13 research outputs found
Baseline characteristics of patients in the reduction of events with darbepoetin alfa in heart failure trial (RED-HF)
- Author
- Adams K.
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- Wormer D.
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- Wysokinski A.
- Xu Z.
- Yan B.
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- Zadionchenko V.
- Zamolyi K.
- Zateyshchikov D.
- Zimlichman R.
- Zolty R.
- Publication venue
- 'Oxford University Press (OUP)'
- Publication date
- 01/01/2013
- Field of study
<p>Aims: This report describes the baseline characteristics of patients in the Reduction of Events with Darbepoetin alfa in Heart Failure trial (RED-HF) which is testing the hypothesis that anaemia correction with darbepoetin alfa will reduce the composite endpoint of death from any cause or hospital admission for worsening heart failure, and improve other outcomes.</p>
<p>Methods and results: Key demographic, clinical, and laboratory findings, along with baseline treatment, are reported and compared with those of patients in other recent clinical trials in heart failure. Compared with other recent trials, RED-HF enrolled more elderly [mean age 70 (SD 11.4) years], female (41%), and black (9%) patients. RED-HF patients more often had diabetes (46%) and renal impairment (72% had an estimated glomerular filtration rate <60 mL/min/1.73 m2). Patients in RED-HF had heart failure of longer duration [5.3 (5.4) years], worse NYHA class (35% II, 63% III, and 2% IV), and more signs of congestion. Mean EF was 30% (6.8%). RED-HF patients were well treated at randomization, and pharmacological therapy at baseline was broadly similar to that of other recent trials, taking account of study-specific inclusion/exclusion criteria. Median (interquartile range) haemoglobin at baseline was 112 (106–117) g/L.</p>
<p>Conclusion: The anaemic patients enrolled in RED-HF were older, moderately to markedly symptomatic, and had extensive co-morbidity.</p>
Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease
- Author
- A Abbate
- A Abhyankar
- A Adams
- A Agafina
- A Akyea-Djamson
- A Alan
- A Alfieri
- A Alfrey
- A Alvarisqueta
- A Amos
- A Anadiotis
- A Anneveldt
- A Antolick
- A Arthur
- A Aslam
- Abaci F
- Abdullakutty J
- Abhaichand R
- Abib E Jr
- Aboufakher R
- Abrantes J
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- Abulencia K
- Acampora D
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- Accini Mendoza Jl
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- Acheatel R
- Actis Mv
- Adams M
- Adjic Nc
- Affaki Gs
- Agarwal Dk
- Aggarwal Rk
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- Aguilar M
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- Ahire N
- Ahmad I
- Ahmed Sh
- Ahn Y
- Aish B
- Aiub F
- Aiub J
- Ajax K
- Ajioka M
- Akai Y
- Akatova E
- Akrap B
- Al Joundi T
- Al-Khalili F
- Albisu J
- Alcalde Jm
- Alcide P
- Alfonso T
- Allen J
- Alllison Dc
- Almaliky T
- Amerena J
- Andersen K
- Andor M
- Angelova I
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- Anita S
- Anker Sd
- Antalik L
- Antonicelli R
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- Apostolovic S
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- Zdrenghea D
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- Zhou H
- Zidova M
- Zielinski M
- Zieve F
- Zineldine A.
- Zirlik A
- Zucchetti C
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2017
- Field of study
Background: Experimental and clinical data suggest that reducing inflammation without affecting lipid levels may reduce the risk of cardiovascular disease. Yet, the inflammatory hypothesis of atherothrombosis has remained unproved. Methods: We conducted a randomized, double-blind trial of canakinumab, a therapeutic monoclonal antibody targeting interleukin-1β, involving 10,061 patients with previous myocardial infarction and a high-sensitivity C-reactive protein level of 2 mg or more per liter. The trial compared three doses of canakinumab (50 mg, 150 mg, and 300 mg, administered subcutaneously every 3 months) with placebo. The primary efficacy end point was nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. RESULTS: At 48 months, the median reduction from baseline in the high-sensitivity C-reactive protein level was 26 percentage points greater in the group that received the 50-mg dose of canakinumab, 37 percentage points greater in the 150-mg group, and 41 percentage points greater in the 300-mg group than in the placebo group. Canakinumab did not reduce lipid levels from baseline. At a median follow-up of 3.7 years, the incidence rate for the primary end point was 4.50 events per 100 person-years in the placebo group, 4.11 events per 100 person-years in the 50-mg group, 3.86 events per 100 person-years in the 150-mg group, and 3.90 events per 100 person-years in the 300-mg group. The hazard ratios as compared with placebo were as follows: in the 50-mg group, 0.93 (95% confidence interval [CI], 0.80 to 1.07; P = 0.30); in the 150-mg group, 0.85 (95% CI, 0.74 to 0.98; P = 0.021); and in the 300-mg group, 0.86 (95% CI, 0.75 to 0.99; P = 0.031). The 150-mg dose, but not the other doses, met the prespecified multiplicity-adjusted threshold for statistical significance for the primary end point and the secondary end point that additionally included hospitalization for unstable angina that led to urgent revascularization (hazard ratio vs. placebo, 0.83; 95% CI, 0.73 to 0.95; P = 0.005). Canakinumab was associated with a higher incidence of fatal infection than was placebo. There was no significant difference in all-cause mortality (hazard ratio for all canakinumab doses vs. placebo, 0.94; 95% CI, 0.83 to 1.06; P = 0.31). Conclusions: Antiinflammatory therapy targeting the interleukin-1β innate immunity pathway with canakinumab at a dose of 150 mg every 3 months led to a significantly lower rate of recurrent cardiovascular events than placebo, independent of lipid-level lowering. (Funded by Novartis; CANTOS ClinicalTrials.gov number, NCT01327846.
Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease
- Author
- A Gorog D
- Abadier R
- Acheatel R
- Al-Joundi B
- Albert M
- Albirini A
- Albisu Di Gennaro J
- Alcocer Gamba M
- Alexandersen P
- Alexeeva N
- Almassi H
- Altunkeser B
- Amerena J
- Amin J
- Ando K
- Apostolova E
- Appel Kf
- Appel M
- Ardissino D
- Arif I
- Armstrong P
- Asbill B
- Aslam A
- Aviles R
- Azocar J
- Bacon J
- Baden M
- Bakbak A
- Bakhai A
- Ballantyne C
- Bang L
- Barbarash O
- Barr C
- Barter Philip J.
- Basson M
- Batchelor W
- Beaudry Y
- Benatar J
- Benton R
- Bernhardi D
- Berrouschot J
- Betteridge J
- Bhagwat R
- Bhargava A
- Bhargava R
- Bhatia P
- Binder R
- Bitzur R
- Blain L
- Blombery P
- Boldueva S
- Borghi C
- Bourhaial H
- Brautigam D
- Brewer H. Bryan
- Brodmann M
- Broncel M
- Bronzwaer P
- Brown K
- Bruckert E
- Brunskill J
- Brønnum-Schou J
- Bucci M
- Bugan W
- Butman S
- Caccavo A
- Cahill T
- Canto J
- Carmichael P
- Castano L
- Cecil J
- Chan K
- Chandler G
- Chandrika Parameswaran A
- Chang K
- Chehayeb R
- Chen J
- Cheng S
- Chenier M
- Chiang Ce
- Chizhov P
- Cho B
- Chorin E
- Cinteza M
- Claudio J
- Cohen K
- Cohn J
- Coleman C
- Collis W
- Colombo H
- Colombo T
- Colquhoun D
- Comerota A
- Conde Diego
- Constantinescu M
- Cooke D
- Copaci I
- Coste P
- Cottin Y
- Coulson W
- Crater T
- Cremer P
- Crenshaw B
- Croaning J
- Crowley K
- Dalby Aj
- Davalos J
- de Groot M
- De los Rios Ibarra M
- De Luca G
- De Melker E
- De Wolf L
- Deen C
- Degregorio M
- Dehart D
- Dehning M
- Delforge M
- Dena V
- Desai V
- Desantis J
- Devedzhiev T
- Devlin G
- Di Lorenzo L
- Dietrich D
- Dillon W
- Dimov B
- Dion D
- Donahoe S
- Dorsel T
- Dosh K
- Doshi A
- Downey H
- Drexel H
- Durr S
- Dy J
- Dyczek A
- Dzupina A
- Earl J
- Edwards R
- El-Ahdab F
- Elbaz M
- Eliaschewitz F
- Elliott J
- Ellison W
- Ennis B
- Erkan A
- Erlinge D
- Evans J
- Fabec D
- Fairlamb J
- Fajardo-Campos P
- Faludi P
- Fanghanel G
- Fazekas F
- Felten W
- Fernandez-Ortiz A
- Finnell Jb
- Flores E
- Foucauld J
- Fox Keith A. A.
- Francis A
- Franken M
- French W
- Fuentes Jiménez F
- Fujii K
- Fujimoto K
- Fujinaga H
- Fukunaga M
- Gamez Jm
- Garcia Puig J
- Gaudet D
- Ge J
- Geisler T
- Gelernt M
- Genest J
- Geohas C.
- George W
- Georgeson S
- Gergel V
- Giannitsis E
- Gibson C. Michael
- Gilchrist I
- Gilmore R
- Gimple L
- Glenny J
- Gniot J
- Goldscher D
- Goodman Shaun G.
- Goodwin T
- Gorog D
- Gosse P
- Gottlieb S
- Goudev A
- Graf R
- Granger Christopher
- Gratsiansky N
- Guarnieri T
- Guasparini G
- Gudipati R
- Guerra Lopez A
- Guerra Jl
- Guizar Sanchez C
- Gupta D
- Gurbel P
- Gurevich V
- Haddad T
- Hala T
- Hamer B
- Hammett C
- Hamoud S
- Han S
- Hansen O
- Hanusch U
- Harding S
- Hart H
- Hearne S
- Henry S
- Hermiller J
- Hernandez García Jm
- Herrman Jp
- Herzog W
- Higa N
- Higashikata T
- Hirschl M
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- Horowitz J
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- Hosokawa S
- Hotchkiss D
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- Kadel C
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- Kandath David
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- Karunaratne H
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- Katzan I
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- Kawamitsu K
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- Kaydashev I
- Kazatani Y
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- Kereiakes D
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- Kim D
- Kimura K
- Kirtane A
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- Kosinski E
- Kouz Simon
- Kovalenko V
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- Mason Denise
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- Matei C
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- Maynard K
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- Mays M
- Mcerlean Ellen
- Mcguire Darren K.
- Melucci M
- Menon Venu
- Merkely B
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- Motiejuniene L
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- Muneer B
- Murray A
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- Nadar V
- Nakamura T
- Natour M
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- Nicholls Stephen J.
- Nicolau Jose C.
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- Nortje H
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- Okopien B
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- O’Keefe D
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- Panchal V
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- Pesant Yves
- Peterson S
- Petrochenkova N
- Pintó Sala X
- Piper P
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- Poi K
- Poirier P
- Polasek P
- Pollock S
- Poock J
- Prado A
- Prashad R
- Preston S
- Prodafikas J
- Proietto J
- Pruna C
- Pytlewski G
- Quadrel M
- Quinlan E
- Rader Daniel
- Raev D
- Raikhel M
- Rama P
- Ramlachan P
- Rangé G
- Rao V
- Rasmussen T
- Raugaliene R
- Rees A
- Reichert P
- Ren H
- Renkin J
- Rhee M
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- Rieker W
- Riesmeyer Jeffrey S.
