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Neal S. Kleiman - One of the best experts on this subject based on the ideXlab platform.
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Therapeutic Use of Intravenous Eptifibatide in Patients Undergoing Percutaneous Coronary Intervention
American Journal of Cardiovascular Drugs, 2004Co-Authors: Juan F. Granada, Neal S. KleimanAbstract:Eptifibatide, a molecule isolated from the venom of the southeastern pygmy rattlesnake, selectively inhibits the platelet receptor IIb/IIIa. The safety and clinical efficacy of eptifibatide in patients undergoing percutaneous coronary intervention (PCI) was first evaluated in the Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis (IMPACT) trial. In this study, the primary combined endpoint (composite of death, myocardial infarction [MI] or target vessel revascularization [TVR] at 30 days) occurred in 9.6% of the patients assigned to eptifibatide bolus followed by the 4-hour infusion versus 12.2% in the Placebo Group (p = 0.67). In the IMPACT-II trial, two different eptifibatide dosages were studied in 4011 patients undergoing elective PCI. The primary endpoint (death, MI, TVR or stent placement for threatened vessel closure at 30 days) occurred in 11.6% in the Placebo Group versus 9.1% in the 135/0.5 eptifibatide Group (p = 0.035) and 10% in the 135/0.75 eptifibatide Group (p = 0.18). The Enhanced Suppression of Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial studied a dose of eptifibatide 3- to 4-fold higher than that used in IMPACT II trial in patients undergoing non-emergent coronary artery stenting (two 180 μg/kg bolus doses 10 minutes apart). The 6-month composite endpoint (death, MI, TVR and ‘bailout’ eptifibatide use) occurred in 18.3% of patients in the Placebo Group versus 14.2% in the eptifibatide Group (p = 0.008) and was maintained at 12 months (22.1% in the Placebo Group vs 17.5% in the eptifibatide Group, p = 0.0068). The Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) study in 10 948 patients was designed to study the effect of eptifibatide in the treatment of acute coronary syndromes (ACS) using two different dosages (180 μg/kg bolus followed by an infusion of either 1.3 μg/kg/min or 2 μg/kg/min. The primary endpoint, a composite of death or MI at 30 days, occurred in 15.7% of Placebo-treated patients and 14.2% of eptifibatide-treated patients (p = 0.042). This difference was maintained at 7 days (11.6% in the Placebo Group vs 10.1% in the eptifibatide Group, p = 0.016) and at 30 days (15.7% in the Placebo Group vs 14.2% in the eptifibatide Group). In the eptifibatide studies, the rates of major bleeding were 0.7% (0.5% in the control Group) in ESPRIT and 2.1% (1.3% in the Placebo Group) in PURSUIT. The incidence of intracranial bleeding was 0.2% in ESPRIT (0.1% in the Placebo Group) and 0.7% in PURSUIT (0.8% in the Placebo Group). Significant thrombocytopenia (platelet count
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Therapeutic use of intravenous eptifibatide in patients undergoing percutaneous coronary intervention: acute coronary syndromes and elective stenting.
