Factors contributing to the adverse drug reactions associated with the dipeptidyl peptidase-4 (DPP-4) inhibitors: A scoping review.

BACKGROUND AND AIM: Adverse drug reactions are one of the contributors to increased hospital admission and length of hospital stay. Among the various antidiabetic agents prescribed, dipeptidyl peptidase-4 (DPP-4) inhibitors have gained wide recognition and shown more persistence than other novel hypoglycemic agents. We performed a scoping review to identify the risk factors contributing to the adverse drug reactions with DPP-4 inhibitors. METHODOLOGY: We followed Preferred Reporting Items for Scoping Review (PRISMA-ScR) Guidelines for reporting the findings. Data sources such as PubMed/MEDLINE, Scopus, Embase, and Cochrane were assessed. We included studies that reported the risk factors contributing to the DPP-4 inhibitor-associated adverse drug reactions. The Joanna Briggs Institute (JBI) critical appraisal checklist was used to assess the methodological quality of the studies. RESULTS: Of the 6406 studies retrieved, 11 studies met our inclusion criteria. Of these 11 studies, seven were post-marketing surveillance studies, one nested case-control study, one comparator cohort study, one food and drug administration (FDA) adverse event reporting system (FAERS)-based observational study, and one questionnaire-based cross-sectional survey study. A total of eight factors were identified that contributed to the DPP-4 inhibitor-associated adverse drug reactions. CONCLUSION: The included studies suggested age >65 years, females, grade 4 and 5 renal impairment, concomitant drugs, disease and drug therapy duration, liver disease, non-smokers, and non-hypertension as risk factors. Further studies should be conducted to provide insight into these risk factors so that the appropriate use of DPP-4 inhibitors in the diabetic population can be encouraged to improve the health-related quality of life. PROSPERO REGISTRATION: CRD42022308764.

Perspectives of patients and healthcare professionals on metabolic monitoring of adult prescribed second-generation antipsychotics for severe mental illness: A meta-synthesis.

OBJECTIVES: We conducted a meta-synthesis of qualitative studies to synthesize the views of psychiatric patients on second-generation antipsychotics (SGAs) and the healthcare providers about the metabolic monitoring of adult-prescribed SGAs. METHODS: A systematic search was conducted in four databases through SCOPUS, PubMed, EMBASE, and CINAHL to identify qualitative studies of patients' and healthcare professionals' perspectives on the metabolic monitoring of SGAs. Initially, titles and abstracts were screened to exclude articles that were not relevant followed by full-text reading. Study quality was assessed by using Critical Appraisal Skills Program (CASP) criteria. Themes were synthesized and presented as per the Interpretive data synthesis process (Evans D, 2002). RESULTS: A total of 15 studies met the inclusion criteria and were analyzed in meta-synthesis. Four themes were identified: 1. Barriers to metabolic monitoring; 2. Patient related concerns to metabolic monitoring; 3. Support system by mental health services to promote metabolic monitoring; and 4. Integrating physical health with mental health services. From the participants' perspectives, barriers to metabolic monitoring were accessibility of services, lack of education and awareness, time/resource constraints, financial hardship, lack of interest on metabolic monitoring, patient capacity and motivation to maintain physical health and role confusion and impact on communication. Education and training on monitoring practices as well as integrated mental health services for metabolic monitoring to promote quality and safe use of SGAs are the most likely approaches to promote adherence to best practices and minimize treatment-related metabolic syndrome in this highly vulnerable cohort. CONCLUSION: This meta-synthesis highlights key barriers from the perspectives of patients and healthcare professionals regarding the metabolic monitoring of SGAs. These barriers and suggested remedial strategies are important to pilot in the clinical setting and to assess the impact of the implementation of such strategies as a component of pharmacovigilance to promote the quality use of SGAs as well as to prevent and/or manage SGAs-induced metabolic syndrome in severe and complex mental health disorders.

Adverse drug reactions of GLP-1 agonists: A systematic review of case reports.

BACKGROUND AND AIM: The importance of glucagon-like peptide-1 (GLP-1) agonists is increasing because of its blood sugar controlling and weight loss properties. The data regarding safety of GLP-1 agonists are limited. This study aims to review case reports and case series on adverse drug reactions (ADRs) of GLP-1 agonist. METHODOLOGY: A comprehensive search was performed in PubMed/Medline, Scopus and Embase to identify literatures. Bibliographic search and open search in Google, Google Scholar, SpringerLink and ResearchGate was performed to identify additional studies. Case reports and case series published the ADRs by the use of GLP-1 agonists in type 2 diabetes patients were included in the study. Reviews, experimental studies, observational studies, grey literature and non English studies were excluded. RESULTS: The study identified 120 cases of GLP-1 agonists associated ADRs (liraglutide - 46, exenatide - 46, dulaglutide - 20, semaglutide - 4, albiglutide - 2, lixisenatide - 2). The major ADRs reported was gastrointestinal disorders (n = 40) followed by renal (n = 23), dermatologic (n = 14), hepatic (n = 10), immunologic (n = 13), endocrine/metabolic (n = 7), hematologic (n = 3), angioedema (n = 3), neurologic (n = 2), cardiovascular (n = 2) and 1 from each of psychiatric, reproductive, generalized edema problems. CONCLUSION: Gastrointestinal problems, particularly pancreatitis was the more frequently reported adverse drug reaction associated with GLP-1 agonist. The most adverse drug reactions were observed with liraglutide and exenatide.

