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1. NT-proBNP Response to Sacubitril/Valsartan in Hospitalized Heart Failure Patients With Reduced Ejection Fraction: TRANSITION Study

Author

Pascual-Figal, D, Wachter, R, Senni, M, Bao, W, Noe, A, Schwende, H, Butylin, D, Prescott, M, Gniot, J, Mozheiko, M, Lelonek, M, Dominguez, A, Horacek, T, Garcia del Rio, E, Kobalava, Z, Mueller, C, Cavusoglu, Y, Straburzynska-Migaj, E, Slanina, M, vom Dahl, J, Ryding, A, Moriarty, A, Robles, M, Villota, J, Quintana, A, Nitschke, T, Garcia Pinilla, J, Bonet, L, Chaaban, S, Filali zaatari, S, Spinar, J, Musial, W, Abdelbaki, K, Belohlavek, J, Fehske, W, Bott, M, Hoegalmen, G, Leiro, M, Ozcan, I, Mullens, W, Kryza, R, Al-Ani, R, Loboz-Grudzien, K, Ermoshkina, L, Hojerova, S, Fernandez, A, Spinarova, L, Lapp, H, Bulut, E, Almeida, F, Vishnevsky, A, Belicova, M, Witte, K, Wong, K, Droogne, W, Delforge, M, Peterka, M, Olbrich, H, Carugo, S, Nessler, J, Mcgill, T, Huegl, B, Akin, I, Moreira, I, Baglikov, A, Thambyrajah, J, Hayes, C, Barrionuevo, M, Yigit, Z, Kaya, H, Klimsa, Z, Radvan, M, Kadel, C, Landmesser, U, Di Tano, G, Lisik, M, Fonseca, C, Oliveira, L, Marques, I, Santos, L, Lenner, E, Letavay, P, Bueno, M, Mota, P, Wong, A, Bailey, K, Foley, P, Hasbani, E, Virani, S, Massih, T, Al-Saif, S, Taborsky, M, Kaislerova, M, Motovska, Z, Cohen, A, Logeart, D, Endemann, D, Ferreira, D, Brito, D, Kycina, P, Bollano, E, Basilio, E, Rubio, L, Aguado, M, Schiavi, L, Zivano, D, Lonn, E, El Sayed, A, Pouleur, A, Heyse, A, Schee, A, Polasek, R, Houra, M, Tribouilloy, C, Seronde, M, Galinier, M, Noutsias, M, Schwimmbeck, P, Voigt, I, Westermann, D, Pulignano, G, Vegsundvaag, J, Da Silva Antunes, J, Monteiro, P, Stevlik, J, Goncalvesova, E, Hulkoova, B, Castro Fernandez, A, Davies, C, Squire, I, Meyer, P, Sheppard, R, Sahin, T, Sochor, K, De Geeter, G, Schmeisser, A, Weil, J, Soares, A, Bulashova, O, Oshurkov, A, Sunderland, S, Glover, J, Exequiel, T, Decoulx, E, Meyer, S, Muenzel, T, Frioes, F, Arbolishvili, G, Tokarcikova, A, Karlstrom, P, Trullas Vila, J, Perez, G, Sankaranarayanan, R, Nageh, T, Alasia, D, Refaat, M, Demirkan, B, Al-Buraiki, J, Karabsheh, S, Pascual-Figal D., Wachter R., Senni M., Bao W., Noe A., Schwende H., Butylin D., Prescott M. F., Gniot J., Mozheiko M., Lelonek M., Dominguez A. R., Horacek T., Garcia del Rio E., Kobalava Z., Mueller C. E., Cavusoglu Y., Straburzynska-Migaj E., Slanina M., vom Dahl J., Ryding A., Moriarty A., Robles M. B., Villota J. N., Quintana A. G., Nitschke T., Garcia Pinilla J. M., Bonet L. A., Chaaban S., Filali zaatari S., Spinar J., Musial W., Abdelbaki K., Belohlavek J., Fehske W., Bott M. C., Hoegalmen G., Leiro M. C., Ozcan I. T., Mullens W., Kryza R., Al-Ani R., Loboz-Grudzien K., Ermoshkina