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Article ; Online: Risk of pancreatitis and pancreatic carcinoma for anti-diabetic medications: findings from real-world safety data analysis and systematic review and meta-analysis of randomized controlled trials.

Muhammed, Asif / Thomas, Christy / Kalaiselvan, Vivekanandan / Undela, Krishna

2023 , Page(s) 1–12

Abstract: Background: The existing evidence from pre- and post-marketing studies is conflicting on the risk of pancreatic events for anti-diabetic medications.: Research design and methods: A retrospective case/non-case study was conducted by using spontaneous ...

Abstract	Background: The existing evidence from pre- and post-marketing studies is conflicting on the risk of pancreatic events for anti-diabetic medications. Research design and methods: A retrospective case/non-case study was conducted by using spontaneous reports on pancreatic events for anti-diabetic medications from the FDA Adverse Event Reporting System (FAERS) and VigiBase. Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), and Information Component (IC) were calculated by a disproportionality analysis. Furthermore, PubMed, Google Scholar, Scopus, and ClinicalTrials.gov were systematically searched for randomized controlled trials (RCTs) on anti-diabetic drugs with pancreatic outcomes. Results: The FAERS data analysis found strong signals on incretin mimetics causing pancreatic events, with sitagliptin having the highest risk [PRR = 24.2, lower bound (LB) ROR = 24.4, IC Conclusion: Evidence from the post-marketing safety data analysis identified a strong association between incretin mimetics and pancreatic events. Fewer events in RCTs may justify insignificant meta-analysis results.
Language	English
Publishing date	2023-11-20
Publishing country	England
Document type	Journal Article
ZDB-ID	2088728-0
ISSN	1744-764X ; 1474-0338
ISSN (online)	1744-764X
ISSN	1474-0338
DOI	10.1080/14740338.2023.2284992
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Article ; Online: Assumptions for disparities in case-fatality rates of coronavirus disease (COVID-19) across the globe.

Undela, K / Gudi, S K

European review for medical and pharmacological sciences

2020 Volume 24, Issue 9, Page(s) 5180–5182

Abstract: In a short span, Coronavirus disease (COVID-19) has become the world pandemic by rapidly spreading almost to all the countries around the globe, irrespective of the continent, population size, economic status and healthcare system. Despite the number of ... ...

Abstract	In a short span, Coronavirus disease (COVID-19) has become the world pandemic by rapidly spreading almost to all the countries around the globe, irrespective of the continent, population size, economic status and healthcare system. Despite the number of cases increasing exponentially in most of the countries, there exist certain disparities in terms of case-fatality rates. As of April 24, 2020, the case-fatality rate of COVID-19 is about 7.0%, with 193,671 deaths and 2,761,121 confirmed cases around the world. Although the United States of America (USA), Spain, Italy, France, and Germany are the top-most affected counties in terms of confirmed cases; France, Italy and Spain are leading the list in terms of case-fatality rates. Therefore, through this mini-review, authors sought to brief on possible assumptions (five D's) that might contribute to the varying case-fatality rates among different countries across the globe.
MeSH term(s)	Betacoronavirus ; COVID-19 ; COVID-19 Testing ; Clinical Laboratory Techniques ; Communicable Disease Control/methods ; Coronavirus Infections/diagnosis ; Coronavirus Infections/mortality ; Delivery of Health Care ; Demography ; France/epidemiology ; Germany/epidemiology ; Health Status Disparities ; Healthcare Disparities ; Humans ; Italy/epidemiology ; Pandemics ; Pneumonia, Viral/mortality ; Risk Factors ; SARS-CoV-2 ; Spain/epidemiology ; United States/epidemiology
Keywords	covid19
Language	English
Publishing date	2020-05-01
Publishing country	Italy
Document type	Journal Article
ZDB-ID	605550-3
ISSN	2284-0729 ; 1128-3602 ; 0392-291X
ISSN (online)	2284-0729
ISSN	1128-3602 ; 0392-291X
DOI	10.26355/eurrev_202005_21215
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Article ; Online: Risk of serious skin and subcutaneous tissue disorders for nimesulide among the pediatric population: a jeopardy identified through the analysis of global individual case safety reports.

Undela, Krishna / Kalaiselvan, Vivekanandan / Gudi, Sai Krishna / Viswam, Subeesh K / Ali, Syed Kashif

Expert opinion on drug safety

2023 , Page(s) 1–6

Abstract: Background: The safety reports arising currently on nimesulide are divulging the jeopardy of skin and subcutaneous tissue disorders (SSTDs).: Research design and methods: The global individual case safety reports on nimesulide-induced SSTDs available ...

