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1.
Introduction:
Acute heart failure syndrome (AHFS) is one of the leading causes of hospital admission in the US. Tolvaptan is a vasopressin V2 receptor antagonist that blocks the effect of arginine vasopressin (AVP) in reabsorbing water from the collecting ducts of the nephrons in congestive heart failure.Aims:
To review the evidence for utilizing tolvaptan in the treatment of AHFS.Evidence review:
Several clinical trials have sought to assess the clinical effects of tolvaptan in heart failure. Compared with placebo, tolvaptan has been shown to reduce bodyweight and improve serum sodium in patients with AHFS without worsening renal function. Tolvaptan appeared to be well tolerated with a good safety profile. It caused a significant reduction in pulmonary capillary wedge pressure compared with placebo, but has yet to demonstrate reversal of cardiac remodeling. A large-scale mortality trial showed no differences in long-term mortality rates between tolvaptan and placebo, although early symptom relief was apparent with tolvaptan and lower diuretic use.Place in therapy:
Tolvaptan has shown to be safe and effective in treating congestion in AHFS. Free water excretion in fluid-overloaded patients vulnerable to cardiorenal compromise with standard diuretic therapy makes V2 vasopressin receptor blockade an attractive adjunct to standard medical therapy aimed at reducing congestion in AHFS. 相似文献2.
AIMS
In vitro studies indicated CYP3A4 alone was responsible for tolvaptan metabolism. To determine the effect of a CYP3A4 inhibitor (ketoconazole) and a CYP3A4 inducer (rifampicin) on tolvaptan pharmacokinetics (PK) and pharmacodynamics (PD), two clinical trials were performed.METHODS
For CYP3A4 inhibition, a double-blind, randomized (5:1), placebo-controlled trial was conducted in 24 healthy subjects given either a single 30 mg dose of tolvaptan (n = 19) or matching placebo (n = 5) on day 1 with a 72 h washout followed by a 3 day regimen of 200 mg ketoconazole, once daily with 30 mg tolvaptan or placebo also given on day 5. For CYP3A4 induction, 14 healthy subjects were given a single dose of 240 mg tolvaptan with 48 h washout followed by a 7 day regimen of 600 mg rifampicin, once daily, with 240 mg tolvaptan also given on the seventh day.RESULTS
When co-administered with ketoconazole, mean Cmax and AUC(0,∞) of tolvaptan were increased 3.48- and 5.40-fold, respectively. Twenty-four hour urine volume increased from 5.9 to 7.7 l. Erythromycin breath testing showed no difference following a single dose of tolvaptan. With rifampicin, tolvaptan mean Cmax and AUC were reduced to 0.13- and 0.17-fold of tolvaptan administered alone. Twenty-four hour urine volume decreased from 12.3 to 8.8 l.CONCLUSIONS
Tolvaptan is a sensitive CYP3A4 substrate with no inhibitory activity. Due to the saturable nature of tolvaptan''s effect on urine excretion rate, changes in the pharmacokinetic profile of tolvaptan do not produce proportional changes in urine output. 相似文献3.
N-Acetylcysteine (NAC)-Induced Hyponatremia Caused by an Electronic Medical Record (EMR) Order Error
Introduction
Intravenous N-acetylcysteine (NAC) causes few adverse drug events, with mild anaphylactoid reactions being the most common. Hyponatremia as a complication of hypoosmolar NAC solution has been reported. We describe how a locally constructed electronic medical record (EMR) order set for IV NAC resulted in a seizure from hyponatremia due to excess free water administration.Case Report
A 13-month-old female with no past medical history presented to a hospital after ingesting an unknown number of acetaminophen 500 mg tablets. The 4-h acetaminophen concentration was 343 mcg/mL, and she was started on IV NAC. 8.2 h into her 21-h IV NAC protocol, she developed a tonic-clonic seizure. Repeat serum sodium was 124 mEq/L, a decrease from 142 mEq/L at the time of admission. She was treated with hypertonic saline, lorazepam, and levetiracetam and had no further seizures. A brain MRI and EEG were both normal. After the seizure was stabilized, the providers noticed that the patient had receive a total of 900 mL of D5W (112.5 mL/kg) in the first 9 h of hospitalization. This was caused by a poorly constructed, restrictive, EMR order set that did not allow customization of the IV NAC preparation.Discussion
Because the 21-h IV NAC administration involves preparation of 3 different doses infused over 3 different time intervals, an order set was developed to reduce ordering errors. However, error in its construction caused the pharmacist to prepare a solution containing too much free water, decreasing patient’s intravascular sodium and resulting in a seizure.Conclusion
The purposes of our case report were to highlight the dangers of overreliance on EMR order sets and to recognize hyponatremic seizures as an adverse reaction of an inappropriately prepared IV NAC. 相似文献4.
