Demographic Profile and Prescribing Patterns of Anti-epileptic Drugs in Indian Epilepsy Patients: Electronic Medical Record-Based Nation-Wide Retrospective Cohort Study.

The aim of this study was to provide real-world data on clinical characteristics, risk factors, and treatment patterns in Indian patients with epilepsy. Electronic medical record (EMR) data of patients diagnosed with epilepsy between January 2001 and December 2019, which included demographics, diagnosis, anti-epileptic drug usage, and underlying risk factors were evaluated. The majority of patients were between the age group of 18 and 55 years (n=3,186), with males accounting for 62% and the remaining 38% being females. Further, the most common comorbidity was hypertension (23.3%, n=1,470), followed by diabetes mellitus (10.8%, n=683) and depression (9.4%, n=597). The most prevalent form of epilepsy was focal epilepsy (n=5,141 81.4%), followed by generalized epilepsy (n=601). Focal epilepsy was most prevalent in males (62%, n=3,167) and most common in the age group of 18-55 years (50.3%, n=2588). Anti-epileptic drug (AED) usage data from 6,318 patients showed that the most commonly prescribed AED alone or in combination for both focal and generalized epilepsy was levetiracetam (41.8%, n= 2645). Data collected from this study are aligned but do not completely agree with the Guidelines for the Management of Epilepsy in India (GEMIND). This affirms treatment initiation with AED monotherapy; however, the treatment choices do not necessarily follow the recommended guidelines to select conventional AEDs, at low strengths, at initiation.

Compassionate drug use: Current status in India.

The World Health Organization defines compassionate use (CU) as a "program that is intended to provide potentially life-saving experimental treatments to patients suffering from a disease for which no satisfactory authorized therapy exists and/or who cannot enter a clinical trial. For many patients, these programs represent their last hope." Over the years, an increasing number of requests and isolated cases have paved the way for more robust CU programs by pharmaceutical companies and guidelines by eminent regulatory bodies globally. In India, although there is no formal mention of the term "Compassionate Use" by the Central Drugs Standard Control Organization, there are provisions in the Drugs and Cosmetics Act 1940 and Rules 1945 to allow drugs to be imported as and when necessary. Such applications can be submitted to the Drug Controller General of India by a hospital, patient, or a pharmaceutical company. The evidence of such use of drugs is underlined by the availability of bedaquiline and delamanid for extensively drug-resistant tuberculosis (TB) and multidrug-resistant TB patients, respectively. CU is in its nascent stage in India owing to the lack of policies and laws needed to govern it. There is a need for regulatory bodies and pharmaceutical companies to work together to extend the spectrum of CU of drugs for the betterment of needy patients.

Evaluation of oral multi-herbal preparation of Dashmoolarishta on mice model of osteoarthritis.

BACKGROUND: Osteoarthritis (OA) is a chronic progressive disease commonly affecting the hip and knee joints. Although synthetic drugs are available and afford symptomatic relief, their side effects pose limitations to their continuous use. So, this research was focused on extracting drugs from indigenous medicinal plants that could have a beneficial effect on osteoarthritis. Dashmoolarishta is one such preparation whose effects have never been studied in comparison with recent drugs like hyaluronic acid (HA), hence this particular study was undertaken. The aim of this study was to evaluate the effects of Dashmoolarishta compared with HA on joint pathology and pain behavior in monosodiumiodoacetate (MIA)-induced OA in experimental mice. METHODS: The study was initiated after obtaining permission from the Animal Ethics Committee. This study was based on the MIA model of osteoarthritis, with mice being divided into five groups viz.: disease control (DC), Dasahmoolarishta high dose (HD) and low dose (LD), sham control (SC) and HA. The OA of the knee joint was induced in these mice using monosodiumiodoacetate. Seven days after induction, animals were subjected to weekly behavioral tests, daily oral Dashmoolarishta, and biweekly HA administration from weeks 2-4. At the end of the 4th week, histopathological examination of the knee joints was done. RESULTS: DC showed significant osteoarthritic changes. At week 4, the behavioral tests and histopathology results of all groups were found to be significant. A significant difference (p<0.05) was found between DC vs. SC, HA, HD, LD for open field test, Rota rod test, knee joint diameter, and Cat walk test. Dashmoolarishta HD and LD showed significant improvement in pain, as assessed by behavioral tests (p<0.05) and pathology, as assessed by knee joint histopathology (p<0.05). CONCLUSIONS: Oral Dashmoolarishta showed reduction in pain and disease activity in MIA-induced osteoarthritis in mice model.

Intra-articular injections of ketamine and 25% dextrose improve clinical and pathological outcomes in the monosodium iodoacetate model of osteoarthritis.

BACKGROUND: The study evaluated the effect of intra-articular injections of ketamine and 25% dextrose with triamcinolone acetate (TA) and hyaluronic acid (HA) on joint pathology and pain behavior in monosodium iodoacetate (MIA)-induced osteoarthritis (OA) in experimental mice. METHODS: In phase I, the MIA-induced OA model was standardized. In phase II, mice were divided into three groups: disease controls (DC), ketamine 12 mg/kg (K12) and ketamine 24 mg/kg (K24) to select an effective dose of ketamine for phase III. In phase III, the groups were: DC, normal controls (NC), K24, 25% dextrose (D25) - 10 µL, TA 6 mg/kg, and HA - 3.5 mg/kg. The effect of ketamine was compared with the standard drugs - TA and HA. In phases II and III, after 7 days following the induction of OA, animals were subjected to weekly behavioral tests and biweekly drug administration from week 2 to week 4. Subsequently, after 4 weeks knee joint samples were collected and sent for histopathological evaluation to a veterinary pathologist. RESULTS: In phase I, the DC group showed significant OA changes as compared to NC on knee joint histopathology scoring. In phase II, all the behavioral tests and knee joint histopathology results demonstrated a significant improvement with K24 as compared to DC. In phase III, significant differences were found between DC vs. HA, DC vs. D25, DC vs. K24, K24 vs. TA, HA vs. TA for open field test and hot plate test (p<0.001), whereas HA and ketamine showed comparable results for these tests. There was a significant improvement in D25, TA and K24, HA groups as compared to DC in histopathology scores, (p<0.05). CONCLUSIONS: The NMDA antagonist effect of ketamine and the proliferative effect of 25% dextrose showed a reduction in pain and disease activity in the OA model.