Evaluating the Efficacy, Safety, and Tolerability of Combination Therapy of Dapagliflozin and Linagliptin Over Dapagliflozin and Vildagliptin in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.

Background Type 2 diabetes mellitus (T2DM) patients commonly undergo metformin monotherapy. This study aims to compare the efficacy, safety, and tolerability of combination therapy of dapagliflozin plus linagliptin versus dapagliflozin plus vildagliptin as add-on therapy in T2DM patients inadequately controlled on metformin. Methodology This was an 18-week, multicenter, randomized, double-blind, active-controlled, parallel-group, phase III clinical study. About 236 participants were randomly assigned to receive either a fixed-dose combination of dapagliflozin 10 mg plus linagliptin 5 mg tablets or a fixed-dose combination of dapagliflozin 10 mg plus vildagliptin SR 100 mg tablets added to metformin monotherapy. The primary outcome was the mean change in hemoglobin A1c (HbA1c) from baseline to the end of week 16. The key secondary endpoints were mean change in postprandial blood glucose (PPBG), fasting blood glucose (FBG), body weight, and the proportion of participants achieving HbA1c less than 7.0%. Results The dapagliflozin/linagliptin combination therapy showed a more significant change in HbA1c from baseline to the end of 16 weeks (mean reduction: -1.59% vs. -1.25%) compared to dapagliflozin/vildagliptin (p < 0.0001). Additionally, compared to the dapagliflozin/vildagliptin group, the dapagliflozin/linagliptin group demonstrated a significant reduction in both PPBG (mean reduction: -59.99 mg/dL vs. -55.34 mg/dL) and FPG (mean reduction: -32.91 mg/dL vs. -26.78 mg/dL). A total of 18 adverse events were reported in 17 (7.20%) participants, all of which were mild and resolved completely. There were no serious adverse events. Conclusions Compared to dapagliflozin and vildagliptin combination therapy, dapagliflozin and linagliptin fixed-dose combination provided clinically significant improvements in glycemic control. Because of its effectiveness, safety, and tolerability, the fixed-dose combination of dapagliflozin and linagliptin was a better option for treating T2DM patients who had previously only received metformin monotherapy.

Predicting antitubercular drug-induced liver injury and its outcome and introducing a novel scoring system.

Background: Tuberculosis (TB) is a major global health problem, mainly in developing countries. Despite the availability of highly effective first-line antitubercular (ATT) drugs, ATT drug-induced liver injury (ATT DILI) leads to treatment interruption and consequently loss of therapeutic efficacy. Methods: In this prospective cohort study from India, all consecutive patients who met inclusion criteria and started on ATT were included. The incidence, risk factors, and outcome of ATT DILI were determined. A clinical prediction score for ATT DILI was derived. Results: A total of 393 patients were included. The incidence of ATT DILI was 9.7% (95% confidence interval 7%-13.2%). HIV infection, daily regimen, disseminated disease, and chronic liver disease were identified as significant risk factors (P < 0.05) for developing DILI. A prediction score derived from the risk factors showed that a score of >5 could predict DILI with a sensitivity of 74% and a specificity of 67%. All-cause mortality in DILI was 4.7%. Conclusion: The incidence of ATT DILI was 9.7% in our cohort with higher incidence among the patients on daily regimen. The study suggests that the combination of risk factors of extensive TB disease, HIV infection, chronic liver disease, and under nutrition increases the vulnerability to DILI, particularly with daily treatment regimen, emphasizing the role of acquired risk factors in the development of DILI.

Diagnostic pathways and direct medical costs incurred by new adult pulmonary tuberculosis patients prior to anti-tuberculosis treatment - Tamil Nadu, India.

