Pilot study of combined therapy with ω-3 fatty acids and niacin in atherogenic dyslipidemia

BackgroundNiacin and ω-3 fatty acids (ω-3 FA) are both nutrients that reduce serum triglyceride and raise high-density lipoprotein cholesterol (HDL-C) levels when used at pharmacological doses. The possibility that these two agents, given in combination, might have additive effects on these lipid parameters has not been examined previously. In addition, the combination might prevent the rise in low-density lipoprotein (LDL)-C levels frequently seen with ω-3 FA treatment.ObjectiveTo determine the effect of therapy of niacin and ω-3 FA alone and in combination versus placebo on lipid parameters in subjects with atherogenic dyslipidemia.MethodsIn a pilot parallel group study, we studied 29 patients with atherogenic dyslipidemia who were assigned to either dual placebo (n = 7), ω-3 FA (3.4 g/d; n = 8), crystalline niacin (3 g/d; n = 7), or the combination (n = 7) for 12 weeks. Fasting lipid profiles were assessed before and after treatment.ResultsChanges in serum triglyceride levels from baseline were 10%, −2%, −17%, and −52%, respectively, while HDL-C concentrations rose by 4%, 10%, 18%, and 33%, respectively. Both of these results were statistically significantly different for combination therapy compared to changes with placebo and ω-3 FA monotherapy (analysis of variance with Tukey’s post-hoc test). No statistically significant changes were seen for LDL-C. Addition of ω-FA to niacin had no effect on niacin-induced flushing.ConclusionFrom this small pilot study, we conclude that combined therapy with niacin and ω-3 FA has beneficial effects on triglyceride and HDL-C levels, and use of these two agents in combination prevents the ω-3 FA-induced rise in LDL-C. Larger studies of this combination therapy are clearly warranted in patient populations with atherogenic dyslipidemia to assess not only lipid effects, but also potential coronary heart disease benefits.     

Efficacy and safety of Hizentra(®) in patients with primary immunodeficiency after a dose-equivalent switch from intravenous or subcutaneous replacement therapy

A prospective, open-label, multicenter, single-arm, Phase III study evaluated the efficacy and safety of Hizentra^®, a 20% human IgG for subcutaneous administration, in 51 primary immunodeficiency patients over 40 weeks. Patients previously on intravenous or subcutaneous IgG were switched to weekly subcutaneous infusions of Hizentra^® at doses equivalent to their previous treatment. IgG levels achieved with Hizentra^® were similar to pre-study levels with subcutaneous, and higher by 17.7% than pre-study levels with intravenous IgG. No serious bacterial infections were reported in the efficacy period. The rate of all infections was 5.18/year/patient, the rates of days missed from work/school, and days spent in hospital were 8.00/year/patient and 3.48/year/patient, respectively. Local reactions (rate 0.060/infusion) were mostly mild (87.3%). No serious, Hizentra^®-related adverse events were reported. Individual median infusion durations ranged between 1.14 and 1.27 h. Hizentra^® maintained or improved serum IgG levels without dose increases and effectively protected patients against infections.     

Efficacy of combination therapy with amantadine,thymosin α1 and α/β interferon in mice infected with influenza a virus

The aim of this study was to examine the effects of the antiviral drug amantadine (AMN) administered in combination with thymosin α1 (Tα1) and murine α/β interferon (IFN) on mice infected with influenza A PR8 virus. Combined treatment with AMN and Tα1, for 4 days, followed by a single injection of IFN, was initiated 1 h after intranasal viral inoculation. The effectiveness of this new chemoimmunotherapy protocol was seen in the longterm survival of a high percentage of animals and was statistically significant when compared to treatment with single agents in conjunction with chemotherapy or to chemotherapy alone. In addition, chemoimmunotherapy treatment reduces the viral titre in the lungs as well as restoring the immunological parameters tested (natural killer cell activity; cytotoxic T-lymphocyte responses; CD4⁺/CD8⁺ lymphocyte subsets) with respect to all other groups. These results suggest the potential use of these immunomodulating agents in combination with an antiviral drug in controlling PR8 influenza virus infection.     

Meropenem versus piperacillin/tazobactam with or without immunoglobulin as second-line therapy for febrile neutropenia in pediatric patients

Background

Although survival of children with hematological diseases and cancer has increased dramatically, life-threatening complications due to bacterial infections occur in 5–10% of febrile episodes in pediatric cancer patients. A prospective randomized study was performed to clarify the usefulness of meropenem (MEPM) and piperacillin/tazobactam (PIPC/TAZ) with or without intravenous immunoglobulin (IVIG) as second-line therapy for pediatric patients with febrile neutropenia (FN).