- Rocco M
- Rogers W
- Rohatgi A
- Ronner E
- Rosenthal S
- Rubba P
- Ruotolo Giacomo
- Rynkiewicz A
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- Taguchi S
- Tahirkheli Naeem
- Takahashi N
- Talano J
- Tall Alan R.
- Tanabe J
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- Tardif Jc
- Tashiro H
- Teklinski A
- Tengmark Bo
- Theron H
- Tishler S
- Tong Yc
- Torosyan N
- Toursarkissian N
- Traboulssi M
- Tran D
- Treasure C
- Trenk D
- Troquay R
- Tsujita K
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- Uchino K
- Ueda O
- Ueng K
- Uhliar R
- Valter I
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- Van-Zyl L
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- Vanwelden J
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- Velimsky T
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- Verhave G
- Vinanska D
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- Visona A
- Vo A
- Vodnansky P
- Vogel C
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- Vora N
- Wali A
- Weerakkody Govinda
- Weinstein D
- Weiss R
- Weisz G
- West S
- Westendorp I
- Whitaker J
- White H
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- Widimsky P
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- Wierzbicka K
- Wilson S
- Wittes J
- Wollaert B
- Wolski Kathy
- Wong B
- Xu D
- Yagensky A
- Yamagishi M
- Yasuda S
- Yeo W
- Yeoman G
- Yeung V
- Young C
- Younis L
- Yu C
- Z Jafar M
- Zakhary B
- Zayas-Torres C
- Zebrack J
- Zelman R
- Zhu J
- Ziada K
- Zrazhevsky K
- Zólyomi S
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2017
- Field of study
BACKGROUND:
The cholesteryl ester transfer protein inhibitor evacetrapib substantially raises the high-density lipoprotein (HDL) cholesterol level, reduces the low-density lipoprotein (LDL) cholesterol level, and enhances cellular cholesterol efflux capacity. We sought to determine the effect of evacetrapib on major adverse cardiovascular outcomes in patients with high-risk vascular disease.
METHODS:
In a multicenter, randomized, double-blind, placebo-controlled phase 3 trial, we enrolled 12,092 patients who had at least one of the following conditions: an acute coronary syndrome within the previous 30 to 365 days, cerebrovascular atherosclerotic disease, peripheral vascular arterial disease, or diabetes mellitus with coronary artery disease. Patients were randomly assigned to receive either evacetrapib at a dose of 130 mg or matching placebo, administered daily, in addition to standard medical therapy. The primary efficacy end point was the first occurrence of any component of the composite of death from cardiovascular causes, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina.
RESULTS:
At 3 months, a 31.1% decrease in the mean LDL cholesterol level was observed with evacetrapib versus a 6.0% increase with placebo, and a 133.2% increase in the mean HDL cholesterol level was seen with evacetrapib versus a 1.6% increase with placebo. After 1363 of the planned 1670 primary end-point events had occurred, the data and safety monitoring board recommended that the trial be terminated early because of a lack of efficacy. After a median of 26 months of evacetrapib or placebo, a primary end-point event occurred in 12.9% of the patients in the evacetrapib group and in 12.8% of those in the placebo group (hazard ratio, 1.01; 95% confidence interval, 0.91 to 1.11; P=0.91).
CONCLUSIONS:
Although the cholesteryl ester transfer protein inhibitor evacetrapib had favorable effects on established lipid biomarkers, treatment with evacetrapib did not result in a lower rate of cardiovascular events than placebo among patients with high-risk vascular disease. (Funded by Eli Lilly; ACCELERATE ClinicalTrials.gov number, NCT01687998 .)
Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes.
- Author
- 6hman P
- Abbott L
- Acheatel R
- Adamkova V
- Adawi F
- Adler A
- Aguliera D
- Aizenberg D
- Akerblom A
- Akinboboye O
- Akpunonu B
- Al-Khatib S
- Alcocer Gamba MA
- Alexander K
- Alfonso L
- Almeida CA
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- Ambrish M
- Ambrosio G
- Amerena J
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- Andersone I
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- Angelescu LM
- Angustias Quesada M
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- Appel KF
- Arauz-Pacheco C
- Argoud G
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- Asamoah-Owusu NJ
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- Bartolacci I
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- Yale JF
- Yan BPY
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- Yeung VT
- Yong H
- Yoon KH
- Yuan Z
- Zabuliene L
- Zaharie DG
- Zaharieva S
- Zaidman C
- Zaluska R
- Zannad F
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- Zhou S
- Zilahi Z
- Zimering M
- Zimmerman R
- Zinman B
- Zrahevskiy K
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2017
- Field of study
Abstract
BACKGROUND:
The cardiovascular effects of adding once-weekly treatment with exenatide to usual care in patients with type 2 diabetes are unknown.
METHODS:
We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly. The primary composite outcome was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The coprimary hypotheses were that exenatide, administered once weekly, would be noninferior to placebo with respect to safety and superior to placebo with respect to efficacy.
RESULTS:
In all, 14,752 patients (of whom 10,782 [73.1%] had previous cardiovascular disease) were followed for a median of 3.2 years (interquartile range, 2.2 to 4.4). A primary composite outcome event occurred in 839 of 7356 patients (11.4%; 3.7 events per 100 person-years) in the exenatide group and in 905 of 7396 patients (12.2%; 4.0 events per 100 person-years) in the placebo group (hazard ratio, 0.91; 95% confidence interval [CI], 0.83 to 1.00), with the intention-to-treat analysis indicating that exenatide, administered once weekly, was noninferior to placebo with respect to safety (P<0.001 for noninferiority) but was not superior to placebo with respect to efficacy (P=0.06 for superiority). The rates of death from cardiovascular causes, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, hospitalization for heart failure, and hospitalization for acute coronary syndrome, and the incidence of acute pancreatitis, pancreatic cancer, medullary thyroid carcinoma, and serious adverse events did not differ significantly between the two groups.
