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pubmed: 0302-2838
Re: Kari A.O. Tikkinen, Anssi Auvinen. Does the Imprecise Definition of Overactive Bladder Serve Commercial Rather than Patient Interests? Eur Urol. In press. DOI: 10.1016/j.eururo.2011.12.013 The Origin of the Term Overactive Bladder, Industry, and Patient Care.
Abrams P, Wein A Re: Kari A.O. Tikkinen, Anssi Auvinen. Does the Imprecise Definition of Overactive Bladder Serve Commercial Rather than Patient Interests? Eur Urol. In press. DOI: 10.1016/j.eururo.2011.12.013 The Origin of the Term Overactive Bladder, Industry, and Patient Care. Eur Urol. 2012 Jan 24; Authors: Abrams P, Wein A PMID: 22297245 [PubMed - as supplied by publisher]
Efficacy and Safety of Everolimus in Elderly Patients With Metastatic Renal Cell Carcinoma: An Exploratory Analysis of the Outcomes of Elderly Patients in the RECORD-1 Trial.
Porta C, Calvo E, Climent MA, Vaishampayan U, Osanto S, Ravaud A, Bracarda S, Hutson TE, Escudier B, Grünwald V, Kim D, Panneerselvam A, Anak O, Motzer RJ Efficacy and Safety of Everolimus in Elderly Patients With Metastatic Renal Cell Carcinoma: An Exploratory Analysis of the Outcomes of Elderly Patients in the RECORD-1 Trial. Eur Urol. 2012 Jan 5; Authors: Porta C, Calvo E, Climent MA, Vaishampayan U, Osanto S, Ravaud A, Bracarda S, Hutson TE, Escudier B, Grünwald V, Kim D, Panneerselvam A, Anak O, Motzer RJ Abstract BACKGROUND: Elderly patients with metastatic renal cell carcinoma (mRCC) may require special treatment considerations, particularly when comorbidities are present. An understanding of the efficacy and safety of targeted agents in elderly patients with mRCC is essential to provide individualized therapy. OBJECTIVE: To evaluate the efficacy and safety of everolimus in elderly patients (those ≥65 and ≥70 yr of age) enrolled in RECORD-1. DESIGN, SETTING, AND PARTICIPANTS: The multicenter randomized RECORD-1 phase 3 trial (Clinicaltrials.gov identifier, NCT00410124; http://www.clinicaltrials.gov) enrolled patients with mRCC who progressed during or within 6 mo of stopping sunitinib and/or sorafenib treatment (n=416). INTERVENTION: Everolimus 10mg once daily (n=277) or placebo (n=139) plus best supportive care. Treatment was continued until disease progression or unacceptable toxicity. MEASUREMENTS: Median progression-free survival (PFS), median overall survival (OS), and time to deterioration in Karnofsky performance status (TTD-KPS) were assessed using the Kaplan-Meier method; the log-rank test was used to compare treatment arms. Other outcomes evaluated included reduction in tumor burden, overall response rate (ORR), and safety. RESULTS AND LIMITATIONS: In RECORD-1, 36.8% of patients were ≥65 yr and 17.5% were ≥70 yr of age. PFS, OS, TTD-KPS, reduction in tumor burden, and ORR were similar in the elderly and the overall RECORD-1 population. Everolimus was generally well tolerated in elderly patients, and most adverse events were grade 1 or 2 in severity. The toxicity profile of everolimus was generally similar in older patients and the overall population; however, peripheral edema, cough, rash, and diarrhea were reported more frequently in the elderly regardless of treatment. The retrospective nature of the analyses was the major limitation. CONCLUSIONS: Everolimus is effective and tolerable in elderly patients with mRCC. When selecting targeted therapies in these patients, the specific toxicity profile of each agent and any patient comorbidities should be considered. PMID: 22297244 [PubMed - as supplied by publisher]
Monotherapy with Tadalafil or Tamsulosin Similarly Improved Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in an International, Randomised, Parallel, Placebo-Controlled Clinical Trial.