《Expert opinion on pharmacotherapy》2013,14(4):637-648
Importance of the field: Hyponatremia (serum sodium concentration <?136 mEq/liter) is a common and potentially life-threatening medical comorbidity seen in patients with psychotic disorders. Tolvaptan, a selective antagonist of the V2-receptor, is FDA-approved for the treatment of clinically significant hypervolemic and euvolemic hyponatremia. This represents a major development in the care of psychotic individuals with hyponatremia.Areas covered in the review: This review provides an overview of the existing literature on prevalence rates and risk factors associated with hyponatremia in psychotic patients (1923 – present). Tolvaptan is discussed as a potential advance in the treatment of hyponatremia in patients with psychotic disorders, and preliminary data are reviewed.What the reader will gain: The reader will gain an appreciation of the prevalence of hyponatremia among psychotic individuals, an understanding of the distinctions between acute and chronic hyponatremia in this population, and awareness that effective treatments are becoming available.Take home message: A modest literature exists regarding prevalence rates and risk factors associated with hyponatremia in psychotic populations. Hyponatremia is common and serious enough to merit clinical concern. Perhaps, now that tolvaptan has been FDA-approved, progress will accelerate and new insights will develop that begin to bring relief from this medical comorbidity among psychotic patients. 相似文献
5.
Whitney J. Goede Jenna K. Lovely Rodney L. Thompson Robert R. Cima 《Hospital pharmacy》2013,48(7):560-567
Background:
Surgical site infections (SSIs) are the leading cause of hospital-acquired infections and are associated with substantial health care costs, with increased morbidity and death. The Surgical Care Improvement Project (SCIP) contains standards that are nationally reported with the aim of improving patient outcomes after surgery. Our institution’s standards for antimicrobial prophylaxis in the perioperative period are more stringent than these measures and may be considered “beyond SCIP.” The 4 elements of appropriate antimicrobial prophylaxis are timing, antibiotic selection, dosing, and intraoperative redosing.Objective:
To quantify antimicrobial SSI prophylaxis compliance in accordance with institutional standards and to identify potential opportunities for improvement.Methods:
Patients aged 18 years or older were included if they had an SSI between January 1, 2009, and June 30, 2010, according to the database maintained prospectively by the Infection Prevention and Control Unit. Adherence to our institution’s practice standards was assessed through analysis of antibiotics administered—timing in relation to the incision, closure, and tourniquet inflation times for the procedure and antibiotic selection, dose, and redosing.Results:
Overall noncompliance with all 4 elements of antimicrobial prophylaxis was 75.4% among the 760 cases. Repeat dosing had the greatest noncompliance (45.1%); antibiotic selection had the lowest incidence of noncompliance (10.8%).Conclusions:
Noncompliance existed in each element of antimicrobial SSI prophylaxis, with antibiotic redosing leading in noncompliance. With the implementation of tools to assist the surgical team in following institutional standards, noncompliance will likely decline and additional research opportunities will exist. 相似文献6.
Susan E. Shoaf Seong Ryul Kim Patricia Bricmont Suresh Mallikaarjun 《European journal of clinical pharmacology》2012,68(12):1595-1603
Purpose
To compare the pharmacokinetics and pharmacodynamics of tolvaptan in Caucasian and Japanese healthy male subjects under fasting and non-fasting conditions.Methods
This was a single-center, parallel-group, randomized, open-label, three-period crossover trial of single oral doses of tolvaptan 30?mg under fasting and non-fasting [a high-fat, high-calorie meal (HFM) or Japanese standard meal] conditions in 25 healthy male Caucasian subjects and 24 healthy male Japanese subjects. Pharmacodynamic endpoints were urine volume and fluid balance for 0 to 24?h postdose.Results
In the fasted state, the plasma tolvaptan Cmax and AUC∞ geometric mean ratios (90 % confidence interval) were 1.105 (0.845–1.444) and 1.145 (0.843–1.554) for Japanese compared to Caucasian subjects. A HFM increased the Cmax and AUC∞ values by about 1.15-fold in both Japanese and Caucasian subjects.. Twenty-four-hour urine volumes paralleled pharmacokinetic changes, but the increases were not clinically significant. Fluid balance in the Japanese men was 1.4- to 2.0-fold more negative than that in the Caucasian men.Conclusion
Tolvaptan pharmacokinetics is not clinically significantly affected by race. Body weight is a factor that affects exposure. Tolvaptan can be administered with or without food. 相似文献7.
