Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 31
Filter
1.
JMIR Res Protoc ; 13: e54486, 2024 May 31.
Article in English | MEDLINE | ID: mdl-38819923

ABSTRACT

BACKGROUND: Screening, brief intervention, and referral to treatment for adolescents (SBIRT-A) is widely recommended to promote detection and early intervention for alcohol and other drug (AOD) use in pediatric primary care. Existing SBIRT-A procedures rely almost exclusively on adolescents alone, despite the recognition of caregivers as critical protective factors in adolescent development and AOD use. Moreover, controlled SBIRT-A studies conducted in primary care have yielded inconsistent findings about implementation feasibility and effects on AOD outcomes and overall developmental functioning. There is urgent need to investigate the value of systematically incorporating caregivers in SBIRT-A procedures. OBJECTIVE: This randomized effectiveness trial will advance research and scope on SBIRT-A in primary care by conducting a head-to-head test of 2 conceptually grounded, evidence-informed approaches: a standard adolescent-only approach (SBIRT-A-Standard) versus a more expansive family-based approach (SBIRT-A-Family). The SBIRT-A-Family approach enhances the procedures of the SBIRT-A-Standard approach by screening for AOD risk with both adolescents and caregivers; leveraging multidomain, multireporter AOD risk and protection data to inform case identification and risk categorization; and directly involving caregivers in brief intervention and referral to treatment activities. METHODS: The study will include 2300 adolescents (aged 12-17 y) and their caregivers attending 1 of 3 hospital-affiliated pediatric settings serving diverse patient populations in major urban areas. Study recruitment, screening, randomization, and all SBIRT-A activities will occur during a single pediatric visit. SBIRT-A procedures will be delivered digitally on handheld tablets using patient-facing and provider-facing programming. Primary outcomes (AOD use, co-occurring behavior problems, and parent-adolescent communication about AOD use) and secondary outcomes (adolescent quality of life, adolescent risk factors, and therapy attendance) will be assessed at screening and initial assessment and 3-, 6-, 9-, and 12-month follow-ups. The study is well powered to conduct all planned main and moderator (age, sex, race, ethnicity, and youth AOD risk status) analyses. RESULTS: This study will be conducted over a 5-year period. Provider training was initiated in year 1 (December 2023). Participant recruitment and follow-up data collection began in year 2 (March 2024). We expect the results from this study to be published in early 2027. CONCLUSIONS: SBIRT-A is widely endorsed but currently underused in pediatric primary care settings, and questions remain about optimal approaches and overall effectiveness. In particular, referral to treatment procedures in primary care remains virtually untested among youth. In addition, whereas research strongly supports involving families in interventions for adolescent AOD, SBIRT-A effectiveness trial testing approaches that actively engage family members in primary care are absent. This trial is designed to help fill these research gaps to inform the critical health decision of whether and how to include caregivers in SBIRT-A activities conducted in pediatric primary care. TRIAL REGISTRATION: ClinicalTrials.gov NCT05964010; https://www.clinicaltrials.gov/study/NCT05964010. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/54486.


Subject(s)
Mass Screening , Primary Health Care , Referral and Consultation , Substance-Related Disorders , Adolescent , Child , Female , Humans , Male , Mass Screening/methods , Substance-Related Disorders/diagnosis , Substance-Related Disorders/therapy , Randomized Controlled Trials as Topic , Multicenter Studies as Topic
2.
Drug Dev Res ; 85(2): e22160, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38380694

ABSTRACT

BAER-101 (formerly AZD7325) is a selective partial potentiator of α2/3-containing γ-amino-butyric acid A receptors (GABAARs) and produces minimal sedation and dizziness. Antiseizure effects in models of Dravet and Fragile X Syndromes have been published. BAER-101 has been administered to over 700 healthy human volunteers and patients where it was found to be safe and well tolerated. To test the extent of the antiseizure activity of BAER-1010, we tested BAER-101 in the Genetic Absence Epilepsy Rats from Strasbourg (GAERS) model, a widely used and translationally relevant model. GAERS rats with recording electrodes bilaterally located over the frontal and parietal cortices were used. Electroencepholographic (EEG) signals in freely moving awake rats were analyzed for spike-wave discharges (SWDs). BAER-101 was administered orally at doses of 0.3-100 mg/kg and diazepam was used as a positive control using a cross-over protocol with a wash-out period between treatments. The number of SWDs was dose-dependently reduced by BAER-101 with 0.3 mg/kg being the minimally effective dose (MED). The duration of and total time in SWDs were also reduced by BAER-101. Concentrations of drug in plasma achieved an MED of 10.1 nM, exceeding the Ki for α2 or α3, but 23 times lower than the Ki for α5-GABAARs. No adverse events were observed up to a dose 300× MED. The data support the possibility of antiseizure efficacy without the side effects associated with other GABAAR subtypes. This is the first report of an α2/3-selective GABA PAM suppressing seizures in the GAERS model. The data encourage proceeding to test BAER-101 in patients with epilepsy.


