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Ami E Iskandrian Timothy M Bateman Luiz Belardinelli Brent Blackburn Manuel D Cerqueira Robert C Hendel Hsiao Lieu John J Mahmarian Ann Olmsted S Richard Underwood Jo?o Vitola Whedy Wang 《Journal of nuclear cardiology》2007,14(5):645-658
BACKGROUND: Earlier phase 1 and 2 studies have shown that regadenoson has desirable features as a stress agent for myocardial perfusion imaging. METHODS AND RESULTS: This multicenter, double-blinded phase 3 trial involved 784 patients at 54 sites. Each patient underwent 2 sets of gated single photon emission computed tomography myocardial perfusion imaging studies: an initial qualifying study with adenosine and a subsequent randomized study with either regadenoson (2/3 of patients) or adenosine. Regadenoson was administered as a rapid bolus (<10 seconds) of 400 mug. The primary endpoint was to demonstrate noninferiority by showing that the difference in the strength of agreement in detecting reversible defects, based on blinded reading, between sequential adenosine-regadenoson images and adenosine-adenosine images, lay above a prespecified noninferiority margin. Other prospectively defined safety and tolerability comparisons and supporting analyses were also performed. The average agreement rate based on the median of 3 independent blinded readers was 0.63 +/- 0.03 for regadenoson-adenosine and 0.64 +/- 0.04 for adenosine-adenosine-a 1% absolute difference with the lower limit of the 95% confidence interval lying above the prespecified noninferiority margin. Side-by-side interpretation of regadenoson and adenosine images provided comparable results for detecting reversible defects. The peak increase in heart rate was greater with regadenoson than adenosine, but the blood pressure nadir was similar. A summed symptom score of flushing, chest pain, and dyspnea was less with regadenoson than adenosine (P = .013). CONCLUSIONS: This phase 3 trial shows that regadenoson provides diagnostic information comparable to a standard adenosine infusion. There were no serious drug-related side effects, and regadenoson was better tolerated than adenosine. 相似文献
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Kaufmann Horacio Vickery Ross Wang Whedy Kanodia Jitendra Shibao Cyndya A. Norcliffe-Kaufmann Lucy Haumann Brett Biaggioni Italo 《Clinical autonomic research》2021,31(6):699-711
Clinical Autonomic Research - In neurogenic orthostatic hypotension, blood pressure falls when upright owing to impaired release of norepinephrine, leading to dizziness. Ampreloxetine, a selective... 相似文献
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Richard Pushkin Steven L. Barriere Whedy Wang G. Ralph Corey Martin E. Stryjewski 《Antimicrobial agents and chemotherapy》2015,59(10):6170-6174
Two phase 3 ATLAS trials demonstrated noninferiority of telavancin compared with vancomycin for complicated skin and skin structure infections. Data from these trials were retrospectively evaluated according to 2013 U.S. Food and Drug Administration (FDA) guidance on acute bacterial skin and skin structure infections. This post hoc analysis included patients with lesion sizes of ≥75 cm2 and excluded patients with ulcers or burns (updated all-treated population; n = 1,127). Updated day 3 (early) clinical response was defined as a ≥20% reduction in lesion size from baseline and no rescue antibiotic. Updated test-of-cure (TOC) clinical response was defined as a ≥90% reduction in lesion size, no increase in lesion size since day 3, and no requirement for additional antibiotics or significant surgical procedures. Day 3 (early) clinical responses were achieved in 62.6% and 61.0% of patients receiving telavancin and vancomycin, respectively (difference, 1.7%, with a 95% confidence interval [CI] of −4.0% to 7.4%). Updated TOC visit cure rates were similar for telavancin (68.0%) and vancomycin (63.3%), with a difference of 4.8% (95% CI, −0.7% to 10.3%). Adopting current FDA guidance, this analysis corroborates previous noninferiority findings of the ATLAS trials of telavancin compared with vancomycin. 相似文献
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Ami E. Iskandrian Timothy M. Bateman Luiz Belardinelli Brent Blackburn Manuel D. Cerqueira Robert C. Hendel Hsiao Lieu John J. Mahmarian Ann Olmsted S. Richard Underwood João Vitola Whedy Wang 《Journal of nuclear cardiology》2007,14(5):645-658
Background Earlier phase 1 and 2 studies have shown that regadenoson has desirable features as a stress agent for myocardial perfusion
imaging.
