Helicobacter pylori eradication regimens in an antibiotic high-resistance European area: A cost-effectiveness analysis.

INTRODUCTION: Helicobacter pylori infection (H pylori-I) affects more than half of the global population and consists an important burden to public health and healthcare expenditures, by contributing to many diseases' pathogenesis. AIM: This study aimed to evaluate the current nonbismuth quadruple eradication regimens in a high antibiotic resistance area, such as Greece, concerning their cost-effectiveness, especially during financial crisis period. MATERIALS AND METHODS: Eight hundred and nine patients who received eradication treatment against H pylori-I were included to evaluate five different regimens, using amoxicillin, clarithromycin, and metronidazole as antibiotics and one proton-pump inhibitor, based on their current eradication rates. Regimes compared 10-day concomitant use of (a) pantoprazole or (b) esomeprazole; 10-day sequential use of (c) pantoprazole or (d) esomeprazole; and 14-day hybrid using esomeprazole. Cost-effectiveness analysis ratio (CEAR) and incremental cost-effectiveness ratios were calculated taking into account all direct costs and cases who needed second-line treatment. Additionally, sensitivity analysis was performed to predict all potential combinations. RESULTS: Ten-day concomitant regimen with esomeprazole was characterized by the lowest CEAR (179.17€) followed by the same regimen using pantoprazole (183.27€). Hybrid regimen, although equivalent in eradication rates, was found to have higher CEAR (187.42€), whereas sequential regimens were not cost-effective (CEAR: 204.12€ and 216.02€ respectively). DISCUSSION: This is the first study evaluating the cost-effectiveness of H pylori-I treatment regimens in a high clarithromycin-resistance (≈26.5%) European area, suggesting the 10-day concomitant regimen with generics using esomeprazole 40 mg as the most appropriate one. National and regional guidelines should include cost-effectiveness in their statements, and further studies are required to clarify the necessity of a wide "test and treat" policy for H pylori-I.

Sequential Helicobacter pylori eradication therapy in Myanmar; a randomized clinical trial of efficacy and tolerability.

BACKGROUND AND AIM: There is little published research to examine the best approach to the management of Helicobacter pylori in Myanmar. This study aimed to determine the relative efficacy and tolerability of sequential eradication therapy compared to Myanmar's current recommendation of a concomitant four drug regimen. METHODS: Patients were screened for H. pylori using monoclonal Stool Antigen Testing (SAT). Those testing positive were randomized 1:1 to receive receive Myanmar's first-line regimen of 14 days of concomitant rabeprazole, clarithromycin, amoxycillin and tinidazole (140 pills, cost US$23) or 10 days of sequential rabeprazole, clarithromycin, amoxycillin and tinidazole (60 pills, cost US$10). Adherence and adverse effects were recorded, and the efficacy of the regimens assessed with repeat SAT. RESULTS: Of the 1011 patients screened for H. pylori infection, 313 (31%) tested positive. There was no statistical difference in the cure rates of the two regimens in either intention-to-treat: 128/157 (82%; 95% confidence interval (CI): 75-87%) receiving sequential therapy versus 123/156 (79%; 95% CI: 72-85%) receiving concomitant therapy (P = 0.55) or per-protocol analysis: 125/131 (95%; 95% CI: 90-98) receiving sequential therapy versus 121/130 (93%; 95% CI: 87-96) receiving concomitant therapy (P = 0.42). Side effects of therapy were reported in 54/157 (47%) patients taking sequential therapy compared with 62/156 (53%) taking concomitant therapy, but this difference did not reach statistical significance (P = 0.33). CONCLUSIONS: In this high-burden, resource-poor setting, less expensive sequential therapy was as effective and as well tolerated as the currently recommended concomitant four drug regimen for eradication of H. pylori.

Analysis of the cost-effectiveness of using vonoprazan-amoxicillin-clarithromycin triple therapy for first-line Helicobacter pylori eradication.