Subject(s)
Epilepsy, Absence , Humans , Rats , Animals , Epilepsy, Absence/drug therapy , Epilepsy, Absence/genetics , Receptors, GABA-A , Patient Discharge , Electroencephalography , Rats, Wistar , gamma-Aminobutyric Acid , Disease Models, Animal
3.
Child Fam Behav Ther ; 45(3): 199-225, 2023.
Article in English | MEDLINE | ID: mdl-37767113

ABSTRACT

This article presents behavioral interventions designed to enhance uptake and retention on medication for opioid use disorder (MOUD) among transition-age youth (16-25 years) enrolled in treatment services. The article describes three relationship-oriented interventions designed to address barriers to MOUD uptake, enhance MOUD adherence planning, and strengthen OUD recovery among youth: Relational Orientation; Medication Education and Decision-making Support, and Family Leadership and Ownership of Adherence to Treatment. These interventions are inter-connected can be delivered flexibly. The article concludes with three case examples that illustrate how these modular interventions can be tailored to meet the needs of diverse client profiles.

4.
J Clin Child Adolesc Psychol ; : 1-17, 2023 Jun 14.
Article in English | MEDLINE | ID: mdl-37314326

ABSTRACT

OBJECTIVE: This pilot study tested pragmatic methods for training therapists in core techniques of two evidence-based interventions (EBIs) for adolescent externalizing problems: cognitive-behavioral therapy (CBT) or family therapy (FT). Training methods were designed to help therapists accurately self-monitor their use of EBIs and increase delivery of EBIs with current clients. The study compared coder training only versus coder training plus fidelity-focused consultation. METHOD: Therapists (N = 42) from seven behavioral health clinics reported on 65 youth clients; four clinics elected to train in CBT and three in FT. Therapists were randomized to either coder training only, consisting of a 25-week observational coder training course (didactic instruction and mock session coding exercises in core EBI techniques); or coder training plus fidelity-focused consultation, consisting of direct-to-therapist fidelity measurement feedback along with fidelity-focused expert consultation. During the 25 weeks of training, therapists submitted self-report data on EBI use along with companion session audiotapes subsequently coded by observational raters. RESULTS: Compared to coder training only, coder training plus fidelity-focused consultation produced superior effects in therapist ability to judge the extensiveness of EBI techniques in online coding sessions, as well as therapist ability to self-rate use of EBI techniques with their own cases. In both conditions, therapists who trained in CBT showed a significant, though modest, increase in real-world delivery of core CBT techniques; this did not occur for FT. CONCLUSIONS: Pragmatic training and consultation methods show promise as viable and effective options for enhancing EBI fidelity monitoring and, for CBT, increasing EBI delivery.