Oelke M, Giuliano F, Mirone V, Xu L, Cox D, Viktrup L Monotherapy with Tadalafil or Tamsulosin Similarly Improved Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in an International, Randomised, Parallel, Placebo-Controlled Clinical Trial. Eur Urol. 2012 Jan 20; Authors: Oelke M, Giuliano F, Mirone V, Xu L, Cox D, Viktrup L Abstract BACKGROUND: Tadalafil improved lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH; LUTS/BPH) in clinical studies but has not been evaluated together with an active control in an international clinical study. OBJECTIVE: Assess tadalafil or tamsulosin versus placebo for LUTS/BPH. DESIGN, SETTING, AND PARTICIPANTS: A randomised, double-blind, international, placebo-controlled, parallel-group study assessed men ≥45 yr of age with LUTS/BPH, International Prostate Symptom Score (IPSS) ≥13, and maximum urinary flow rate (Q(max)) ≥4 to ≤15ml/s. Following screening and washout, if needed, subjects completed a 4-wk placebo run-in before randomisation to placebo (n=172), tadalafil 5mg (n=171), or tamsulosin 0.4mg (n=168) once daily for 12 wk. MEASUREMENTS: Outcomes were assessed using analysis of covariance (ANCOVA) or ranked analysis of variance (ANOVA) (continuous variables) and Cochran-Mantel-Haenszel test or Fisher exact test (categorical variables). RESULTS AND LIMITATIONS: IPSS significantly improved versus placebo through 12 wk with tadalafil (-2.1; p=0.001; primary efficacy outcome) and tamsulosin (-1.5; p=0.023) and as early as 1 wk (tadalafil and tamsulosin both -1.5; p<0.01). BPH Impact Index significantly improved versus placebo at first assessment (week 4) with tadalafil (-0.8; p<0.001) and tamsulosin (-0.9; p<0.001) and through 12 wk (tadalafil -0.8, p=0.003; tamsulosin -0.6, p=0.026). The IPSS Quality-of-Life Index and the Treatment Satisfaction Scale-BPH improved significantly versus placebo with tadalafil (both p<0.05) but not with tamsulosin (both p>0.1). The International Index of Erectile Function-Erectile Function domain improved versus placebo with tadalafil (4.0; p<0.001) but not tamsulosin (-0.4; p=0.699). Q(max) increased significantly versus placebo with both tadalafil (2.4ml/s; p=0.009) and tamsulosin (2.2ml/s; p=0.014). Adverse event profiles were consistent with previous reports. This study was limited in not being powered to directly compare tadalafil versus tamsulosin. CONCLUSIONS: Monotherapy with tadalafil or tamsulosin resulted in significant and numerically similar improvements versus placebo in LUTS/BPH and Q(max). However, only tadalafil improved erectile dysfunction. TRIAL REGISTRATION: Clinicaltrials.gov ID NCT00970632. PMID: 22297243 [PubMed - as supplied by publisher]
Re: postfertilization autophagy of the sperm organelles prevents paternal mitochondrial DNA transmission.
Mayorga-Torres BJ, Cardona-Maya W Re: postfertilization autophagy of the sperm organelles prevents paternal mitochondrial DNA transmission. Eur Urol. 2012 Mar;61(3):625-6 Authors: Mayorga-Torres BJ, Cardona-Maya W PMID: 22289978 [PubMed - in process]
Re: dutasteride improves outcomes of benign prostatic hyperplasia when evaluated for prostate cancer risk reduction: secondary analysis of the reduction by dutasteride of prostate cancer events trial.
Oelke M Re: dutasteride improves outcomes of benign prostatic hyperplasia when evaluated for prostate cancer risk reduction: secondary analysis of the reduction by dutasteride of prostate cancer events trial. Eur Urol. 2012 Mar;61(3):624-5 Authors: Oelke M PMID: 22289977 [PubMed - in process]
Re: a prospective, randomized pilot study evaluating the effects of metformin and lifestyle intervention on patients with prostate cancer receiving androgen deprivation therapy.