BACKGROUND: Vonoprazan (VPZ)-based triple therapy has been reported to have greater efficacy than a proton pump inhibitor (PPI)-based triple therapy for Helicobacter pylori (H. pylori) eradication. However, because VPZ is more expensive than PPIs such as rabeprazole (RPZ), economic evaluation is essential. METHODS: We performed a retrospective study on 209 patients who underwent first-line eradication of H. pylori infection in Fuyoukai Murakami Hospital from 1 March 2015 to 31 March 2016. Patients who received VPZ, amoxicillin (AMPC) and clarithromycin (CAM) were assigned to the VPZ/AC group (n = 111) and patients who received RPZ, AMPC and CAM to the RPZ/AC group (n = 98). We compared the patients' backgrounds, including age, gender, use of high-dose CAM, past history of peptic ulcer, smoking and drug-related adverse events between the two groups. We defined cost as direct medical costs per patient and effectiveness as the first-line eradication rate in the intention-to-treat (ITT) analysis and analyzed the cost-effectiveness using the cost-effectiveness ratio (CER) and incremental cost-effectiveness ratio (ICER). RESULTS: There was no significant difference in the patients' backgrounds. The ITT analysis revealed an eradication rate of 94.6% for VPZ/AC and 86.7% for RPZ/AC. VPZ/AC cost 1155.4 Japanese yen (JPY) higher than RPZ/AC (34063.4 vs. 32908.0, JPY). CER of VPZ/AC was less than that of RPZ/AC (360.1 vs. 379.4, JPY per percent) and ICER of VPZ/AC was 147.0 JPY (1.28 Euro (EUR), 1 EUR =115 JPY) per percent. CONCLUSIONS: VPZ/AC was more cost-effective than RPZ/AC as first-line therapy for H. pylori eradication.

Sequential therapy versus standard triple drug therapy for eradication of Helicobacter pylori in patients with perforated duodenal ulcer following simple closure.

BACKGROUND: Resistance to clarithromycin, a component of standard triple therapy, leads to inconsistent eradication rates of Helicobacter pylori infection. Some studies have shown higher eradication rates for H. pylori using sequential regimen. This study was done to compare the eradication rates for H. pylori infection between the standard triple drug therapy and the sequential therapy. METHODS: Seventy-three patients with perforated duodenal ulcer following simple closure with H. pylori infection were randomized to receive either standard triple drug therapy or the sequential therapy. Standard triple drug therapy comprised of omeprazole, clarithromycin, and amoxicillin for 10 days. Sequential therapy comprised of omeprazole and amoxicillin or the first 5 days followed by omeprazole, clarithromycin, and amoxicillin for the next 5 days. Follow-up endoscopy was done at 2 months to assess the eradication rates, compliance, and side effects with each regimen. RESULTS: Eradication rates for standard triple therapy and sequential regimen were 81.25% and 87.09%, respectively (p = 0.732). The cost of sequential therapy was cheaper and incidence of side effects and compliance were similar in each group. CONCLUSION: Standard triple therapy and sequential therapy have similar efficacy for eradication of H. pylori and sequential therapy is an economical alternative to standard triple therapy.

Oral versus i.v. antibiotics for community-acquired pneumonia in children: a cost-minimisation analysis.

Community-acquired pneumonia represents a high financial burden to healthcare providers. This manuscript seeks to estimate and compare the costs of treating children hospitalised with community-acquired pneumonia, with oral and intravenous antibiotics, thus determining which treatment is cost minimising. A cost-minimisation analysis was undertaken alongside a randomised controlled non-blinded equivalence trial. 232 children (from eight paediatric centres in England) diagnosed with pneumonia, who required admission to hospital, were randomised to receive oral amoxicillin or i.v. benzyl penicillin. The analysis considered the cost to the health service, patients and society, from pre-admission until the child was fully recovered. Oral amoxicillin and i.v. benzyl penicillin have equivalent efficacy. Children treated with i.v. antibiotics were found to have significantly longer in-patient stays (3.12 versus 1.93 days; p<0.001). i.v. treatment was found to be more expensive than oral treatment ( pound1,256 versus pound769; difference pound488; 95% CI: pound233- pound750), such that treatment of community-acquired pneumonia with oral amoxicillin would result in savings of between pound473 and pound518 per child (euro545 and euro596 per child) admitted. The findings demonstrate that oral amoxicillin is a cost-effective treatment for the majority of children admitted to hospital with pneumonia.

