Gastroesophageal Reflux Disease Associated With Anxiety: Efficacy and Safety of Fixed Dose Combination of Amitriptyline and Pantoprazole.

BACKGROUND: The aim of the study was to evaluate the efficacy and tolerability of fixed dose combination of amitriptyline and pantoprazole in gastroesophageal reflux disease (GERD) associated with anxiety. METHODS: A non-randomized, open-labeled, non-comparative, multi-center study was conducted in a total of 99 patients (77 men and 22 women, mean age 44.16 ± 11.53 years). Each patient was administered a fixed dose combination of amitriptyline 10 mg and pantoprazole 40 mg once a day, for 4 weeks. GERD questionnaire, hospital anxiety and depression score (HADS) and SF-8 questionnaire (short-form health survey) were performed at baseline and at the end of study as assessment tools. RESULTS: At the end of study, data were extractable only in 96 patients because three patients were dropped out due to loss of follow-up at week 4. GERD symptoms and anxiety score reduced significantly (P < 0.0001) at week 4 compared to baseline. SF-8 score also improved significantly (P < 0.0001) at week 4. There were no adverse events reported. CONCLUSION: Amitriptyline and pantoprazole combination was found to be effective and safe for management in GERD patients with coexisting anxiety.

Evaluation of efficacy and tolerability of fixed dose combination of ofloxacin with ornidazole infusion (infusion O2) in the management of diarrhoea and dysentery.

Acute diarrhoea in adults is one of the most commonly encountered medical emergency in general practice and is responsible for considerable morbidity around the world. To evaluate the efficacy and tolerability of fixed dose combination of ofloxacin with ornidazole infusion (infusion O2) in the management of diarrhoea and dysentery, a study was carried out among 290 patients, age group from 18 to 65 years suffering from diarrhoea, dysentery, gastro-enteritis. Study drug infusion O2, (Medley Pharmaceutical, Mumbai) containing ofloxacin 200 mg + ornidazole 500 mg was administrated twice daily for a duration of 5 days. Number of soft or watery stool, body temperature, nausea, abdominal pain, gas and flatulence were recorded at baseline and at the end of the study. Tolerability and efficacy was evaluated based on the global assessment by the investigator based on a 3-point scale marked as excellent/good/poor. Two hundred and fifty-six-patients (160 male and 96 female) were included for final analysis, 34 patients lost to follow-up. Mean number of watery stool per day was reduced from 9.273 +/- 0.4537 to 1.375 +/- 0.07001 (p < 0.0001) by infusion O2. Body temperature was significantly reduced from 38.055 +/- 0.045 degrees C to 36.778 +/- 0.016 degrees C (p < 0.0001) at the end of the study. Pretreatment symptom nausea was significantly reduced in 90.34% of patients. Improvement in vomiting symptoms was reported in 72.35% of patients after administration of anti-emetic drug; 96.84% and 77.25% of patients reported improvement in abdominal pain and gas/flatulence respectively at the end of the trial by infusion O2. As per investigators' assessment about efficacy of trial drug, 98.43% of patients reported good to excellent and 1.56% reported poor efficacy. As per investigators' assessment about tolerability 98.43% of patients reported good to excellent and 1.17% reported poor tolerability. Minor incidences of nausea, gastritis, metallic taste were reported in 7.42%, 7.14%, and 5.85% of patients respectively. No serious adverse events were reported which led to withdrawal of patient from the study. Result of this study shows that, combination of ofloxacin with ornidazole infusion (infusion O2) significantly reduces number of watery stool and associated symptoms like nausea, abdominal pain, flatulence/gas with excellent tolerability.

Evaluation of efficacy and tolerability of RB Tone forte tablet in the treatment of pregnancy anaemia.

In India < 90% of anaemia cases are estimated to be due to iron deficiency, because high iron requirements during pregnancy are not easily fulfilled by dietary intake. Ferrous ascorbate is widely prescribed iron salt in India but still no trial of ferrous ascorbate in Indian patients has been published. The study is to aim the evaluation of efficacy and tolerability of RB Tone forte tablet in the treatment of pregnancy anaemia. Fifty-five pregnant women (> 18 years) with haemoglobin value between 8 and 11 g/dl in 13th week of pregnancy were included in the study. The duration of study was 6 months. Study drug RB Tone forte tablet, (Medley pharmaceutical, Mumbai) containing ferrous ascorbate equivalent to elemental iron 100 mg + folic acid 1.5 mg + elemental zinc 22.5 mg was prescribed once daily to all pregnant women from 13th week of pregnancy for a duration of 6 months. Haemoglobin was assessed at the beginning of the therapy and at the end of the trial. Study included birth weight and gestational age as outcomes because of a need for more information on the functional consequences of iron supplementation during pregnancy. Tolerability was evaluated based on the global assessment by the investigator and patients on a 3-point scale marked as excellent/good/poor. Fifty patients were included for final analysis, 5 patients lost to follow-up. Haemoglobin levels increased from the mean baseline value of 8.950 +/- 0.1422 g/dl to 11.91 +/- 0.07840 g/dl, with mean increase of 2.964 +/- 0.1624 g/dl at the end of trial (p < 0.0001). Mean birth weight of infants (n = 50) was found to be 3079 +/- 25.10 g. Mean gestational age at the time of delivery was 38 weeks. No preterm delivery was reported, As per investigators assessment about tolerability of trial drug, 48% of patients reported good, 46% excellent and 6% reported poor tolerability. As per patient's assessment about tolerability 92% of patients reported good to excellent tolerability and 8% reported poor tolerability. All patients reported excellent gastro-intestinal tolerability of study drug. Positive effect on pregnancy outcome like gestational age and birth weight is mainly attributed to vasodilating property of ferrous ascorbate and beneficial effect of zinc. Ferrous ascorbate must be preferred as first choice of oral iron salt due to positive effect on haemoglobin value, vasodilating property and superior tolerability.

