Browsing by Author "Kaur U."
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Item Atypical extrapyramidal manifestation of a typical antipsychotic with serotonergic antidepressant(Springer Science and Business Media Deutschland GmbH, 2024) Singh R.; Chakrabarti S.S.; Kaur U.Introduction: Typical antipsychotics are known to produce extrapyramidal side effects such as drug induced parkinsonism, acute dystonia, akathisia, tardive dyskinesias and rabbit syndrome. Rabbit syndrome is characterized by vertical rhythmic motion of the mouth and lips, resembling chewing movements of a rabbit. Reason for the report: Rabbit syndrome seen in patients on antidopaminergic therapies is characterized by vertical rhythmic movements of perioral region, has a late onset, and characteristically spares the tongue. The main aim of the report is to highlight atypical manifestation of antipsychotic associated Rabbit syndrome in the presence of a serotonergic antidepressant. Case summary: An elderly patient presented with atypical rabbit syndrome with relatively acute onset, horizontal movements of jaw and marked tongue involvement after haloperidol-escitalopram initiation. Outcome: The patient improved with discontinuation of antipsychotic. The tongue involvement was believed to be secondary to escitalopram use. Graphical Abstract: (Figure presented.) � The Author(s), under exclusive licence to Tehran University of Medical Sciences 2023.Item Drug-related problems in older adults in outpatient settings: Results from a 6-year long prospective study in a tertiary hospital of north India(John Wiley and Sons Inc, 2024) Kaur U.; Chakrabarti S.S.; Gupta G.K.; Singh A.; Gambhir I.S.Aim: Drug-related problems (DRPs) are a common cause of hospitalization in older patients. So far, these issues have been studied in hospitalized settings, and evidence on patterns and outcomes of DRPs, such as adverse drug reactions, is relatively scarce in older outpatients. The main aim of this study was to provide a comprehensive description and possible solutions for DRPs in older adults in outpatient settings. Methods: The study was carried out from January 2015 to September 2021 in a tertiary hospital in north India. Patients aged ?50 years with DRPs were enrolled. DRPs causing hospitalization, drug interactions and drug�disease interactions were identified, along with preventive measures. Results: Of 10 400 patients registered, 1031 DRPs occurred in 666 patients (9.9%). Adverse drug reactions were the major DRPs (n = 933, 8.9%). Metabolic disorders were the commonest DRP in individuals aged ?65 years compared with gastrointestinal disorders in the 50�64 years group. Drug interactions and drug�disease interactions contributed to 20.1% and 7.9% of patients, respectively. Nearly 15.8% of DRPs directly led to hospitalization, with drug-induced metabolic disturbances and movement disorders as the common causes. The Naranjo scale was not applicable in 35.3% of patients, and drug interactions were the commonest cause. Frequent monitoring, omission of unnecessary drugs, slow titration and proper instructions on therapy, together, could avoid one-third of DRPs. Conclusion: One out of 10 prescriptions of older outpatients carries a DRP. New-onset metabolic and neurological disturbances should prompt a thorough drug history. A multifaceted holistic approach can prevent significant drug-related morbidity and requires future evaluation. Geriatr Gerontol Int 2024; 24: 285�291. � 2023 Japan Geriatrics Society.Item Late-Onset Inflammatory Bowel Disease and Flares in Adenoviral and Inactivated Coronavirus Vaccine Recipients(Lippincott Williams and Wilkins, 2024) Kaur U.; Krishna D.V.V.; Reddy J.; Reddy N.T.S.; Dehade A.; Chakrabarti S.S.; Yadav D.P.[No abstract available]Item Lecanemab: More Questions Than Answers!