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1. Management of dyslipidaemia in patients with coronary heart disease: Results from the ESC-EORP EUROASPIRE V survey in 27 countries

Author

De Backer, G., Jankowski, P., Kotseva, K., Mirrakhimov, E., Reiner, Z., Rydén, L., Tokgözoğlu, L., Wood, D., De Bacquer, D., Abreu, A., Aguiar, C., Badariene, J., Bruthans, J., Castro Conde, A., Cifkova, R., Crowley, J., Davletov, K., Bacquer, D. De, De Smedt, D., De Sutter, J., Deckers, J.W., Dilic, M., Dolzhenko, M., Druais, H., Dzerve, V., Erglis, A., Fras, Z., Gaita, D., Gotcheva, N., Grobbee, D.E., Gyberg, V., Hasan Ali, H., Heuschmann, P., Hoes, A.W., Lalic, N., Lehto, S., Lovic, D., Maggioni, A.P., Mancas, S., Marques-Vidal, P., Mellbin, L., Miličić, D., Oganov, R., Pogosova, N., Reiner, Ž., Stagmo, M., Störk, S., Sundvall, J., Tsioufis, K., Vulic, D., Wood, D.A., Jennings, C., Adamska, A., Adamska, S., Tuomilehto, J., Schnell, O., Fiorucci, E., Glemot, M., Larras, F., Missiamenou, V., Maggioni, A., Taylor, C., Ferreira, T., Lemaitre, K., Raman, L., DeSmedt, D., Willems, A.M., De Pauw, M., Vervaet, P., Bollen, J., Dekimpe, E., Mommen, N., Van Genechten, G., Dendale, P., Bouvier, C.A., Chenu, P., Huyberechts, D., Persu, A., Begic, A., Durak Nalbantic, A., Dzubur, A., Hadzibegic, N., Iglica, A., Kapidjic, S., Osmanagic Bico, A., Resic, N., Sabanovic Bajramovic, N., Zvizdic, F., Kovacevic-Preradovic, T., Popovic-Pejicic, S., Djekic, D., Gnjatic, T., Knezevic, T., Kos, Lj, Stanetic, B., Topic, G., Georgiev, Borislav, Terziev, A., Vladimirov, G., Angelov, A., Kanazirev, B., Nikolaeva, S., Tonkova, D., Vetkova, M., Milicic, D., Bosnic, A., Dubravcic, M., Glavina, M., Mance, M., Pavasovic, S., Samardzic, J., Batinic, T., Crljenko, K., Delic-Brkljacic, D., Dula, K., Golubic, K., Klobucar, I., Kordic, K., Kos, N., Nedic, M., Olujic, D., Sedinic, V., Blazevic, T., Pasalic, A., Percic, M., Sikic, J., Cífková, R., Hašplová, K., Šulc, P., Wohlfahrt, P., Mayer, O., Jr., Cvíčela, M., Filipovský, J., Gelžinský, J., Hronová, M., Hasan-Ali, H., Bakery, S., Mosad, E., Hamed, H.B., Ibrahim, A., Elsharef, M.A., Kholef, E.F., Shehata, A., Youssef, M., Elhefny, E., Farid, H., Moustafa, T.M., Sobieh, M.S., Kabil, H., Abdelmordy, A., Kiljander, E., Kiljander, P., Koukkunen, H., Mustonen, J., Cremer, C., Frantz, S., Haupt, A., Hofmann, U., Ludwig, K., Melnyk, H., Noutsias, M., Karmann, W., Prondzinsky, R., Herdeg, C., Hövelborn, T., Daaboul, A., Geisler, T., Keller, T., Sauerbrunn, D., Walz-Ayed, M., Ertl, G., Leyh, R., Ehlert, T., Klocke, B., Krapp, J., Ludwig, T., Käs, J., Starke, C., Ungethüm, K., Wagner, M., Wiedmann, S., Tolis, P., Vogiatzi, G., Sanidas, E., Tsakalis, K., Kanakakis, J., Koutsoukis, A., Vasileiadis, K., Zarifis, J., Karvounis, C., Gibson, I., Houlihan, A., Kelly, C., O'Donnell, M., Bennati, M., Cosmi, F., Mariottoni, B., Morganti, M., Cherubini, A., Di Lenarda, A., Radini, D., Ramani, F., Francese, M.G., Gulizia, M.M., Pericone, D., Aigerim, K., Zholdin, B., Amirov, B., Assembekov, B., Chernokurova, E., Ibragimova, F., Kodasbayev, A., Markova, A., Asanbaev, A., Toktomamatov, U., Tursunbaev, M., Zakirov, U., Abilova, S., Arapova, R., Bektasheva, E., Esenbekova, J., Neronova, K., Baigaziev, K., Baitova, G., Zheenbekov, T., Andrejeva, T., Bajare, I., Kucika, G., Labuce, A., Putane, L., Stabulniece, M., Klavins, E., Sime, I., Gedvilaite, L., Pečiuraite, D., Sileikienė, V., Skiauteryte, E., Solovjova, S., Sidabraite, R., Briedis, K., Ceponiene, I., Jurenas, M., Kersulis, J., Martinkute, G., Vaitiekiene, A., Vasiljevaite, K., Veisaite, R., Plisienė, J., Šiurkaitė, V., Vaičiulis, Ž., Czarnecka, D., Kozieł, P., Podolec, P., Nessler, J., Gomuła, P., Mirek-Bryniarska, E., Bogacki, P., Wiśniewski, A., Pająk, A., Wolfshaut-Wolak, R., Bućko, J., Kamiński, K., Łapińska, M., Paniczko, M., Raczkowski, A., Sawicka, E., Stachurska, Z., Szpakowicz, M., Musiał, W., Dobrzycki, S., Bychowski, J., Kosior, D.A., Krzykwa, A., Setny, M., Rak, A., Gąsior, Z., Haberka, M., Szostak-Janiak, K., Finik, M., Liszka, J., Botelho, A., Cachulo, M., Sousa, J., Pais, A., Durazzo, A., Matos, D., Gouveia, R., Rodrigues, G., Strong, C., Guerreiro, R., Aguiar, J., Cruz, M., Daniel, P., Morais, L., Moreira, R., Rosa, S., Rodrigues, I., Selas, M., Apostu, A., Cosor, O., Gaita, L., Giurgiu, L., Hudrea, C., Maximov, D., Moldovan, B., Mosteoru, S., Pleava, R., Ionescu, M., Parepa, I., Arutyunov, A., Ausheva, A., Isakova, S., Karpova, A., Salbieva, A., Sokolova, O., Vasilevsky, A., Pozdnyakov, Y., Antropova, O., Borisova, L., Osipova, I., Aleksic, M., Crnokrak, B., Djokic, J., Hinic, S., Vukasin, T., Zdravkovic, M., Lalic, N.M., Jotic, A., Lalic, K., Lukic, L., Milicic, T., Macesic, M., Stanarcic Gajovic, J., Stoiljkovic, M., Djordjevic, D., Kostic, S., Tasic, I., Vukovic, A., Jug, B., Juhant, A., Krt, A., Kugonjič, U., Chipayo Gonzales, D., Gómez Barrado, J.J., Kounka, Z., Marcos Gómez, G., Mogollón Jiménez, M.V., Ortiz Cortés, C., Perez Espejo, P., Porras Ramos, Y., Colman, R., Delgado, J., Otero, E., Pérez, A., Fernández-Olmo, M.R., Torres-LLergo, J., Vasco, C., Barreñada, E., Botas, J., Campuzano, R., González, Y., Rodrigo, M., de Pablo, C., Velasco, E., Hernández, S., Lozano, C., González, P., Castro, A., Dalmau, R., Hernández, D., Irazusta, F.J., Vélez, A., Vindel, C., Gómez-Doblas, J.J., García Ruíz, V., Gómez, L., Gómez García, M, Jiménez-Navarro, M., Molina Ramos, A., Marzal, D., Martínez, G., Lavado, R., Vidal, A., Boström-Nilsson, V., Kjellström, B., Shahim, B., Smetana, S., Hansen, O., Stensgaard-Nake, E., Klijn, A.J., Mangus, T.J.P., Peters, R.J.G., Scholte op Reimer, W., Snaterse, M., Aydoğdu, S., Ç Erol, Otürk, S., Tulunay Kaya, C., Ahmetoğlu, Y., Ergene, O., Akdeniz, B., Çırgamış, D., Akkoyun H Kültürsay, S., Kayıkçıoğlu, M., Çatakoğlu, A.B., Çengel, A., Koçak, A.A., Ağırbaşlı, M.A., Açıksarı, G., Çekin, M.E., Kaya, E.B., Koçyiğit, D., Öngen, Z., Özmen, E., Sansoy, V., Kaya, A., Oktay, V., Temizhan, A., Ünal, S., İ Yakut, Kalkan, A.K., Bozkurt, E., Kasapkara, H.A., Faradzh, C., Hrubyak, L., Konoplianyk, L., Kozhuharyova, N., Lobach, L., Nesukai, V., Nudchenko, O., Simagina, T., Yakovenko, L., Azarenko, V., Potabashny, V., Bazylevych, A., Bazylevych, M., Kaminska, K., Panchenko, L., Shershnyova, O., Ovrakh, T., Serik, S., Kolesnik, T., Kosova, H., Hoye P Atkin, A., Fellowes, D., Lindsay, S., Atkinson, C., Kranilla, C., Vinod, M., Beerachee, Y., Bennett, C., Broome, M., Bwalya, A., Caygill, Lindsay, Dinning, L., Gillespie, A., Goodfellow, R., Guy, J., Idress, T., Mills, C., Morgan, C., Oustance, N., Singh, N., Yare, M., Jagoda, J.M., Bowyer, H., Christenssen, V., Groves, A., Jan, A., Riaz, A., Gill, M., Sewell, T.A., Gorog, D., Baker, M., De Sousa, P., Mazenenga, T., Porter, J., Haines, F., Peachey, T., Taaffe, J., Wells, K., Ripley, D.P., Forward, H., McKie, H., Pick, S.L., Thomas, H.E., Batin, P.D., Exley, D., Rank, T., Wright, J., Kardos, A., Sutherland, S.-B., Wren, L., Leeson, P., Barker, D., Moreby, B., Sawyer, J., Stirrup, J., Brunton, M., Brodison, A., Craig, J., Peters, S., Kaprielian, R., Bucaj, A., Mahay, K., Oblak, M., Gale, C., Pye, M., McGill, Y., Redfearn, H., Fearnley, M., De Backer, Guy, Jankowski, Piotr, Kotseva, Kornelia, Mirrakhimov, Erkin, Reiner, Željko, Rydén, Lars, Tokgözoğlu, Lale, Wood, David, and De Bacquer, Dirk

