7 research outputs found
Effect of alirocumab on mortality after acute coronary syndromes. An analysis of the ODYSSEY OUTCOMES randomized clinical trial
- Author
- Abbas J
- Abbate A
- Abdullakutty J
- Abdullkutty J
- Abhyanakar AD
- Aboyans V
- Abrantes JAM
- Abu-Fadel M
- Acevedo M
- Adamkova V
- Adamo A
- Adhyapak S
- Agarwal H
- Aggarwal R
- Aggarwal RK
- Agnetti V
- Aguirre A
- Ahmed H
- Ahremark U
- Ahuad Guerrero RA
- Aidar Ayoub JC
- Airaksinen JK
- Aitken D
- Akatova E
- Akhter F
- Ako J
- Akright L
- Akyea-Djamson A
- Al Joundi T
- Al-Windy NYY
- Alan D
- Alcocer Gamba MA
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- Alexandru TM
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- Alonso Martin JJ
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- Yao Z
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- Yerra SK
- Yin W-H
- Yong H
- Yoon JH
- Younis L
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- Yusoff K
- Yusoff K
- Zahger D
- Zaidman CJ
- Zainea M
- Zaman A
- Zapata G
- Zdravko B
- Zea Nunez CA
- Zeiher AM
- Zeiher AM
- Zhang R
- Zhang W
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- Zhang Z
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- Zheleznyy V
- Zheng Y
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- Zirlik A
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- Zobouyan I
- Zong W
- Zrazhevsky K
- Zurakowski A
- Zuran I
- Zweiker R
- Publication venue
- 'Ovid Technologies (Wolters Kluwer Health)'
- Publication date
- 04/01/2019
- Field of study
Background: Previous trials of PCSK9 (proprotein convertase subtilisin-kexin type 9) inhibitors demonstrated reductions in major adverse cardiovascular events, but not death. We assessed the effects of alirocumab on death after index acute coronary syndrome. Methods: ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) was a double-blind, randomized comparison of alirocumab or placebo in 18 924 patients who had an ACS 1 to 12 months previously and elevated atherogenic lipoproteins despite intensive statin therapy. Alirocumab dose was blindly titrated to target achieved low-density lipoprotein cholesterol (LDL-C) between 25 and 50 mg/dL. We examined the effects of treatment on all-cause death and its components, cardiovascular and noncardiovascular death, with log-rank testing. Joint semiparametric models tested associations between nonfatal cardiovascular events and cardiovascular or noncardiovascular death. Results: Median follow-up was 2.8 years. Death occurred in 334 (3.5%) and 392 (4.1%) patients, respectively, in the alirocumab and placebo groups (hazard ratio [HR], 0.85; 95% CI, 0.73 to 0.98; P=0.03, nominal P value). This resulted from nonsignificantly fewer cardiovascular (240 [2.5%] vs 271 [2.9%]; HR, 0.88; 95% CI, 0.74 to 1.05; P=0.15) and noncardiovascular (94 [1.0%] vs 121 [1.3%]; HR, 0.77; 95% CI, 0.59 to 1.01; P=0.06) deaths with alirocumab. In a prespecified analysis of 8242 patients eligible for ≥3 years follow-up, alirocumab reduced death (HR, 0.78; 95% CI, 0.65 to 0.94; P=0.01). Patients with nonfatal cardiovascular events were at increased risk for cardiovascular and noncardiovascular deaths (P<0.0001 for the associations). Alirocumab reduced total nonfatal cardiovascular events (P<0.001) and thereby may have attenuated the number of cardiovascular and noncardiovascular deaths. A post hoc analysis found that, compared to patients with lower LDL-C, patients with baseline LDL-C ≥100 mg/dL (2.59 mmol/L) had a greater absolute risk of death and a larger mortality benefit from alirocumab (HR, 0.71; 95% CI, 0.56 to 0.90; Pinteraction=0.007). In the alirocumab group, all-cause death declined wit h achieved LDL-C at 4 months of treatment, to a level of approximately 30 mg/dL (adjusted P=0.017 for linear trend). Conclusions: Alirocumab added to intensive statin therapy has the potential to reduce death after acute coronary syndrome, particularly if treatment is maintained for ≥3 years, if baseline LDL-C is ≥100 mg/dL, or if achieved LDL-C is low. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01663402
Neuromodulation dans le traitement des troubles fonctionnels de la vessie
- Author
- A Abello
- A Apostolidis
- BF Blok
- C Ozkul
- D Liberman
- DL Wenzler
- DS Engeler
- E Finazzi-Agro
- F Cruz
- GS Brindley
- J Bartley
- J Groen
- J Wollner
- J Yamashiro
- JM Guzman-Negron
- JN Panicker
- KD Sievert
- KM Peters
- KM Peters
- M Bywater
- M Tellenbach
- MP Schneider
- MP Schneider
- PM Braun
- R DasGupta
- S Siegel
- SC Knupfer
- SJ Weissbart
- T Gross
- TM Kessler
- TM Kessler
- Publication venue
- 'Springer Science and Business Media LLC'
- Publication date
- Field of study
Is there a role for sacral neuromodulation in patients with neurogenic lower urinary tract dysfunction?
