Advances in Therapy Journal Impact Factor & Information

Publisher: Springer Verlag

Journal description

Advances in Therapy is an international peer reviewed journal dedicated to the rapid publication of studies in clinical medicine, including research on existing drugs and drugs in development across a range of therapeutic areas. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research papers, drug reviews, case reports and other contributions to drug therapy, diagnosis, instrtumentation and related fields.

Current impact factor: 2.27

Impact Factor Rankings

2015 Impact Factor Available summer 2016
2014 Impact Factor 2.272
2013 Impact Factor 2.438
2012 Impact Factor 2.125
2011 Impact Factor 2.105
2010 Impact Factor 1.668
2009 Impact Factor 0.936
2008 Impact Factor 0.973
2007 Impact Factor 0.719
2006 Impact Factor 0.712
2005 Impact Factor 0.667
2004 Impact Factor 0.829
2003 Impact Factor 1.047
2002 Impact Factor 0.828
2001 Impact Factor 0.468
2000 Impact Factor 0.896
1999 Impact Factor 0.403
1998 Impact Factor 0.385
1997 Impact Factor 0.408
1996 Impact Factor 0.301
1995 Impact Factor 0.169
1994 Impact Factor 0.324
1993 Impact Factor 0.115

Impact factor over time

Impact factor

Additional details

5-year impact 2.13
Cited half-life 4.90
Immediacy index 0.44
Eigenfactor 0.00
Article influence 0.61
Website Advances in Therapy website
ISSN 1865-8652
OCLC 220889595
Material type Series, Periodical
Document type Journal / Magazine / Newspaper

