Clinical Therapeutics Journal Impact Factor & Information

Publisher: Elsevier

Journal description

Clinical Therapeutics provides a rapid publication of original reports of recent developments in drug therapy. The journal serves an international audience of research clinicians in academia and industry by quickly disseminating their findings through major biomedical databases.The journal features three sections: Clinical Studies, Review Articles, and Pharmaceutical Economics & Health Policy. Published articles range from pilot studies, which explore new drugs and existing drugs for applications, to large multicenter Phase III and IV trials and postmarketing studies. Audience: Research Clinicians in Academia and Industry, Practicing Physicians, Pharmacologists, and Specialists in Pharmacoeconomics, Outcomes Research and Health Policy.

Current impact factor: 2.73

Impact Factor Rankings

2015 Impact Factor Available summer 2016
2014 Impact Factor 2.731
2013 Impact Factor 2.586
2012 Impact Factor 2.23
2011 Impact Factor 2.321
2010 Impact Factor 2.551
2009 Impact Factor 3.25
2008 Impact Factor 3.064
2007 Impact Factor 3.261
2006 Impact Factor 2.893
2005 Impact Factor 3.03
2004 Impact Factor 3.009
2003 Impact Factor 2.67
2002 Impact Factor 3.073
2001 Impact Factor 2.721
2000 Impact Factor 2.069
1999 Impact Factor 1.955
1998 Impact Factor 1.539
1997 Impact Factor 1.045

Impact factor over time

Impact factor

Additional details

5-year impact 2.56
Cited half-life 7.10
Immediacy index 1.09
Eigenfactor 0.01
Article influence 0.80
Website Clinical Therapeutics website
Other titles Clinical therapeutics (Online)
ISSN 0149-2918
OCLC 43029633
Material type Document, Periodical, Internet resource
Document type Internet Resource, Computer File, Journal / Magazine / Newspaper

Publisher details


  • Pre-print
    • Author can archive a pre-print version
  • Post-print
    • Author can archive a post-print version
  • Conditions
    • Authors pre-print on any website, including arXiv and RePEC
    • Author's post-print on author's personal website immediately
    • Author's post-print on open access repository after an embargo period of between 12 months and 48 months
    • Permitted deposit due to Funding Body, Institutional and Governmental policy or mandate, may be required to comply with embargo periods of 12 months to 48 months
    • Author's post-print may be used to update arXiv and RepEC
    • Publisher's version/PDF cannot be used
    • Must link to publisher version with DOI
    • Author's post-print must be released with a Creative Commons Attribution Non-Commercial No Derivatives License
    • Publisher last reviewed on 03/06/2015
  • Classification