Assessment of Association between Antihypertensive Drug Use and Occurrence of New-onset Diabetes in South Indian Patients.

OBJECTIVE: The objective of this study was to determine the association between antihypertensive drug use and new-onset diabetes (NOD) in patients with hypertension (HTN). MATERIALS AND METHODS: A retrospective observational study was conducted in a tertiary care hospital located in south India. Patients diagnosed with HTN and HTN with diabetes between January 2012 and December 2016, were identified and studied. Medical records of these patients from Medical Record Department were evaluated by medical record review method, and relevant data were recorded in a case record form. Statistical evaluation by chi-square method and odds ratio (OR) was carried out to appraise the incidence of NOD in patients taking antihypertensive medications. RESULTS: A total of 1250 patients with HTN were screened, and based on inclusion and exclusion criteria, 952 patients were enrolled in the study; among which, 537 were patients with HTN and 415 were patients with diabetic HTN. The majority of the patients with HTN and patients with diabetic HTN were from the age-group of above 60 years. The most commonly prescribed drugs observed in our study population were amlodipine in 94 (22.7%) patients. OR was calculated and it was observed that the combination therapy has a fivefold risk for the development of NOD in patients with HTN, followed by Angiotensin II receptor blockers (2.06) (confidence interval [CI]: 1.56-2.73), diuretics (1.33) (CI: 0.95-1.85), non-Dihydropyridine calcium channel blockers (DHP CCBs) (1.3) (CI: 0.51-3.30), vasodilators (1.13) (CI: 0.40-3.15), and Angiotensin converting enzyme inhibitors (1.06) (0.68-1.64). CONCLUSION: Patients on non-DHP CCBs, diuretics, and combination antihypertensives showed more chances of developing NOD.

Identification of risk factors and metabolic monitoring practices in patients on antipsychotic drugs in South India.

The objectives of this study were to identify the risk factors for metabolic syndrome in patients on antipsychotics and to compare the frequency of metabolic monitoring with evidence-based guidelines. We conducted a retrospective cohort study in a tertiary care health institution of South India. The study included patients with schizophrenia, bipolar disorder, and schizoaffective disorders prescribed with antipsychotic drugs. Data was collected from the medical records department. American Diabetic Association/American Psychiatric Association (ADA/APA) guidelines were used as a reference standard to assess the monitoring for metabolic parameters. Diagnosis of metabolic syndrome was done according to the National Cholesterol Education Program-Adult Treatment Panel III (NCEP-ATP III) guidelines. Risk factors for metabolic syndrome and frequency of metabolic monitoring were analyzed. A total of 668 patients were included for clinical audit. About 16.5 % of the patients were diagnosed with metabolic syndrome. Age >50 years (Odds Ratio (OR) 2.00; p value <0.001) and duration of antipsychotic treatment>5 years (OR 1.55; p value< 0.05) were recognized as the independent risk factors for metabolic syndrome using multiple logistic regression. Blood pressure (BP) and fasting blood sugar (FBS) levels were documented in 99.7 % and 47 % of cases at baseline respectively, however, subsequent annual data on BP and FBS monitoring was reduced to 72.7 % and 46 % respectively. Weight was documented in 60 % of the cases at baseline, whereas the subsequent data on four times the annual assessment of weight was reduced to 9.8 %. The extent of documentation of metabolic monitoring parameters was inadequate.

Assessment of cost of illness for diabetic patients in South Indian tertiary care hospital.

BACKGROUND: The impact of diabetes on health-care expenditures has been increasingly recognized. To formulate an effective health planning and resource allocation, it is important to determine economic burden. OBJECTIVE: The objective of this study is to assess the cost of illness (COI) for diabetic inpatients with or without complications. METHODOLOGY: The study was conducted in the medicine wards of tertiary care hospital after ethical approval by the Institutional Ethical Committee. A total of 116 each diabetic with or without complications were selected and relevant data were collected using COI questionnaire and data were analyzed using SPSS version 20. Mann-Whitney U test is used to assess the statistical significant difference in the cost of treatment of diabetes alone and with complications'. P ≤ 0.05 was considered statistically significant. RESULTS: Total COI includes the cost of treatment, investigation, consultation fee, intervention cost, transportation, days lost due to work, and hospitalization. The median of total COI for diabetic care without any complication was Rs. 22,456.97/- per patient per annum and with complication was Rs. 30,634.45/-. Patients on dialysis had to spend 7.3 times higher, and patients with cardiac intervention had to spend 7.4 times higher than diabetic patients without any complication. CONCLUSION: Treatment costs were many times higher in patients with complications and with cardiac and renal interventions. Complications in diabetic patients will increase the economic burden to family and also to the society.

