Randomized Comparison of Initiating the Fixed-Ratio Combination of iGlarLixi or Biosimilar Insulin Glargine Together With Gliclazide in Participants of South Asian Origin With Type 2 Diabetes: VARIATION 2 SA Trial.

OBJECTIVES: The objective of this study was to compare initiation of a fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) vs insulin glargine U100 (iGlar) along with gliclazide, exclusively in people of South Asian origin with type 2 diabetes (T2D). METHODS: The Variability of glucose Assessed in a Randomized trial comparing the Initiation of A Treatment approach with biosimilar basal Insulin analog Or a titratable iGlarLixi combinatioN in type 2 diabetes among South Asian participants (VARIATION 2 SA) trial (ClinicalTrials.gov identifier: NCT03819790) randomized insulin-naïve adults with T2D having glycated hemoglobin (A1C) 7.1% to 11% to initiate either iGlarLixi or iGlar + gliclazide. Insulin doses were titrated similarly to a prebreakfast glucose target of 4.0 to 5.5 mmol/L. Average time in range (TIR) on a masked continuous glucose monitor (CGM), A1C, fasting plasma glucose (FPG) and weight were assessed at the end of the 12-week treatment period. RESULTS: Mean baseline characteristics for the 104 randomized participants were similar between treatment groups, including the following: age, 59±11 years; diabetes duration, 13.7±7.3 years; and A1C, 8.5%±1.2%. Coprimary outcomes of average TIRs within 24- and 12-h (6 am to 6 pm) periods at the end of trial were 70.5%±16.8% and 72.9%±17.6% for iGlarLixi, whereas these TIRs were 65.6%±21.6% and 67.3%±20.7% for the iGlar + gliclazide regimen, respectively, with no significant differences between groups (p=0.35 for 24-h TIR and p=0.14 for 12-h TIR). No significant difference in secondary outcomes was observed between treatment groups. Self-reported hypoglycemic events throughout the trial period and CGM-reported hypoglycemia (<4 and <3 mmol/L) were similar between randomized treatments. CONCLUSIONS: Initiation of iGlarLixi resulted in similar TIR, A1C, FPG, weight and hypoglycemia compared with the more affordable option of starting iGlar + gliclazide in adults of South Asian origin with T2D.

Emerging Needs and Viability of Telepsychiatry During and Post COVID-19 Era: A Literature Review.

The coronavirus disease 2019 (COVID-19) pandemic has resulted in nationwide stay-at-home orders in an effort to slow the spread severely impacting the healthcare sector. Telepsychiatry provides a platform bridging the gap through advanced technologies connecting mental health providers and patients who need their services, overcoming previous barriers of great distances, lack of transportation, and even time constraints. The most obvious benefit is increased accessibility to mental healthcare, especially in underserved and remote areas where there is no easy access for in-person care. It is important to note that benefits are not limited to patients, but also allow clinicians greater flexibility in scheduling and reduced practice overhead costs, both of which aid with physician burnout and burden. Telepsychiatry during COVID-19 provides its own unique advantages over in-person visits. The risk of exposure to healthcare workers and patients receiving care is reduced, allowing immunocompromised patients to receive much-needed psychiatric care. Without the need to meet in person, self-isolating psychiatrists can still provide care, decreasing strain on their co-workers. Although telepsychiatry is relatively new, it has already exhibited considerable success in its effectiveness at treating psychiatric conditions and widespread corollary benefits. Telepsychiatric consults may be carried out synchronously and asynchronously, each having benefits and setbacks. Different mobile application interventions have been explored, which are available for the purpose of both monitoring/assessing patients and/or providing treatment. The scope of conditions these applications address is broad, from anxiety disorders to schizophrenia to depression. As promising and beneficial telepsychiatry may seem, it is necessary to recognize that building the program can be challenging. It involves adapting to new methods in medicine. We highlighted barriers to general telepsychiatry, the most prominent being technological literacy of both physician and patient, and possible negative effects of eliminating the in-person patient-doctor interaction.

The Opioid Epidemic and Primary Headache Disorders: A Nationwide Population-Based Study.