5.
J Clin Child Adolesc Psychol ; 52(6): 850-865, 2023.
Article in English | MEDLINE | ID: mdl-35384750

ABSTRACT

OBJECTIVE: Pragmatic procedures for sustaining high-fidelity delivery of evidence-based interventions are needed to support implementation in usual care. This study tested an online therapist training system, featuring observational coder training and self-report fidelity feedback, to promote self-report acumen and routine use of family therapy (FT) techniques for adolescent behavior problems. METHOD: Therapists (N = 84) from nine substance use and mental health treatment sites reported on 185 adolescent clients. Therapists submitted baseline data on FT technique use with clients, completed a workshop introducing the 32-week training system, and were randomly assigned by site to Core Training versus Core Training + Consultation. Core Training included a therapist coder training course (didactic instruction and mock session coding exercises in 13 FT techniques) and fidelity feedback procedures depicting therapist-report data on FT use. Consultation convened therapists and supervisors for one-hour monthly sessions with an external FT expert. During the 32 weeks of training, therapists submitted self-report data on FT use along with companion session audiotapes subsequently coded by observational raters. RESULTS: Therapist self-report reliability and accuracy both increased substantially during training. Observers reported no increase over time in FT use; therapists self-reported a decrease in FT use, likely an artifact of their improved self-report accuracy. Consultation did not enhance therapist self-report acumen or increase FT use. CONCLUSIONS: Online training methods that improve therapist-report reliability and accuracy for FT use may confer important advantages for treatment planning and fidelity monitoring. More intensive and/or different training interventions appear needed to increase routine FT delivery.


Subject(s)
Adolescent Behavior , Family Therapy , Adolescent , Humans , Feedback , Reproducibility of Results , Pilot Projects
6.
Article in English | MEDLINE | ID: mdl-38707487

ABSTRACT

This article introduces the Relationship-Oriented Recovery System for Youth (RORSY) protocol, which is designed to increase uptake of Medications for Opioid Use Disorder (MOUD) and related services among adolescents and young adults. Youth exhibit alarmingly poor rates of MOUD initiation and adherence, OUD services involvement and long-term recovery success. RORSY attends to three developmentally unique recovery needs of this age group: assess and bolster youth recovery capital, prioritize involvement of concerned significant others, and use digital direct-to-consumer recovery supports. RORSY contains five evidence-informed intervention modules that can be flexibly tailored to meet the individual and relationship needs of a given youth: Relational Orientation, Youth Recovery Management Planning, Relational Recovery Management Planning, Relationship Skills Building, and Digital Recovery Support Planning. The article concludes with practice and policy recommendations for making relationship-building a top clinical priority for addressing youth OUD.

7.
J Marital Fam Ther ; 48(1): 178-203, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34435387

ABSTRACT

This article updates the evidence-based on couple and family therapy interventions for substance use disorders (SUD) since publication of the previous JMFT reviews in 2012. It first summarizes previous reviews along with findings from more recent reviews and meta-analytic studies. It then presents study design and methods criteria used to select 13 studies of couple and family therapy for level of support evaluation. Cumulative level of support designations are then determined for identified treatment approaches. Findings indicate that systemic family therapy is well-established as a standalone treatment, and behavioral family therapy and behavioral couple therapy are probably efficacious as standalone treatments and well-established as part of a multicomponent treatment. The article then suggests practice guidelines with regard to treatment modality considerations and implementation challenges. It concludes with future directions for delivering couple and family interventions in routine systems of care for SUD.


Subject(s)
Couples Therapy , Substance-Related Disorders , Behavior Therapy , Family Therapy , Humans , Substance-Related Disorders/therapy
8.
Adm Policy Ment Health ; 49(2): 298-311, 2022 03.
Article in English | MEDLINE | ID: mdl-34476623

ABSTRACT

Therapist-report measures of evidence-based interventions have enormous potential utility as quality indicators in routine care; yet, few such tools have shown strong psychometric properties. This study describes reliability and validity characteristics of a therapist-report measure of family therapy techniques for treating adolescent conduct and substance use problems: Inventory of Therapy Techniques for Core Elements of Family Therapy (ITT-CEFT). Study participants included 31 staff therapists treating 68 adolescent clients in eight community-based mental health and substance use clinics. Therapists submitted ITT-CEFT checklists and companion audio recordings for 189 sessions. The ITT-CEFT contains 13 techniques identified as core elements of three manualized family therapy models that are empirically supported for the target group. Therapists also reported on their use of three motivational interventions, and independent observers coded the submitted recordings. ITT-CEFT factor validity was shown via confirmatory factor analyses of the tool's theoretical structure. Derived modules were: Family Engagement (four items; Cronbach's α = .72); Relational Orientation (five items; α = .74); and Interactional Change (four items; α = .66). Concurrent validity analyses showed fair-to-excellent therapist reliability compared to observer ratings (ICCs range .64-.75); they showed moderate therapist accuracy compared to observer mean scores, reflecting a tendency to overestimate delivery of the techniques. Discriminant validity analyses showed tool differentiation from motivational interventions. Results offer provisional evidence for the feasibility of using the therapist-report ITT-CEFT to anchor quality procedures for family therapy interventions in real-world settings.Trial Registration: The parent clinical trial is registered at www.ClinicalTrials.gov , ID: NCT03342872 (registration date: 11.10.17).


