A qualitative and quantitative comparison of adverse drug reaction data of anti-epileptic drugs in various sources of drug information

Background: It is essential to spread awareness about known adverse drug reactions (ADRs) for identification, prevention and their proper management. The aim of this study is to assess disparities in documented ADRS of antiepileptic drugs in various sources of drug information.Methods: An observational, cross sectional study was done to compare different drug information sources for ADRs. Six sources of information namely: National Formulary India (2011), Drug Today (2018), Current index of medical specialties (CIMS), and some textbooks like Lippincott’s illustrated reviews: Pharmacology (2012), Brenner and Stevens' Pharmacology (2018) and George and Goodman and Gilman's (GG): The pharmacological basis of therapeutics (2018) were critically analysed for ADRs of a total of 34 drugs. Prototype drugs and most commonly prescribed antiepileptic drugs, were chosen for study. They were categorized according to therapeutic classification and guidelines by Indian Society of Epilepsy. ADRs were categorized according to various body systems, and serious and life threatening ADRs, then were tabulated and compared. Qualitative and quantitative analysis of this data was also done.Results: None of analysed sources mentioned all antiepileptic drugs. GG contained information for maximum number of drugs studied (76.4%) and National Formulary of India gave information for (52.9%) drugs only. There was wide variability among various resources while listing ADRs. CIMS listed maximum number of ADRs (85.5%) while minimum was included in Brenner and Stevens' Pharmacology (13%) for all antiepileptic drugs. The quality of data though limited was relatively better in CIMS, but none of sources studied were found to be complete.Conclusions: No source of information provided complete information about adverse effects of all 34 anti-epileptic drugs. Academicians and policymakers can work towards providing complete ADR information in all sources of information and updating it from time to time. Thus, making drug use safer in patients of epilepsy

Characteristics and Outcomes of Patients Admitted With Type 2 Myocardial Infarction

Type 2 myocardial infarction (Type 2 MI) is a common problem and carries a high diagnostic uncertainty. Large studies exploring outcomes in type 2 MI are lacking. Nationwide Readmission Database (2017) was queried using the International Classification of Diseases codes (ICD-10-CM) to identify type 2 MI patients. Characteristics, in-hospital outcomes, 30-day readmissions, and predictors of in-hospital mortality as well as 30-day readmissions were explored. We identified 21,738 patients with a diagnosis of type 2 MI. Most common primary diagnosis at presentation included infection/sepsis (27.5%), hypertensive heart disease (15.3%) and pulmonary diseases (8.5%). Overall, in-hospital mortality and 30-day readmission for patients with type 2 MI were 9.0% and 19.1% respectively. On multivariable analysis, significant predictors of increased in-hospital mortality included male gender, coexisting atrial fibrillation/flutter, peripheral vascular disease, coagulopathy, malignancy, and fluid/electrolyte abnormalities. Significant predictors of 30-day readmission were coexisting diabetes mellitus, atrial fibrillation/ flutter, carotid artery stenosis, anemia, COPD, CKD and prior history of myocardial infarction, A primary diagnosis of sepsis, pulmonary issues including respiratory failure, neurological conditions including stroke carried highest risk of mortality however readmission risk was not influenced by primary diagnosis at presentation. In conclusion, approximately 1 in 10 patients admitted for type 2 MI died during admission, and nearly 1 in 5 patients were readmitted at 30 days after discharge. In-hospital mortality varied based on associated primary diagnosis at presentation. Proposed predictive model for mortality and 30-day readmission in our study can help to target high risk patients for post-Type 2 MI care

Transcatheter aortic valve replacement in aortic regurgitation: The U.S. experience

Background: Transcatheter aortic valve replacement (TAVR) can be an effective option for high-risk Aortic Regurgitation (AR) patients. Although international experiences of TAVR for AR are published, U.S. data are limited. This study sought to report the short-term outcomes of TAVR in AR in the U.S. population. Methods: Study cohorts were derived from the Nationwide Inpatient Sample (NIS) and Nationwide Readmissions Database (NRD) 2016–17. TAVR and AR were identified using ICD-10-CM-codes. The key outcomes were all-cause mortality, disabling stroke, valvular complications, complete heart block (CHB)/permanent pacemaker placement (PPM), open-heart surgery, acute kidney injury (AKI) requiring dialysis, and vascular complications. Multivariate logistic regression was used to adjust for confounders. Results: 915 patients from the NIS (male-71%, age ≥65–84.2%) and 822 patients from the NRD (male-69.3%, age ≥65–80.5%) underwent TAVR for AR. The median length of stay (LOS) was 4 days for both cohorts. In-hospital mortality was 2.7%, and 30-day mortality was 3.3%. Disabling strokes were noted in 0.6% peri-procedurally and 1.8% at 30-days. Valve-related complications were 18–19% with paravalvular leak (4–7%) being the most common. Approximately 11% of patients developed CHB and/or needed PPM in both cohorts. In NRD, 2.2% of patients required dialysis for AKI, 1.5% developed vascular complications, and 0.6% required open-heart surgery within 30-days post-procedure. Anemia was predictive of increased overall complications and valvular complications, whereas peripheral vascular disease was a predictor of increased valvular complications and CHB/PPM. Conclusion: TAVR is a promising option in AR. Further studies are necessary for the expansion of TAVR as the standard treatment in AR

Transcatheter aortic valve replacement in aortic regurgitation: The U.S. experience

Background: Transcatheter aortic valve replacement (TAVR) can be an effective option for high-risk Aortic Regurgitation (AR) patients. Although international experiences of TAVR for AR are published, U.S. data are limited. This study sought to report the short-term outcomes of TAVR in AR in the U.S. population. Methods: Study cohorts were derived from the Nationwide Inpatient Sample (NIS) and Nationwide Readmissions Database (NRD) 2016–17. TAVR and AR were identified using ICD-10-CM-codes. The key outcomes were all-cause mortality, disabling stroke, valvular complications, complete heart block (CHB)/permanent pacemaker placement (PPM), open-heart surgery, acute kidney injury (AKI) requiring dialysis, and vascular complications. Multivariate logistic regression was used to adjust for confounders. Results: 915 patients from the NIS (male-71%, age ≥65–84.2%) and 822 patients from the NRD (male-69.3%, age ≥65–80.5%) underwent TAVR for AR. The median length of stay (LOS) was 4 days for both cohorts. In-hospital mortality was 2.7%, and 30-day mortality was 3.3%. Disabling strokes were noted in 0.6% peri-procedurally and 1.8% at 30-days. Valve-related complications were 18–19% with paravalvular leak (4–7%) being the most common. Approximately 11% of patients developed CHB and/or needed PPM in both cohorts. In NRD, 2.2% of patients required dialysis for AKI, 1.5% developed vascular complications, and 0.6% required open-heart surgery within 30-days post-procedure. Anemia was predictive of increased overall complications and valvular complications, whereas peripheral vascular disease was a predictor of increased valvular complications and CHB/PPM. Conclusion: TAVR is a promising option in AR. Further studies are necessary for the expansion of TAVR as the standard treatment in AR