Publications in this journal

  • [Show abstract] [Hide abstract]
    ABSTRACT: This manuscript has been accepted for publication on 10-13-2015: The Neurobics Trial is a single-blinded parallel group randomized controlled trial. Enrollment began March 2015 and is ongoing. Eligible participants include patients greater than 60 years old scheduled for non-emergent, non-cardiac, non-neurological surgery at our institution. Patients are consented and screened at our Outpatient Preoperative Assessment Clinic to rule out preexisting cognitive dysfunction, significant mental health disease and history of surgery requiring general anesthesia in the preceding six months. Participants meeting criteria are randomized to complete 1 hour a day of electronic tablet-based cognitive exercise for 10 days prior to surgery or no preoperative intervention. Compliance with the effective dose of ten total hours of preoperative exercise is verified upon return of the patient for surgery with time logs created by the software application and by patient self-reporting. The main study objective is to compare effectiveness of preoperative cognitive exercise verses no intervention for lowering the incidence of postoperative delirium. Following surgery, patients are evaluated for delirium in the post-anesthesia recovery area, and then twice daily for the remainder of their hospitalization. Additionally, post-operative quality of recovery is assessed daily, along with pain scores and opiate utilization. More comprehensive cognitive assessments are completed just prior to discharge for baseline comparison, and quality of recovery is assessed via telephone interview at 7, 30 and 90 days post-surgery. The primary outcome is incidence of delirium during the post-operative hospitalization period. Randomization is computer generated, with allocation concealment in opaque envelops. All post-operative assessments are completed by blinded study personnel. The study is actively recruiting with 19 patients consented to-date, and a total of 264 patients required for study completion; therefore no data analysis is currently underway. Trial Registry:; Identifier: CT02230605. Funded by The Ohio State Wexner Medical Center with no-fee utilization of Lumosity cognitive exercise software provided by Lumos Labs, Inc.
    Clinical Therapeutics 10/2015; DOI:10.1016/j.clinthera.2015.10.013
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    ABSTRACT: Purpose: The purpose of this study was to perform a weight-adjusted indirect comparison to approximate the relative efficacy of everolimus versus axitinib among patients with second-line metastatic renal cell carcinoma in whom sunitinib therapy previously failed. Methods: Individual patient data from the RECORD-1 (Renal Cell Cancer Treatment With Oral RAD001 Given Daily) Phase III clinical trial provided information for patients taking everolimus. Summary baseline clinical and demographic characteristics and progression-free survival (PFS) outcomes were available for patients taking axitinib who were included in the AXIS (axitinib versus sorafenib) Phase III clinical trial. A Bayesian latent class mixture model differentiating responders and nonresponders and with imbedded Weibull regression on PFS was used to identify sex, Memorial Sloan-Kettering Cancer Center risk score, and time receiving prior sunitinib therapy as prognostic factors for PFS based on posterior probability >95%. Patients taking everolimus were weighted up or down based on their combination of prognostic variables. Weights were calculated by dividing the proportion of patients observed in AXIS for a given characteristic by the proportion observed in RECORD-1 and taking the product of the values derived for all three weighting variables considered. Weighted PFS distributions were derived with bootstrapped 95% CIs and compared with those reported for the AXIS trial. Findings: After weighting, distributions of the 3 key baseline characteristics were more closely aligned between the 2 studies; however, some differences remained. A slightly lower rate of poor-risk patients was evident in RECORD-1 (30%) versus AXIS (36%), and a 9% lower proportion of males was observed in the everolimus group compared with the axitinib group. Distributions of time receiving prior sunitinib therapy were almost equivalent between the treatment arms. A median PFS of 4.7 months (95% CI, 3.5-10.6 months) was observed for patients in the weighted everolimus group compared with 4.8 months (95% CI, 4.5-6.4 months) in the AXIS trial. Implications: Similar median PFS point estimates and overlapping CIs suggest that everolimus and axitinib have similar efficacy. Although these results do not negate the need for direct comparison, this study may be used to inform clinical and reimbursement decisions until such evidence is available.
    Clinical Therapeutics 10/2015; DOI:10.1016/j.clinthera.2015.09.013
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    ABSTRACT: Background Proinflammatory stimuli and proatherogenic factors are known to reduce the level of endothelial-derived netrin-1, a secreted laminin-like protein that attenuates recruitment of circulating monocytes within atherosclerotic plaques. This study investigated the effect of aspirin, routinely used for the prevention of cardiovascular disease, on serum netrin-1 levels in healthy subjects. Materials and Methods Serum netrin-1 was measured using an enzyme-linked immunosorbent assay (ELISA) in samples collected from 60 subjects before and after 28 days of treatment with 300 mg aspirin daily. ELISAs were performed to assess serum levels of intercellular adhesion molecule-1 (ICAM-1), E-selectin, and urinary 11-dehdyro-thromboxane B2 levels (TXB2). Serum creatinine and salicylate levels were measured using the creatininase enzymatic method on a Roche C8000 analyser and a Cobas Fara automated analyser (Roche) respectively. Creatinine clearance was calculated using the Cockcroft-Gault equation. The Research Ethics Committee approved this study and subjects signed consent forms. Results Serum netrin-1 levels were reduced following aspirin treatment (66.06 ± 22.98 pg/mL versus 79.79 ± 34.91 pg/mL at baseline; P = 0.0022). There was a linear association between the percentage change in netrin-1 and level of serum salicylate (r2 = 0.413, P = .0013). TXB2 levels fell in all subjects post-treatment, confirming adherence to treatment (32.99 ± 18.35 ng/mmol creatinine versus 143.7 ± 54.25 ng/mmol creatinine at baseline; P < 0.0001). Serum ICAM-1 and E-selectin levels were not modified by treatment. Creatinine clearance decreased following aspirin (103.2 ± 26.13 mL/min versus 110.5 ± 26.95 mL/min at baseline; P = 0.0011). Conclusion This study demonstrates that serum netrin-1 is reduced following treatment with aspirin. The TXB2 measurements show effective platelet inhibition in the whole population. We observed no change in ICAM-1 or E-selectin levels suggestive of an effect on the vascular endothelial function. Netrin-1 is a known biomarker of renal impairment. We propose that the reduction in netrin-1 is secondary to drug-induced renal dysfunction, as evidenced by a decrease in creatinine clearance.
    Clinical Therapeutics 08/2015; 37(8):e32–e33. DOI:10.1016/j.clinthera.2015.05.102