CONCLUSIONS:
Among patients with type 2 diabetes with or without previous cardiovascular disease, the incidence of major adverse cardiovascular events did not differ significantly between patients who received exenatide and those who received placebo. (Funded by Amylin Pharmaceuticals; EXSCEL ClinicalTrials.gov number, NCT01144338 .)
Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials
- Author
- Aaronson Keith
- Abadier Rafik
- Abbasi Siddique A.
- Abdullah Shuaib
- Abelson Mark
- Abhayaratna Walter
- Ablasser Klemens
- Aboyans Victor
- Abo‐Auda Wael
- Abuannadi Mohammad
- Adams Kirkwood
- Adams Kirkwood F.
- Adhya Shaumik
- Adler Alexander
- Aggarwala Gaurav
- Agostoni Piergiuseppe
- Ahmad Saad
- Aiub Jorge Roberto
- Al Mohammad Abdallah
- Alharethi Rami
- Alieksieieva Liudmyla
- Almeida Filipa
- Almousalli Omar
- Amano Tetsuya
- Amanullah Aman
- Ambardekar Amrut
- Amerena John
- Anand Inder
- Anderson William
- Ando Kenji
- Andreka Peter
- Antalik Lubomir
- Aradi Daniel
- Araiza Raul Reyes
- Arbolishvili Georgy
- Ariani Mehrdad
- Arias‐Mendoza Alexandra
- Arora Raveen
- Arroyo Julian Alonso Coronel
- Artis Andre
- Asakura Masanori
- Asano Hiroshi
- Ashcom Thomas
- Aslam Shamaila
- Asubiaro Joshua
- Atherton John
- Avaca Horacio Alberto
- Babapulle Mohan
- Bacal Fernando
- Badak Ozer
- Badariene Jolita
- Badat Aysha
- Baker Mathue
- Balsam Pawel
- Banerji Sourin
- Barbarash Olga
- Barbetseas Ioannis
- Barr Craig
- Barros e Silva Pedro Gabriel Melo
- Barua Rajat
- Bauerlein Eugene Joseph
- Baweja Paramdeep
- Bednarkiewicz Zbigniew
- Beelen Driek
- Begg Alistair
- Bekar Lutfu
- Belenkiy Dmitriy
- Belohlavek Jan
- Beltrame John
- Berdague Philippe
- Berglund Stefan
- Berk Martin
- Berkowski Piotr
- Berra Fernando Colombo
- Bertolet Barry
- Besada Diego Alejandro
- Beug Daniel
- Bezzegh Katalin
- Bhagwat Ravi
- Bhargava Rakesh
- Biering‐Sørensen Tor
- Bilato Claudio
- Blicharski Tomasz
- Boccalandro Fernando
- Boehm Michael
- Boehmer John
- Bogaev Roberta
- Bolshakova Olga
- Boman Kurt
- Bonderman Diana
- Bonet Luis Almenar
- Bonfanti Alberto Cadena
- Bordonava Anselmo Paulino
- Bostick Brian
- Boswijk Dirk
- Bourgeois Ronald
- Bourhaial Hakima
- Bouza Manuel
- Braga Joao Carlos
- Brasca Daniela Garcia
- Brinkley Douglas
- Brito Dulce
- Brunetti Natale Daniele
- Bruno Marco Raul Litvak
- Bu Peili
- Burgess Lesley
- Busak Ladislav
- Buynak Robert
- Buysschaert Ian
- Bykov Alexander
- Böhm Michael
- Caccavo Alberto
- Canesin Manoel
- Cardona Jose
- Cardoso Juliano
- Carluccio Erberto
- Carrasco Jose Alfredo Pagola
- Carson Peter
- Castillo Armando Garcia
- Cavallini Claudio
- Cavusoglu Yuksel
- Cech Vladimir
- Celik Ahmet
- Celutkiene Jelena
- Cepelak Michal
- Cerci Rodrigo Julio
- Chandra Lokesh
- Chandrasekaran Badrinathan
- Chang David
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- Cox Jeremy
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- Cruz Kimberly
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- Teerlink John R.
- Terasaki Toshiro
- Terasawa Akihiro
- Tereschenko Sergey
- Timofeev Alexander
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- Tocchetti Carlo Gabriele
- Todorov Georgi
- Tognon Alexandre
- Tomcsanyi Janos
- Tomcsanyi Janos
- Toth Kalman
- Treasure Charles
- Trebacz Jaroslaw
- Trevelyan Jasper
- Triana Miguel Urina
- Trichon Benjamin
- Trochu Jean Noel
- Tsabedze Nqoba
- Tsao Lana
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- Usui Makoto
- Utsu Noriaki
- Vaccari Christopher
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- Van Zyl Louis
- Vandekerckhove Hans
- Vandekerckhove Hans
- Vanhecke Thomas
- Varin Claire
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- Vasilev Ivaylo
- Vasilyeva Larysa
- Vaz Garth
- Vazquez Eduardo Salcido
- Vega Mario
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- Venegas Manuel Eduardo Rodriguez
- Videbaek Lars
- Vidotti Maria Helena
- Vijay Nampalli
- Vilamajo Oscar Alberto Gomez
- Vilchez Francisco Gonzalez
- Villani Giovanni Quinto
- Villoch Mario
- Villota Julio Eduardo Nuñez
- Vinanska Daniela
- Vincenzi Antonella
- Vinereanu Dragos
- Vinereanu Dragos
- Vishnevsky Alexander
- Voevoda Mikhail
- Vogel Daniel
- Voicu Olga‐Cristina
- Volterrani Maurizio
- Voors Adriaan
- Voors Adriaan A.