(Adis, 2024) Kaur U.; Reddy J.; Tiwari A.; Chakrabarti S.; Chakrabarti S.S.The approval of lecanemab by the US Food and Drug Administration has been touted as a defining moment in the treatment of Alzheimer�s disease. Lecanemab, an anti-amyloid beta monoclonal antibody, is the first Alzheimer�s disease drug targeting amyloid beta that has shown statistically significant cognitive benefits in phase III trials. However, there have been many questions raised over the clinical relevance of the otherwise minimal cognitive improvements. Furthermore, its rapid approval has been mired in controversy, in addition to the reports of adverse events such as amyloid-related imaging abnormalities and several deaths of participants in the lecanemab trials. Here, we analyze the evidence supporting lecanemab as an amyloid beta therapy and also discuss the concerns raised about its efficacy and safety. � 2023, The Author(s), under exclusive licence to Springer Nature Switzerland AG.Item Patterns and outcomes of late onset thyroid disturbances after COVID-19 vaccination: A report of 75 cases(John Wiley and Sons Inc, 2024) Kaur U.; Reddy N.T.S.; Reddy J.; Krishna D.V.V.; Dehade A.; Agrawal N.K.Isolated cases of subacute thyroiditis exist in the early period of COVID-19 vaccination, largely after mRNA vaccines. Here we report late onset thyroid disturbances and persistent health issues in patients of thyroid disorders after COVID-19 vaccination. Seventy-five patients with post COVID-19 vaccination thyroid disturbances were identified. Among these, 41 had flare of underlying thyroid illness, majority occurring at a median time lag of 28.4 weeks since 2nd dose. Thirty-one cases of new onset hypothyroidism and three of new onset hyperthyroidism were reported, with a median time lag respectively of 17.2 and 22.6 weeks since 2nd dose. Most cases occurred after ChAdOx1-nCoV-19, which was the commonest vaccine employed in mass roll out in India. Significant improvement was observed in majority, after a median follow up of 22�26 weeks. New onset health issues persisting for ?4 weeks were reported in 37.3% and were common in individuals with history of COVID-19 before vaccine. New onset metabolic, musculoskeletal, and reproductive disorders were the common health complaints. Active monitoring is warranted for late onset adverse events after COVID-19 vaccines of all types. Larger studies with involvement of unvaccinated individuals are required to understand the incidence and causality of late onset thyroid disturbances after COVID-19 vaccines. � 2023 John Wiley & Sons Ltd.Item Patterns, outcomes, and preventability of clinically manifest drug-drug interactions in older outpatients: a subgroup analysis from a 6-year-long observational study in North India(Springer Science and Business Media Deutschland GmbH, 2024) Kaur U.; Reddy J.; Reddy N.T.S.; Gambhir I.S.; Yadav A.K.; Chakrabarti S.S.Older adults are vulnerable to adverse drug reactions (ADRs) and drug-drug interactions (DDIs). Evidence on clinically manifest DDIs in older outpatients is scanty. The present study aims to report clinically manifest DDIs, their risk factors, and preventive measures. A subgroup analysis of a 6-year (2015�2021) long prospective study was conducted in a tertiary hospital in North India. Older outpatients with ADRs constituted the study participants. Among 933 ADRs reported in 10,400 patient registrations, clinically manifest DDIs were involved in 199 (21.3%). DDIs accounted for 29.9%, 26.5%, and 21.3% of drug-related metabolic, vascular, and nervous system disorders, respectively. Movement disorders (n = 18), hypotension (n = 16), and hypoglycemia (n = 15) were the most common manifestations. Eighty-six percent of DDIs were of the pharmacodynamic type, and 13.1% were immune-mediated. Around 35% of DDIs resulted in hospitalization, with hyponatremia, movement disorder, and renal impairment as the common reasons. Older adults with Parkinsonism, infection, coronary artery disease, neuropsychiatric disease, and diabetes mellitus, respectively, had 3.28, 2.85, 1.97, 1.76, and 1.80 times higher odds of DDIs. Those receiving ? 10 drugs had 5.31 times higher odds of DDIs compared to individuals receiving 1�4 drugs. �Avoiding the causative drug,� �optimal monitoring of the patient,� and �start-low and go-slow� policy together could prevent 85% of DDIs. In conclusion,�every fifth case of ADRs and nearly one third of ADR-related hospitalizations in older adults are related to DDIs. Movement disorder, hypotension, and hypoglycemia are the common manifestations. A holistic approach with drug omission, optimal patient monitoring, and slow titration of therapy can prevent significant DDIs in older adults. � The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2024.Item RETRACTED ARTICLE: Long-Term Safety Analysis of the BBV152 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India (Drug Safety, (2024), 47, 12)(Adis, 2024) Kaur U.; Jaiswal A.; Jaiswal A.; Singh K.; Pandey