Evaluation of antiplaque activity of Azadirachta indica leaf extract gel--a 6-week clinical study.

Various chemical agents have been evaluated over the years with respect to their antimicrobial effects in the oral cavity; however, all are associated with side effects that prohibit regular long-term use. Therefore, the effectiveness of neem (Azadirachta indica A. Juss) leaf extract against plaque formation was assessed in males between the age group of 20-30 years over a period of 6 weeks. Present study includes formulation of mucoadhesive dental gel containing Azadirachta indica leaf extract (25 mg/g). A 6-week clinical study was conducted to evaluate the efficacy of neem extract dental gel with commercially available chlorhexidine gluconate (0.2% w/v) mouthwash as positive control. Microbial evaluation of Streptococcus mutans and Lactobacilli species was carried out to determine the total decrease in the salivary bacterial count over a period of treatment using a semi-quantitative four quadrant streaking method. The results of the study suggested that the dental gel containing neem extract has significantly (P<0.05) reduced the plaque index and bacterial count than that of the control group.

Assessment of Drug-Drug Interactions among Renal Failure Patients of Nephrology Ward in a South Indian Tertiary Care Hospital.

Polypharmacy is common in drug prescriptions of chronic kidney disease patients. A study of the prescription patterns of drugs with potential interactions would be of interest to prevent drug related adverse events. A prospective observational study of six months (Dec 2009-May 2010) was carried out among the chronic kidney disease patients admitted to the nephrology ward of a South Indian tertiary care hospital. The pattern and rates of drug-drug interactions seen in the prescriptions of these patients was studied. Among the 205 prescriptions included, a total of 474 interactions were reported, making 2.7 interactions per prescription with incidence rates of 76.09%. Around 19.62% of interactions were of major severity. Most common interactions were found between ascorbic acid and cyanocobalamine (12.45%), clonidine and metoprolol (3.80%) respectively. Hypo or hypertension (31.65%), decreased drug efficacy (29.11%) and hypo or hyperglycemia (14.14%), were the most commonly reported clinical outcomes of the drug interactions. Cardiovascular drugs (calcium channel blockers and beta blockers; 52%) constitute the major class of drugs involved in interactions. As most of the interactions had a delayed onset, long term follow-up is essential to predict the clinically significant outcomes of these interactions. Hence, drug interactions are commonly seen in the prescriptions of chronic kidney disease patients which can lead to serious adverse events if not detected early. Need for collaboration with a clinical pharmacist and electronic surveillance, which are absent in developing countries like India, is emphatic.

Potential drug interactions in patients admitted to cardiology wards of a south Indian teaching hospital.

BACKGROUND: The potential drug-drug interaction (pDDI) increases as the number of concomitant medications increases. Patients with cardiovascular disorders are at higher risk for drug- drug interactions because of the types and number of drugs they receive. While drug interactions are reported to be common, there is no published report of the prevalence of such interactions among Indian cardiac patients. The aim of the present study was to identify the pattern of pDDI and document any observed interaction. It was also planned to evaluate the demography of patients and correlate it with the drug-drug interactions. METHOD: A prospective observational study from Oct 2007 to Apr 2008 was carried out in 'cardiology department' of a hospital in South India. Those patients who were taking at least two drugs and had a hospital stay of at least 48 hours were included in the study. The medications of the patients were analyzed for possible interactions. Factors associated with pDDI were studied. The actual interactions that were observed during the hospital stay in the study subjects were documented. RESULTS: A total of 812 patients were included in the study. 388 pDDIs were identified among 249 patients. The incidence of pDDI was 30.67%. The most common potential interactions were between aspirin & heparin (29.38%), and clopidogrel & heparin (7.21%). Drug classes most commonly involved were antiplatelets, anticoagulants and diuretics. Majority of interactions were of moderate severity, delayed onset, and pharmacodynamic in nature. Total 68 actual interactions were observed in the observed cases. CONCLUSION: The present study identified pDDIs and also documented interactions in cardiovascular patients. Factors which had correlation with adverse drug interactions were identified. This study highlights the need for screening prescriptions of cardiovascular patients for pDDIs and proactive monitoring of patients who have identified risk factors; this helps in detection and prevention of possible adverse drug interactions.