- Voronkov Leonid
- Vraa Soren
- Wada Atsuyuki
- Wahid Faisal
- Wal Ruud
- Wang Yi
- Wang Zhifang
- Watanabe Naoki
- Wei Yu
- Weir Robin
- Westenfeld Ralf
- Wheeler Matthew
- Whellan David
- Wiggers Henrik
- Wilkett Matt
- Willems Frank
- Williams Celeste
- Wlodarczyk Aleksander
- Wodlin Peter
- Wong Kenneth
- Wozakowska‐Kaplon Beata
- Wu Weiheng
- Yagensky Andriy
- Yamamoto Mitsutaka
- Yan Jing
- Yang Ping
- Yang Xuming
- Yang Zhenyu
- Yeoman Gary
- Yigit Zerrin
- Yilmaz Mehmet B.
- Yoshida Takeshi
- Yoshikawa Masaki
- Yousuf Kabir
- Yuan Zuyi
- Yuge Masaru
- Zabowka Maciej
- Zaca Valerio
- Zaidman Cesar
- Zanetti Fernando Tomas Lanas
- Zannad Faiez
- Zapata Gerardo
- Zdrenghea Dumitru
- Zeman Kamil
- Zeymer Uwe
- Zhang Jinguo
- Zhang Lily
- Zhang Shouyan
- Zhang Xuelian
- Zhang Yuhui
- Zhang Yuqing
- Zheng Yang
- Zheng Zhe
- Zhou Changyong
- Zieroth Shelley
- Zilahi Zsolt
- Zimmet Hendrik
- Zolty Ronald
- Zrazhevskiy Konstantin
- Zwaan Coenraad
- Publication venue
- 'Wiley'
- Publication date
- 01/11/2020
- Field of study
Aims:
The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials.
Methods and Results:
Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure < 100 mmHg (n = 1127), estimated glomerular filtration rate < 30 mL/min/1.73 m2 (n = 528), and treated with sacubitril‐valsartan at baseline (n = 1594).
Conclusions:
GALACTIC‐HF enrolled a well‐treated, high‐risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation
Treatment of Anemia with Darbepoetin Alfa in Systolic Heart Failure
- Author
- Adams K
- Adams K
- Adamson P
- Adler A
- Admon D
- Agarwal D
- Aggarwal A
- Agostoni P
- Aguilar-Romero R
- Akshay S. Desai
- Albanese M
- Albizem M
- Albuquerque D
- Aldo P. Maggioni
- Almeida D
- Altenberger J
- Altschul L
- Altschuller A
- Alunni G
- Amerena J
- Amirani H
- Amuchastegui M
- Anand I
- Anand I
- Andreou C
- Angelo GD
- Anguita M
- Anker SD
- Anker SD
- Ansari M
- Antezana G
- Antonishen M
- Apetrei E
- Apetrei E
- Aroutiounov G
- Ashok J
- Aspe y Rosas J
- Aspe y Rosas J
- Badat A
- Bagdonas A
- Bahl V
- Ballyuzek M
- Banchs H
- Banerjee P
- Banerjee S
- Banish D
- Bank A
- Barbagelata A
- Barkoudah E
- Barnard D
- Barsi B
- Bart B
- Basart D
- Bauer F
- Bayat J
- Bellinger R
- Belziti C
- Benn A
- Benov H
- Berk M
- Berrazueta J
- Berry B
- Berukstis E
- Bethala V
- Bilazarian S
- Bini R
- Bisognano J
- Bleyer F
- Bluguermann J
- Blum M
- Boccanelli A
- Bocchi E
- Boehmer J
- Bolognese L
- Bordignon S
- Bordoloi A
- Bouchard A
- Boyle A
- Bozkurt B
- Bronnum-Schou J
- Brown C
- Bruckner I
- Bruguera i Cortada J
- Bugueno C
- Buijs E
- Burlew B
- Burnham K
- Butler J
- Butler J
- Caccavo M
- Call J
- Camacho A
- Cambier P
- Campana C
- Campbell P
- Cappola T
- Carasca E
- Carbonieri E
- Cardona Munoz E
- Cardona-Muñoz E
- Carlson R
- Carpino C
- Carr-White G
- Carson P
- Cartasegna L
- Castro P
- Castro-Jimenez J
- Celutkiene J
- Chandler B
- Chandra R
- Chandraratna P
- Charlier F
- Chavez-Herrera J
- Checco L
- Cheng S
- Chernick R
- Chockalingam K
- Chompalova B
- Chopda M
- Chopra V
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- Publication venue
- Publication date
- 01/01/2013
- Field of study
<p>BACKGROUND</p><p>Patients with systolic heart failure and anemia have worse symptoms, functional capacity, and outcomes than those without anemia. We evaluated the effects of darbepoetin alfa on clinical outcomes in patients with systolic heart failure and anemia.</p><p>METHODS</p><p>In this randomized, double-blind trial, we assigned 2278 patients with systolic heart failure and mild-to-moderate anemia (hemoglobin level, 9.0 to 12.0 g per deciliter) to receive either darbepoetin alfa (to achieve a hemoglobin target of 13 g per deciliter) or placebo. The primary outcome was a composite of death from any cause or hospitalization for worsening heart failure.</p><p>RESULTS</p><p>The primary outcome occurred in 576 of 1136 patients (50.7%) in the darbepoetin alfa group and 565 of 1142 patients (49.5%) in the placebo group (hazard ratio in the darbepoetin alfa group, 1.01; 95% confidence interval, 0.90 to 1.13; P = 0.87). There was no significant between-group difference in any of the secondary outcomes. The neutral effect of darbepoetin alfa was consistent across all prespecified subgroups. Fatal or nonfatal stroke occurred in 42 patients (3.7%) in the darbepoetin alfa group and 31 patients (2.7%) in the placebo group (P = 0.23). Thromboembolic adverse events were reported in 153 patients (13.5%) in the darbepoetin alfa group and 114 patients (10.0%) in the placebo group (P = 0.01). Cancer-related adverse events were similar in the two study groups.</p><p>CONCLUSIONS</p><p>Treatment with darbepoetin alfa did not improve clinical outcomes in patients with systolic heart failure and mild-to-moderate anemia. Our findings do not support the use of darbepoetin alfa in these patients. (Funded by Amgen; RED-HF ClinicalTrials.gov number, NCT00358215.)</p>
Evolocumab and clinical outcomes in patients with cardiovascular disease
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- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2017
- Field of study
