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1.  Xerostomia induced by radiotherapy: an overview of the physiopathology, clinical evidence, and management of the oral damage 
Background
The irradiation of head and neck cancer (HNC) often causes damage to the salivary glands. The resulting salivary gland hypofunction and xerostomia seriously reduce the patient’s quality of life.
Purpose
To analyze the literature of actual management strategies for radiation-induced hypofunction and xerostomia in HNC patients.
Methods
MEDLINE/PubMed and the Cochrane Library databases were electronically evaluated for articles published from January 1, 1970, to June 30, 2013. Two reviewers independently screened and included papers according to the predefined selection criteria.
Results
Sixty-one articles met the inclusion criteria. The systematic review of the literature suggests that the most suitable methods for managing the clinical and pathophysiological consequences of HNC radiotherapy might be the pharmacological approach, for example, through the use of cholinergic agonists when residual secretory capacity is still present, and the use of salivary substitutes. In addition, a modified diet and the patient’s motivation to enhance oral hygiene can lead to a significant improvement.
Conclusion
Radiation-induced xerostomia could be considered a multifactorial disease. It could depend on the type of cancer treatment and the cumulative radiation dose to the gland tissue. A preventive approach and the correct treatment of the particular radiotherapeutic patient can help to improve the condition of xerostomia.
doi:10.2147/TCRM.S70652
PMCID: PMC4325830
radiation-induced xerostomia; salivary gland hypofunction; management strategies
2.  Peripherally inserted central catheter thrombosis incidence and risk factors in cancer patients: a double-center prospective investigation 
Background
Peripherally inserted central catheters (PICCs) are widely used in chemotherapy, but the reported PICC thrombosis incidence varies greatly, and risks of PICC thrombosis are not well defined. This study was to investigate the incidence and risk factors of PICC-related upper extremity vein thrombosis in cancer patients.
Methods
This was a prospective study conducted in two tertiary referral hospitals from May 2010 to February 2013. Cancer patients who were subject to PICC placement were enrolled and checked by Doppler ultrasound weekly for at least 1 month. Univariable and multivariable logistic regression analyses were applied for identification of risk factors.
Results
Three hundred and eleven cancer patients were enrolled in the study. One hundred and sixty (51.4%) developed PICC thrombosis, of which 87 (54.4%) cases were symptomatic. The mean time interval from PICC insertion to thrombosis onset was 11.04±5.538 days. The univariable logistic regression analysis showed that complications (odds ratio [OR] 1.686, P=0.032), less activity (OR 1.476, P=0.006), obesity (OR 3.148, P=0.000), and chemotherapy history (OR 3.405, P=0.030) were associated with PICC thrombosis. Multivariate analysis showed that less activity (OR 9.583, P=0.000) and obesity (OR 3.466, P=0.014) were significantly associated with PICC thrombosis.
Conclusions
The incidence of PICC thrombosis is relatively high, and nearly half are asymptomatic. Less activity and obesity are risk factors of PICC-related thrombosis.
doi:10.2147/TCRM.S73379
PMCID: PMC4321638
PICC; complication; clinical study; catheter-related thrombosis; upper extremity vein thrombosis
3.  Alpha-1 proteinase inhibitors for the treatment of alpha-1 antitrypsin deficiency: safety, tolerability, and patient outcomes 
Alpha-1 antitrypsin (AAT) deficiency remains an underrecognized genetic disease with predominantly pulmonary and hepatic manifestations. AAT is derived primarily from hepatocytes; however, macrophages and neutrophils are secondary sources. As the natural physiological inhibitor of several proteases, most importantly neutrophil elastase (NE), it plays a key role in maintaining pulmonary protease–antiprotease balance. In deficient states, unrestrained NE activity promotes damage to the lung matrix, causing structural defects and impairing host defenses. The commonest form of AAT deficiency results in a mutated Z AAT that is abnormally folded, polymerized, and aggregated in the liver. Consequently, systemic levels are lower, resulting in diminished pulmonary concentrations. Hepatic disease occurs due to liver aggregation of the protein, while lung destruction ensues from unopposed protease-mediated damage. In this review, we will discuss AAT deficiency, its clinical manifestations, and augmentation therapy. We will address the safety and tolerability profiles of AAT replacement in the context of patient outcomes and cost-effectiveness and outline future directions for work in this field.
doi:10.2147/TCRM.S51474
PMCID: PMC4321641
alpha-1; augmentation; deficiency; replacement; emphysema
4.  Anterior cervical discectomy and fusion versus anterior cervical corpectomy and fusion in the treatment of multilevel cervical spondylotic myelopathy: systematic review and a meta-analysis 
Background
To date, the decision to treat multilevel cervical spondylotic myelopathy (CSM) with anterior cervical discectomy and fusion (ACDF) or anterior cervical corpectomy and fusion (ACCF) remains controversial. Therefore, we conducted a meta-analysis to quantitatively determine the efficacy of ACDF and ACCF in the treatment of multilevel CSM.
