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Kanchan Tyagi,1 Nidhi Bharal Agarwal,2 Prem Kapur,3 Sunil Kohli,3 Rajinder K Jalali4 1Department of Pharmaceutical Medicine, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, 110062, India; 2Centre for Translational and Clinical Research, School of Chemical & Life Sciences, Jamia Hamdard, New Delhi, 110062, India; 3Hamdard Institute of Medical Sciences and, Research, HAH Centenary Hospital, New Delhi, 110062, India; 4Physician and Healthcare Consultant. Formerly, Sun Pharmaceuticals Industries Limited, Gurgaon, 122015, IndiaCorrespondence: Nidhi Bharal AgarwalCentre for Translational and Clinical Research, School of Chemical & Life Sciences, Jamia Hamdard, New Delhi, 110062, IndiaTel +91 9818334770Email nidhi.bharal@gmail.comPurpose: Type 2 diabetes mellitus (T2DM), a metabolic disorder, remains associated with a physiological impairment affecting large populations worldwide. Onset of T2DM is multifactorial where obesity and abnormal basal metabolic rate are considered most critical. Of people diagnosed with T2DM, about 80% are also obese. It is also reported that obese individuals have an increased odds of developing depression, whereas T2DM is estimated to increase the incidence by two-fold. The preponderance of research data demonstrates that T2DM alters the serum level of cortisol and adiponectin which are known to be associated with neuronal physiology. The study explored, how a metabolic disorder like T2DM is linked with the altered plasma level of cortisol and adiponectin, the risk factors for stress and depression.Patients and Methods: A cross-sectional population study was conducted in T2DM patients using a bimodal approach. First approach used questionnaires, (1) Patient Health Questionnaire (PHQ-9) and (2) Stress Coping Inventory Questionnaire (SCQ) to assess signs and symptoms of depression and stress, respectively, in T2DM patients. In the second approach, robust biochemical analysis was conducted for serum adiponectin and cortisol levels.Results: An association of T2DM in stress and depression was evaluated in 158 subjects (105 T2DM obese patients and 53 healthy controls). A lower PHQ-9 score and adiponectin levels were seen in T2DM obese patients compared to healthy controls (p< 0.05). Further, results also depicted a lower adiponectin levels in T2DM obese patients with depression compared to T2DM obese patients without depression (p< 0.05). The study did not find a significant difference in cortisol serum levels among the T2DM and control groups. However, a higher level of serum cortisol was reported in T2DM obese patients with depression over those T2DM obese patients who lacked depression (p< 0.05).Conclusion: The findings suggest that T2DM obese patients might have a higher risk of developing stress and depression. Further, biochemical parameters, adiponectin and cortisol, might be the potential biomarkers for T2DM and may help in early diagnosis of these comorbid conditions.Keywords: type 2 diabetes mellitus, depression, stress, PHQ-9, SCQ, adiponectin, cortisol

Himanshu Sharma,1 Prem Kapur,2 Rajinder K Jalali,3 Kiran Dubey11Department of Pharmacology, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi 110062, India; 2Department of Medicine, Hamdard Institute of Medical Sciences and Research (HIMSR) and HAH-Centenary Hospital, Jamia Hamdard, New Delhi, India; 3Sushant Lok Phase-1, Gurgaon, Haryana 122001, IndiaCorrespondence: Kiran DubeyDepartment of Pharmacology, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi 110062, IndiaTel +91 981 059 0843Email kirandubey@gmail.comPurpose: Chronic Obstructive Pulmonary Disease (COPD) is considered as a risk factor for atherosclerosis and a leading cause of mortality due to cardiovascular disease (CVD). The study assessed the association of COPD with atherosclerotic risk factors and compared the predictor role of various cardiovascular (CV) risk score calculators in Indian subjects with COPD.Patients and methods: Forty subjects with stable COPD and forty age, gender and body mass index (BMI)-matched healthy controls were included in the case-control study conducted in a tertiary care hospital. Atherogenic indices were calculated by using the values of lipid parameters. CV risk calculators were utilized to assess the 10-year CV risk for the COPD group.Results: The study subjects had a mean age of 60.83±12.40 years in COPD group and 57.73±9.49 years in control group (p=0.213). Gender distribution was similar in both the groups. The mean High sensitivity C-reactive protein (hs-CRP) levels were 3.70±2.37 mg/L in COPD group and 2.39±2.23 mg/L in control group. The hs-CRP levels were significantly higher in COPD than in control subjects (p=0.012). Using bivariate correlations, we found significant positive correlations between hs-CRP and atherogenesis indices-atherogenic index of plasma, cardiogenic risk ratio, atherogenic coefficient in COPD patients [(r=0.4265, p

