Self-reported predictors of depressive symptomatology in an elderly population with type 2 diabetes mellitus: a prospective cohort study

<p>Abstract</p> <p>Background</p> <p>The prevalence of depression increases among the elderly with chronic medical conditions like diabetes. Hence, the purpose of this study was to determine predictors of depressive symptomatology in Medicare enrolled elderly population with type 2 diabetes mellitus.</p> <p>Methods</p> <p>A prospective cohort study was conducted by administrating health risk assessment questionnaire to elderly (≥65 years) with type 2 diabetes. Responses were linked with administrative claim's data. Data were obtained from elderly with type 2 diabetes who were enrolled in Medicare Health Maintenance Organization (HMO) in southeastern United States. The instrument collected information related to demographics, health status, medication use, and healthcare service utilization prior to enrollment. Responses were combined with the administrative claims data of HMO to obtain information on actual utilization of healthcare resources. The Short Form Center for Epidemiologic Studies Depression scale was used to assess depressive symptoms. Multivariable logistic regression analyses were conducted to determine predictor variables.</p> <p>Results</p> <p>Of 792 respondents, about 17% had depressive symptoms. Almost 96% of patients were using 1 or more antidiabetic medications. Overall, increased risk of depression was associated with lower health related quality of life (HRQoL) (OR: 0.97; 95% CI: 0.96–0.98) and higher impairments in instrumental activities of daily living (IADLs) (OR: 1.31; 95% CI: 1.14–0.52) in elderly patients. Poor health related quality of life (OR: 0.97, 95%CI: 0.95–0.99) was associated with higher risk of depression in patients on insulin therapy.</p> <p>Conclusion</p> <p>Impairments in daily activities and lower HRQoL were predictors of depressive symptomatology in elderly with diabetes. Determinants of depression varied according to pharmacotherapeutic class of antidiabetic medications.</p

Efficacy and safety of paracetamol, phenylephrine, chlorpheniramine maleate and sodium citrate in Indian paediatric patients with common cold: an active post-marketing surveillance study

Background: The common cold, mainly caused by viruses, brings discomfort to children with symptoms like sneezing, congestion, runny nose, and sore throat. As no specific antiviral treatments are available to relieve common cold symptoms, it is typically managed using decongestants, antihistamines, and antipyretics. This study aims to assess the safety and efficacy of a fixed-dose combination (FDC) of paracetamol, phenylephrine, chlorpheniramine maleate and sodium citrate in children aged 2 to 12 years with common cold. Methods: This non-randomized, open-label, non-comparative, active post-marketing surveillance (PMS) study was conducted across multiple centres in India, involving 417 patients. The study assessed efficacy using the total symptom score (TSS) scale over 5 days with visits on days 1, 3, and 5. Safety was evaluated based on adverse events reported by patients on days 3 and 5 of the trial. Results: Initially, 417 patients were enrolled in the active PMS, of which 309 completed the study. The mean TSS showed a notable decrease from 8.95 at visit 1 to 0.19 at visit 3, depicting a significant reduction i.e., 97.90% as compared to baseline. At visit 1, most patients (95.79%) exhibited severe symptoms, whereas by visit 3, 83.82% were symptom-free, with only 16.18% experiencing mild symptoms. Conclusions: This active PMS study examined the safety and efficacy of an FDC of paracetamol, phenylephrine, chlorpheniramine maleate and sodium citrate in treating common cold in children in India. The findings indicate a significant reduction in symptoms, with many patients becoming symptom-free by the third visit, demonstrating its efficacy and safety

Efficacy and safety of a fixed dose combination of paracetamol, chlorpheniramine maleate and phenylephrine in treatment of common cold: a phase IV, open-labelled, multi-centric study

Background: Acute coryza or common cold affects the upper airways, sometimes in association with low-grade fever and systemic symptoms, and usually presents with at least two of the following symptoms: cough, dysphonia, throat discomfort, sore throat, nasal congestion, rhinorrhoea, sneezing, headaches, myalgia and fever. A triple combination of analgesics, decongestants and antihistamines provides better relief for multiple symptoms in common cold and allergic rhinitis according to various studies. A combination of Paracetamol as an analgesic, anti-inflammatory and antipyretic, Chlorpheniramine maleate, an anti-histaminic and Phenylephrine as a nasal decongestant is popular in the treatment of common cold. Hence the present study was planned to evaluate efficacy and safety of this combination in treatment of common cold.Methods: This was a phase IV, open-labelled, multicentric study in 159 patients. Efficacy assessment was done by analyzing the reduction in mean TSS at each follow-up visit and safety assessment was done by analyzing the adverse events during the study.Results: There was reduction in mean TSS from 6.62 (day 1) to 3.56 (day 3) and 0.69 (day 5). Most of the patients had >50% reduction in total symptom score at visit 3 and 58.49% patients had complete relief from the symptoms at the end of study. Out of 159 patients, 26 i.e. 16.36% experienced adverse events. Sedation and drowsiness (6.29%) were the most common adverse event seen in patients.Conclusions: A fixed dose combination of Chlorpheniramine maleate, Paracetamol, and Phenylephrine is safe and effective in the treatment of common cold