Methods and Results This multicenter, double-blinded phase 3 trial involved 784 patients at 54 sites. Each patient underwent 2 sets of gated single
photon emission computed tomography myocardial perfusion imaging studies: an initial qualifying study with adenosine and a
subsequent randomized study with either regadenoson (2/3 of patients) or adenosine. Regadenoson was administered as a rapid
bolus (<10 seconds) of 400 μg. The primary endpoint was to demonstrate noninferiority by showing that the difference in the
strength of agreement in detecting reversible defects, based on blinded reading, between sequential adenosine-regadenoson
images and adenosine-adenosine images, lay above a prespecified noninferiority margin. Other prospectively defined safety
and tolerability comparisons and supporting analyses were also performed. The average agreement rate based on the median of
3 independent blinded readers was 0.63±0.03 for regadenoson-adenosine and 0.64±0.04 for adenosine-adenosine—a 1% absolute
difference with the lower limit of the 95% confidence interval lying above the prespecified noninferiority margin. Side-by-side
interpretation of regadenoson and adenosine images provided comparable results for detecting reversible defects. The peak
increase in heart rate was greater with regadenoson than adenosine, but the blood pressure nadir was similar. A summed symptom
score of flushing, chest pain, and dyspnea was less with regadenoson than adenosine (P=.013).
Conclusions This phase 3 trial shows that regadenoson provides diagnostic information comparable to a standard adenosine infusion. There
were no serious drug-related side effects, and regadenoson was better tolerated than adenosine. 相似文献
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Howard J Eisen Jon Kobashigawa Anne Keogh Robert Bourge Dale Renlund Robert Mentzer Edwin Alderman Hannah Valantine Georges Dureau Donna Mancini Richard Mamelok Robert Gordon Whedy Wang Mandeep Mehra Maria Rosa Constanzo Manfred Hummel Jay Johnson 《The Journal of heart and lung transplantation》2005,24(5):517-525
BACKGROUND: This study reports the 36-month results of a randomized, double-blind, active-controlled trial of mycophenolate mofetil (MMF) vs azathioprine (AZA) in heart transplant patients. METHODS: Patients were randomized at the time of transplant to receive MMF (1,500 mg twice a day, N = 327) or AZA (1.5 to 3 mg/kg in 4 daily doses, N = 323) in addition to cyclosporine and corticosteroids; 289 patients in each group received study drug. Data were analyzed in all randomized patients (enrolled) and in patients who received study medications (treated). Clinical and graft assessments continued for 36 months. RESULTS: For the co-primary end-point, 53 of 289 (18.3%) AZA-treated patients either died or received another transplant compared with 34 of 289 (11.8%) MMF-treated patients (p < 0.01). Time to re-transplantation or patient death was significantly shorter for AZA- than MMF-treated patients (p = 0.029). In patients undergoing intravascular ultrasound, the change in mean maximal intimal thickness was less for the MMF group than for the AZA group (0.06 +/- 0.03 mm vs 0.13 +/- 0.03 mm, respectively; p = 0.056). No significant differences between treatments were observed in quantitative coronary angiographic measurements of transplant coronary vasculopathy. Congestive heart failure, atrial arrhythmia and leukopenia were more common in the AZA group, whereas diarrhea, esophagitis, Herpes simplex, Herpes zoster and cytomegalovirus (CMV) tissue invasion were more common in MMF-treated patients. CONCLUSION: MMF reduces mortality and graft loss up to 36 months after transplantation. 相似文献
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Anti-ischemic effects and long-term survival during ranolazine monotherapy in patients with chronic severe angina 总被引:6,自引:0,他引:6
Chaitman BR Skettino SL Parker JO Hanley P Meluzin J Kuch J Pepine CJ Wang W Nelson JJ Hebert DA Wolff AA;MARISA Investigators 《Journal of the American College of Cardiology》2004,43(8):1375-1382