Moyad MA Re: a prospective, randomized pilot study evaluating the effects of metformin and lifestyle intervention on patients with prostate cancer receiving androgen deprivation therapy. Eur Urol. 2012 Mar;61(3):623-4 Authors: Moyad MA PMID: 22289976 [PubMed - in process]
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Re: Kari A.O. Tikkinen, Anssi Auvinen. Does the Imprecise Definition of Overactive Bladder Serve Commercial Rather than Patient Interests? Eur Urol. In press. DOI: 10.1016/j.eururo.2011.12.013 The Origin of the Term Overactive Bladder, Industry, and Patient Care.
Abrams P, Wein A Re: Kari A.O. Tikkinen, Anssi Auvinen. Does the Imprecise Definition of Overactive Bladder Serve Commercial Rather than Patient Interests? Eur Urol. In press. DOI: 10.1016/j.eururo.2011.12.013 The Origin of the Term Overactive Bladder, Industry, and Patient Care. Eur Urol. 2012 Jan 24; Authors: Abrams P, Wein A PMID: 22297245 [PubMed - as supplied by publisher]
Efficacy and Safety of Everolimus in Elderly Patients With Metastatic Renal Cell Carcinoma: An Exploratory Analysis of the Outcomes of Elderly Patients in the RECORD-1 Trial.
Porta C, Calvo E, Climent MA, Vaishampayan U, Osanto S, Ravaud A, Bracarda S, Hutson TE, Escudier B, Grünwald V, Kim D, Panneerselvam A, Anak O, Motzer RJ Efficacy and Safety of Everolimus in Elderly Patients With Metastatic Renal Cell Carcinoma: An Exploratory Analysis of the Outcomes of Elderly Patients in the RECORD-1 Trial. Eur Urol. 2012 Jan 5; Authors: Porta C, Calvo E, Climent MA, Vaishampayan U, Osanto S, Ravaud A, Bracarda S, Hutson TE, Escudier B, Grünwald V, Kim D, Panneerselvam A, Anak O, Motzer RJ Abstract BACKGROUND: Elderly patients with metastatic renal cell carcinoma (mRCC) may require special treatment considerations, particularly when comorbidities are present. An understanding of the efficacy and safety of targeted agents in elderly patients with mRCC is essential to provide individualized therapy. OBJECTIVE: To evaluate the efficacy and safety of everolimus in elderly patients (those ≥65 and ≥70 yr of age) enrolled in RECORD-1. DESIGN, SETTING, AND PARTICIPANTS: The multicenter randomized RECORD-1 phase 3 trial (Clinicaltrials.gov identifier, NCT00410124; http://www.clinicaltrials.gov) enrolled patients with mRCC who progressed during or within 6 mo of stopping sunitinib and/or sorafenib treatment (n=416). INTERVENTION: Everolimus 10mg once daily (n=277) or placebo (n=139) plus best supportive care. Treatment was continued until disease progression or unacceptable toxicity. MEASUREMENTS: Median progression-free survival (PFS), median overall survival (OS), and time to deterioration in Karnofsky performance status (TTD-KPS) were assessed using the Kaplan-Meier method; the log-rank test was used to compare treatment arms. Other outcomes evaluated included reduction in tumor burden, overall response rate (ORR), and safety. RESULTS AND LIMITATIONS: In RECORD-1, 36.8% of patients were ≥65 yr and 17.5% were ≥70 yr of age. PFS, OS, TTD-KPS, reduction in tumor burden, and ORR were similar in the elderly and the overall RECORD-1 population. Everolimus was generally well tolerated in elderly patients, and most adverse events were grade 1 or 2 in severity. The toxicity profile of everolimus was generally similar in older patients and the overall population; however, peripheral edema, cough, rash, and diarrhea were reported more frequently in the elderly regardless of treatment. The retrospective nature of the analyses was the major limitation. CONCLUSIONS: Everolimus is effective and tolerable in elderly patients with mRCC. When selecting targeted therapies in these patients, the specific toxicity profile of each agent and any patient comorbidities should be considered. PMID: 22297244 [PubMed - as supplied by publisher]
Monotherapy with Tadalafil or Tamsulosin Similarly Improved Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in an International, Randomised, Parallel, Placebo-Controlled Clinical Trial.