A.; Chauhan M.; Rai M.; Kansal S.; Patwardhan K.; Jaisawal V.; Chakrabarti S.S.The Editor has retracted this article as he no longer has confidence in the conclusions as stated in the article. Post-publication review concluded that the reported adverse events of special interest (AESIs) were presented in a way that could lead to ambiguous or incorrect interpretations regarding the relationship with the BBV152 vaccine. Given these findings, the editor and the publisher have decided that this article should be removed on public health grounds. The authors disagree with this retraction. � The Author(s)Item Should Glucokinase be Given a Chance in Diabetes Therapeutics? A Clinical-Pharmacological Review of Dorzagliatin and Lessons Learned So Far(Adis, 2024) Kaur U.; Pathak B.K.; Meerashahib T.J.; Krishna D.V.V.; Chakrabarti S.S.Despite advances in the management of type 2 diabetes mellitus (T2DM), one-third of patients with diabetes do not achieve the desired glycemic goal. Considering this inadequacy, many agents that activate glucokinase have been investigated over the last two decades but were withdrawn before submission for marketing permission. Dorzagliatin is the first glucokinase activator that has been granted approval for T2DM, only in China. As overstimulation of glucokinase is linked with pathophysiological disturbances such as fatty liver and cardiovascular issues and a loss of therapeutic efficacy with time. This review aims to highlight the benefits of glucokinase activators vis-�-vis the risks associated with chronic enzymatic activation. We discuss the multisystem disturbances expected with chronic activation of the enzyme, the lessons learned with glucokinase activators of the past, the major efficacy and safety findings with dorzagliatin and its pharmacological properties, and the status of other glucokinase activators in the pipeline. The approval of dorzagliatin in China was based on the SEED and the DAWN trials, the major pivotal phase III trials that enrolled patients with T2DM with a mean glycosylated hemoglobin of 8.3�8.4%, and a mean age of 53�54.5�years from multiple sites in China. Patients with uncontrolled diabetes, cardiac diseases, organ dysfunction, and a history of severe hypoglycemia were excluded. Both trials had a randomized double-blind placebo-controlled phase of 24�weeks followed by an open-label phase of 28�weeks with dorzagliatin. Drug-na�ve patients with T2DM with a disease duration of 11.7�months were enrolled in the SEED trial while the DAWN trial involved patients with T2DM with a mean duration of 71.5�months and receiving background metformin therapy. Compared with placebo, the decline in glycosylated hemoglobin at 24�weeks was more with dorzagliatin with an estimated treatment difference of ?�0.57% in the SEED trial and ?�0.66% in the DAWN trial. The desired glycosylated hemoglobin (<�7%) was also attained at more than two times higher rates with dorzagliatin. The glycemic improvement was sustained in the SEED trial but decreased over 52�weeks in the DAWN trial. Hyperlipidemia was observed in 12�14% of patients taking dorzagliatin versus 9�11% of patients receiving a placebo. Additional adverse effects noticed over 52�weeks with dorzagliatin included an elevation in liver enzymes, hyperuricemia, hyperlacticacidemia, renal dysfunction, and cardiovascular disturbances. Considering the statistically significant improvement in glycosylated hemoglobin with dorzagliatin in patients with T2DM, the drug may be given a chance in treatment-na�ve patients with a shorter disease history. However, with the waning therapeutic efficacy witnessed in patients with long-standing diabetes, which was also one of the potential concerns with previously tested molecules, extended studies involving patients with chronic and uncontrolled diabetes are needed to comment upon the long-term therapeutic performance of dorzagliatin. Likewise, evidence needs to be generated from other countries, patients with organ dysfunction, a history of severe hypoglycemia, cardiac diseases, and elderly patients before extending the use of dorzagliatin. Apart from monitoring lipid profiles, long-term safety studies of dorzagliatin should involve the assessment of serum uric acid, lactate, renal function, liver function, and cardiovascular parameters. � The Author(s), under exclusive licence to Springer Nature Switzerland AG 2024.
