The Experts below are selected from a list of 309 Experts worldwide ranked by ideXlab platform
Shinichi Kitamura - One of the best experts on this subject based on the ideXlab platform.
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Delapril versus manidipine in hypertensive therapy to halt the type-2-diabetes-mellitus-associated nephropathy.
Diabetes research and clinical practice, 2000Co-Authors: Teruo Shiba, Masahiro Inoue, Hisaya Tada, Yoichi Hayashi, Yukichi Okuda, Rie Fujita, Fuminori Makino, Chieko Takahasi, Shigeru Kageyama, Shinichi KitamuraAbstract:Thirty-nine hypertensive patients with type 2 diabetes mellitus were followed under long-term Treatment (Mean, 20.7 months) with manidipine hydrochloride, a Ca antagonist, or delapril hydrochloride, an ACE inhibitor, at nine institutions. Both the Treatments showed similar antihypertensive effects, although slight but significantly larger decreases were observed in systolic and Mean blood pressures at months 12 and 24 in the patients treated with manidipine (P
Teruo Shiba - One of the best experts on this subject based on the ideXlab platform.
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Delapril versus manidipine in hypertensive therapy to halt the type-2-diabetes-mellitus-associated nephropathy.
Diabetes research and clinical practice, 2000Co-Authors: Teruo Shiba, Masahiro Inoue, Hisaya Tada, Yoichi Hayashi, Yukichi Okuda, Rie Fujita, Fuminori Makino, Chieko Takahasi, Shigeru Kageyama, Shinichi KitamuraAbstract:Thirty-nine hypertensive patients with type 2 diabetes mellitus were followed under long-term Treatment (Mean, 20.7 months) with manidipine hydrochloride, a Ca antagonist, or delapril hydrochloride, an ACE inhibitor, at nine institutions. Both the Treatments showed similar antihypertensive effects, although slight but significantly larger decreases were observed in systolic and Mean blood pressures at months 12 and 24 in the patients treated with manidipine (P
Rob Scott - One of the best experts on this subject based on the ideXlab platform.
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effect of evolocumab or ezetimibe added to moderate or high intensity statin therapy on ldl c lowering in patients with hypercholesterolemia the laplace 2 randomized clinical trial
JAMA, 2014Co-Authors: Jennifer G Robinson, Ransi Somaratne, Patric Nelson, Bettina S Nedergaard, Jonathan Fialkow, David Ramstad, Jason C Legg, Joel M Neutel, William J. Rogers, Rob ScottAbstract:Importance In phase 2 studies, evolocumab, a fully human monoclonal antibody to PCSK9, reduced LDL-C levels in patients receiving statin therapy. Objective To evaluate the efficacy and tolerability of evolocumab when used in combination with a moderate- vs high-intensity statin. Design, Setting, and Patients Phase 3, 12-week, randomized, double-blind, placebo- and ezetimibe-controlled study conducted between January and December of 2013 in patients with primary hypercholesterolemia and mixed dyslipidemia at 198 sites in 17 countries. Interventions Patients (n = 2067) were randomized to 1 of 24 Treatment groups in 2 steps. Patients were initially randomized to a daily, moderate-intensity (atorvastatin [10 mg], simvastatin [40 mg], or rosuvastatin [5 mg]) or high-intensity (atorvastatin [80 mg], rosuvastatin [40 mg]) statin. After a 4-week lipid-stabilization period, patients (n = 1899) were randomized to compare evolocumab (140 mg every 2 weeks or 420 mg monthly) with placebo (every 2 weeks or monthly) or ezetimibe (10 mg or placebo daily; atorvastatin patients only) when added to statin therapies. Main Outcomes and Measures Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) level at the Mean of weeks 10 and 12 and at week 12. Results Evolocumab reduced LDL-C levels by 66% (95% CI, 58% to 73%) to 75% (95% CI, 65% to 84%) (every 2 weeks) and by 63% (95% CI, 54% to 71%) to 75% (95% CI, 67% to 83%) (monthly) vs placebo at the Mean of weeks 10 and 12 in the moderate- and high-intensity statin-treated groups; the LDL-C reductions at week 12 were comparable. For moderate-intensity statin groups, evolocumab every 2 weeks reduced LDL-C from a baseline Mean of 115 to 124 mg/dL to an on-Treatment Mean of 39 to 49 mg/dL; monthly evolocumab reduced LDL-C from a baseline Mean of 123 to 126 mg/dL to an on-Treatment Mean of 43 to 48 mg/dL. For high-intensity statin groups, evolocumab every 2 weeks reduced LDL-C from a baseline Mean of 89 to 94 mg/dL to an on-Treatment Mean of 35 to 38 mg/dL; monthly evolocumab reduced LDL-C from a baseline Mean of 89 to 94 mg/dL to an on-Treatment Mean of 33 to 35 mg/dL. Adverse events were reported in 36%, 40%, and 39% of evolocumab-, ezetimibe-, and placebo-treated patients, respectively. The most common adverse events in evolocumab-treated patients were back pain, arthralgia, headache, muscle spasms, and pain in extremity (all Conclusions and Relevance In this 12-week trial conducted among patients with primary hypercholesterolemia and mixed dyslipidemia, evolocumab added to moderate- or high-intensity statin therapy resulted in additional LDL-C lowering. Further studies are needed to evaluate the longer-term clinical outcomes and safety of this approach for LDL-C lowering. Trial Registration clinicaltrials.gov Identifier:NCT01763866
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Effect of evolocumab or ezetimibe added to moderate- or high-intensity statin therapy on LDL-C lowering in patients with hypercholesterolemia: the LAPLACE-2 randomized clinical trial.
