Entity

Time filter

Source Type

Le Touquet – Paris-Plage, France

Le Heuzey J.-Y.,Hopital Europeen Georges Pompidou | De Ferrari G.M.,Fondazione IRCCS Policlinico San Matteo | Radzik D.,Sanofi S.A. | Zhu J.,Sun Yat Sen University | Davy J.-M.,Montpellier University
Journal of Cardiovascular Electrophysiology | Year: 2010

Dronedarone versus Amiodarone in Patients with AF. Introduction: We compared the efficacy and safety of amiodarone and dronedarone in patients with persistent atrial fibrillation (AF). Methods: Five hundred and four amiodarone-naïve patients were randomized to receive dronedarone 400 mg bid (n = 249) or amiodarone 600 mg qd for 28 days then 200 mg qd (n = 255) for at least 6 months. Primary composite endpoint was recurrence of AF (including unsuccessful electrical cardioversion, no spontaneous conversion and no electrical cardioversion) or premature study discontinuation. Main safety endpoint (MSE) was occurrence of thyroid-, hepatic-, pulmonary-, neurologic-, skin-, eye-, or gastrointestinal-specific events, or premature study drug discontinuation following an adverse event. Results: Median treatment duration was 7 months. The primary composite endpoint was 75.1 and 58.8% with dronedarone and amiodarone, respectively, at 12 months (hazard ratio [HR] 1.59; 95% confidence interval [CI] 1.28-1.98; P < 0.0001), mainly driven by AF recurrence with dronedarone compared with amiodarone (63.5 vs 42.0%). AF recurrence after successful cardioversion was 36.5 and 24.3% with dronedarone and amiodarone, respectively. Premature drug discontinuation tended to be less frequent with dronedarone (10.4 vs 13.3%). MSE was 39.3 and 44.5% with dronedarone and amiodarone, respectively, at 12 months (HR = 0.80; 95% CI 0.60-1.07; P = 0.129), and mainly driven by fewer thyroid, neurologic, skin, and ocular events in the dronedarone group. Conclusion: In this short-term study, dronedarone was less effective than amiodarone in decreasing AF recurrence, but had a better safety profile, specifically with regard to thyroid and neurologic events and a lack of interaction with oral anticoagulants. © 2010 Wiley Periodicals, Inc. Source


Chikwe J.,Mount Sinai Medical Center | Filsoufi F.,Mount Sinai Medical Center | Carpentier A.F.,Hopital Europeen Georges Pompidou
Nature Reviews Cardiology | Year: 2010

Choosing the optimal aortic valve prosthesis for middle-aged patients (late 40s to early 60s) with aortic stenosis presents a challenge. The available options all have substantial drawbacks that must be considered in the decision-making process. Current data indicate that there is little or no difference in survival between mechanical and bioprosthetic aortic valve replacement in middle-aged patients at 10-15 years after surgery. Patients who receive a mechanical valve replacement have an annual risk of major hemorrhagic or embolic events of 2-4% per year for life compared with about 1% per year for patients who have a bioprosthetic valve. However, bioprostheses are associated with an increasing risk of structural valve degeneration from 10 years postimplantation, and most patients will require reoperation if they survive much longer than a decade. The mortality risk associated with reoperation is similar to that of primary surgery for most patients, and does not seem to impact on the 15-year survival in this patient group. The Ross procedure, in which the aortic valve is replaced with a pulmonary autograft, can provide improved freedom from morbidity, but operative mortality is probably double that of isolated aortic valve replacement and most patients will require reoperation. Informed patient choice is the most important factor in deciding which valve to use, with biological valves increasingly favored over mechanical valves in middle-aged patients. © 2010 Macmillan Publishers Limited. All rights reserved. Source