Methods
We searched several databases for related research articles published in English or Chinese. We extracted and assessed the data independently. We determined the pooled data, data heterogeneity, and overall effect, respectively.
Results
We identified 15 eligible studies with 1,368 patients. We found that blood loss and numbers of complications during surgery in ACDF were significantly less that in ACCF; however, other clinical outcomes, such as operation time, bone fusion failure, post Japanese Orthopedic Association scores, recovery rates, and visual analog scale scores between ACDF and ACCF with multilevel CSM were not significantly different.
Conclusion
Our results strongly suggest that surgical treatments of multilevel CSM are similar in terms of most clinical outcomes using ACDF or ACCF.
doi:10.2147/TCRM.S72699
PMCID: PMC4321642
meta-analysis; therapy; anterior cervical discectomy and fusion; anterior cervical corpectomy and fusion; cervical spondylotic myelopathy
5.  Comparative efficacy and safety of local and systemic methotrexate injection in cesarean scar pregnancy 
Objective
To investigate the efficacy of methotrexate (MTX) injection in treatment of cesarean scar pregnancy (CSP).
Method
A randomized controlled study was performed in 104 CSP patients receiving either local or systemic MTX injection at the Peking Union Medical College Hospital from the year 2008 to 2013.
Results
Complete cure was defined as regression of ultrasonographic findings and normalization of serum β-hCG within 60 days. It was regarded as delayed cure if additional dilation and curettage (D&C) was needed. The overall cure rate (complete cure plus delayed cure) was 69.2% versus 67.3% for local injection versus systemic administration (P>0.05). The median time for serum β-hCG remission and uterine mass disappearance after systemic administration (42 [21–69] days and 40 [20–67] days) were significantly lower than those receiving local injection (56 [24–92] days and 53 [23–88] days), with P=0.029 and 0.046, respectively. The mean pretreatment serum β-hCG (human chorionic gonadotropin) level and lesion size in cured group (21,941±18,351 mIU/mL and 2.9±1.3 cm, respectively) were significantly lower than those in the failed group (37,047±30,864 mIU/mL and 3.6±1.3) with P=0.038 and 0.044, respectively.
Conclusion
MTX injection is effective in CSP treatment. Systemic administration shows similar overall cure rate compared to local injection, but requires shorter time for serum β-hCG remission and uterine mass disappearance.
doi:10.2147/TCRM.S76050
PMCID: PMC4315462
cesarean scar pregnancy; methotrexate injection; local; systemic
6.  Statin therapy in patients with acute coronary syndrome: low-density lipoprotein cholesterol goal attainment and effect of statin potency 
Background
Elevated low-density lipoprotein cholesterol (LDL-C) is associated with an increased risk of coronary artery disease. Current guidelines recommend an LDL-C target of <70 mg/dL (<1.8 mmol/L) for acute coronary syndrome (ACS) patients, and the first-line treatment to lower lipids is statin therapy. Despite current guidelines and the efficacious lipid-lowering agents available, about half of patients at very high risk, including ACS patients, fail to achieve their LDL-C goal. This study assessed LDL-C goal attainment according to use of high and low potency statins in routine practice in Thailand.
Methods
A retrospective cohort study was performed by retrieving data from medical records and the electronic hospital database for a tertiary care hospital in Thailand between 2009 and 2011. Included were ACS patients treated with statins at baseline and with follow-up of LDL-C levels. Patients were divided into high or low potency statin users, and the proportion reaching the LDL-C goal of <70 mg/dL was determined. A Cox proportional hazard model was applied to determine the relationship between statin potency and LDL-C goal attainment. Propensity score adjustment was used to control for confounding by indication.
Results
Of 396 ACS patients (60% males, mean age 64.3±11.6 years), 229 (58%) were treated with high potency statins and 167 (42%) with low potency statins. A quarter reached their target LDL-C goal (25% for patients on high potency statins and 23% on low potency statins). High potency statins were not associated with increased LDL-C goal attainment (adjusted hazards ratio 1.22, 95% confidence interval 0.79–1.88; P=0.363).