Neelam Kaushal,1 Divya Vohora,1 Rajinder K Jalali,2 Sujeet Jha3 1Pharmaceutical Medicine, Department of Pharmacology, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, 2Medical Affairs and Clinical Research, Sun Pharmaceutical Industries Limited, Gurgaon, 3Institute of Endocrinology, Diabetes and Metabolism, Max Healthcare Inst. Ltd, New Delhi, India Purpose: Oxidative stress has been implicated as a fundamental mechanism in the decline of bone mass. Reactive oxygen species are reported to suppress osteoblast generation and differentiation and enhance osteoclast development and activity. Increasing evidence suggests favorable effect of serum uric acid (UA) on bone metabolism due to its antioxidant properties. Therefore, we investigated the association between serum UA levels and bone mineral density (BMD) in healthy adult Indian subjects.Materials and methods: We reviewed the medical records of 524 subjects who had undergone preventive health check-ups in a tertiary care hospital that included UA and BMD measurements at femur neck, total femur, and lumbar spine. Subjects concomitantly taking drugs or having a medical condition that would affect the bone metabolism or UA levels were excluded.Results: The final analysis included 310 subjects (mean age: 47.2±12.2 years; females: 43.5%; males: 56.5%). Study population was categorized into two groups based on the group median value for UA (ie, 5.4 mg/dL). BMD was significantly higher at all skeletal sites in subjects with UA >5.4 mg/dL compared to subjects with UA ≤5.4 mg/dL (p

Ankur Arora,1,2 Rajinder K Jalali,1,2 Divya Vohora1 1School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India; 2Medical Affairs and Clinical Research, Sun Pharmaceutical Industries Limited, Gurgaon, Haryana, India Background: Numerous reporting biases have been known to affect spontaneous reporting databases. The Weber effect, which constitutes a peak in adverse event (AE) reporting of a drug at the end of second year after regulatory approval followed by a continuous decline thereafter, has been considered an important bias for a long time. The existence of this bias in AE reporting of oncology drugs remains an underevaluated area, prompting a targeted examination.Methods: The US Food and Drug Administration (USFDA) Adverse Event Reporting System (FAERS) was studied for AE reporting patterns of 5 years of 15 new molecular entities (NMEs) and biologics used in oncology. This 5-year period started from the USFDA date of approval for the NMEs and biologics. The number of AEs reported for each of the drugs was plotted against time (years). The AE reporting patterns were specifically examined for the existence of the Weber effect. In addition, AE reporting rate patterns of 5 years of seven NMEs and biologics used in oncology were examined.Results: A total of 50,630 AE reports were logged in to the FAERS for all 15 drugs examined for AE reporting patterns. We observed five distinct AE reporting patterns for 15 drugs; however, none of the AE patterns were identical to the Weber effect. We did not observe a consistent AE reporting rate pattern for the seven drugs examined for AE reporting rates. With the exception of one drug (cetuximab), none of the drugs exhibited a second-year peak in AE reporting rates. This peak was not followed by continuous decline in AE reporting rate thereafter.Conclusion: This study does not support the existence of the Weber effect in AE reporting of oncology drugs. The contemporary AE reporting of oncology drugs does not exhibit a consistent pattern. Keywords: Weber effect, adverse event reporting patterns, oncology drugs, USFDA, FAERS