Jamie Sebaaly Laura Beth Parsons Nicole A. Pilch Wendy Bullington Genevieve L. Hayes Heather Easterling 《Hospital pharmacy》2015,50(6):505-513
Background:
Medication reconciliation is one of the more challenging aspects of inpatient care, and its accuracy is paramount to safe transitions of care. Studies have shown that pharmacists have a role in medication reconciliation through improving patient safety and avoiding costs associated with medication errors. The wide-scale use of pharmacists in this process has been limited by time constraints, cost, and lack of resources.Objective:
This study evaluates the impact of pharmacists in resolving medication errors, decreasing readmission rates, and reducing institutional costs during the discharge medication reconciliation process.Methods:
Pharmacists evaluated discharge medication reconciliation documentation for patients to determine its accuracy, the accuracy of the admission reconciliation documentation, and any potential issues unrelated to accuracy. Analysis of these data determined the time required for pharmacist involvement, the number of errors identified by pharmacists, the quality of pharmacist interventions, the cost avoidance for each error, and the overall impact on hospital readmission.Results:
During the 7-week study period, pharmacists performed 67 discharge medication reviews and identified 84 errors. Seventy-five percent were considered to be significant and 6% were considered to be serious. The 30-day readmission rate in the study cohort was 18% compared with 20% in the control group. Based on the clinical severity scale and pharmacist salaries, pharmacist interventions resulted in $42,300 in cost avoidance.Conclusion:
Pharmacists involved in this pilot discharge process identified and resolved significant errors on medication reconciliation orders that resulted in a financial benefit to the institution. 相似文献8.
9.
Kim SE Whittington JI Nguyen LM Ambrose PJ Corelli RL 《American journal of pharmaceutical education》2010,74(10):190
Objectives
To determine pharmacy students'' perceptions of a required research project in a doctor of pharmacy curriculum.Methods
A survey instrument was administered to senior pharmacy students to determine their perceptions of the project advisor and overall project experience and their postgraduation employment plans.Results
Two-hundred twenty-nine (81.5%) students completed a survey instrument. The majority agreed or strongly agreed that the project provided a valuable learning experience (88.2%), provided a competitive advantage for postgraduate job opportunities (73.2%), and should be a continued graduation requirement (74.2%). Respondents with plans for a residency or fellowship were more likely than those entering a community or hospital/institutional pharmacy to agree that completion of the project made them more qualified or marketable and should be continued as a graduation requirement (p < 0.05).Conclusions
A required research project was perceived by pharmacy students to be a beneficial experience. Students pursuing residency or fellowship were more likely to feel the project was beneficial than students entering the workforce. 相似文献10.
Purpose
Tolvaptan is a selective vasopressin V2 receptor antagonist that can be given orally once daily for treatment of clinically significant hypervolemic and euvolemic hyponatremia (US and Europe) or extracellular volume expansion despite taking other diuretics (Japan). In vitro studies indicated that tolvaptan was a CYP3A4 substrate. 相似文献11.
Objective
To determine the successful implementation and effectiveness of program-level learning outcomes for a 4-year bachelor of science pharmacy degree program.Methods
A comprehensive and iterative program evaluation framework was implemented and quantitative and qualitative data were gathered.Results
The critical factors in the successful development and implementation of program-level learning outcomes in this context were program accreditation, the leadership qualities of the curriculum chair, a strong and adequately resourced curriculum team that was able to engage and mobilize the faculty learning community, and scholarly approaches to curriculum reform.Conclusion
An integrated range of institutional and programmatic strategies enhance the implementation of program-level learning outcomes in a 4-year undergraduate curriculum. 相似文献12.