Quality and Brands of Amoxicillin Formulations in Nairobi, Kenya.

Antibiotics are among the most counterfeited anti-infectious medicines in developing countries. Amoxicillin is one of the commonly prescribed, affordable, and easily accessible antibiotic in Kenya. It is a broad-spectrum antibiotic hence commonly used in chemotherapy. This study sought to determine the quality and identify the various brands of amoxicillin and its combination amoxicillin/clavulanic acid marketed in Nairobi County. Nairobi is the capital city of Kenya, gateway for imports and exports, and the headquarters to most of the pharmaceutical distributors. Ten wards in Nairobi County representing different socioeconomic settings were purposively sampled for the study. A detailed questionnaire was used to collect background data on brands of amoxicillin and amoxicillin/clavulanic acid in the market. A total of 106 different brands were found in the market: 85 were imports while 21 were locally manufactured. Fifty-three samples were analyzed with reference to the United States Pharmacopoeia. Amoxicillin and clavulanic acid contents for oral suspensions were determined immediately after reconstitution and 7 days thereafter to determine their stability during the prescription period. On day seven, 23.1% (3 out of 13) of amoxicillin and 66.7% (8 out of 12) amoxicillin/clavulanic acid oral suspensions presented levels below recommended limits. Uniformity of weight for amoxicillin capsules noted 13.6% (3 out of 22) failure rate, while amoxicillin/clavulanic acid tablets complied. Potency determination for all amoxicillin capsules analyzed were within required limits, but amoxicillin/clavulanic acid tablets showed 33.3% (2 out of 6) noncompliance. For amoxicillin capsule and amoxicillin/clavulanic acid tablet dissolution tests, there was 10.5% (2 out of 19) and 50% (2 out of 4) noncompliance, respectively. Overall, 37.7% of the drugs analyzed failed to comply with the Pharmacopoeia. These results highlight the presence of poor-quality amoxicillin formulations in Nairobi County, affirming the need for regular postmarket surveillance to inform on the situation of antibiotic quality in the Kenyan market.

Evaluation of different proton pump inhibitors combined with bismuth quadruple regimens in Helicobacter pylori eradication.

To evaluate the efficacy and economics of different proton pump inhibitors (PPIs) combined with bismuth quadruple regimens for Helicobacter pylori (Hp) eradication, a retrospective analysis method was used to collect Hp-positive patients who were treated with a bismuth-containing quadruple regimen (PPIs + amoxicillin + furazolidone + colloid pectin bismuth) from the outpatient department of gastroenterology in our hospital from January to June 2017. A total of 1410 patients were included in the study and divided into four groups according to different PPIs: group A (pantoprazole sodium enteric-coated capsules, 352 cases), group B (esomeprazole magnesium enteric-coated tablets, 462 cases), group C (pantoprazole sodium enteric-coated tablets, 392 cases) and group D (rabeprazole sodium enteric-coated tablets, 204 cases). The eradication rate of Hp and cost-saving in each group were then compared. There were no significant differences of gender (P = 0.526) and age (P = 0.366) between each Hp treatment regimen. The eradication rates of groups A, B, C and D were 91.48%, 89.83%, 86.73% and 90.69%, respectively. No statistical differences of Hp eradication rates were observed between each group yet (P > 0.05). However, the cost of group A was the lowest. In the present study, the Hp eradication rates between different PPIs regimens were similar in treating Hp infection. Nevertheless, the point in favor of pantoprazole capsules is the slightly higher Hp eradication rate and lower drug cost than other PPIs, which provides a significant evidence for the clinical medication decision in treating Hp infection.

Investigating the exposure of Iranian households to catastrophic health expenditure due to the need to purchase medicines.