Conclusion
There was no significant effect of high potency statins on LDL-C goal attainment. Moreover, this study showed low LDL-C goal attainment for patients on either low or high potency statins. The reasons for the low LDL-C goal attainment rate warrants further investigation.
doi:10.2147/TCRM.S75608
PMCID: PMC4315463
LDL-C goal attainment; statins; potency statins; high risk; propensity score
7.  Neural circuits in anxiety and stress disorders: a focused review 
Anxiety and stress disorders are among the most prevalent neuropsychiatric disorders. In recent years, multiple studies have examined brain regions and networks involved in anxiety symptomatology in an effort to better understand the mechanisms involved and to develop more effective treatments. However, much remains unknown regarding the specific abnormalities and interactions between networks of regions underlying anxiety disorder presentations. We examined recent neuroimaging literature that aims to identify neural mechanisms underlying anxiety, searching for patterns of neural dysfunction that might be specific to different anxiety disorder categories. Across different anxiety and stress disorders, patterns of hyperactivation in emotion-generating regions and hypoactivation in prefrontal/regulatory regions are common in the literature. Interestingly, evidence of differential patterns is also emerging, such that within a spectrum of disorders ranging from more fear-based to more anxiety-based, greater involvement of emotion-generating regions is reported in panic disorder and specific phobia, and greater involvement of prefrontal regions is reported in generalized anxiety disorder and posttraumatic stress disorder. We summarize the pertinent literature and suggest areas for continued investigation.
doi:10.2147/TCRM.S48528
PMCID: PMC4315464
fear; anxiety; neuroimaging
8.  Prognostic role of serum C-reactive protein in esophageal cancer: a systematic review and meta-analysis 
Background
Recent studies have shown that C-reactive protein (CRP) is a useful predictive factor in several cancers; however, its role in esophageal cancer (EC) is controversial.
Methods
A systematic literature search was performed using Medline, PubMed, and Web of Science to analyze the prognostic value of serum CRP in patients with EC. A meta-analysis was performed to assess the association between serum CRP and overall survival (OS) in patients with EC.
Results
A total of eight studies involving 1,471 patients were included in our study. Our pooled results demonstrated that a high level of serum CRP was associated with poor OS (hazard ratio [HR]: 1.40, 95% confidence interval [CI]: 1.25–1.57, I2=81.3%, P<0.0001). Subgroup analyses were performed in further investigations. When the patients were segregated according to treatment, pathological type, and cut-off level, high levels of serum CRP were found to be significantly correlated with OS.
Conclusion
Our meta-analysis revealed that high levels of serum CRP were significantly associated with poor OS in patients with EC.
doi:10.2147/TCRM.S70954
PMCID: PMC4309787  PMID: 25653533
CRP; esophageal cancer; meta-analysis
9.  Target-controlled infusion and population pharmacokinetics of landiolol hydrochloride in patients with peripheral arterial disease 
Purpose
We previously determined the pharmacokinetic (PK) parameters of landiolol in healthy male volunteers and gynecological patients. In this study, we determined the PK parameters of landiolol in patients with peripheral arterial disease.
Methods
Eight patients scheduled to undergo peripheral arterial surgery were enrolled in the study. After inducing anesthesia, landiolol hydrochloride was administered at target plasma concentrations of 500 and 1,000 ng/mL for 30 minutes each. A total of 112 data points of plasma concentration were collected from the patients and used for the population PK analysis. A population PK model was developed using a nonlinear mixed-effect modeling software program (NONMEM).
Results
The patients had markedly decreased heart rates at 2 minutes after initiation of landiolol hydrochloride administration; however, systolic blood pressures were lower than the baseline values at only five time points. The concentration time course of landiolol was best described by a two-compartment model with lag time. The estimates of PK parameters were as follows: total body clearance, 30.7 mL/min/kg; distribution volume of the central compartment, 65.0 mL/kg; intercompartmental clearance, 48.3 mL/min/kg; distribution volume of the peripheral compartment, 54.4 mL/kg; and lag time, 0.633 minutes. The predictive performance of this model was better than that of the previous model.
Conclusion
The PK parameters of landiolol were best described by a two-compartment model with lag time. Distribution volume of the central compartment and total body clearance of landiolol in patients with peripheral arterial disease were approximately 64% and 84% of those in healthy volunteers, respectively.
doi:10.2147/TCRM.S74867
PMCID: PMC4303402  PMID: 25653534
landiolol hydrochloride; pharmacokinetics; target-controlled infusion; peripheral arterial disease; TCI; pharmacokinetic parameters; PAD
10.  Tapentadol extended release in the management of peripheral diabetic neuropathic pain 
Tapentadol, a μ-opioid agonist and norepinephrine reuptake inhibitor, has been found to be an effective medication for a wide variety of chronic pain conditions, including back pain, cancer-related pain, and arthritic pain. It has also been found to have fewer gastrointestinal side effects than more traditional opioid-based therapies. More recently, tapentadol extended release has been demonstrated to be effective in the management of painful diabetic neuropathy, an often debilitating condition affecting approximately one-third of all patients with diabetes. This review highlights the most up-to-date basic and clinical studies by focusing on the mechanisms of action of tapentadol and its clinical efficacy, especially with regard to painful diabetic neuropathy.
