5 research outputs found
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
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- Boldueva S
- Borghi C
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- Brautigam D
- Brewer H. Bryan
- Brodmann M
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- Bruckert E
- Brunskill J
- Brønnum-Schou J
- Bucci M
- Bugan W
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- Cahill T
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- Colombo H
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- Conde Diego
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- Davalos J
- de Groot M
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- Takahashi N
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- Teklinski A
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- Tong Yc
- Torosyan N
- Toursarkissian N
- Traboulssi M
- Tran D
- Treasure C
- Trenk D
- Troquay R
- Tsujita K
- Tyden P
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- Uchino K
- Ueda O
- Ueng K
- Uhliar R
- Valter I
- van Cleeff M
- van Eck J
- Van Leendert R
- Van-Zyl L
- Vangel S
- Vangerow Burkhard
- Vanwelden J
- Vazquez-Tanus J
- Velimsky T
- Venter T
- Verhave G
- Vinanska D
- Violante Ortiz R
- Visona A
- Vo A
- Vodnansky P
- Vogel C
- vom Dahl J
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- Wali A
- Weerakkody Govinda
- Weinstein D
- Weiss R
- Weisz G
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- Westendorp I
- Whitaker J
- White H
- White L
- Widimsky P
- Wiersma J
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- Wilson S
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- 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 Anacetrapib in Patients with Atherosclerotic Vascular Disease
- Author
- Aaltonen M
- Abdur Rahman M
- Abell T
- Abide W. Jr
- Acheatel R
- Achiri P
- Acon J
- Adams T
- Affinito S
- Agarwal S
- Aggarwal K
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- Ahlström P
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- Airaksinen A
- Ait-sadi R
- Akers J
- Al-jumaily J
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- Alberti A
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- Allen T
- Allworth M
- Almond E
- Aloisi A
- Alternburg C
- Alton M
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- Amundson A
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- Steen D
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- Zhang Ting
- Zhang Wen
- Zhang X
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- Zhao C
- Zhao JIAYI STELLA
- Zhao L
- Zhao P
- Zhao R
- Zhao Y
- Zheng Y
- Zheng Z
- Zhi Y
- Zhong H
- Zhong R
- Zhou C
- Zhou Juan
- Zhou Xingyu
- Zhou Yingyuan
- Zhu Wangqin
- Zhu X
- Zhu Y
- Ziefle S
- Zilz N
- Zineldine A
- Zlatewa R
- Zoghbi J
- Zong C
- Zong D
- Zong X
- Zuchelkowski A
- Zulauf N
- Ågårdh A
- Öner A
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2017
- Field of study
BACKGROUND:
Patients with atherosclerotic vascular disease remain at high risk for cardiovascular events despite effective statin-based treatment of low-density lipoprotein (LDL) cholesterol levels. The inhibition of cholesteryl ester transfer protein (CETP) by anacetrapib reduces LDL cholesterol levels and increases high-density lipoprotein (HDL) cholesterol levels. However, trials of other CETP inhibitors have shown neutral or adverse effects on cardiovascular outcomes.
METHODS:
We conducted a randomized, double-blind, placebo-controlled trial involving 30,449 adults with atherosclerotic vascular disease who were receiving intensive atorvastatin therapy and who had a mean LDL cholesterol level of 61 mg per deciliter (1.58 mmol per liter), a mean non-HDL cholesterol level of 92 mg per deciliter (2.38 mmol per liter), and a mean HDL cholesterol level of 40 mg per deciliter (1.03 mmol per liter). The patients were assigned to receive either 100 mg of anacetrapib once daily (15,225 patients) or matching placebo (15,224 patients). The primary outcome was the first major coronary event, a composite of coronary death, myocardial infarction, or coronary revascularization.
RESULTS:
During the median follow-up period of 4.1 years, the primary outcome occurred in significantly fewer patients in the anacetrapib group than in the placebo group (1640 of 15,225 patients [10.8%] vs. 1803 of 15,224 patients [11.8%]; rate ratio, 0.91; 95% confidence interval, 0.85 to 0.97; P=0.004). The relative difference in risk was similar across multiple prespecified subgroups. At the trial midpoint, the mean level of HDL cholesterol was higher by 43 mg per deciliter (1.12 mmol per liter) in the anacetrapib group than in the placebo group (a relative difference of 104%), and the mean level of non-HDL cholesterol was lower by 17 mg per deciliter (0.44 mmol per liter), a relative difference of -18%. There were no significant between-group differences in the risk of death, cancer, or other serious adverse events.
CONCLUSIONS:
Among patients with atherosclerotic vascular disease who were receiving intensive statin therapy, the use of anacetrapib resulted in a lower incidence of major coronary events than the use of placebo. (Funded by Merck and others; Current Controlled Trials number, ISRCTN48678192 ; ClinicalTrials.gov number, NCT01252953 ; and EudraCT number, 2010-023467-18 .)