  • Clinical Therapeutics 08/2015; 37(8):e139. DOI:10.1016/j.clinthera.2015.05.399

  • Clinical Therapeutics 08/2015; 37(8):e113. DOI:10.1016/j.clinthera.2015.05.322
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    ABSTRACT: Purpose Evidence suggests that clinical outcomes for people with type 2 diabetes mellitus can be improved through multifactorial treatment. The key challenges in the successful treatment of type 2 diabetes include maintaining tight glycemic control, minimizing the risk of hypoglycemia, controlling cardiovascular risk factors, and reducing or controlling weight. The aim of the present analysis was to evaluate the cost per patient achieving a composite clinical end point (glycosylated hemoglobin <7%, with no weight gain and no hypoglycemic events) in patients with type 2 diabetes in Quebec, Quebec, Canada, receiving liraglutide 1.2 mg, liraglutide 1.8 mg, thiazolidinedione, sulfonylurea, insulin glargine, sitagliptin, or exenatide. Methods The proportion of patients achieving control was taken from a meta-analysis that was based on the Phase III trial program of liraglutide. Treatment costs, estimated from a health care payer perspective, were calculated on the basis of the trials included in the meta-analysis and captured the study drug, needles, self-monitoring of blood glucose (SMBG) test strips, SMBG lancets, and other antidiabetes medications received. Cost-effectiveness in terms of cost per patient achieving the composite end point (cost of control) was evaluated with an economic model developed in Microsoft Excel. No discounting was applied to cost or clinical outcomes because these were not projected beyond a 1-year time horizon. Sensitivity analyses were performed. Findings Liraglutide 1.8 mg was associated with the lowest number needed to treat, with 3 patients needing to be treated to bring 1 patient to the composite end point. Pioglitazone was associated with the highest number needed to treat, with 17 patients requiring treatment to bring 1 patient to the composite end point. Evaluation of only annual pharmacy costs indicated that liraglutide 1.8 mg was the most costly treatment at Can$2780 per patient per year. Pioglitazone and glimepiride were associated with the lowest direct annual costs. Combining the clinical efficacy data with the annual cost of medications produced cost of control values of Can$6070 (liraglutide 1.2 mg), Can$6949 (liraglutide 1.8 mg), Can$7237 (glimepiride), Can$7704 (exenatide), Can$8297 (insulin glargine), Can$8741 (pioglitazone), and Can$9270 (sitagliptin) per patient achieving the composite end point. Implications Liraglutide 1.2 mg and 1.8 mg were associated with the lowest cost of control values, driven by the high proportion of patients achieving the composite end point, which offset the higher medication costs. A relatively low cost of control value was achieved for glimepiride, driven by low acquisition costs, despite relatively few patients achieving the composite end point.
    Clinical Therapeutics 07/2015; 37(8). DOI:10.1016/j.clinthera.2015.05.496
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    ABSTRACT: This article reviews the diagnostically challenging presentation of mast cell activation disease (MCAD) and current thoughts regarding interactions between microbiota and MCs. A search for all studies on interactions between mast cells, mast cell activation disease, and microbiota published on and between 1960 and 2015 was conducted using the search terms mast cell, mastocyte, mastocytosis, mast cell activation, mast cell activation disease, mast cell activation syndrome, microbiome, microbiota. A manual review of the references from identified studies was also conducted. Studies were excluded if they were not accessible electronically or by interlibrary loan. Research increasingly is revealing essential involvement of MCs in normal human biology and in human disease. Via many methods, normal MCs-present sparsely in every tissue-sense their environment and reactively exert influences that, directly and indirectly, locally and remotely, improve health. The dysfunctional MCs of the "iceberg" of MCAD, on the other hand, sense abnormally, react abnormally, activate constitutively, and sometimes (in mastocytosis, the "tip" of the MCAD iceberg) even proliferate neoplastically. MCAD causes chronic multisystem illness generally, but not necessarily, of an inflammatory ± allergic theme and with great variability in behavior among patients and within any patient over time. Furthermore, the range of signals to which MCs respond and react include signals from the body's microbiota, and regardless of whether an MCAD patient has clonal mastocytosis or the bulk of the iceberg now known as MC activation syndrome (also suspected to be clonal but without significant MC proliferation), dysfunctional MCs interact as dysfunctionally with those microbiota as they interact with other human tissues, potentially leading to many adverse consequences. Interactions between microbiota and MCs are complex at baseline. The potential for both pathology and benefit may be amplified when compositionally variant microbiota interact with aberrant MCs in various types of MCAD. More research is needed to better understand and leverage these interactions. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.
    Clinical Therapeutics 03/2015; 37(5). DOI:10.1016/j.clinthera.2015.02.008