Subject(s)
Adolescent Behavior , Family Therapy , Adolescent , Humans , Psychometrics , Quality Indicators, Health Care , Reproducibility of Results , Self Report
9.
Adm Policy Ment Health ; 49(1): 139-151, 2022 01.
Article in English | MEDLINE | ID: mdl-34297259

ABSTRACT

A foundational strategy to promote implementation of evidence-based interventions (EBIs) is providing EBI training to therapists. This study tested an online training system in which therapists practiced observational coding of mock video vignettes demonstrating family therapy techniques for adolescent behavior problems. The study compared therapists ratings to gold-standard scores to measure therapist reliability (consistency across vignettes) and accuracy (approximation to gold scores); tested whether reliability and accuracy improved during training; and tested therapist-level predictors of overall accuracy and change in accuracy over time. Participants were 48 therapists working in nine community behavioral health clinics. The 32-exercise training course provided online instruction (about 15 min/week) in 13 core family therapy techniques representing three modules: Family Engagement, Relational Orientation, Interactional Change. Therapist reliability in rating technique presence (i.e., technique recognition) remained moderate across training; reliability in rating extensiveness of technique delivery (i.e., technique judgment) improved sharply over time, from poor to good. Whereas therapists on average overestimated extensiveness for almost every technique, their tendency to give low-accuracy scores decreased. Therapist accuracy improved significantly over time only for Interactional Change techniques. Baseline digital literacy and submission of self-report checklists on use of the techniques in their own sessions predicted coding accuracy. Training therapists to be more reliable and accurate coders of EBI techniques can potentially yield benefits in increased EBI self-report acumen and EBI use in daily practice. However, training effects may need to improve from those reported here to avail meaningful impact on EBI implementation.Trial Registration: The parent clinical trial is registered at www.ClinicalTrials.gov , ID: NCT03342872 (registration date: 11.10.17).


Subject(s)
Allied Health Personnel , Family Therapy , Adolescent , Humans , Parents , Reproducibility of Results , Self Report
10.
Cogn Behav Pract ; 27(4): 426-441, 2020 Nov.
Article in English | MEDLINE | ID: mdl-34103883

ABSTRACT

Adolescent externalizing problems (AEPs), including serious conduct problems, delinquency, and substance misuse, are the most common adolescent behavioral issues in specialty care. High rates of comorbidity between conduct and substance use problems necessitate multidomain treatment strategies that can effectively address the AEP spectrum. One strategy to increase delivery of evidence-based interventions for multiproblem youth in usual care is to focus on core elements of empirically supported treatments that can be judiciously applied to clients presenting with diverse clinical profiles. This article describes six core practice elements of the cognitive-behavioral treatment (CBT) approach for AEPs: (1) Functional Analysis of Behavior Problems; (2) Prosocial Activity Sampling; (3) Cognitive Monitoring and Restructuring; (4) Emotion Regulation Training; (5) Problem-solving Training; (6) Communication Training. Integrated delivery of these core CBT elements is illustrated in two case examples, and implications for treatment planning for youth with AEPs are discussed.