Patient-Level Pooled Analysis of Ultrasound Renal Denervation in the Sham-Controlled RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO Trials
- Author
- Abbott JD
- Abetu Y
- Abraham A
- Abraham J
- Adams K
- Adams T
- Agdirlioglu T
- Aggarwal S
- Akinapelli A
- Al-Janabi F
- Albright MJ
- Alhmoudi A
- Allen M
- Alvarez CR
- Anderson R
- Anning C
- Arakelian P
- Aseltine L
- Augustin D
- Awkar A
- Azizi M
- Bae R
- Bagnall A
- Bailly-Sommeville C
- Bajzer C
- Balawon A
- Bangalore S
- Barb I
- Barman NC
- Basile J
- Batres C
- Beauloye C
- Beckett D
- Bent C
- Benzuly K
- Beohar N
- Berge C
- Bernardo N
- Bertolet B
- Bertrand F
- Bhatia K
- Biedermann S
- Biswas S
- Blankestijn P
- Bloch MJ
- Bohm M
- Boros M
- Bottone S
- Bouvier A
- Boyette A
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- Brantley H
- Bridgett V
- Briki R
- Bunte M
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- Buttner M
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- Chandra V
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- Devireddy C
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- Roberson M
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- Roongsritong C
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- Rump LC
- Salazer T
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- Schmid A
- Schmid C
- Schmieder RE
- Scholl T
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- Semenec T
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- Sharif F
- Sharp ASP
- Shin MS
- Shishehbor M
- Sinclair J
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- Sobieszczky P
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- Starkey E
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- Stijleman I
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- Tecklenburg A
- Teklinski A
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- Todoran T
- Topham C
- Touchton A
- Trabitzsch B
- Tran A
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- Trillaud H
- Tulik L
- Tuohy E
- Tutor I
- Uder M
- Ullery S
- van Ramshorst J
- van Zwam WH
- Vefali H
- Veis J
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- von zur Muhlen C
- Voskuil M
- Vranken J
- Wachter A
- Wade T
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- Weil J
- Weinberg M
- Wells B
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- Zagoria R
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- Zidar D
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- Zusman R
- Publication venue
- 'American Medical Association (AMA)'
- Publication date
- 10/05/2023
- Field of study
Ezetimibe added to statin therapy after acute coronary syndromes
- Author
- Aagnes I
- Aambakk MB
- Aase O
- Aaser E
- Abdel-Latief A
- Abell T
- Aboufakher R
- Abramson B
- Abrantes J
- Achilli A
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- Addington J
- Adgey A
- Adjei A
- Agarwal J
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- Agraou B
- Aguirre O
- Ahmed A
- Ahmed O
- Ahsan A
- Airaksinen J
- Airoldi F
- Aji J
- Akkad H
- Akubzanova E
- Al-Ani R
- Al-Jumaily J
- Alameda J
- Albirini A
- Albuquerque A
- Albuquerque D
- Alcasena S
- Alexander J
- Alfonso F
- Ali MI
- Alings MA
- Allall O
- Allen J
- Allen RP
- Allred S
- Almeira AS
- Alonso L
- Alsagheer S
- Alshaher M
- Altschuller A
- Alvarez J
- Alvarez J
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- Anaszewicz M
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- Andersson E
- Andersson G
- Andrade G
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- Andrea B
- Andreou C
- Antonangelo A
- Antorrena I
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- Zuppiroli A
- Zwart PA
- Zweiker R
- Ångman K
- Édes I
- Östberg S
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2015
- Field of study
BACKGROUND: Statin therapy reduces low-density lipoprotein (LDL) cholesterol levels and the risk of cardiovascular events, but whether the addition of ezetimibe, a nonstatin drug that reduces intestinal cholesterol absorption, can reduce the rate of cardiovascular events further is not known. METHODS: We conducted a double-blind, randomized trial involving 18,144 patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days and had LDL cholesterol levels of 50 to 100 mg per deciliter (1.3 to 2.6 mmol per liter) if they were receiving lipid-lowering therapy or 50 to 125 mg per deciliter (1.3 to 3.2 mmol per liter) if they were not receiving lipid-lowering therapy. The combination of simvastatin (40 mg) and ezetimibe (10 mg) (simvastatin-ezetimibe) was compared with simvastatin (40 mg) and placebo (simvastatin monotherapy). The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, unstable angina requiring rehospitalization, coronary revascularization ( 6530 days after randomization), or nonfatal stroke. The median follow-up was 6 years. RESULTS: The median time-weighted average LDL cholesterol level during the study was 53.7 mg per deciliter (1.4 mmol per liter) in the simvastatin-ezetimibe group, as compared with 69.5 mg per deciliter (1.8 mmol per liter) in the simvastatin-monotherapy group (P<0.001). The Kaplan-Meier event rate for the primary end point at 7 years was 32.7% in the simvastatin-ezetimibe group, as compared with 34.7% in the simvastatin-monotherapy group (absolute risk difference, 2.0 percentage points; hazard ratio, 0.936; 95% confidence interval, 0.89 to 0.99; P = 0.016). Rates of pre-specified muscle, gallbladder, and hepatic adverse effects and cancer were similar in the two groups. CONCLUSIONS: When added to statin therapy, ezetimibe resulted in incremental lowering of LDL cholesterol levels and improved cardiovascular outcomes. Moreover, lowering LDL cholesterol to levels below previous targets provided additional benefit
Vorapaxar in the secondary prevention of atherothrombotic events
- Author
- A. Ahsan
- A. Albirini
- A. Altschuller
- A. Antolick
- A. Arthur
- A. Bank
- A. Belemer
- A. Berni
- A. Betriu
- A. Biton
- A. Brady
- A. Brito
- A. Brock
- A. Bura-Riviere
- A. Caceres
- A. Cale
- A. Camp
- A. Campolongo
- A. Carvalho
- A. Centurion
- A. Cerny
- A. Claxton
- A. Cohen
- A. Comerota
- A. Csanyi
- A. Czlonkowska
- A. Da Silva
- A. DaCosta
- A. Dahlmans
- A. Del Rio Ligorit
- A. Desai
- A. Dijkshoorn
- A. Doerr
- A. Domzal-Stryga
- A. Don
- A. Elgasen
- A. Elis
- A. Engstrom
- A. Fallden-Gunnnarsson
- A. Fernandez
- A. Findik
- A. Fiscella
- A. Ford
- A. Frey
- A. Galla
- A. Gallino
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- W. Zwinnen
- W.B. Campbell
- W.D. Doty
- W.G. Carlini
- W.P. Klinke
- W.P. McGuinn
- W.R. Ardito
- W.R. Cashion
- W.W. Wilson
- X. Garcia-Moll
- X. Liu
- Y. Aladro Benito
- Y. Chandrashekhar
- Y. Cottin
- Y. Feldman
- Y. Hirano
- Y. Hiraoka
- Y. Honda
- Y. Lampl
- Y. Manabe
- Y. Niinuma
- Y. Okada
- Y. Oono
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- Z. Gasior
- Z. Kalita
- Z. Klimsa
- Z. Kornacewicz-Jach
- Z. Lorenc
- Z. Mohamed
- Z. Monhart
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2012
- Field of study
Item does not contain fulltextBACKGROUND: Thrombin potently activates platelets through the protease-activated receptor PAR-1. Vorapaxar is a novel antiplatelet agent that selectively inhibits the cellular actions of thrombin through antagonism of PAR-1. METHODS: We randomly assigned 26,449 patients who had a history of myocardial infarction, ischemic stroke, or peripheral arterial disease to receive vorapaxar (2.5 mg daily) or matching placebo and followed them for a median of 30 months. The primary efficacy end point was the composite of death from cardiovascular causes, myocardial infarction, or stroke. After 2 years, the data and safety monitoring board recommended discontinuation of the study treatment in patients with a history of stroke owing to the risk of intracranial hemorrhage. RESULTS: At 3 years, the primary end point had occurred in 1028 patients (9.3%) in the vorapaxar group and in 1176 patients (10.5%) in the placebo group (hazard ratio for the vorapaxar group, 0.87; 95% confidence interval [CI], 0.80 to 0.94; P<0.001). Cardiovascular death, myocardial infarction, stroke, or recurrent ischemia leading to revascularization occurred in 1259 patients (11.2%) in the vorapaxar group and 1417 patients (12.4%) in the placebo group (hazard ratio, 0.88; 95% CI, 0.82 to 0.95; P=0.001). Moderate or severe bleeding occurred in 4.2% of patients who received vorapaxar and 2.5% of those who received placebo (hazard ratio, 1.66; 95% CI, 1.43 to 1.93; P<0.001). There was an increase in the rate of intracranial hemorrhage in the vorapaxar group (1.0%, vs. 0.5% in the placebo group; P<0.001). CONCLUSIONS: Inhibition of PAR-1 with vorapaxar reduced the risk of cardiovascular death or ischemic events in patients with stable atherosclerosis who were receiving standard therapy. However, it increased the risk of moderate or severe bleeding, including intracranial hemorrhage. (Funded by Merck; TRA 2P-TIMI 50 ClinicalTrials.gov number, NCT00526474.)