BACKGROUND: Tuberculosis (TB) patients face substantial delays prior to treatment initiation, and out of pocket (OOP) expenditures often surpass the economic productivity of the household. We evaluated the pre-diagnostic cost and health seeking behaviour of new adult pulmonary TB patients registered at Primary Health Centres (PHCs) in Vellore district, Tamil Nadu, India. METHODS: This descriptive study, part of a randomised controlled trial conducted in three rural Tuberculosis Units from Dec 2012 to Dec 2015, collected data on number of health facilities, dates of visits prior to the initiation of anti-tuberculosis treatment, and direct OOP medical costs associated with TB diagnosis. Logistic regression analysis examined the factors associated with delays in treatment initiation and OOP expenditures. RESULTS: Of 880 TB patients interviewed, 34.7% presented to public health facilities and 65% patients sought private health facilities as their first point of care. The average monthly individual income was $77.79 (SD 57.14). About 69% incurred some pre-treatment costs at an average of $39.74. Overall, patients experienced a median of 6 days (3-11 IQR) of time to treatment initiation and 21 days (10-30 IQR) of health systems delay. Age ≤ 40 years (aOR: 1.73; CI: 1.22-2.44), diabetes (aOR: 1.63; CI: 1.08-2.44) and first visit to a private health facility (aOR: 17.2; CI: 11.1-26.4) were associated with higher direct OOP medical costs, while age ≤ 40 years (aOR: 0.64; CI: 0.48-0.85) and first visit to private health facility (aOR: 1.79, CI: 1.34-2.39) were associated with health systems delay. CONCLUSION: The majority of rural TB patients registering at PHCs visited private health facilities first and incurred substantial direct OOP medical costs and delays prior to diagnosis and anti-tuberculosis treatment initiation. This study highlights the need for PHCs to be made as the preferred choice for first point of contact, to combat TB more efficiently.

Purple urine bag syndrome: time for awareness.

Purple urine bag syndrome occurs commonly in long-term catheterized patients causing significant stress for patients, care takers, and health care providers. This may lead to unwarranted investigation as well as treatment when not identified early. Demographic changes in Indian population with increasing geriatric care make it a case to increase awareness of this condition among health care providers in primary and secondary care settings.

Determinants of postpartum anemia among women from a rural population in southern India.

BACKGROUND: Even though the problem of anemia during pregnancy has been adequately emphasized, very little attention has been paid to postpartum anemia. The objective of the current study was to estimate the mean change in maternal hemoglobin from 36 weeks' gestation to 6 weeks postpartum and to identify the factors associated with anemia during the postpartum period among women in a rural development block in Tamil Nadu, India. METHODS: Ninety-three pregnant women were interviewed using a structured questionnaire at 36 weeks' gestation and then at 2 and 6 weeks postpartum. Blood samples were collected from the participants at 36 weeks' gestation and at 6 weeks postpartum. Paired t-tests assessing the difference in mean hemoglobin prepartum and postpartum, univariate analysis, and multiple logistic regression to identify factors associated with postpartum anemia were done using Statistical Package for the Social Sciences version 12 for Microsoft Windows software. RESULTS: The proportion of study subjects who were anemic (hemoglobin <11 g/dL) at 36 weeks' gestation was 26.8% and at 6 weeks postpartum was 47.3% (hemoglobin <12 g/dL). The mean hemoglobin at 36-38 weeks' gestation was 11.70±1.43 g/dL and at 6 weeks postpartum was 12.10±1.27 g/dL. Anemia at 36 weeks' gestation (odds ratio [OR] 10.47, 95% confidence interval [CI] 2.37-42.34), heavy blood loss perceived by the mother during delivery (OR 12.91, 95% CI 2.01-61.25), younger maternal age (<21 years, OR 2.45, 95% CI 1.28-23.86), and inadequate iron supplementation during the postpartum period (OR 3.53, 95% CI 1.18-11.37) were identified as significant factors associated with anemia at 6 weeks postpartum. CONCLUSION: Anemia during the third trimester of pregnancy, heavy bleeding perceived by the mother during delivery, younger maternal age, and inadequate iron supplementation during the postpartum period were associated with postpartum anemia.