ABSTRACT Background India ranks second in the global diabetes epidemic, with about 89 million individuals living with Type 2 diabetes mellitus (T2DM). We compared the efficacy and safety of fixed‐dose combination (FDC) of glimepiride, voglibose, and extended‐release metformin (GLIME+VOGLI+MET‐ER) with voglibose and metformin (VOGLI+MET) and glimepiride and metformin (GLIME+MET). Methods A Phase IV, randomized, open‐label, active‐controlled study was performed in adult patients with T2DM poorly controlled with metformin. Patients received twice daily doses of GLIME+VOGLI+MET‐ER (1 + 0.2 + 500 mg: Trivolib 1, 2 + 0.2 + 500 mg: Trivolib 2); or VOGLI+MET (0.2 + 500 mg, 0.3 + 500 mg) or GLIME+MET (1 + 500 mg, 2 + 500 mg). The primary endpoint was the change in HbA1c from baseline. Results Of the 458 patients screened, 399 were randomized (GLIME+VOGLI+MET‐ER [n = 133], VOGLI+MET (n = 135), and GLIME+MET [n = 131]). The mean baseline HbA1c was ~8.35% (~67.77 mmol/mol). All the treatments showed a significant reduction in HbA1c at Weeks 12 and 24. Mean change in % (mmol/mol) HbA1c was significantly more with GLIME+VOGLI+MET‐ER versus VOGLI+MET and GLIME+MET at Week 12 (−1.02 ± 0.60 [−11.2 ± 6.52] vs. −0.68 ± 0.64 [−7.49 ± 6.95], p < 0.001 and −0.88 ± 0.49 [−9.65 ± 5.34], p = 0.0154) and Week 24 (−1.57 ± 0.74 [−17.2 ± 8.14] vs. −1.11 ± 0.80 [−12.2 ± 8.79], p < 0.001 and −1.28 ± 0.60 [−14.0 ± 6.56], p = 0.0002). Overall, 49 adverse events (AEs) were reported in 32/399 (8.0%) patients. One patient each in GLIME+VOGLI+MET‐ER and VOGLI+MET groups had level 1 hypoglycemia requiring no management. No severe or serious AEs were reported. Conclusions In adult patients with T2DM inadequately controlled on metformin monotherapy, GLIME+VOGLI+MET‐ER demonstrated superior HbA1c reduction compared with VOGLI+MET and GLIME+MET at Weeks 12 and 24. Study medications were safe and well‐tolerated. Trial Registration: Clinical Trial Registry India—CTRI/2020/11/029080 [Registered on: 12/11/2020].
BACKGROUND:Benign paroxysmal positional vertigo (BPPV) is the most common cause of recurrent vertigo and is typically monocanalicular, affecting a single semicircular canal at a time. Multicanalicular involvement, particularly when associated with canalith jam (CJ) or conversion to cupulolithiasis, is rare and poses significant diagnostic and therapeutic challenges. CASE PRESENTATION:A 76-year-old woman presented with acute positionally triggered vertigo following a mild traumatic brain injury (mTBI) from a road traffic accident (motorbike slip with cranial impact; transient loss of consciousness < a few minutes, no scalp or ear, nose or throat bleeding). Sequential otoneurologic examinations identified canalolithiasis of right posterior semicircular canal (PSC) and bilateral horizontal semicircular canals (HSC). A quick liberatory rotation maneuver successfully resolved right PSC canalolithiasis but precipitated a CJ in right HSC. Subsequent maneuvers confirmed bilateral HSC canalolithiasis, with later conversion of left HSC canalolithiasis to HSC cupulolithiasis. Stepwise treatment utilizing the head-shaking maneuver (HSM), Gufoni (GM), and Zuma maneuvers (ZM) resulted in complete symptom resolution. CONCLUSION:This case illustrates the dynamic nature of otoconia migration in multicanalicular BPPV following mTBI. It emphasizes the critical role of meticulous sequential otoneurologic testing, physiotherapy-guided repositioning maneuvers, and heightened awareness of CJ as a potential complication of these procedures.
BACKGROUND:A combination of inhaled corticosteroids (ICS) and long-acting β₂-agonists (LABA) is recommended for symptomatic asthma patients. Asthma control with single maintenance and reliever therapy (SMART) in patients remains poor with frequent nighttime awakenings, increased reliever use & severe exacerbations, including non-adherence. Once-daily FF/VI, an ultra LABA/ICS, has proven efficacy and safety in asthma with better adherence than multi-day regimens. METHODS:This prospective, multi-center, post-marketing (PROMISE-OD) study evaluated FF/VI DPI (100/25 mcg or 200/25 mcg) over 12 weeks in symptomatic asthma patients (≥12 years) on conventional therapies. RESULTS:Among 178 enrolled patients, 177 completed the study (53.9% females & mean age 44.8±15 years). Mean trough FEV1 improved by 180.5±810.7 ml (p=0.003) at week 4 & by 258.8±846.6 ml (p<0.0001) at week 12. The mean ACQ-5 score also reduced by -0.8±0.8 at week 4 and -1.3±0.9 at week 12 (p<0.0001). Adverse events occurred in 15.7% of patients, with no SAEs reported. Rescue medication was low (3.4% at week 4 & 5.1% at week 12). High patient and physician satisfaction was also observed. CONCLUSION:FF/VI DPI demonstrated significant improvements in lung function and asthma control with high patient satisfaction and a favorable safety profile, establishing it as a promising maintenance therapy for asthma management in Indian patients.
Vats, Ajay K; Castellucci, Andrea; Kothari, Sudhir; Vats, Shreya; Minocha, Priyanka Author Information
