Rectal indomethacin or intravenous gabexate mesylate as prophylaxis for acute pancreatitis post-endoscopic retrograde cholangiopancreatography.

OBJECTIVE: We aimed to evaluate the results in our case series of AP ERCP over the last three years. The prophylaxis for acute pancreatitis (AP) post-endoscopic retrograde cholangiopancreatography (ERCP) consists of rectal indomethacin, but some studies are not concordant. PATIENTS AND METHODS: We compared 241 ERCP performed from January 2014 to February 2015 with intravenous gabexate mesylate (Group A), with the 387 ERCP performed from March 2015 to December 2016 with rectal indomethacin (Group B) as prophylaxis for AP post-ERCP. RESULTS: There were 8 (3.31%) AP post-ERCP in Group A vs. 4 (1.03%) in Group B. CONCLUSIONS: Rectal indomethacin shows a better statistically significant performance than intravenous gabexate mesylate in the prophylaxis of AP post-ERCP, besides being cheaper.

Benefit-risk of corticosteroids in acute gout patients: An updated meta-analysis and economic evaluation.

The efficacy, safety and health-economic outcomes were compared between corticosteroid and non-corticosteroid treatments in acute gout patients. All electronic literatures comparing the curative effects or full economic evaluations of corticosteroids versus non-corticosteroids on acute pain in acute gout patients and published until June 30, 2017 in any language were searched through PubMed, EMBASE, Web of Science, and Cochrane Central Register of Controlled Trials. Pooled odds ratios with 95% confidence intervals and standard(or weighted) mean difference were calculated using random-or fixed-effects models according to the I2 statistic test of heterogeneity. Economic elevations were combined through qualitative narrative synthesis. Finally, seven randomized controlled trials(RCTs) involving 929 patients were included here and suggested corticosteroids had comparable analgesic efficacy to non-corticosteroids on day 5. As for inflammation and PGA, corticosteroids might outperform non-corticosteroids in reducing tenderness and swelling. Corticosteroids versus non-corticosteroids could significantly reduce incidence of only serious adverse advents, but not total adverse advents, with substantial heterogeneity. Qualitative narrative synthesis of economic elevation involving only one study shows corticosteroids are more cost-effective than indomethacin. The existing RCTs do not provide sufficient or precise evidence that corticosteroids are superior to non-corticosteroids in pain relief of acute gout patients. Therefore, studies on chronic use of corticosteroids or comparative studies with colchicine, tramadol and/or opiates may be needed in the future, as is patient satisfaction with analgesic control.

An Expedited Care Pathway with Ambulatory Brachial Plexus Analgesia Is a Cost-effective Alternative to Standard Inpatient Care after Complex Arthroscopic Elbow Surgery: A Randomized, Single-blinded Study.

BACKGROUND: Common standard practice after complex arthroscopic elbow surgery includes hospital admission for 72 h. The authors hypothesized that an expedited care pathway, with 24 h of hospital admission and ambulatory brachial plexus analgesia and continuous passive motion at home, results in equivalent elbow range of motion (ROM) 2 weeks after surgery compared with standard 72-h hospital admission. METHODS: A randomized, single-blinded study was conducted after obtaining approval from the research ethics board. Forty patients were randomized in a 1:1 ratio using a computer-generated list of random numbers into an expedited care pathway group (24-h admission) and a control group (72-h admission). They were treated equally aside from the predetermined hospital length of stay. RESULTS: Patients in the control (n = 19) and expedited care pathway (n = 19) groups achieved similar elbow ROM 2 weeks (119 ± 18 degrees and 121 ± 15 degrees, P = 0.627) and 3 months (130 ± 18 vs. 130 ± 11 degrees, P = 0.897) postoperatively. The mean difference in elbow ROM at 2 weeks was 2.6 degrees (95% CI, -8.3 to 13.5). There were no differences in analgesic outcomes, physical function scores, and patient satisfaction up to 3 months postoperatively. Total hospital cost of care was 15% lower in the expedited care pathway group. CONCLUSION: The results suggest that an expedited care pathway with early hospital discharge followed by ambulatory brachial plexus analgesia and continuous passive motion at home is a cost-effective alternative to 72 h of hospital admission after complex arthroscopic elbow surgery.

Prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a cost-effectiveness analysis.

OBJECTIVES: The aim of the present study was to perform a comparative cost-effectiveness analysis of the different strategies used to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) acute pancreatitis. METHODS: We performed a cost-effectiveness decision analysis of 4 prophylactic strategies (nonsteroidal anti-inflammatory drugs or NSAIDs, pancreatic stent, stent plus rectal indomethacin, and no prophylaxis) in a simulated cohort of 300 patients during 1 year. Treatment effectiveness was defined as the number of patients who did not develop post-ERCP pancreatitis. RESULTS: The baseline costs of each strategy were as follows: rectal NSAID $359,098, pancreatic stent $426,504, stent plus rectal indomethacin $479,153, and no prophylaxis $491,275. The mean number of cases developing post-ERCP pancreatitis was 16, 21, 23, and 37 for the strategies rectal NSAID, pancreatic stent, stent plus rectal indomethacin, and no prophylaxis, respectively. Taking rectal NSAID prophylaxis as the reference strategy, the odds ratio of an episode of post-ERCP acute pancreatitis after pancreatic stent placement was 1.33 (95% confidence interval [CI], 0.68-2.61); after stent plus indomethacin, it was 1.40 (95% CI, 0.72-2.73), and after no prophylaxis, it was 2.49 (95% CI, 1.35-4.59). CONCLUSIONS: Rectal NSAID administration proved to be the most cost-effective prophylactic strategy used to prevent post-ERCP pancreatitis. The strategy of no prophylaxis for this complication should be avoided.

Contrast-enhanced sonothrombolysis in a porcine model of acute peripheral arterial thrombosis and prevention of anaphylactic shock.

Acute peripheral arterial thrombosis can be threatening to life and limb. Dissolution of the thrombus local catheter-directed intra-arterial infusion of fibrinolytic agents such as urokinase is the standard therapy for thrombosis; however, this method is time-intensive, and amputation of the affected limb is still needed in 10-30% of cases. Furthermore, thrombolytic therapy carries the risk of bleeding complications. The use of small gas-filled bubbles, or ultrasound contrast agents (UCAs), in combination with ultrasound has been investigated as an improved thrombolytic therapy in acute coronary and cerebral arterial thrombosis. The authors describe a porcine model of acute peripheral arterial occlusion to test contrast-enhanced sonothrombolysis approaches that combine ultrasound, UCAs and fibrinolytic agents and recommend a strategy for preventing severe allergic reactions to UCAs in the pigs.

Does rectal indomethacin eliminate the need for prophylactic pancreatic stent placement in patients undergoing high-risk ERCP? Post hoc efficacy and cost-benefit analyses using prospective clinical trial data.

OBJECTIVES: A recent large-scale randomized controlled trial (RCT) demonstrated that rectal indomethacin administration is effective in addition to pancreatic stent placement (PSP) for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk cases. We performed a post hoc analysis of this RCT to explore whether rectal indomethacin can replace PSP in the prevention of PEP and to estimate the potential cost savings of such an approach. METHODS: We retrospectively classified RCT subjects into four prevention groups: (1) no prophylaxis, (2) PSP alone, (3) rectal indomethacin alone, and (4) the combination of PSP and indomethacin. Multivariable logistic regression was used to adjust for imbalances in the prevalence of risk factors for PEP between the groups. Based on these adjusted PEP rates, we conducted an economic analysis comparing the costs associated with PEP prevention strategies employing rectal indomethacin alone, PSP alone, or the combination of both. RESULTS: After adjusting for risk using two different logistic regression models, rectal indomethacin alone appeared to be more effective for preventing PEP than no prophylaxis, PSP alone, and the combination of indomethacin and PSP. Economic analysis revealed that indomethacin alone was a cost-saving strategy in 96% of Monte Carlo trials. A prevention strategy employing rectal indomethacin alone could save approximately $150 million annually in the United States compared with a strategy of PSP alone, and $85 million compared with a strategy of indomethacin and PSP. CONCLUSIONS: This hypothesis-generating study suggests that prophylactic rectal indomethacin could replace PSP in patients undergoing high-risk ERCP, potentially improving clinical outcomes and reducing healthcare costs. A RCT comparing rectal indomethacin alone vs. indomethacin plus PSP is needed.