Managing dyslipidaemia: evolving role of combination therapy.

Dyslipidaemia is one of the most important modifiable risk factors for coronary disease. Despite the availability of highly effective lipid-modifying agents, many patients still do not reach lipid targets established by national guidelines. This, in turn, has prompted a resurgence of the search for drugs and algorithms that favourably affect the lipid profile. The preventive efforts made so far have demonstrated that lowering low density lipoprotein-cholestrol is one action that individuals and populations can do with significant success in delaying the onset of clinical events, but at the same time one should not neglect high density lipoprotein and triglyceride levels as they also play a significant role in the risk of developing complications. Combination regimens should be considered for use in patients who fail to meet target values and are compliant with their current therapy. Although the use of combination therapy varies considerably across the globe, this treatment strategy is becoming increasingly more common as treatment guidelines recommend more aggressive therapy in order to achieve lower target cholesterol goals.

Evaluation of safety and efficacy of telmisartan-amlodipine combination in treating hypertension.

The objective of this open, non-comparative, prospective postmarketing surveillance (PMS) study was to identify, validate and quantify the safety and efficacy associated with the use of fixed dose combination (FDC) of telmisartan 40 mg + amlodipine 5 mg (T40+A5) in hypertensive patients with or without concomitant diabetes. The data was collected from 72 centres from all over India during the period of June 2007 to February 2008. A total of 251 patients of either sex and those who were newly diagnosed stage II hypertension, or those who were uncontrolled on monotherapy with or without diabetes mellitus were included in this study. Patients were prescribed with T40+A5 combination orally. Systolic BP (SBP), diastolic BP (DBP) and heart rate (HR) were measured at the start and at the end of 2, 4 and 8 weeks of treatment. Primary efficacy end points were reduction in clinical SBP/ DBP from baseline to study end and number of patients achieving JNC VII goals. Tolerability was assessed by treatment-emergent adverse events. Out of 251 patients, 208 patients had completed the study (120 males and 88 females), 42 were lost to follow-up the study and one patient was withdrawn due to adverse effects. The mean age of the patients was 54.5 +/- 0.98 years for males and 52.94 +/- 1.078 years for females. Diabetes mellitus was seen in 64.9% of cases, dyslipidaemia in 2.88%, previous IHD in 7.2% cases and chronic obstructive pulmonary disease (COPD) in 0.50% of cases. Reduction in the mean SBP was found to be 12.08%, 18.92% and 22.90% at the end of 2, 4 and 8 weeks respectively (p < 0.001). Reduction in the mean DBP was found to be 10.09%, 14.55% and 17.19% at the end of 2, 4 and 8 weeks respectively (p < 0.001). At the end of the study it was found that 86.3% of the hypertensive patients and 70% diabetic hypertensive patients achieved the JNC VII recommended goals. The overall incidence of ADRs was 7.69% with headache (1.92%) and vertigo (1.44%), as the commonest side-effect. According to physician's assessment of efficacy and tolerability 99.5% of total cases showed good to excellent response. In the treatment of stage II hypertensive patient the FDC of T40+A5 (Telar-AM) was found to be significantly effective in the reduction of SBP as well as DBP. Overall incidence of ADRs was lower and FDC of T40+A5 is well tolerated.

EVOLVE (nebivolol evaluation for efficacy and safety in the treatment of hypertension) postmarketing surveillance study.

The objective of EVOLVE [nebivolol (nevol) evaluation for efficacy and safety in the treatment of hypertension], a postmarketing surveillance (PMS) study is to identify, validate and quantify the safety and efficacy associated with the use of nebivolol. EVOLVE study was an open-label, non-comparative, prospective, one month follow-up study of 301 patients of either sex with stage 1 hypertension, as defined by the JNC VII guidelines. The data was collected from 27 centres from all over India during the period August, 2006 to December, 2006. Nebivolol (2.5-5 mg/day) was given for 1 month. Clinical assessment was done at the start of the treatment and at 15th day and 30th day follow-ups. Concomitant medications administered were also recorded. Baseline mean systolic blood pressure (SBP) was 157.73 +/- 14.16 mm Hg which dropped to 135.13 +/- 11.15 mm Hg at the end of the study. At the end of 1 month treatment the change in mean SBP was 22.6 mm Hg ie, 14.32% reduction from baseline which was statistically significant (p < 0.001). Also the baseline mean diastolic blood pressure (DBP) was 97.21 +/- 8.25 mm Hg that dropped to 83.69 +/- 6.63 mm Hg at the end of the study. At the end of one month treatment the change in mean DBP was 13.52 mmHg ie, 13.9% reduction from baseline which was significant (p < 0.001). The heart rate in this study showed a significant decrease from 86.13 +/- 9.35 at basal to 75.09 +/- 7.42 at the end of the study (p < 0.001). It was observed that at the end of one month of treatment, majority of the patients ie, 97.75% of total cases showed good to excellent response to nebivolol. EVOLVE PMS study showed that nebivolol hydrochloride is very safe and only 8.2% of cases (n = 22) reported adverse effects, the commonest being dizziness (3.28%). Less than 1% patients reported nausea, constipation, headache, weakness, tiredness and pedal oedema; 99.25% of patients reported good to excellent tolerability; 82.33% patients achieved the goals recommended by JNC VII. EVOLVE PMS study confirms the safety and efficacy of nebivolol hydrochloride in Indian population.