American journal of cardiovascular drugs : drugs devices and other interventions, 2004Co-Authors: Juan F. Granada, Neal S. KleimanAbstract:Eptifibatide, a molecule isolated from the venom of the southeastern pygmy rattlesnake, selectively inhibits the platelet receptor IIb/IIIa. The safety and clinical efficacy of eptifibatide in patients undergoing percutaneous coronary intervention (PCI) was first evaluated in the Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis (IMPACT) trial. In this study, the primary combined endpoint (composite of death, myocardial infarction [MI] or target vessel revascularization [TVR] at 30 days) occurred in 9.6% of the patients assigned to eptifibatide bolus followed by the 4-hour infusion versus 12.2% in the Placebo Group (p = 0.67). In the IMPACT-II trial, two different eptifibatide dosages were studied in 4011 patients undergoing elective PCI. The primary endpoint (death, MI, TVR or stent placement for threatened vessel closure at 30 days) occurred in 11.6% in the Placebo Group versus 9.1% in the 135/0.5 eptifibatide Group (p = 0.035) and 10% in the 135/0.75 eptifibatide Group (p = 0.18). The Enhanced Suppression of Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial studied a dose of eptifibatide 3- to 4-fold higher than that used in IMPACT II trial in patients undergoing non-emergent coronary artery stenting (two 180 μg/kg bolus doses 10 minutes apart). The 6-month composite endpoint (death, MI, TVR and ‘bailout’ eptifibatide use) occurred in 18.3% of patients in the Placebo Group versus 14.2% in the eptifibatide Group (p = 0.008) and was maintained at 12 months (22.1% in the Placebo Group vs 17.5% in the eptifibatide Group, p = 0.0068). The Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) study in 10 948 patients was designed to study the effect of eptifibatide in the treatment of acute coronary syndromes (ACS) using two different dosages (180 μg/kg bolus followed by an infusion of either 1.3 μg/kg/min or 2 μg/kg/min. The primary endpoint, a composite of death or MI at 30 days, occurred in 15.7% of Placebo-treated patients and 14.2% of eptifibatide-treated patients (p = 0.042). This difference was maintained at 7 days (11.6% in the Placebo Group vs 10.1% in the eptifibatide Group, p = 0.016) and at 30 days (15.7% in the Placebo Group vs 14.2% in the eptifibatide Group). In the eptifibatide studies, the rates of major bleeding were 0.7% (0.5% in the control Group) in ESPRIT and 2.1% (1.3% in the Placebo Group) in PURSUIT. The incidence of intracranial bleeding was 0.2% in ESPRIT (0.1% in the Placebo Group) and 0.7% in PURSUIT (0.8% in the Placebo Group). Significant thrombocytopenia (platelet count
Juan F. Granada - One of the best experts on this subject based on the ideXlab platform.
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Therapeutic Use of Intravenous Eptifibatide in Patients Undergoing Percutaneous Coronary Intervention
American Journal of Cardiovascular Drugs, 2004Co-Authors: Juan F. Granada, Neal S. KleimanAbstract:Eptifibatide, a molecule isolated from the venom of the southeastern pygmy rattlesnake, selectively inhibits the platelet receptor IIb/IIIa. The safety and clinical efficacy of eptifibatide in patients undergoing percutaneous coronary intervention (PCI) was first evaluated in the Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis (IMPACT) trial. In this study, the primary combined endpoint (composite of death, myocardial infarction [MI] or target vessel revascularization [TVR] at 30 days) occurred in 9.6% of the patients assigned to eptifibatide bolus followed by the 4-hour infusion versus 12.2% in the Placebo Group (p = 0.67). In the IMPACT-II trial, two different eptifibatide dosages were studied in 4011 patients undergoing elective PCI. The primary endpoint (death, MI, TVR or stent placement for threatened vessel closure at 30 days) occurred in 11.6% in the Placebo Group versus 9.1% in the 135/0.5 eptifibatide Group (p = 0.035) and 10% in the 135/0.75 eptifibatide Group (p = 0.18). The Enhanced Suppression of Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial studied a dose of eptifibatide 3- to 4-fold higher than that used in IMPACT II trial in patients undergoing non-emergent coronary artery stenting (two 180 μg/kg bolus doses 10 minutes apart). The 6-month composite endpoint (death, MI, TVR and ‘bailout’ eptifibatide use) occurred in 18.3% of patients in the Placebo Group versus 14.2% in the eptifibatide Group (p = 0.008) and was maintained at 12 months (22.1% in the Placebo Group vs 17.5% in the eptifibatide Group, p = 0.0068). The Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) study in 10 948 patients was designed to study the effect of eptifibatide in the treatment of acute coronary syndromes (ACS) using two different dosages (180 μg/kg bolus followed by an infusion of either 1.3 μg/kg/min or 2 μg/kg/min. The primary endpoint, a composite of death or MI at 30 days, occurred in 15.7% of Placebo-treated patients and 14.2% of eptifibatide-treated patients (p = 0.042). This difference was maintained at 7 days (11.6% in the Placebo Group vs 10.1% in the eptifibatide Group, p = 0.016) and at 30 days (15.7% in the Placebo Group vs 14.2% in the eptifibatide Group). In the eptifibatide studies, the rates of major bleeding were 0.7% (0.5% in the control Group) in ESPRIT and 2.1% (1.3% in the Placebo Group) in PURSUIT. The incidence of intracranial bleeding was 0.2% in ESPRIT (0.1% in the Placebo Group) and 0.7% in PURSUIT (0.8% in the Placebo Group). Significant thrombocytopenia (platelet count
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Therapeutic use of intravenous eptifibatide in patients undergoing percutaneous coronary intervention: acute coronary syndromes and elective stenting.