AIMS
To determine the prevalence and treatment of hypertension, dyslipidaemia and both together in the UK between 1998 and 2006.METHODS
We used The Health Improvement Network (THIN) a general practice-based database from 1998 to 2006 and we compared the 1998 and 2003 data to that taken from the Health Survey for England (HSE) in 1998 and 2003.RESULTS
The prevalence (treatment) of hypertension was 25.3% (11.4%) in 1998, 27.8% (15.1%) in 2003 and 26.9% (16.2%) in 2006 in THIN. In HSE it was 37.3% (9.6%) in 1998 and 32.9% (13.8%) in 2003. For dyslipidaemia the figures were 8.6% (1.9%), 18.5% (6.5%) and 24.4% (9.8%) for THIN and 67.8% (2.3%) and 74.9% (7.0%) for HSE. Concurrent hypertension and dyslipidaemia in THIN increased from 5.5% (1.1%) in 1998 to 13.5% (4.5%) in 2003 and 17.4% (7.1%) in 2006. The prevalence of both conditions was 30.6% (0.7%) in HSE in 1998 and 28.7% (3.1%) in 2003.CONCLUSIONS
There has been a progressive improvement in the detection and treatment of hypertension, dyslipidaemia and both conditions together between 1998 and 2006. However, much still needs to be done to improve the diagnosis and treatment of hypertension, hypercholesterolaemia and concurrent hypertension and hypercholesterolaemia in the United Kingdom.WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT
- The 1998 and 2003 Health Survey for England revealed a high prevalence of hypertension and hypercholesterolaemia in the population of England.
- Major changes in the reimbursement of primary care for the management of both hypertension and hypercholesterolaemia have occurred in the UK.
WHAT THIS STUDY ADDS
- Using a GP database we have examined the proportion of subjects diagnosed and treated for hypertension and hypercholesterolaemia over time. To examine the true population rates and primary care data we compared the results of the Health survey for England in both 1998 and 2003 with the recorded data on GP computers.
- Despite current guidelines, many patients with hypertension and/or hypercholesterolaemia are under-treated and, even amongst those who are treated, many do not achieve their blood pressure and/or lipid targets.
- Although treatment rates in the UK have improved recently, particularly for lipid-lowering therapies, they remain suboptimal.
13.
Aim:
To develop a novel gastroretentive drug delivery system based on a self-microemulsifying (SME) lipid mixture for improving the oral absorption of the immunosuppressant tacrolimus.Methods:
Liquid SME mixture, composed of Cremophor RH40 and monocaprylin glycerate, was blended with polyethylene oxide, chitosan, polyvinylpyrrolidone and mannitol, and then transformed into tablets via granulation, with ethanol as the wetting agent. The tablets were characterized in respect of swelling, bioadhesive and SME properties. In vitro dissolution was conducted using an HCl buffer at pH 1.2. Oral bioavailability of the tablets was examined in fasted beagle dogs.Results:
The tablet could expand to 13.5 mm in diameter and 15 mm in thickness during the initial 20 min of contact with the HCl buffer at pH 1.2. The bioadhesive strength was as high as 0.98±0.06 N/cm2. The SME gastroretentive sustained-release tablets preserved the SME capability of the liquid SME formations under transmission electron microscope. The drug-release curve was fit to the zero-order release model, which was helpful in reducing fluctuations in blood concentration. Compared with the commercially available capsules of tacrolimus, the relative bioavailability of the SME gastroretentive sustained-release tablets was 553.4%±353.8%.Conclusion:
SME gastroretentive sustained-release tablets can enhance the oral bioavailability of tacrolimus with poor solubility and a narrow absorption window. 相似文献14.
Objective
The aim of this study was to determine the efficacy of sustained-release fampridine (4-aminopyridine) in veterans with multiple sclerosis (MS) with limited ambulatory ability, and its impact on motor function in an outpatient setting.Design
Retrospective.Setting
Tertiary referral center [Veterans Affairs (VA) Medical Center].Participants
Veterans; 20 MS patients were prescribed dalfampridine (10 mg twice daily) due to their difficulty with walking based on patient and caregiver report and clinician impression of change in the ability to ambulate based on prior 10-meter (10M) and 2-minute walk tests (2MWTs).Intervention
Not applicable.Main Outcome Measures
The primary outcome measures were mean changes in walking speed (10M walk test), walking distance (2MWT), and Total Functional Independence Measure (TFIM). Improvement of >20 % in walking speed was indicated as a clinically meaningful change.Results
Treatment with dalfampridine resulted in significant improvement in walking speed and endurance (p < 0.05). Walking speed increased by 33 % and walking endurance by 31 %, representing clinically meaningful improvement. This change was not influenced by change in muscle tone. This improvement in mobility was associated with a clinically significant change in motor function. Adverse effects, including insomnia, dizziness, and headache, were experienced by five patients who discontinued the medication after a minimum of 4 weeks.Conclusion
Treatment with dalfampridine resulted in clinically relevant improvements in walking speed and endurance in MS patients with limited ambulation and helped improve their motor function.Electronic supplementary material
The online version of this article (doi:10.1007/s40268-013-0020-x) contains supplementary material, which is available to authorized users. 相似文献15.
