Background/Aims: Oral EDP-514 is a potent core protein inhibitor of hepatitis B virus (HBV) replication, which produced a >4-log viral load reduction in HBV-infected chimeric mice with human liver cells. This study evaluated the safety, pharmacokinetics, and antiviral activity of three doses of EDP-514 in treatment-naive viremic patients with HBeAgpositive or -negative chronic HBV infection. Methods: Patients with HBsAg detectable at screening and at least 6 months previously were eligible. HBeAg-positive and -negative patients had a serum/plasma HBV DNA level ≥20,000 and ≥2,000 IU/mL, respectively. Twenty-five patients were randomized to EDP-514 200 (n=6), 400 (n=6) or 800 mg (n=7) or placebo (n=6) once daily for 28 days. Results: A dose-related increase in EDP-514 exposure (AUClast and Cmax) was observed across doses. At Day 28, mean reductions in HBV DNA were –2.9, –3.3, –3.5 and –0.2 log10 IU/mL with EDP-514 200 mg, 400 mg, 800 mg, and placebo groups, respectively. The corresponding mean change from baseline for HBV RNA levels was –2.9, –2.4, –2.0, and –0.02 log10 U/mL. No virologic failures were observed. No clinically meaningful changes from baseline were observed for HBsAg, HBeAg or HBcrAg. Nine patients reported treatment emergent adverse events of mild or moderate severity with no discontinuations, serious AEs or deaths. Conclusions In treatment-naïve viremic patients, oral EDP-514 was generally safe and well-tolerated, displayed PK profile supportive of once-daily dosing, and markedly reduced HBV DNA and HBV RNA.

OBJECTIVE: This study aims to determine the prevalence of low bone mass density (BMD) among premenopausal women with type 2 Diabetes Mellitus, the factors associated with low BMD and the relationships between BMD in association to the duration of DM, the type of physical activity and calcium intake of the patient.METHODOLOGY: This prospective study involved 33 patients seen at the Fatima Medical Center - OPD on October 2004. Bone mass density was determined using the dual-energy x-ray absorptiometry (DEXA scan). Relationship associations were computed using Chi square.RESULTS: Mean age was 49.55 yrs, mean weight 59.00 kg, mean height 1.56 m and mean duration of DM was 3.58 yrs. Only 27 percent of the subjects have low BMD. Majority (64 percent) have normal body mass index (BMI). As to the duration of DM, nine (27 percent) were newly diagnosed with less than one year duration, 45 percent had diabetes for 1-5 years. Most of the subjects (73 percent) are classified with moderate physical activity. As to their calcium intake, fifteen (45 percent) were not taking any calcium supplement, twelve (36 percent) in less than once a week calcium, and six (18 percent) more than once a week.CONCLUSION: There is minor prevalence (27 percent) of low BMD among the premenopausal type 2 diabetics. Factors associated with low bone mass density (age, BMI) had no significant association in this study. (Author)
Diabetes Mellitus ; Diabetes Mellitus, Type 2 ; Prospective Studies ; Absorptiometry, Photon

Objective To asses the effects of Gamma nail and DHS/Richard (dynamic hip screw) in the treatment of proximal femoral fractures. Methods A meta analysis of all the relevant randomized controlled trials (RCTs) was performed. We included randomized and quasi randomized controlled trials in patients with proximal femoral fracture to compare Gamma nail and DHS/Richard. Results First we identified 88 papers on comparison of Gamma nail and DHS/Richard in the treatment of proximal femoral fractures published from 1969 to 2003. 7 trials involving 1256 patients were identified as meeting all the eligibility criteria. 3 investigators independently graded study quality and abstracted relevant data, including information on mortality rates, wound infection, function, revision in patients with a proximal femoral fracture. 4 trials, which included a total of 621 patients, provided detailed information on mortality rates over the first 6 postoperative months. We found there was no significant difference in the relative risk of death in the first 6 months postoperative between treatments of Gamma nail and those of compression hip screw (relative risk 1.17;P=0.51). 6 trials that included a total of 1083 patients provided data on operative complications. The risk of operative complications from Gamma nail fixation appeared to be higher than that from compression screw and side plate fixation but not higher than that from compression hip screw (relative risk 1.41; P=0.02). We also found an obvious increase in the relative risk of fracture of femoral shaft between Gamma nail and compression hip screw (relative risk 6.99; P=0.00). Patients treated with Gamma nail had a higher rate of revision compared with those with compression hip screw, but there was no significant difference between the two groups (relative risk 1.85; P=0.20). In addition, wound infection, operative blood loss and functional recovery were similar between the tow groups(relative risk 0.98 for wound infection and 1.02 for function). Operating time for Gamma nail patients was significantly less than that for DHS/Richard ones (P