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Subcutaneous treprostinil is well tolerated with infrequent site changes and analgesics.

ABSTRACT: Abstract Continuous prostanoid infusions are recommended for patients with advanced pulmonary arterial hypertension. Infusion site pain has discouraged some physicians from considering subcutaneous (SQ) treprostinil therapy even though it has safety and convenience advantages over intravenous epoprostenol. We conducted a 1-year prospective study of patients utilizing SQ treprostinil. We provided counseling on infrequent site changes and a written analgesic protocol including narcotics. After placement of a new site, subjects recorded daily pain scores and analgesic use. Twenty-six of 29 patients consented, including 4 patients who had recently started therapy. They returned 203 diaries, and we captured every site change in a diary. Sixteen subjects returned 8 or fewer diaries during 12 months, and 20% of diaries documented only mild discomfort. The majority of diaries documented brief periods of severe pain, but this had generally abated by day 7. Contrary to published guidelines, infusion site pain was independent of treprostinil dose in a rigorous analysis. There were 3 significant local reactions but no systemic illness. No subject discontinued SQ treprostinil because of site discomfort. Subjects reported satisfaction with their treatment using a validated assessment, and quality-of-life scores were favorable. A strategy emphasizing infrequent site changes and early analgesia can facilitate use of SQ treprostinil. These data may allow physicians to consider treprostinil earlier in the treatment algorithm for this fatal disease.

SUBMITTER: White RJ

PROVIDER: S-EPMC4070817 | biostudies-other | 2013 Sep

REPOSITORIES: biostudies-other

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Project description:Allergy to house dust mite is one of the most common causes of allergic rhinitis. A novel tyrosine-adsorbed, modified allergen product, Acarovac Plus, developed for the treatment of perennial mite allergy seeks to address the underlying cause of allergic rhinitis in this instance. One of two dosing regimens may be used, either the Conventional Regimen or the Cluster Regimen. We sought to compare the efficacy and safety of a specific immunotherapy, developed for the treatment of perennial mite allergy, administered under a Conventional and Clustered dosing schedule in patients with persistent allergic rhinitis. Thirty adult patients, between 18 and 65 years old, with allergic rhinitis and/or asthma secondary to hypersensitivity to Dermatophagoides pteronyssinus were administered with either conventional or cluster initial regime, with a final visit one week after the last dose administration. The efficacy to the Conventional and Cluster regimens was measured using a Nasal Challenge Test monitoring clinical symptoms and peak nasal inspiratory flow. Total IgE, serum-specific inmunoglobulins (IgE and IgG4) to Dermatophagoides pteronyssinus and relevant cytokines (IFN-?, IL-4, IL-5, IL-10 and IL-13) were assessed. A Satisfaction Questionnaire (TSQM) was completed after each patient's final visit. The tolerability of the vaccine was assessed monitoring adverse reactions. No adverse events were recorded in either conventional or cluster regime. The specific Nasal Challenge Test led to a decrease in symptom scores and a significant decrease in mean nasal peak inspiratory flow drop was recorded in both dosing regimen groups. A significant increase in IgG4-specific antibody titres was assessed. No significant changes were observed in concentrations of total IgE, specific IgE or cytokines (IFN-?, IL-4, IL-5, IL-10 and IL-13). Patients declared themselves most satisfied in relation to "Secondary effects", with high overall satisfaction in both groups. Cluster and conventional specific immunotherapy resulted in no adverse reaction(s) and led to similar improvements in immunological parameters, clinical efficacy (Nasal Challenge Test) and high overall satisfaction.

Project description:INTRODUCTION:Dolutegravir (DTG) is recommended as part of first-line antiretroviral therapy (ART) for people living with HIV(PLHIV). We sought to determine the rate of adverse events (AEs) and discontinuations among Thais treated during acute HIV infection (AHI) and switched to DTG-based regimens. METHODS:Thai participants in the SEARCH010/RV254 cohort who initiated ART during AHI and switched to DTG for at least 48 weeks were prospectively observed and included in the analysis. Rates and characteristics of DTG-related AEs and discontinuations were described. RESULTS:A total of 313 Thai participants were included in the analysis. The median age was 29 years, 96% were male, 64% had a Bachelor's degree or higher and 16% had a body mass index (BMI) <18.5 kg/m2 . Participants were on ART for a median of 124 weeks before switching to DTG. The median (IQR) body weight increased from 63 (56 to 70) kg before to 65 (58 to 73) kg (p < 0.0001) after 48 weeks of DTG. Forty-nine (16%) developed DTG-related AEs, corresponding to an incidence of 16.6 per 100 person-years. Neuropsychiatric symptoms were most frequently encountered (n = 25, 8%), followed by laboratory abnormalities (n = 16, 5%). Six (2%) discontinued DTG, corresponding to an incidence of 2.4 per 100 person-years. All discontinuations were due to increased liver enzymes in the presence of hepatitis C virus coinfection. In the multivariate analysis, incident hepatitis C virus infection was the only risk factor for discontinuing DTG (hazard ratio 59.4, 95% CI 8.5 to 297.9, p < 0.0001). Neither low BMI nor concurrent abacavir therapy was associated with discontinuation. CONCLUSIONS:DTG was well tolerated with few discontinuations in this cohort of young men. Incident hepatitis C virus infection was a driver of liver-related AEs leading to discontinuations. In populations at risk, regular testing for hepatitis C virus during ART is recommended to anticipate possible AEs, guide management and improve safety.

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Subcutaneous treprostinil is well tolerated with infrequent site changes and analgesics.

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