Publisher details

Springer Verlag

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  • Classification

Publications in this journal

  • [Show abstract] [Hide abstract]
    ABSTRACT: Introduction: It can be a challenge to manage glycemic control in patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD), due to both patient and medication issues. Although most antihyperglycemic medications can be used in mild kidney disease, many medications are either not advised or require dose adjustments in more advanced CKD. This review summarizes product label information, pharmacokinetic and clinical studies, and clinical guidelines relevant to use of antihyperglycemic medications in CKD. Methods: Product labels and guidelines from North America and Europe, as well as pharmacokinetic and clinical studies of diabetes medication use in CKD were identified through Medline and PubMed searches, up to February 2015. Available data are summarized and correlations between treatment recommendations and available research are discussed, as are glycemic targets for patients with CKD. Results: Newer medications have significantly more data available than older medications regarding use in CKD, although larger clinical studies are still lacking for some drugs. As CKD advances, dose adjustment is needed for many medications [numerous dipeptidyl peptidase-4 inhibitors, some insulins, sodium glucose co-transporter 2 (SGLT2) inhibitors], although not for others (thiazolidinediones, meglitinides). Some medications are not recommended for use in more advanced CKD (metformin, SGLT2 inhibitors, some glucagon-like protein-1 receptor agonists) for safety or efficacy reasons. There is not always good alignment between label recommendations, pharmacokinetic or clinical studies, and guideline recommendations for use of these drugs in CKD. In particular, controversy remains about the use of metformin in moderate CKD and appropriate use of liraglutide and sulfonylureas in advanced CKD. Conclusion: Considerable variability exists with respect to recommendations and clinical data for the many antihyperglycemic drugs used in patients with T2DM and CKD. Funding: Eli Lilly and Company.
    Advances in Therapy 11/2015; DOI:10.1007/s12325-015-0261-x
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    ABSTRACT: Introduction: High-dose intravenous esomeprazole is the only approved pharmacological treatment for the prevention of peptic ulcer rebleeding (currently approved in over 100 countries worldwide), but has not yet been approved in China. This study aimed to evaluate a high-dose esomeprazole intravenous regimen vs. an active control (cimetidine) for the prevention of rebleeding in Chinese patients with a high risk of peptic ulcer rebleeding who had undergone primary endoscopic hemostatic treatment. Methods: This was a parallel-group study conducted at 20 centers in China. The study comprised a randomized, double-blind, intravenous treatment phase of 72 h in which 215 patients received either high-dose esomeprazole (80 mg + 8 mg/h) or cimetidine (200 mg + 60 mg/h), followed by an open-label oral treatment phase in which all patients received esomeprazole 40 mg tablets once daily for 27 days. The primary outcome was the rate of clinically significant rebleeding within the first 72 h after initial endoscopic hemostatic therapy. Secondary outcomes included the rates of clinically significant rebleeding within 7 and 30 days; proportions of patients who had endoscopic retreatment and other surgery due to rebleeding; and number of blood units transfused. Results: The rate of clinically significant rebleeding within 72 h was low overall (3.3%) and numerically lower in patients treated with esomeprazole compared with cimetidine (0.9% vs. 5.6%). Overall, the results of the secondary outcomes also showed a numerical trend towards superiority of esomeprazole over cimetidine. All treatments were well tolerated. Conclusion: In this phase 3, multicenter, randomized trial conducted in China, esomeprazole showed a numerical trend towards superior clinical benefit over cimetidine in the prevention of rebleeding in patients who had successfully undergone initial hemostatic therapy of a bleeding peptic ulcer, with a similar safety and tolerability profile. These findings suggest that esomeprazole may be an alternative treatment option to cimetidine for this indication in China. Funding: AstraZeneca. Trial registration: identifier, NCT01757275.
    Advances in Therapy 11/2015; DOI:10.1007/s12325-015-0265-6