BACKGROUND: Catastrophic health expenditure (CHE) is an indicator used by the World Health Organization (WHO) to assess equity in households' payments to the health system. In this paper, we prospectively calculated the population at risk of facing catastrophic expenditure due to purchasing three selected medicines (metformin, atorvastatin and amoxicillin) in Iran. METHOD: This study draws on the data set of the Iranian National Household Survey of 38244 households in Iran. CHE was calculated based on "capacity to pay" using different thresholds. RESULTS: 20, 16 and 3 households had to spend more than 40% of their capacity to pay on amoxicillin, atorvastatin and metformin respectively. Lowest priced generic (LPG) medicines were found more affordable than the original brand (OB) medicines. Age, literacy and gender of head of household, economic status, settlement, size and number of breadwinners in the households share important association with CHE. CONCLUSION: Requirement of these specific medicines for long-term may subject the Iranian households to CHE. The study demonstrates important and specific insights for health policy makers in Iran to protect the households from healthcare catastrophes.

Has UK guidance affected general practitioner antibiotic prescribing for otitis media in children?

BACKGROUND: Since 1997, UK guidance has advocated limiting antibiotic prescribing for otitis media. It is not known whether this has influenced general practitioner prescribing practice. Aims and objectives To investigate the trends in diagnoses and antibiotic prescribing for otitis media in children in relation to guidance. METHODS: We used the General Practice Research Database to conduct time-trend analyses of diagnoses and antibiotic prescribing for otitis media in 3 months to 15 years old, between 1990 and 2006. RESULTS: A total of 1 210 237 otitis media episodes were identified in 464 845 children; two-thirds (68%; 818 006) received antibiotics. Twenty-two percent (267 335) were classified as acute, 85% (227 335) of which received antibiotics. Overall, antibiotic prescribing for otitis media declined by 51% between 1995 and 2000. Much of this reduction predated guidance. During this period, prescribing for otitis media coded as acute increased by 22%. Children diagnosed with acute otitis media were more likely to receive antibiotics than otitis media not coded as acute (P < 0.05). From 2000 prescribing plateaued, despite publication of further guidance. Otitis media diagnoses consistently paralleled prescribing. CONCLUSIONS: The reduction in antibiotic prescribing for otitis media predated guidance. The simultaneous decrease in prescribing for non-acute otitis media and increase for acute otitis media suggest diagnostic transfer, possibly to justify the decision to treat.

Quality of medicines in southern Togo: Investigation of antibiotics and of medicines for non-communicable diseases from pharmacies and informal vendors.

Substandard and falsified medicines represent a serious threat for public health and patient safety. Especially in low and middle-income countries, the prevalence of substandard and falsified medicines is reportedly high. However, reliable information on the prevalence of poor-quality medicines is scarce. In this study, 12 essential medicines, including antibiotics, antidiabetics, cardiac drugs and antiasthmatic drugs, were collected from six informal vendors and six licensed pharmacies in the southern part of Togo (regions Maritime and Plateaux). A mystery shopper approach was used in both types of outlets. In total, 64 samples were collected from licensed pharmacies and 30 from informal vendors. Both availability of medicines and prices of medicines were higher in licensed pharmacies than in informal vendors. 92 medicine samples were analyzed by visual examination, followed by chemical analysis for the content and for the dissolution of the active pharmaceutical ingredients according to the respective monographs of the United States Pharmacopoeia. 7 samples (8%) did not comply with the pharmacopoeial specifications, and one sample (1%) showed even extreme deviations. None of the samples was obviously falsified. However, one sample of amoxicillin capsules contained only 47% of the declared content of the active pharmaceutical ingredient, indicating that it may represent amoxicillin capsules 250 mg, rather than 500mg as declared on the label. Medicines stated to originate from Asia (i.e. mainly from India and China) showed a significantly higher proportion (24%) of non-compliant samples than those from Africa and Europe (4%, p = 0.007). High failure rates were observed in medicines both from informal vendors (13%) and from licensed pharmacies (5%), but the difference between both groups was not statistically significant (p = 0.152). The observed high prevalence of substandard medicines requires action from regulatory authorities and health care providers. Testing of selected samples for related substances indicated that inappropriate transport and storage conditions may have been an important cause for substandard quality.