L., Hojerova S., Fernandez A. A., Spinarova L., Lapp H., Bulut E., Almeida F., Vishnevsky A., Belicova M., Witte K., Wong K., Droogne W., Delforge M., Peterka M., Olbrich H. -G., Carugo S., Nessler J., McGill T. H., Huegl B., Akin I., Moreira I., Baglikov A., Thambyrajah J., Hayes C., Barrionuevo M. R., Yigit Z., Kaya H., Klimsa Z., Radvan M., Kadel C., Landmesser U., Di Tano G., Lisik M. B., Fonseca C., Oliveira L., Marques I., Santos L. M., Lenner E., Letavay P., Bueno M. G., Mota P., Wong A., Bailey K., Foley P., Hasbani E., Virani S., Massih T. A., Al-Saif S., Taborsky M., Kaislerova M., Motovska Z., Cohen A. A., Logeart D., Endemann D., Ferreira D., Brito D., Kycina P., Bollano E., Basilio E. G., Rubio L. F., Aguado M. G., Schiavi L. B., Zivano D. F., Lonn E., El Sayed A., Pouleur A. -C., Heyse A., Schee A., Polasek R., Houra M., Tribouilloy C., Seronde M. F., Galinier M., Noutsias M., Schwimmbeck P., Voigt I., Westermann D., Pulignano G., Vegsundvaag J., Da Silva Antunes J. A., Monteiro P., Stevlik J., Goncalvesova E., Hulkoova B., Castro Fernandez A. J., Davies C., Squire I., Meyer P., Sheppard R., Sahin T., Sochor K., De Geeter G., Schmeisser A., Weil J., Soares A. O., Bulashova O. V., Oshurkov A., Sunderland S. J., Glover J., Exequiel T., Decoulx E., Meyer S., Muenzel T., Frioes F., Arbolishvili G., Tokarcikova A., Karlstrom P., Trullas Vila J. C., Perez G. P., Sankaranarayanan R., Nageh T., Alasia D. C., Refaat M., Demirkan B., Al-Buraiki J., Karabsheh S., Pascual-Figal, D, Wachter, R, Senni, M, Bao, W, Noe, A, Schwende, H, Butylin, D, Prescott, M, Gniot, J, Mozheiko, M, Lelonek, M, Dominguez, A, Horacek, T, Garcia del Rio, E, Kobalava, Z, Mueller, C, Cavusoglu, Y, Straburzynska-Migaj, E, Slanina, M, vom Dahl, J, Ryding, A, Moriarty, A, Robles, M, Villota, J, Quintana, A, Nitschke, T, Garcia Pinilla, J, Bonet, L, Chaaban, S, Filali zaatari, S, Spinar, J, Musial, W, Abdelbaki, K, Belohlavek, J, Fehske, W, Bott, M, Hoegalmen, G, Leiro, M, Ozcan, I, Mullens, W, Kryza, R, Al-Ani, R, Loboz-Grudzien, K, Ermoshkina, L, Hojerova, S, Fernandez, A, Spinarova, L, Lapp, H, Bulut, E, Almeida, F, Vishnevsky, A, Belicova, M, Witte, K, Wong, K, Droogne, W, Delforge, M, Peterka, M, Olbrich, H, Carugo, S, Nessler, J, Mcgill, T, Huegl, B, Akin, I, Moreira, I, Baglikov, A, Thambyrajah, J, Hayes, C, Barrionuevo, M, Yigit, Z, Kaya, H, Klimsa, Z, Radvan, M, Kadel, C, Landmesser, U, Di Tano, G, Lisik, M, Fonseca, C, Oliveira, L, Marques, I, Santos, L, Lenner, E, Letavay, P, Bueno, M, Mota, P, Wong, A, Bailey, K, Foley, P, Hasbani, E, Virani, S, Massih, T, Al-Saif, S, Taborsky, M, Kaislerova, M, Motovska, Z, Cohen, A, Logeart, D, Endemann, D, Ferreira, D, Brito, D, Kycina, P, Bollano, E, Basilio, E, Rubio, L, Aguado, M, Schiavi, L, Zivano, D, Lonn, E, El