Abstract	Background: The safety reports arising currently on nimesulide are divulging the jeopardy of skin and subcutaneous tissue disorders (SSTDs). Research design and methods: The global individual case safety reports on nimesulide-induced SSTDs available at VigiBase® were analyzed up to 31 March 2023. Disproportionality analyses viz. Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), and Information Component (IC) were performed to identify the quantitative signals. Results: Out of 33,983,649 de-duplicated cases available in the VigiBase Conclusions: Identifying the giant quantitate association between nimesulide and serious & life-threatening reactions like SJS and TEN, precautionary measures need to be taken by the regulatory authorities to prevent nimesulide-induced SSTDs among the pediatric population.
Language	English
Publishing date	2023-11-01
Publishing country	England
Document type	Journal Article
ZDB-ID	2088728-0
ISSN	1744-764X ; 1474-0338
ISSN (online)	1744-764X
ISSN	1474-0338
DOI	10.1080/14740338.2023.2274416
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Article ; Online: SGLT2 inhibitors associated pancreatitis: signal identification through disproportionality analysis of spontaneous reports and review of case reports.

Palapra, Hibathulla / Viswam, Subeesh K / Kalaiselvan, Vivekanandan / Undela, Krishna

International journal of clinical pharmacy

2022 Volume 44, Issue 6, Page(s) 1425–1433

Abstract: Background: In recent times, pancreatitis has been one of the most frequently reported adverse events for sodium-glucose cotransporter-2 (SGLT2) inhibitors.: Aim: To evaluate the potential association between SGLT2 inhibitors and the risk of ... ...

Abstract	Background: In recent times, pancreatitis has been one of the most frequently reported adverse events for sodium-glucose cotransporter-2 (SGLT2) inhibitors. Aim: To evaluate the potential association between SGLT2 inhibitors and the risk of pancreatitis by analyzing the spontaneous reports through disproportionality analysis and reviewing case reports. Method: A retrospective case/non-case study was conducted using spontaneous reports from the FDA Adverse Event Reporting System (FAERS), VigiBase, and the Canadian Adverse Reaction Database (CARD). Disproportionality analysis was performed by calculating the Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), and the Information Component (IC). In parallel, a review of case reports was conducted on SGLT2 inhibitors-induced pancreatitis. Results: A total of 524, 510, and 40 spontaneous reports of pancreatitis suspected to be caused by SGLT2 inhibitors were identified from FAERS, VigiBase, and CARD, respectively. Through the disproportionality analysis of FAERS data, a signal was identified between the SGLT2 inhibitors and pancreatitis, with empagliflozin having highest risk [PRR = 3.9; Lower Bound (LB) ROR = 3.4; IC Conclusion: The current study found a potential risk of pancreatitis with the use of SGLT2 inhibitors. There is an urgent need to thoroughly investigate the same and take the necessary action to avoid or minimize the risk.
MeSH term(s)	Humans ; Sodium-Glucose Transporter 2 Inhibitors/adverse effects ; Pharmacovigilance ; Adverse Drug Reaction Reporting Systems ; Retrospective Studies ; Canada ; Pancreatitis/chemically induced ; Pancreatitis/diagnosis ; Pancreatitis/epidemiology
Chemical Substances	Sodium-Glucose Transporter 2 Inhibitors
Language	English
Publishing date	2022-10-12
Publishing country	Netherlands
Document type	Case Reports ; Review ; Journal Article
ZDB-ID	2601204-2
ISSN	2210-7711 ; 2210-7703 ; 0928-1231
ISSN (online)	2210-7711
ISSN	2210-7703 ; 0928-1231
DOI	10.1007/s11096-022-01476-7
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Article: Impact of medical conditions and medications received during pregnancy on adverse birth outcomes: A hospital-based prospective case-control study.

Undela, Krishna / Gurumurthy, Parthasarathi / Sujatha, M S

Perspectives in clinical research

2021 Volume 14, Issue 1, Page(s) 10–15

Abstract: Purpose: In view of the raising rate of adverse birth outcomes (ABOs) across the globe, this study was conducted to assess the impact of medical conditions and medications received during pregnancy on ABOs.: Materials and methods: A prospective case- ... ...