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    ABSTRACT: Introduction: Latanoprostene bunod is a novel nitric oxide (NO)-donating prostaglandin F2α receptor agonist in clinical development for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. We evaluated the effect of latanoprostene bunod 0.024% instilled once daily (QD) on lowering IOP over a 24-h period in healthy Japanese subjects following 14 days of treatment. Methods: This was a single-arm, single-center, open-label clinical study of 24 healthy Japanese male volunteers. A baseline IOP profile was established in both eyes in the sitting position at 8 PM, 10 PM, 12 AM, 2 AM, 4 AM, 8 AM, 10 AM, 12 PM, and 4 PM using a Goldmann applanation tonometer. Subjects subsequently instilled latanoprostene bunod 0.024% QD at 8 PM for 14 days in both eyes. The absolute and change from baseline in sitting IOP was assessed on day 14. Results: The mean (SD) age of the subjects was 26.8 (6.3) years, and mean (SD) baseline IOP was 13.6 (1.3) mmHg in the study eye. Latanoprostene bunod 0.024% instilled QD for 14 days reduced IOP at all the evaluated time points (P < 0.001) with a mean (SD) 24-h reduction of 3.6 (0.8) mmHg or 27% from the baseline in the study eye. Peak and trough IOP lowering occurred at 8 AM and 8 PM (12 and 24 h following instillation) with a mean reduction of 4.2 (1.8) mmHg, or 30%, and 2.8 (2.2) mmHg, or 20%, respectively. Punctate keratitis and ocular hyperemia, both mild in severity, were the most common adverse events. Conclusion: Latanoprostene bunod ophthalmic solution 0.024%, dosed QD for 14 days, significantly lowered mean IOP in healthy Japanese subjects during the entire 24-h period. Studies of latanoprostene bunod in patients diagnosed with normal tension glaucoma are warranted. Trial registration: identifier NCT01895985. Funding: Bausch & Lomb, Inc.
    Advances in Therapy 11/2015; DOI:10.1007/s12325-015-0260-y
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    ABSTRACT: Introduction: Clinical trials have demonstrated the efficacy of all-oral direct-acting antiviral (DAA) regimens in the treatment of patients infected with hepatitis C virus (HCV). This study assessed real-world effectiveness of two recently approved regimens; paritaprevir/ritonavir/ombitasvir; dasabuvir (3D), and sofosbuvir/ledipasvir (SOF/LDV) in patients with HCV genotype 1. Methods: A retrospective analysis of administrative claims data (IMS Health Patient-Centric Data Warehouse/Medivo database) from October 1, 2013 to August 14, 2015 was conducted. Patients ≥19 years of age with a HCV genotype 1 infection, a prescription fill for 3D or SOF/LDV, and ≥1 HCV viral load (VL) assessment from weeks 4-30 post-treatment were selected for analysis. Percentages of patients achieving sustained virologic response (SVR; defined as HCV RNA ≤43 IU/mL) were determined. Unadjusted SVR rates were compared between treatment groups using Fisher's exact tests. SVR rates were also assessed using multivariate regression with adjustment for age group, sex, and treatment history. Analyses were repeated for a subset of patients with VL assessment from 12 to 30 weeks post-treatment. Results: A total of 1707 (44 3D and 1663 SOF/LDV) patients were included. The majority (60%) were male, 49% were aged 55-64 years, and 97% were treatment-naïve 1 year prior to index. The unadjusted relative risk (RR) for achieving SVR in patients treated with SOF/LDV compared with 3D was 0.98%, 95% confidence interval (CI): 0.93-1.02. After adjusting for the baseline covariates, the RR was 0.98%, 95% CI: 0.94-1.03. Conclusions: In this early view of real-world data, effectiveness of all-oral DAA regimens in HCV genotype 1 patients was concordant with results from registration trials. SVR rates were similar for the two regimens. Further studies are needed to confirm these results. Funding: AbbVie, Inc.
    Advances in Therapy 11/2015; DOI:10.1007/s12325-015-0258-5
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    ABSTRACT: Introduction: Sodium glucose co-transporter 2 inhibitors decrease hemoglobin A1c (HbA1c) and blood pressure (BP) and slightly increase low-density lipoprotein cholesterol (LDL-C) in patients with type 2 diabetes mellitus (T2DM). The effects of baseline BP and LDL-C on the safety and efficacy of canagliflozin in patients were analyzed post hoc in a phase III study. Methods: Japanese patients with T2DM were classified by baseline systolic BP (SBP) of <130 or ≥130 mmHg, diastolic BP (DBP) of <80 or ≥80 mmHg, and LDL-C of <120 or ≥120 mg/dL. Canagliflozin was administered daily to patients for 52 weeks at doses of either 100 mg (n = 584) or 200 mg (n = 715). The effects of canagliflozin on the incidence of adverse events (AEs), BP, and LDL-C were evaluated. Results: No clear differences were observed in overall safety among the subgroups classified by baseline SBP, DBP, or LDL-C, except for a slight imbalance in AEs associated with volume depletion with 200 mg of canagliflozin. The decrease in mean SBP and DBP was evident in subgroups with baseline SBP ≥130 mmHg and DBP ≥80 mmHg. Mean LDL-C was decreased in subgroups with baseline LDL-C ≥120 mg/dL at both canagliflozin doses, and they were slightly increased, but did not exceed 120 mg/dL in subgroups with baseline LDL-C <120 mg/dL. The changes in HbA1c and body weight from those observed at baseline were not different between subgroups classified by SBP, DBP, and LDL-C at either dose. Conclusion: The present post hoc analysis indicates that canagliflozin is well tolerated irrespective of baseline BP and LDL-C in patients with T2DM. Trial registration: identifier, NCT01387737. Funding: Mitsubishi Tanabe Pharma Corporation.