OBJECTIVES: The primary objective of the Monotherapy Assessment of Ranolazine In Stable Angina (MARISA) trial was to determine the dose-response relationship of ranolazine, a potentially new anti-anginal compound, on symptom-limited exercise duration. BACKGROUND: Fatty acids rise precipitously in response to stress, including acute myocardial ischemia. Ranolazine is believed to partially inhibit fatty acid oxidation, shift metabolism toward carbohydrate oxidation, and increase the efficiency of oxygen use. METHODS: Patients (n = 191) with angina-limited exercise discontinued anti-anginal medications and were randomized into a double-blind four-period crossover study of sustained-release ranolazine 500, 1,000, or 1,500 mg, or placebo, each administered twice daily for one week. Exercise testing was performed at the end of each treatment during both trough and peak ranolazine plasma concentrations. RESULTS: Exercise duration at trough increased with ranolazine 500, 1,000, and 1,500 mg twice daily by 94, 103, and 116 s, respectively, all greater (p < 0.005) than the 70-s increase on placebo. Dose-related increases in exercise duration at peak and in times to 1 mm ST-segment depression at trough and peak and to angina at trough and peak were also demonstrated (all p < 0.005). Ranolazine had negligible effects on heart rate and blood pressure. One year survival rate combining data from the MARISA trial and its open-label follow-on study was 96.3 +/- 1.7%. CONCLUSIONS: In chronic angina patients, ranolazine monotherapy was well tolerated and increased exercise performance throughout its dosing interval at all doses studied without clinically meaningful hemodynamic effects. One-year survival was not lower than expected in this high-risk patient population. This metabolic approach to treating myocardial ischemia may offer a new therapeutic option for chronic angina patients. 相似文献
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Chaitman BR Pepine CJ Parker JO Skopal J Chumakova G Kuch J Wang W Skettino SL Wolff AA;Combination Assessment of Ranolazine In Stable Angina 《JAMA》2004,291(3):309-316
Context Many patients with chronic angina experience anginal episodes despite revascularization and antianginal medications. In a previous trial, antianginal monotherapy with ranolazine, a drug believed to partially inhibit fatty acid oxidation, increased treadmill exercise performance; however, its long-term efficacy and safety have not been studied in combination with -blockers or calcium antagonists in a large patient population with severe chronic angina. Objectives To determine whether, at trough levels, ranolazine improves the total exercise time of patients who have symptoms of chronic angina and who experience angina and ischemia at low workloads despite taking standard doses of atenolol, amlodipine, or diltiazem and to determine times to angina onset and to electrocardiographic evidence of myocardial ischemia, effect on angina attacks and nitroglycerin use, and effect on long-term survival in an open-label observational study extension. Design, Setting, and Patients A randomized, 3-group parallel, double-blind, placebo-controlled trial of 823 eligible adults with symptomatic chronic angina who were randomly assigned to receive placebo or 1 of 2 doses of ranolazine. Patients treated at the 118 participating ambulatory outpatient settings in several countries were enrolled in the Combination Assessment of Ranolazine In Stable Angina (CARISA) trial from July 1999 to August 2001 and followed up through October 31, 2002. Intervention Patients received twice-daily placebo or 750 mg or 1000 mg of ranolazine. Treadmill exercise 12 hours (trough) and 4 hours (peak) after dosing was assessed after 2, 6 (trough only), and 12 weeks of treatment. Main Outcome Measures Change in exercise duration, time to onset of angina, time to onset of ischemia, nitroglycerin use, and number of angina attacks. Results Trough exercise duration increased by 115.6 seconds from baseline in both ranolazine groups (pooled) vs 91.7 seconds in the placebo group (P = .01). The times to angina and to electrocardiographic ischemia also increased in the ranolazine groups, at peak more than at trough. The increases did not depend on changes in blood pressure, heart rate, or background antianginal therapy and persisted throughout 12 weeks. Ranolazine reduced angina attacks and nitroglycerin use by about 1 per week vs placebo (P<.02). Survival of 750 patients taking ranolazine during the CARISA trial or its associated long-term open-label study was 98.4% in the first year and 95.9% in the second year. Conclusion Twice-daily doses of ranolazine increased exercise capacity and provided additional antianginal relief to symptomatic patients with severe chronic angina taking standard doses of atenolol, amlodipine, or diltiazem, without evident adverse, long-term survival consequences over 1 to 2 years of therapy. 相似文献
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