An Open label, Prospective, Multi-Center, Observational Study to Evaluate the Lipid Lowering Efficacy and Safety of Rosuvastatin in Indian Dyslipidemics in Routine Clinical Practice.

Altered cholesterol levels in the blood or dyslipidemia is a major modifiable risk factor for CVD and is closely associated with the pathophysiology of CVD. Asians, particularly Indians, have a unique pattern of dyslipidemia; with lower HDL cholesterol, increased triglyceride levels and higher proportion of small dense LDL cholesterol, with characteristic centripetal obesity. ‘Statins’ belong to the group of 3-hydroxy-3-methylglutaryl Coenzyme A reductase inhibitors that have been shown to reduce levels of total and LDL cholesterol. Study Objective: To evaluate the lipid lowering efficacy and safety of Rosuvastatin in Indian dyslipidemics in routine clinical practice by measuring the percent change in Total Cholesterol, LDL, TG and HDL over a period of 16 weeks. Methodology : This was a multicentric, open-labeled, post-marketing surveillance study. A committee of key opinion leaders was formed. A total of 1200 doctors were approached of whom 800 provided us with subject data. Each participating doctor was given case report forms and requested to recruit patients according to the inclusion and exclusion criteria. Lipid profile of each recruited patient was done before initiating therapy and at the end of 4 months. Rosuvastatin was given at a dose of either 5mg/ 10mg OD for 4 months. Results : A total of 11, 656 subjects were recruited into this study out of which 10, 410 complete case report forms were considered (n=10410). The study included 65% males and 35% females. Majority of the subjects were in the age group of 46-55years (35.2%) and 56-65 years (29.4%). In this study, the total cholesterol (TC), LDL-C, Triglycerides (TG) has significantly decreased by 46.13%, 53.74% and 41.93% respectively. Also the HDLC levels increased by 26.84%, thereby, indicating a significant change in the levels of all the dyslipidemic indicators. With the reported number of adverse events (n=4) related to Rosuvastatin, it is evident that the drug is safe and tolerable. There were no significant changes observed in the liver and renal function tests with Rosuvastatin reiterating their safety. Conclusion : Rosuvastatin has shown greater efficacy in lowering LDL cholesterol and non-HDL-cholesterol concentrations. It has been shown to enable more patients to reach their LDL cholesterol goals and to do so with an acceptable safety profile.

Tamsulosin and spontaneous expulsion of ureteral stones

ureteral stones have a high rate of spontaneous expulsion, especially when they are smaller than 6 mm. some medications including corticosteroids, Ca channel blockers and alpha-blocker have been used by some to enhance spontaneous stone passage. In this paper we evaluate the effect of Tamsulosin in spontaneous stone passage in a clinical trial study. We performed clinical trial study of 100 renal colic patients with lower ureteral stones and stone size less than 7 mm determined by CT scan, KUB or ultrasonography of UVJ region who didn't have UTI, intractable pain or any indications of immediate intervention during January 2006 and April 2007.50 of the patients got only standard regime of analgesics and 50 of them got standard regime and Tamsulosin [0.4 mg/d]. The stone expulsion rate was 60% [30/50 patients] for group A and 86% [43/50] for group B [P=0.01] with a mean expulsion time of 8.1 +/- 2.2 [range 3.5-12] and 5.1 +/- 2.7 days [range 1.8-10.5] [P=0.005]. Tamsulosin increase spontaneous stone passage and decrease expulsion time and analgesic use significantly

[Effects of tamsolusin on serum testosterone and gonadotropins concentration in adult male rats]

Tamsulosin hydrochloride [HCl] is an alpha-1 adrenoceptor antagonist and its ability to inhibit alpha-1 adrenoceptor is more than alpha-2 adrenoceptor. Due to the important therapeutic role of Tamsulosin HCl in benign prostatic hyperplasia [BPH], its side effects on the endocrine axes are also very important. The aim of the present research was to determine the effect of Tamsulosin HCl on serum level of testosterone and gonadotropins, and also on the spermatogengsis in adult male rats. In this experimental study, 40 adult male Wistar rats were randomly divided into 5 groups of 8. The experimental groups received 100, 300, and 600 mg/kg/day of Tamsulosin for 28 days. The sham group were treated with distilled water and the control group received nothing. The blood samples were taken on day 28 and the blood concentration of LH, FSH and testosterone were measured by RIA. Simulataneously, the testes of all rats were removed to assess the possible histological changes. The results were analysed using ANOVA and Duncan tests. The level of significance was considered at p