Sayed, A, Pouleur, A, Heyse, A, Schee, A, Polasek, R, Houra, M, Tribouilloy, C, Seronde, M, Galinier, M, Noutsias, M, Schwimmbeck, P, Voigt, I, Westermann, D, Pulignano, G, Vegsundvaag, J, Da Silva Antunes, J, Monteiro, P, Stevlik, J, Goncalvesova, E, Hulkoova, B, Castro Fernandez, A, Davies, C, Squire, I, Meyer, P, Sheppard, R, Sahin, T, Sochor, K, De Geeter, G, Schmeisser, A, Weil, J, Soares, A, Bulashova, O, Oshurkov, A, Sunderland, S, Glover, J, Exequiel, T, Decoulx, E, Meyer, S, Muenzel, T, Frioes, F, Arbolishvili, G, Tokarcikova, A, Karlstrom, P, Trullas Vila, J, Perez, G, Sankaranarayanan, R, Nageh, T, Alasia, D, Refaat, M, Demirkan, B, Al-Buraiki, J, Karabsheh, S, Pascual-Figal D., Wachter R., Senni M., Bao W., Noe A., Schwende H., Butylin D., Prescott M. F., Gniot J., Mozheiko M., Lelonek M., Dominguez A. R., Horacek T., Garcia del Rio E., Kobalava Z., Mueller C. E., Cavusoglu Y., Straburzynska-Migaj E., Slanina M., vom Dahl J., Ryding A., Moriarty A., Robles M. B., Villota J. N., Quintana A. G., Nitschke T., Garcia Pinilla J. M., Bonet L. A., Chaaban S., Filali zaatari S., Spinar J., Musial W., Abdelbaki K., Belohlavek J., Fehske W., Bott M. C., Hoegalmen G., Leiro M. C., Ozcan I. T., Mullens W., Kryza R., Al-Ani R., Loboz-Grudzien K., Ermoshkina L., Hojerova S., Fernandez A. A., Spinarova L., Lapp H., Bulut E., Almeida F., Vishnevsky A., Belicova M., Witte K., Wong K., Droogne W., Delforge M., Peterka M., Olbrich H. -G., Carugo S., Nessler J., McGill T. H., Huegl B., Akin I., Moreira I., Baglikov A., Thambyrajah J., Hayes C., Barrionuevo M. R., Yigit Z., Kaya H., Klimsa Z., Radvan M., Kadel C., Landmesser U., Di Tano G., Lisik M. B., Fonseca C., Oliveira L., Marques I., Santos L. M., Lenner E., Letavay P., Bueno M. G., Mota P., Wong A., Bailey K., Foley P., Hasbani E., Virani S., Massih T. A., Al-Saif S., Taborsky M., Kaislerova M., Motovska Z., Cohen A. A., Logeart D., Endemann D., Ferreira D., Brito D., Kycina P., Bollano E., Basilio E. G., Rubio L. F., Aguado M. G., Schiavi L. B., Zivano D. F., Lonn E., El Sayed A., Pouleur A. -C., Heyse A., Schee A., Polasek R., Houra M., Tribouilloy C., Seronde M. F., Galinier M., Noutsias M., Schwimmbeck P., Voigt I., Westermann D., Pulignano G., Vegsundvaag J., Da Silva Antunes J. A., Monteiro P., Stevlik J., Goncalvesova E., Hulkoova B., Castro Fernandez A. J., Davies C., Squire I., Meyer P., Sheppard R., Sahin T., Sochor K., De Geeter G., Schmeisser A., Weil J., Soares A. O., Bulashova O. V., Oshurkov A., Sunderland S. J., Glover J., Exequiel T., Decoulx E., Meyer S., Muenzel T., Frioes F., Arbolishvili G., Tokarcikova A., Karlstrom P., Trullas Vila J. C., Perez G. P., Sankaranarayanan R., Nageh T., Alasia D. C., Refaat M., Demirkan B., Al-Buraiki J., and Karabsheh S.

