One of the largest spontaneous adverse events reporting databases in the world is the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Unfortunately, researchers face many obstacles in analyzing data from the FAERS database. One of the major obstacles is the unstructured entry of drug names into the FAERS, as reporters might use generic names or trade names with different naming structures from all over the world and, in some cases, with typographical errors. Moreover, report duplication is a known problem in spontaneous adverse event-reporting systems, including the FAERS database. Hence, thorough text processing for database entries, especially drug name entries, coupled with a practical case-deduplication logic, is a prerequisite to analyze the database, which is a time- and resource-consuming procedure. In this study, we provide a clean, deduplicated, and ready-to-import dataset into any relational database management software of the FAERS database up to September 2021. Drug names are standardized to the RxNorm vocabulary and normalized to the single active ingredient level. Moreover, a pre-calculated disproportionate analysis is provided, which includes the reporting odds ratio (ROR), proportional reporting ratio (PRR), Chi-squared analysis with Yates correction ($x^2$), and information component (IC) for each drug-adverse event pair in the database.

The incidence of dengue is rising steadily in Malaysia since the first major outbreak in 1973. Despite aggressive measures taken by the relevant authorities, Malaysia is still facing worsening dengue crisis over the past few years. There is an urgent need to evaluate dengue cases for better understanding of clinic-laboratory spectrum in order to combat this disease. A retrospective analysis of dengue patients admitted to a tertiary care teaching hospital during the period of six years (2008 – 2013) was performed. Patient’s demographics, clinical and laboratory findings were recorded via structured data collection form. Patients were categorized into dengue fever (DF) and dengue hemorrhagic fever (DHF). Appropriate statistical methods were used to compare these two groups in order to determine difference in clinico-laboratory characteristics and to identify independent risk factors of DHF. A total 667 dengue patients (30.69 ± 16.13 years; Male: 56.7 %) were reviewed. Typical manifestations of dengue like fever, myalgia, arthralgia, headache, vomiting, abdominal pain and skin rash were observed in more than 40 % patients. DHF was observed in 79 (11.8 %) cases. Skin rash, dehydration, shortness of breath, pleural effusion and thick gall bladder were more significantly (P < 0.05) associated with DHF than DF. Multivariate regression analysis demonstrated presence of age > 40 years (OR: 4.1, P < 0.001), secondary infection (OR: 2.7, P = 0.042), diabetes mellitus (OR: 2.8, P = 0.041), lethargy (OR: 3.1, P = 0.005), thick gallbladder (OR: 1.7, P = 0.029) and delayed hospitalization (OR: 2.3, P = 0.037) as independent predictors of DHF. Overall mortality was 1.2 % in our study. Current study demonstrated that DF and DHF present significantly different clinico-laboratory profile. Older age, secondary infection, diabetes mellitus, lethargy, thick gallbladder and delayed hospitalization significantly predict DHF. Prior knowledge of expected clinical profile and predictors of DHF/DSS development would provide information to identify individuals at higher risk and on the other hand, give sufficient time to clinicians for reducing dengue related morbidity and mortality.

Even though depression is one of the most common psychiatric disorders, it is under-recognized in hemodialysis (HD) patients. Existing literature does not provide enough information on evaluation of predictors of depression among HD patients. The objective of the current study was to determine the prevalence and predictors of depression among HD patients. A multicenter prospective follow-up study. All eligible confirmed hypertensive HD patients who were consecutively enrolled for treatment at the study sites were included in the current study. HADS questionnaire was used to assess the depression level among study participants. Patients with physical and/or cognitive limitations that prevent them from being able to answer questions were excluded. Two hundred twenty patients were judged eligible and completed questionnaire at the baseline visit. Subsequently, 216 and 213 patients completed questionnaire on second and final follow up respectively. The prevalence of depression among patients at baseline, 2nd visit and final visit was 71.3, 78.2 and 84.9% respectively. The results of regression analysis showed that treatment given to patients at non-governmental organizations (NGO’s) running HD centers (OR = 0.347, p-value = 0.039) had statistically significant association with prevalence of depression at final visit. Depression was prevalent in the current study participants. Negative association observed between depression and hemodialysis therapy at NGO’s running centers signifies patients’ satisfaction and better depression management practices at these centers.

