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Abstract Objective ESPRITE (Study 508; NCT03836924) evaluated the real‐world safety, tolerability, and efficacy of adjunctive perampanel in patients aged ≥12 years with focal‐onset seizures (FOS), with or without focal to bilateral tonic–clonic seizures (FBTCS), in India. Methods ESPRITE was a prospective, multicenter, single‐arm, observational, Phase IV study with a 6‐month Treatment Period. Patients were aged ≥12 years and had been prescribed perampanel for adjunctive treatment of FOS, with or without FBTCS. Assessments included incidence of treatment‐emergent adverse events (TEAEs; primary endpoint), median percent reduction in seizure frequency per 28 days from baseline, 50% responder rates, and seizure‐freedom rates. Results Overall, 200 patients were enrolled (199 patients in the Safety Analysis Set and 174 patients who completed all visits in the main efficacy analyses). TEAEs (all mild or moderate in severity) were reported in 18.1% (n = 36/199) of patients (the most common were dizziness [3.0%] and irritability [2.0%]). TEAEs leading to discontinuation of perampanel were reported in 2.0% of patients; no deaths or serious TEAEs occurred. At 6 months, median percent reduction in seizure frequency was 100.0%, 50% responder rate was 83.3%, and seizure‐freedom rate was 49.4%. Significance Adjunctive perampanel (at a mean daily dose of 4 mg/day) was shown to be well tolerated and effective in patients aged ≥12 years with FOS, with or without FBTCS, from India. Plain Language Summary Many patients do not receive adequate treatment for epilepsy and need effective seizure control medications. In this 6‐month clinical study, 199 patients from India, aged 12 years or older, added perampanel to the anti‐seizure medications they were already taking. At 6 months, 49% of patients experienced no seizures since starting perampanel and seizure frequency was reduced by half in 83% of patients. Side effects occurred in 18% of patients (most commonly dizziness and irritability) and caused 2% to stop perampanel; no deaths were reported. Perampanel was an effective and generally safe added medication for patients with epilepsy from India.

Extensive soft tissue defects pose a great deal of challenge to the reconstructive surgeon. The aim of this study is to analyze the outcome of free anterolateral thigh (ALT) flaps for soft tissue reconstruction of defects following tumor excision, trauma and post burn. A retrospective review of 19 patients undergoing ALT Flaps for various reasons from Dec 2018 to Jan 2021 was performed to determine perioperative factors, demographic profile, complications and outcomes. The mean age of the study population was 47.2 years. The male to female ratio was 2.16:1 (68.5 % male, 31.5% females). The etiology of soft tissue defect was post-tumor resection-47.36%, truam-36.8%, post burn reconstruction-10.5%. The defect sites were most commonly leg-31.5%, upper extremity-26.3%, buccal mucosa-15.7%, scalp-10.5%, tongue-10.5%, breast-5.2%. Flaps were harvested from right thigh in 52% of cases and left thigh in 58% of the cases. Donor site was closed primarily in 11 cases (57.8%), SSG coverage was done for 8 cases (42.8%). The minimum hospital stay post op was 12 days, maximum being 45 days. Postoperative complications were seen in 36.8% of the cases. Partial flap necrosis occurred in 3 cases (15.7%), complete necrosis in 1 case (5.2%), donor site morbidity was seen in 3 cases (15.7%). In the post-operative period hematoma and infection occurred in 3 cases. ALT Flap in experienced hands provide reliable coverage of large soft tissue defects with excellent aesthetic and functional outcomes with minimal donor site morbidity. [J Med Allied Sci 2023; 13(1):26-32]

Study objectives: Lemborexant (LEM) is a dual orexin receptor antagonist approved for treating adults with insomnia. We analyzed the efficacy (subjective sleep outcomes) and safety of LEM over 12 months in the subgroup of Asian subjects from Study E2006-G000-303 (Study 303). Methods: Study 303 was a 12-month, randomized, placebo-controlled (first 6 months), double-blind, parallel-group, phase 3 study of adults with insomnia disorder. During the 6-month Period 1, subjects were randomized (1:1:1) to placebo, LEM 5 mg (LEM5), or LEM 10 mg (LEM10); LEM subjects continued treatment in the following 6-month Period 2. Outcome measures included subject-reported (subjective) sleep onset latency (sSOL), sleep efficiency (sSE), wake after sleep onset (sWASO), total sleep time (sTST), Insomnia Severity Index (ISI), and Patient Global Impression–Insomnia version (PGI-I). Treatment-emergent adverse events (TEAEs) were assessed. Results: Overall, 178 Asian subjects (Japanese, n = 161; Chinese, n = 4; other Asian, n = 13) were included. Greater decreases in sSOL and sWASO and increases in sSE and sTST from baseline were observed with LEM vs placebo at 6 months; LEM benefits were sustained through 12 months. Greater decreases in ISI total score were seen with LEM vs placebo at 6 months; improvements from baseline with LEM continued through 12 months. For each PGI-I item, LEM-treated subjects had more positive medication effects than placebo-treated subjects at 6 months; these effects were maintained with LEM in Period 2. TEAEs were generally mild to moderate. Conclusions: LEM improved subjective sleep parameters and was well-tolerated in Asian subjects with insomnia disorder over 12 months. Clinical trial registration: ClinicalTrials.gov, NCT02952820; ClinicalTrialsRegister.eu, EudraCT Number 2015-001463-39.

