Safety of Simparica Trio® (sarolaner, pyrantel, moxidectin) in heartworm-infected dogs.

BACKGROUND: Assessment of the safety of heartworm preventatives in dogs with pre-existing patent heartworm (Dirofilaria immitis) infections is necessary because rapid adult worm and microfilarial death can lead to severe clinical complications, including thromboembolism and anaphylactic shock in dogs. The aim of this study was to determine the clinical safety of Simparica Trio® (sarolaner, pyrantel, moxidectin) in heartworm-infected dogs and the degree of microfilaricidal and adulticidal activity of three consecutive monthly treatments of Simparica Trio. METHODS: Twenty-four laboratory Beagle dogs were implanted with 10 male and 10 female D. immitis (ZoeKY isolate), and once infection was patent, they were randomized equally among three groups to receive no treatment, 1× or 3× the maximum recommended label dose of Simparica Trio. Dogs in the treated groups received Simparica Trio on days 0, 28 and 56. In-life assessments included body weight, physical examinations, clinical observations, daily general health observations, a quantitative estimate of food consumption and blood collections for pharmacokinetic (PK) analysis, microfilariae (MF) counts and D. immitis antigen testing. At the end of the study the heart, lungs and pleural and peritoneal cavities were examined for adult D. immitis worms. RESULTS: Simparica Trio was generally well tolerated. Emesis occurred at low frequency in all groups including control. Abnormal stool occurred occasionally in the 1× and 3× groups throughout the 3-month study. Fever (> 104 °F/40 °C) was recorded in one 1× and one 3× dog 1 day after the first dose and resolved by the following day. No severe hypersensitivity reactions occurred. The mean number of circulating microfilariae (MF) counts in the control group increased from 12,000/ml at study start (Day 0) to > 20,000/ml at Day 28 and remained > 20,000/ml for the duration of the study. The least squares means of circulating MF were reduced by 69.8% on Day 1 and 97.4% on Day 7 for the 1× group and remained at > 99% lower than the control group for the remainder of the study. Similarly, least squares means of circulating MF were reduced by 85.3% on Day 1 and 93.9% on Day 7 for the 3× group and remained > 98% lower than the control group for the remainder of the study. At the end of the study, the mean number of implanted adult worms recovered was < 10 per sex in all groups with 90%, 85% and 75% of live adult heartworms recovered in control, 1× and 3× treatment groups, respectively. Low numbers of dead adult worms were recovered in 1× and 3×, with none in control. Following each dose, the moxidectin and sarolaner AUC and Cmax had close to dose proportional increases. CONCLUSIONS: This study demonstrated that Simparica Trio (sarolaner, pyrantel, moxidectin) was well tolerated when administered to heartworm-positive dogs at 1× and 3× the maximum recommended dose at 28-day intervals for 3 consecutive months. Simparica Trio significantly reduced microfilaria counts in both treatment groups, without significant clinical consequences. At the doses administered, Simparica Trio had minor adulticidal activity but resulted in no clinical sequelae.

Low ERCP Volume Is Associated with More Industry Representative Interactions but Similar Training of Nurses.

BACKGROUND: Data on ERCP nurses and associate (ERCP-NA) training and comfort are lacking. Healthcare industry representative (HCIR) influence may be greater in low-volume units (LVUs) due to decreased procedure and device familiarity. AIM: The aim of this study was to compare ERCP-NA training, safety, and HCIR relationships between LVU and high-volume unit (HVU) ERCP facilities. METHODS: We conducted an electronic survey of all Society of Gastroenterology Nurses and Associates (SGNA) members assessing: (1) demographics and procedure volume, (2) ERCP training and radiation safety, and (3) HCIR interactions. Responses were stratified by ERCP volume. RESULTS: Among 832 SGNA member respondents (median age 55), 615 (74%) worked as an ERCP-NA; 41% derived from LVUs. The majority of ERCP-NAs, irrespective of unit volume, had observed <50 ERCPs before starting. Except for lead glasses, the majority (>80%) adhered to basic radiation safety, irrespective of unit volume. LVUs were more likely than HVU ERCP-NAs to agree that HCIRs were requested for intra-procedure assistance (24 vs. 19%, p = 0.008), asked for input on the next choice of device (22 vs. 15%, p = 0.01), and assist in device usage (27 vs. 22%, p = 0.04). Irrespective of volume, 30% agreed that they were more likely to utilize a company's devices if that HCIR was present. CONCLUSIONS: ERCP-NA training before independent participation in ERCP is suboptimal. HCIRs are frequently requested for assistance during ERCPs, especially in LVUs. HCIR impact on ERCP outcomes and device utilization and whether enhanced ERCP-NA training will impact the role of HCIR, require further study.

