Retrospective Observational Study on Assessing Sitagliptin and Dapagliflozin as a Fixed-Dose Combination in the Indian Population With Type 2 Diabetes Mellitus: The SIDAXA Study.

Introduction Type 2 diabetes mellitus (T2DM), a prevalent chronic metabolic disorder, necessitates multifaceted treatment approaches. Emerging studies highlight the cardiovascular advantages of sodium-glucose transport protein 2 (SGLT2) and dipeptidyl peptidase 4 (DPP-4) inhibitors in T2DM. This investigation delves into the synergistic effects of the fixed-dose combination (FDC) of sitagliptin and dapagliflozin, offering insights into its safety and efficacy for the Indian population. Methods This real-world, retrospective, observational study spanned 328 cases across 111 Indian centres, evaluating the safety, efficacy, and clinical utilization of the sitagliptin and dapagliflozin FDC in T2DM patients after obtaining ethical approval. Assessments at baseline, week four, and week 12 encompassed hemoglobin A1C (HbA1C), fasting plasma glucose (FPG), postprandial blood glucose (PPBG), low-density lipoprotein cholesterol (LDL-C), systolic blood pressure (SBP), diastolic blood pressure (DBP), and weight change. The statistical analysis was done using Statistical Package for Social Sciences (SPSS) version 29.0.1.0(171) (IBM Corp., Armonk, NY, USA) with a significance level p<0.05. Results Study participants [mean age: 51.14±5.55 years, 77.74% (n=255) males, 22.26% (n=73) females] exhibited prevalent risk factors like sedentary lifestyle (n=167, 50.91%) and smoking (n=147, 44.82%). Comorbidities included hypertension (n=235, 71.65%) and dyslipidaemia (n=139, 42.38%). Metformin (n=282, 85.98%) and sulfonylurea (n=134, 40.85%) were commonly prescribed concomitant oral antidiabetic agents (OADs). FDC administration significantly reduced HbA1c by 1.05 ± 0.83% (p < 0.0001) at week 12. FPG and PPBG showed significant reductions of 22.98 ± 22.23 mg/dL (p < 0.0001), 165.50 ± 37.02 mg/dL and 40.94 ± 36.04 mg/dL (p < 0.0001) at four weeks respectively. By week 12, significant reductions were noted in SBP (14.61±13.98mmHg reduction, p-value <0.0001), DBP (7.80±8.45mmHg reduction, p-value <0.0001), and LDL-C levels (18.14±23.95 mg/dL reduction, p-value <0.0001). In patients with established cardiovascular disease, there was reduction in HbA1c levels by 1.02 ± 0.63% after 12 weeks, with FPG decreasing by 54.52 ± 32.67 mg/dL and PPBG decreasing by 88.73 ± 44.90 mg/dL. Treatment-emergent adverse events included headache, changes in micturition, genital mycotic infection, and nausea and diarrhoea which were mild, transient, and necessitated no treatment discontinuation. Conclusion The FDC of sitagliptin and dapagliflozin significantly improved glycaemic control and lipid profiles in T2DM patients, particularly those with coronary artery disease. It demonstrated a favourable safety profile in the Indian population, signifying its potential as an effective and well-tolerated therapeutic option in patients with established cardiovascular disease.

Real-World Assessment of Personalized Approach With Voglibose Fixed-Dose Combination in Type 2 Diabetes Mellitus.

BACKGROUND: Post-prandial hyperglycemia (PPHG) remains a complex aspect in the management of type 2 diabetes mellitus (T2DM) in the Indian population due to uncertainty in the optimal utilization of alpha-glucosidase inhibitors (AGIs) either as standalone therapy or in combination, whether initiated initially or as a sequential therapy. METHODS: This was a post-approval, observational, multicentric clinical study conducted at 50 centers according to principles of the International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use Guideline for Good Clinical Practice (ICH-GCP) and Declaration of Helsinki and local ethics approval. Descriptive and analytical statistics were applied for conclusion and categorical variables using SPSS version 29.0.1.0 (171) (Armonk, NY: IBM Corp.). RESULTS: Protocol analyses of 515 cases revealed baseline demographics as follows: age 57.35±10.04 years, weight 72.86±10.92 kg, and BMI 28.33±6.07 kg/m2. Comorbidities included hypertension (N=169, 32.82%), thyroid disorders (N=99, 19.22%), and heart failure (N=92, 17.86%). Concomitant oral antidiabetics (OADs) prescribed as DPP4i (9.50%), SGLT2i (19.20%), and DPP4i+SGLT2i (7.20%). Study drug reduced glycosylated hemoglobin (HbA1c) by 13.77% (1.25% mean change, p<0.01), fasting blood glucose (FBG) by 23.69% (44.61 mg/dL mean change, p<0.01), post-prandial blood glucose (PPBG) by 24.57% (70.46 mg/dL mean change, p<0.01), and body weight by 4.43% (3.21 kg mean change, p<0.01) over 12 weeks. A total of 161 patients accomplished targeted PPBG of <180 mg/dL (119.13 mg/dL mean change, p<0.01). Regression analysis considering PPBG and HbA1c ≤7.5% showed a weak correlation between them (R-value=0.13, R-squared value=0.02), whereas between PPBG and HbA1c ≤9% yielded moderate positive correlation (R-value=0.53, R-squared value=0.28). There were no adverse events reported or analyzed during the observation period. CONCLUSION: Voglibose fixed-dose combination (FDC) demonstrates significant effectiveness at the initial dosage when started early in the management of T2DM and high PPBG levels. Moreover, it exhibits good tolerability, thereby contributing to higher compliance among Indian patients who consume a high-carbohydrate diet.