- Author
- Alejandro Aparicio
- Andretta E
- Arlen AM
- Averbeck MA
- Blok B
- Chaabane W
- Chen G
- Chermansky CJ
- De Wachter S
- Drossaerts J
- Elkelini MS
- Engeler DS
- Gajewski JB
- Goldman HB
- Greenberg D.
- Groen LA
- Guzman-Negron JM
- Hu M
- Jorge Moreno-Palacios
- Kessler TM
- Kolek MJ
- Lansen-Koch SM
- Lombardi G
- Lombardi G
- Lombardi G
- Marcio Augusto Averbeck
- Matzel KE
- Minardi D
- Myer ENB
- Nicholson WJ
- Okafor H
- Peters KM
- Peyronnet B
- Powell CR
- Puccini F
- Sharifiaghdas F
- Wexner SD
- Wöllner J
- Publication venue
- 'FapUNIFESP (SciELO)'
- Publication date
- Field of study
What Is New in Neuromodulation?
- Author
- A Quirouet
- A Shafik
- A Venara
- AA van der Wilt
- AK Das
- B Amend
- C Burton
- C Gross
- C Simillis
- Courtenay K. Moore
- D De Ridder
- EA Gormley
- ER Sirls
- F Hameury
- GP Thomas
- HMK van Breda
- I Ramírez-García
- J Booth
- J Brégeon
- J Gilleran
- J Pizarro-Berdichevsky
- J Salatzki
- JB Gajewski
- JC Lloyd
- JD Redshaw
- Jessica J. Rueb
- JM Guzman-Negron
- JPFA Heesakkers
- KM Peters
- KM Peters
- KM Peters
- LL Zimmerman
- LL Zimmerman
- M Hidalgo-Pujol
- M Katz
- MP Schneider
- PM Hanno
- PTJ Janssen
- S Mehmood
- S Musco
- S Siegel
- Samir Derisavifard
- Scott MacDiarmid
- T Vancaillie
- Publication venue
- 'Springer Science and Business Media LLC'
- Publication date
- Field of study
Overactive Bladder in Diabetes Mellitus
- Author
- A Balthazar
- A Davenport
- A Mohee
- Adonis K. Hijaz
- AT Hanna-Mitchell
- B Cetinel
- BM Inouye
- BT Haylen
- C Dumoulin
- C Gratzke
- C-C Wang
- Carol A. C. Coupland
- D Wang
- D Xu
- David D. Sheyn
- DE Irwin
- Deborah J. Lightner
- DH Daniels
- DJ Osborn
- DM Kendig
- E Fırat
- EC Park
- Emily A. Slopnick
- F Daneshgari
- F Daneshgari
- F Daneshgari
- F Daneshgari
- G Gaziev
- G Palleschi
- HFA Moossdorff-Steinhauser
- HH Lai
- I Milsom
- JM Guzman-Negron
- JS Brown
- Kirtishri Mishra
- KM Peters
- KS Coyne
- L Mathieu
- LA Birder
- Laura Bukavina
- NS Klee
- P Ravindra
- PJ Levin
- R Angioli
- R Veeratterapillay
- R-T Liu
- RS Eapen
- S Mustafa
- S Phelan
- S Siegel
- T Davis
- T Szasz
- Vaishnavi Narayanamurthy
- W Abu-Ashour
- W. Stewart
- WC Knowler
- WR Rowley
- Y Cui
- Y-W Yang
- YS Suh
- Publication venue
- 'Springer Science and Business Media LLC'
- Publication date
- Field of study
Risk categorization using New American College of Cardiology/American Heart Association guidelines for cholesterol management and its relation to alirocumab treatment following acute coronary syndromes
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- Zurakowski A
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- Zweiker R
- Publication venue
- 'Ovid Technologies (Wolters Kluwer Health)'
- Publication date
- 01/08/2019
- Field of study
Background: The 2018 US cholesterol management guidelines recommend additional lipid-lowering therapies for secondary prevention in patients with low-density lipoprotein cholesterol ≥70 mg/dL or non−high-density lipoprotein cholesterol ≥100 mg/dL despite maximum tolerated statin therapy. Such patients are considered at very high risk (VHR) based on a history of >1 major atherosclerotic cardiovascular disease (ASCVD) event or a single ASCVD event and multiple high-risk conditions. We investigated the association of US guideline-defined risk categories with the occurrence of ischemic events after acute coronary syndrome and reduction of those events by alirocumab, a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor. Methods: In the ODYSSEY OUTCOMES trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab), patients with recent acute coronary syndrome and residual dyslipidemia despite optimal statin therapy were randomly assigned to alirocumab or placebo. The primary trial outcome (major adverse cardiovascular events, ie, coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or hospitalization for unstable angina) was examined according to American College of Cardiology/American Heart Association risk category. Results: Of 18 924 participants followed for a median of 2.8 years, 11 935 (63.1%) were classified as VHR: 4450 (37.3%) had multiple prior ASCVD events and 7485 (62.7%) had 1 major ASCVD event and multiple high-risk conditions. Major adverse cardiovascular events occurred in 14.4% of