doi:10.2147/TCRM.S32193
PMCID: PMC4298300  PMID: 25609974
chronic pain; neuropathic pain; pharmacology; analgesia; pain management
11.  Effect of combination tablets containing amlodipine 10 mg and irbesartan 100 mg on blood pressure and cardiovascular risk factors in patients with hypertension 
Background
Hypertension is one of the major risk factors for cardiovascular and cerebrovascular disease and mortality. Patients who receive insufficient doses of antihypertensive agents or who are poorly adherent to multidrug treatment regimens often fail to achieve adequate blood pressure (BP) control. The aim of this study was to determine the efficacy of an angiotensin II receptor blocker (ARB) and calcium channel blocker (CCB) combination tablet containing a regular dose of irbesartan (100 mg) and a high dose of amlodipine (10 mg) with regard to lowering BP and other risk factors for cardiovascular disease.
Methods
We retrospectively evaluated data from 68 patients with essential hypertension whose treatment regimen was changed either from combination treatment with an independent ARB and a low-dose or regular-dose CCB or from a combination tablet of ARB and a low-dose or regular-dose CCB to a combination tablet containing amlodipine 10 mg and irbesartan 100 mg, because of incomplete BP control. Previous treatments did not include irbesartan as the ARB.
Results
The combination tablet decreased systolic and diastolic BP. In addition, it significantly decreased serum uric acid, low-density lipoprotein cholesterol, and increased high-density lipoprotein cholesterol levels, independent of the BP-lowering effect. Treatment with the combination tablet did not affect serum triglycerides, plasma glucose, glycated hemoglobin, serum potassium or creatinine levels, or the urinary albumin excretion rate.
Conclusion
The combination tablet containing amlodipine 10 mg and irbesartan 100 mg had a greater BP-lowering effect than an ARB and a low-dose or regular-dose CCB. In addition, the combination tablet had more favorable effects on serum uric acid, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol levels in patients with hypertension.
doi:10.2147/TCRM.S72299
PMCID: PMC4296916  PMID: 25624765
blood pressure; combination tablet; uric acid; low-density lipoprotein cholesterol; high-density lipoprotein cholesterol
12.  Rhegmatogenous retinal detachment due to a macular hole in a patient with pars planitis: a case report 
We report a rare case of rhegmatogenous retinal detachment due to a full-thickness macular hole in a young patient with pars planitis. This study was an interventional case report. A 38-year-old Asian man presented with acute reduction of vision in his left eye. His past ocular history revealed a precedent of two intravitreal steroid injections in his left eye, and fundoscopy revealed a total bullous retinal detachment along with 360° snowbanking at the pars plana. Precise preoperative visualization of the posterior pole was impossible due to a dense nuclear cataract. During surgery, an unexpected full-thickness macular hole with no associated epiretinal membrane was observed, which resulted in the retinal detachment. This case of chronic pars planitis complicated with a full-thickness macular hole resulting in retinal detachment was successfully treated with vitrectomy, internal limiting membrane peeling, and perfluoropropane tamponade. Visual acuity improved from hand movements to 6/36 Snellen at 12 months postsurgery. This case report illustrates the rare but possible association between pars planitis with macular hole formation and subsequent retinal detachment, underlying the beneficiary outcome of vitrectomy surgery both diagnostically and therapeutically.
doi:10.2147/TCRM.S70711
PMCID: PMC4284013  PMID: 25565856
retinal detachment; macular hole; pars planitis; vitrectomy
13.  The effect of nonsurgical periodontal treatment on serum and saliva chitotriosidase activities in patients with periodontitis and coronary artery disease 
Background
Plasma chitotriosidase activity, which is a marker of macrophage activation, has been reported to increase in inflammatory conditions and atherosclerosis. Chronic periodontitis has likely an important role in the development of coronary artery disease. In this study, we aimed to analyze the effect of chronic periodontitis on salivary and plasma chitotriosidase activities in patients with or without coronary atherosclerosis.
Methods
Fifty subjects were divided into four groups as controls (n=13), periodontitis (n=11), coronary artery disease (n=13), and periodontitis + coronary artery disease (n=13). Plasma and saliva chitotriosidase activities were measured by a fluorimetric method in all groups before the nonsurgical treatment of periodontitis and 5 weeks posttreatment in periodontitis groups.
Results
Salivary chitotriosidase activity was decreased after nonsurgical periodontal treatment in patients having periodontitis with or without coronary atherosclerosis. However, plasma activities remained unchanged.