11.
Trials ; 20(1): 700, 2019 Dec 10.
Article in English | MEDLINE | ID: mdl-31822294

ABSTRACT

BACKGROUND: Innovations in clinical training and support that enhance fidelity to evidence-based treatment (EBT) for adolescent behavior problems are sorely needed. This study will develop an online training system to address this gap: Measurement Training and Feedback System for Implementation (MTFS-I). Using procedures intended to be practical and sustainable, MTFS-I is designed to increase two aspects of therapist behavior that are fundamental to boosting EBT fidelity: therapist self-monitoring of EBT delivery, and therapist utilization of core techniques of EBTs in treatment sessions. This version of MTFS-I focuses on two empirically supported treatment approaches for adolescent conduct and substance use problems: family therapy and cognitive behavioral therapy (CBT). METHODS/DESIGN: MTFS-I expands on conventional measurement feedback systems for client outcomes by adding training in observational coding to promote EBT self-monitoring and focusing on implementation of EBT treatment techniques. It has two primary components. (1) The training component, delivered weekly in two connected parts, involves self-monitored learning modules containing brief clinical descriptions of core EBT techniques and mock session coding exercises based on 5-8 min video segments that illustrate delivery of core techniques. (2) The feedback component summarizes aggregated therapist-reported data on EBT techniques used with their active caseloads. MTFS-I is hosted online and requires approximately 20 min per week to complete for each treatment approach. This randomized trial will first collect data on existing delivery of family therapy and CBT techniques for youth in outpatient behavioral health sites (Baseline phase). It will then randomize site clinicians to two study conditions (Implementation phase): Training Only versus Training + Feedback + Consultation. Therapists will choose whether to train in family therapy, CBT, or both. Study aims will compare clinician performance across study phase and between study conditions on MTFS-I uptake, reliability and accuracy in EBT self-monitoring, and utilization of EBT techniques in treatment sessions (based on observer coding of audiotapes). DISCUSSION: Study contributions to implementation science and considerations of MTFS-I sustainability are discussed. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03722654. Registered on 29 October 2018.


Subject(s)
Adolescent Behavior , Cognitive Behavioral Therapy , Conduct Disorder/therapy , Family Therapy , Formative Feedback , Psychotherapy/education , Substance-Related Disorders/therapy , Adolescent , Age Factors , Attitude of Health Personnel , Conduct Disorder/diagnosis , Conduct Disorder/psychology , Health Knowledge, Attitudes, Practice , Humans , Multicenter Studies as Topic , Professional Practice Gaps , Randomized Controlled Trials as Topic , Substance-Related Disorders/diagnosis , Substance-Related Disorders/psychology , Time Factors , Treatment Outcome , United States
12.
Lipids Health Dis ; 15(1): 116, 2016 Jul 12.
Article in English | MEDLINE | ID: mdl-27405296

ABSTRACT

BACKGROUND: LDL-C, non-HDL-C and ApoB levels are inter-correlated and all predict risk of atherosclerotic cardiovascular disease (ASCVD) in patients with type 2 diabetes mellitus (T2DM) and/or high TG. These levels are lowered by extended-release niacin (ERN), and changes in the ratios of these levels may affect ASCVD risk. This analysis examined the effects of extended-release niacin/laropiprant (ERN/LRPT) on the relationships between apoB:LDL-C and apoB:non-HDL-C in patients with T2DM. METHODS: T2DM patients (n = 796) had LDL-C ≥1.55 and <2.97 mmol/L and TG <5.65 mmol/L following a 4-week, lipid-modifying run-in (~78 % taking statins). ApoB:LDL-C and apoB:non-HDL-C correlations were assessed after randomized (4:3), double-blind ERN/LRPT or placebo for 12 weeks. Pearson correlation coefficients between apoB:LDL-C and apoB:non-HDL-C were computed and simple linear regression models were fitted for apoB:LDL-C and apoB:non-HDL-C at baseline and Week 12, and the correlations between measured apoB and measured vs predicted values of LDL-C and non-HDL-C were studied. RESULTS: LDL-C and especially non-HDL-C were well correlated with apoB at baseline, and treatment with ERN/LRPT increased these correlations, especially between LDL-C and apoB. Despite the tighter correlations, many patients who achieved non-HDL-C goal, and especially LDL-C goal, remained above apoB goal. There was a trend towards greater increases in these correlations in the higher TG subgroup, non-significant possibly due to the small number of subjects. CONCLUSIONS: ERN/LRPT treatment increased association of apoB with LDL-C and non-HDL-C in patients with T2DM. Lowering LDL-C, non-HDL-C and apoB with niacin has the potential to reduce coronary risk in patients with T2DM.


