Background. Liraglutide in a 3.0 mg subcutaneous dose daily is approved for weight reduction. Objectives. Objectives are to evaluate the efficacy and safety of liraglutide 3.0 mg in patients with overweight and obesity irrespective of diabetic status. Methods. We conducted an electronic database search in PubMed, Embase, and https://ClinicalTrial.gov to identify all randomized control trials (RCTs) that evaluated the efficacy and safety of liraglutide 3.0 mg dose compared to placebo in overweight (≥27 kg/m2) and obese (≥30 kg/m2) patients above 18 years of age. Results. We compared the pooled estimate of the study results between liraglutide 3.0 mg groups and placebo groups both in diabetic and nondiabetic patients. The efficacy outcomes that were found to be significant among respective studies involving nondiabetic patients vs. diabetic patients were mean change in body weight from baseline: 12 studies [MD = −5.04 kg (95% CI = −5.60, −4.49), P < 0.001 , I2 = 92.95%] vs. 2 studies [MD = −4.14 kg (95% CI = −4.95, −3.32), P < 0.001 , I2 = 0%], reduction in waist circumference from baseline: 8 studies [MD = −3.64 cm (95% CI = −4.43, −2.85), P < 0.001 , I2 = 96.5%] vs. 2 studies [MD = −3.11 cm (95% CI = −3.88, −2.34), P < 0.001 , I2 = 0%], BMI reduction from baseline: 5 studies [MD = −1.95 kg/m2 (95% CI = −2.22, −1.68) vs. 1 study [MD = −1.86 kg/m2 (95% CI = −2.14, −1.57), P < 0.001 , I2 = 0%, P < 0.001 , I2 = 95.6%], proportion of patients losing more than 5% of weight loss from baseline: 8 studies [RR = 2.21, (95% CI = 1.89, 2.58), P = 0.03 , I2 = 59.02%] vs. 2 studies [RR = 2.34, (95% CI = 1.93, 2.85), P = 0.39 , I2 = 0.00%], and 10% weight loss from baseline: 7 studies [RR = 3.36, (95% CI = 1.92, 5.91), P = 0.00 , I2 = 87.03%] vs. 2 studies [RR = 3.64, (95% CI = 2.46, 5.40), P = 0.81 , I2 = 0.00%]. Safety outcome assessment with use of liraglutide 3.0 mg compared with placebo in respective nondiabetic vs. diabetic patients revealed significant proportion of patients experiencing the adverse events: 9 studies [RR = 1.11, (95% CI = 1.04, 1.18), P = 0.00 I2 = 79.15%] vs. 2 studies [RR = 1.06, (95% CI = 1.01, 1.11), P = 0.42 , I2 = 0.03%] but similar risk of serious adverse events: 9 studies [RR = 1.03, (95% CI = 0.70, 1.51), P = 0.26 , I2 = 18.54%] vs. 2 studies [RR = 1.11, (95% CI = 0.67, 1.84), P = 0.25 , I2 = 23.77%] and TDAEs: 4 studies [RR = 0.89, (95% CI = 0.35, 2.28), P = 0.03 , I2 = 61.89%] vs. 1 study [RR = 2.53, (95% CI = 1.00, 6.37)]. However, the pooled estimates irrespective of the glycaemic status were mean change in body weight from baseline: 14 RCT [MD = −4.91 kg (95% CI = −5.43, −4.39), P < 0.001 , I2 = 92.35%], reduction in waist circumference from baseline: 10 studies [MD = −3.55 cm, (95% CI = −4.21, −2.89), P < 0.001 , I2 = 94.99%], BMI reduction from baseline: 6 studies [MD = −1.86 kg/m2, (95% CI = −2.14, −1.57), P < 0.001 , I2 = 96.14%], and proportion of patients losing more than 5% and 10% of weight from baseline: [RR = 2.23, (95% CI = 1.98, 2.52), P < 0.001 , I2 = 48.87%] and [RR = 3.28, (95% CI = 2.23, 4.83), P < 0.001 , I2 = 78.98%], respectively. Also, the proportion of patients experiencing the adverse event was more with liraglutide 3.0 mg compared with placebo 11 study [RR = 1.09, (95% CI = 1.04, 1.15), P < 0.01 , I2 = 76.60%] and similar risk for both serious adverse events: 11 studies [RR = 1.09, (95% CI = 1.04, 1.15), P < 0.01 , I2 = 76.60%] and TDAEs: 5 studies [RR = 1.14, (95% CI = 0.50, 2.60), P < 0.01 , I2 = 64.93%] with liraglutide compared with placebo. Conclusions. Liraglutide in 3.0 mg subcutaneous dose demonstrated significant weight reduction with a reasonable safety profile for patients with overweight or obesity regardless of diabetic status compared to placebo.