    Advances in Therapy 11/2015; DOI:10.1007/s12325-015-0255-8
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    ABSTRACT: Introduction: Ivabradine has opened up new possibilities for treating stable angina and chronic heart failure by lowering heart rate. Ivabradine lowers heart rate by selectively inhibiting the I f current in the sinoatrial node. This study aimed to determine whether the decrease in heart rate achieved with ivabradine was accompanied by hemodynamic changes that might lead to an enhancement of endothelial function. Methods: Thirty patients with stable angina pectoris were included in the study. Ivabradine (5 mg bid) was added to the recommended standard treatment. Endothelial function was assessed at baseline and after 3 months of ivabradine therapy, with an Endo-PAT 2000 device (Itamar Medical, Israel). This device was recently developed for the noninvasive assessment for endothelial dysfunction. We evaluated reactive hyperemia index (RHI), which reflects endothelial function, and augmentation index (AI), which provides an indication of arterial stiffness. Results: The study population consisted of 25 (83.3%) men and five (16.7%) women. The mean age of the patients was 65.4 ± 6.7 years. Twenty-eight (93.3%) patients had a history of myocardial infarction (ST-segment elevation myocardial infarction or non-ST-segment elevation myocardial infarction), 23 (76.6%) had undergone revascularization (percutaneous coronary intervention or coronary artery bypass graft), 16 (53.3%) had type 2 diabetes mellitus, and 29 (96.6%) had arterial hypertension. The mean resting heart rate decreased significantly, from 77 ± 7 bpm at the start of the study to 65 ± 6 bpm after treatment (P < 0.0001). Endothelial function was found to have improved significantly after 3 months of ivabradine therapy. Mean RHI before treatment was 1.54 ± 0.30, suggesting probable endothelial dysfunction, whereas mean RHI at the end of the study was 1.83 ± 0.36 (P < 0.0001). AI also improved significantly on treatment, from 21 ± 20% to 10 ± 21% (P < 0.0001). Conclusion: The addition of ivabradine to the treatment regimen of patients with stable angina pectoris both lowered heart rate and improved endothelial function. However, broader, randomized, double-blind, placebo-controlled clinical trials are required to confirm these findings. Funding: Sponsorship for this study was funded by a VEGA grant no. 1/0858/11. Article processing charges were funded by Servier.
    Advances in Therapy 11/2015; DOI:10.1007/s12325-015-0253-x
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    ABSTRACT: Heart failure has seen a number of therapeutic advances in recent years. Despite this, heart failure is still related to increasing rates of morbidity, repeated hospitalizations, and mortality. Ivabradine is a recent treatment option for heart failure. It has a mode of action that includes reduction in heart rate, and leads to improvement in outcomes related to heart failure mortality and morbidity, as demonstrated by the results of the SHIFT trial in patients with systolic heart failure, functional classes II and III on the New York Heart Association classification, and left ventricular ejection fraction ≤35%. These results are intriguing since many heart failure drugs reduce heart rate without such benefits, or with quite different effects, making it more difficult to understand the novelty of ivabradine in this setting. Many of the drugs used in heart failure modify heart rate, but most have other pathophysiological effects beyond their chronotropic action, which affect their efficacy in preventing morbidity and mortality outcomes. For instance, heart rate reduction at rest or exercise with ivabradine prolongs diastolic perfusion time, improves coronary blood flow, and increases exercise capacity. Another major difference is the increase in stroke volume observed with ivabradine, which may underlie its beneficial cardiac effects. Finally, there is mounting evidence from both preclinical and clinical studies that ivabradine has an anti-remodeling effect, improving left ventricular structures and functions. All together, these mechanisms have a positive impact on the prognosis of ivabradine-treated patients with heart failure, making a compelling argument for use of ivabradine in combination with other treatments. Funding: Servier.
    Advances in Therapy 11/2015; 32(10). DOI:10.1007/s12325-015-0257-6