Subject(s)
Apolipoprotein B-100/blood , Cholesterol, LDL/blood , Delayed-Action Preparations/therapeutic use , Hyperlipidemias/drug therapy , Hypolipidemic Agents/therapeutic use , Indoles/therapeutic use , Niacin/therapeutic use , Adult , Aged , Aged, 80 and over , Blood Glucose/metabolism , Cholesterol, HDL/blood , Diabetes Mellitus, Type 2/blood , Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/physiopathology , Double-Blind Method , Fasting , Female , Humans , Hyperlipidemias/blood , Hyperlipidemias/physiopathology , Hypoglycemic Agents/therapeutic use , Insulin/blood , Male , Middle Aged , Triglycerides/blood
13.
Vasc Health Risk Manag ; 11: 165-72, 2015.
Article in English | MEDLINE | ID: mdl-25750540

ABSTRACT

BACKGROUND: The degree of glycemic control in patients with type 2 diabetes mellitus (T2DM) may alter lipid levels and may alter the efficacy of lipid-modifying agents. OBJECTIVE: Evaluate the lipid-modifying efficacy of extended-release niacin/laropiprant (ERN/LRPT) in subgroups of patients with T2DM with better or poorer glycemic control. METHODS: Post hoc analysis of clinical trial data from patients with T2DM who were randomized 4:3 to double-blind ERN/LRPT or placebo (n=796), examining the lipid-modifying effects of ERN/LRPT in patients with glycosylated hemoglobin or fasting plasma glucose levels above and below median baseline levels. RESULTS: At Week 12 of treatment, ERN/LRPT significantly improved low-density lipoprotein cholesterol, high-density lipoprotein cholesterol (HDL-C), non-high-density lipoprotein cholesterol, triglycerides, and lipoprotein (a), compared with placebo, with equal efficacy in patients above or below median baseline glycemic control. Compared with placebo, over 36 weeks of treatment more patients treated with ERN/LRPT had worsening of their diabetes and required intensification of antihyperglycemic medication, irrespective of baseline glycemic control. Incidences of other adverse experiences were generally low in all treatment groups. CONCLUSION: The lipid-modifying effects of ERN/LRPT are independent of the degree of baseline glycemic control in patients with T2DM (NCT00485758).


Subject(s)
Biomarkers/blood , Blood Glucose/drug effects , Diabetes Mellitus, Type 2/drug therapy , Dyslipidemias/drug therapy , Hypoglycemic Agents/therapeutic use , Hypolipidemic Agents/therapeutic use , Indoles/therapeutic use , Lipids/blood , Niacin/therapeutic use , Aged , Blood Glucose/metabolism , Delayed-Action Preparations , Diabetes Mellitus, Type 2/blood , Diabetes Mellitus, Type 2/diagnosis , Double-Blind Method , Drug Combinations , Drug Interactions , Dyslipidemias/blood , Dyslipidemias/diagnosis , Female , Glycated Hemoglobin/metabolism , Humans , Hypoglycemic Agents/adverse effects , Hypolipidemic Agents/adverse effects , Indoles/adverse effects , Male , Middle Aged , Niacin/adverse effects , Time Factors , Treatment Outcome
14.
Sci Transl Med ; 4(148): 148ra115, 2012 Aug 22.
Article in English | MEDLINE | ID: mdl-22914621

ABSTRACT

Nicotinic acid (niacin) induces beneficial changes in serum lipoproteins and has been associated with beneficial cardiovascular effects. Niacin reduces low-density lipoprotein, increases high-density lipoprotein, and decreases triglycerides. It is well established that activation of the seven-transmembrane G(i)-coupled receptor GPR109A on Langerhans cells results in release of prostaglandin D2, which mediates the well-known flushing side effect of niacin. Niacin activation of GPR109A on adipocytes also mediates the transient reduction of plasma free fatty acid (FFA) levels characteristic of niacin, which has been long hypothesized to be the mechanism underlying the changes in the serum lipid profile. We tested this "FFA hypothesis" and the hypothesis that niacin lipid efficacy is mediated via GPR109A by dosing mice lacking GPR109A with niacin and testing two novel, full GPR109A agonists, MK-1903 and SCH900271, in three human clinical trials. In mice, the absence of GPR109A had no effect on niacin's lipid efficacy despite complete abrogation of the anti-lipolytic effect. Both MK-1903 and SCH900271 lowered FFAs acutely in humans; however, neither had the expected effects on serum lipids. Chronic FFA suppression was not sustainable via GPR109A agonism with niacin, MK-1903, or SCH900271. We conclude that the GPR109A receptor does not mediate niacin's lipid efficacy, challenging the long-standing FFA hypothesis.