Despite promising role of diuretics to manage fluid overload among chronic kidney disease (CKD) patients, their use is associated with adverse renal outcomes. Current study aimed to determine the extent of renal deterioration with diuretic therapy. A total 312 non-dialysis dependent CKD (NDD-CKD) patients were prospectively followed-up for one year. Fluid overload was assessed via bioimpedance spectroscopy. Estimated GFR (eGFR) was calculated from serum creatinine values by using Chronic Kidney Disease- Epidemiology Collaboration (CKD-EPI) equation. Out of 312 patients, 64 (20.5%) were hypovolemic while euvolemia and hypervolemia were observed in 113 (36.1%) and 135 (43.4%) patients. Overall 144 patients were using diuretics among which 98 (72.6%) were hypervolemic, 35 (30.9%) euvolemic and 11 (17.2%) were hypovolemic. The mean decline in estimated GFR of entire cohort was -2.5 ± 1.4 ml/min/1.73m² at the end of follow up. The use of diuretics was significantly associated with decline in eGFR. A total of 36 (11.5%) patients initiated renal replacement therapy (RRT) and need of RRT was more profound among diuretic users. The use of diuretics was associated with adverse renal outcomes indicated by decline in eGFR and increasing risk of RRT initiation in our cohort of NDD-CKD patients. Therefore, it is cautiously suggested to carefully prescribe diuretics by keeping in view benefit versus harm for each patient.

Dengue induced acute kidney injury (AKI) imposes heavy burden of illness in terms of morbidity and mortality. A retrospective study was conducted to investigate incidence, characteristics, risk factors and clinical outcomes of AKI among dengue patients. A total 667 dengue patients (2008–2013) were retrospectively evaluated and were stratified into AKI and non-AKI groups by using AKIN criteria. Two groups were compared by using appropriate statistical methods. There were 95 patients (14.2%) who had AKI, with AKIN-I, AKIN-II and AKIN-III in 76.8%, 16.8% and 6.4% patients, respectively. Significant differences (P<0.05) in demographics and clinico-laboratory characteristics were observed between patients with and without AKI. Presence of dengue hemorrhagic fever [OR (95% CI): 8.0 (3.64–17.59), P<0.001], rhabdomyolysis [OR (95% CI): 7.9 (3.04–20.49)], multiple organ dysfunction [OR (95% CI): 34.6 (14.14–84.73), P3 days) was also observed among AKI patients (OR = 1.3, P = 0.044). Additionally, 48.4% AKI patients had renal insufficiencies at discharge that were signicantly associated with severe dengue, secondary infection and diabetes mellitus. Overall mortality was 1.2% and all fatal cases had AKI. The incidence of AKI is high at 14.2% among dengue patients, and those with AKI portended significant morbidity, mortality, longer hospital stay and poor renal outcomes. Our findings suggest that AKI in dengue is likely to increase healthcare burden that underscores the need of clinicians’ alertness to this highly morbid and potentially fatal complication for optimal prevention and management.

SETTINGS: Although Pakistan has a high burden of multidrug-resistant tuberculosis (MDR-TB), little is known about the management and treatment outcomes of MDR-TB patients in Pakistan. OBJECTIVE: To evaluate management and predictors of unsuccessful treatment outcomes among MDR-TB patients. METHODS: In this observational cohort study, 196 MDR-TB patients enrolled at the Programmatic Management Unit for drug-resistant TB of Lady Reading Hospital, Peshawar, Pakistan, between 1 January 2012 and 28 February 2013 were included. Patients were followed until an outcome was recorded or 31 January 2015. RESULTS: Extensive concurrent resistance to ofloxacin (OFX) and pyrazinamide (54.6%) was observed. Among 181 patients for whom treatment outcome was available, 135 (74.6%) were cured, 1 (0.6%) completed treatment, 35 (19.3%) died, 8 (4.4%) failed treatment and 2 (1.1%) defaulted. In multivariate analysis, predictors of unsuccessful treatment outcome (death, failure and default) were age >40 years (OR 3.412, P = 0.009), baseline body weight <40 kg (OR 2.966, P = 0.020), concurrent comorbidity (OR 3.785, P = 0.023), resistance to OFX (OR 2.777, P = 0.023), lung cavitations at baseline chest X-ray (OR 5.253, P < 0.001) and regimen modification due to adverse events (OR 3.492, P = 0.037). CONCLUSION: The treatment outcome results were encouraging. Patients with identifiable predictors of poor treatment outcome should receive enhanced clinical management. Early detection and management of mild adverse effects can help prevent regimen modification and may improve treatment outcomes.