Endoscope storage time: assessment of microbial colonization up to 21 days after reprocessing.

BACKGROUND: Insufficient data exist for how long endoscopes can be stored after reprocessing. Concern about possible microbial colonization has led to various recommendations for reprocessing intervals among institutions, with many as short as 5 days. A significant cost savings could be realized if it can be demonstrated that endoscopes may be stored for as long as 21 days without risk of clinically significant contamination. OBJECTIVE: To demonstrate whether flexible endoscopes may be stored for as long as 21 days after reprocessing without colonization by pathogenic microbes. DESIGN: Prospective, observational study. SETTING: Tertiary care center. ENDOSCOPES: Four duodenoscopes, 4 colonoscopes, and 2 gastroscopes. INTERVENTION: Microbial testing of endoscope channels. MAIN OUTCOME MEASUREMENTS: Culture results at days 0, 7, 14, and 21. RESULTS: There were 33 positive cultures from 28 of the 96 sites tested (29.2% overall contamination rate). Twenty-nine of 33 isolates were typical skin or environmental contaminants, thus clinically insignificant. Four potential pathogens were cultured, including Enterococcus, Candida parapsilosis, α-hemolytic Streptococcus, and Aureobasidium pullulans; all were likely clinically insignificant as each was only recovered at 1 time point at 1 site, and all grew in low concentrations. There were no definite pathogenic isolates. LIMITATIONS: Single center. CONCLUSION: Endoscopes can be stored for as long as 21 days after standard reprocessing with a low risk of pathogenic microbial colonization. Extension of reprocessing protocols to 21 days could effect significant cost savings.

Ethnic issues in endoscopy.

This is one of a series of statements discussing the use of GI endoscopy in common clinical situations. The Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy (ASGE) prepared this text. In preparing this guideline, a search of the medical literature was performed by using PubMed. Additional references were obtained from the bibliographies of the identified articles and from recommendations of expert consultants. When few or no data exist from well-designed prospective trials, emphasis is placed on results from large series and reports from recognized experts. Guidelines for appropriate use of endoscopy are based on a critical review of the available data and expert consensus at the time the guidelines are drafted. Further controlled clinical studies may be needed to clarify aspects of this guideline. This guideline may be revised as necessary to account for changes in technology, new data, or other aspects of clinical practice. The recommendations are based on reviewed studies and are graded on the quality of the supporting evidence (Table 1). The strength of individual recommendations is based on both the aggregate evidence quality and an assessment of the anticipated benefits and harms. Weaker recommendations are indicated by phrases such as "we suggest," whereas stronger recommendations are typically stated as "we recommend." This guideline is intended to be an educational device to provide information that may assist endoscopists in providing care to patients. This guideline is not a rule and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment. Clinical decisions in any particular case involve a complex analysis of the patient's condition and available courses of action. Therefore, clinical considerations may lead an endoscopist to take a course of action that varies from this guideline.

Minimum staffing requirements for the performance of GI endoscopy.

This is one of a series of statements discussing the use of GI endoscopy in common clinical situations. The Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy (ASGE) prepared this text. In preparing this guideline, a search of the medical literature was performed by using PubMed. Additional references were obtained from the bibliographies of the identified articles and from recommendations of expert consultants. Guidelines for appropriate use of endoscopy are based on a critical review of the available data and expert consensus at the time the guidelines are drafted. Further controlled clinical studies may be needed to clarify aspects of this guideline. This guideline may be revised as necessary to account for changes in technology, new data, or other aspects of clinical practice. This guideline is intended to be an educational device to provide information that may assist endoscopists in providing care to patients. This guideline is not a rule and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment. Clinical decisions in any particular case involve a complex analysis of the patient's condition and available courses of action. Therefore, clinical considerations may lead an endoscopist to take a course of action that varies from these guidelines.