Exposure-Response Model of Subcutaneous C1-Inhibitor Concentrate to Estimate the Risk of Attacks in Patients With Hereditary Angioedema

Subcutaneous C1-inhibitor (HAEGARDA, CSL Behring), is a US Food and Drug Administration (FDA)-approved, highly concentrated formulation of a plasma-derived C1-esterase inhibitor (C1-INH), which, in the phase III Clinical Studies for Optimal Management in Preventing Angioedema with Low-Volume Subcutaneous C1-inhibitor Replacement Therapy (COMPACT) trial, reduced the incidence of hereditary angioedema (HAE) attacks when given prophylactically. Data from the COMPACT trial were used to develop a repeated time-to-event model to characterize the timing and frequency of HAE attacks as a function of C1-INH activity, and then develop an exposure-response model to assess the relationship between C1-INH functional activity levels (C1-INH(f)) and the risk of an attack. The C1-INH(f) values of 33.1%, 40.3%, and 63.1% were predicted to correspond with 50%, 70%, and 90% reductions in the HAE attack risk, respectively, relative to no therapy. Based on trough C1-INH(f) values for the 40 IU/kg (40.2%) and 60 IU/kg (48.0%) C1-INH (SC) doses, the model predicted that 50% and 67% of the population, respectively, would see at least a 70% decrease in the risk of an attack

Long-Term Outcomes with Subcutaneous C1-Inhibitor Replacement Therapy for Prevention of Hereditary Angioedema Attacks

Background: For the prevention of attacks of hereditary angioedema (HAE), the efficacy and safety of subcutaneous human C1-esterase inhibitor (C1-INH[SC]; HAEGARDA, CSL Behring) was established in the 16-week Clinical Study for Optimal Management of Preventing Angioedema with Low-Volume Subcutaneous C1-Inhibitor Replacement Therapy (COMPACT). Objective: To assess the long-term safety, occurrence of angioedema attacks, and use of rescue medication with C1-INH(SC). Methods: Open-label, randomized, parallel-arm extension of COMPACT across 11 countries. Patients with frequent angioedema attacks, either study treatment-naive or who had completed COMPACT, were randomly assigned (1:1) to 40 IU/kg or 60 IU/kg C1-INH(SC) twice per week, with conditional uptitration to optimize prophylaxis (ClinicalTrials.gov registration no. NCT02316353). Results: A total of 126 patients with a monthly attack rate of 4.3 in 3 months before entry in COMPACT were enrolled and treated for a mean of 1.5 years; 44 patients (34.9%) had more than 2 years of exposure. Mean steady-state C1-INH functional activity increased to 66.6% with 60 IU/kg. Incidence of adverse events was low and similar in both dose groups (11.3 and 8.5 events per patient-year for 40 IU/kg and 60 IU/kg, respectively). For 40 IU/kg and 60 IU/kg, median annualized attack rates were 1.3 and 1.0, respectively, and median rescue medication use was 0.2 and 0.0 times per year, respectively. Of 23 patients receiving 60 IU/kg for more than 2 years, 19 (83%) were attack-free during months 25 to 30 of treatment. Conclusions: In patients with frequent HAE attacks, long-term replacement therapy with C1-INH(SC) is safe and exhibits a substantial and sustained prophylactic effect, with the vast majority of patients becoming free from debilitating disease symptoms

Long-Term Outcomes with Subcutaneous C1-Inhibitor Replacement Therapy for Prevention of Hereditary Angioedema Attacks

Background For the prevention of attacks of hereditary angioedema (HAE), the efficacy and safety of subcutaneous human C1-esterase inhibitor (C1-INH[SC]; HAEGARDA, CSL Behring) was established in the 16-week Clinical Study for Optimal Management of Preventing Angioedema with Low-Volume Subcutaneous C1-Inhibitor Replacement Therapy (COMPACT). Objective To assess the long-term safety, occurrence of angioedema attacks, and use of rescue medication with C1-INH(SC). Methods Open-label, randomized, parallel-arm extension of COMPACT across 11 countries. Patients with frequent angioedema attacks, either study treatment-naive or who had completed COMPACT, were randomly assigned (1:1) to 40 IU/kg or 60 IU/kg C1-INH(SC) twice per week, with conditional uptitration to optimize prophylaxis (ClinicalTrials.gov registration no. NCT02316353). Results A total of 126 patients with a monthly attack rate of 4.3 in 3 months before entry in COMPACT were enrolled and treated for a mean of 1.5 years; 44 patients (34.9%) had more than 2 years of exposure. Mean steady-state C1-INH functional activity increased to 66.6% with 60 IU/kg. Incidence of adverse events was low and similar in both dose groups (11.3 and 8.5 events per patient-year for 40 IU/kg and 60 IU/kg, respectively). For 40 IU/kg and 60 IU/kg, median annualized attack rates were 1.3 and 1.0, respectively, and median rescue medication use was 0.2 and 0.0 times per year, respectively. Of 23 patients receiving 60 IU/kg for more than 2 years, 19 (83%) were attack-free during months 25 to 30 of treatment. Conclusions In patients with frequent HAE attacks, long-term replacement therapy with C1-INH(SC) is safe and exhibits a substantial and sustained prophylactic effect, with the vast majority of patients becoming free from debilitating disease symptoms