Background: Hypertension guidelines recommend the use of 2 agents with synergistic action when >1 agent is needed to achieve blood pressure goals. Newer antihypertensive treatment combinations include fixed-dose combinations of an angiotensin receptor blocker and a calcium channel blocker. Objective: The I-COMBINE study aimed to determine whether the antihypertensive efficacy of the fixed-dose combination irbesartan 150 mg/amlodipine 5 mg (I150/A5) was superior to that of amlodipine 5 mg (A5) monotherapy in lowering home systolic blood pressure (HSBP) after 5 weeks' treatment. Methods: The I-COMBINE study was a 10-week, multicenter, Phase III, prospective, randomized, parallel-group, open-label with blinded-endpoint study. The main inclusion criterion was essential uncontrolled hypertension (SBP ≥145 mm Hg at office, after at least 4 weeks of A5 monotherapy administered once daily). Patients continued to receive A5 for 7 to 10 days and were randomized to either monotherapy with A5 for 5 weeks then amlodipine 10 mg (A10) for the next 5 weeks or to a fixed-dose combination therapy (I150/A5 then I150/A10). Safety profile was assessed by recording adverse events reported by patients or observed by the investigator. Results: Following enrollment, 290 patients were randomized to treatment, and 287 (mean [SD] age, 57.3 [11.2] years; 48% male) were included in the intention-to-treat analysis: 144 patients treated with I150/A5 then I150/A10, and 143 patients treated with A5 then A10. At randomization, mean HSBP was similar in both groups: 148.5 (10.3) mm Hg in the I150/A5 group and 149.2 (9.7) mm Hg in the A5 group. At week 5, the adjusted mean difference in HSBP between groups was -6.2 (1.0) mm Hg (P < 0.001). The proportion of controlled patients (mean home blood pressure <135 and 85 mm Hg) was significantly higher in the I150/A5 group than in the A5 group (P < 0.001). Treatment-emergent adverse events were experienced by 13.8% of I150/A5-treated patients and 11.9% of A5-treated patients during the first 5-week period, and by 15.8% of I150/A10-treated patients and 17.0% of A10-treated patients during the second 5-week period. Two serious adverse events were reported with the fixed-dose combination; both patients recovered. Conclusions: Data from this adult population with essential hypertension suggest greater efficacy with the fixed-dose combination I150/A5 over A5 monotherapy in lowering SBP after 5 weeks. Both treatment regimens were well tolerated throughout the study. ClinicalTrials.gov identifier: NCT00956644. © 2012 Elsevier HS Journals, Inc. Source


Background: Hypertension guidelines recommend the use of 2 agents with synergistic action when >1 agent is needed to achieve blood pressure goals. Newer antihypertensive treatment combinations include fixed-dose combinations of an angiotensin receptor blocker and a calcium channel blocker. Objective: The I-ADD study aimed to demonstrate whether the antihypertensive efficacy of fixed-dose combination irbesartan 300 mg/amlodipine 5 mg (I300/A5) was superior to that of irbesartan (I300) monotherapy in lowering home systolic blood pressure after 10 weeks' treatment. Methods: The I-ADD study was a 10-week, multicenter, Phase III, prospective, randomized, parallel-group, open-label with blinded-end point study. The main inclusion criterion was essential uncontrolled hypertension (systolic blood pressure ≥145 mm Hg at office after at least 4 weeks of irbesartan 150 mg [I150] monotherapy administered once daily). Patients continued to receive I150 for 7 to 10 days and were randomized to either monotherapy with I150 for 5 weeks then I300 for the next 5 weeks, or to a fixed-dose combination therapy (I150/A5, then I300/A5). Safety profile was assessed by recording adverse events reported by patients or observed by the investigator. Results: Following enrollment, 325 patients were randomized to treatment, and 320 (mean [SD] age, 56.7 [11.4] years; 41% male) were included in the intention-to-treat analysis: 155 patients treated with I150/A5 then I300/A5, and 165 patients treated with I150 then I300. At randomization, mean home systolic blood pressure was similar in both groups: 152.7 (11.8) mm Hg in the I150/A5 group and 150.4 (10.1) mm Hg in the I150 group. At week 10, the adjusted mean difference in home systolic blood pressure between groups was -8.8 (1.1) mm Hg (P < 0.001). The percentage of controlled patients (mean home blood pressure <135 and 85 mm Hg) was nearly 2-fold higher in the I300/A5 group versus the I300 group (P < 0.001). Treatment-emergent adverse events were experienced by 10.5% of I300/A5-treated patients and 6.6% of I300-treated patients during the second 5-week period. Three serious adverse events were reported; 2 with monotherapy (1 with I150 and 1 with I300) and 1 with fixed-dose combination I300/A5. All patients affected by serious adverse events made a full recovery. Conclusions: These 10-week data from this patient population suggest a greater antihypertensive efficacy of the fixed-dose combination I300/A5 over I300 alone in lowering systolic blood pressure. Both treatments were well tolerated throughout the study. ClinicalTrials.gov identifier: NCT00957554. © 2012 Elsevier HS Journals, Inc. Source


Housset M.,Hopital Europeen Georges Pompidou
Bulletin du cancer | Year: 2010

Bladder cancer is the second most common urologic tumor after prostate cancer. Radical cystectomy is the standard treatment of localized muscle-invasive tumors. However, urinary diversion (using a conduit or continent diversion) following radical cystectomy can be debilitating. Moreover, delayed metastases appear frequently in spite of radical surgery. So, for selected patients, chemoradiotherapy is a valid therapeutic alternative to cystectomy. Cisplatin or derivatives are administered concurrently to radiation therapy up to 60-65 Gy. Patients undergo control cystoscopy at mid-course in treatment in order to select responders from non responders. This review summarizes the main published series of radiochemotherapy in invasive bladder cancer. Results for local control, survivals, bladder preservation rates and toxicity are presented. Source

Discover hidden collaborations