Guidelines for the treatment of severe acute malnutrition: a systematic review of the evidence for antimicrobial therapy.

Background Severe acute malnutrition (SAM) affects nearly 20 million children worldwide and is responsible for up to 1 million deaths per year in children under the age of 5 years. Current WHO guidelines recommend oral amoxicillin for children with uncomplicated malnutrition and parenteral benzylpenicillin and gentamicin for those with complicated malnutrition. Because of cost pressures and increasing antimicrobial resistance, the administration of empirical antibiotics for children with SAM has recently been debated. Methods A systematic review of the current published literature was undertaken to assess the efficacy, safety, cost-effectiveness and pharmacokinetics of antimicrobial treatment of children with SAM in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Results The initial search found 712 papers, eight of which met the inclusion criteria. Quality assessment of the studies was performed as per the Grading of Recommendations Assessment, Development and Evaluation guidelines. International guidelines and clinical data registries were also reviewed which identified inconsistencies in current first- and second-line therapies and dosing regimens. Conclusion Current evidence supports the continued use of broad-spectrum oral amoxicillin for treating children with uncomplicated SAM as outpatients. There is no strong evidence to justify changing the current parenteral therapy guidelines for children admitted with complicated SAM, although they should be clarified to harmonise the dosage regimen of amoxicillin for the treatment of SAM to 40 mg/kg twice daily, and to continue parenteral antimicrobials beyond 2 days if indicated by the clinical condition.

Non-prescribed sale of antibiotics for acute childhood diarrhea and upper respiratory tract infection in community pharmacies: a 2 phase mixed-methods study.

Background: Although prohibited by law and legal regulatory frameworks, non-prescribed sale of antibiotics in community medicine retail outlets (CMROs) remains a serious problem in Ethiopia. The aim of this study was to document the extent of and motivations behind non-prescribed sale of antibiotics among CMROs in Gondar town, Ethiopia. Methods: A 2 phase mixed-methods study (a simulated patient visit followed by an in-depth interview) was conducted among CMROs in Gondar town, Ethiopia. Two clinical case scenarios (acute childhood diarrhea and upper respiratory tract infection) were presented and the practice of non-prescribed sale were measured and results were reported as percentages. Pharmacy staff (pharmacists and pharmacy assistants) were interviewed to examine factors/motivations behind dispensing antibiotics without a valid prescription. Results: Out of 100 simulated visits (50 each scenarios) presented to drug retail outlets, 86 cases (86%) were provided with one or more medications. Of these, 18 (20.9%) asked about past medical and medication history and only 7 (8.1%) enquired about the patient's history of drug allergy. The most frequently dispensed medication for acute childhood diarrhoea simulation were oral rehydration fluid (ORS) with zinc (n = 16) and Metronidazole (n = 15). Among the dispensed antibiotics for upper respiratory infection simulation, the most common was Amoxicillin (n = 23) followed by Amoxicillin-clavulanic acid capsule (n = 19) and Azithromycin (n = 15). Perceived financial benefit, high expectation and/or demand of customers and competition among pharmacies were cited as the main drivers behind selling antibiotics without a prescription. Conclusions: A stringent law and policy enforcement regarding the sale of antibiotics without a valid prescription should be in place. This will ultimately help to shift the current pharmacy practices from commercial and business-based interests/practices to the provision of primary healthcare services to the community.

Single-dose azithromycin versus erythromycin or amoxicillin for Chlamydia trachomatis infection during pregnancy: a meta-analysis of randomised controlled trials.