Evaluation of clinical outcomes of raised intraocular pressure following intravitreal triamcinolone acetonide injection.

Aim: To assess the incidence, risk factors, and treatment outcomes in intravitreal triamcinolone acetonide injection (IVTA) induced intraocular pressure rise and to compare IOP rise in 1-mg and 2-mg IVTA. Materials and methods: Prospective observational study conducted in all eyes receiving IVTA. Any pre-existing glaucoma and patients who received IVTA or dexamethasone implant in the last 6 months were excluded. Results: 9 between 61-70 years of age developed an IOP spike. The mean and standard deviation of age in years was 61.95 ± 8.70. Maximum eyes had ME due to Diabetic Retinopathy (53.3%). All cases of uveitic ME were reported to have an IOP spike. 2 out of 3 high myopic eyes and 1 eye with thyroid abnormality had an IOP spike. High IOP was found in 13 eyes, with more than 25 mm Hg rise in 4 eyes and more than 5 mm Hg rise from baseline IOP in 9 eyes. The mean and standard deviation of time taken for IOP raise (in days) was 46.39 ± 37.68. A total of 38 eyes received 1 mg of IVTA and the rest 22 received 2 mg of IVTA. 23.7% of 1 mg eyes experienced an IOP rise while it was 18.2% in eyes with 2 mg IVTA. The injection was repeated in 12 eyes and 41.7% developed an IOP spike among them. The independent "t" test results showed that there was a significant difference in the mean of IOP (Pre-injection) concerning the IOP rise (P=0.007*). 1 eye had IVTA crystals in the anterior chamber with raised IOP of 30 mm Hg. 1 out of 13 eyes with raised IOP needed 2 AGMs, the other 12 eyes responded well to 1 AGM. Discussion: IVTA is widely used in refractory cases of ME and steroid-induced glaucoma is the most common side effect of IVTA. To the best of our knowledge, there is a lack of literature on prospective studies on IVTA-associated risk factors, patterns of IOP elevation, and treatment outcomes. The pre-injection mean ± SD baseline IOP for uneventful eyes was 12.87±2.65 and the pre-injection mean IOP for eyes with IOP event was 15.23±2.89 (P=0.007*). Conclusion: We proposed that TA is an independent risk factor for post-intravitreal injection IOP spike. IVTA causes a maximum IOP spike at 1 to 2 months and has a protracted course that responds to anti-glaucoma medications. High baseline IOP, a repeated dose of IVTA, the presence of TA crystals in the anterior chamber, and high myopia were associated with significant IOP elevation. Abbreviations: ACD = Anterior chamber depth, AS = Anterior segment, AGM = Anti-glaucoma medications, ARMD = Age-related macular degeneration, BCVA = Best-corrected visual acuity, BRVO = Branch retinal vein occlusion, CCT = Central corneal thickness, CRVO = Central retinal vein occlusion, CME = Cystoid macular edema, CNVM = Choroidal neovascularization membrane, CSME = Clinically significant macular edema, DR = Diabetic retinopathy, ERM = Epiretinal membrane, IOP = Intraocular pressure, IGS = Irvine-Grass syndrome, GAGs = Glycosaminoglycans, IVTA = Intravitreal triamcinolone acetonide injection, ME = Macular edema, NVG = Neovascular glaucoma, OHT = Ocular hypertension, PDS = Pigment dispersion syndrome, PACG = Primary closed angle glaucoma, POAG = Primary open-angle glaucoma, PXF = Pseudoexfoliation, VA = Visual acuity, VEGF = Vascular endothelial growth factors, VH = Vonherick's grading, SD = Standard deviation, TA = Triamcinolone acetonide, TIGR = Trabecular meshwork inducible glucocorticoid response.

Is 20/20 visual outcome a reality in rubella cataract? - Prognostic factors in children with cataract associated with congenital rubella syndrome.

