PMID- 34783839 OWN - NLM STAT- MEDLINE DCOM- 20211126 LR - 20220517 IS - 1538-3598 (Electronic) IS - 0098-7484 (Print) IS - 0098-7484 (Linking) VI - 326 IP - 19 DP - 2021 Nov 16 TI - Effect of Sacubitril/Valsartan vs Standard Medical Therapies on Plasma NT-proBNP Concentration and Submaximal Exercise Capacity in Patients With Heart Failure and Preserved Ejection Fraction: The PARALLAX Randomized Clinical Trial. PG - 1919-1929 LID - 10.1001/jama.2021.18463 [doi] AB - IMPORTANCE: There is limited evidence on the benefits of sacubitril/valsartan vs broader renin angiotensin system inhibitor background therapy on surrogate outcome markers, 6-minute walk distance, and quality of life in patients with heart failure and mildly reduced or preserved left ventricular ejection fraction (LVEF >40%). OBJECTIVE: To evaluate the effect of sacubitril/valsartan on N-terminal pro-brain natriuretic peptide (NT-proBNP) levels, 6-minute walk distance, and quality of life vs background medication-based individualized comparators in patients with chronic heart failure and LVEF of more than 40%. DESIGN, SETTING, AND PARTICIPANTS: A 24-week, randomized, double-blind, parallel group clinical trial (August 2017-October 2019). Of 4632 patients screened at 396 centers in 32 countries, 2572 patients with heart failure, LVEF of more than 40%, elevated NT-proBNP levels, structural heart disease, and reduced quality of life were enrolled (last follow-up, October 28, 2019). INTERVENTIONS: Patients were randomized 1:1 either to sacubitril/valsartan (n = 1286) or to background medication-based individualized comparator (n = 1286), ie, enalapril, valsartan, or placebo stratified by prior use of a renin angiotensin system inhibitor. MAIN OUTCOMES AND MEASURES: Primary end points were change from baseline in plasma NT-proBNP level at week 12 and in the 6-minute walk distance at week 24. Secondary end points were change from baseline in quality of life measures and New York Heart Association (NYHA) class at 24 weeks. RESULTS: Among 2572 randomized patients (mean age, 72.6 years [SD, 8.5 years]; 1301 women [50.7%]), 2240 (87.1%) completed the trial. At baseline, the median NT-proBNP levels were 786 pg/mL in the sacubitril/valsartan group and 760 pg/mL in the comparator group. After 12 weeks, patients in the sacubitril/valsartan group (adjusted geometric mean ratio to baseline, 0.82 pg/mL) had a significantly greater reduction in NT-proBNP levels than did those in the comparator group (adjusted geometric mean ratio to baseline, 0.98 pg/mL) with an adjusted geometric mean ratio of 0.84 (95% CI, 0.80 to 0.88; P < .001). At week 24, there was no significant between-group difference in median change from baseline in the 6-minute walk distance with an increase of 9.7 m vs 12.2 m (adjusted mean difference, -2.5 m; 95% CI, -8.5 to 3.5; P = .42). There was no significant between-group difference in the mean change in the Kansas City Cardiomyopathy Questionnaire clinical summary score (12.3 vs 11.8; mean difference, 0.52; 95% CI, -0.93 to 1.97) or improvement in NYHA class (23.6% vs 24.0% of patients; adjusted odds ratio, 0.98; 95% CI, 0.81 to 1.18). The most frequent adverse events in the sacubitril/valsartan group vs the comparator group were hypotension (14.1% vs 5.5%), albuminuria (12.3% vs 7.6%), and hyperkalemia (11.6% vs 10.9%). CONCLUSIONS AND RELEVANCE: Among patients with heart failure and left ventricular ejection factor of higher than 40%, sacubitril/valsartan treatment compared with standard renin angiotensin system inhibitor treatment or placebo resulted in a significantly greater decrease in plasma N-terminal pro-brain natriuretic peptide levels at 12 weeks but did not significantly improve 6-minute walk distance at 24 weeks. Further research is warranted to evaluate potential clinical benefits of sacubitril/valsartan in these patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03066804. FAU - Pieske, Burkert AU - Pieske B AD - Department of Internal Medicine and Cardiology, Charite University Medicine, Campus Virchow Klinikum, Berlin, Germany. AD - Department of Internal Medicine and Cardiology, German Heart Center, Berlin, Germany. AD - German Center for Cardiovascular Research (DZHK), Partner Site Berlin, Berlin, Germany. AD - Berlin Institute of Health (BIH), Berlin, Germany. FAU - Wachter, Rolf AU - Wachter R AD - Clinic and Policlinic for Cardiology, University Hospital Leipzig, Clinic for Cardiology and Pneumology, University Medical Center Gottingen, Gottingen, Germany. AD - German Center for Cardiovascular Research (DZHK), partner site Gottingen, Gottingen, Germany. FAU - Shah, Sanjiv J AU - Shah SJ AD - Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois. AD - Bluhm Cardiovascular Institute, Northwestern University Feinberg School of Medicine, Chicago, Illinois. FAU - Baldridge, Abigail AU - Baldridge A AD - Bluhm Cardiovascular Institute, Northwestern University Feinberg School of Medicine, Chicago, Illinois. FAU - Szeczoedy, Peter AU - Szeczoedy P AD - Novartis Pharma AG, Basel, Switzerland. AD - Now with Vifor Pharma Management Ltd, Glattbrugg, Switzerland. FAU - Ibram, Ghionul AU - Ibram G AD - Novartis Pharmaceuticals, East Hanover, New Jersey. FAU - Shi, Victor AU - Shi V AD - Novartis Pharmaceuticals, East Hanover, New Jersey. FAU - Zhao, Ziqiang AU - Zhao Z AD - Novartis Pharma Co Ltd, Shanghai, China. FAU - Cowie, Martin R AU - Cowie MR AD - Royal Brompton Hospital, London, United Kingdom. AD - School of Cardiovascular Medicine & Sciences, Faculty of Life Sciences & Medicine, King's College London, London, United Kingdom. CN - PARALLAX Investigators and Committee members LA - eng SI - ClinicalTrials.gov/NCT03066804 PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - JAMA JT - JAMA JID - 7501160 RN - 0 (Aminobutyrates) RN - 0 (Angiotensin Receptor Antagonists) RN - 0 (Biomarkers) RN - 0 (Biphenyl Compounds) RN - 0 (Drug Combinations) RN - 0 (Peptide Fragments) RN - 0 (pro-brain natriuretic peptide (1-76)) RN - 114471-18-0 (Natriuretic Peptide, Brain) RN - 80M03YXJ7I (Valsartan) RN - WB8FT61183 (sacubitril and valsartan sodium hydrate drug combination) SB - IM CIN - JAMA. 2021 Nov 16;326(19):1913-1915. PMID: 34783856 MH - Aged MH - Aminobutyrates/adverse effects/pharmacology/*therapeutic use MH - Angiotensin Receptor Antagonists/adverse effects/pharmacology/*therapeutic use MH - Biomarkers/blood MH - Biphenyl Compounds/adverse effects/pharmacology/*therapeutic use MH - Double-Blind Method MH - Drug Combinations MH - Exercise Tolerance/*drug effects MH - Female MH - Heart Failure/blood/*drug therapy/physiopathology MH - Humans MH - Male MH - Middle Aged MH - Natriuretic Peptide, Brain/*blood MH - Peptide Fragments/*blood MH - Quality of Life MH - Stroke Volume MH - Valsartan/adverse effects/pharmacology/*therapeutic use MH - Walk Test PMC - PMC8596197 COIS- Conflict of Interest Disclosures: Dr Pieske reported receiving personal fees from Bayer, Bristol Myers Squib, Medscape, MSD, Novartis, and Servier and grants and personal fees from Astra-Zeneca. Dr Wachter reported receiving personal fees from Daiichi Sankyo, Gilead, Novartis, Pfizer, Pharmacosmos, and Servier; grants and personal fees from Boehringer Ingelheim, CVRx, and Medtronic; grants from Bundesministerium fur Bildung und Forschung, the European Union, and Deutsche Forschungsgemeinschaft. Dr Shah reported receiving grants and personal fees from Actelion, AstraZeneca, Novartis, and Pfizer; grants from Corvia; and personal fees from Abbott, Amgen, Aria CV, Axon, Bayer, Boehringer-Ingelheim, Boston Scientific, Bristol Myers Squib, Cardiora, CVRx, Cyclerion, Cytokinetics, Edwards Lifesciences, Eisai, Imara, Ionis, Ironwood, Janssen, Lilly Medical, Merck, MyoKardia, Novo Nordisk, Prothena, Regeneron, Sanofi, Shifamed, Tenax, and United Therapeutics. Drs Szecsody, Shi, and Zhao and Ms Ibram, reported being employees of study sponsor (Novartis). Dr Cowie reported receiving personal fees from AstraZeneca, Bayer, Boehringer Ingelheim, Medtronic, Novartis, Novo Nordisk, Roche, and Servier and grants and personal fees from Abbott and Boston Scientific. No other disclosures were reported. 