Introduction The opioid epidemic has been linked to several other health problems, but its impact on headache disorders has not been well studied. We performed a population-based study looking at the prevalence of opioid use in headache disorders and its impact on outcomes compared to non-abusers with headaches. Methodology We performed a cross-sectional analysis of the Nationwide Inpatient Sample (years 2008-2014) in adults hospitalized for primary headache disorders (migraine, tension-type headache [TTH], and cluster headache [CH]) using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes. We performed weighted analyses using the chi-square test, Student's t-test, and Cochran-Armitage trend test. Multivariate survey logistic regression analysis with weighted algorithm modelling was performed to evaluate morbidity, disability, and discharge disposition. Among US hospitalizations during 2013-2014, regression analysis was performed to evaluate the odds of having opioid abuse among headache disorders. Results A total of 5,627,936 headache hospitalizations were present between 2008 and 2014 of which 3,098,542 (55.06%), 113,332 (2.01%), 26,572 (0.47%) were related to migraine, TTH, and CH, respectively. Of these headache hospitalizations, 128,383 (2.28%) patients had abused opioids. There was a significant increase in the prevalence trend of opioid abuse among patients with headache disorders from 2008 to 2014. The prevalence of migraine (63.54% vs. 54.86%), TTH (2.29% vs. 2.01%), and CH (0.59% vs. 0.47%) was also higher among opioid abusers than non-abusers (p<0.0001). Opioid abusers with headaches were more likely to be younger (43 years old vs. 50 years old), men (30.17% vs. 24.78%), white (80.83% vs. 73.29%), Medicaid recipients (30.15% vs. 17.03%), and emergency admissions (85.4% vs. 78.51%) as compared to opioid non-abusers with headaches (p<0.0001). Opioid abusers with headaches had higher prevalence and odds of morbidity (4.06% vs. 3.70%; adjusted odds ratio [aOR]: 1.48; 95% CI: 1.39-1.59), severe disability (28.14% vs. 22.43%; aOR: 1.58; 95% CI: 1.53-1.63), and discharge to non-home location (17.13% vs. 18.41%; aOR: 1.35; 95% CI: 1.30-1.40) as compared to non-abusers. US hospitalizations in years 2013-2014 showed the migraine (OR: 1.61; 95% CI: 1.57-1.66), TTH (OR: 1.43; 95% CI: 1.22-1.66), and CH (OR: 1.34; 95% CI: 1.01-1.78) were linked with opioid abuse. Conclusion Through this study, we found that the prevalence of migraine, TTH, and CH was higher in opioid abusers than non-abusers. Opioid abusers with primary headache disorders had higher odds of morbidity, severe disability, and discharge to non-home location as compared to non-abusers.

Pimavanserin in Parkinson's Disease-induced Psychosis: A Literature Review.

Pimavanserin was approved for treating Parkinson's disease (PD) psychosis, based upon 21 completed studies. This review article is to understand PD psychosis and assess the efficacy and safety of pimavanserin. A literature search was carried out using the keyword "pimavanserin" and cross-referencing it with PD, psychosis, efficacy, safety and clinical trial. Participants in pimavanserin group were associated with a 5.79-point decrease in symptoms for PD psychosis (SAPS-PD) scale compared to the 2.73-point decrease seen in the placebo group (P < .001). There were statistically significant improvements in the persecutory delusions, ideas of reference, and global ratings of delusions in pimavanserin group. Pimavanserin was well tolerated with no significant adverse events or worsening of motor function. Pimavanserin at 34 mg daily was shown to be effective for PD-induced psychosis in past clinical trials.

Thirty-Day Outcomes of Fenestrated and Chimney Endovascular Repair and Open Repair of Juxtarenal, Pararenal, and Suprarenal Abdominal Aortic Aneurysms Using National Surgical Quality Initiative Program Database (2012-2016).

BACKGROUND:: Fenestrated endovascular repair (FEVAR) and chimney endovascular repair (ChEVAR) endovascular repair offer a less invasive alternative to open aortic repair (OAR) in managing juxtarenal, pararenal, and suprarenal abdominal aortic aneurysms (AAAs). The aim of this study is to evaluate the 30-day postoperative outcomes following endovascular and open repair of nonruptured AAA involving the renal vessels. STUDY DESIGN:: All patients undergoing endovascular (FEVAR and ChEVAR) and open repair of juxtarenal, pararenal, and suprarenal AAA in National Surgical Quality Improvement Program database from 2012 to 2016 were included. Continuous and categorical covariates were analyzed using medians and χ2/Fisher exact test, respectively. Multivariable logistic regression analyses were performed to evaluate primary (mortality) and secondary (renal and cardiopulmonary failure) outcomes between open versus endovascular approach. RESULTS:: A total of 1191 patients underwent AAA repair using open (72%) or endovascular (FEVAR: 14%, ChEVAR: 14%) approach. In univariate analysis, no significant difference in 30-day mortality was seen between the 3 groups (FEVAR: 2.47% vs ChEVAR: 7.32% vs OAR: 6.13%, P = .13). However, 30-day major complications including renal failure (9.36% vs 6.10% vs 1.85%, P = .003) and cardiopulmonary complications (19.77% vs 3.66% vs 4.94%, P < 001) failure were significantly higher in patients undergoing OAR versus ChEVAR versus FEVAR. After adjusting for potential confounders, OAR was associated with 2- to 5-folds increased risk of mortality (odds ratio, OR [95% confidence interval, CI]: 2.14 [1.09-4.21], P = .03), renal (OR [95% CI]: 2.87 [1.48-5.57], P = .002), and cardiopulmonary failure (OR [95% CI]: 4.63 [2.47-8.67], P < .001) compared to any endovascular repair. CONCLUSION:: Using a large national surgical data set, our study found 2- to 5-folds higher mortality and morbidity in patients undergoing open versus endovascular repair of AAA involving the renal vessels. Endovascular repair seems to be a safer approach, especially when managing older patients with AAA.