Abstract

Objectives: This study examined the effects of sacubitril/valsartan on N-terminal pro–B-type natriuretic peptide (NT-proBNP) levels and determined patient characteristics associated with favorable NT-proBNP reduction response. Background: NT-proBNP levels reflect cardiac wall stress and predict event risk in patients with acute decompensated heart failure (ADHF). Methods: Post-hoc analysis of the TRANSITION (Comparison of Pre- and Post-discharge Initiation of Sacubitril/Valsartan Therapy in HFrEF Patients After an Acute Decompensation Event) study, including stabilized ADHF patients with reduced ejection fraction, randomized to open-label sacubitril/valsartan initiation in-hospital (pre-discharge) versus post-discharge. NT-proBNP was measured at randomization (baseline), discharge, and 4 and 10 weeks post-randomization. A favorable NT-proBNP response was defined as reduction to ≤1,000 pg/ml or >30% from baseline. Results: In patients receiving sacubitril/valsartan in-hospital, NT-proBNP was reduced by 28% at discharge, with 46% of patients obtaining favorable NT-proBNP reduction response compared with a 4% reduction and 18% favorable response rate in patients initiated post-discharge (p < 0.001). NT-proBNP was reduced similarly in patients initiating sacubitril/valsartan pre- and post-discharge (reduction at 4 weeks: 25%/22%; 10 weeks: 38%/34%) with comparable favorable response rates (46%/42% and 51%/48% at 4 and 10 weeks, respectively). NT-proBNP favorable response at 4 weeks was associated with lower risk of first heart failure (HF) rehospitalization or cardiovascular death through 26 weeks (hazard ratio: 0.57; 95% confidence interval [CI]: 0.38 to 0.86; p = 0.007). Predictors of a favorable response at 4 weeks were starting dose ≥49/51 mg twice daily, higher baseline NT-proBNP, lower baseline serum creatinine, de novo HF, no atrial fibrillation, angiotensin-converting enzyme inhibitor–naive or angiotensin receptor blocker–naive, and no prior myocardial inf

Published
2020

2. NT-proBNP Response to Sacubitril/Valsartan in Hospitalized Heart Failure Patients With Reduced Ejection Fraction: TRANSITION Study