American journal of cardiovascular drugs : drugs devices and other interventions, 2004Co-Authors: Juan F. Granada, Neal S. KleimanAbstract:Eptifibatide, a molecule isolated from the venom of the southeastern pygmy rattlesnake, selectively inhibits the platelet receptor IIb/IIIa. The safety and clinical efficacy of eptifibatide in patients undergoing percutaneous coronary intervention (PCI) was first evaluated in the Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis (IMPACT) trial. In this study, the primary combined endpoint (composite of death, myocardial infarction [MI] or target vessel revascularization [TVR] at 30 days) occurred in 9.6% of the patients assigned to eptifibatide bolus followed by the 4-hour infusion versus 12.2% in the Placebo Group (p = 0.67). In the IMPACT-II trial, two different eptifibatide dosages were studied in 4011 patients undergoing elective PCI. The primary endpoint (death, MI, TVR or stent placement for threatened vessel closure at 30 days) occurred in 11.6% in the Placebo Group versus 9.1% in the 135/0.5 eptifibatide Group (p = 0.035) and 10% in the 135/0.75 eptifibatide Group (p = 0.18). The Enhanced Suppression of Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial studied a dose of eptifibatide 3- to 4-fold higher than that used in IMPACT II trial in patients undergoing non-emergent coronary artery stenting (two 180 μg/kg bolus doses 10 minutes apart). The 6-month composite endpoint (death, MI, TVR and ‘bailout’ eptifibatide use) occurred in 18.3% of patients in the Placebo Group versus 14.2% in the eptifibatide Group (p = 0.008) and was maintained at 12 months (22.1% in the Placebo Group vs 17.5% in the eptifibatide Group, p = 0.0068). The Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) study in 10 948 patients was designed to study the effect of eptifibatide in the treatment of acute coronary syndromes (ACS) using two different dosages (180 μg/kg bolus followed by an infusion of either 1.3 μg/kg/min or 2 μg/kg/min. The primary endpoint, a composite of death or MI at 30 days, occurred in 15.7% of Placebo-treated patients and 14.2% of eptifibatide-treated patients (p = 0.042). This difference was maintained at 7 days (11.6% in the Placebo Group vs 10.1% in the eptifibatide Group, p = 0.016) and at 30 days (15.7% in the Placebo Group vs 14.2% in the eptifibatide Group). In the eptifibatide studies, the rates of major bleeding were 0.7% (0.5% in the control Group) in ESPRIT and 2.1% (1.3% in the Placebo Group) in PURSUIT. The incidence of intracranial bleeding was 0.2% in ESPRIT (0.1% in the Placebo Group) and 0.7% in PURSUIT (0.8% in the Placebo Group). Significant thrombocytopenia (platelet count
Anthony J. Levitt - One of the best experts on this subject based on the ideXlab platform.
