Abstract

Background: Empirical therapy with antisecretory agents like PPIs and H2RAs has long been the traditional approach in the initial management of uninvestigated dyspepsia.

Aim: The objective of the study was to examine relief of dyspepsia with lafutidine, a second-generation H2-RA, and rabeprazole and to compare their efficacy.

Methods: This was a randomized, open, comparative trial in adult uninvestigated dyspeptic patients, who had at least moderate severity of symptoms, defined as a score of ≥4 on a 7-point global overall symptom (GOS) scale, and were randomized to receive once daily either lafutidine 10 mg or rabeprazole 20 mg for 4 weeks.

Results: A total of 236 patients were enrolled, out of which 194 patients were included in the analysis. At the end of week 4, a significant difference was observed for symptom relief (lafutidine 89.90% versus rabeprazole 65.26%, P<.01) and symptom resolution (lafutidine 70.71% versus rabeprazole 25.26%, P<.01). Both the drugs were well tolerated.

Conclusion: Both lafutidine and rabeprazole provide symptom relief in patients with heartburn-dominant uninvestigated dyspepsia. The present study confirms the appropriateness of lafutidine as an empiric treatment and superior efficacy for primary care practice patients with dyspepsia.

ABSTRACT

Introduction: Hypertension, being a multi factorial disease, is well managed by using fixed dose combination of antihypertensive agents.

Aim: To assess the safety and clinical efficacy of the fixed dose combination of S(-)Amlodipine and Hydrochlorothiazide (ESLO-D) in patients with hypertension.

Materials & Methods: Seventy four practicing physi.zians throughout India collaborated in the recruitment of 145 hypertensive patients, over a period of eight months. These patients were administered fixed dose combination of 2.5mg S(-)Amlodipine and 12.5mg Hydrochlorothiazide (ESLO-D). They were observed for adverse events and changes in their blood pressure and heart rate over a period of four weeks.

Results: Significant decrease in systolic blood pressure, diastolic blood pressure and heart rate by a mean of 22.95 ± 11.77 mmHg, 12.57 ± 8.62 mmHg and 5.84 ± 6.69 beats/min respectively were observed after treatment with the fixed dose combination of S(-) Amlodipine and hydrochlorothiazide (ESLO-D) for 4 weeks. The JNC VII recommended target blood pressure goal of < 140/90 mmHg was achieved in 80% of the patients while 67.74% of them achieved the target heart rate goal of < 83 beats/min at the end of 4 weeks. The combination also decreased systolic blood pressure by 18% among patients with isolated systolic hypertension. The therapy was found to be well tolerated by the study population.

Conclusion: These findings provide further evidence of the role of fixed dose combination therapy with S(-)Amlodipine and hydrochlorothiazide (ESLO-D) in the management of hypertension, including isolated systolic hypertension.

Key words: Hypertension, S(-)Amlodipine, Hydrochlorothiazide, fixed dose combination, blood pressure

ABSTRACT

Background and Objective: Tolperisone hydrochloride is a centrally acting muscle relaxant that has been used for the symptomatic treatment of spasticity and muscle spasm. The present observational study was undertaken to assess the safety and efficacy of Tolperisone (Myotop-150) in Indian patients.

Settings and Design: An observational study involving 92 physicians across the various states of India, who prescribed Tolperisone (Myotop-150) to their patients.

Methods and Material: The demographic exposure and outcome data of the patients who were prescribed Myotop-150 (Tolperisone hydrochloride) were obtained from the completed case record forms which were received from the physicians. Adverse events which were observed during the therapy were recorded. Symptom severity was given a scoring on a 7-point Likert scale before and after the therapy.

Results: Data was collected for 165 patients, with a mean age of 43.88 ± (SD) 11.27 years [Range: 15 to 72 years]. At the baseline, the mean ± SD of the score on the 7-point Likert scale was 4.96 ± 1.01. After treatment with tolperisone, the mean score was 1.87 ± 0.91, with a significant reduction of 3.08 ± 1.14; p < 0.0001. After therapy, 42.04% of the patients reported “no problem”. In 88.02% of the patients who were treated, the physicians rated the treatment with tolperisone as excellent, very good or good. Side-effects were observed in 7.88% of the patients.

Conclusions: The present observational study demonstrates that the therapy with tolperisone is an effective and well- tolerated strategy in patients with diseases or conditions which are associated with spasticity or muscle spasm.