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.

Efficacy and Tolerability of Meroplan S (Meropenem 1 g and Sulbactam 0.5 g) (ETIOS) in the Management of Lower Respiratory Tract Infections caused by Gram-negative Pathogens in Adults: A Post Marketing Observational Study.

Background: The rapid and ongoing spread of antimicrobial-resistant bacteria throughout all healthcare institutions is considered a critical medical and public health issue. Gram-negative bacteria are resistant to multiple drugs and are increasingly resistant to most available antibiotics. Given the high mortality rates caused by drug-resistant Gram-negative bacteria such as Klebsiella, Acinetobacter, Pseudomonas aeruginosa and Escherichia coli and the difficulty of developing new potent antibiotics to target the problematic pathogens, combination regimens are under ardent evaluation as new strategies to overcome increasing drug resistance. Carbapenems such as meropenem have assumed an important antibiotic niche for therapy of various multidrugresistant Gram-negative infections with good safety profile. However, the percentage of carbapenem-resistant enterobacteriaceae (CRE) increased by 4-fold over the last decade and that one particular form of CRE, a resistant form of Klebsiella pneumoniae, has increased 7-fold. Extended-release beta-lactamases (ESBL) production is one of the main bacterial resistance mechanisms to carbapenem antibiotics. The use of ESBL inhibitors like sulbactam combined with carbapenem antibiotics allows the inactivation of ESBLs produced by Gram-negative pathogens. Additionally, sulbactam has an intrinsic antimicrobial activity against penicillin binding proteins. By restoring or expanding the activity of meropenem, the combination with sulbactam offers a new approach to the management of lower respiratory tract infections caused by Gram-negative pathogens. A post marketing observational study was undertaken to evaluate the efficacy and tolerability of (Meropenem 1 g and Sulbactam 0.5 g) injection in the management of lower respiratory tract infections caused by Gram-negative pathogens in adults.

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.