Abstract	Purpose: In view of the raising rate of adverse birth outcomes (ABOs) across the globe, this study was conducted to assess the impact of medical conditions and medications received during pregnancy on ABOs. Materials and methods: A prospective case-control study was conducted at the Department of Obstetrics and Gynecology of a tertiary care hospital over a period of 3 years from July 2015 to June 2018. Liveborn and stillborn neonates included in the study were categorized into cases and controls based on the presence or absence of composite ABOs, respectively. Binary logistic regression analysis was used to identify the risk factors for ABOs among medical conditions and medications received by mothers during their current pregnancy. Results: Among 1214 neonates included in the study, 556 (45.8%) were identified with composite ABOs, the majority were low birth weight (320 [26.4%]) and preterm birth 300 (24.7%). After adjusting for confounding factors, it was identified that hypertension (adjusted odds ratio [aOR] 7.3), oligohydramnios (aOR 3.9), anemia (aOR 3.2), nifedipine (aOR 10.0), nicardipine (aOR 5.3), and magnesium sulfate (aOR 5.3) were the risk factors for overall and specific ABOs like preterm birth and low birth weight. It was also identified that the early detection and management of hypertension with antihypertensives like labetalol and methyldopa can reduce the risk of preterm birth by 93% and 88%, respectively. Conclusion: Medical conditions such as hypertension, oligohydramnios, and anemia and medications such as nifedipine, nicardipine, and magnesium sulfate during pregnancy were identified as the risk factors for overall and specific ABOs like preterm birth and low birth weight.
Language	English
Publishing date	2021-10-23
Publishing country	India
Document type	Journal Article
ZDB-ID	2593231-7
ISSN	2229-5488 ; 2229-3485
ISSN (online)	2229-5488
ISSN	2229-3485
DOI	10.4103/picr.picr_16_21
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Article: Prevalence, Risk Factors, and Cost Burden of Fall-Related Hospital Admissions in india.

Puvvada, Rahul Krishna / Undela, Krishna / Parthasarathi, Gurumurthy

The Senior care pharmacist

2021 Volume 36, Issue 7, Page(s) 343–349

Abstract: OBJECTIVE: ...

Abstract	OBJECTIVE:
MeSH term(s)	Accidental Falls ; Aged ; Female ; Hospitals ; Humans ; India/epidemiology ; Male ; Prevalence ; Risk Factors
Language	English
Publishing date	2021-06-08
Publishing country	United States
Document type	Journal Article ; Observational Study
ISSN	2639-9636
ISSN	2639-9636
DOI	10.4140/TCP.n.2021.343
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Article ; Online: Efficacy, safety, and tolerability of isoniazid preventive therapy for tuberculosis in people living with HIV.

Jagi, Jaya Laxmi / Thomas, Christy / Gudi, Sai Krishna / Undela, Krishna

AIDS (London, England)

2022 Volume 37, Issue 3, Page(s) 455–465

Abstract: Objective: The aim of this study was to systematically assess the efficacy, safety, and tolerability of isoniazid preventive therapy (IPT) for tuberculosis (TB) in people with HIV (PWH).: Design: A systematic review and meta-analysis.: Methods: A ... ...

Abstract	Objective: The aim of this study was to systematically assess the efficacy, safety, and tolerability of isoniazid preventive therapy (IPT) for tuberculosis (TB) in people with HIV (PWH). Design: A systematic review and meta-analysis. Methods: A thorough literature search was performed using PubMed, Cochrane CENTRAL, and Google Scholar from their inception to June 30, 2021. All randomized controlled trials (RCTs) investigating the efficacy, safety, or tolerability of IPT on PWH compared with placebo or active comparators were included in the study. The heterogeneity among the studies was identified by using the I2 statistic and Cochran's Q test. Results: Out of the 924 nonduplicate RCTs identified through database searching and other sources, 26 studies comprising 38 005 patients were included. The overall effect estimate identified the reduction of active TB incidence [odds ratio (OR) 0.69; 95% confidence interval (95% CI) 0.57-0.84; P < 0.001], but not all-cause mortality (OR 0.91; 95% CI 0.82, 1.02; P = 0.10) with IPT compared with the control. In addition, no significant association was identified between the use of IPT and the risk of peripheral neuropathy (OR 1.50; 95% CI 0.96-2.36; P = 0.08) and hepatotoxicity (OR 1.21; 95% CI 0.97-1.52; P = 0.09). Conclusion: This systematic review and meta-analysis identified a significant reduction in the incidence of active TB, but not all-cause mortality, among PWH who received IPT compared with the control. Lesser number of outcomes may be the reason for nonsignificant results in terms of safety outcomes of IPT. Therefore, there is a need for extensive and long-term studies to address these issues further, especially in TB/HIV endemic areas.
MeSH term(s)	Humans ; Isoniazid/adverse effects ; Antitubercular Agents/adverse effects ; HIV Infections/drug therapy ; Tuberculosis/epidemiology ; Tuberculosis/prevention & control ; Tuberculosis/drug therapy ; Longitudinal Studies
Chemical Substances	Isoniazid (V83O1VOZ8L) ; Antitubercular Agents
Language	English
Publishing date	2022-11-22
Publishing country	England
Document type	Systematic Review ; Meta-Analysis ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	639076-6
ISSN	1473-5571 ; 0269-9370 ; 1350-2840
ISSN (online)	1473-5571
ISSN	0269-9370 ; 1350-2840
DOI	10.1097/QAD.0000000000003436
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Article ; Online: Effect of garlic extract on markers of lipid metabolism and inflammation in coronary artery disease (CAD) patients: A systematic review and meta-analysis.