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    ABSTRACT: Introduction: Benign prostatic hyperplasia causes partial bladder outlet obstruction (pBOO), and many patients with pBOO are affected by not only voiding symptoms but also storage symptoms. We previously suggested that enhancement of 5-hydroxytryptamine (5-HT)-induced bladder contraction in the pBOO bladder may be one cause of storage symptoms. However, little is known about the presence of 5-HT in rat bladders. In this study, we hypothesized that mast cells are a source of 5-HT and investigated the distribution of mast cells and 5-HT in the bladders of rats with pBOO. Methods: The bladders of female Sprague-Dawley rats were subjected to pBOO and sham operations for 1 week, were isolated, and were fixed for light or electron microscopy. Mast cells and 5-HT in the bladders were detected by toluidine blue staining and immunohistochemical staining, respectively. The mast cells were counted under a light microscope. Degranulated mast cells were observed under an electron microscope and counted under a light microscope. Results: Mast cells were present in the mucosa/submucosa region in sham rat bladders. Their number was increased in the detrusor muscle/subserosa/serosa region, especially the subserosal layer, in pBOO rat bladders. The localization of mast cells almost matched that of 5-HT-positive cells in consecutive sections. Degranulated mast cells were present in sham and pBOO rat bladders, but the proportion of degranulated mast cells was significantly increased in every region in pBOO rat bladders compared with that in sham rat bladders. Conclusion: These results suggest that mast cells contain 5-HT and are more abundant locally in the subserosal layer of pBOO rat bladders. 5-HT released from mast cells could stimulate 5-HT2 receptors on the detrusor muscle, and this may underlie storage symptoms. Funding: Asahi Kasei Pharma Corp.
    Advances in Therapy 10/2015; 32. DOI:10.1007/s12325-015-0243-z
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    ABSTRACT: Funding: Eli Lilly and Company.
    Advances in Therapy 10/2015; 32(10). DOI:10.1007/s12325-015-0244-y
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    ABSTRACT: Introduction: The aim of this study was to investigate whether the efficacy of liraglutide observed in randomized controlled trials translates into therapeutic benefits in the French population during routine clinical practice. Methods: This observational, prospective, multicenter study included 3152 adults with type 2 diabetes who had recently started or were about to start liraglutide treatment. During 2 years of follow-up, an evaluation of the reasons for prescribing liraglutide, maintenance dose of liraglutide, changes in combined antidiabetic treatments, level of glycemic control, change in body weight and body mass index (BMI), patient satisfaction with diabetes treatment and safety of liraglutide were investigated. The primary study endpoint was the proportion of patients still receiving liraglutide and presenting with HbA1c <7.0% after 2 years of follow-up. Results: At the end of the study, 29.5% of patients maintained liraglutide treatment and reached the HbA1c target. Mean (±SD) HbA1c, fasting plasma glucose concentration, body weight and BMI were significantly reduced from baseline [8.46% (±1.46) to 7.44% (±1.20); 180 (±60) to 146 (±44) mg/dL; 95.2 (±20.0) to 91.1 (±19.6) kg; 34.0 (±7.2) to 32.5 (±6.9) kg/m(2); respectively, all P < 0.0001]. Patient treatment satisfaction increased, with the mean diabetes treatment satisfaction questionnaire status version score increasing from 22.17 (±7.64) to 28.55 (±5.79), P < 0.0001. The main adverse event type was gastrointestinal, with a frequency of 10.9%, and the percentage of patients suffering ≥1 hypoglycemic episode decreased from 6.9% to 4.4%. Conclusion: The results of the EVIDENCE study suggest that the effectiveness of liraglutide in real-world clinical practice is similar to that observed in randomized controlled trials. Funding: Novo Nordisk A/S. Trial registration: identifier, NCT01226966.
    Advances in Therapy 10/2015; 32(9). DOI:10.1007/s12325-015-0245-x