Published
2019
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2. Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial

Author

Bosi, E, Choudhary, P, de Valk, H, Lablanche, S, Castaneda, J, de Portu, S, Da Silva, J, Re, R, Vorrink-de Groot, L, Shin, J, Kaufman, F, Cohen, O, Laurenzi, A, Caretto, A, Slatterly, D, Henderson-Wilson, M, Weisnagel, S, Dube, M, Julien, V, Trevisan, R, Lepore, G, Bellante, R, Hramiak, I, Spaic, T, Driscoll, M, Borot, S, Clergeot, A, Khiat, L, Hammond, P, Ray, S, Dinning, L, Tonolo, G, Manconi, A, Ledda, M, de Ranitz, W, Silvius, B, Wojtusciszyn, A, Farret, A, Vriesendorp, T, Immeker-de Jong, F, van der Linden, J, Brink, H, Alkemade, M, Schaepelynck-Belicar, P, Galie, S, Treglia, C, Benhamou, P, Haddouche, M, Hoogma, R, Leelarathna, L, Shaju, A, James, L, Bosi E., Choudhary P., de Valk H. W., Lablanche S., Castaneda J., de Portu S., Da Silva J., Re R., Vorrink-de Groot L., Shin J., Kaufman F. R., Cohen O., Laurenzi A., Caretto A., Slatterly D., Henderson-Wilson M., Weisnagel S. J., Dube M. -C., Julien V. -E., Trevisan R., Lepore G., Bellante R., Hramiak I., Spaic T., Driscoll M., Borot S., Clergeot A., Khiat L., Hammond P., Ray S., Dinning L., Tonolo G., Manconi A., Ledda M. S., de Ranitz W., Silvius B., Wojtusciszyn A., Farret A., Vriesendorp T., Immeker-de Jong F., van der Linden J., Brink H. S., Alkemade M., Schaepelynck-Belicar P., Galie S., Treglia C., Benhamou P. -Y., Haddouche M., Hoogma R., Leelarathna L., Shaju A., James L., Bosi, E, Choudhary, P, de Valk, H, Lablanche, S, Castaneda, J, de Portu, S, Da Silva, J, Re, R, Vorrink-de Groot, L, Shin, J, Kaufman, F, Cohen, O, Laurenzi, A, Caretto, A, Slatterly, D, Henderson-Wilson, M, Weisnagel, S, Dube, M, Julien, V, Trevisan, R, Lepore, G, Bellante, R, Hramiak, I, Spaic, T, Driscoll, M, Borot, S, Clergeot, A, Khiat, L, Hammond, P, Ray, S, Dinning, L, Tonolo, G, Manconi, A, Ledda, M, de Ranitz, W, Silvius, B, Wojtusciszyn, A, Farret, A, Vriesendorp, T, Immeker-de Jong, F, van der Linden, J, Brink, H, Alkemade, M, Schaepelynck-Belicar, P, Galie, S, Treglia, C, Benhamou, P, Haddouche, M, Hoogma, R, Leelarathna, L, Shaju, A, James, L, Bosi E., Choudhary P., de Valk H. W., Lablanche S., Castaneda J., de Portu S., Da Silva J., Re R., Vorrink-de Groot L., Shin J., Kaufman F. R., Cohen O., Laurenzi A., Caretto A., Slatterly D., Henderson-Wilson M., Weisnagel S. J., Dube M. -C., Julien V. -E., Trevisan R., Lepore G., Bellante R., Hramiak I., Spaic T., Driscoll M., Borot S., Clergeot A., Khiat L., Hammond P., Ray S., Dinning L., Tonolo G., Manconi A., Ledda M. S., de Ranitz W., Silvius B., Wojtusciszyn A., Farret A., Vriesendorp T., Immeker-de Jong F., van der Linden J., Brink H. S., Alkemade M., Schaepelynck-Belicar P., Galie S., Treglia C., Benhamou P. -Y., Haddouche M., Hoogma R., Leelarathna L., Shaju A., and James L.

Abstract

Background: Hypoglycaemia unawareness and severe hypoglycaemia can increase fear of hypoglycaemia and the risk of subsequent hypoglycaemic events. We aimed to assess the safety and efficacy of insulin pump therapy with integrated continuous glucose monitoring (CGM) and a suspend-before-low feature (Medtronic MiniMed 640G with SmartGuard) in hypoglycaemia-prone adults with type 1 diabetes. Methods: SMILE was an open-label randomised controlled trial done in people aged 24–75 years with type 1 diabetes for 10 years or longer, HbA1c values of 5·8–10·0% (40–86 mmol/mol), and at high risk of hypoglycaemia (recent severe hypoglycaemia or hypoglycaemia unawareness defined by a Clarke or Gold score ≥4). Participants were enrolled from 16 centres (eg, clinics, hospitals, or university medical centres) in Canada, France, Italy, the Netherlands, and the UK. After baseline run-in phase (2 weeks), participants were randomly assigned to the MiniMed 640G pump (continuous subcutaneous insulin infusion) with self-monitoring of blood glucose (control group) or to the MiniMed 640G system with the suspend-before-low feature enabled (intervention group), for 6 months. The study statistician analysing the data was masked to group assignment until final database lock; because of the nature of the intervention, participants and treating clinicians could not be masked to group assignment. The primary outcome was the mean number of sensor hypoglycaemic events, defined as 55 mg/dL (3·1 mmol/L) or lower, and was analysed on an intention-to-treat basis in all randomly assigned participants. This trial is registered with ClinicalTrials.gov, number NCT02733991, and is completed. Findings: Between Dec 7, 2016, and March 27, 2018, 153 participants with a mean age 48·2 [12·4] years were randomly assigned: 77 to the control group (mean age 47·4 [12·5] years) and 76 to the intervention group (mean age 49·0 [12·2] years). After 6 months, the intervention group had significantly fewer hypoglycaemic even