Conclusion
Although this study has some limitations like small sample size and short study duration, it can suggest that salivary chitotriosidase can have the potential to be used as a very useful and practical marker to evaluate the success of the periodontal treatment and/or host response.
Key finding
Salivary chitotriosidase can be used as a marker for the evaluation of the success of the periodontal treatment and/or host response.
doi:10.2147/TCRM.S76286
PMCID: PMC4284029  PMID: 25565855
chitotriosidase; chronic periodontitis; coronary artery disease; nonsurgical periodontal treatment
14.  Treatment of adult-onset Still’s disease: a review 
Adult-onset Still’s disease (AOSD) is a rare inflammatory disorder that has been recently classified as a polygenic autoinflammatory disorder. The former classification, based on the disease course, seems to be quite dated. Indeed, there is accumulating evidence that AOSD can be divided into two distinct phenotypes based on cytokine profile, clinical presentation, and outcome, ie, a “systemic” pattern and an “articular” pattern. The first part of this review deals with the treatments that are currently available for AOSD. We then present the different strategies based on the characteristics of the disease according to clinical presentation. To do so, we focus on the two subsets of the disease. Finally, we discuss the management of life-threatening complications of AOSD, along with the therapeutic options during pregnancy.
doi:10.2147/TCRM.S64951
PMCID: PMC4278737  PMID: 25653531
adult-onset Still’s disease; treatment; anakinra; tocilizumab; canakinumab
15.  Diagnosis and management of xerostomia and hyposalivation 
Xerostomia, the subjective complaint of dry mouth, and hyposalivation remain a significant burden for many individuals. Diagnosis of xerostomia and salivary gland hypofunction is dependent upon a careful and detailed history and thorough oral examination. There exist many options for treatment and symptom management: salivary stimulants, topical agents, saliva substitutes, and systemic sialogogues. The aim of this review is to investigate the current state of knowledge on management and treatment of patients affected by xerostomia and/or hyposalivation.
doi:10.2147/TCRM.S76282
PMCID: PMC4278738  PMID: 25653532
saliva stimulation; dry mouth; saliva substitutes; sialogogues
16.  Effectiveness and safety of Humalog Mix 50/50 versus Humalog Mix 75/25 in Chinese patients with type 2 diabetes 
Humalog Mix 75/25 insulin analog is widely used in the People’s Republic of China to treat type 2 diabetes mellitus, but the Humalog Mix 50/50 analog is not as yet widely used or assessed. The purpose of this 12-week, parallel-group, randomized, treat-to-target study was to evaluate the difference in clinical efficacy, safety, and outcome of treatment between Humalog Mix 50/50 and Humalog Mix 75/25 analogs in Chinese patients with type 2 diabetes mellitus. In total, 146 insulin-naïve patients with type 2 diabetes mellitus and aged 18–75 years were randomized and treated twice a day with either Humalog Mix 50/50 (group A) or Humalog Mix 75/25 (group B). We monitored levels of fasting blood glucose, 2-hour postprandial blood glucose, and glycosylated hemoglobin (HbA1c) in patients in both groups prior to and 3 months post treatment, the average time to achieve target blood glucose level, and frequency of hypoglycemic episodes during treatment. We found that group A showed better glycemic control as per fasting blood glucose and 2-hour postprandial blood glucose than group B. Moreover, HbA1c levels in group A (5.5%±1.4%) were lower by 1.0%±0.1% (P<0.05) compared with those in group B (6.5%±1.5%). The time to achieve glucose control was shorter (P<0.05) in group A (12.6±3.6 days) than in group B (22.3±4.7 days). Regarding safety, no significant adverse events or severe hypoglycemia on treatment was observed in either group. Additionally, the 1:1 ratio of Humalog Mix 50/50 showed a trend towards fewer episodes of nocturnal hypoglycemia. Thus, compared with Humalog Mix 75/25, the high-proportion premix insulin analog, Humalog Mix 50/50 showed better glycemic control, achieved target blood glucose levels more rapidly and without an increase in hypoglycemic episodes in Chinese type 2 diabetic individuals and is recommended for use in clinical practice.
doi:10.2147/TCRM.S75602
PMCID: PMC4278736  PMID: 25565854
type 2 diabetes mellitus; Chinese type 2 diabetics; Humalog Mix 50/50; Humalog Mix 75/25; premixed insulin lispro 50/50; premixed insulin lispro 75/25
17.  Bayesian imperfect information analysis for clinical recurrent data 
In medical research, clinical practice must often be undertaken with imperfect information from limited resources. This study applied Bayesian imperfect information-value analysis to realistic situations to produce likelihood functions and posterior distributions, to a clinical decision-making problem for recurrent events. In this study, three kinds of failure models are considered, and our methods illustrated with an analysis of imperfect information from a trial of immunotherapy in the treatment of chronic granulomatous disease. In addition, we present evidence toward a better understanding of the differing behaviors along with concomitant variables. Based on the results of simulations, the imperfect information value of the concomitant variables was evaluated and different realistic situations were compared to see which could yield more accurate results for medical decision-making.
