Deviant Dosing: A Post hoc Analysis of Pharmacist Characteristics Related to Renal Dosing Decisions.

BACKGROUND: A recent study demonstrated that pharmacists presented with multiple estimating equations deviated from recommended dosing guidance more often than pharmacists who were presented with a single estimate on clinical vignettes. OBJECTIVES: To identify characteristics associated with an increased tendency to deviate from approved recommendations. METHODS: Participant data were split into 2 cohorts: pharmacists who chose a dose that was inconsistent with dosing recommendations on at least 1 of the 4 vignettes and pharmacists who did not deviate on a single case. Bivariate analysis of demographic- and practice-related variables were conducted between groups using the χ2, Mann-Whitney U, or Student t-test for nominal, ordinal, and continuous variables, respectively. Statistically different covariates between groups (P < 0.05) were assessed using multivariable linear regression. RESULTS: Survey data from 154 inpatient pharmacists, 71 of whom deviated on at least 1 clinical vignette, were analyzed. On univariate analysis, deviator pharmacists were more likely to have completed postgraduate residency training (68% vs 41%; P < 0.05) and board certification (39% vs 20%; P < 0.05). Deviator pharmacists were also more likely to have been presented with multiple renal estimates as opposed to a single estimate and had differing renal dosing practices at baseline (P < 0.05). Following multivariable regression, residency training, mismatched baseline renal practices, and multiple renal estimates remained independent predictors (P < 0.05) of dosing deviation. CONCLUSION AND RELEVANCE: Higher clinical training, practice variation, and multiple renal estimates may affect renal dosing practices. Prospective, statistically powered studies are needed to verify these hypotheses.

The Impact of Multiple Renal Estimates on Pharmacist Dosing Recommendations: A Randomized Trial.

BACKGROUND: Numerous equations are used for estimation of renal function, and many electronic medical records report multiple clearance estimates to assist with drug dosing. It is unknown whether the presence of multiple clearance estimates affects clinical decision-making. OBJECTIVE: To determine whether the presence of multiple renal clearance estimates affects pharmacist drug dosing decisions. METHODS: A randomized trial in the form of an electronic survey including 4 clinical vignettes was delivered to hospital pharmacists. Vignettes consisted of a patient presenting with an acute pulmonary embolism requiring enoxaparin therapy. Pharmacists were randomized to receive a single estimate of renal function or multiple estimates for all vignettes. The primary outcome was deviation from approved recommendations on at least 1 vignette. The χ2 test was used to detect differences in deviation rates between groups. Logistic regression was performed to adjust for the effects of potentially confounding variables. RESULTS: A total of 154 studies were completed (73 in the multiple-estimate group and 81 in the single-estimate group). Pharmacists presented with multiple renal estimates were significantly more likely to deviate from recommended dosing regimens than pharmacists presented with a single estimate (54.7% vs 38.2%; P = 0.04). The results were driven primarily by the 2 vignettes that included discordance among Cockcroft-Gault equation creatinine clearance estimates. Logistic regression identified multiple estimates as the only independent predictor of deviation (P = 0.04). CONCLUSION AND RELEVANCE: Pharmacists provided with a single renal clearance estimate were more likely to adhere to approved dosing recommendations than pharmacists provided with multiple estimates.

Dual- Versus Mono-Bronchodilator Therapy in Moderate to Severe COPD: A Meta-analysis.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) guidelines recommend both long-acting and dual bronchodilator therapy. It is unclear if there are differences in efficacy and safety. OBJECTIVE: This meta-analysis evaluates the efficacy of dual therapy with long-acting ß-agonist (LABA) + long acting muscarinic antagonist (LAMA) compared with monotherapy with LAMA for COPD. METHODS: We searched PubMed, CINAHL, and Web of Science databases from inception through March 2020 to identify English-language, prospective randomized controlled trials (RCTs) that compared dual therapy with monotherapy in adult patients with COPD. Risk of bias was assessed using the Jadad score. Overall analysis was performed using Review Manager 5.3. Treatment effect was determined with the random-effects model using the Mantel-Haenszel method and was reported as mean difference (MD) with 95% CI. RESULTS: A total of 18 RCTs were included (n = 6086; median Jadad score 5/5) that compared LAMA + LABA with LAMA. There was a greater improvement in forced expiratory volume at 1 s (FEV1) with dual therapy compared with LAMA: MD = 0.08; 95% CI = [0.05, 0.11]. There was no difference in St George Respiratory Questionnaire (SGRQ) scores between groups: OR = -0.85; 95% CI = [-1.83, 0.13]. There were no differences in overall adverse events (OR = 1.00; 95% CI = 0.92, 1.09), serious adverse events (OR = 1.01; 95% CI = 0.86, 1.18), or cardiovascular events (OR = 0.88; 95% CI = 0.58, 1.34). CONCLUSION AND RELEVANCE: Dual therapy improves FEV1 and is as safe as LAMA. Dual therapy does not improve SGRQ scores more than LAMA.