Published
2019

4. Management of dyslipidaemia in patients with coronary heart disease: Results from the ESC-EORP EUROASPIRE V survey in 27 countries

Author

De Backer, Guy Jankowski, Piotr Kotseva, Kornelia and Mirrakhimov, Erkin Reiner, Zeljko Ryden, Lars Tokgozoglu, Lale Wood, David De Bacquer, Dirk Abreu, A. Aguiar, C. and Badariene, J. Bruthans, J. Castro Conde, A. Cifkova, R. and Crowley, J. Davletov, K. De Smedt, D. De Sutter, J. and Deckers, J. W. Dilic, M. Dolzhenko, M. Druais, H. and Dzerve, V. Erglis, A. Fras, Z. Gaita, D. Gotcheva, N. and Grobbee, D. E. Gyberg, V. Ali, H. Hasan Heuschmann, P. and Hoes, A. W. Lalic, N. Lehto, S. Lovic, D. Maggioni, A. P. Mancas, S. Marques-Vidal, P. Mellbin, L. Milicic, D. Oganov, R. Pogosova, N. Stagmo, M. Stoerk, S. and Sundvall, J. Tsioufis, K. Vulic, D. Wood, D. A. and Jennings, C. Adamska, A. Adamska, S. Mellbin, L. and Tuomilehto, J. Schnell, O. Fiorucci, E. Glemot, M. and Larras, F. Missiamenou, V. Maggioni, A. Taylor, C. and Ferreira, T. Lemaitre, K. Raman, L. Sundvall, J. and DeSmedt, D. De Sutter, J. Willems, A. M. De Pauw, M. and Vervaet, P. Bollen, J. Dekimpe, E. Mommen, N. Van Genechten, G. Dendale, P. Bouvier, C. A. Chenu, P. and Huyberechts, D. Persu, A. Dilic, M. Begic, A. Nalbantic, A. Durak Dzubur, A. Hadzibegic, N. Iglica, A. Kapidjic, S. Bico, A. Osmanagic Resic, N. Bajramovic, N. Sabanovic and Zvizdic, F. Vulic, D. Kovacevic-Preradovic, T. and Popovic-Pejicic, S. Djekic, D. Gnjatic, T. Knezevic, T. and Kovacevic-Preradovic, T. Kos, Lj Popovic-Pejicic, S. and Stanetic, B. Topic, G. Gotcheva, N. Georgiev, Borislav and Terziev, A. Vladimirov, G. Angelov, A. Kanazirev, B. and Nikolaeva, S. Tonkova, D. Vetkova, M. Milicic, D. and Bosnic, A. Dubravcic, M. Glavina, M. Mance, M. and Pavasovic, S. Samardzic, J. Batinic, T. Crljenko, K. and Delic-Brkljacic, D. Dula, K. Golubic, K. Klobucar, I. and Kordic, K. Kos, N. Nedic, M. Olujic, D. Sedinic, V. and Blazevic, T. Pasalic, A. Percic, M. Sikic, J. Bruthans, J. Cifkova, R. Hasplova, K. Sulc, P. Wohlfahrt, P. and Mayer, Jr., O. Cvicela, M. Filipovsky, J. Gelzinsky, J. and Hronova, M. Hasan-Ali, H. Bakery, S. Mosad, E. Hamed, H. B. Ibrahim, A. Elsharef, M. A. Kholef, E. F. Shehata, A. and Youssef, M. Elhefny, E. Farid, H. Moustafa, T. M. and Sobieh, M. S. Kabil, H. Abdelmordy, A. Lehto, S. and Kiljander, E. Kiljander, P. Koukkunen, H. Mustonen, J. and Cremer, C. Frantz, S. Haupt, A. Hofmann, U. Ludwig, K. and Melnyk, H. Noutsias, M. Karmann, W. Prondzinsky, R. and Herdeg, C. Hoevelborn, T. Daaboul, A. Geisler, T. and Keller, T. Sauerbrunn, D. Walz-Ayed, M. Ertl, G. Leyh, R. Stoerk, S. Heuschmann, P. Ehlert, T. Klocke, B. and Krapp, J. Ludwig, T. Kaes, J. Starke, C. Ungethuem, K. and Wagner, M. Wiedmann, S. Tsioufis, K. Tolis, P. and Vogiatzi, G. Sanidas, E. Tsakalis, K. Kanakakis, J. and Koutsoukis, A. Vasileiadis, K. Zarifis, J. Karvounis, C. and Crowley, J. Gibson, I. Houlihan, A. Kelly, C. O'Donnell, M. Bennati, M. Cosmi, F. Mariottoni, B. Morganti, M. and Cherubini, A. Di Lenarda, A. Radini, D. Ramani, F. and Francese, M. G. Gulizia, M. M. Pericone, D. Davletov, K. and Aigerim, K. Bekbolat, Z. Amirov, B. Assembekov, B. and Chernokurova, E. Ibragimova, F. Kodasbayev, A. Markova, A. and Asanbaev, A. Toktomamatov, U. Tursunbaev, M. Zakirov, U. and Abilova, S. Arapova, R. Bektasheva, E. Esenbekova, J. and Neronova, K. Asanbaev, A. Baigaziev, K. Toktomamatov, U. and Zakirov, U. Baitova, G. Zheenbekov, T. Erglis, A. and Andrejeva, T. Bajare, I. Kucika, G. Labuce, A. Putane, L. Stabulniece, M. Dzerve, V. Klavins, E. Sime, I. and Badariene, J. Gedvilaite, L. Peciuraite, D. Sileikiene, V. and Skiauteryte, E. Solovjova, S. Sidabraite, R. Briedis, K. and Ceponiene, I. Jurenas, M. Kersulis, J. Martinkute, G. and Vaitiekiene, A. Vasiljevaite, K. Veisaite, R. Plisiene, J. Siurkaite, V. Vaiciulis, Z. Czarnecka, D. Koziel, P. and