doi:10.2147/TCRM.S67011
PMCID: PMC4278741  PMID: 25565853
Bayesian value-of-information; recurrent events; chronic granulomatous disease
18.  Patient risk factors for developing a drug-related problem in a cardiology ward 
Background
Because of the high incidence of drug-related problems (DRPs) among hospitalized patients with cardiovascular diseases and their potential impact on morbidity and mortality, it is important to identify the most susceptible patients, who therefore require closer monitoring of drug therapy.
Purpose
To identify the profile of patients at higher risk of developing at least one DRP during hospitalization in a cardiology ward.
Method
We consecutively included all patients hospitalized in the cardiology ward of a teaching hospital in 2009. DRPs were identified through a computerized warning system designed by the pharmacy department and integrated into the electronic medical record.
Results
A total of 964 admissions were included, and at least one DRP was detected in 29.8%. The variables associated with a higher risk of these events were polypharmacy (odds ratio [OR]=1.228; 95% confidence interval [CI]=1.153–1.308), female sex (OR=1.496; 95% CI=1.026–2.180), and first admission (OR=1.494; 95% CI=1.005–2.221).
Conclusion
Monitoring patients through a computerized warning system allowed the detection of at least one DRP in one-third of the patients. Knowledge of the risk factors for developing these problems in patients admitted to hospital for cardiovascular problems helps in identifying the most susceptible patients.
doi:10.2147/TCRM.S71749
PMCID: PMC4275111  PMID: 25565852
cardiovascular diseases; patient safety; drug therapy monitoring; computerized provider order entry; clinical pharmacist; pharmacy warning system
19.  Prescriber utilization of dalfampridine extended release tablets in multiple sclerosis: a retrospective pharmacy and medical claims analysis 
Purpose
This study aimed to characterize the prescribing of dalfampridine extended release (D-ER) 10 mg tablet treatment in people with multiple sclerosis (MS).
Methods
A retrospective cohort study was performed using Medco pharmacy and medical claims. Medical claims were used to identify MS patients with more than one prescription for D-ER with 1 year of prior continuous enrollment (n=704). These patients were matched 2:1 on age, sex, and health insurance source with a comparison group of MS patients who were treatment naïve for D-ER (n=1,403). Categorical data were analyzed by χ2 test; ordinal data by Wilcoxon rank sum test; and continuous data by Student’s t-test.
Results
Most patients were women aged 45–64 years. In the year preceding D-ER initiation, the prevalence of seizure and renal impairment was numerically lower in the D-ER cohort relative to those who were D-ER naïve (seizure: 3.1% versus 4.7%, respectively; renal impairment: 4.3% versus 5.1%, respectively); however, prescriptions for antiepileptic drugs in the two cohorts were comparable. In the year preceding treatment initiation, 62% of the D-ER cohort was prescribed MS-specific disease-modifying therapies relative to 45% who were D-ER naïve.
Conclusion
Seizure and renal impairment rates among D-ER-naïve patients were consistent with published literature, yet rates among those prescribed D-ER during the year preceding treatment initiation were slightly lower than rates among D-ER-naïve patients. Given that D-ER is contraindicated in patients with history of seizure or moderate or severe renal impairment, lower rates may indicate that risk-minimization strategies contributed to the lower prevalence.
doi:10.2147/TCRM.S75837
PMCID: PMC4274131  PMID: 25565851
disease-modifying therapy; database; seizures; renal impairment; pharmacoepidemiology
20.  Trabectedin for advanced soft tissue sarcomas: optimizing use 
Patients with locally advanced or metastatic soft tissue sarcoma have a poor outlook with median survival in the order of 1 year. There is therefore an urgent need for novel agents to impact this disease. Trabectedin is one such novel agent that has demonstrated activity for patients with advanced soft tissue sarcoma and it was licensed in Europe in 2007 for patients in the second-line setting or first-line in those patients deemed unsuitable to receive cytotoxics. In order to best serve patients with novel agents, it is imperative to understand the mechanism or mechanisms of action and the best ways of assessing response in order to optimize antitumor activity. Frequently, the mechanism of action and the optimal means of assessing response will be different from those of traditional cytotoxics. Trial design should reflect these factors to ensure that active drugs are not wrongly marked as futile. This review discusses a number of factors that may influence the optimization of trabectedin use. These factors include the administration schedule, the optimal timing of trabectedin administration in the disease process, the histopathological and molecular subtypes that may be most sensitive to trabectedin, the challenge of assessing response, particularly using radiology, and, finally, the safety considerations with this agent.
