Aims
To assess efficacy and safety of omeprazole in laryngitis due to laryngopharyngeal reflux disease (LPRD).
Materials and methods
It was a prospective, randomized, open label study conducted in 90 patients with laryngitis due to LPRD. Group A (n = 45) received omeprazole and advice about life style modification, group B (n = 45) received only advice about life style modification. Reflux symptom index (RSI), reflux finding score (RFS), quality of life (QoL) and voice handicap index (VHI) were evaluated at 0, 4 and 8 weeks.
Results
P ercentage r eduction i n R SI a nd R FS w as s ignificantly higher in group A after 8 weeks (37 vs 29%, 18 vs 13% respectively). Excess throat mucus, clearing of throat and erythema of posterior larynx improved considerably in group A compared to group B.
Conclusion
Omeprazole could be a significant addition to life style modification in LPRD patients particularly for signs and symptoms, such as excess throat mucus, clearing of throat and erythema of posterior larynx.
How to cite this article
Doshi K, Varghese A, Badyal DK. Evaluation of Omeprazole in the Treatment of Laryngopharyngeal Reflux Disease: A Single Center, Prospective and Randomized Study. Int J Otorhinolaryngol Clin 2015;7(2):45-50.
BackgroundPemetrexed-platinum doublet therapy is a standard treatment for stage IIIb/IV nonsquamous non small cell lung cancer (NSCLC). While the regimen is associated with several grade ≥3 toxicities, hyponatremia is not a commonly reported adverse effect. Here we report an unusually high incidence of grade ≥3 hyponatremia in Indian patients receiving pemetrexed-platinum doublet, and the pharmacological basis for this phenomenon.MethodsForty-six patients with advanced NSCLC were enrolled for a bioequivalence study of two pemetrexed formulations. All patients received the pemetrexed-platinum doublet for six cycles followed by single-agent pemetrexed maintenance until progression. Pharmacokinetic blood samples were collected at predefined time points during the first cycle and the concentration-time profile of pemetrexed was investigated by noncompartmental analysis. Hyponatremic episodes were investigated with serum electrolytes, serum osmolality, urinary sodium, and urine osmolality.ResultsSixteen of 46 patients (35%) had at least one episode of grade ≥3 hyponatremia. Twenty-four episodes of grade ≥3 hyponatremia were observed in 200 cycles of doublet chemotherapy. Plasma exposure to pemetrexed was significantly higher in patients with high-grade hyponatremia than in those with low-grade or no hyponatremia (P=0.063 and P=0.001, respectively). Pemetrexed clearance in high-grade hyponatremia was quite low compared with normal and low-grade hyponatremia (P=0.001 and P=0.055, respectively). Median pemetrexed exposure in this cohort was much higher than that reported in the literature from Western studies.ConclusionHigher exposure to pemetrexed is associated with grade ≥3 hyponatremia. The pharmacogenetic basis for higher exposure to pemetrexed in Indian patients needs further investigation.
Pretreatment serum sodium level is an important prognostic marker in Stage IIIb/IV NSCLC patients. The simple possibility of testing coupled with low cost makes it an attractive biomarker.
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