Journal of the American Medical Association, 2014Co-Authors: Jennifer G Robinson, Ransi Somaratne, Patric Nelson, Bettina S Nedergaard, Jonathan Fialkow, David Ramstad, Jason C Legg, Joel M Neutel, William J. Rogers, Rob ScottAbstract:In phase 2 studies, evolocumab, a fully human monoclonal antibody to PCSK9, reduced LDL-C levels in patients receiving statin therapy. To evaluate the efficacy and tolerability of evolocumab when used in combination with a moderate- vs high-intensity statin. Phase 3, 12-week, randomized, double-blind, placebo- and ezetimibe-controlled study conducted between January and December of 2013 in patients with primary hypercholesterolemia and mixed dyslipidemia at 198 sites in 17 countries. Patients (n = 2067) were randomized to 1 of 24 Treatment groups in 2 steps. Patients were initially randomized to a daily, moderate-intensity (atorvastatin [10 mg], simvastatin [40 mg], or rosuvastatin [5 mg]) or high-intensity (atorvastatin [80 mg], rosuvastatin [40 mg]) statin. After a 4-week lipid-stabilization period, patients (n = 1899) were randomized to compare evolocumab (140 mg every 2 weeks or 420 mg monthly) with placebo (every 2 weeks or monthly) or ezetimibe (10 mg or placebo daily; atorvastatin patients only) when added to statin therapies. Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) level at the Mean of weeks 10 and 12 and at week 12. Evolocumab reduced LDL-C levels by 66% (95% CI, 58% to 73%) to 75% (95% CI, 65% to 84%) (every 2 weeks) and by 63% (95% CI, 54% to 71%) to 75% (95% CI, 67% to 83%) (monthly) vs placebo at the Mean of weeks 10 and 12 in the moderate- and high-intensity statin-treated groups; the LDL-C reductions at week 12 were comparable. For moderate-intensity statin groups, evolocumab every 2 weeks reduced LDL-C from a baseline Mean of 115 to 124 mg/dL to an on-Treatment Mean of 39 to 49 mg/dL; monthly evolocumab reduced LDL-C from a baseline Mean of 123 to 126 mg/dL to an on-Treatment Mean of 43 to 48 mg/dL. For high-intensity statin groups, evolocumab every 2 weeks reduced LDL-C from a baseline Mean of 89 to 94 mg/dL to an on-Treatment Mean of 35 to 38 mg/dL; monthly evolocumab reduced LDL-C from a baseline Mean of 89 to 94 mg/dL to an on-Treatment Mean of 33 to 35 mg/dL. Adverse events were reported in 36%, 40%, and 39% of evolocumab-, ezetimibe-, and placebo-treated patients, respectively. The most common adverse events in evolocumab-treated patients were back pain, arthralgia, headache, muscle spasms, and pain in extremity (all
Cecilia Stålsby Lundborg - One of the best experts on this subject based on the ideXlab platform.
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Antibiotics in Wastewater of a Rural and an Urban Hospital before and after Wastewater Treatment, and the Relationship with Antibiotic Use-A One Year Study from Vietnam.