Purpose: The aim of this study ws to evaluate prognostic factors associated with final visual outcome in patients with congenital cataract associated with congenital rubella syndrome. Methods: A prospective interventional analysis of preoperative systemic and ocular features of 56 eyes of 28 seropositive infants of less than 12 months presenting to us with bilateral cataract was performed. All infants were surgically treated with cataract extraction, posterior capsulorhexis, and anterior vitrectomy followed by visual rehabilitation. Intraocular lens implantation was done in children after 2 years of age. Outcome data were collected till children reached the fifth chronological age. Chi-square test was used as a test of significance for qualitative data. Results: Of the 56 eyes, 44.6% eyes had vision better than 20/60. Important preoperative factors related to poor visual prognosis were morphology of cataract (P = 0.004), microphthalmos (P < 0.001), features suggestive of iris hypoplasia (P < 0.001), optic atrophy (P < 0.001), nystagmus (P = 0.02), and associated neurological anomalies (P = 0.0023). We found no significant statistical association between postoperative visual outcome and isolated rubella retinopathy, cloudy cornea, cardiological, and ontological abnormalities. Conclusion: Cataract associated with rubella is a common cause of congenital cataract in developing countries. Determining prognostic factors helps us in parent counseling and planning treatment protocols. Nevertheless, early detection and treatment with adequate multidisciplinary approach remains priority for improving long-term visual outcomes.

Ophthalmic surgical training in Karnataka and Southern India: Present status and future interests from a survey of final-year residents.

SETTINGS AND DESIGN: This study documents a survey of final-year ophthalmology postgraduates on the subject of their surgical training and their future plans after residency. PURPOSE: This survey aimed to answer the question, "What is the present status of surgical training in ophthalmic training centers?" by obtaining information from students about (1) various methods used in surgical training (2) numbers and types of surgeries performed by them in the training centers (3) their plans after residency. MATERIALS AND METHODS: A questionnaire containing 21 questions was distributed to 155 students attending an intensive 4-day teaching program. The questions related to orientation training, wet lab training, facilities for training, free surgical camps and detailed information about numbers and types of surgeries observed and performed. Completed questionnaires were collected, and responses analyzed. RESULTS: One hundred and seven completed responses were analyzed. The majority had not received formal orientation training. More than half had undergone wet lab training. Most residents performed their first ophthalmic surgery during the 1 st year of residency and went to the operation theatre multiple times a week. Most of the students planned to undergo further training after residency. More than half of the students found their surgical training to be fair or satisfactory. CONCLUSIONS: The number and frequency of ophthalmic surgeries done by residents appear satisfactory, but further efforts from trainers on enhancing the quality and range of surgical training would benefit students and improve their satisfaction.

Feedback of final year ophthalmology postgraduates about their residency ophthalmology training in South India.

BACKGROUND AND AIMS: This study documents a survey of final-year ophthalmology postgraduate students on the subject of their residency training. A similar survey conducted 7 years ago published in IJO had concluded that the residency program was not up to expectations in many centers. Our study aimed to see if ophthalmology training and student perceptions differed since then. MATERIALS AND METHODS: For our study, we added a few questions to the same questionnaire used in the article "which is the best method to learn ophthalmology? Resident doctors' perspective of ophthalmology training" published in IJO, Vol. 56 (5). RESULTS: Forty-nine students (62.02%) returned completed forms. Most students desired an orientation program on entering residency, and wished to undergo diagnostic training initially. Case-presentation with demonstration and Wet-lab learning were most preferred. There was a big difference between the number of surgeries students actually performed and the number they felt would have been ideal. CONCLUSION: On the whole, the students still felt the need for improved training across all aspects of ophthalmology.

Detection of Y STR markers of male fetal dna in maternal circulation.

BACKGROUND: Circulating fetal cells and cell free DNA in the maternal blood has been shown to help in prenatal diagnosis of genetic disorders without relying on invasive procedures leading to significant risk of pregnancy loss. AIM: The current study was undertaken to detect the male fetal population using Y STR markers DYS 19, DYS 385 and DYS 392 and also to study the extent of persistence of fetal DNA in the mother following delivery. MATERIALS AND METHODS: Blinded study was conducted on 50 mothers delivering male and female babies. Cellular and cell free DNA was extracted from maternal and fetal cord blood and amplified for Y STR markers by PCR. RESULTS: The amplification sensitivity of Y specific STR, DYS19 was 100% (22/22) in the male fetal DNA samples. The incidence of other STRs, i.e., DYS385 and DYS392 were 91% (20/22) each. Analysis of results revealed that thirteen of the twenty six women had detectable male fetal DNA at the time of delivery. However fetal DNA was not detectable twenty four hours after delivery. CONCLUSION: Preliminary results show that the separation of fetal cell-free DNA in the maternal circulation is a good low-cost approach for the future development of novel strategies to provide non-invasive techniques for early prenatal diagnosis.

Poisoning due to white seed variety of Abrus precatorius.

We report an unusual case of poisoning involving the white seed variety of Abrus precatorius that caused serious manifestations in a middle-aged male who had consumed the seeds on the advice of a folk medicine practitioner. He recovered after a prolonged duration of hospital treatment without any subsequent complications or sequelae. The case is being reported on account of its rarity.