This review aimed to compare data regarding the effectiveness and safety of azithromycin with alternative regimens in the treatment of pregnant women with Chlamydia trachomatis infection. PubMed and Scopus databases were searched to identify relevant randomised controlled trials (RCTs). The main analysis focused on comparison of azithromycin with erythromycin. In a secondary analysis, azithromycin was compared with erythromycin or amoxicillin. Eight RCTs studying 587 pregnant women with microbiologically documented C. trachomatis infection were included in the meta-analysis. Overall, there was no difference between azithromycin and erythromycin regarding treatment success in intention-to-treat patients (pooled odds ratio (OR)=2.66, 95% confidence interval (CI) 0.69-10.29) or in clinically evaluated patients (OR=1.46, 95% CI 0.56-3.78). Furthermore, azithromycin was associated with fewer gastrointestinal adverse events (OR=0.11, 95% CI 0.07-0.18), fewer total adverse events (OR=0.11, 95% CI 0.07-0.18), a smaller proportion of patients who withdrew from the study (OR=0.12, 95% CI 0.04-0.37) and better compliance (OR=23.7, 95% CI 9.34-60.14) than erythromycin. The results of the secondary analysis comparing azithromycin with erythromycin or amoxicillin were similar to those of the main analysis. In conclusion, azithromycin was associated with similar effectiveness but less adverse events compared with erythromycin or amoxicillin in the treatment of pregnant women with C. trachomatis infection.

Cost-effectiveness analysis of treatment options for acute otitis media.

PURPOSE: This study evaluated the costs and utility of observation and routine antibiotic treatment options for children with acute otitis media. METHODS: The cost-effectiveness analysis was performed among children aged 6 months to 12 years seen in primary care offices. The interventions studied were watchful waiting as practiced in the Netherlands, delayed prescription, 5 days of amoxicillin, and 7 to 10 days of amoxicillin. The main outcome measure was cost per quality-adjusted life-year (QALY). RESULTS: In the base case analysis, delayed prescription was the least costly option and 7 to 10 days of amoxicillin was the most effective. The incremental cost utility ratio (ICUR) of 7 to 10 days of amoxicillin compared with delayed prescription was 56,000 dollars per QALY gained. Watchful waiting and 5 days of amoxicillin were inferior options. The results were sensitive to the rate of nonattendance in the delayed prescription strategy: when the rate was less than 23%, watchful waiting was the least costly option and delayed prescription was an inferior option. Probabilistic sensitivity analysis, in which all model variables were simultaneously varied, showed with 95% certainty that compared with delayed prescription, 7 to 10 days of amoxicillin had a 61% probability of having an ICUR of greater than 50,000 dollars per QALY gained, and watchful waiting had a 23% probability of having an ICUR of less than 50,000 dollars per QALY gained. CONCLUSIONS: Economically, an approach to the treatment of acute otitis media with either an initial period of observation or routine treatment with amoxicillin is reasonable.

[Consumption of medications during the cholera epidemic in Douala, Cameroon (2004)]. / Consommation de médicaments lors de l'épidémie de choléra de Douala (2004).

To prepare for cholera outbreaks, stockpiles of supplies, rehydration salts/ solutions and appropriate antibiotics must be placed in strategic locations to ensure a prompt and effective response. However specific needs have not been evaluated up to now. The purpose of this report is to give an accurate account of medical supplies that were consumed during the cholera epidemic in Douala in 2004. Consumption of medication for the entire epidemic was measured by crosschecking data from the provincial pharmaceutical supply centre with the order forms, stock sheets and records of hospitals. Cost was calculated based on pricing data from the National Supply Center. For the 5 020 confirmed cases of cholera that were treated in the 14 hospitals in Douala from January to September 2004, consumption consisted of 499,746 doxycycline tablets, 235,881 amoxicilline tablets, 122,781 rehydration salt packets, and 60,217 units of Ringer Lactate (500 ml). The total cost of medications and consumables was 52,229,311 CFAF (approximately 80,000 Euro). Although updated recommendations are not available, comparison with the existing ones shows that the consumption levels observed were 5 times higher for both rehydration and antibiotherapy. The mean cost of treatment in Douala was 13 Euro per reported patient. This cost rose to 15 Euro if antibiotic prophylaxis was prescribed for all contacts. These findings can be useful in planning for future epidemics by allowing recommendations to be updated. We propose the follow supply levels for 50,000 inhabitants with an attack rate of 0.2%: 10,000 doxycycline tablets, 5000 amoxicilline tablets (500 mg), 2500 SRO packs (for 2500 liters) and 600 liters of Ringer Lactate.