Podolec, P. Nessler, J. Gomula, P. Mirek-Bryniarska, E. and Bogacki, P. Wisniewski, A. Pajak, A. Wolfshaut-Wolak, R. and Bucko, J. Kaminski, K. Lapinska, M. Paniczko, M. and Raczkowski, A. Sawicka, E. Stachurska, Z. Szpakowicz, M. and Musial, W. Dobrzycki, S. Bychowski, J. Kosior, D. A. and Krzykwa, A. Setny, M. Kosior, D. A. Rak, A. Gasior, Z. and Haberka, M. Gasior, Z. Haberka, M. Szostak-Janiak, K. and Finik, M. Liszka, J. Botelho, A. Cachulo, M. Sousa, J. Pais, A. Aguiar, C. Durazzo, A. Matos, D. and Gouveia, R. Rodrigues, G. Strong, C. Guerreiro, R. and Aguiar, J. Abreu, A. Cruz, M. Daniel, P. Morais, L. and Moreira, R. Rosa, S. Rodrigues, I. Selas, M. Gaita, D. and Mancas, S. Apostu, A. Cosor, O. Gaita, L. Giurgiu, L. Hudrea, C. Maximov, D. Moldovan, B. Mosteoru, S. and Pleava, R. Ionescu, M. Parepa, I. Pogosova, N. and Arutyunov, A. Ausheva, A. Isakova, S. Karpova, A. and Salbieva, A. Sokolova, O. Vasilevsky, A. Pozdnyakov, Y. and Antropova, O. Borisova, L. Osipova, I. Lovic, D. and Aleksic, M. Crnokrak, B. Djokic, J. Hinic, S. Vukasin, T. Zdravkovic, M. Lalic, N. M. Jotic, A. Lalic, K. and Lukic, L. Milicic, T. Macesic, M. Gajovic, J. Stanarcic and Stoiljkovic, M. Djordjevic, D. Kostic, S. Tasic, I. and Vukovic, A. Fras, Z. Jug, B. Juhant, A. Krt, A. and Kugonjic, U. Chipayo Gonzales, D. Gomez Barrado, J. J. and Kounka, Z. Marcos Gomez, G. Mogollon Jimenez, M. V. Ortiz Cortes, C. Perez Espejo, P. Porras Ramos, Y. Colman, R. and Delgado, J. Otero, E. Perez, A. Fernandez-Olmo, M. R. and Torres-LLergo, J. Vasco, C. Barrenada, E. Botas, J. and Campuzano, R. Gonzalez, Y. Rodrigo, M. de Pablo, C. and Velasco, E. Hernandez, S. Lozano, C. Gonzalez, P. and Castro, A. Dalmau, R. Hernandez, D. Irazusta, F. J. and Velez, A. Vindel, C. Gomez-Doblas, J. J. Garcia Ruiz, V. and Gomez, L. Gomez Garcia, M. Jimenez-Navarro, M. Molina Ramos, A. Marzal, D. Martinez, G. Lavado, R. Vidal, A. and Bostrom-Nilsson, V. Kjellstrom, B. Shahim, B. Smetana, S. and Hansen, O. Stensgaard-Nake, E. Deckers, J. W. Klijn, A. J. Mangus, T. J. P. Peters, R. J. G. Reimer, W. Scholte Op and Snaterse, M. Aydogdu, S. Erol, C. Oturk, S. Kaya, C. Tulunay Ahmetoglu, Y. Ergene, O. Akdeniz, B. Cirgamis, D. Kultursay, S. Akkoyun H. Kayikcioglu, M. Catakoglu, A. B. and Cengel, A. Kocak, A. A. Agirbasli, M. A. Aciksari, G. and Cekin, M. E. Kaya, E. B. Kocyigit, D. Ongen, Z. and Ozmen, E. Sansoy, V. Kaya, A. Oktay, V. Temizhan, A. and Unal, S. Yakut, I. Kalkan, A. K. Bozkurt, E. Kasapkara, H. A. Dolzhenko, M. Faradzh, C. Hrubyak, L. Konoplianyk, L. Kozhuharyova, N. Lobach, L. Nesukai, V. Nudchenko, O. and Simagina, T. Yakovenko, L. Azarenko, V. Potabashny, V. and Bazylevych, A. Bazylevych, M. Kaminska, K. Panchenko, L. and Shershnyova, O. Ovrakh, T. Serik, S. Kolesnik, T. and Kosova, H. Adamska, A. Adamska, S. Jennings, C. Atkin, A. Hoye P. Fellowes, D. Lindsay, S. Atkinson, C. and Kranilla, C. Vinod, M. Beerachee, Y. Bennett, C. Broome, M. Bwalya, A. Caygill, Lindsay Dinning, L. Gillespie, A. and Goodfellow, R. Guy, J. Idress, T. Mills, C. Morgan, C. Oustance, N. Singh, N. Yare, M. Jagoda, J. M. and Bowyer, H. Christenssen, V. Groves, A. Jan, A. Riaz, A. and Gill, M. Sewell, T. A. Gorog, D. Baker, M. De Sousa, P. Mazenenga, T. Porter, J. Haines, F. Peachey, T. and Taaffe, J. Wells, K. Ripley, D. P. Forward, H. McKie, H. and Pick, S. L. Thomas, H. E. Batin, P. D. Exley, D. and Rank, T. Wright, J. Kardos, A. Sutherland, S. -B. Wren, L. Leeson, P. Barker, D. Moreby, B. Sawyer, J. and Stirrup, J. Brunton, M. Brodison, A. Craig, J. Peters, S. Kaprielian, R. Bucaj, A. Mahay, K. Oblak, M. and Gale, C. Pye, M. McGill, Y. Redfearn, H. Fearnley, M. and EUROASPIRE V Collaborators Writing Comm Sci Steering Executive Comm Coordinating Ctr Diabet Ctr Data Management Ctr Stat Anal Ctr Cent Lab Study Ctr Org Investigators Other