Introduction: A key determinant of the success of any study is the recruitment and subsequent retention of participants. Screen failure and dropouts impact both the scientific validity and financial viability of any study. We carried out this audit with the objective of evaluating the recruitment and retention of participants in clinical studies conducted over the last five years at our center. Methods: Studies completed between 2014 and 2018 at our center were included. Screening ledgers and study trackers were hand searched for screen failures and dropouts. Four pre-identified predictors were evaluated – risk as per the classification of Indian Council of Medical Research 2017 Ethical Guideline, nature of funding, study design, and nature of participants. Association of the predictors with screen failures and dropouts was determined using crude odds ratios along with 95% confidence intervals. All analyses were done at 5% significance using Microsoft Excel 2016. Results: A total of n = 19 completed studies had n = 2567 screened and n = 2442 enrolled participants with a screen failure and dropout rate of 5% and 4%, respectively. We found 59% screen failures due to abnormal laboratory values. The main reasons for dropouts were lost to follow-up 86 (88%). High-risk and interventional studies were the predictors for both screen failures and dropouts, but pharmaceutical industry-funded studies and healthy participants were predictors for only screen failures. Conclusion: Risk, funding, study design, and nature of participants are important to be considered while planning studies to minimize screen failures and dropouts.
INTRODUCTIONDrugs therapy in elderly is challenging, because of pharmacokinetic changes of ageing which often results in drug-drug interactions leading to disproportionately high rate of ADRs. ADRs are responsible for 3%-13% of all the admissions and complicate 5%-20% of hospital stay in patients aged more than 65 years.1 Age-related polypathology often demands multiple medications giving rise to polypharmacy among elderly. Polypharmacy increases the risk of drug-related events such as falls, confusion and functional decline in elderly. Polypharmacy, in-turn increases the risks of negative health outcomes like drug interactions, ADRs, hospital admission leading to economic burden. Previous studies have reported depression, cumulative co-morbidity; inappropriate prescribing practice and selected chronic conditions like diabetes mellitus and congestive heart failure as the Positive correlates of polypharmacy.2 The other factors negatively influence polypharmacy were identified to be smoking, alcohol consumption, cognitive ability, physical status and ADRs before admission. 3Identifying the predictors of polypharmacy in elderly will help to frame interventional strategies to rationalize the prescribing practices.Psychological well-being is considered as one of the important index of successful aging. Elderly population often succumbs to depression because of multiple medical ailments or individual's self-perceived health. 4 The association of depression and polypharmacy appears to be bidirectional. Depression was found to be a main ABSTRACT Background: Polypharmacy is a reliable indicator of irrational prescribing particularly among elderly. Polypharmacy increases the risk of adverse drug reactions (ADRs) exponentially imposing higher economic burden. Addressing and evaluating the prescribing practices in elderly will rationalize the drug utilization leading to improvement in quality of health care. The present study was taken to evaluate the determinants of polypharmacy and its association with depression, defined as a 15 item geriatric depression scale (GDS) >6, in elderly patients. Methods: This prospective cohort study was conducted at department of medicine, Victoria hospital, Bengaluru 100 patients aged 60 and above years was enrolled. Relevant data regarding patients' demographic details, smoking and alcohol consumption, medical diagnosis and drug details were collected. Geriatric Depression Scale was used to diagnose depression. Results: Out of 100 patients screened, 36% were males and 64% were females. Polypharmacy was noted in 73% of the elderly, of which 43% had cumulative co morbidity (≥4 diagnoses). 68% were found to have a GDS score of ≥6, which corresponded to Depression. Patients with depression (GDS score ≥6) had 1.54 (OR-1.54, 95% CI-0.59-4.01) times more risk of encountering polypharmacy (≥4 drugs). Cumulative co-morbidity (OR-1.52, 95% CI-1.08-2.11, p <0.05) was identified as an independent correlate of polypharmacy. Conclusions: Increasing age, males, Cumulative comorbidity of ≥4 diagnoses and ...
Monitoring and audits are two distinct processes that ensure that the rights and safety of the participants are protected, and data integrity is maintained. The present narrative summates authors' experiences with monitoring and audits by sponsor along with challenges faced by the site. It also offers potential solutions for challenges faced during the process of monitoring and audits. It is important to remember that no monitoring or audit can ever substitute for a well-designed and articulated protocol. In addition, a determined approach by the investigator and his/her team to ensure that all aspects of the protocol are adhered to in totality will go a long way in assuring quality.
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