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The Absence of a Placebo Group Is a Serious Limitation of the STAR*D Trial/Re: The Absence of a Placebo Group Is a Serious Limitation of the STAR*D Trial
The Canadian Journal of Psychiatry, 2011Co-Authors: Daniel A. Gorman, Elia Abi-jaoude, Mark Sinyor, Ayal Schaffer, Anthony J. LevittAbstract:Dear Editor: Given the complexity of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial, we appreciated Sinyor et al's1 lucid review. The absence of a Placebo Group, however, is a serious limitation of STAR*D that deserved greater emphasis, particularly in light of recent meta-analyses of randomized controlled trials (RCTs) of antidepressants (ADs).2"3 Although we agree that "inclusion of a Placebo arm would have meant a departure from the principle of pragmatism,"1· p IM the existing evidence did not justify such a purely pragmatic trial. Comparing active treatments without a Placebo Group is appropriate when at least one of the treatments has established benefits, but according to the metaanalyses cited, ADs have little or no benefit compared with Placebo for mild to moderate depression. This has particular implications for STAR* D, which included many mildly depressed patients. We recognize that the findings of the meta-analyses are controversial. Even if these studies are set aside, however, it remains that the superiority of ADs over Placebo has not been established in depressed patients who are treated not in standard RCTs but in the real-world settings of STAR*D. The absence of a Placebo Group may improve STAR*D's generalizability to clinical practice, but the considerable cost is that the trial provides little information about the effectiveness of the treatments in this context. Indeed, given the striking result that no differences were found between medications with completely different mechanisms of action, it is likely that nonspecific factors - such as the Placebo effect and the experience of being in treatment - were much more important than the specific treatments themselves. Further, as depression is typically an episodic illness that remits on its own within a year,4 and STAR*D lasted about a year for patients who progressed to the end of the fourth treatment level, it is difficult to interpret the cumulative 67% remission rate in patients who remained in the study. The meaning of this figure becomes even less clear when one considers that many patients dropped out of the study or relapsed during the 12-month naturalistic follow-up. The authors conclude that the results of STAR*D "have shed important light on the effectiveness of current treatment strategies for patients with depression."1· p L54 However, we would argue that because of the absence of a Placebo Group, STAR*D obscures more than it illuminates. In fact, the very decision not to include a Placebo Group implies that the benefits of ADs are better established than current evidence suggests. References 1. Sinyor M, Schaffer A, Levitt A. The Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Trial: a review. Can J Psychiatry. 2010;55:126-135. 2. Kirsch I, Deacon BJ, Huedo-Medina TB, et al. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med. 2008;5:e45. 3. Fournier JC, DeRubeis RJ, Hollon SD, et al. Antidepressant drug effects and depression severity: a patient-level meta-analysis. JAMA. 2010;303:47-53. 4. Posternak MA, Solomon DA, Leon AC, et al. The naturalistic course of unipolar major depression in the absence of somatic therapy. J Nerv Ment Dis. 2006; 1 94:324-329. Daniel A Gorman, MD, FRCPC Elia Abi-Jaoude, MSc, MD, FRCPC Toronto, Ontario Reply Re: The Absence of a Placebo Group Is a Serious Limitation of the STAR*D Trial Dear Editor: We would like to thank Dr Gorman and Dr Abi-Jaoude for their letter. …
Antoni Dávalos - One of the best experts on this subject based on the ideXlab platform.
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Clinical Trials in Acute Stroke: Is it ethical to randomise patients to the Placebo Group?.
Stroke, 2000Co-Authors: Joaquín Serena, Mar Castellanos, Yolanda Silva, Teresa Osuna, Francisco José Álvarez, Antoni DávalosAbstract:P178 The ethics of randomising a patient to the Placebo Group in acute stroke clinical trials has been called into question in one study as these patients may be deprived of routinely applied therapies. No other study has previously analysed this hypothesis. Objective: To compare the prognosis at day 90 of patients included in clinical trials of acute stroke and randomised to the Placebo Group with patients not included in any clinical trial. Material and Methods: 50 patients consecutively included in the Placebo Group (CLASS, ECASS-II, Trafermin, GAIN), and 50 patients not included in any clinical trial randomly selected from those sharing similar characteristics (age, sex, stroke severity and stroke subtype using the TOAST criteria) and hospitalised during the same period. Results: No differences were found in neurological attention delay, Canadian scale at admission, final infarct volume and length of hospital stay. The Placebo Group had a lower proportion of progressing stroke than the control Group (14% vs. 25%). Infectious and cardiovascular complications were more frequent in the Placebo Group (12% vs. 6% and 15% vs. 8%, respectively). However, the Placebo Group displayed a more favourable outcome at day 90 (Figure). Conclusions: Inclusion in a Placebo Group in acute stroke clinical trials results in a significant benefit. This advantage may be explained by a more active intervention over progressing stroke, resulting from a higher rate of detection and control of the related factors.
Eduardo Schor - One of the best experts on this subject based on the ideXlab platform.
