A prospective, multicenter, clinical Study to evaluate the Safety, Pharmacokinetics, and Efficacy of Bleed Outcomes, with HemoRel-A® in severe Hemophilia A Patients

Background and aims: Drug-resistant epilepsy (DRE) is a common and important neurological problem to identify with scope for curative surgical treatment if underlying cause is delineated. There are very few prospective structured studies in our population. This study aimed to look at the neuroimaging profile of DRE presenting in a tertiary care center in South India. Materials and methods: All patients diagnosed clinically as DRE as per International League Against Epilepsy (ILAE) criteria and who underwent magnetic resonance imaging (MRI) over a period of 24 months were included in the study. Their clinical and MRI features were documented and analyzed. Results: A total of 150 patients diagnosed with DRE were included in the study. Clinically, 96 of them presented with generalized tonic-clonic seizures (GTCS), 36 with complex partial seizures (CPS), 14 with simple focal seizures, and two each with atonic seizures and focal seizures with secondary generalization. Magnetic resonance imaging (done in 1.5 T) was normal in 32%. In those with abnormal MRI, mesial temporal sclerosis (MTS) was the commonest pathology seen in 41.3%, followed by cortical malformations (6.7%), tumors (2.6%), vascular malformations (2.7%), and other nonspecific lesions (12%). Conclusion: The clinical and neuroimaging profile of DRE showed that DRE is more common in younger age (of less than 30 years); presents mainly with GTCS or CPS; mesial temporal sclerosis is the commonest underlying pathology which was bilateral in 8.6%; temporal lobe lesions predominate (49.3% of all DRE); and cortical malformation, low-grade tumors, and vascular lesions are other important causes.

Efficacy and Safety of Montelukast Plus Fexofenadine Fixed Dose Combination in Allergic Rhinitis : Results of Post-Marketing Study In India.

Background:Allergic rhinitis is one of the most common conditions in clinical practice. Motelukast and second generation antihistamine fexofenadine are routinely used in the management of allergic rhinitis. Individually both drugs have been found to be effective in allergic rhinitis. Fixed dose combination of montelukast 10 mg plus fexofenadine 120 mg is available in India is also used in the treatment of allergic rhinitis. Objective: To evaluate the efficacy and safety of montelukast and fexofenadine fixed dose combination in the management of patients with allergic rhinitis. Material and methods: Post marketing observational study was conducted in 809 patients from all over India. All the patients were treated with montelukast 10 mg plus fexofenadine 120 mg fixed dose combination once daily for 14 days. The primary outcome criteria was the change in total symptom score (Sum of total nasal symptom score and total ocular symptom score) at the end of study compared to baseline. The secondary outcome criteria included change in total nasal symptom score (nasal congestion, rhinorrhea, nasal itching, and sneezing) and total ocular symptom score (Itching/burning eyes, tearing/ watering eyes and eye redness) at the end of study compared to baseline and physician’s and patient’s global assessment for efficacy and tolerability. The patients were evaluated at baseline, day 7 and day 14 for efficacy evaluation while the safety parameters were assessed at screening and day 14. Results: The fixed dose combination of fexofenadine plus montelukast was significantly effective in reducing total symptom score, total nasal symptom score and total ocular symptom score (p<0.0001 for all parameters). The global assessment of efficacy evaluation by both patient and investigators demonstrated “excellent to good” efficacy in >95% of patients. Most of the study population reported “good” tolerability with the fixed drug combination. No adverse events were reported in the study. Conclusion: The fixed dose combination of fexofenadine plus montelukast was found to be efficacious and well tolerated in allergic rhinitis in Indian adult patients.

Prevalence Study of Vitamin D Deficiency and to Evaluate the Efficacy of Vitamin D3 Granules 60,000 IU Supplementation in Vitamin D Deficient Apparently Healthy Adults.

Objective: The objective of this study was to assess the prevalence of vitamin D deficiency in apparently healthy urban adults and to evaluate the efficacy of vitamin D3 granules 60,000 IU supplementation in increasing serum 25 hydroxyvitamin D [25(OH)D] levels. Material and methods: Healthy adults in an urban hospital were screened for 25(OH)D (radioimmunoassay method). Those found to be deficient or insufficient in vitamin D (defined as 25(OH)D <30 ng/ml) were supplemented with oral cholecalciferol granules 60,000 IU/week for eight weeks. Serum 25(OH)D level was estimated at the end of 60 days. Results: A total of 510 subjects (age 19-66 years) were enrolled for the study. Baseline data was available for 474 subjects and 178 subjects consumed a total of eight sachets as per the study protocol. Of these 178 subjects, 94.94% subjects were found to be vitamin D deficient (<20 ng/ml) and the mean plasma vitamin D3 25(OH)D level was 9.36 ng/ml (±5.19) at baseline. At the end of the study, the mean 25(OH)D plasma level was noted to be 29.28 ng/ml (±13.57). The mean change from baseline was 19.92 ng/ml (±13.25). Among these 178 participants only 5.06% had 25(OH)D >20 ng/ml at baseline, which increased to 78.09% at the end of the study following vitamin D3 supplementation for eight weeks. Conclusion: This study showed that vitamin D deficiency is highly prevalent in the urban healthy adult population. Eight weeks of vitamin D3 60,000 IU/week oral granules supplementation increased serum 25(OH)D to optimal levels.