peer reviewedBACKGROUND Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and lowers low-density lipoprotein (LDL) cholesterol levels by approximately 60%. Whether it prevents cardiovascular events is uncertain. METHODS We conducted a randomized, double-blind, placebo-controlled trial involving 27,564 patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg per deciliter (1.8 mmol per liter) or higher who were receiving statin therapy. Patients were randomly assigned to receive evolocumab (either 140 mg every 2 weeks or 420 mg monthly) or matching placebo as subcutaneous injections. The primary efficacy end point was the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary efficacy end point was the composite of cardiovascular death, myocardial infarction, or stroke. The median duration of follow-up was 2.2 years. RESULTS At 48 weeks, the least-squares mean percentage reduction in LDL cholesterol levels with evolocumab, as compared with placebo, was 59%, from a median baseline value of 92 mg per deciliter (2.4 mmol per liter) to 30 mg per deciliter (0.78 mmol per liter) (P<0.001). Relative to placebo, evolocumab treatment significantly reduced the risk of the primary end point (1344 patients [9.8%] vs. 1563 patients [11.3%]; hazard ratio, 0.85; 95% confidence interval [CI], 0.79 to 0.92; P<0.001) and the key secondary end point (816 [5.9%] vs. 1013 [7.4%]; hazard ratio, 0.80; 95% CI, 0.73 to 0.88; P<0.001). The results were consistent across key subgroups, including the subgroup of patients in the lowest quartile for baseline LDL cholesterol levels (median, 74 mg per deciliter [1.9 mmol per liter]). There was no significant difference between the study groups with regard to adverse events (including new-onset diabetes and neurocognitive events), with the exception of injection-site reactions, which were more common with evolocumab (2.1% vs. 1.6%). CONCLUSIONS In our trial, inhibition of PCSK9 with evolocumab on a background of statin therapy lowered LDL cholesterol levels to a median of 30 mg per deciliter (0.78 mmol per liter) and reduced the risk of cardiovascular events. These findings show that patients with atherosclerotic cardiovascular disease benefit from lowering of LDL cholesterol levels below current targets. © 2017 Massachusetts Medical Society
Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients
- Author
- Abbott J. Dawn
- Abdullah S.
- Abib E.
- Ables L. R.
- Abrantes J. A. M.
- Acosta R.
- Adams A.
- Adams F.
- Adroer Martori R.
- Agafina A. S.
- Agaiby J. M.
- Aggarwala G.
- Agraou B.
- AguilarSalinas C. A.
- Ahmad A.
- Ajala B.
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- Akhtar N.
- Akright L.
- Aksentiev S.
- Al-Zoebi A.
- Alappat P.
- Albert M.
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- Altafullah I. M.
- Alvarado O. P.
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- Andersen J. L.
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- Anderson Patricia
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- Zubek V.
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2017
- Field of study
BACKGROUN
Evolocumab and clinical outcomes in patients with cardiovascular disease
- Author
- Abelson M
- Aboufakher R
- Abrahamsen Te
- Accini Mendoza Jl
- Acheatel R
- Ackermann D
- Adamkova V
- Adams M
- Adlam D
- Aggarwal R
- Aggarwal S
- Ahsan A
- Ainsworth P
- Airody Govinda R
- Akai A
- Ako J
- Al-Bahrani A
- Al-Joundi T
- Aldegather J
- Aldrete Velasco Ja
- Alfieri A
- Alt I
- Alzohaili O
- Amerena J
- Amin J
- Amoedo R
- Amuchastegui M
- Anderson T
- Andreka P
- Andreotti F
- Angoulvant D
- Ansell B
- Antalik L
- Antkowiak-Piatyszek K
- Appel K
- Arakawa T
- Arana Londoño C
- Ardissino D
- Ardito Wr
- Arkhipov M
- Arsenescu-Georgescu C
- Asamoah N
- Ascaso Gimilio Jf
- Atar S
- Atassi K
- Athyros V
- Auerbach E
- Awtry E
- Baass A
- Badariene J
- Badat A
- Badila E
- Bae J
- Baigent C
- Bain S
- Baird I
- Baker J
- Balbay Y
- Baldari D
- Ballantyne C
- Bammert A
- Banach M
- Bandh S
- Banerjee S
- Banik M
- Banikova A
- Barbarash O
- Barcinas R
- Barnum O
- Barroso de Souza Wk
- Bart B
- Barton J
- Bata I
- Batalla E
- Bayat J
- Bazzoni Ruiz Ae
- Bednarkiewicz Z
- Beer Hj
- Begg A
- Beltrame J
- Bendermacher P
- Benton R
- Berger C
- Bergeron J
- Bergler-Klein J
- Berglund S
- Berlacher P
- Bernstein M
- Bertolet B
- Bertolim Precoma D
- Bhagwat R
- Bhargava R
- Bhushan R
- Biasucci Lm
- Bilianou H
- Blagden M
- Blaha V
- Blasko P
- Blicharski T
- Blignaut S
- Blokhin A
- Blumberg E
- Bodanese Lc
- Bokern M
- Bolshakova O
- Bonaca Mp
- Bonnet B
- Bosiljanoff P
- Boswijk D
- Botero Lopez R
- Bourhaial H
- Bousboulas S
- Brabec T
- Brezina B
- Bronnum-Schou J
- Brotanek J
- Broughton R
- Brown C
- Brown Wv
- Bubnova M
- Budoff M
- Burgess L
- Burianova H
- Burrough B
- Butler R
- Buysschaert I
- Bystryk L
- Capps N
- Cappuccio F
- Cardona Muñoz Eg
- Carhart R
- Cariou B
- Carr K
- Case C
- Castellanos Bueno R
- Catez E
- Caulfield M
- Cayla G
- Cech V
- Cepelak M
- Ceska R
- Cha J
- Chandra L
- Chapman K
- Charlier F
- Charng Mj
- Charvat J
- Chauhan A
- Cheek Hb
- Chehayeb R
- Chen J
- Chen X
- Chen Y
- Chenu P
- Cheung D
- Cho Y
- Choi D
- Chopra Vk
- Chorin E
- Christensen T
- Christofides E
- Cifkova R
- Civeira Murillo F
- Cizinsky S
- Clardy D
- Claxton E
- Clements B
- Cobos Jl
- Coching Rm
- Coetzer Tf
- Coisne D
- Collins J
- Colombo H
- Coman I
- Conejeros Kindel C
- Connolly D
- Constance C
- Contzen C
- Cordero Fort A
- Cornel Jh
- Coronel Arroyo Ja
- Cosmi F
- Cottin Y
- Cox N
- Crater T
- Crean P
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- Cross D
- Crowley D
- Cruickshank K
- Cuadrado Ja
- Cui H
- Cui Y
- Cummings M
- Cuneo C
- Cunha Borges Jl
- Cure Cure Ca
- Cygler J
- Dabrowska M
- Dabrowski M
- Dahlén G
- Dai H
- Dan Ga
- Danias P
- Darius H
- Dauber I
- Dave K
- Davila W