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Contraceptive effect of Uncaria tomentosa (cat's claw) in rats with experimental
2011Co-Authors: João Nogueira Neto, Frederico Lucas, Rafael Antonio, Mariana Santana Xavier, Eduardo SchorAbstract:PURPOSE: Evaluate the histological changes in parenchymas epithelial layer of the uterus and ovarian of rats with induced endometriosis, treated with Uncaria tomentosa extract. METHODS: 29 rats with experimental endometriosis, were selected and divided in three Groups: The uncaria Group received 32mg/ml of Uncaria tomentosa extract, 1ml administered daily and the Placebo Group received 1ml of saline 0.9% per day, during for 14 days (both Groups); the leuprolide Group received leuprolide acetate 1mg/kg body weight applied single subcutaneous dose. In the 15 th day of treatment the uterine horn and ovaries were removed for histopathological analysis. RESULTS: The uncaria Group presented nine samples (90%) with immature ovarian follicles, whereas the Placebo Group did not present any case and in the leuprolide Group there were eight rats (88%) with the same change. The Placebo Group showed mature corpus luteum in all animals, occurring less frequent in uncaria (10%) and leuprolide (22%) Groups. The uterine epithelium showed weak proliferative in nine (90%) samples of the uncaria Group, in two (20%) animals in the Placebo Group and seven (77.8%) rats in the leuprolide Group. CONCLUSIONS: The findings suggest that Uncaria tomentosa has contraceptive effect.
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Contraceptive effect of Uncaria tomentosa (cat's claw) in rats with experimental endometriosis
Acta Cirurgica Brasileira, 2011Co-Authors: João Nogueira Neto, Mariana Santana Xavier, Frederico Lucas Lima Paiva Cavalcante, Rafael Antonio Freire Carvalho, Taciana Gabrielle Pinheiro De Moura Rodrigues, Pablo Gustavo Ribeiro Furtado, Eduardo SchorAbstract:PURPOSE: Evaluate the histological changes in parenchyma´s epithelial layer of the uterus and ovarian of rats with induced endometriosis, treated with Uncaria tomentosa extract. METHODS: 29 rats with experimental endometriosis, were selected and divided in three Groups: The uncaria Group received 32mg/ml of Uncaria tomentosa extract, 1ml administered daily and the Placebo Group received 1ml of saline 0.9% per day, during for 14 days (both Groups); the leuprolide Group received leuprolide acetate 1mg/kg body weight applied single subcutaneous dose. In the 15th day of treatment the uterine horn and ovaries were removed for histopathological analysis. RESULTS: The uncaria Group presented nine samples (90%) with immature ovarian follicles, whereas the Placebo Group did not present any case and in the leuprolide Group there were eight rats (88%) with the same change. The Placebo Group showed mature corpus luteum in all animals, occurring less frequent in uncaria (10%) and leuprolide (22%) Groups. The uterine epithelium showed weak proliferative in nine (90%) samples of the uncaria Group, in two (20%) animals in the Placebo Group and seven (77.8%) rats in the leuprolide Group. CONCLUSIONS: The findings suggest that Uncaria tomentosa has contraceptive effect.
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Contraceptive effect of Uncaria tomentosa (cat's claw) in rats with experimental endometriosis.
Acta cirurgica brasileira, 2011Co-Authors: João Nogueira Neto, Mariana Santana Xavier, Frederico Lucas Lima Paiva Cavalcante, Rafael Antonio Freire Carvalho, Pablo Gustavo Ribeiro Furtado, Taciana Gabrielle Pinheiro De Moura Rodrigues, Eduardo SchorAbstract:Evaluate the histological changes in parenchyma's epithelial layer of the uterus and ovarian of rats with induced endometriosis, treated with Uncaria tomentosa extract. 29 rats with experimental endometriosis, were selected and divided in three Groups: The uncaria Group received 32 mg/ml of Uncaria tomentosa extract, 1 ml administered daily and the Placebo Group received 1 ml of saline 0.9% per day, during for 14 days (both Groups); the leuprolide Group received leuprolide acetate 1mg/kg body weight applied single subcutaneous dose. In the 15th day of treatment the uterine horn and ovaries were removed for histopathological analysis. The uncaria Group presented nine samples (90%) with immature ovarian follicles, whereas the Placebo Group did not present any case and in the leuprolide Group there were eight rats (88%) with the same change. The Placebo Group showed mature corpus luteum in all animals, occurring less frequent in uncaria (10%) and leuprolide (22%) Groups. The uterine epithelium showed weak proliferative in nine (90%) samples of the uncaria Group, in two (20%) animals in the Placebo Group and seven (77.8%) rats in the leuprolide Group. The findings suggest that Uncaria tomentosa has contraceptive effect.