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    ABSTRACT: Introduction: This large multicenter study aimed to assess the impact of the use of multimedia tools on the duration and the quality of the conversation between healthcare providers (urologists, radiotherapists and nurses) and their patients. Methods: 30 urological centers in Belgium used either videos or other instructive tools in their consultation with prostate cancer patients. Each consultation was evaluated for duration and quality using a visual analog scale. Results: In total, 905 patient visits were evaluated: 447 without and 458 with video support. During consultations with video support, an average of 2.3 videos was shown. Video support was judged to be practical and to improve the quality of consultations, without loss of time, regardless of patient age or stage of disease management (p > 0.05). Conclusion: Healthcare providers indicate that the use of videos improved patient comprehension about prostate cancer, as well as the quality information exchange, without increasing consultation time. The use of video material was feasible in daily practice, and was easy to understand, relevant and culturally appropriate, even for the most elderly men. Multimedia education also helped to empower men to actively participate in their healthcare and treatment discussions. Funding: Ipsen NV.
    Advances in Therapy 09/2015; 32(9). DOI:10.1007/s12325-015-0248-7
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    ABSTRACT: A growing body of evidence suggests that 5-hydroxytryptamine (5-HT; serotonin) has both physiological and pathological functions in the lower urinary tract. A wide variety of 5-HT receptor subtypes are variably expressed in different organs, both peripheral and central. On urinary bladder smooth muscle, 5-HT1A, 5-HT2, 5-HT3, and 5-HT7 subtypes could function as postjunctional receptors. Postjunctional 5-HT2 receptors induce detrusor contraction of the bladder body. 5-HT1A is suggested to have a similar effect to 5-HT2, while 5-HT3 might suppress detrusor contraction evoked by direct muscle stimulation. Postjunctional 5-HT7 is reported to induce relaxation of the bladder neck, which might be required for efficient voiding. 5-HT1A, 5-HT2A, 5-HT2C, 5-HT3, 5-HT4, and 5-HT7 subtypes also could act as prejunctional receptors in autonomic excitatory nerve terminals. 5-HT2A, 5-HT2C, 5-HT3, 5-HT4, and 5-HT7 subtypes facilitate the neurogenic contraction of the detrusor by enhancing cholinergic or purinergic transmission, whereas 5-HT1A receptors might inhibit the release of acetylcholine in the detrusor. Furthermore, 5-HT1D could be involved in the suppression of ATP release from the urothelium, aiding visceral sensation of the urinary bladder. In the central pathways controlling the micturition reflex, 5-HT1A, 5-HT2A, and 5-HT7 are involved in regulation of bladder and urethral sphincter activities. Their functions, especially that of 5-HT1A, vary in a species- and site (spinal or supraspinal)- dependent manner. In addition to urinary bladder, 5-HT could be involved in prostate contraction and cell proliferation. Evidence indicates that 5-HT receptor subtypes may be novel therapeutic targets for lower urinary tract symptoms. Funding: Grants-in-Aid for Scientific Research (C) (KAKENHI 23590707, 24590722, and 26460694) from the Japan Society for the Promotion of Science.
    Advances in Therapy 09/2015; 32. DOI:10.1007/s12325-015-0240-2
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    Advances in Therapy 09/2015; 32. DOI:10.1007/s12325-015-0241-1
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    ABSTRACT: Introduction This study investigated the mRNA expression pattern and distribution of 5-hydroxytryptamine (5-HT) receptors 5-HT2A, 5-HT2B, 5-HT3A, 5-HT4, and 5-HT7 within the urothelium and detrusor of normal bladder tissue and in the urothelium of bladders from patients with benign prostatic hyperplasia (BPH). Methods Normal urinary bladder specimens were obtained from 13 patients undergoing radical cystectomy due to bladder cancer (normal group) and BPH specimens were obtained from 27 benign prostatic obstruction patients receiving transurethral prostatectomy or retropubic prostatectomy. Receptor subtype mRNA expression was determined by real-time reverse transcription polymerase chain reaction on urothelium, detrusor, and whole mucosal preparations. Receptor distribution was determined by immunohistochemistry. Results In normal tissues, expressions of 5-HT2B and 5-HT7 receptor mRNAs in the urothelium, detrusor, and whole mucosa were greater than the average expression for all receptor subtype mRNAs. 5-HT2B receptor protein was distributed in the apical urothelium and among the detrusor smooth muscle layers. In contrast, the 5-HT7 receptors were within the urothelium middle cell layers and detrusor smooth muscle cells. The expression pattern of each 5-HT receptor subtype mRNA within the BPH urothelium was similar to that in the normal urothelium. The expression level of 5-HT2A receptor mRNA in the BPH group was significantly lower than the normal group; however, the expressions of both 5-HT3A and 5-HT7 mRNAs were significantly higher. The expressions of both 5-HT2B and 5-HT4 mRNAs were not significantly different between the normal and BPH groups. Conclusion In normal urinary bladders, the expressions of both 5-HT2B and 5-HT7 mRNAs were higher compared to the 5-HT2A, 5-HT3A, and 5-HT4 mRNAs. The distributions of 5-HT2B and 5-HT7 receptors were different in the urothelium and detrusor layers. The 5-HT3A and 5-HT7 receptor mRNAs in the BPH group were significantly higher compared to the normal urothelium, while the 5-HT2A mRNA was significantly lower. Funding Asahi Kasei Pharma Corporation.