placebo-treated patients at VHR versus 5.6% of those not at VHR. In the VHR category, major adverse cardiovascular events occurred in 20.4% with multiple prior ASCVD events versus 10.7% with 1 ASCVD event and multiple high-risk conditions. Alirocumab was associated with consistent relative risk reductions in both risk categories (hazard ratio=0.84 for VHR; hazard ratio=0.86 for not VHR; Pinteraction=0.820) and by stratification within the VHR group (hazard ratio=0.86 for multiple prior ASCVD events; hazard ratio=0.82 for 1 major ASCVD event and multiple high-risk conditions; Pinteraction=0.672). The absolute risk reduction for major adverse cardiovascular events with alirocumab was numerically greater (but not statistically different) in the VHR group versus those not at VHR (2.1% versus 0.8%; Pinteraction=0.095) and among patients at VHR with multiple prior ASCVD events versus a single prior ASCVD event (2.4% versus 1.8%; Pinteraction=0.661). Conclusions: The US guideline criteria identify patients with recent acute coronary syndrome and dyslipidemia who are at VHR for recurrent ischemic events and who may derive a larger absolute benefit from treatment with alirocumab. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01663402
Edoxaban versus warfarin in patients with atrial fibrillation
- Author
- Abdullakutty J
- Abi-Mansour P
- Abril SB
- Accini J
- Accini M
- Acikel M
- Acikel M
- Adachi C
- Adams K
- Adams K
- Adamus J
- Adler J
- Adler P
- Agarwal D
- Aggarwal R
- Aggarwal R
- Agirov M
- Agraou B
- Ahmad A
- Ahmadpour H
- Ahuad Guerrero R
- Ajioka M
- Akhter F
- Akihisa U
- Akilli H
- Al-Maliky T
- Al-Zoebi A
- Albert L. Waldo
- Albisu J
- Albulescu P
- Alexander J
- Alexandrova L
- Alexopoulos D
- Alexopoulos D
- Alhakim M
- Aliyar P
- Allall O
- Allison J
- Allman J
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- Ŝpinar J
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2013
- Field of study
Contains fulltext :
125374.pdf (publisher's version ) (Open Access)BACKGROUND: Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects. The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known. METHODS: We conducted a randomized, double-blind, double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in 21,105 patients with moderate-to-high-risk atrial fibrillation (median follow-up, 2.8 years). The primary efficacy end point was stroke or systemic embolism. Each edoxaban regimen was tested for noninferiority to warfarin during the treatment period. The principal safety end point was major bleeding. RESULTS: The annualized rate of the primary end point during treatment was 1.50% with warfarin (median time in the therapeutic range, 68.4%), as compared with 1.18% with high-dose edoxaban (hazard ratio, 0.79; 97.5% confidence interval [CI], 0.63 to 0.99; P<0.001 for noninferiority) and 1.61% with low-dose edoxaban (hazard ratio, 1.07; 97.5% CI, 0.87 to 1.31; P=0.005 for noninferiority). In the intention-to-treat analysis, there was a trend favoring high-dose edoxaban versus warfarin (hazard ratio, 0.87; 97.5% CI, 0.73 to 1.04; P=0.08) and an unfavorable trend with low-dose edoxaban versus warfarin (hazard ratio, 1.13; 97.5% CI, 0.96 to 1.34; P=0.10). The annualized rate of major bleeding was 3.43% with warfarin versus 2.75% with high-dose edoxaban (hazard ratio, 0.80; 95% CI, 0.71 to 0.91; P<0.001) and 1.61% with low-dose edoxaban (hazard ratio, 0.47; 95% CI, 0.41 to 0.55; P<0.001). The corresponding annualized rates of death from cardiovascular causes were 3.17% versus 2.74% (hazard ratio, 0.86; 95% CI, 0.77 to 0.97; P=0.01), and 2.71% (hazard ratio, 0.85; 95% CI, 0.76 to 0.96; P=0.008), and the corresponding rates of the key secondary end point (a composite of stroke, systemic embolism, or death from cardiovascular causes) were 4.43% versus 3.85% (hazard ratio, 0.87; 95% CI, 0.78 to 0.96; P=0.005), and 4.23% (hazard ratio, 0.95; 95% CI, 0.86 to 1.05; P=0.32). CONCLUSIONS: Both once-daily regimens of edoxaban were noninferior to warfarin with respect to the prevention of stroke or systemic embolism and were associated with significantly lower rates of bleeding and death from cardiovascular causes. (Funded by Daiichi Sankyo Pharma Development; ENGAGE AF-TIMI 48 ClinicalTrials.gov number, NCT00781391.)