Antibiotic treatment In patients with chronic low back pain and Modic changes (the AIM study): study protocol for a randomised controlled trial.

BACKGROUND: A previous randomised controlled trial (RCT) of patients with chronic low back pain (LBP) and vertebral bone marrow (Modic) changes (MCs) on magnetic resonance imaging (MRI), reported that a 3-month, high-dose course of antibiotics had a better effect than placebo at 12 months' follow-up. The present study examines the effects of antibiotic treatment in chronic LBP patients with MCs at the level of a lumbar disc herniation, similar to the previous study. It also aims to assess the cost-effectiveness of the treatment, refine the MRI assessment of MCs, and further evaluate the impact of the treatment and the pathogenesis of MCs by studying genetic variability and the gene and protein expression of inflammatory biomarkers. METHODS/DESIGN: A double-blinded RCT is conducted at six hospitals in Norway, comparing orally administered amoxicillin 750 mg, or placebo three times a day, over a period of 100 days in patients with chronic LBP and type I or II MCs at the level of a MRI-confirmed lumbar disc herniation within the preceding 2 years. The inclusion will be stopped when at least 80 patients are included in each of the two MC type groups. In each MC type group, the study is designed to detect (ß = 0.1, α = 0.05) a mean difference of 4 (standard deviation 5) in the Roland Morris Disability Questionnaire score between the two treatment groups (amoxicillin or placebo) at 1-year follow-up. The study includes cost-effectiveness measures. Blood samples are assessed for security measures and for possible inflammatory mediators and biomarkers at different time points. MCs are evaluated on MRI at baseline and after 12 months. A blinded intention-to-treat analysis of treatment effects will be performed in the total sample and in each MC type group. DISCUSSION: To ensure the appropriate use of antibiotic treatment, its effect in chronic LBP patients with MCs should be re-assessed. This study will investigate the effects and cost-effectiveness of amoxicillin in patients with chronic LBP and MCs at the level of a disc herniation. The study may also help to refine imaging and characterise the biomarkers of MCs. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02323412 . Registered on 21 November 2014.

A naturalistic comparison of amoxicillin/clavulanate extended release versus immediate release in the treatment of acute bacterial sinusitis in adults: A retrospective data analysis.

BACKGROUND: Choosing the most effective treatment for acute bacterial sinusitis (ABS) is helpful to avoid treatment failure. To date, studies comparing antibiotic options for ABS have compared amoxicillin/clavulanate (AMX/CA) immediate release (IR) versus other antibiotics, but have not included AMX/CA extended release (XR). OBJECTIVE: The purpose of this study was to determine whether the clinical advantages of AMX/CA XR found in a clinical trial setting translate to a naturalistic setting, relative to AMX/CA IR. METHODS: Data for this retrospective analysis were obtained from a managed care benchmark database that included >25 million patients from >30 health plans covering 7 US census divisions. Data from all patients aged > or =18 years with an index diagnosis of ABS between July 1, 2001, and December 31, 2003, were included. Episodes of ABS were classified as treatment successes (no additional prescriptions for antibiotics, ABS-related emergency department [ED] visits, or ABS-related inpatient hospitalizations within 30 days after the index prescription) or failures (> or =1 subsequent antibiotic prescription, an ABS-related ED visit, or an ABS-related inpatient hospitalization within 30 days after the index prescription). Treatment failures were subclassified as early or late. Mean costs were assessed for medical claims linked with a primary diagnosis of ABS and antibiotic pharmacy claims within the follow-up time period (through February 28, 2004). Descriptive statistics for demographic characteristics, utilization patterns, and success rates were calculated for each cohort. A multivariate general linear regression model was developed to assess differences in costs between the 2 cohorts. RESULTS: : Of the patients with an index antibiotic prescription filled within 3 days of ABS diagnosis (n = 241,511), a total of 3224 in the AMX/CA XR cohort (mean [SD] age, 41.8 [11.6] years; women, 57.7%) and 23,638 in the AMX/CA IR cohort (mean [SD] age, 41.9 [11.6] years; women, 62.7%) were included in the analysis. The rate of treatment success in patients treated with AMX/CA XR was 82.8% versus 81.0% in patients treated with AMX/CA IR (P < 0.015). Treatment success costs were significantly lower than treatment failure costs regardless of an early or late designation and ranged from 98 dollars to 110 dollars per episode (P < 0.001). After adjustment for background covariates, the mean cost of treating an episode of ABS was significantly lower for patients receiving AMX/CA XR versus those receiving AMX/CA IR (166.32 dollars vs 177.34 dollars [US 2004 dollars]; P < 0.001), representing a mean cost savings of 11.02 dollars per patient treated with AMX/CA XR over AMX/CA IR for ABS, regardless of treatment outcome. CONCLUSIONS: The results from this data analysis suggest that AMX/CA XR had significantly higher treatment success in ABS relative to AMX/CA IR in this naturalistic setting. AMX/CA XR was associated with significantly decreased total ABS-related costs in these adults.