Efficacy of Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome: A Systematic Review.

Objective: Cannabinoid hyperemesis syndrome (CHS) is characterized by cyclic vomiting, abdominal pain, and alleviation of symptoms via hot showers in chronic cannabinoid users. Capsaicin is recommended as a reasonable first-line treatment approach for CHS despite limited clinical evidence regarding its use. The objective of this study is to systematically review the efficacy data for capsaicin in CHS. Data Sources: A literature search using keywords related to cannabinoids, emesis, and capsaicin was performed in MEDLINE, CINAHL, and EMBASE from inception through March 31, 2019. Study Selection and Data Extraction: Studies and published abstracts in which capsaicin was used for CHS and clinical outcomes were reported were eligible for inclusion. Data Synthesis: A total of 241 articles were screened, of which 5 full-text articles and 6 conference abstracts were included. Full-text case reports (n = 3) and case series (n = 2) found capsaicin to be effective in a total of 18 patients. Published abstracts were in the form of case reports (n = 1), case series (n = 3), and retrospective cohort studies (n = 2). Relevance to Patient Care and Clinical Practice: Capsaicin use was described as beneficial in all case series and case reports; however, both retrospective cohort studies were unable to find a significant benefit for capsaicin on primary outcomes (emergency department length of stay). Conclusion: Current data for capsaicin efficacy in CHS is of low methodological quality. However, the limited data on alternative antiemetic therapies and capsaicin's favorable risk-benefit profile make it a reasonable adjunctive treatment option.

Therapeutic Enoxaparin in the Morbidly Obese Patient: A Case Report and Review of the Literature.

Enoxaparin is a low molecular weight heparin commonly used in the treatment of venous thromboembolisms (VTEs); however, evidence on optimal empiric dosing recommendations are lacking in patients with morbid obesity. Utilization of an absolute dose cap, anti-Xa monitoring, and reduced empiric dosing are among the techniques used in this population. We describe a case of a morbidly obese man (body-mass index, BMI: 68.2 kg/m2, total body weight: 236 kg) who required therapeutic enoxaparin for suspected pulmonary embolism (PE) and critical limb ischemia as a bridge therapy during warfarin initiation. An initial empiric dose of 200 mg Q12 hours (0.85 mg/kg) resulted in an anti-Xa level of 1.01 IU/mL following the fifth dose, and no dose modification was deemed necessary. He experienced no adverse effects from treatment. This report adds to a growing body of evidence illustrating the need for reduced empiric weight-based doses of enoxaparin in the morbidly obese population and raises the question of whether dose capping is an appropriate practice in the clinical setting of morbidly obese patients with acute VTE.

Pharmacotherapy in Acutely Anemic Jehovah's Witnesses: An Evidence-Based Review.

OBJECTIVE: To determine the pharmacological treatment methods available to anemic Jehovah's Witnesses (JW). DATA SOURCES: MEDLINE and PubMed were searched from inception through February 2018 using the search terms Jehovah's Witnesses, treatment, erythropoietin, hemoglobin-based oxygen carrier, Sanguinate, Hemopure, bleeding, and anemia. STUDY SELECTION AND DATA EXTRACTION: All clinical trials, cohort studies, case-control studies, and observational trials involving pharmacotherapy in anemic JW patients were evaluated. Case reports and bibliographies were also analyzed for inclusion. DATA SYNTHESIS: Two studies involving the use of erythropoietin (EPO) and one study involving recombinant factor VIIa were included. Information was also included from other pharmacotherapeutic modalities that had case report data only. Current published evidence is limited with regard to evidence-based management of JW patients. High-dose EPO, intravenous iron supplementation, and hemostatic agents have demonstrated good clinical outcomes in case reports. EPO doses as high as 40 000 units daily have been advocated by some experts; however, pharmacokinetic studies do not support dose-dependent effects. Hemoglobin-based oxygen carriers (HBOCs) are currently not Food and Drug Administration approved. They are available through expanded access programs and may represent a lifesaving modality in the setting of severe anemia. CONCLUSIONS: There are currently not enough data to make definitive recommendations on the use of pharmacological agents to treat severe anemia in the JW population. Further evidence utilizing EPO and HBOCs will be beneficial to guide therapy.