Farhad Etezadi Pejman Pourfakhr Mojtaba Mojtahedzade Atabak Najafi Reza Shariat Moharari Kourosh Karimi Yarandi Mohammad Reza Khajavi 《Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences》2012,20(1):36
Background
Recently, several studies have been conducted to determine the optimal strategy for intra-operative fluid replacement therapy in renal transplantation surgery. Since infusion of sodium bicarbonate as a buffer seems to be safer than other buffer compounds (lactate, gluconate, acetate)that indirectly convert into it within the liver, We hypothesized tight control of metabolic acidosis by infusion of sodium bicarbonate may improve early post-operative renal function in renal transplant recipients.Methods
120 patients were randomly divided into two equal groups. In group A, bicarbonate was infused intra-operatively according to Base Excess (BE) measurements to achieve the normal values of BE (−5 to +5 mEq/L). In group B, infusion of bicarbonate was allowed only in case of severe metabolic acidosis (BE ≤ −15 mEq/L or bicarbonate ≤ 10 mEq/L or PH ≤ 7.15). Minute ventilation was adjusted to keep PaCO2 within the normal range. Primary end-point was sampling of serum creatinine level in first, second, third and seventh post-operative days for statistical comparison between groups. Secondary objectives were comparison of cumulative urine volumes in the first 24 h of post-operative period and serum BUN levels which were obtained in first, second, third and seventh post-operative days.Results
In group A, all of consecutive serum creatinine levels were significantly lower in comparison with group B. With regard to secondary outcomes, no significant difference between groups was observed.Conclusion
Intra-operative tight control of metabolic acidosis by infusion of Sodium Bicarbonate in renal transplant recipients may improve early post-operative renal function. 相似文献16.
Kimmel SE Schelleman H Berlin JA Oslin DW Weinstein RB Kinman JL Sauer WH Lewis JD 《British journal of clinical pharmacology》2011,72(3):514-517
AIM
To evaluate whether selective serotonin re-uptake inhibitor (SSRI) exposure influences the risk of myocardial infarction (MI) in patients with depression.METHODS
This study included 693 patients with MI (cases) and 2772 controls. Conditional logistic regression was used to calculate the odds ratio (OR).RESULTS
SSRI exposure may be associated with a reduced MI risk (OR = 0.77, 95% CI 0.57, 1.03). However, reduced risk was only observed with longer term use (OR = 0.73, 95% CI 0.53, 1.00) and not with shorter term use (OR = 1.15, 95% CI: 0.65, 2.05).CONCLUSIONS
Only longer term use of SSRIs was associated with reduced MI risk, suggesting that other mechanisms, besides an acute anti-platelet effect, may reduce MI risk. 相似文献17.
18.
Background:
Pharmacists and pharmacy technicians have an opportunity to impact the quality of the medication histories and improve patient safety by ensuring accurate medication lists are obtained and complete reconciliation has occurred with the admission medication orders by owning the admission medication reconciliation process.Objective:
To compare the quality of a pharmacy-based medication reconciliation program on admission utilizing pharmacists and technicians to the usual multidisciplinary process.Methods:
This was a retrospective chart review process improvement study at a 186-bed tertiary care inpatient facility. Primary outcomes included both the accuracy of pre-admission medications listed and the reconciliation of those medications with admission inpatient orders. Technicians obtained patient medication histories. Pharmacists checked the technician-obtained medication histories and ensured reconciliation of those medications with admission orders.Results:
Medication accuracy increased from 45.8% to 95% per patient (P < .001) and medication reconciliation increased from 44.2% to 92.8% (P < .001) and remained above benchmark.Conclusion:
A pharmacy-based medication reconciliation program utilizing both pharmacists and technicians significantly increased the accuracy and reconciliation of medications on admission. These gains were maintained for the duration of the 6-month period studied and beyond per continued process improvement data collection. 相似文献19.