International journal of environmental research and public health, 2016Co-Authors: La Thi Quynh Lien, Nguyen Quynh Hoa, Nguyen Thi Kim Chuc, Nguyen Thi Minh Thoa, Ho Dang Phuc, Vishal Diwan, Nguyen Thanh Dat, Ashok J. Tamhankar, Cecilia Stålsby LundborgAbstract:Hospital effluents represent an important source for the release of antibiotics and antibiotic resistant bacteria into the environment. This study aims to determine concentrations of various antibiotics in wastewater before and after wastewater Treatment in a rural hospital (60 km from the center of Hanoi) and in an urban hospital (in the center of Hanoi) in Vietnam, and it aims to explore the relationship between antibiotic concentrations in wastewater before wastewater Treatment and quantities of antibiotics used in the rural hospital, over a period of one year in 2013. Water samples were collected using continuous sampling for 24 h in the last week of every month. The data on quantities of antibiotics delivered to all inpatient wards were collected from the Pharmacy department in the rural hospital. Solid-phase extraction and high performance liquid chromatography-tandem mass spectrometry were used for chemical analysis. Significant concentrations of antibiotics were present in the wastewater both before and after wastewater Treatment of both the rural and the urban hospital. Ciprofloxacin was detected at the highest concentrations in the rural hospital’s wastewater (before Treatment: Mean = 42.8 µg/L; after Treatment: Mean = 21.5 µg/L). Metronidazole was detected at the highest concentrations in the urban hospital’s wastewater (before Treatment: Mean = 36.5 µg/L; after Treatment: Mean = 14.8 µg/L). A significant correlation between antibiotic concentrations in wastewater before Treatment and quantities of antibiotics used in the rural hospital was found for ciprofloxacin (r = 0.78; p = 0.01) and metronidazole (r = 0.99; p < 0.001).
Ekkehard Glimm - One of the best experts on this subject based on the ideXlab platform.
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Conditionally unbiased and near unbiased estimation of the selected Treatment Mean for multistage drop-the-losers trials
Biometrical journal. Biometrische Zeitschrift, 2013Co-Authors: Jack Bowden, Ekkehard GlimmAbstract:The two-stage drop-the-loser design provides a framework for selecting the most promising of K experimental Treatments in stage one, in order to test it against a control in a confirmatory analysis at stage two. The multistage drop-the-losers design is both a natural extension of the original two-stage design, and a special case of the more general framework of Stallard & Friede (2008) (Stat. Med. 27, 6209–6227). It may be a useful strategy if deselecting all but the best performing Treatment after one interim analysis is thought to pose an unacceptable risk of dropping the truly best Treatment. However, estimation has yet to be considered for this design. Building on the work of Cohen & Sackrowitz (1989) (Stat. Prob. Lett. 8, 273–278), we derive unbiased and near-unbiased estimates in the multistage setting. Complications caused by the multistage selection process are shown to hinder a simple identification of the multistage uniform minimum variance conditionally unbiased estimate (UMVCUE); two separate but related estimators are therefore proposed, each containing some of the UMVCUEs theoretical characteristics. For a specific example of a three-stage drop-the-losers trial, we compare their performance against several alternative estimators in terms of bias, Mean squared error, confidence interval width and coverage.
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Empirical Bayes estimation of the selected Treatment Mean for two-stage drop-the-loser trials: a meta-analytic approach
Statistics in medicine, 2013Co-Authors: Jack Bowden, Werner Brannath, Ekkehard GlimmAbstract:Point estimation for the selected Treatment in a two-stage drop-the-loser trial is not straightforward because a substantial bias can be induced in the standard maximum likelihood estimate (MLE) through the first stage selection process. Research has generally focused on alternative estimation strategies that apply a bias correction to the MLE; however, such estimators can have a large Mean squared error. Carreras and Brannath (Stat. Med. 32:1677-90) have recently proposed using a special form of shrinkage estimation in this context. Given certain assumptions, their estimator is shown to dominate the MLE in terms of Mean squared error loss, which provides a very powerful argument for its use in practice. In this paper, we suggest the use of a more general form of shrinkage estimation in drop-the-loser trials that has parallels with model fitting in the area of meta-analysis. Several estimators are identified and are shown to perform favourably to Carreras and Brannath's original estimator and the MLE. However, they necessitate either explicit estimation of an additional parameter measuring the heterogeneity between Treatment effects or a quite unnatural prior distribution for the Treatment effects that can only be specified after the first stage data has been observed. Shrinkage methods are a powerful tool for accurately quantifying Treatment effects in multi-arm clinical trials, and further research is needed to understand how to maximise their utility.