Abstract

Background and aims: One of the objectives of the ESC-EORP EUROASPIRE V survey is to determine how well European guidelines on the management of dyslipidaemias are implemented in coronary patients. Methods: Standardized methods were used by trained technicians to collect information on 7824 patients from 130 centers in 27 countries, from the medical records and at a visit at least 6 months after hospitalization for a coronary event. All lipid measurements were performed in one central laboratory. Patients were divided into three groups: on high-intensity LDL-C-lowering-drug therapy (LLT), on low or moderate-intensity LLT and on no LLT. Results: At the time of the visit, almost half of the patients were on a high-intensity LLT. Between hospital discharge and the visit, LLT had been reduced in intensity or interrupted in 20.8% of the patients and had been started or increased in intensity in 11.7%. In those who had interrupted LLT or had reduced the intensity, intolerance to LLT and the advice of their physician were reported as the reason why in 15.8 and 36.8% of the cases, respectively. LDL-C control was better in those on a high-intensity LLT compared to those on low or moderate intensity LLT. LDL-C control was better in men than women and in patients with self-reported diabetes. Conclusions: The results of the EUROASPIRE V survey show that most coronary patients have a less than optimal management of LDL-C. More professional strategies are needed, aiming at lifestyle changes and LLT adapted to the need of the individual patient.

Published
2019

5. Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE)

Author

Hallowell, N, Heller, S, Elliott, J, Waugh, N, Amiel, S, Choudhary, P, Evans, M, Green, F, Hammond, P, Jaap, A, Kennon, B, Lindsay, R, Mansell, P, Baillie, J, Beckwith, A, Brown, H, Callaby, K, Davenport, K, Donald, S, Faghahati, L, Hartnell, S, Housden, A, Pabla, KK, Croxon, N, Macdonald, S, Mohammed, M, Steel, V, Valentine, K, Young, P, Boal, A, Clerkin, P, Doran, L, Flynn, J, Gibb, E, Peddie, H, Quinn, B, Rogers, H, Shephard, J, Carling, J, Collins, A, Dinning, L, Hare, C, Lodge, J, Ray, S, Brown, D, Farmer, J, Cox, A, Cheyette, C, East, L, Ellul, J, Hunt, K, Shaw, K, Stothard, B, Diamond, L, Aniello, L, Anderson, D, Cockerell, K, Heaney, V, Hutchison, A, Zammitt, N, Babington, G, Bird, G, Evans, J, Gazis, T, Maude, N, Nunnick, K, Spick, D, Fenn, L, Gianfrancesco, C, Gordon, V, Greaves, L, Hudson, S, Naylor, V, Nisbet, C, Taylor, C, Towse, K, Ward, C, Cooper, C, Dimairo, M, Lee, E, White, D, Hackney, G, Papaioannou, D, Whatley, E, Bradburn, M, Campbell, M, Basarir, H, and Hallowell, N

Subjects
Insulin pump, Type 1 diabetes, medicine.medical_specialty, Intention-to-treat analysis, business.industry, Insulin, medicine.medical_treatment, 030209 endocrinology & metabolism, General Medicine, medicine.disease, Confidence interval, 03 medical and health sciences, 0302 clinical medicine, Quality of life, medicine, Physical therapy, 030212 general & internal medicine, Cluster randomised controlled trial, business, Psychosocial, RC
Abstract