Biologic-Induced Infections in Inflammatory Bowel Disease: The TNF-α Antagonists.

OBJECTIVE: To review the mechanism and association of infectious risk among the tumor-necrosis factor α (TNF-α) antagonists used in inflammatory bowel disease. DATA SOURCES: A PubMed literature search was performed using the following search terms: infliximab, adalimumab, certolizumab, golimumab, inflammatory bowel disease, crohn's, ulcerative colitis, adverse effects, adverse events, safety, and infection. STUDY SELECTION AND DATA EXTRACTION: Meta-analyses and cohort studies with outcomes pertaining to quantitative infectious risk were reviewed. Case reports and case series describing association between TNF-α inhibitors and infection were also reviewed. DATA SYNTHESIS: A total of 7 recent meta-analyses of randomized trials demonstrate inconclusive association of infection with TNF-α antagonists. Registry data suggest that medications carry an independent risk of opportunistic infections. Risk factors for infection include older age, malnutrition, diabetes, and possibly combination therapy. Reported infections vary widely but include intracellular and granulomatous bacteria, viruses, and fungi. CONCLUSION: TNF-α antagonists are associated with an increased risk of opportunistic infection, although this risk has not been demonstrated conclusively in randomized controlled trials. Knowledge of concomitant risk factors, mechanism of infectious risk, and available treatment options can improve patient care in the clinical setting.

Meta-Analysis: Vancomycin Treatment Failures for MRSA Bacteremia Based on MIC Determined by E-test.

Background: Vancomycin is used to treat serious infections caused by methicillin-resistant Staphylococcus aureus (MRSA). It is unclear whether MRSA isolates with minimum inhibitory concentration (MIC) 1.5 to 2 µg/mL are successfully treated with vancomycin. Objective: Evaluate vancomycin failure rates in MRSA bacteremia with an MIC <1.5 versus ≥1.5 µg/mL, and MIC ≤1 versus ≥2 µg/mL. Methods: A literature search was conducted using MESH terms vancomycin, MRSA, bacteremia, MIC, treatment and vancomycin failure to identify human studies published in English. All studies of patients with MRSA bacteremia treated with vancomycin were included if they evaluated vancomycin failures, defined as mortality, and reported associated MICs determined by E-test. Study sample size, vancomycin failure rates, and corresponding MIC values were extracted and analyzed using RevMan 5.2.5. Results: Thirteen studies including 2955 patients met all criteria. Twelve studies including 2861 patients evaluated outcomes using an MIC cutoff of 1.5 µg/mL. A total of 413 of 1186 (34.8%) patients with an MIC <1.5 and 531 of 1675 (31.7%) patients with an MIC of ≥1.5 µg/mL experienced treatment failure (odds ratio = 0.72, 95% confidence interval = 0.49-1.04, P = .08). Six studies evaluated 728 patients using the cutoffs of ≤1 and ≥2 µg/mL. A total of 384 patients had isolates with MIC ≤1 µg/mL, 344 had an MIC ≥2 µg/mL. Therapeutic failure occurred in 87 and 102 patients, respectively (odds ratio = 0.61, 95% confidence interval = 0.34-1.10, P = .10). As heterogeneity between the studies was high, a random-effects model was used. Conclusion: Vancomycin MIC may not be an optimal sole indicator of vancomycin treatment failure in MRSA bacteremia.

Effect of bariatric surgery on hypertension: a meta-analysis.

