Published
- 2015
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6. Linagliptin Effects on Heart Failure and Related Outcomes in Individuals With Type 2 Diabetes Mellitus at High Cardiovascular and Renal Risk in CARMELINA
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McGuire D, Alexander J, Johansen O, Perkovic V, Rosenstock J, Cooper M, Wanner C, Kahn S, Toto R, Zinman B, Baanstra D, Pfarr E, Schnaidt S, Meinicke T, George J, von Eynatten M, Marx N, Aizenberg D, Fiorella A, Edgardo N, Belen C, Alonso P, Walter M, Maia K, Guillermo S, Leandro B, Constanza R, Alejandra N, Melina C, Ariel I, Rodrigo C, Alvarez C, Jorge M, Gabriel C, German S, Bartolacci I, Bolobanich G, Tale T, Meritano M, Echeverria M, Gerrini S, Alvarez M, Torrijos N, Berli M, Coggiola J, Castaneda G, Rode R, Milessi R, Roude A, Bono J, Caresani J, Arias V, Westberg J, Allende G, Liberman A, Bordonava A, Almagro S, Gerbaudo C, Schiavi L, Budassi N, Cecilia M, Buncuga M, Carlos S, Osvaldo T, Mercedes S, Calella P, Agustina V, Aljandro M, Alberto D, Fiorella M, Cantero M, Cariganano M, Anadon P, Cartasegna L, Gabriela M, Fernanda A, Alberto R, Chacon C, Jazmin F, Colombo H, Coni E, Mattausch S, Thomsenhall K, della Torre M, Morandini M, Berra F, Margarita H, Commendatore V, Tedesco J, Bolzan P, Cuneo C, Narcisa G, Caputi V, Pablo S, Sandra G, Pacora F, Tinari M, Jure H, Parody M, Toranzo A, Frechtel G, Yohena S, Lovecchio S, Muller C, Martin S, Olivera C, Breyaui M, Bianchi G, Garcia C, Luciana V, Florencia F, Ruben G, Gelersztein E, Rey G, Sanchez C, Fornasari L, Di Pierro L, Giacomi G, Miguel S, Laura T, Gonzalo C, Ramon C, Glenny J, Koretzky M, Porto A, Tiberio O, Ellenberg A, Saurral R, Igarzabal C, Vilamajo O, Matkovich J, de Lapertosa S, Villagra M, Cuzziol G, de la Cruz M, Pinchetti R, Mierez M, Lopez C, Gorosito V, Gabito A, Kleiban A, Grosembacher L, Adrian P, Paula R, Javier G, Kraft F, Andres F, Krynski F, Nicolas P, Marcelo F, Alfredo F, de la Fuente R, Natalia C, Luquez H, Recuero Y, Becchetti N, Ruiz M, Costantino M, Vazquez G, Guzman C, Pelatia P, Maffei L, Sassone S, Yantorno M, Prado G, Khron B, Maldonado N, Gustavo L, Veronica V, Marino J, Elizabeth A, Alejandra C, Oscar R, Azize G, Gallardo M, Escudero M, Vargas E, Ramos H, Lucero C, Najenson M, Crocci I, Chiesa A, Nardone L, Dominguez S, Zanini A, Manghi F, Grossman M, Giudice G, Romeo A, Piskorz D, Miguel C, Susana D, Noeli U, Rosa S, Martin V, Soledad A, Virginia M, Lorena G, Prado A, Veronica L, Eduardo H, Adolfo P, Florencia W, Rista L, Scolari C, Rojas N, Bertolio V, Zarandon R, Jair S, Orlando C, Sanabria H, Ignacio D, Viviana C, Marina R, Sarjanovich R, Scaro G, Huerta C, Mana M, Gutierrez M, Dain A, Gavicola R, Sessa H, Sacripanti J, Felman R, Vilarino P, Sicer M, Lagrutta M, Sala J, Casabella T, Cecilia H, Carlos B, Vines G, Javier R, Vico M, Lanchiotti P, Martella C, Torres L, Villarino A, Molina M, Martinez J, Farias C, Bertola S, Rojas M, Guzman P, Nisi J, Martinez D, Barrionuevo M, Vita N, Lopez A, Vottero E, Giuliano M, Paron L, Vogel D, Mele P, Imposti H, Dominguez A, Zaidman C, Fernando G, Beck M, Beltrame P, Chemello D, Junior