    Advances in Therapy 09/2015; 32. DOI:10.1007/s12325-015-0242-0
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    ABSTRACT: Introduction: Advanced renal cell carcinoma (RCC) shows a propensity for extending into the tributaries of the renal veins, which poses a notable surgical challenge. In this study we addressed the question as to whether patients with RCC and vein involvement can be identified as having a significant risk of immediate death associated with surgery preoperatively. Materials and methods: A total of 118 patients with RCC and vein involvement from February 1999 until November 2012 were evaluated. The association of early mortality within 60 days after the intervention was tested with various covariates including: age, body mass index (BMI), preoperative serum C-reactive protein, preoperative serum creatinine, preoperative hemoglobin level, tumor diameter, suspicion of metastasis on prior computed tomography, documented cardiac insufficiency, extent of vein invasion, prior myocardial infarction, TNM stage, American Society of Anesthesiologists score, New York Heart Association classification and Karnofsky index. A multiple logistic regression model was used to test all risk factors including the combination of an elevated BMI with an impaired Karnofsky index with all covariates. Results: A total of 17 patients died within 60 days after the operation with most patients dying from cardio-embolic complications during the first two quartiles of the observation, while later deaths were mostly attributable to sequelae of surgical complications. None of the tested risk factors were significantly associated with early mortality in the logistic regression model. The presence of an elevated BMI (≥30 kg/m(2)) in combination with a Karnofsky index ≤70% predicted early death in univariate (p = 0.006) and multivariate analysis (p = 0.023). Death rates for patients with BMI <30 kg/m(2) and Karnofsky index >70%, BMI ≥ 30 kg/m(2) or Karnofsky index ≤70%, BMI ≥30 kg/m(2) and Karnofsky index ≤70% were 5%, 14.8% and 37.5%, respectively. Conclusion: The risk of early death is dramatically elevated to more than one-third of cases with elevated BMI and unfavorable Karnofsky index in patients with RCC and vein involvement. Patients need to be counseled in this regard especially when planning cytoreductive treatment without curative intent.
    Advances in Therapy 09/2015; 32(8). DOI:10.1007/s12325-015-0235-z
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    ABSTRACT: Introduction: Inflammatory autoimmune diseases (rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriasis, and psoriatic arthritis) have a considerable impact on patients' quality of life and healthcare budgets. Biosimilar infliximab (Remsima(®)) has been authorized by the European Medicines Agency for the management of inflammatory autoimmune diseases based on a data package demonstrating efficacy, safety, and quality comparable to the reference infliximab product (Remicade(®)). This analysis aims to estimate the 1-year budget impact of the introduction of Remsima in five European countries. Methods: A budget impact model for the introduction of Remsima in Germany, the UK, Italy, the Netherlands, and Belgium was developed over a 1-year time horizon. Infliximab-naïve and switch patient groups were considered. Only direct drug costs were included. The model used the drug-acquisition cost of Remicade. The list price of Remsima was not known at the time of the analysis, and was assumed to be 10-30% less than that of Remicade. Key variables were tested in the sensitivity analysis. Results: The annual cost savings resulting from the introduction of Remsima were projected to range from 2.89 million (Belgium, 10% discount) to 33.80 million (Germany, 30% discount). If any such savings made were used to treat additional patients with Remsima, 250 (Belgium, 10% discount) to 2602 (Germany, 30% discount) additional patients could be treated. The cumulative cost savings across the five included countries and the six licensed disease areas were projected to range from 25.79 million (10% discount) to 77.37 million (30% discount). Sensitivity analyses showed the number of patients treated with infliximab to be directly correlated with projected cost savings, with disease prevalence and patient weight having a smaller impact, and incidence the least impact. Conclusion: The introduction of Remsima could lead to considerable drug cost-related savings across the six licensed disease areas in the five European countries. Funding: Mundipharma International Ltd.
    Advances in Therapy 09/2015; 32(8). DOI:10.1007/s12325-015-0233-1