Oral prednisolone is more cost-effective than oral indomethacin for treating patients with acute gout-like arthritis.

OBJECTIVES: Acute gouty arthritis is often treated with NSAIDs, but recent studies have suggested that treatment with prednisolone has at least equivalent analgesic efficacy and fewer adverse effects. No formal economic analysis has been performed earlier. In this study, we aimed to compare the economic impact of oral indomethacin therapy and oral prednisolone therapy in the treatment of acute gout in patients presenting to an emergency department in Hong Kong. METHODS: Data from a previously published randomized controlled trial were used to compare the costs of the two treatment options. Direct, incremental costs incurred in the 2 weeks after the initial presentation were considered from the perspective of the healthcare provider. Costs were subdivided into those incurred in the emergency department phase; admission on day 1 to the emergency department's observation ward; admission subsequently to the general medical ward for adverse events and reattendance to the hospital outpatients' or emergency department. RESULTS: The prednisolone strategy resulted in cost savings in the emergency department of HK$5.67 (US$0.73; pound0.37) and in medical admissions of HK$1727.48 (US$221.47; pound111.45) per patient treated. Overall, the average saving with prednisolone was HK$1235 (US$158.33; pound79.68) per patient treated, which was equivalent to one admission bed/day saved for every two patients treated. Treatment for each of the six patients in the indomethacin group admitted for serious adverse effects cost the healthcare provider HK$13 244 (US$1697.95; pound854.45). CONCLUSION: Treatment of acute gouty arthritis with a 5-day course of prednisolone is significantly more cost-effective than treatment with indomethacin.

A cost decision analysis of 4 tocolytic drugs.

OBJECTIVE: The purpose of this study was to determine the optimal tocolytic agent, based on a cost decision analysis. STUDY DESIGN: A PubMed search of commonly used tocolytics was performed to determine the probability of adverse events. Cost for an agent was determined by acquisition cost and the probability and cost of adverse events. A decision tree was constructed to determine which tocolytic had the lowest total costs, with subsequent sensitivity analysis. RESULTS: A total of 19 clinical trials combined for a cohort of 1073 patients (indomethacin, 176 patients; magnesium sulfate, 451 patients; nifedipine, 176 patients; and terbutaline, 270 patients). The probability of adverse events was 57.9% for terbutaline, 22.0% for magnesium sulfate, 27.2% for nifedipine, and 11.4% for indomethacin. Nifedipine ($16.75) and indomethacin ($15.40) were the least expensive treatment options, compared with magnesium sulfate ($197.90) and terbutaline ($399.02) because of the cost of monitoring and treating adverse events. CONCLUSION: If one elects a tocolytic, both nifedipine and indomethacin should be the agents of choice, based on a cost decision analysis.

Cost-effectiveness of prophylactic indomethacin in very-low-birth-weight infants.