Subject(s)
Fatty Acids/metabolism , Niacin/pharmacology , Receptors, G-Protein-Coupled/metabolism , Receptors, Nicotinic/metabolism , Animals , Dose-Response Relationship, Drug , Fatty Acids/blood , Humans , Lipolysis/drug effects , Lipoproteins/blood , Male , Mice , Mice, Inbred C57BL , Niacin/administration & dosage , Pyrazoles/pharmacology , Receptors, G-Protein-Coupled/agonists
15.
J Clin Lipidol ; 5(4): 281-7, 2011.
Article in English | MEDLINE | ID: mdl-21784373

ABSTRACT

BACKGROUND: Niacin compounds lower serum phosphorus concentrations in patients with end-stage renal disease. METHODOLOGY: We evaluated the impact of extended release niacin, given in fixed-dose combination with laropiprant, a specific inhibitor of prostaglandin-mediated, niacin-induced flushing, versus placebo, on serum phosphorus concentrations measured serially (at weeks 0, 4, 8, 12, 18, 24, 30, and 36) during a 36-week randomized, controlled trial. All subjects had a confirmed diagnosis of type 2 diabetes (n = 446 niacin/laropiprant; n = 339 placebo). Estimated glomerular filtration rate ranged from 36 to 184 mL/min/1.73 m(2), with n = 111 (14.1%) having a value <60 mL/min/1.73 m(2). Subjects received one tablet daily of extended-release niacin/laropiprant (1g niacin/ 20 mg laropiprant) for the first 4 weeks, and 2 tablets once daily, thereafter, or matched placebo. Niacin lowered serum phosphorus concentrations by 0.36 mg/dL (95% CI: -0.40, -0.31; P < .001), relative to placebo, from baseline values of 3.57 and 3.56 mg/dL in the niacin and placebo groups, respectively. Subgroup analyses revealed no evidence for phosphorus-lowering effect modification by these baseline variables: glomerular filtration rate <60 (n = 111;14.1%) vs ≥60 mL/min/m(2) (n = 674; 85.9%); phosphorus ≤3.5 mg/dL (n = 392; 49.9%) vs >3.5 mg/dL (n = 393; 50.1%); or prior statin use (n = 618; 78.7%) vs nonuse (n = 167; 21.3%). CONCLUSIONS AND IMPLICATIONS: These data confirm that niacin's phosphorus-lowering effects-which may have therapeutic implications for the management of hyperphosphatemia and possible prevention of cardiorenal outcomes in renal disease-extend across a broad spectrum of renal function in type 2 diabetics without stage 4 or 5 chronic kidney disease (a glomerular filtration rate ≥30 mL/min/1.73 m(2)).


Subject(s)
Delayed-Action Preparations , Diabetes Mellitus, Type 2/complications , Hyperphosphatemia/drug therapy , Indoles/therapeutic use , Niacin/therapeutic use , Phosphorus/blood , Aged , Diabetes Mellitus, Type 2/blood , Diabetes Mellitus, Type 2/drug therapy , Double-Blind Method , Drug Combinations , Female , Glomerular Filtration Rate , Humans , Hypolipidemic Agents/administration & dosage , Hypolipidemic Agents/adverse effects , Hypolipidemic Agents/therapeutic use , Indoles/administration & dosage , Indoles/adverse effects , Kidney Failure, Chronic/complications , Male , Middle Aged , Niacin/administration & dosage , Niacin/adverse effects , Receptors, Prostaglandin/antagonists & inhibitors
17.
Gastroenterol Nurs ; 30(5): 337-41, 2007.
Article in English | MEDLINE | ID: mdl-18049202

ABSTRACT

Gastrostomy tubes are used for primary and supplemental feeding and gastric decompression. The purpose of the study was to compare the complication rate of gastrostomy tube placement by either endoscopic or fluoroscopic technique. Between 1996 and 2004, the surgical and radiological services at a Level I trauma hospital placed gastrostomy tubes in 378 patients (endoscopy=268, fluoroscopy=110). The percutaneous gastrostomy group comprised 71% of the cohort with a mean age of 51+/-21 (range: 1-93 years of age), and the percutaneous radiographic gastrostomy group comprised the remaining cohort (29%) with a mean age of 57+/-19 (range: 17-95 years of age). Fifty-eight percent of the percutaneous gastrostomy group were female (n=155) and 42% were male (n=113), whereas the gender distribution for the percutaneous radiographic gastrostomy group was 33% female (n=36) and 67% male (n=74). There was an overall complication rate of 36% (22% and 70% for the endoscopic and fluoroscopic methods, respectively). The most frequent complication in both types of techniques was tube dislodgement (endoscopic=32% [19/268]; fluoroscopic=27% [21/110]). There were very few serious complications. Women had a higher rate of postprocedure complications than did men, at 35% versus 27%. We conclude that gastrostomy tube placement by either endoscopic or fluoroscopic methods results in a number of complications, though most of them are minor. Patients must therefore be informed that this is not a complication-free procedure.