Author

Pascual-Figal D., Wachter R., Senni M., Bao W., Noe A., Schwende H., Butylin D., Prescott M. F., Gniot J., Mozheiko M., Lelonek M., Dominguez A. R., Horacek T., Garcia del Rio E., Kobalava Z., Mueller C. E., Cavusoglu Y., Straburzynska-Migaj E., Slanina M., vom Dahl J., Ryding A., Moriarty A., Robles M. B., Villota J. N., Quintana A. G., Nitschke T., Garcia Pinilla J. M., Bonet L. A., Chaaban S., Filali zaatari S., Spinar J., Musial W., Abdelbaki K., Belohlavek J., Fehske W., Bott M. C., Hoegalmen G., Leiro M. C., Ozcan I. T., Mullens W., Kryza R., Al-Ani R., Loboz-Grudzien K., Ermoshkina L., Hojerova S., Fernandez A. A., Spinarova L., Lapp H., Bulut E., Almeida F., Vishnevsky A., Belicova M., Witte K., Wong K., Droogne W., Delforge M., Peterka M., Olbrich H. -G., Carugo S., Nessler J., McGill T. H., Huegl B., Akin I., Moreira I., Baglikov A., Thambyrajah J., Hayes C., Barrionuevo M. R., Yigit Z., Kaya H., Klimsa Z., Radvan M., Kadel C., Landmesser U., Di Tano G., Lisik M. B., Fonseca C., Oliveira L., Marques I., Santos L. M., Lenner E., Letavay P., Bueno M. G., Mota P., Wong A., Bailey K., Foley P., Hasbani E., Virani S., Massih T. A., Al-Saif S., Taborsky M., Kaislerova M., Motovska Z., Cohen A. A., Logeart D., Endemann D., Ferreira D., Brito D., Kycina P., Bollano E., Basilio E. G., Rubio L. F., Aguado M. G., Schiavi L. B., Zivano D. F., Lonn E., El Sayed A., Pouleur A. -C., Heyse A., Schee A., Polasek R., Houra M., Tribouilloy C., Seronde M. F., Galinier M., Noutsias M., Schwimmbeck P., Voigt I., Westermann D., Pulignano G., Vegsundvaag J., Da Silva Antunes J. A., Monteiro P., Stevlik J., Goncalvesova E., Hulkoova B., Castro Fernandez A. J., Davies C., Squire I., Meyer P., Sheppard R., Sahin T., Sochor K., De Geeter G., Schmeisser A., Weil J., Soares A. O., Bulashova O. V., Oshurkov A., Sunderland S. J., Glover J., Exequiel T., Decoulx E., Meyer S., Muenzel T., Frioes F., Arbolishvili G., Tokarcikova A., Karlstrom P., Trullas Vila J. C., Perez G. P., Sankaranarayanan R., Nageh T., Alasia D. C., Refaat M., Demirkan B., Al-Buraiki J., Karabsheh S., Pascual-Figal, D, Wachter, R, Senni, M, Bao, W, Noe, A, Schwende, H, Butylin, D, Prescott, M, Gniot, J, Mozheiko, M, Lelonek, M, Dominguez, A, Horacek, T, Garcia del Rio, E, Kobalava, Z, Mueller, C, Cavusoglu, Y, Straburzynska-Migaj, E, Slanina, M, vom Dahl, J, Ryding, A, Moriarty, A, Robles, M, Villota, J, Quintana, A, Nitschke, T, Garcia Pinilla, J, Bonet, L, Chaaban, S, Filali zaatari, S, Spinar, J, Musial, W, Abdelbaki, K, Belohlavek, J, Fehske, W, Bott, M, Hoegalmen, G, Leiro, M, Ozcan, I, Mullens, W, Kryza, R, Al-Ani, R, Loboz-Grudzien, K, Ermoshkina, L, Hojerova, S, Fernandez, A, Spinarova, L, Lapp, H, Bulut, E, Almeida, F, Vishnevsky, A, Belicova, M, Witte, K, Wong, K, Droogne, W, Delforge, M, Peterka, M, Olbrich, H, Carugo, S, Nessler, J, Mcgill, T, Huegl, B, Akin, I, Moreira, I, Baglikov, A, Thambyrajah, J, Hayes, C, Barrionuevo, M, Yigit, Z, Kaya, H, Klimsa, Z, Radvan, M, Kadel, C, Landmesser, U, Di Tano, G, Lisik, M, Fonseca, C, Oliveira, L, Marques, I, Santos, L, Lenner, E, Letavay, P, Bueno, M, Mota, P, Wong, A, Bailey, K, Foley, P, Hasbani, E, Virani, S, Massih, T, Al-Saif, S, Taborsky, M, Kaislerova, M, Motovska, Z, Cohen, A, Logeart, D, Endemann, D, Ferreira, D, Brito, D, Kycina, P, Bollano, E, Basilio, E, Rubio, L, Aguado, M, Schiavi, L, Zivano, D, Lonn, E, El Sayed, A, Pouleur, A, Heyse, A, Schee, A, Polasek, R, Houra, M, Tribouilloy, C, Seronde, M, Galinier, M, Noutsias, M, Schwimmbeck, P, Voigt, I, Westermann, D, Pulignano, G, Vegsundvaag, J, Da Silva Antunes, J, Monteiro, P, Stevlik, J, Goncalvesova, E, Hulkoova, B, Castro Fernandez, A, Davies, C, Squire, I, Meyer, P, Sheppard, R, Sahin, T, Sochor, K, De Geeter, G, Schmeisser, A, Weil, J, Soares, A, Bulashova, O, Oshurkov, A, Sunderland, S, Glover, J, Exequiel, T, Decoulx, E, Meyer, S, Muenzel, T, Frioes, F, Arbolishvili, G, Tokarcikova, A, Karlstrom, P, Trullas Vila, J, Perez, G, Sankaranarayanan, R, Nageh, T, Alasia, D, Refaat, M, Demirkan, B, Al-Buraiki, J, and Karabsheh, S