R, Abreu A, Fernandes V, Saboia J, Rodrigues L, Carvalho M, Gurgel M, Gadelha D, Ramos C, Borba V, Golbert M, Pitthan M, Golbert L, Valentini R, Canani L, Gross J, Valenti A, Sartori C, Dutra O, Azevedo E, Azevedo A, Vaz R, Vaz H, da Costa F, da Costa L, Panarotto D, Lain F, Camazzola F, Dellomea B, Rech R, Pizzato P, Nunes C, Jaeger C, Silveira D, Wagner L, Machado L, Rea R, de Bem A, Alves J, Jonasson T, Malucelli F, Betti R, Lerario A, Lisboa H, Bem J, Tres G, Tavares C, Nardi A, Pozzatto M, Backes L, Reolao J, Scariot E, Ziguer E, Baldissera D, Griz L, Antunes D, Victor F, Freire K, Barros A, Costi B, Sa M, Carneiro A, Felicio J, Felicio K, Penha P, Ferreira J, Melo F, Alves A, Souza A, Costa L, Pinheiro D, Turatti L, Augusto G, Leanca C, Santomauro A, Forti A, Sena R, Marinho A, Facanha C, de Souza K, de Souza A, de Queiroz W, Leite S, Vieira S, Gubert L, Olsen A, Piazzetta G, Fuck A, Ferreira M, Fortes J, Brandao T, Alves F, Radice E, dos Santos J, de Almeida R, Franco D, Saporito W, Eliaschewitz F, de Siqueira K, Bona R, Genestreti P, de Castro D, Visconti G, Sampaio C, Palhares F, Konigsfeld H, Alves E, Feder C, Leao B, Saraiva J, Rodovalho S, Costa M, Pires N, Figueiredo E, Werner G, Garcia J, de Paiva I, Quirino B, Botelho R, da Silva R, Navarro A, Lourenco C, Pereira A, Arantes F, Boner D, Saad J, Falchetto E, Washizu E, Mandil A, Pimenta N, Tofani F, Fonseca T, Teixeira L, Maia L, Lemos M, Mouco O, Nakazone M, Weiand L, Bohn J, Hissa M, Araripe F, Carvalho F, Cancado G, Wang R, Chacra A, Fusaro A, de Mendonca E, Cercato C, Halpern A, Alves B, Braile M, Sestito R, Mustafa E, Ferreira V, Sbardellini B, de Almeida P, Guimaraes F, Piedade M, Bienert I, Braga J, Daher R, Hirakawa T, Terra E, Farias E, Figueiredo M, Lima L, Moraes K, Avelino I, Flato U, Plavnik F, Portes E, Moreira M, Vendramini M, Veloso R, Padilha M, Rodrigues A, Adam R, Santos S, Sayeg N, Guerrero D, Madeira M, Siqueira J, Pinheiro R, Villacorta A, Mellazi A, Braga T, Kaiser S, Paolino B, Lefterov I, Marinchev A, Angelova S, Klyuchkova N, Lybomirova Z, Kerekovski Y, Kuneva T, Penkova D, Levterov G, Videnova E, Georgieva P, Shinkov A, Borissova A, Vlahov J, Dakovska-Dekova L, Lucheva M, Luchev P, Temelkova M, Borisova K, Tsenov S, Andreeva V, Margaritov V, Arasheva G, Lozanov L, Borisov R, Gorcheva D, Henein S, Whatley S, Boutros M, Kalyniuk N, Berlingieri J, Nisker W, Hoag G, Hepburn D, Harvey M, Manjoo P, Yale J, Sherman M, Tsoukas M, Rehman W, Mason M, Santerre M, De Kock J, Barkhuizen F, Rooke C, Gill C, Kooy J, Burgoyne G, de Kock J, Degen G, Hockman L, Invik R, Roberts P, Ward K, Alasaad H, Susan A, Davies V, Gupta N, Milhalidis J, Grossman L, Agawal N, Yared Z, Rwaheed, Nouhad S, Nahla A, Khandwala H, Warwick A, Wadehra D, Manan A, Vecchiarelli J, Aslam N, Ferrao A, St-Maurice F, Collette R, Davey B, Nawaz S, Coutu B, Costi P, Greiss I, Mansour F, Raymond J, St-Phard W, Nadra I, Della Siega A, Barahona L, Klinke P, Contractor H, Fryer M, Chandra N, Conti B, Telzer L, Sorensen S, Lounsbury N, Martin E, Mitchell L, Pelzer E, Nelson S, Jones M, Cox J, Luco G, Trhoughton T, Labonte R, Chouinard G, Frechette