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.

An Observational Study of Essentiale-L in the Treatment of Patients with Fatty Liver Disease.

Background: The most common forms of liver disease are alcoholic fatty liver disease and nonalcoholic fatty liver disease (NAFLD), which lead to cirrhosis, liver failure and death. Essential phospholipids play an important role in the management of these conditions. Polyenephosphatidylcholine (PPC) is a major active ingredient in essential phospholipids. It has a high bioavailability and affinity for cellular and subcellular membranes, and helps to maintain membrane fluidity and function. Essentiale-L comprises of PPC, which is a mixture of 94-96% of polyunsaturated phosphatidylcholine. It is prescribed in the management of viral hepatitis and fatty liver disease. Objective: There are only few recent clinical studies conducted in India regarding the role of Essentiale-L in the management of fatty liver disease therefore, we undertook this openlabel, nonrandomized, real clinical practice study, on adult patients diagnosed with fatty liver disease including NAFLD as well as alcoholic fatty liver disease (AFLD). Methods: All adult patients satisfying the inclusion and exclusion criteria were included in the study. Patients diagnosed with fatty liver disease including NAFLD as well as AFLD were treated for 90 days with Essentiale-L two capsules thrice-daily. Vital signs, adverse effects and laboratory evaluations (liver function tests, lipid profile and fasting blood glucose tests) were recorded at baseline (Day 0), Day 7, Day 21, Day 30, Day 60 and Day 90. Results: Essentiale-L showed a consistent improvement in both clinical as well as laboratory parameters in patients with fatty liver disease. The decrease in the liver enzyme levels from baseline was significant at Days 60 and 90 (p < 0.05). However, the decrease in serum total cholesterol, low-density lipoprotein (LDL) cholesterol and triglyceride levels was significant only at Day 90 (p < 0.05). The change in fasting blood glucose levels from baseline were not significant. Conclusion: Essentiale-L is a safe and effective option in patients with fatty liver disease. It can be safely recommended in patients with type 2 diabetes along with fatty liver disease since it did not alter the blood glucose levels significantly.

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.

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.