doi:10.2147/TCRM.S49330
PMCID: PMC4270297  PMID: 25540587
trabectedin; soft tissue sarcomas; ET-743; myxoid lipoarcomas; optimal administration
21.  Prospective study of incidence and predictors of peripheral intravenous catheter-induced complications 
Background
Although intravenous therapy is one of the most commonly performed procedures in hospitalized patients, it remains susceptible to infectious and noninfectious complications. Previous studies investigated peripheral intravenous catheter (PIVC) complications mainly in pediatrics, but apparently none were investigated among Saudi adult populations. The aim of this study was to assess the pattern and complications of PIVCs at King Abdulaziz Medical City (KAMC), Riyadh, Saudi Arabia.
Methods
An observational prospective cohort study investigated PIVCs pattern and complications among adults with PIVCs, admitted to various wards at KAMC. PIVCs-related clinical outcomes (pain, phlebitis, leaking, and others) were recorded in 12-hour intervals, using the Visual Inspection Phlebitis scale. Density incidence (DI) and cumulative incidence (CI) of complications and their relative risks (RRs) were calculated. Regression analyses were applied and significance limits were set at P<0.05.
Results
During the study period, 359 adults were included, mounting to 842 PIVCs and 2,505 catheter days. The majority of patients, 276 (76.9%), had medical, chief admission complaints, whereas 83 (23.1%) were trauma/surgical and infectious cases. Complicated catheters were found in 141 (39.3%) patients, with 273 complications (32.4/100 catheters), in 190 complicated catheters (CI =22.56/100 catheters and DI =75.84/1,000 catheter days). Phlebitis ranked first among complications, 148 (CI =17.6%), followed by pain 64 (CI =7.6%), leaking 33 (CI =3.9%), dislodgement 20 (CI =2.4%), and extravasations and occlusion 4 (CI =0.5% each). Phlebitis was predicted with female sex (P<0.001), insertion in fore/upper arm (P=0.024), and infusion of medication (P=0.02). Removal time for PIVCs insertion was not a significant predictor of phlebitis (RR =1.46, P=0.08).
Conclusion
Incidence of complications in this study was significantly higher than rates in previous studies. Better insertion techniques may be sought to lower the incidences of PIVC complications, thus extending their onset beyond day 3. Changing catheters is recommended when clinically indicated rather than routinely post-72 hours.
doi:10.2147/TCRM.S74685
PMCID: PMC4266329  PMID: 25525365
catheter-induced complications; peripheral venous catheter; phlebitis; thrombo-phlebitis; incidence; prospective study
22.  Low perfusion index affects the difference in glucose level between capillary and venous blood 
Aim
In emergency cases, finger stick testing is primarily used to check the blood glucose value of patients since it takes longer to obtain the venous value. In critical patients, under conditions that cause an increase in metabolic state and level of stress, there occurs considerable difference in glucose levels between capillary and venous measurements. This study aimed to investigate the comparability of capillary and venous glucose values, according to the perfusion index level obtained with the Masimo Radical-7® device, in critical patients aged 18 years and over.
Method
We conducted this prospective and observational study in the emergency department of the Eskisehir Osmangazi University hospital between November 3, 2008 and February 2, 2009.
Results
The blood glucose of 300 critical patients was checked by finger stick in the emergency unit. The participants with normal vital signs had perfusion index between 0 and 5; the results obtained by the two methods were more consistent for perfusion index values of 6 and over. The results were most consistent in aged participants with normal vital sign findings and low perfusion index and in young patients with high perfusion index. In the cases where at least one of the vital signs was abnormal, the glucose values obtained by the two methods were more consistent when the perfusion index was 6 or over. In this group, independently from the perfusion index value, the consistency was higher in younger patients compared with aged patients.
Conclusion
In the emergency department, perfusion index value measured by Masimo Radical-7 and capillary blood glucose levels can serve in blood sugar management in critically ill patients.