- Davis Br
- Davis G
- Davis M
- Dawood S
- de Belder M
- De Caterina R
- De Ferrari Gm
- De Jong Dm
- De La Cruz A
- De la Peña Topete Gdj
- De los Rios Ibarra Mo
- De Meulemeester M
- De Nooijer C
- De Raedt H
- de Sa Cunha R
- De Souza J
- Dear H
- Deedwania Pc
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- Delgado E
- Demir M
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- Dronov D
- du Toit M
- Du Y
- Duarte Barbosa Ec
- Dubaniewicz W
- Duchesne L
- Dunaj M
- Dunbar R
- Durlach V
- Dutra O
- Duzenli M
- Dwivedi Sk
- Dyke C
- Dzupina A
- Earl J
- Eaton C
- Ebenbichler C
- Eberli F
- Ebrahim I
- Edes I
- Eglite R
- Egstrup K
- El Shahawy M
- Elam M III
- Elbl L
- Eliaschewitz Fg
- Elisaf M
- Ellery A
- Engel E
- Engelbrecht J
- Ercan E
- Erglis A
- Erickson B
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- Estepar Ra
- Ezhov Mv
- Fagan T
- Fairlie H
- Falck G
- Fan Kyy
- Farhat N
- Farris N
- Farshid A
- Fedele Francesco
- Fernandes Manenti Er
- Fernandez S
- Ferrari E
- Ferreira Rossi Pr
- Ferreira J
- Ferri C
- Ferrieres J
- Fialkow J
- Filipová S
- Finlayson J
- Fiore G
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- Fiserova N
- Fishbein G
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- Focil A
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- Giugliano Robert P.
- Glenny Ja
- Go A
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- Gonzalez Juanatey Jr
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- Gordeev I
- Gorog D
- Gossard D
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- Gotchev D
- Gouni-Berthold I
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- Gruberg L
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- Hsia C
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- Huang C
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- Ibrahim H
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- Zamorano Gomez Jl
- Zarich S
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- Zdrenghea D
- Zechowicz T
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- Zemanek J
- Zeng X
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- Zhao S
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- Zidkova E
- Zieba B
- Ziegler O
- Zilahi Z
- Zrazhevskiy K
- Östergren J
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2017
- Field of study
BACKGROUND Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and lowers low-density lipoprotein (LDL) cholesterol levels by approximately 60%. Whether it prevents cardiovascular events is uncertain. METHODS We conducted a randomized, double-blind, placebo-controlled trial involving 27,564 patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg per deciliter (1.8 mmol per liter) or higher who were receiving statin therapy. Patients were randomly assigned to receive evolocumab (either 140 mg every 2 weeks or 420 mg monthly) or matching placebo as subcutaneous injections. The primary efficacy end point was the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary efficacy end point was the composite of cardiovascular death, myocardial infarction, or stroke. The median duration of follow-up was 2.2 years. RESULTS At 48 weeks, the least-squares mean percentage reduction in LDL cholesterol levels with evolocumab, as compared with placebo, was 59%, from a median baseline value of 92 mg per deciliter (2.4 mmol per liter) to 30 mg per deciliter (0.78 mmol per liter) (P<0.001). Relative to placebo, evolocumab treatment significantly reduced the risk of the primary end point (1344 patients [9.8%] vs. 1563 patients [11.3%]; hazard ratio, 0.85; 95% confidence interval [CI], 0.79 to 0.92; P<0.001) and the key secondary end point (816 [5.9%] vs. 1013 [7.4%]; hazard ratio, 0.80; 95% CI, 0.73 to 0.88; P<0.001). The results were consistent across key subgroups, including the subgroup of patients in the lowest quartile for baseline LDL cholesterol levels (median, 74 mg per deciliter [1.9 mmol per liter]). There was no significant difference between the study groups with regard to adverse events (including new-onset diabetes and neurocognitive events), with the exception of injection-site reactions, which were more common with evolocumab (2.1% vs. 1.6%). CONCLUSIONS In our trial, inhibition of PCSK9 with evolocumab on a background of statin therapy lowered LDL cholesterol levels to a median of 30 mg per deciliter (0.78 mmol per liter) and reduced the risk of cardiovascular events. These findings show that patients with atherosclerotic cardiovascular disease benefit from lowering of LDL cholesterol levels below current targets
Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients
- Author
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- Abib E Jr
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- Urina-Triana Ma
- Uusinarkaus Kt
- Vaca Ce
- Vahed Ya
- Valdez Lopez Hg
- Valtonen M
- Van Alem Ap
- van Beek E
- van Daele Me
- van de Borne P
- van de Wal Rm
- van de Wetering Ml
- van de Wiel A
- van der Meer P
- van der Walt E
- van der Zwaan Ct
- Van Gaal W
- van Hal Jm
- Van het Hof-Wiersma Jj
- van Kempen Ww
- Van Koningsbruggen P
- van Landegem P
- van Leendert Rj
- van Nieuwenhuizen E
- van Rossum P
- van Royen N
- van Zyl Lj
- Vannatta B
- Vanttinen E
- Varleta P
- Vazan A
- Vazquez-Tanus Jb
- Veenendaal A
- Vejar M
- Venereo Jm
- Venter Dj
- Verdeza C
- Vertes A
- Vervoort G
- Verwerft J
- Vesely J
- Vico Ml
- Viergever Ep
- Viklund J
- Vila Belmonte A
- Villaman-Bencosme Y
- Vinanska D
- Vincent J.