Cost effectiveness of amoxicillin for lower respiratory tract infections in primary care: an economic evaluation accounting for the cost of antimicrobial resistance.

BACKGROUND: Lower respiratory tract infections (LRTIs) are a major disease burden and are often treated with antibiotics. Typically, studies evaluating the use of antibiotics focus on immediate costs of care, and do not account for the wider implications of antimicrobial resistance. AIM: This study sought to establish whether antibiotics (principally amoxicillin) are cost effective in patients with LRTIs, and to explore the implications of taking into account costs associated with resistance. DESIGN AND SETTING: Multinational randomised double-blinded trial in 2060 patients with acute cough/LRTIs recruited in 12 European countries. METHOD: A cost-utility analysis from a health system perspective with a time horizon of 28 days was conducted. The primary outcome measure was the quality-adjusted life year (QALY). Hierarchical modelling was used to estimate incremental cost-effectiveness ratios (ICERs). RESULTS: Amoxicillin was associated with an ICER of €8216 (£6540) per QALY gained when the cost of resistance was excluded. If the cost of resistance is greater than €11 (£9) per patient, then amoxicillin treatment is no longer cost effective. Including possible estimates of the cost of resistance resulted in ICERs ranging from €14 730 (£11 949) per QALY gained - when only multidrug resistance costs and health care costs are included - to €727 135 (£589 856) per QALY gained when broader societal costs are also included. CONCLUSION: Economic evaluation of antibiotic prescribing strategies that do not include the cost of resistance may provide misleading results that could be of questionable use to policymakers. However, further work is required to estimate robust costs of resistance.

Noninvasive Helicobacter pylori testing for the "test-and-treat" strategy: a decision analysis to assess the effect of past infection on test choice.

BACKGROUND: Clinical guidelines support a noninvasive Helicobacter pylori "test-and-treat" strategy for individuals with uncomplicated dyspepsia. However, consensus is lacking regarding the preferred noninvasive testing method. OBJECTIVE: To use decision analytic modeling to estimate the clinical and economic outcomes associated with noninvasive tests designed to detect either H pylori antibody or active H pylori infection. DESIGN: Decision analytic model. PATIENTS: A simulated patient cohort with uncomplicated dyspepsia. INTERVENTIONS: The simulated dyspepsia cohort underwent antibody testing or testing to detect active H pylori infection (active testing). Individuals testing positive received eradication therapy. MAIN OUTCOME MEASURES: Appropriate and inappropriate treatment prescribed, cost per patient treated, incremental cost per unnecessary treatment avoided. RESULTS: Active testing led to a substantial reduction in unnecessary treatment for patients without active infection (antibody, 23.7; active, 1.4 per 100 patients) at an incremental cost of $37 per patient. The clinical advantage and cost-effectiveness of active testing was enhanced as the percentage of individuals with a positive antibody test result from past, but not current, infection increased. CONCLUSIONS: Active testing for H pylori infection significantly decreases the inappropriate use of antimicrobial therapy when compared with antibody testing. The advantages of active testing should be enhanced as the widespread use of antimicrobial agents increases the proportion of patients with antibody to H pylori, but without active infection.