Gadidala, Sai Kumar / Johny, Ebin / Thomas, Christy / Nadella, Mounika / Undela, Krishna / Adela, Ramu

Phytotherapy research : PTR

2023 Volume 37, Issue 6, Page(s) 2242–2254

Abstract: Several preclinical studies have focused on the beneficial effects of garlic on cardiovascular diseases, but the results were inconsistent. We performed a systematic review and meta-analysis on the effect of garlic powder tablets and aged garlic extract ( ...

Abstract	Several preclinical studies have focused on the beneficial effects of garlic on cardiovascular diseases, but the results were inconsistent. We performed a systematic review and meta-analysis on the effect of garlic powder tablets and aged garlic extract (AGE) in CAD patients, mainly focusing on blood pressure, coronary artery calcification, lipid profile, and inflammatory markers. We searched PubMed, Cochrane CENTRAL, and Google Scholar to identify randomized controlled trials which examined garlic's effect on CAD patients. The standardized mean difference with 95% CI was calculated using fixed-effect or random-effect models. Garlic has shown statistically significant changes of HDL (SMD = 0.18; 95% CI = -0.00 to 0.37; p = .05); LDL (SMD = -0.27; 95% CI = -0.46 to -0.08; p = .004), apolipoprotein-A (SMD = 0.68; 95% CI = 0.24 1.13; p = .002), C-RP (SMD = -0.59; 95% CI = -0.92 to -0.25; p = .0007), IL-6 (SMD = -1.08; 95% CI = -2.17 to 0.01; p = .05), homocysteine (SMD = -0.66; 95% CI = -1.04 to -0.28; p = .0007) and CAC score (SMD = -1.61; 95% CI = -2.66 to -0.57; p = .003). In the case of subgroup analysis, the overall effect was significantly effective in reducing TC, LDL levels and improving HDL levels in CV risk patients. Our study findings provide consistent evidence that intake of garlic reduces CVD risk factors. However, garlic could be considered a safe natural medicine to debilitate inflammation in CAD patients.
MeSH term(s)	Humans ; Coronary Artery Disease/drug therapy ; Garlic ; Lipid Metabolism ; Inflammation/drug therapy ; Cardiovascular Diseases ; Plant Extracts/pharmacology ; Plant Extracts/therapeutic use
Chemical Substances	Plant Extracts
Language	English
Publishing date	2023-01-14
Publishing country	England
Document type	Meta-Analysis ; Systematic Review ; Journal Article
ZDB-ID	639136-9
ISSN	1099-1573 ; 0951-418X
ISSN (online)	1099-1573
ISSN	0951-418X
DOI	10.1002/ptr.7729
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Article: Assumptions for disparities in case-fatality rates of coronavirus disease (COVID-19) across the globe

Undela, K / Gudi, S K

Eur Rev Med Pharmacol Sci

Abstract	In a short span, Coronavirus disease (COVID-19) has become the world pandemic by rapidly spreading almost to all the countries around the globe, irrespective of the continent, population size, economic status and healthcare system. Despite the number of cases increasing exponentially in most of the countries, there exist certain disparities in terms of case-fatality rates. As of April 24, 2020, the case-fatality rate of COVID-19 is about 7.0%, with 193,671 deaths and 2,761,121 confirmed cases around the world. Although the United States of America (USA), Spain, Italy, France, and Germany are the top-most affected counties in terms of confirmed cases; France, Italy and Spain are leading the list in terms of case-fatality rates. Therefore, through this mini-review, authors sought to brief on possible assumptions (five D's) that might contribute to the varying case-fatality rates among different countries across the globe.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #32432785
Database	COVID19

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Article ; Online: Macrolides versus placebo for chronic asthma.

Undela, Krishna / Goldsmith, Lucy / Kew, Kayleigh M / Ferrara, Giovanni

The Cochrane database of systematic reviews

2021 Volume 11, Page(s) CD002997

Abstract: Background: Asthma is a chronic disease in which inflammation of the airways causes symptomatic wheezing, coughing and difficult breathing. Macrolides are antibiotics with antimicrobial and anti-inflammatory activities that have been explored for the ... ...