A, Rheaume M, Cusson J, Faucher J, Dery V, Kelly A, Miranda B, Al-Kayssi N, Malette P, Rheault P, Fredette P, Dumas R, Palardy J, Belanger A, Boucher P, Doyon B, Charbonneau J, Bailey G, Odendaal M, Stephan K, Badenhorst J, Knight D, Thurgood A, Johnston M, Cooper-Rosen E, Jagger R, Green M, Weisnagel S, Gangloff A, Bergeron J, Pesant Y, Chevalier P, Woo V, Hurd C, Ruckert G, Lira J, Navarro G, Venegas M, Gonzalez P, Montecinos H, Vidal G, Fernandez M, Varas J, Fernandez C, Aguilar J, Marin R, Kindel C, Yovaniniz P, Gherman O, Aravena M, Carvajal J, Macias E, Corrado P, Lazcano M, Garrido B, Charme G, Carrasco J, Vignolo P, Saavedra S, Gajardo V, Saavedra C, Santamaria D, del Castillo B, Balda I, Zurvarra V, Fu G, Jiang D, Huang H, Wang M, Song J, Lu W, Lin Y, Lu Z, Shi Y, Zhong M, Zhao X, Chen D, Zhang G, He Y, Shi P, Chu K, Gao Q, Deng W, Zhang J, Zhang Y, Chen H, Liu E, Xie Y, Lin R, Tan W, Yuan Z, Wang Y, Ren J, Yu H, Luo M, Ma W, Shi W, Xu H, Xu M, Liu G, Dong Y, Bai B, Guo R, Liu X, Gao Y, Li S, Xu X, Liu P, Dong X, Wang S, Fu F, Jiang Q, Meng C, Yin X, Lu Y, Cui Y, Su G, Miao W, Wei F, Zhao Q, Li Z, Gao X, Lozno H, Prada W, Figueroa W, Ordonez A, Quintero E, Vallejo G, Contreras C, Escobar J, Alvaran J, Ortiz L, Marin M, Montoya C, Mendoza J, Manjarres J, Navarro B, Martinez G, Bonfanti A, Perci X, de la Hoz L, Arroyo J, Rendon C, Lopez J, Escobar N, Franco J, Lozano M, Zapata C, Ibarra L, Barrero A, Sarmiento A, Lozada H, Olitte M, Florez L, Munoz C, Quintero G, Correa G, Ruiz S, Dorado A, Causa A, Palma E, Morales A, Arteaga J, Beltran J, Granados M, Rubio A, Dada F, Bueno W, Rivera R, Corredor K, Romero V, Accini F, Palmera J, Ruiz G, Ortega M, Sanchez A, Lora Y, Cano J, Duque S, Thiriez S, Castano M, Giraldo P, Boljkovac Z, Grcic I, Balen M, Zukanovic S, Jeric M, Dvorscak D, Car S, Knezevic A, Herceg D, Franov B, Miskovic V, Bakula M, Hadak A, Superba M, Rubes J, Gornik I, Hamzic J, Ballek L, Sedlackova L, Hejlova J, Galatikova D, Huskova A, Zak P, Flekac M, Mraz M, Potuznik P, Palova S, Novak P, Okenka L, Matuska J, Rohac F, Vondrak K, Reichert P, Shamasna A, Skopek J, Lejskova M, Jiruska M, Lang P, Podoubsky R, Svobodova J, Cifkova R, Jozifova M, Krajcoviechova A, Wolfhart P, Sulc P, Silhova E, Cechakova M, Machova V, Balkova J, Peterka M, Votocek S, Prosecky R, Valis M, Barton P, Tomek J, Pumprla J, Axmannova M, Vitaskova R, Sincl F, Horanska P, Richter B, Malicherova E, Roderova E, Jenickova P, Winkelmann B, Finger C, Klausmann G, Milek K, Schwabe M, Weiss N, Mahlmann A, Werth S, Schmidt C, Schoell I, London M, Steidl E, Orban K, Taeschner H, Bonigut S, Schiefke I, Schwittay A, Kornmann O, Eich A, Franke S, Kis J, Szobota E, Danos P, Beke E, Grosz A, Csecsei G, Ferenczy J, Filo A, Ferencz I, Mihaly E, Baranyi T, Revesz K, Schlezak J, Harcsa E, Dombroczki Z, Kocsis I, Juhasz E, Literati-Nagy B, Kulcsar E, Bezzeg K, Kemeny V, Peterfai E, Buday B, Keltai K, Balo T, Somogyi A, Nagy G, Oroszlan T, Bagosi Z, Bujtor Z, Tabak A, Ferencz V, Domjan B, Tanczer T, Palinkas A, Karolyi H, Kovacs K, Csaszar I, Palhegyi E, Engelhalter G, Horthy R, Vanko E, Szabo G, Sipos G, Szigyarto