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Cerezo JG FIR - Encinar, Julio Blazquez IR - Encinar JB FIR - Delgado, Francisco Gomez IR - Delgado FG FIR - Iborra, Pau Llacer IR - Iborra PL FIR - Jurad, Francisco Javier Camacho IR - Jurad FJC FIR - Seller, Julia IR - Seller J FIR - Kiatchoosakun, Songsak IR - Kiatchoosakun S FIR - Chirakarnjanakorn, Srisakul IR - Chirakarnjanakorn S FIR - Sansanayudh, Nakarin IR - Sansanayudh N FIR - Srimahachota, Suphot IR - Srimahachota S FIR - Thongsri, Tomon IR - Thongsri T FIR - Mahavanakul, Weera IR - Mahavanakul W FIR - Sahin, Tayfun IR - Sahin T FIR - Yigit, Zerrin IR - Yigit Z FIR - Melek, Mehmet IR - Melek M FIR - Akin, Mustafa IR - Akin M FIR - Cavusoglu, Yuksel IR - Cavusoglu Y FIR - Koc, Mevlut IR - Koc M FIR - Ozcan, Ismail Turkay IR - Ozcan IT FIR - Turgut, Okan Onur IR - Turgut OO FIR - Yilmaz, Mehmet Birhan IR - Yilmaz MB FIR - Altay, Hakan IR - Altay H FIR - Muderrisoglu, Haldun IR - Muderrisoglu H FIR - Badak, Ozer IR - Badak O FIR - Tekten, Tarkan IR - Tekten T FIR - Oguzhan, Abdurrahman IR - Oguzhan A FIR - Kucuk, Murathan IR - Kucuk M FIR - Mahmood, Shahid IR - Mahmood S FIR - Dewhurst, Matthew J IR - Dewhurst MJ FIR - Asamoah-Owusu, N'Jaimeh IR - Asamoah-Owusu N FIR - Clifford, Piers IR - Clifford P FIR - Takhar, Amrit IR - Takhar A FIR - Hayes, Chris IR - Hayes C FIR - Moriarty, Andrew IR - Moriarty A FIR - Witte, Klaus IR - Witte K FIR - Cooke, Justin IR - Cooke J FIR - Haas, Donald IR - Haas D FIR - Portnay, Edward IR - Portnay E FIR - Feitell, Scott IR - Feitell S FIR - Brown, Christopher S IR - Brown CS FIR - Hattler, Brack IR - Hattler B FIR - Fail, Peter IR - Fail P FIR - Haddad, Tariq IR - Haddad T FIR - Rama, Bhola IR - Rama B FIR - Kapoor, Nikhil IR - Kapoor N FIR - Aslam, Shamaila IR - Aslam S FIR - Peters, Michael IR - Peters M FIR - Sanchez, Eulogio IR - Sanchez E FIR - Vijayasekaran, Sridhar IR - Vijayasekaran S FIR - Lupovitch, Steven D IR - Lupovitch SD FIR - Jonsson, Orvar IR - Jonsson O FIR - Schmalfuss, Carsten IR - Schmalfuss C FIR - Jain, Anuj IR - Jain A FIR - Mentzer, Gina IR - Mentzer G FIR - Lepor, Norman IR - Lepor N FIR - Mignone, John IR - Mignone J FIR - Drummond, Waymon IR - Drummond W FIR - Soverow, Jonathan IR - Soverow J FIR - Gaggin, Hanna IR - Gaggin H FIR - Garver, Robert I IR - Garver RI FIR - Martinez-Castrillon, Melvin IR - Martinez-Castrillon M FIR - Jaffrani, Naseem IR - Jaffrani N FIR - Harris, Barry D IR - Harris BD FIR - Bernstein, Marc IR - Bernstein M FIR - Sizemore, B Clay IR - Sizemore BC FIR - Wells, Terry IR - Wells T FIR - Schwartz, Alan Charles IR - Schwartz AC FIR - Alhaddad, Mohsin IR - Alhaddad M FIR - White, Alexander IR - White A FIR - Dargie, Henry IR - Dargie H FIR - Komajda, Michel IR - Komajda M FIR - Foley, Robert IR - Foley R FIR - Francis, Gary IR - Francis G FIR - Pocock, Stuart IR - Pocock S FIR - Kaplan, Allen P IR - Kaplan AP FIR - Brown, Nancy IR - Brown N FIR - Zuraw, Bruce IR - Zuraw B FIR - Busse, Paula J IR - Busse PJ EDAT- 2021/11/17 06:00 MHDA- 2021/11/27 06:00 PMCR- 2022/05/16 CRDT- 2021/11/16 12:24 PHST- 2021/11/16 12:24 [entrez] PHST- 2021/11/17 06:00 [pubmed] PHST- 2021/11/27 06:00 [medline] PHST- 2022/05/16 00:00 [pmc-release] AID - 2786245 [pii] AID - joi210116 [pii] AID - 10.1001/jama.2021.18463 [doi] PST - ppublish SO - JAMA. 2021 Nov 16;326(19):1919-1929. doi: 10.1001/jama.2021.18463.