Abstract	Background: Asthma is a chronic disease in which inflammation of the airways causes symptomatic wheezing, coughing and difficult breathing. Macrolides are antibiotics with antimicrobial and anti-inflammatory activities that have been explored for the long-term control of asthma symptoms. Objectives: To assess the effects of macrolides compared with placebo for managing chronic asthma. Search methods: We searched the Cochrane Airways Group Specialised Register up to March 2021. We also manually searched bibliographies of previously published reviews and conference proceedings and contacted study authors. We included records published in any language in the search. Selection criteria: We included randomised controlled clinical trials (RCTs) involving both children and adults with asthma treated with macrolides versus placebo for four or more weeks. Primary outcomes were exacerbation requiring hospitalisation, severe exacerbations (exacerbations requiring emergency department (ED) visits or systemic steroids, or both), symptom scales, asthma control questionnaire (ACQ, score from 0 totally controlled, to 6 severely uncontrolled), Asthma Quality of Life Questionnaire (AQLQ, with score from 1 to 7 with higher scores indicating better QoL), rescue medication puffs per day, morning and evening peak expiratory flow (PEF; litres per minutes), forced expiratory volume in one second (FEV Data collection and analysis: Two review authors independently examined all records identified in the searches then reviewed the full text of all potentially relevant articles before extracting data in duplicate from all included studies. As per protocol, we used a fixed-effect model. We conducted a sensitivity analysis for analyses with high heterogeneity (I Main results: Twenty-five studies met the inclusion criteria, randomising 1973 participants to receive macrolide or placebo for at least four weeks. Most of the included studies reported data from adults (mean age 21 to 61 years) with persistent or severe asthma, while four studies included children. All participants were recruited in outpatient settings. Inclusion criteria, interventions and outcomes were highly variable. The evidence suggests macrolides probably deliver a moderately sized reduction in exacerbations requiring hospitalisations compared to placebo (odds ratio (OR) 0.47, 95% confidence interval (CI) 0.20 to 1.12; studies = 2, participants = 529; moderate-certainty evidence). Macrolides probably reduce exacerbations requiring ED visits and/or treatment with systemic steroids (rate ratio (RaR) 0.65, 95% CI 0.53 to 0.80; studies = 4, participants = 640; moderate-certainty evidence). Macrolides may reduce symptoms (as measured on symptom scales) (standardised mean difference (SMD) -0.46, 95% CI -0.81 to -0.11; studies = 4, participants = 136 very low-certainty evidence). Macrolides may result in a little improvement in ACQ (SMD -0.17, 95% CI -0.31 to -0.03; studies = 5, participants = 773; low-certainty evidence). Macrolides may have little to no effect on AQLQ (mean difference (MD) 0.24, 95% CI 0.12 to 0.35; studies = 6, participants = 802; very low-certainty evidence). For both the ACQ and the AQLQ the suggested effect of macrolides versus placebo did not reach a minimal clinically important difference (MCID, 0.5 for ACQ and AQLQ) (ACQ: low-certainty evidence; AQLQ: very low-certainty evidence). Due to high heterogeneity (I Authors' conclusions: Existing evidence suggests an effect of macrolides compared with placebo on the rate of exacerbations requiring hospitalisation. Macrolides probably reduce severe exacerbations (requiring ED visit and/or treatment with systemic steroids) and may reduce symptoms. However, we cannot rule out the possibility of other benefits or harms because the evidence is of very low quality due to heterogeneity among patients and interventions, imprecision and reporting biases. The results were mostly driven by a well-designed, well powered RCT, indicating that azithromycin may reduce exacerbation rate and improve symptom scores in severe asthma. The review highlights the need for researchers to report outcomes accurately and according to standard definitions. Macrolides can reduce exacerbation rate in people with severe asthma. Future trials could evaluate if this effect is sustained across all the severe asthma phenotypes, the comparison with newer biological drugs, whether effects persist or wane after treatment cessation and whether effects are associated with infection biomarkers.
MeSH term(s)	Adult ; Anti-Bacterial Agents/adverse effects ; Asthma/drug therapy ; Disease Progression ; Humans ; Macrolides/therapeutic use ; Middle Aged ; Quality of Life ; Young Adult
Chemical Substances	Anti-Bacterial Agents ; Macrolides
Language	English
Publishing date	2021-11-22
Publishing country	England
Document type	Journal Article ; Review ; Systematic Review
ISSN	1469-493X
ISSN (online)	1469-493X
DOI	10.1002/14651858.CD002997.pub5
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