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    ABSTRACT: The Patient Protection and Affordable Care Act (ACA) aims to expand coverage to the previously uninsured, improve the quality of coverage, and help eliminate inefficiencies in the health care market. We evaluated the implications of ACA on the drug industry by examining the impact on the “Dinner-for-Three” dynamic in our health care system. We can think of our system as an odd dinner party in which one person pays (the insurer), one orders the meal (the physician), and yet another eats the meal (the patient). This dynamic requires us to examine each stakeholder and how they interact with one another to assess the impact of the ACA. Of the 6.7 million initial exchange enrollees, ~3.8 million subjects were previously uninsured. A higher percentage of these enrollees are using their pharmacy benefit, and they are disproportionately filling prescriptions for specialty drugs relative to those covered in employer-sponsored plans. Formulary designs in exchange plans are passing on higher cost-sharing for prescription drugs to the patient. ACA has also resulted in the development of accountable care organizations (ACOs); these organizations may play a role going forward in the management of drug spending and the development of formularies and protocols that impact drug prescribing. Payers are tightening control over drug spending and are finding physicians and physician groups increasingly less reluctant allies in doing so. Patients are faced by more complexity than ever in the health care system and are expected to take a more active role in responsibly managing the cost of their care. It is increasingly critical that drug manufacturers develop robust value propositions and communicate that value to all stakeholders. They should re-evaluate trial investment decisions and consider changes in price setting, rebates (how much and to whom), copay programs, and physician and patient support programs in light of changing market needs.
    Clinical Therapeutics 03/2015; 15(4). DOI:10.1016/j.clinthera.2015.02.013
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    ABSTRACT: Avibactam is a novel non-β-lactam β-lactamase inhibitor currently being assessed in combination with ceftazidime, ceftaroline fosamil, and aztreonam. The objectives of this study were to investigate the pharmacokinetics, safety, and tolerability of avibactam in healthy young (aged 18-45 years) and elderly (aged ≥65 years) volunteers of both sexes. This was a Phase I, open-label study in which healthy volunteers aged ≥18 years were enrolled into 4 cohorts: young male, young female, elderly male, and elderly female (n = 8 in each group). Subjects were excluded if they had any condition requiring regular medication or any other relevant conditions. All subjects received a single dose of avibactam 500 mg/100 mL given intravenously over 30 minutes. Pharmacokinetic measurements included Cmax, Tmax, AUC0-∞, plasma clearance, and t½. Within the two age categories the mean age across male and female subjects was well matched. The majority of subjects in the young cohort were black (≥62.5%), whilst the majority of those in the elderly cohorts were white (≥75%). Mean avibactam plasma clearance was similar between the young male, young female, and elderly male cohorts (10.16, 10.34, and 9.82 L/h, respectively), and slightly lower in elderly women (7.98 L/h). Mean Cmax was similar in young male, young female, and elderly female subjects (33.8, 36.9, and 38.4 µg/mL) but lower in elderly male subjects (26.5 µg/mL). Point estimates comparing the ratio of Cmax in male and female subjects over all age groups suggested that Cmax values were 18% lower (90% CI, 30%-5% lower) in male subjects compared with female subjects. Mean AUC0-∞ data were similar between the young male, young female, and elderly male cohorts (49.86, 49.75, and 52.40 µg·h/mL) but higher in elderly women (66.23 µg·h/mL). Point estimates comparing the ratio of AUC0-∞ in elderly and young subjects across both sexes suggested that AUC0-∞ values were 17% higher (90% CI, 5%-31%) in elderly subjects compared with young subjects. The t½ was slightly longer for elderly subjects compared with younger subjects. The most common adverse event was administration/venipuncture site bruising (6 events); all adverse events were mild. No notable differences in pharmacokinetics were observed between the male and female cohorts. The generalizability of the study is limited due to its small sample size. However, the small differences observed between the young and elderly cohorts are not sufficient to warrant dosing adjustments based on age. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.
    Clinical Therapeutics 03/2015; 37(4). DOI:10.1016/j.clinthera.2015.01.009
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    ABSTRACT: Laxative-refractory opioid-induced constipation (OIC) is defined as OIC despite using 2 laxatives with a different mechanism of action (based on the Anatomical Therapeutic Chemical Classification System level 4 term [contact laxatives, osmotically acting laxatives, softeners/emollients, enemas, and others]). OIC has a significant impact on the treatment and quality of life of patients with severe chronic pain. This noninterventional, observational, real-life study in Belgium investigated the efficacy of prolonged-release oxycodone/naloxone combination (PR OXN) treatment regarding pain relief and OIC compared with previous prolonged-release oxycodone (PR OXY) treatment for laxative-refractory OIC in daily clinical practice.
    Clinical Therapeutics 03/2015; 34(4). DOI:10.1016/j.clinthera.2015.02.010