M, Sebo N, Paragh G, Zsiros N, Szentimrei R, Pal D, Kobling T, Szanto I, Varadi Z, Bajnok L, Szujo S, Nemes O, Bajnok A, Mezosi E, Bodis B, Marton Z, Konyves L, Farago M, Kiss G, Kiss O, Nagy E, Takacs R, Nyitray S, Abraham G, Fehertemplomi K, Deak L, Dezso E, Karneili E, Deeb D, Zloczower M, Mahmid R, Zolotov S, Hochberg I, Elias M, Goldstein L, Poletaev V, Rock W, Koren O, Saliba W, Wolf F, Adawi F, Nimer A, Mosenzon O, Raz I, Potekhin M, Cahn A, Yulian T, Zvulunov E, Israel H, Shpitz D, Bar-Or I, Chananashvili L, Irena L, Dessau H, Halabe A, Vishlitzky V, Nabriski D, Baraf L, Itelman M, Schiff E, Willner N, Fireman-Klein E, Svistunov V, Dotan Y, Pavlichev O, Saig L, Bashkin A, Kuyantseva E, Gershkov S, Nodelman M, Arbel Y, Bogomolny N, Leshem-Rubinow E, Rofe M, Chorin E, Havkuk O, Wainstein J, Feldman D, Fujino Y, Kitamura H, Toriumi Y, Ishiguro H, Naganuma T, Shu S, Suzuki K, Hirota Y, Hayashi T, Hozawa K, Fukui T, Abe Y, Yamauchi K, Maruyama M, Matsumura S, Kozuma R, Nagai Y, Kihara Y, Maeda H, Nakanishi K, Iitsuka T, Hatori M, Shinozaki Y, Akiyama D, Kawabe M, Takei M, Sato A, Kawai Y, Kitajima K, Ide M, Sato N, Morisaki H, Nakashima K, Takayanagi H, Watanabe H, Iwahashi N, Tsujimoto M, Hibuse K, Hata T, Ueno K, Tatsuma H, Wakida Y, Ito T, Mizuno R, Fujita H, Konishi N, Kanehira T, Watanabe R, Miyaoka H, Okada T, Yamamoto M, Okita S, Murakami H, Todo Y, Umeoka F, Hori K, Shiraishi K, Tada F, Shimizu T, Tamai J, Sasaki C, Okuzima Y, Yasuda M, Iwaita Y, Tanaka K, Rha S, Na J, Cho D, Cho Y, Hwang E, Choi T, Won K, Kim H, Kim S, Oh D, Lee J, Choi H, Chung H, Park H, Suh Y, Kim Y, Kim N, Kim K, An J, Kim J, Park K, Kwak S, Kim M, Hwangbo Y, Lee D, Hong A, Kim L, Oh C, Moon S, Jung C, Jin J, Hyun B, Yang Y, Kong S, Yoon K, Yang H, Hong T, Oh J, Park J, Lee H, Choi J, Ahn J, Han S, Park W, Jo S, Suh 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Robins G, Colyar L, Hutchins C, Sturm D, Hart K, Phillips T, Montgomery C, Albrecht W, Fehlis K, Overman D, Box M, Villarreal-Martinez D, David-Svatek D, Ajani D, Shaikh Z, Wheeler K, Brown M, Ghosh C, Bandukwala I, Kleber S, Madden J, Bishara M, Perry K, Paoli-Bruno J, Abreu E, Espiritu R, Zmeili O, Christensen T, Grubb S, Beloff S, Caugh A, van Dijk C, Yalavarthy R, DeGraauw J, Fabian S, Gillum D, Corrigan G, Singh H, Jensen K, DeMore S, Montague T, Zieve F, Levy J, Fredrickson S, Tarkington P, Chapla P, Salacata A, Walls U, Iyer R, Nguyen K, Lettman J, Appleman B, Safavie F, Scaliem L, Eder F, Maklad S, Schlaen B, Molstead J, Hartwell J, Hubish D, Little R, Rando K, Kelly R, Drury M, Young P, Wininger S, Harman A, Daza R, Robbin S, Sanchez M, Rivera I, Garcia-Estrada M, Iglesias N, Dobs A, Andrade A, Falkowski S, Parrott T, Koon A, Wood T, Burkett E, Chavous K, Gupta A, Estes C, Loud D, Rhodes S, Chen M, Bromley L, Palma R, Kattan D, Kirk U, Tatu H, Stamatin R, Lupea S, Frasie M, 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Satyavolu S, Dev D, Yalamanchili H, Sumeyye C, Fernandes H, Chaleff F, Jancko M, Trenche S, Kaplan W, Wilcox S, Goisse M, Rua M, Black J, Chapman K, Suh D, Yan L, Song D, Chanara S, Houchin V, McKeinness A, Sotolongo