Objective To compare the effectiveness of insulin pumps with multiple daily injections for adults with type 1 diabetes, with both groups receiving equivalent training in flexible insulin treatment.Design Pragmatic, multicentre, open label, parallel group, cluster randomised controlled trial (Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE) trial).Setting Eight secondary care centres in England and Scotland.Participants Adults with type 1 diabetes who were willing to undertake intensive insulin treatment, with no preference for pumps or multiple daily injections. Participants were allocated a place on established group training courses that taught flexible intensive insulin treatment (“dose adjustment for normal eating,” DAFNE). The course groups (the clusters) were then randomly allocated in pairs to either pump or multiple daily injections.Interventions Participants attended training in flexible insulin treatment (using insulin analogues) structured around the use of pump or injections, followed for two years.Main outcome measures The primary outcomes were a change in glycated haemoglobin (HbA1c) values (%) at two years in participants with baseline HbA1c value of ≥7.5% (58 mmol/mol), and the proportion of participants achieving an HbA1c value of Results 317 participants (46 courses) were randomised (156 pump and 161 injections). 267 attended courses and 260 were included in the intention to treat analysis, of which 235 (119 pump and 116 injection) had baseline HbA1c values of ≥7.5%. Glycaemic control and rates of severe hypoglycaemia improved in both groups. The mean change in HbA1c at two years was −0.85% with pump treatment and −0.42% with multiple daily injections. Adjusting for course, centre, age, sex, and accounting for missing values, the difference was −0.24% (−2.7 mmol/mol) in favour of pump users (95% confidence interval −0.53 to 0.05, P=0.10). Most psychosocial measures showed no difference, but pump users showed greater improvement in treatment satisfaction and some quality of life domains (dietary freedom and daily hassle) at 12 and 24 months.Conclusions Both groups showed clinically relevant and long lasting decreases in HbA1c, rates of severe hypoglycaemia, and improved psychological measures, although few participants achieved glucose levels currently recommended by national and international guidelines. Adding pump treatment to structured training in flexible intensive insulin treatment did not substantially enhance educational benefits on glycaemic control, hypoglycaemia, or psychosocial outcomes in adults with type 1 diabetes. These results do not support a policy of providing insulin pumps to adults with poor glycaemic control until the effects of training on participants’ level of engagement in intensive self management have been determined.Trial Registration Current Controlled Trials ISRCTN61215213.

Published
2017
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6. Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial

Author

Haddouche, Aini, Bellanne‐Chantelot, Christine, Rod, Anne, Fournier, Luc, Chiche, Laurence, Gautier, Jean‐Francois, Timsit, José, Laboureau, Sandrine, Chaillous, Lucy, Valero, Rene, Larger, Etienne, Jeandidier, Nathalie, Wilhelm, Jean‐Marie, Popelier, Marc, Guillausseau, Pierre‐Jean, Thivolet, Charles, Lecomte, Pierre, Benhamou, Pierre‐Yves, Reznik, Yves, Bosi, Emanuele, Choudhary, Pratik, De Valk, Harold, Lablanche, Sandrine, Castaneda, Javier, De Portu, Simona, Da Silva, Julien, Ré, Roseline, Vorrink-de Groot, Linda, Shin, John, Kaufman, Francine, Cohen, Ohad, Laurenzi, Andrea, Caretto, Amelia, Slatterly, David, Henderson-Wilson, Marcia, Weisnagel, S. John, Dubé, Marie-Christine, Julien, Valérie-Ève, Trevisan, Roberto, Lepore, Giuseppe, Bellante, Rosalia, Hramiak, Irene, Spaic, Tamara, Driscoll, Marsha, Borot, Sophie, Clergeot, Annie, Khiat, Lamia, Hammond, Peter, Ray, Sutapa, Dinning, Laura, Tonolo, Giancarlo, Manconi, Alberto, Ledda, Maura Serena, de Ranitz, Wendela, Silvius, Bianca, Wojtusciszyn, Anne, Farret, Anne, Vriesendorp, Titia, Immeker-de Jong, Folkje, van der Linden, Joke, Brink, Huguette, Alkemade, Marije, Schaepelynck-Belicar, Pauline, Galie, Sébastien, Tréglia, Clémence, Haddouche, Myriam, Hoogma, Roel, Leelarathna, Lalantha, Shaju, Angel, James, Linda, Institut National de l'Environnement Industriel et des Risques (INERIS), Service de Chirurgie digestive [Bordeaux], CHU Bordeaux [Bordeaux], Service de diabétologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Clinique d'Endocrinologie, Maladies Métaboliques et Nutrition, Hôpital Laennec, Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Institut Cochin (IC UM3 (UMR 8104 / U1016)), Centre National de la Recherche Scientifique (CNRS)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Strasbourg, Pharmacologie Endocrinienne, Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Institut National de la Recherche Agronomique (INRA), Université de Liège, Centre Hospitalier Universitaire [Grenoble] (CHU), Laboratory of Fundamental and Applied Bioenergetics = Laboratoire de bioénergétique fondamentale et appliquée (LBFA), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Dipartimento di Biologia Evoluzionistica 'Leo Pardi', Università degli Studi di Firenze = University of Florence [Firenze] (UNIFI), King's College Hospital (KCH), University Medical Center [Utrecht], Medtronic Bakken Research Center BV, Medtronic Diabetes, International Trading Sàrl , Tolochenaz, Switzerland, Human Computer Technology Laboratory (HCTLab), Universidad Autonoma de Madrid (UAM), Service de Diabétologie - Endocrinologie [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Institute of Child Health, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Endocrinologie, Hôpital Sainte-Marguerite [CHU - APHM] (Hôpitaux Sud )-CHU Marseille, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Cochin [AP-HP], Hôpital de la Conception [CHU - APHM] (LA CONCEPTION ), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Hôpital Lariboisière, Institut National de la Recherche Agronomique (INRA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire de bioénergétique fondamentale et appliquée (LBFA), Université Grenoble Alpes (UGA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Joseph Fourier - Grenoble 1 (UJF), Università degli Studi di Firenze [Firenze], Service de diabétologie - endocrinologie, Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon)-Hôpital Jean Minjoz, Service de diabétologie - endocrinologie [Besançon], Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon)-Hôpital Jean Minjoz-Université de Franche-Comté (UFC), Bosi, E, Choudhary, P, de Valk, H, Lablanche, S, Castaneda, J, de Portu, S, Da Silva, J, Re, R, Vorrink-de Groot, L, Shin, J, Kaufman, F, Cohen, O, Laurenzi, A, Caretto, A, Slatterly, D, Henderson-Wilson, M, Weisnagel, S, Dube, M, Julien, V, Trevisan, R, Lepore, G, Bellante, R, Hramiak, I, Spaic, T, Driscoll, M, Borot, S, Clergeot, A, Khiat, L, Hammond, P, Ray, S, Dinning, L, Tonolo, G, Manconi, A, Ledda, M, de Ranitz, W, Silvius, B, Wojtusciszyn, A, Farret, A, Vriesendorp, T, Immeker-de Jong, F, van der Linden, J, Brink, H, Alkemade, M, Schaepelynck-Belicar, P, Galie, S, Treglia, C, Benhamou, P, Haddouche, M, Hoogma, R, Leelarathna, L, Shaju, A, James, L, Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hospices Civils de Lyon (HCL), Université Joseph Fourier - Grenoble 1 (UJF)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA), Bosi, E., Choudhary, P., de Valk, H. W., Lablanche, S., Castaneda, J., de Portu, S., Da Silva, J., Re, R., Vorrink-de Groot, L., Shin, J., Kaufman, F. R., Cohen, O., Laurenzi, A., Caretto, A., Slatterly, D., Henderson-Wilson, M., Weisnagel, S. J., Dube, M. -C., Julien, V. -E., Trevisan, R., Lepore, G., Bellante, R., Hramiak, I., Spaic, T., Driscoll, M., Borot, S., Clergeot, A., Khiat, L., Hammond, P., Ray, S., Dinning, L., Tonolo, G., Manconi, A., Ledda, M. S., de Ranitz, W., Silvius, B., Wojtusciszyn, A., Farret, A., Vriesendorp, T., Immeker-de Jong, F., van der Linden, J., Brink, H. S., Alkemade, M., Schaepelynck-Belicar, P., Galie, S., Treglia, C., Benhamou, P. -Y., Haddouche, M., Hoogma, R., Leelarathna, L., Shaju, A., and James, L.