Subject(s)
Fluoroscopy/adverse effects , Gastroscopy/adverse effects , Gastrostomy/adverse effects , Intubation, Gastrointestinal/adverse effects , Adolescent , Adult , Aged , Aged, 80 and over , Child , Child, Preschool , Cross Infection/etiology , Equipment Failure/statistics & numerical data , Female , Fluoroscopy/statistics & numerical data , Gastroscopy/statistics & numerical data , Gastrostomy/statistics & numerical data , Hematoma/etiology , Humans , Infant , Intubation, Gastrointestinal/statistics & numerical data , Male , Middle Aged , Patient Education as Topic , Patient Selection , Peritonitis/etiology , Pneumoperitoneum/etiology , Retrospective Studies , Trauma Centers
19.
Cardiovasc Intervent Radiol ; 29(6): 935-46, 2006.
Article in English | MEDLINE | ID: mdl-16967225

ABSTRACT

The endovascular procedure for repair of abdominal aortic aneurysms has had an enormous impact on the treatment of this challenging disease. Complications, however, do occur and it is important to have a thorough understanding of the array of complications and appropriate management strategies. In this review of endovascular complications, we describe early and late complications paying particular attention to preventive, treatment and surveillance strategies.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Postoperative Complications/etiology , Vascular Surgical Procedures/adverse effects , Aortic Aneurysm, Abdominal/therapy , Blood Vessel Prosthesis/adverse effects , Clinical Trials as Topic , Embolization, Therapeutic/adverse effects , Embolization, Therapeutic/instrumentation , Humans , Population Surveillance , Postoperative Complications/physiopathology , Postoperative Complications/prevention & control , Stents/adverse effects , Time Factors , Vascular Patency , Vascular Surgical Procedures/instrumentation
20.
J Trauma ; 60(5): 1083-6, 2006 May.
Article in English | MEDLINE | ID: mdl-16688074

ABSTRACT

BACKGROUND: The purpose of this study was to develop a computed tomography (CT) scan screening test to predict the need for intervention in patients with splenic injury. METHODS: CT scans of 20 patients with blunt injury to the spleen were reviewed to identify findings that correlated with the need for intervention (surgery or embolization). A screening test was created and then validated in CT scans from 56 consecutive patients. RESULTS: Three findings correlated with the need for intervention: 1) devascularization or laceration involving 50% or more of the splenic parenchyma, 2) contrast blush greater than one centimeter in diameter (from active extravasation of intravenous contrast material or pseudoaneurysm formation), and 3) a large hemoperitoneum. The sensitivity of the screening test was 100%, specificity was 88%, and overall accuracy was 93%. CONCLUSIONS: These CT scan grading criteria appears to reliably predict the need for invasive management in patients with blunt injury to the spleen.


Subject(s)
Diagnosis, Computer-Assisted , Splenic Rupture/diagnostic imaging , Splenic Rupture/surgery , Tomography, X-Ray Computed , Wounds, Nonpenetrating/diagnostic imaging , Wounds, Nonpenetrating/surgery , Adult , Angiography , Decision Making, Computer-Assisted , Embolization, Therapeutic , Extravasation of Diagnostic and Therapeutic Materials/diagnostic imaging , Extravasation of Diagnostic and Therapeutic Materials/surgery , Female , Florida , Hemoperitoneum/diagnostic imaging , Hemoperitoneum/surgery , Humans , Ischemia/diagnostic imaging , Ischemia/surgery , Male , Needs Assessment , Sensitivity and Specificity , Spleen/blood supply , Splenic Artery/diagnostic imaging , Splenic Artery/injuries , Statistics as Topic , Trauma Centers
SELECTION OF CITATIONS
SEARCH DETAIL
...