A Randomized, Open Label, Multicentre Study to Evaluate the Safety and Efficacy of Cough Mixture CS1 (Pholcodeine and Promethazine - Tixylix) Versus CS2 (Noscapine, Ammonium Chloride, Sodium Citrate) in Treatment of Children with Dry Cough.

The objective of this study was to compare the efficacy and safety of cough mixture containing pholcodeine and promethazine - Tixylix (CS1) to a cough mixture which has noscapine, ammonium chloride, and sodium citrate (CS2) as its constituents in treatment of children suffering from dry cough. A total of 208 patients were enrolled at 4 sites. Of these, 179 (94 receiving CS1 and 99 receiving CS2) completed the study. Results of this study suggest that both the cough mixtures were comparable as per evaluation of their primary parameters. According to global assessment for efficacy and tolerability by parents on Day 7, Group CS1 performed better than CS2. It was also observed that no AE was reported in Group CS1 as compared to 2 AEs in Group CS2. To conclude, cough mixture combination of pholcodeine and promethazine - Tixylix exhibited efficacy and safety that was comparable with cough mixture which has noscapine, ammonium chloride, and sodium citrate. It was proven to be efficacious, safe and well tolerated in the select population.

Safety and Efficacy of Balofox (Balofloxacin) in the Treatment of Uncomplicated Urinary Tract Infections in Adults (BUTA Study).

Objective: To evaluate the safety and efficacy of Balofox (Balofloxacin) in the treatment of Uncomplicated Urinary Tract Infections in Adults. Design: Open, prospective, noncomparative, observational, multi-center, post-marketing study. Setting: 248 physicians across India in clinical and hospital settings. Patients: A total of 3511 patients of either sex above 18 years of age with laboratory and/or clinical diagnosis of urinary tract infection were administered Balofox (Balofloxacin) orally two times daily for 5-7 days. Respiratory system abnormalities, cardiovascular abnormalities, nervous system abnormalities and abdominal symptoms were seen in 554 patients. Body temperature, abdominal pain and burning during micturation were recorded at baseline and then on days 2, 3, 4, 5 and 6. Global assessment was done by physician independently at the end of therapy on a 4-point Likert scale. Results: Of the 8063 patients enrolled in the study with, 6977 patients had urinary tract infection, but data of 3466 patients was excluded from analysis due to insufficient data and an intention-to-treat analysis done for efficacy on 3511 patients. The body temperature reduced from 102.12°F at baseline to 99.03°F on day 3 (p<0.0001), and upto 97.72 on day 6 (p<0.0001). The scores for abdominal pain and burning during micturation also significantly (p<0.05) reduced on days 2, 3, 5, & 6 from baseline. The commonly reported adverse events were nausea (5.95%), headache (1.85%), vomiting (1.77%), vertigo and giddiness (1.62%), hyperacidity (1.05%). For global assessment of response to therapy, more than 95% doctors reported the response to therapy as good. More than 90% of doctors reported the tolerability of the drug to be good. Conclusion: Balofox is safe and effective in the management of uncomplicated urinary tract infection in adults.

An Efficacy, Safety and Tolerability Study of Ferrous Ascorbate and Folic Acid (Phosfomin-XT) in Iron Deficiency Anemia.

Aim: This study was aimed to assess efficacy, safety and tolerability of combination of ferrous ascorbate and folic acid (Phosfomin-XT) in patients with iron deficiency anemia (IDA). Settings and design: A total of 56 patients, who were between 18-55 years of age, with hemoglobin (Hb) 6-9 g/dl and serum ferritin <15 mg/l also complying with the inclusion and exclusion criteria in the protocol were enrolled in the study after obtaining necessary approvals and informed consent. All were dispensed with Phosfomin-XT fixed-dose combination (FDC) of ferrous ascorbate (equivalent to elemental iron 100 mg) + folic acid 1.5 mg tablet once-daily after food for eight weeks. Patients were assessed at baseline and Weeks 2, 4, 6 and 8 for change in Hb level, clinical evaluation and target Hb achievement. Results: Baseline mean Hb was 08.39 ± 0.75 g/dl, which significantly increased to 9.76 ± 0.70 g/dl (16.3%) at Week 2 and further increased to 10.70 ± 0.70 g/dl (27.53%) at Week 4. At Week 6, it increased to 11.55 ± 0.67 g/dl (37.7%) and at Week 8, it increased to 12.53 ± 1.09 g/dl. Conclusions: The present study concludes that Phosfomin-XT (ferrous ascorbate, equivalent to elemental iron 100 mg + folic acid 1.5 mg) tablet should be preferred as first choice of oral iron salts to treat IDA due to positive effect on Hb value and superior tolerability.