PURPOSE: Obesity is a growing epidemic leading to worldwide public health concerns. Bariatric surgery is an option for patients with a body mass index (BMI) >40 kg/m(2) or BMI of >35 kg/m(2) with serious comorbid conditions. This meta-analysis examines the effect of bariatric surgery on the improvement or resolution of hypertension. METHODS: Two independent investigators conducted a literature search of PubMed (1990-2013) and Cochrane databases using the terms bariatric surgery and hypertension to identify appropriate human adult studies published in English. Studies were included if they reported the number of patients with hypertension prior to undergoing any bariatric surgery procedure and whether the hypertension improved or resolved postsurgery. The number of patients with hypertension and their response rates were extracted and analyzed using RevMan 5.2.5. RESULTS: In all, 31 prospective and 26 retrospective studies met all criteria. The types of bariatric surgery performed included Roux-en-Y, gastric banding, laparoscopic adjustable gastric banding, vertical gastric banding, sleeve gastrectomy, duodenal switch, and biliopancreatic diversion. The time to first follow-up after surgery varied from 1 week to 7 years. Of the 57 studies, 32 reported improvement of hypertension in 32 628 of 51 241 patients (odds ratio [OR] = 13.24; 95% CI = 7.73, 22.68; P < 0.00001); 46 studies reported the resolution of hypertension in 24 902 of 49 844 patients (OR = 1.70; 95% CI = 1.13, 2.58; P = 0.01). A random-effects model was used because the heterogeneity between the studies was high (I (2) = 97%). CONCLUSION: The results of this meta-analysis indicate that patients who undergo bariatric surgery experience improvement and resolution of their hypertension.

Teduglutide for the Treatment of Short Bowel Syndrome.

OBJECTIVE: To review the pharmacology, pharmacokinetics, clinical efficacy, and safety of the newly approved drug, teduglutide, for the treatment of short bowel syndrome (SBS). DATA SOURCES: Literature was retrieved through PubMed (1966-March 2014) using the search term teduglutide. The authors applied the filters Humans and English language, resulting in 47 publications. STUDY SELECTION AND DATA EXTRACTION: The authors reviewed the 47 citations to extract those that were published clinical trials. Bibliographies of recent review articles and editorials were evaluated for additional pertinent publications for inclusion. The methods and results from each of the trials were extracted. DATA SYNTHESIS: Teduglutide has been studied in SBS in 3 phase III trials. Teduglutide decreases parenteral nutrition (PN) volume requirements, with 1 study showing a reduction of 4.4 ± 3.8 L/wk with teduglutide 0.05 mg/kg versus 2.3 ± 2.7 L/wk with placebo; P < 0.001. In another study, teduglutide improved graded response scores, which are based on the intensity and duration of the reduction of PN use (16/35 assigned to teduglutide 0.05 mg/kg vs 1/16 assigned to placebo; P = 0.007). The dosing range studies have indicated that the optimal dose of teduglutide is 0.05 mg/kg daily subcutaneously. There are a number of adverse effects reported in the trials, including abdominal pain or distention, injection site reactions, nausea, headaches, and fluid overload among others. There is also a concern for the development of malignancy with teduglutide, and therefore, it is not recommended in patients with active gastrointestinal malignancies. CONCLUSIONS: Overall, teduglutide appears to be a promising agent for the treatment of SBS.

A scaffolded problem-based learning course for first-year pharmacy students.

BACKGROUND AND PURPOSE: There has been an increased use of active learning pedagogies in pharmacy curricula. Structured, complex pedagogies such as problem-based learning (PBL) may require rigorous training for students to be successful. We aim to describe the development and implementation of an introductory PBL course for first-year pharmacy students. We describe the theoretical framework for course development, including the educational philosophies informing the course design. Development of PBL skills and professional behavior were evaluated using student self-assessment throughout the course. EDUCATIONAL ACTIVITY AND SETTING: This introductory PBL course was developed using educational philosophies to scaffold student learning of the pedagogy and development of PBL skills. A student self-assessment was administered at two time points throughout the course. The self-assessment contained items related to PBL skills and professional behaviors. Self-assessment scores were compared with facilitator evaluations of student performance to determine reliability of self-assessment results. FINDINGS: Eighty-eight students completed both self-assessments (93.6% response rate). Self-assessment of PBL skills increased significantly. There was no improvement in self-assessed professional behaviors. Self-assessment scores did not correlate with facilitator assessment of student performance in a small group. SUMMARY: Integrating a scaffolded, theoretically sound educational approach to introduce students to the PBL pedagogy improves students' self-assessed PBL skills but not professional behavior.

Treating bugs with bugs: the role of probiotics as adjunctive therapy for Helicobacter pylori.

