An open-label, multicenter, randomized, parallel, single-dose, comparative bioavailability study of two triamcinolone hexacetonide injectable suspensions in patients with knee osteoarthritis

Background: Triamcinolone hexacetonide (THA), a synthetic glucocorticoid with low solubility, can provide sustained pain relief and less systemic side effects in patients with knee osteoarthritis. This study aimed to characterize pharmacokinetic profile of THA-test product containing 20 mg/ml injectable suspension and compare its bioavailability with the standard reference in Indian patients with knee osteoarthritis. Methods: In this open-label, randomized, multicenter study, 44 adult patients were randomized (1:1; test n=23, reference n=21) to receive a single dose of test or reference products. The primary objective was to characterize the pharmacokinetic profile and compare bioavailability of both products via serum triamcinolone acetonide (TCA) concentration. Secondary objectives included safety and tolerability evaluation, impact on hypothalamic-pituitary-adrenal axis, and efficacy of test and reference products in reducing index knee pain. Results: Both products were absorbed with a median Tmax of 23.9 hours. Comparative bioavailability analysis demonstrated no statistically significant formulation effect for ln-transformed Cmax (1098.052 pg/ml for test, 1333.850 pg/ml for reference) and AUC0-t (159112.561 pg×h/ml for test, 211531.035 pg×h/ml for reference) for TCA. T/R ratio for Cmax was 82.3% and T/R ratio for AUC0-t was 75.2%, with >100% inter-subject variability for both Cmax and AUC0-t. Additionally, recovery time of cortisol levels of test and reference arms was 96 hours and 456 hours, respectively. Both products significantly reduced knee pain (p<0.0001). Conclusions: The test product provided lower systemic exposure and faster recovery of serum cortisol levels than the reference, while still providing similar beneficial effect in sustained index knee pain reduction

Nations within a nation: variations in epidemiological transition across the states of India, 1990–2016 in the Global Burden of Disease Study

18% of the world's population lives in India, and many states of India have populations similar to those of large countries. Action to effectively improve population health in India requires availability of reliable and comprehensive state-level estimates of disease burden and risk factors over time. Such comprehensive estimates have not been available so far for all major diseases and risk factors. Thus, we aimed to estimate the disease burden and risk factors in every state of India as part of the Global Burden of Disease (GBD) Study 2016

A case report of Usher's syndrome with psychosis: Challenges in diagnosis and management

Usher's syndrome is a heterogeneous autosomal recessive disorder characterized by dual sensory impairment in the form of profound congenital hearing loss and progressive visual loss due to retinal degeneration. There are only a few reports describing patients with Usher's syndrome presenting with psychotic features, and the exact etiology of its psychiatric manifestation is not clearly known. Herein, the authors report a case of Usher's syndrome with psychotic symptoms. Furthermore, the authors discuss the possible etiologies of psychotic symptoms in such cases and the challenges faced while assessing these symptoms in patients with sensory impairment

Unusual case of recurrent SMART (stroke-like migraine attacks after radiation therapy) syndrome

Stroke-like migraine attacks after radiation therapy (SMART) syndrome is a rare delayed complication of cerebral radiation therapy. A 53-year-old female initially presented with headache, confusion and left homonymous hemianopia. Her medical history was notable for cerebellar hemangioblastoma, which was treated with radiation in 1987. Her initial brain MRI (magnetic resonance imaging) revealed cortical enhancement in the right temporo-parieto-occipital region. She improved spontaneously in 2 weeks and follow-up scan at 4 weeks revealed no residual enhancement or encephalomalacia. She presented 6 weeks later with aphasia. Her MRI brain revealed similar contrast-enhancing cortical lesion but on the left side. Repeat CSF studies was again negative other than elevated protein. She was treated conservatively and recovered completely within a week. Before diagnosing SMART syndrome, it is important to rule out tumor recurrence, encephalitis, posterior reversible encephalopathy syndrome (PRES) and stroke. Typically the condition is self-limiting, and gradually resolves