R, Gutierrez K, Miranda-Palma B, Solano M, Jain M, Needell J, Banerjee A, Jarratt M, Hantel S, Lees K, Welty F, Freedman S, Parhofer K, Birkeland K, McGill J, Tijssen J, Clemmensen P, Pehrson S, Grande P, Januzzi J, Wood M, Petrie M, Sairanen T, Tatlisumak T, Soinne L, Kase C, Turan T, Mann J, Agarwal R, Fogarty D, Navaneethan S, Srinivas T, Forsmark C, Frossard J, Gelrud A, Mayerle J, Lee R, Heist R, Sullivan R, Buchbinder E, Chodak G, Edelman M, Thompson V, Coles A, and CARMELINA Investigators
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cardiovascular disease ,type 2 diabetes mellitus ,heart failure ,chronic kidney diseases - Abstract
Background: Individuals with type 2 diabetes mellitus are at increased risk for heart failure (HF), particularly those with coexisting atherosclerotic cardiovascular disease and/or kidney disease. Some but not all dipeptidyl peptidase-4 inhibitors have been associated with increased HF risk. We performed secondary analyses of HF and related outcomes with the dipeptidyl peptidase-4 inhibitor linagliptin versus placebo in CARMELINA (The Cardiovascular and Renal Microvascular Outcome Study With Linagliptin), a cardiovascular outcomes trial that enrolled participants with type 2 diabetes mellitus and atherosclerotic cardiovascular disease and/or kidney disease. Methods: Participants in 27 countries with type 2 diabetes mellitus and concomitant atherosclerotic cardiovascular disease and/or kidney disease were randomized 1:1 to receive once daily oral linagliptin 5 mg or placebo, on top of standard of care. All hospitalization for HF (hHF), cardiovascular outcomes, and deaths were prospectively captured and centrally adjudicated. In prespecified and post hoc analyses of HF and related events, Cox proportional hazards models adjusting for region and baseline history of HF were used. Recurrent hHF events were analyzed using a negative binomial model. In a subset of participants with left ventricular ejection fraction captured within the year before randomization, HF-related outcomes were assessed in subgroups stratified by left ventricular ejection fraction > or 50%. Results: CARMELINA enrolled 6979 participants (mean age, 65.9 years; estimated glomerular filtration rate, mL/min per 1.73m(2); hemoglobin A1c, 8.0%; 62.9% men; diabetes mellitus duration, 14.8 years), including 1873 (26.8%) with a history of HF at baseline. Median follow-up was 2.2 years. Linagliptin versus placebo did not affect the incidence of hHF (209/3494 [6.0%] versus 226/3485 [6.5%], respectively; hazard ratio [HR], 0.90; 95% CI, 0.74-1.08), the composite of cardiovascular death/hHF (HR, 0.94; 95% CI, 0.82-1.08), or risk for recurrent hHF events (326 versus 359 events, respectively; rate ratio, 0.94; 95% CI, 0.75-1.20). There was no heterogeneity of linagliptin effects on hHF by history of HF at baseline, baseline estimated glomerular filtration rate or urine albumin-creatinine ratio, or prerandomization left ventricular ejection fraction. Conclusions: In a large, international cardiovascular outcome trial in participants with type 2 diabetes mellitus and concomitant atherosclerotic cardiovascular disease and/or kidney disease, linagliptin did not affect the risk of hHF or other selected HF-related outcomes, including among participants with and without a history of HF, across the spectrum of kidney disease, and independent of previous left ventricular ejection fraction. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01897532.