Subjects
Adult, Male, Insulin pump, Pediatrics, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, [SDV]Life Sciences [q-bio], Population, glucose, hemoglobin A1c, insulin, antidiabetic agent, 030209 endocrinology & metabolism, Low insulin, law.invention, 03 medical and health sciences, Insulin Infusion Systems, 0302 clinical medicine, Endocrinology, Randomized controlled trial, law, Internal Medicine, medicine, Humans, Hypoglycemic Agents, Insulin, 030212 general & internal medicine, education, ComputingMilieux_MISCELLANEOUS, education.field_of_study, Type 1 diabetes, Continuous glucose monitoring, business.industry, Middle Aged, medicine.disease, Hypoglycemia, 3. Good health, Diabetes Mellitus, Type 1, Hypoglycaemia unawareness, Female, Open label, business
Abstract

Background: Hypoglycaemia unawareness and severe hypoglycaemia can increase fear of hypoglycaemia and the risk of subsequent hypoglycaemic events. We aimed to assess the safety and efficacy of insulin pump therapy with integrated continuous glucose monitoring (CGM) and a suspend-before-low feature (Medtronic MiniMed 640G with SmartGuard) in hypoglycaemia-prone adults with type 1 diabetes. Methods: SMILE was an open-label randomised controlled trial done in people aged 24–75 years with type 1 diabetes for 10 years or longer, HbA1c values of 5·8–10·0% (40–86 mmol/mol), and at high risk of hypoglycaemia (recent severe hypoglycaemia or hypoglycaemia unawareness defined by a Clarke or Gold score ≥4). Participants were enrolled from 16 centres (eg, clinics, hospitals, or university medical centres) in Canada, France, Italy, the Netherlands, and the UK. After baseline run-in phase (2 weeks), participants were randomly assigned to the MiniMed 640G pump (continuous subcutaneous insulin infusion) with self-monitoring of blood glucose (control group) or to the MiniMed 640G system with the suspend-before-low feature enabled (intervention group), for 6 months. The study statistician analysing the data was masked to group assignment until final database lock; because of the nature of the intervention, participants and treating clinicians could not be masked to group assignment. The primary outcome was the mean number of sensor hypoglycaemic events, defined as 55 mg/dL (3·1 mmol/L) or lower, and was analysed on an intention-to-treat basis in all randomly assigned participants. This trial is registered with ClinicalTrials.gov, number NCT02733991, and is completed. Findings: Between Dec 7, 2016, and March 27, 2018, 153 participants with a mean age 48·2 [12·4] years were randomly assigned: 77 to the control group (mean age 47·4 [12·5] years) and 76 to the intervention group (mean age 49·0 [12·2] years). After 6 months, the intervention group had significantly fewer hypoglycaemic events per participant per week (1·1 [SD 1·2] vs 4·1 [3·4] mean events, model-based treatment effect −2·9 [95% CI −3·5 to −2·3]; p

Published
2019
Full Text
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