doi:10.2147/TCRM.S73359
PMCID: PMC4242686  PMID: 25429227
glucose; capillary; venous; perfusion index; Masimo Radical-7®
23.  Current perspectives on bisphosphonate treatment in Paget’s disease of bone 
Paget’s disease of bone is a chronic metabolic bone disease with focal increase in bone turnover. The exact etiology of the disease is uncertain, although genetic and environmental factors are believed to be important. Bisphosphonate is the main class of medication being used to control disease activity via its antiresorptive effect. This review discusses the controversies concerning the use of bisphosphonates in the treatment of Paget’s disease of bone, the efficacy of different bisphosphonates in controlling disease activity, and the possible rare side effects of bisphosphonates. Symptoms are the main indication for treatment in Paget’s disease of bone. As treatment benefits in asymptomatic individuals remain controversial and nonevidence based, the decision to treat these patients should be individualized to their risk and benefit profiles. There are several trials conducted to evaluate and compare the efficacy of different regimes of bisphosphonates for treating Paget’s disease of bone. Most trials used biochemical markers rather than clinical symptoms or outcomes as parameters for comparison. Zoledronate is an attractive option as it can achieve high rates of biochemical remission and sustain long duration of suppression by a single dose. Atypical femoral fracture and osteonecrosis of the jaw are two rare and severe side effects reported, possibly related to the use of bisphosphonates in patients with osteoporosis and malignancy-induced hypercalcemia. As the regimes of bisphosphonates used for treating Paget’s disease of bone are different from those two diseases, the risks of developing these two possible side effects are expected to be very low, although this remains unknown. Vitamin D and calcium supplement should be given to patients at risk of vitamin D insufficiency when given zoledronate, as symptomatic hypocalcemia may develop. For those intolerant of bisphosphonates, subcutaneous calcitonin can be used for a limited period due to its associated risk of malignancy.
doi:10.2147/TCRM.S58367
PMCID: PMC4242688  PMID: 25429226
osteitis deformans; antiresorptive; alkaline phosphatase
24.  Vulnerable COPD patients with comorbidities: the role of roflumilast 
Roflumilast is a selective phosphodiesterase-4 (PDE-4) inhibitor that was approved by the US Food and Drug Administration in February 2011 for the management of chronic obstructive pulmonary disease (COPD). Literature was retrieved through PubMed using the terms “roflumilast” and “COPD”. Reference citations from publications identified were also reviewed. All articles published in English using the terms “roflumilast” and “COPD” were retrieved. For evaluation of clinical efficacy, published Phase III studies and pooled analyses of Phase III trials were included. In seven published Phase III trials, roflumilast at 500 μg daily showed improvements in lung function as measured by pre- and post-bronchodilator forced expiratory volume in 1 second. Roflumilast appears to be useful in vulnerable patients who are at high risk for exacerbations. Roflumilast was found to be effective when administered alone and with concomitant long-acting bronchodilator therapy in the Caucasian and Asian population. Patients with severe-to-very severe COPD, chronic bronchitis, and frequent history of exacerbations derived the greatest benefit with roflumilast. Compared to the standard of care therapies, roflumilast is more cost-prohibitive. Roflumilast was well tolerated, with the most common adverse events observed in clinical trials being diarrhea, nausea, and headache. Weight loss and increased risk of psychiatric events have also been observed with roflumilast in clinical trials. Roflumilast is a safe and effective option for the treatment of COPD.
doi:10.2147/TCRM.S55105
PMCID: PMC4242693  PMID: 25429225
roflumilast; COPD; phosphodiesterase-4 inhibitor
25.  A systematic review of the outcomes of osteoporotic fracture patients after hospital discharge: morbidity, subsequent fractures, and mortality 
Purpose
Osteoporotic fracture is the main complication of osteoporosis. The current management is to discharge patients as early as possible so they can get back to their daily activities. Once discharged, there are three main issues relating to morbidity, mortality, and risk of a subsequent fracture that need to be addressed and discussed. Therefore, the aim of this systematic review was to summarize and evaluate the evidence from published literature, to determine the outcome of osteoporotic fracture patients after their hospital discharge.
Methods
The MEDLINE and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases were searched, using the terms “osteoporosis”, “fracture”, “osteoporotic fracture”, “hip fracture”, and “vertebral fracture”. We included only human studies published in English between 2004 and 2014. The reference lists of included studies were thoroughly reviewed in search for other relevant studies.
Results
A total of 18 studies met the selection criteria. Most were observational and cohort studies. Out of all the studies, five studies looked into the morbidity, six studies looked into the risk of subsequent fractures, and seven studies looked into mortality. Vertebral fracture caused the greatest health burden, but hip fracture patients were the main users of informal care after hospital discharge. There was an increased risk of a subsequent fracture after a primary fracture compared with the control group, a cohort comparison, or the general population. Osteoporotic fractures, especially hip fractures, are associated with higher mortality rate despite the advances in the management of osteoporotic fracture cases.
Conclusion
There is strong evidence to show that after hospital discharge, osteoporotic fracture patients are faced with higher morbidity, subsequent fractures, and mortality.
doi:10.2147/TCRM.S72456
PMCID: PMC4242696  PMID: 25429224
osteoporosis; hip fracture; vertebral fracture

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