Simplicity and Efficacy of a Once-Daily Antiretroviral Regimen with Didanosine,Lamivudine, and Efavirenz in Naïve Patients: The VESD Study

Abstract

Purpose: Our aim was to analyze the efficacy and safety of didanosine-lamivudine-efavirenz in a cohort of HIV patients starting antiretroviral therapy between January and September 2003. Method: We undertook a prospective, open-label, observational, multicenter study. Results: 163 patients were enrolled. Over a 48-week period, plasma HIV RNA levels declined sharply, with a median decrease at the end of the observation time of >4.62 log copies/mL. The proportion of patients achieving a plasma HIV RNA level below 50 copies/mL was 62.9% (intention-to-treat analysis) at the end of the study period. The mean CD4 cell count increased steadily over time by 199 cells/mL. Antiviral efficacy was similar in patients with a baseline HIV RNA level above or below 100,000 copies/mL. Overall, 57 (34.1%) patients interrupted therapy; 9 due to lack of treatment response, 18 due to adverse side-effects, and 30 patients lost to follow-up or who withdrew their consent. Adherence was very high (90%-95%) and quality of life was good or very good in 69%. Conclusion: The once-daily combination of didanosine-lamivudine-efavirenz resulted in sustained viral suppression and was well-accepted by patients under real-life conditions, even immunosuppressed patients and those with a high viral load. Associated adverse events and virological failures were few.     

Enhanced efficacy of imipenem-colistin combination therapy against multiple-drug-resistant Enterobacter cloacae: in vitro activity and a Galleria mellonella model

Background/Purpose

To investigate the in vitro and in vivo activity of imipenem-colistin combination against multidrug-resistant Enterobacter cloacae infections in order to determine whether it should be explored further.

Efficacy and safety of imidacloprid 10 %/moxidectin 1 % spot-on formulation in the treatment of feline infection by Capillaria aerophila

The nematode Capillaria aerophila (Trichuroidea, Trichuridae) affects the respiratory system of cats and other animals and occasionally of human beings. Infected cats may show bronchovesicular sounds, inflammation, sneezing, wheezing and, chronic cough and, sometimes, bronchopneumonia and respiratory failure. The present study evaluated the efficacy and safety of the antiparasitic spot-on formulation containing imidacloprid 10?%/moxidectin 1?% (Advocate?, Bayer Animal Health) in the treatment of natural feline infection with the lungworm C. aerophila. The efficacy of Advocate? administered once was tested on days 7?±?1 and 11?±?1 following treatment at day 0 and compared to faecal egg counts on days -6?±?1 and -2?±?1. Overall, 36 cats treated either with Advocate? (treatment group, n?=?17 cats) or left untreated (control group, n?=?19 cats) were included in the study. Geometric means of faecal egg counts values in eggs per gram of faeces were 124.03 prior to treatment and 0.26 posttreatment in treatment group, while 107.03 and 123.94 pre- and posttreatment in the untreated cats. Post-baseline egg counts showed a 99.79?% reduction in Advocate?-treated animals in comparison with cats which were left untreated. Also, treated cats showed no adverse events. This trial demonstrated that Advocate? spot-on formulation is safe and effective in the treatment of feline lung capillariosis caused by C. aerophila.     

The association of sleep with inflammatory bowel disease in children and adolescents

Aim

To systematically review literature investigating sleep quality in children and adolescents with inflammatory bowel disease (IBD).

Methods

Electronic databases were searched (BASE, Cochrane Database of Systematic Reviews, DIMDI, PsychArticles, PsychInfo, Psychjournals, Psychline, PSYNDEX, Pubmed, Science Direct, Web of Science, Wiley Online Library) by two researchers. Eligible studies were all that studied sleep disorders in the context of IBD in children and adolescents (6–17 years of age).

Results

Out of 40 references identified, five studies (all cross-sectional, three of them controlled) were eligible and included in this study. The publications showed that children and adolescents with IBD have significant sleep problems, adding to their impaired quality of life.

Conclusion

The published data provide evidence suggesting an impact of IBD and its severity on sleep in children and adolescents. However, with regard to the low methodological quality, the incongruity of the studies concerning outcome measure, and their focus of exploration, further studies are warranted to highlight the interrelationship.

     

Efficacy and safety of “unboosting” atazanavir in a randomized controlled trial among HIV-infected patients receiving tenofovir DF

Objectives: To assess safety and efficacy of a switch to unboosted atazanavir (ATV) among HIV-infected adults receiving ATV/ritonavir (r) and tenofovir disoproxil fumarate (TDF).

Methods: HIV-infected adults with viral load (VL) <40 copies/mL at screening and <150 copies/mL consistently for ≥3 months while receiving a regimen including ATV/r and TDF were randomized to continue ATV/r 300/100 mg daily (control) or change to ATV 400 mg daily (switch), while maintaining their TDF backbone. The primary outcome was proportion of subjects without treatment failure (regimen switch or VL > 200 copies/mL twice consecutively) at 48 weeks.

Results: Fifty participants (46 male, median age 47 years) were randomized, 25 to each arm. At week 48, treatment success occurred in 76% in the control arm and 92% in the switch arm (ITT, p = 0.25). ATV trough levels at week 9 were higher in controls (median 438 ng/mL) than in the switch arm (median 124 ng/mL) (p = 0.003), as was total bilirubin at week 48 (median 38 μmol/L and 28 μmol/L, respectively; p = 0.02). Estimated glomerular filtration rate (eGFR) decreased in the control arm (p = 0.007), but did not change in the switch arm. At week 48, eGFR was higher in the switch arm (median 96 mL/min) than in the control arm (median 85 mL/min) (p = 0.035), but the arms were similar with respect to fasting glucose, C-reactive protein, and lipid parameters.

Conclusions: Switching from ATV/r to unboosted ATV appears to be safe and effective in selected virologically suppressed patients receiving TDF-containing regimens, and may have favorable effects on bilirubin and renal function.