Oelke M, Giuliano F, Mirone V, Xu L, Cox D, Viktrup L Monotherapy with Tadalafil or Tamsulosin Similarly Improved Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in an International, Randomised, Parallel, Placebo-Controlled Clinical Trial. Eur Urol. 2012 Jan 20; Authors: Oelke M, Giuliano F, Mirone V, Xu L, Cox D, Viktrup L Abstract BACKGROUND: Tadalafil improved lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH; LUTS/BPH) in clinical studies but has not been evaluated together with an active control in an international clinical study. OBJECTIVE: Assess tadalafil or tamsulosin versus placebo for LUTS/BPH. DESIGN, SETTING, AND PARTICIPANTS: A randomised, double-blind, international, placebo-controlled, parallel-group study assessed men ≥45 yr of age with LUTS/BPH, International Prostate Symptom Score (IPSS) ≥13, and maximum urinary flow rate (Q(max)) ≥4 to ≤15ml/s. Following screening and washout, if needed, subjects completed a 4-wk placebo run-in before randomisation to placebo (n=172), tadalafil 5mg (n=171), or tamsulosin 0.4mg (n=168) once daily for 12 wk. MEASUREMENTS: Outcomes were assessed using analysis of covariance (ANCOVA) or ranked analysis of variance (ANOVA) (continuous variables) and Cochran-Mantel-Haenszel test or Fisher exact test (categorical variables). RESULTS AND LIMITATIONS: IPSS significantly improved versus placebo through 12 wk with tadalafil (-2.1; p=0.001; primary efficacy outcome) and tamsulosin (-1.5; p=0.023) and as early as 1 wk (tadalafil and tamsulosin both -1.5; p<0.01). BPH Impact Index significantly improved versus placebo at first assessment (week 4) with tadalafil (-0.8; p<0.001) and tamsulosin (-0.9; p<0.001) and through 12 wk (tadalafil -0.8, p=0.003; tamsulosin -0.6, p=0.026). The IPSS Quality-of-Life Index and the Treatment Satisfaction Scale-BPH improved significantly versus placebo with tadalafil (both p<0.05) but not with tamsulosin (both p>0.1). The International Index of Erectile Function-Erectile Function domain improved versus placebo with tadalafil (4.0; p<0.001) but not tamsulosin (-0.4; p=0.699). Q(max) increased significantly versus placebo with both tadalafil (2.4ml/s; p=0.009) and tamsulosin (2.2ml/s; p=0.014). Adverse event profiles were consistent with previous reports. This study was limited in not being powered to directly compare tadalafil versus tamsulosin. CONCLUSIONS: Monotherapy with tadalafil or tamsulosin resulted in significant and numerically similar improvements versus placebo in LUTS/BPH and Q(max). However, only tadalafil improved erectile dysfunction. TRIAL REGISTRATION: Clinicaltrials.gov ID NCT00970632. PMID: 22297243 [PubMed - as supplied by publisher]
Re: postfertilization autophagy of the sperm organelles prevents paternal mitochondrial DNA transmission.
Mayorga-Torres BJ, Cardona-Maya W Re: postfertilization autophagy of the sperm organelles prevents paternal mitochondrial DNA transmission. Eur Urol. 2012 Mar;61(3):625-6 Authors: Mayorga-Torres BJ, Cardona-Maya W PMID: 22289978 [PubMed - in process]
Re: dutasteride improves outcomes of benign prostatic hyperplasia when evaluated for prostate cancer risk reduction: secondary analysis of the reduction by dutasteride of prostate cancer events trial.
Oelke M Re: dutasteride improves outcomes of benign prostatic hyperplasia when evaluated for prostate cancer risk reduction: secondary analysis of the reduction by dutasteride of prostate cancer events trial. Eur Urol. 2012 Mar;61(3):624-5 Authors: Oelke M PMID: 22289977 [PubMed - in process]
Re: a prospective, randomized pilot study evaluating the effects of metformin and lifestyle intervention on patients with prostate cancer receiving androgen deprivation therapy.
Moyad MA Re: a prospective, randomized pilot study evaluating the effects of metformin and lifestyle intervention on patients with prostate cancer receiving androgen deprivation therapy. Eur Urol. 2012 Mar;61(3):623-4 Authors: Moyad MA PMID: 22289976 [PubMed - in process]
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