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Background: Disc replacement arthroplasty previously has been shown to be an effective alternative to spine fusion for the treatment of single-level lumbar degenerative disc disease. The purpose of the present study was to determine the twenty-four-month results of a clinical trial of the ProDisc-L total disc replacement as compared with spinal fusion for the treatment of degenerative disc disease at two contiguous vertebral levels from L3 to S1.Methods: A total of 237 patients were treated in a randomized controlled trial designed as a non-inferiority study for regulatory application purposes. Blocked randomization was performed with use of a 2:1 ratio of total disc arthroplasty to circumferential arthrodesis. Evaluations, including patient self-assessments, physical and neurological examinations, and radiographic examinations, were performed preoperatively, six weeks postoperatively, and three, six, twelve, eighteen, and twenty-four months postoperatively.Results: At twenty-four months, 58.8% (eighty-seven) of 148 patients in the total disc replacement group were classified as a statistical success, compared with 47.8% (thirty-two) of sixty-seven patients in the arthrodesis group; non-inferiority was demonstrated. The mean Oswestry Disability Index in both groups significantly improved from baseline (p < 0.0001); the mean percentage improvement for the total disc replacement group was significantly better than that for the arthrodesis group (p = 0.0282). An established clinical criterion for success, a ≥15-point improvement in the Oswestry Disability Index from baseline, occurred in 73.2% (109) of 149 patients in the total disc replacement group and 59.7% (thirty-seven) of sixty-two patients in the arthrodesis group. The Short Form-36 physical component scores were significantly better for the total disc replacement group as compared with the arthrodesis group (p = 0.0141 at twenty-four months). Visual analog scale scores for satisfaction significantly favored total disc replacement from three to twenty-four months. At twenty-four months, 78.2% (111) of 142 patients in the total disc replacement group and 62.1% (thirty-six) of fifty-eight patients in the arthrodesis group responded "yes" when asked if they would have the same surgery again. Lumbar spine range of motion on radiographs averaged 7.8° at the superior disc and 6.2° at the inferior disc in patients with total disc replacement. Reduction in narcotics usage significantly favored the total disc replacement group at twenty-four months after surgery (p = 0.0020).Conclusions: Despite the relatively short duration of follow-up and design limitations, the present study suggests that two-level lumbar disc arthroplasty is an alternative to and offers clinical advantages in terms of pain relief and functional recovery in comparison with arthrodesis. Longer-term follow-up is needed to determine the risks for implant wear and/or degenerative segment changes. [ABSTRACT FROM AUTHOR]

Objective: The objective of the study was to evaluate the endometrial safety of a 10 microg estradiol vaginal tablet in the treatment of vaginal atrophy in postmenopausal women. Methods: A total of 336 healthy, non-hysterectomized, postmenopausal women (age 59.5 +/- 6.16 years, 9.4 +/- 5.9 years from last menses) were treated with a 10 microg estradiol vaginal tablet for 12 months (once daily for 2 weeks and then twice weekly for 50 weeks). Endometrial histology was analyzed at baseline and at the end of the trial. Results: Of the 336 enrolled subjects, 292 (86.9%) completed the 52-week study. All 336 subjects received an endometrial biopsy at baseline, and 283 had biopsy results at week 52, when 258 out of the 283 biopsy samples were classified as 'atrophic' or 'inactive' endometrium. There were 21 with 'no tissue' despite a repeat biopsy attempt to obtain endometrial tissue, one had insufficient tissue with endometrial thickness >4 mm, one was 'weakly proliferative' and two revealed polyps. No cases of endometrial hyperplasia or endometrial cancer were reported. The mean endometrial thickness decreased from 2.04 mm (n = 334) from study start to 1.94 mm (n = 293) after 52 weeks, and the estradiol levels remained at the low postmenopausal level. Conclusions: After 12 months of treatment with the 10 microg estradiol vaginal tablet, there was no suggestion of endometrial stimulation and no cases of endometrial hyperplasia or cancer reported. This study provides reassuring data on the endometrial safety of treatment with the 10 microg estradiol vaginal tablet for 1 year in a large group of postmenopausal, non-hysterectomized women with vaginal atrophy. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The purpose of this meta-analysis was to compare outcomes for AngioJet thrombectomy versus percutaneous coronary intervention (PCI) without thrombectomy in acute myocardial infarction (AMI) patients. BACKGROUND: PCI is the preferred treatment for revascularizing the infarct-related artery in patients with AMI. There is controversy about the benefits of thrombectomy as an adjunct to PCI. METHODS: AMI studies published between January 1, 1999, and March 1, 2007, were used to compare AngioJet thrombectomy plus PCI to PCI alone. Bayesian meta-analytic estimates were used to estimate the odds ratios (95% CI) for short-term mortality, major adverse cardiac events (MACE), and final TIMI 3 flow. RESULTS: The AngioJet data included 11 studies and 1,018 patients. The PCI data included 81 studies and 24,076 patients. The AngioJet group included more patients with large thrombus burden, rescue PCI after failed thrombolytic therapy, and longer symptom duration compared to the PCI group. Despite the higher risk profile of AngioJet patients, the groups had similar odds of short-term mortality, 0.98 (0.53, 1.50), MACE, 1.25 (0.54, 2.40), and final TIMI 3 flow, 1.12 (0.70, 2.27). CONCLUSION: AngioJet thrombectomy results in clinical and angiographic outcomes that are similar to PCI in lower risk AMI patients. These observations suggest that AngioJet thrombectomy may reduce the additional risk associated with visible thrombus in the infarct-related lesion. [ABSTRACT FROM AUTHOR]

The influence of diet and genetics was investigated in a healthy white person who had distinctly low methylprednisolone clearance. Pharmacokinetic and pharmacodynamic parameter values were similar on 2 occasions during the consumption of a low-carbohydrate diet and a Weight Watchers diet, indicating that the decreased clearance was unlikely attributable to a change in diet composition. Although the subject was found to be homozygous for CYP3A5*3, genetic findings were not significant for a number of other CYP3A4 and CYP3A5 allelic variants. Because of the high prevalence of CYP3A5*3/*3 in whites and because 5 of 7 white control subjects are also homozygous for CYP3A5*3, this genotype cannot fully explain the reduced metabolism of the drug. Other genetic or contributing factors might have been involved. New polymerase chain reaction-based genotyping methods for functionally defective CYP3A5*6, *8, *9, and *10 alleles were developed in this study. These assays will be useful for CYP3A5 genotype analysis in future clinical studies. [ABSTRACT FROM AUTHOR]