OBJECTIVE: To review the literature on the role of probiotics as adjunctive therapy in the treatment of Helicobacter pylori infections. DATA SOURCES: Literature was accessed through MEDLINE (1966-March 2011) using the terms H. pylori, probiotic, Lactobacillus, Bifidobacterium, Saccharomyces, Bacillus clausii, and Propionibacterium. Article references were hand-searched for additional relevant articles and abstracts. STUDY SELECTION AND DATA EXTRACTION: All English-language articles published in full were evaluated. Randomized, double-blind, placebo-controlled trials assessing the use of probiotics combined with standard eradication therapy of H. pylori infection in adults were included in the review. DATA SYNTHESIS: Various probiotics, including Lactobacillus spp., Saccharomyces spp., Bifidobacterium spp., and B. clausii, reduce adverse effects such as nausea, taste disturbance, diarrhea, and epigastric pain, and increase tolerability of H. pylori eradication therapy. Based on the studies reviewed, probiotics do not affect H. pylori eradication rates. CONCLUSIONS: Probiotics may be beneficial in reducing adverse effects and increasing tolerability of H. pylori eradication regimens. They may especially be helpful in patients with recurrent H. pylori infection and a history of gastrointestinal adverse effects with antibiotics. Pharmacists can play an important role in educating patients regarding probiotic use during H. pylori eradication therapy.

Reliability and Validity of a Checklist to Evaluate Student Performance in a Problem-Based Learning Group.

Objective. To validate a problem-based learning (PBL) evaluation checklist to assess individual Doctor of Pharmacy (PharmD) students' performance in a group. Methods. In 2013, a performance checklist was developed and standardized. To evaluate the reliability and discriminant validity of the checklist, pharmacy students' evaluation scores from 2015-2016 were assessed along with overall program grade point averages (GPA), and scores on knowledge and problem-solving examinations. Predictive analysis software was used to analyze the data. Results. Seventy facilitators generated 1506 evaluation reports for 191 (90 third-year and 101 second-year) students over eight PBL cases. The mean (SD) total score was 40.6 (2.5) for P3s and 39.1 (2.7) for P2s out of a possible 44.2 points. Students' scores improved each semester. Interrater reliability based on intraclass correlation coefficient for all cases was 0.67. Internal reliability as determined by Cronbach alpha was >0.7 for all binary checklist items across all cases. Discriminant validity assessed using Pearson correlation coefficient showed that the total score from the checklist did not correlate with knowledge or problem-solving examination scores. Conclusion. This unique PBL checklist proved to be a reliable and valid tool to assess student performance in small group sessions in a PharmD curriculum.

Effectiveness of probiotics in the treatment of irritable bowel syndrome.

Recently, the use of tegaserod and alosetron -- drugs approved for the treatment of irritable bowel syndrome (IBS) -- has been restricted because of adverse events. This has resulted in a need for additional modalities for the treatment of IBS. Our objective was to determine the effectiveness of probiotics in the global relief of symptoms associated with IBS and in the improvement of flatulence, abdominal pain, transit time, and bacterial counts. Using the MEDLINE database from 1966-October 2007 and manually searching article references for relevant articles and abstracts, we identified 14 blinded, placebo-controlled clinical trials of the effectiveness of probiotics in the treatment of IBS. Of 11 studies in which overall symptom relief was assessed, seven indicated a significant improvement with probiotics versus placebo. Five of eight investigations of abdominal pain and distention revealed a benefit with probiotic use. Four studies demonstrated an improvement in symptomatic flatulence in probiotic treatment groups, whereas one study showed no significant benefit. Four of five studies of the effects of probiotics on colonic transit time revealed a benefit compared with placebo. As probiotics have shown benefit and possess a favorable adverse-effect profile, their use may represent an option for symptom relief in patients with IBS. However, additional data are necessary before probiotics can become a standard of care in the treatment of IBS, a complex and chronic condition.

Multi-matrix system mesalamine: to use or not to use.