OBJECTIVE: To perform cost-effectiveness analysis to facilitate the decision-making process surrounding use of indomethacin in preterm infants to lower the incidence of patent ductus arteriosus (PDA), intraventricular hemorrhage (IVH), and death. METHODS: A MEDLINE literature search from 1966 to July 2000 was performed to identify relevant randomized, controlled trials (RCTs), as well as cohort and retrospective case-control studies. A decision tree was built representing the choice to use or not use indomethacin, and the potential outcome costs. Probabilities of being in each chance node were obtained from this search. Where data probabilities were not clear, a sensitivity analysis was conducted. RESULTS: There was no difference in the expected survival per year; however, there was a significant difference when effectiveness was measured as quality-adjusted life years (QALYs), resulting in 11 and 10 years for the indomethacin and control groups, respectively. The indomethacin treatment cost was $95,157 and that of the control groups was $99,955. The cost effectiveness per life expectancy of being in the indomethacin and control groups was $7142 and $7727, respectively. The sensitivity analysis for PDA closure and prevention of IVH for infants eventually developing PDA versus those without PDA showed no difference. The cost-effectiveness analysis per QALY was $8443 for the indomethacin treatment and $9168 for the control group. CONCLUSIONS: The prophylactic use of indomethacin is less costly and more effective within an important range of certainty. However, this analysis does not include several potentially confounding factors, such as antenatal steroid use or indomethacin-induced renal toxicity. Depending on the frequency with which these factors arise, economic projections may be considerably altered against the early use of indomethacin.

Stability of reconstituted indomethacin sodium trihydrate in original vials and polypropylene syringes.

The stability of reconstituted indomethacin sodium trihydrate 0.5 mg/mL in sterile water for injection for 14 days at either 2-6 degrees C or room temperature (21-25 degrees C) in the drug's original vial and in polypropylene syringes was studied. Twenty 1-mg vials of indomethacin sodium trihydrate were reconstituted with 2 mL of Sterile Water for Injection, USP. Solution from 10 vials was drawn into 20 1-mL disposable polypropylene syringes. Five vials and 10 syringes were stored at 21-25 degrees C, and the other 5 vials and 10 syringes were stored at 2-6 degrees C. Samples were taken on days 0, 1, 2, 4, 5, 7, 9, 12, and 14 and analyzed by liquid chromatography. Physical inspections and pH determinations were made as well. Throughout the study period, all solutions stored at 2-6 degrees C retained more than 95% of the initial indomethacin concentration. At room temperature, solutions stored in syringes retained more than 95% of the initial indomethacin concentration. Solutions stored in glass vials contained only 89.7% of the initial concentration on day 14. Solutions stored at room temperature in either syringes or vials had greater amounts of degradation products than solutions stored at 2-6 degrees C. Reconstituted indomethacin sodium trihydrate 0.5 mg/mL was stable for 14 days when stored in polypropylene syringes at 2-6 or 21-25 degrees C and in its original glass vials at 2-6 degrees C. When stored in the glass vials at 21-25 degrees C, the reconstituted drug was stable for 12 days.

Cost savings using a stepped-care prescribing protocol for nonsteroidal anti-inflammatory drugs.

OBJECTIVE: To lower nonsteroidal anti-inflammatory drug (NSAID) costs while maintaining quality patient care and clinician satisfaction. DESIGN: Before and after 21-month trial with one study site and two control sites and a questionnaire that was sent to 203 clinicians. SETTING AND SUBJECTS: Two military medical centers and two affiliated primary care clinics. All beneficiaries filling outpatient NSAID prescriptions. INTERVENTIONS: An NSAID prescribing protocol was implemented requiring a trial of either ibuprofen or indomethacin before new prescription of more expensive NSAIDs. One control center used an NSAID computer cost-prompt and the other had no intervention. MAIN OUTCOME MEASURES: The proportion of expensive NSAIDs prescribed at each institution and total NSAID costs adjusted for prescription volume. Clinician acceptance and patient impact were assessed by the questionnaire. RESULTS: Study site clinicians (n=158) reported very few protocol-related patient care problems. A minority (9%) of study site clinicians considered the protocol very bothersome, and only 2% felt it should be discontinued. Quarterly use of expensive NSAIDs at the study site fell from 34% to 21%, decreasing costs by 30% (P<.001). In contrast, the site with a computer cost-prompt had only a 5% decrease in NSAID costs, while costs at the site with no intervention increased 2%. CONCLUSIONS: For drugs with similar benefits and adverse effects, a "stepped formulary" approach requiring an initial trial of one of the less expensive agents can maintain physician prescribing choices and satisfaction while lowering costs.