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    ABSTRACT: Purpose: Within the past decade, many new classes of drugs have received approval from the US Food and Drug Administration for treatment of type 2 diabetes mellitus, including glucagon-like peptide-1agonists, dipeptidyl peptidase-4 inhibitors, and the sodium-glucose cotransporter-2 inhibitors. Many trials have been performed, and several more are currently ongoing to evaluate these drugs. This review addresses the broad therapeutic and pleiotropic effects of these drugs. The review also discusses the role of these drugs in the treatment paradigm for type 2 diabetes and identifies patients who would be suitable candidates for treatment with these drugs. Methods: In this comprehensive evidence-based review, the following databases were searched from 1990 to the present: PubMed/MEDLINE, Scopus, CINAHL,, the World Health Organization International Clinical Trials Registry Portal, and the American Diabetes Association and European Association for the Study of Diabetes abstract databases. Randomized clinical trials (RCTs) were only included for the main therapeutic and cardiovascular (CV) effects of these drug classes. For pleiotropic effects, RCTs were included unless no RCTs exist, in which case other studies as specified in the detailed Methods section were included. Findings: All 3 drug classes are effective in lowering hemoglobin A1c between 0.4% and 1.4%, depending on the drug class and population selected. These drug classes have beneficial effects on CV risk factors, such as weight, lipids, and blood pressure, in addition to lowering blood glucose levels. The CV tolerability of some drugs has been evaluated and found to be neutral; however, most trials are currently ongoing to assess CV tolerability. There are no concrete guidelines to determine where these drugs fit in the diabetes management paradigm, and there are ongoing trials to determine the best combination drug with metformin. Implications: These 3 drug classes will potentially increase the armamentarium against hyperglycemia. However, the specific combinations with other antidiabetic drugs and populations that will best benefit from these drugs are still being tested. Future research is also being conducted on the use of glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors in patients with type 1 diabetes.
    Clinical Therapeutics 03/2015; 37(6). DOI:10.1016/j.clinthera.2015.02.016
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    ABSTRACT: Premature newborns present unique challenges for the caregiver. Their clinical fragility and immature immune system places them at increased risk for bacterial and viral infections. Current clinical standard of care mandates invasive phlebotomy to assess an infant for an infection. However, serial blood draws can lead to blood transfusions and the infliction of noxious stimuli to this vulnerable population. Salivary screening for common neonatal morbidities, such as infections, could vastly improve the care for these infants and positively affect their long-term clinical outcomes. Recent technological advancements have improved our ability to detect thousands of proteins and/or microbes from a single salivary sample, making noninvasive assessment in neonates a possibility. This article reviews the clinical applications and challenges associated with integrating salivary analysis for infectious surveillance into the neonatal population. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.
    Clinical Therapeutics 03/2015; 37(3). DOI:10.1016/j.clinthera.2015.02.006
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    ABSTRACT: Melanoma is an aggressive malignancy that has a complex relationship with the host immune system. Immunotherapies have long been a mainstay of melanoma therapy, and advanced therapies continue to be effective in treating this disease. Immune checkpoint blockade has proven to be a novel target in melanoma, with the approval of cytotoxic T-lymphocyte antigen-4 (CTLA-4)-targeted therapy. This review evaluates the role of CTLA-4-targeted therapies in the treatment of metastatic melanoma, with a focus on mechanisms, efficacy, toxicity, and future directions of this therapy. A search was performed in PubMed to identify relevant clinical studies that explored the clinical experience with CTLA-4-targeted therapy in melanoma. Signaling through CTLA-4 causes deactivation of T cells after the initial stimulatory signals. Therapies that block CTLA-4 lead to increased T-cell function and an antitumor response in patients with metastatic melanoma. The adverse event profile of these agents is different from that seen with more traditional cancer therapies and consists of dermatitis, colitis, and other autoimmune toxicities. In addition, the pattern of response is different from that seen with traditional cytotoxic therapies, with some patients experiencing initial progression followed by response and some patients having long-term durable responses. Extensive clinical evidence supports the use of CTLA-4-targeted agents in the treatment of metastatic melanoma. The durability of response seen in patients receiving these agents has changed the landscape for patients with melanoma. Combination therapies and other agents with similar mechanisms warrant further exploration for the treatment of metastatic melanoma. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.
    Clinical Therapeutics 03/2015; 37(4). DOI:10.1016/j.clinthera.2015.02.003