OBJECTIVE: To evaluate the role of Multi-Matrix System (MMX) mesalamine in the treatment of ulcerative colitis (UC). DATA SOURCES: Literature was obtained through searches of MEDLINE (1966-October 2007) and a bibliographic review of published articles. Key terms used in the searches included ulcerative colitis, mesalamine, MMX, SPD476, and Lialda. STUDY SELECTION AND DATA EXTRACTION: All English-language articles that were identified through the search were evaluated. All primary literature was included in the review. DATA SYNTHESIS: The standard treatment for the induction and maintenance of remission in patients with mild-to-moderate UC is aminosalicylate products (mesalamine, sulfasalazine, balasalazide, olsalazine). Current mesalamine formulations are not ideal for long-term treatment due to issues with patient adherence secondary to complex dosing regimens and high pill burden. Clinical studies show that MMX mesalamine achieves clinical and endoscopic remission more frequently compared with placebo or mesalamine enema. Patients receiving MMX mesalamine achieved statistically significant clinical and endoscopic remission when compared with those taking placebo (34.1% vs 12.9%; p < 0.001 with 2.4 g/day vs placebo, and 29.2% vs 12.9%; p = 0.009 with 4.8 g/day vs placebo). Similarly, in another study, significantly more patients achieved remission in the MMX mesalamine groups compared with patients in the placebo group (40.5% vs 22.1% with 2.4 g/day vs placebo; p = 0.01, and 41.2% vs 22.1% with 4.8 g/day vs placebo; p = 0.007). MMX mesalamine is well tolerated, with headache, flatulence, and abdominal pain being the most frequently reported adverse events. CONCLUSIONS: Current evidence supports the use of MMX mesalamine for treatment of mild-to-moderate UC by demonstrating that MMX mesalamine 2.4-4.8 g daily induces remission. It has the advantage of once-daily dosing regimens with lower pill burden than comparable products and, as an oral agent, may have better patient acceptability compared with topical mesalamine formulations. Therefore, MMX mesalamine is an option in patients with UC. The cost of MMX mesalamine is comparable to that of oral and rectal formulations of mesalamine. Further pharmacoeconomic studies are warranted to examine the cost impact of MMX mesalamine.

Adherence to GOLD Guidelines in the Inpatient COPD Population.

PURPOSE: The Global Initiative for Chronic Obstructive Lung Disease guidelines provide recommendations to manage chronic obstructive lung disease (COPD) exacerbations. This study assessed the management of inpatient COPD exacerbations at an urban teaching hospital. METHODS: A retrospective cohort analysis of adults admitted between December 2010 and August 2012 with a COPD exacerbation was conducted. Patient demographics, length of stay (LOS), Charlson comorbidity score, inpatient pulmonary medications, and 30-day readmission were collected. Descriptive statistics characterized guideline adherence and readmission. RESULTS: 94 patients were included with median LOS of 3 days (interquartile range [IQR]: 1-5 days) and median Charlson comorbidity score of 6 (IQR: 5-8). All patients received an inhaled short-acting beta agonist, and 52 (55.3%) also received an inhaled short-acting anticholinergic. Seventy-eight (83%) received systemic corticosteroids, of which 3 received guideline-recommended doses. Sixty-four (68.1%) received antibiotics for a pulmonary indication, of which 71.9% received appropriate antibiotics per indication. Of the 94 patients, 2 were managed in complete adherence with GOLD recommendations. A total of 24 (25.5%) patients were readmitted within 30 days of discharge, 9 of these for COPD. CONCLUSION: COPD exacerbation treatment deviated from GOLD recommendations. This provides opportunities for further optimization of treatment of COPD exacerbations.

Tegaserod for constipation-predominant irritable bowel syndrome.

Tegaserod, a selective and partial agonist at the 5-hydroxytryptamine (5-HT [serotonin]) receptor subtype 4 (5-HT4), is the only United States Food and Drug Administration-approved drug for the treatment of constipation-predominant irritable bowel syndrome (IBS) in women. The drug's stimulation of 5-HT4 receptors on intestinal enterocytes increases peristaltic activity and fluid secretion into the gut lumen, facilitating stool passage. In addition, affinity of tegaserod for 5-HT4 receptors modulates visceral sensitivity, which helps alleviate abdominal pain associated with constipation-predominant IBS. The drug's pharmacokinetic and pharmacodynamic parameters do not differ significantly with age or sex. Tegaserod safely and effectively relieves overall gastrointestinal symptoms and abdominal discomfort and normalizes bowel habits in patients with constipation-predominant IBS. It is associated with few drug interactions. In clinical studies, tegaserod was well tolerated, and its adverse-effect profile was similar to that of placebo. Severe diarrhea, as well as abdominal pain, flatulence, headache, and nausea, were the most commonly reported events. Patients who experience severe diarrhea should discontinue the drug. With the data available, tegaserod remains an option for patients with constipation-predominant IBS.

Prevention of postoperative nausea and vomiting.