- Vincent S
- Vinyoles Bargallo E
- Violante Ortiz R
- Vishlitzky V
- Vishneva E
- Visser Rp
- Visseren F
- Vivekananthan K
- Vizel S
- Vlach Jj
- Vodnansky P
- Voehringer Hf
- Vogel Dr
- Vohnout B
- Vojacek J
- Volkova A
- Voller H
- von Engelhardt Cb
- von Hodenberg Ef
- Vora Kn
- Vora Sk
- Voros P
- Vrablik M.
- Vrkoc J
- Vukotic G
- Wadud K
- Wainstein J
- Wakefield Ph
- Wakeling J
- Walczak M
- Walczewska J
- Walukiewica P
- Wang D
- Wang E
- Wang G
- Wang Y
- Wasserburger B
- Waxler Ar
- Wayne Jd
- Weber D
- Weber K
- Wegner J
- Wei C
- Weigmann I
- Weinstein Dl
- Weiss R
- Welker Ja
- Welty F
- Wenetz Lm
- Wermuth S
- Wesson T
- West Sh
- Westerndorp I
- Wetzel T
- White H.
- Whitlock L
- Whitney Rt
- Wiggers H
- William M
- Williams Dg
- Williams M
- Willis Jg
- Willits Vl
- Winkelmann B
- Witt N
- Wittmann I
- Woehrle J
- Worner Diz F
- Wozniak I
- Wright R. S.
- Wronska D
- Wuerzner G
- Wychota K
- Xu P
- Xue L
- Yakusevich Vv
- Yang P
- Yang X
- Yao Lc
- Yared Z
- Yarows Sa
- Yigit Z
- Yoon J
- Yunis C.
- Zadra R
- Zaidman Cj
- Zamorano Gomez Jl
- Zannad F
- Zarandon Rb
- Zarich Sw
- Zateyshchikov D
- Zavaro Sh
- Zebrack Js
- Zeig S
- Zemek S
- Zemour G
- Zeng X
- Zeno Ml
- Zhang L
- Zhang X
- Zhang Y
- Zhao Y
- Zhou C
- Zhou Y
- Zhu Y
- Zidkova E
- Zieba B
- Zilahi Z
- Zoet-Nugteren Sk
- Zrazhevskiy K
- Zubek V
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2017
- Field of study
Bococizumab is a humanized monoclonal antibody that inhibits proprotein convertase subtilisin- kexin type 9 (PCSK9) and reduces levels of low-density lipoprotein (LDL) cholesterol. We sought to evaluate the efficacy of bococizumab in patients at high cardiovascular risk. METHODS In two parallel, multinational trials with different entry criteria for LDL cholesterol levels, we randomly assigned the 27,438 patients in the combined trials to receive bococizumab (at a dose of 150 mg) subcutaneously every 2 weeks or placebo. The primary end point was nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina requiring urgent revascularization, or cardiovascular death; 93% of the patients were receiving statin therapy at baseline. The trials were stopped early after the sponsor elected to discontinue the development of bococizumab owing in part to the development of high rates of antidrug antibodies, as seen in data from other studies in the program. The median follow-up was 10 months. RESULTS At 14 weeks, patients in the combined trials had a mean change from baseline in LDL cholesterol levels of -56.0% in the bococizumab group and +2.9% in the placebo group, for a between-group difference of -59.0 percentage points (P<0.001) and a median reduction from baseline of 64.2% (P<0.001). In the lower-risk, shorter-duration trial (in which the patients had a baseline LDL cholesterol level of ≥70 mg per deciliter [1.8 mmol per liter] and the median follow-up was 7 months), major cardiovascular events occurred in 173 patients each in the bococizumab group and the placebo group (hazard ratio, 0.99; 95% confidence interval [CI], 0.80 to 1.22; P = 0.94). In the higher-risk, longer-duration trial (in which the patients had a baseline LDL cholesterol level of ≥100 mg per deciliter [2.6 mmol per liter] and the median follow-up was 12 months), major cardiovascular events occurred in 179 and 224 patients, respectively (hazard ratio, 0.79; 95% CI, 0.65 to 0.97; P = 0.02). The hazard ratio for the primary end point in the combined trials was 0.88 (95% CI, 0.76 to 1.02; P = 0.08). Injection-site reactions were more common in the bococizumab group than in the placebo group (10.4% vs. 1.3%, P<0.001). CONCLUSIONS In two randomized trials comparing the PCSK9 inhibitor bococizumab with placebo, bococizumab had no benefit with respect to major adverse cardiovascular events in the trial involving lower-risk patients but did have a significant benefit in the trial involving higher-risk patients