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- 2019
7. Effect of Linagliptin vs Placebo on Major Cardiovascular Events in Adults With Type 2 Diabetes and High Cardiovascular and Renal Risk The CARMELINA Randomized Clinical Trial
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- Abstract
IMPORTANCE Type 2 diabetes is associated with increased cardiovascular (CV) risk. Prior trials have demonstrated CV safety of 3 dipeptidyl peptidase 4 (DPP-4) inhibitors but have included limited numbers of patients with high CV risk and chronic kidney disease. OBJECTIVE To evaluate the effect of linagliptin, a selective DPP-4 inhibitor, on CV outcomes and kidney outcomes in patients with type 2 diabetes at high risk of CV and kidney events. DESIGN, SETTING, AND PARTICIPANTS Randomized, placebo-controlled, multicenter noninferiority trial conducted from August 2013 to August 2016 at 605 clinic sites in 27 countries among adults with type 2 diabetes, hemoglobin A(1c) of 6.5% to 10.0%, high CV risk (history of vascular disease and urine-albumin creatinine ratio [UACR] > 200mg/g), and high renal risk (reduced eGFR and micro-or macroalbuminuria). Participants with end-stage renal disease (ESRD) were excluded. Final follow-up occurred on January 18, 2018. INTERVENTIONS Patients were randomized to receive linagliptin, 5 mg once daily (n = 3494), or placebo once daily (n = 3485) added to usual care. Other glucose-lowering medications or insulin could be added based on clinical need and local clinical guidelines. MAIN OUTCOMES AND MEASURES Primary outcomewas time to first occurrence of the composite of CV death, nonfatalmyocardial infarction, or nonfatal stroke. Criteria for noninferiority of linagliptin vs placebo was defined by the upper limit of the 2-sided 95% CI for the hazard ratio (HR) of linagliptin relative to placebo being less than 1.3. Secondary outcome was time to first occurrence of adjudicated death due to renal failure, ESRD, or sustained 40% or higher decrease in eGFR from baseline. RESULTS Of 6991 enrollees, 6979 (mean age, 65.9 years; eGFR, 54.6 mL/min/1.73m2; 80.1% with UACR > 30mg/g) received at least 1 dose of study medication and 98.7% completed the study. During a median follow-up of 2.2 years, the primary outcome occurred in 434 of 3494 (12.4%) and 420 of 3485 (12.1%) in the linagliptin and placebo groups, respectively, (absolute incidence rate difference, 0.13 [95% CI,-0.63 to 0.90] per 100 person-years) (HR, 1.02; 95% CI, 0.89-1.17; P
- Published
- 2019
8. Zirconia products for aluminum-smelting furnaces
- Author
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Starikov, N. A., Logoida, V. M., Fomenko, V. A., and Bogoslovskaya, L. N.
- Published
- 1973
- Full Text
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