Abstract Objective This post hoc analysis assessed the efficacy and safety of adjunctive perampanel in patients (aged ≥ 12 years) with focal seizures (FS), with/without focal to bilateral tonic‐clonic seizures (FBTCS), or generalized tonic‐clonic seizures (GTCS) in India. Methods Centers in India were identified from six double‐blind, randomized, Phase II and Phase III studies of adjunctive perampanel (2–12 mg/day) and their open‐label extensions (OLEx). Efficacy assessments included median percent change in seizure frequency per 28 days, 50% and 75% responder and seizure‐freedom rates. Treatment‐emergent adverse events (TEAEs) were monitored. Results Overall, 128 patients (placebo, n = 39; perampanel, n = 89) were included in the double‐blind Safety Analysis Set and 126 (FS, n = 113 [placebo, n = 32; perampanel, n = 81]; FBTCS, n = 35 [placebo, n = 14; perampanel, n = 21]; GTCS, n = 13 [placebo, n = 6; perampanel, n = 7]) comprised the Full Analysis Set. Median percent reductions in seizure frequency per 28 days for placebo vs perampanel for Indian patients were as follows: 34.8% vs 49.8% (FS; not significant [NS]) and 43.1% vs 60.5% (FBTCS; NS) at 4–12 mg/day, respectively, and −22.4% vs 8.2% (GTCS; NS) at 8 mg/day, respectively. Fifty‐percent responder rates were 37.5% vs 55.1% (FS; NS), 42.9% vs 60.0% (FBTCS; NS), and 16.7% vs 42.9% (GTCS; NS), respectively; seizure‐freedom rates were 0.0% vs 5.8%, 7.1% vs 10.0%, and 0.0% vs 14.3%, respectively (all NS). Overall, 110 patients entered OLEx studies (FS, n = 99; GTCS, n = 11). Perampanel was efficacious for up to four years for FS and FBTCS and two years for GTCS. Across double‐blind and OLEx studies, TEAEs occurred in 58.4% and 83.6% of Indian perampanel‐treated patients, respectively; dizziness was most common. Efficacy and safety outcomes were generally similar overall between Indian and non‐Indian patients. Significance These data suggest adjunctive perampanel (up to 12 mg/day) may be a suitable anti‐seizure medication for patients (aged ≥ 12 years) with FS, with/without FBTCS, or GTCS in India.

Background: The ‘Asia-Pacific Expert Panel (APEX) for donepezil 23 mg' met in November 2015 to review evidence for the recently approved high dose of donepezil and to provide recommendations to help physicians in Asia make informed clinical decisions about using donepezil 23 mg in patients with moderate-to-severe Alzheimer's disease (AD). Summary: In a global phase III study (study 326) in patients with moderate-to-severe AD, donepezil 23 mg/day demonstrated significantly greater cognitive benefits versus donepezil 10 mg/day, with a between-treatment difference in mean change in the Severe Impairment Battery score of 2.2 points (p Key Message: Donepezil 23 mg is a valuable treatment for patients with AD, particularly those with advanced disease. The APEX emphasized the importance of patient selection (AD severity, tolerability of lower doses of donepezil, and absence of contraindications), a stepwise titration strategy for dose escalation, and appropriate monitoring and counseling of patients and caregivers in the management of patients with AD.

Background: Chronic kidney disease (CKD) coexisting with type 2 diabetes mellitus (DM) leads to coronary artery disease. The present study compares clopidogrel and low-dose aspirin as prophylactic therapy against coronary events in patients with CKD with diabetes. Methods: Total 80 patients of CKD with type 2 DM were randomized and allocated to clopidogrel and aspirin groups to receive the drug at a dose of 75 mg and 150 mg once daily respectively for 8 weeks as add-on therapy. Main outcome was change in blood pressure, metabolic parameters, renal function, inflammatory biomarkers, platelet aggregability and (UKPDS) United Kingdom Prospective Diabetes Study risk scoring. Results: Significant decrease in blood pressure (P < 0.01), total cholesterol (P = 0.02), LDL (P < 0.01), triglyceride (P < 0.01) and a better glycemic control (P < 0.01) was found in clopidogrel group. Renal markers and electrolytes have been improved in clopidogrel group but in aspirin group there was deterioration (2.5%) of creatinine clearance. Clopidogrel group has shown a significant decrease in hsCRP (P < 0.01), UKPDS risk scoring (P < 0.01) and better anti-aggregatory effect. Conclusions: Clopidogrel has prophylactic role in CKD with type 2 DM due to better control of metabolic parameters, renal function and inflammatory burden in comparison to aspirin.

Background : Contact lens induced trauma to the corneal epithelium results in increased release of inflammatory mediators. The keratocyte apoptosis is directly related to epithelial injury and has been correlated with increased production of nitric oxide. Potent antioxidant enzymes protect cells from oxidative damage by inactivating reactive oxygen species and thus inhibiting apoptosis. This study aims at determination of total nitric oxide and antioxidant enzymes in tears which will be an indirect criteria for assessing apoptosis. Materials and Methods : Nitric oxide and antioxidant enzymes were estimated in tears of 25 soft contact lens wearers and compared with 25 age and sex matched controls. Results : Statistically significant increase of nitric oxide (P< 0.001), superoxide dismutase (P< 0.001) and glutathione peroxidase (P< 0.001) levels was seen in tears of contact lens wearers as compared to controls. There was also statistically significant increase in the levels of antioxidant enzymes, superoxide dismutase (P< 0.05) and glutathione peroxidase (P< 0.01), with increase in the total duration of contact lens wear in years. Conclusions : Increase in the level of nitric oxide and antioxidant enzymes in tears of contact lens wearers suggested that contact lens wear suppresses the process of apoptosis. However, it was also postulated that the increased levels of nitric oxide balances the anti-apoptotic activities of increased levels of antioxidant enzymes by its pro-apoptotic activity leading to protective outcomes in contact lens wearers.