Molfino N.A.,Drug Development Consultant |
Kuna P.,Medical University of Lodz |
Leff J.A.,InterMune Inc. |
Oh C.K.,Glenmark Pharmaceuticals |
And 4 more authors.
BMJ Open | Year: 2016
Objectives: We wished to evaluate the effects of an antigranulocyte-macrophage colony-stimulating factor monoclonal antibody (KB003) on forced expiratory volume in 1 s (FEV1), asthma control and asthma exacerbations in adult asthmatics inadequately controlled by long-acting bronchodilators and inhaled/ oral corticosteroids. Settings: 47 ambulatory asthma care centres globally. Primary outcome measures: Change in FEV1 at week 24. Participants: 311 were screened, 160 were randomised and 129 completed the study. Interventions: 7 intravenous infusions of either 400 mg KB003 or placebo at baseline and weeks 2, 4, 8, 12, 16 and 20. Primary and secondary outcome measures: FEV1 at week 24, asthma control, exacerbation rates and safety in all participants as well as prespecified subgroups. Main results: In the KB003 treated group, FEV1 at week 24 improved to 118 mL compared with 54 mL in the placebo group (p=0.224). However, FEV1 improved to 253 vs 26 mL at week 24 (p=0.02) in eosinophilic asthmatics (defined as >300 peripheral blood eosinophils/mL at baseline) and comparable improvements were seen at weeks 20 (p=0.034) and 24 (p=0.077) in patients with FEV1 reversibility .20% at baseline and at weeks 4 ( p=0.029), 16 (p=0.018) and 20 (p=0.006) in patients with prebronchodilator FEV1 .50% predicted at baseline. There were no effects on asthma control or exacerbation rates. The most frequent adverse events in the KB003 group were rhinosinusitis and headache. There was no significant difference in antidrug antibody response between placebo and treated groups. There were no excess infections or changes in biomarkers known to be associated with the development of pulmonary alveolar proteinosis. Conclusions: Higher doses and/or further asthma phenotyping may be required in future studies with KB003. Trial registration number: NCT01603277; Results.
Mohan J.C.,Fortis Hospital |
Jain R.,Glenmark Pharmaceuticals |
Chamle V.,Glenmark Pharmaceuticals |
Bhargava A.,Glenmark Pharmaceuticals
Journal of Clinical and Diagnostic Research | Year: 2015
Objective: To assess the short term safety and tolerability of a fixed dose combination (FDC) of olmesartan, amlodipine and hydrochlorothiazide (OAH) in real-world clinical setting in India. Materials and Methods: Physicians were requested to provide eight weeks observational clinical event data of the patients prescribed with FDC of Olmesartan (20/40mg), Amlodipine (5mg) and hydrochlorothiazide (12.5mg) in the prescription event monitoring (PEM) forms. Data on patients’ demographics, indication for FDC, concomitant medication and other relevant history was also collected and was analysed with descriptive statistics. Results: Two hundred thirty eight physicians provided data of 4763 patients. Mean age of the population was 55±7 years and males were 59.3%. The commonest indication for the FDC was uncontrolled hypertension (60.7%). Diabetes and dyslipidemia were present in 37.9% and 35.1% respectively.Concomitant medications included statins (42.3%), oral anti-diabetic (33.7%) and antiplatelet agents (24.7%). Pedal oedema (0.29%) was the most common adverse event (AE) reported followed by headache (0.16%), giddiness (0.15%), light headedness (0.15) and stroke (0.15%). Other less common (0.04%) reported AEs were tiredness, dizziness, gastritis, hypersomnia, hypoglycaemia, lower respiratory tract infection (LRTI), weakness, diarrhea, labyrinthitis, urinary tract infection, hyponatremia and hypotension.Occurrence of AEs was more common in patients with uncontrolled hypertension (60.74%). Conclusion: The FDC of olmesartan, amlodipine and hydrochlorothiazide prescribed most frequently for patients with uncontrolled hypertension and co-morbidities was found to be safe and well tolerated over a short period of observation. © 2015, Journal of Clinical and Diagnostic Research. All Rights Reserved.
Pukar M.M.,General Surgery |
Hajare A.L.,Glenmark Pharmaceuticals |
Krishnaprasad K.,Glenmark Pharmaceuticals |
Bhargava A.I.,Glenmark Pharmaceuticals
Journal of Clinical and Diagnostic Research | Year: 2014
Skin and soft tissue infections represent a continuum of symptoms that range from uncomplicated cellulitis to the potentially lethal entity necrotizing fasciitis that is often considered to be microbial invasions of the epidermis, dermis and subcutaneous tissues. Garenoxacin, a newer oral des-fluoroquinolone having potent antimicrobial activity against wide variety of common pathogens involved in skin and skin structure infections (SSTIs), including the resistant strains offer the advantage of broad spectrum of coverage including gram positive, gram negative and anaerobic organisms. This case study indicates the utility of garenoxacin in treating skin and soft tissue infections caused by road traffic accidents.