OBJECTIVE: To review the literature on the prevention of postoperative nausea and vomiting (PONV) in adults. DATA SOURCES: Literature retrieval was accessed through MEDLINE (1966-December 2006) using the terms postoperative nausea and vomiting, prevention and treatment. Article references were hand-searched for additional relevant articles and abstracts. STUDY SELECTION AND DATA EXTRACTION: All studies published in English were evaluated. Those dealing with prevention and treatment of PONV in adults were included in the review. DATA SYNTHESIS: Evidence suggests that providing prophylactic antiemetic medications in high-risk surgical patients is warranted. 5-HT3 receptor antagonists are widely used, with no one agent being clearly superior. However, studies have shown other types of agents to be more cost-effective. CONCLUSIONS: The first step in the prevention of PONV is assessment and reduction of risk factors. Although nonpharmacologic therapies may play a role in the treatment of PONV, the mainstay of therapy for PONV is pharmacologic modalities. Patients at moderate to high risk for PONV need prophylactic antiemetic therapy. High-risk patients may require combination therapy with 2 or 3 agents from different antiemetic classes. Rescue antiemetic therapy is needed by patients who actually develop PONV. The agents of choice in such cases should be from antiemetic classes different from those used for prophylaxis of PONV.

Mild-to-moderate ulcerative colitis: your role in patient compliance and health care costs.

BACKGROUND: Ulcerative colitis (UC) is a chronic relapsing disease necessitating lifelong treatment. Most patients present with mild-to-moderate disease characterized by alternating periods of remission and clinical relapse. Continued disease progression and relapse of UC over time are associated with an increased risk of colorectal cancer (CRC). OBJECTIVE: To discuss the latest treatment options for mild-to-moderate UC, to review the current data involving the economics of UC, and to demonstrate the relationship between treatment adherence, clinical relapse, inflammation severity, CRC risk, and treatment outcomes. SUMMARY: One of the main goals of therapy in UC is to induce and maintain a long-lasting remission of disease to reduce or avoid the high personal and financial costs of relapse. In recent studies, researchers have demonstrated a link between increased colonic inflammation and CRC risk, highlighting the importance of preventing relapse, which can lead to costly surgical procedures and hospital stays and thus increase the cost of treatment 2- to 20-fold. The risk of disease relapse is affected by several factors, of which the most prominent is nonadherence to maintenance therapy. Nonadherence to therapy can be associated with several other factors, including forgetfulness, male sex, complicated dosing regimens, treatment delivery methods (oral vs. rectal), and pill burden. In the treatment of mild-to-moderate UC, 5-aminosalicyclic acid (5-ASA) is the standard first-line therapy and the treatment of choice for maintaining remission of disease. Novel formulations of 5-ASA and newly devised high-dose 5-ASA regimens offer more options for the treatment of UC and thus may lead to improved treatment adherence, longer remission, and improved patient well-being. CONCLUSION: Periods of remission during UC treatment must be aggressively maintained to prevent relapse and decrease the risk of an unfavorable outcome. By controlling the risks and conditions that lead to therapeutic nonadherence and relapse among patients with UC, clinicians can increase the likelihood of long-term remission and ensure favorable long-term outcomes.

Biosimilars in Inflammatory Bowel Disease - Accumulating Clinical Evidence.

INTRODUCTION: Biologic antagonists to tumor necrosis factor alpha (TNF- α) are effective medications and have become well established in the treatment of both Crohn's disease and ulcerative colitis. Biosimilar medications, which are medications deemed to be equivalent to reference biologic products in terms of clinical effectiveness, safety, pharmacokinetic analysis, and immunogenicity, have now been approved in inflammatory bowel diseases (IBD) based on indication exploration from clinical data in alternate disease states. Clinicians use these products with caution secondary to lack of clinical experience. Areas Covered: The authors performed a literature search using the following keywords: CT-P13, biosimilar, adalimumab, infliximab, ABP 501, and inflammatory bowel disease. Bibliographies were also reviewed for pertinent articles. Articles pertaining to the clinical efficacy of biosimilars in IBD were included. Expert commentary: The phase 3 trials, which provided the clinical justification to bring TNF- α biosimilars to market, were in rheumatoid arthritis and ankylosing spondylitis; however, new clinical data suggests that biosimilar products have equivalent safety and efficacy to reference products in IBD. This has led to an increased acceptance amongst practicing gastroenterologists and a potential reduction in healthcare costs.