Subjects
Heart Failure, acute decompensated heart failure, Aminobutyrates, Biphenyl Compounds, Aftercare, Stroke Volume, TRANSITION study, Patient Discharge, Peptide Fragments, Angiotensin Receptor Antagonists, Drug Combinations, sacubitril/valsartan, Natriuretic Peptide, Brain, Humans, Valsartan, heart failure with reduced ejection fraction, N-terminal pro–B-type natriuretic peptide
Abstract

Objectives: This study examined the effects of sacubitril/valsartan on N-terminal pro–B-type natriuretic peptide (NT-proBNP) levels and determined patient characteristics associated with favorable NT-proBNP reduction response. Background: NT-proBNP levels reflect cardiac wall stress and predict event risk in patients with acute decompensated heart failure (ADHF). Methods: Post-hoc analysis of the TRANSITION (Comparison of Pre- and Post-discharge Initiation of Sacubitril/Valsartan Therapy in HFrEF Patients After an Acute Decompensation Event) study, including stabilized ADHF patients with reduced ejection fraction, randomized to open-label sacubitril/valsartan initiation in-hospital (pre-discharge) versus post-discharge. NT-proBNP was measured at randomization (baseline), discharge, and 4 and 10 weeks post-randomization. A favorable NT-proBNP response was defined as reduction to ≤1,000 pg/ml or >30% from baseline. Results: In patients receiving sacubitril/valsartan in-hospital, NT-proBNP was reduced by 28% at discharge, with 46% of patients obtaining favorable NT-proBNP reduction response compared with a 4% reduction and 18% favorable response rate in patients initiated post-discharge (p < 0.001). NT-proBNP was reduced similarly in patients initiating sacubitril/valsartan pre- and post-discharge (reduction at 4 weeks: 25%/22%; 10 weeks: 38%/34%) with comparable favorable response rates (46%/42% and 51%/48% at 4 and 10 weeks, respectively). NT-proBNP favorable response at 4 weeks was associated with lower risk of first heart failure (HF) rehospitalization or cardiovascular death through 26 weeks (hazard ratio: 0.57; 95% confidence interval [CI]: 0.38 to 0.86; p = 0.007). Predictors of a favorable response at 4 weeks were starting dose ≥49/51 mg twice daily, higher baseline NT-proBNP, lower baseline serum creatinine, de novo HF, no atrial fibrillation, angiotensin-converting enzyme inhibitor–naive or angiotensin receptor blocker–naive, and no prior myocardial infarction. Conclusions: In-hospital initiation of sacubitril/valsartan produced rapid reductions in NT-proBNP, statistically significant at discharge. A favorable NT-proBNP response over time was associated with a better prognosis and predicted by higher starting dose and predisposing clinical profile. (Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event [TRANSITION]; NCT02661217)

Published
2020

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