Randomized trial results

Randomized trial results are mixed when candidates for second-line therapy are treated with combinations of antiandrogens plus either LHRH... 

Schneeweiss S, Patrick AR, Stunner T, Brookhart MA, Avom J et al. 2007. Increasing levels of restriction in pharmacoepidemiologic database studies of elderly and comparison with randomized trial results. Med. Care 45 S131-S142. 

Several clinical trials have been conducted with streptokinase adrninistered either intravenously or by direct infusion into a catheterized coronary artery. The results from 33 randomized trials conducted between 1959 and 1984 have been examined (75), and show a significant decrease in mortaUty rate (15.4%) in enzyme-treated patients vs matched controls (19.2%). These results correlate well with an ItaUan study encompassing 11,806 patients (76), in which the overall reduction in mortaUty was 19% in the streptokinase-treated group, ie, 1.5 million units adrninistered intravenously, compared with placebo-treated controls. The trial also shows that a delay in the initiation of treatment over six hours after the onset of symptoms nullifies any benefit from this type of thrombolytic therapy. Conversely, patients treated within one hour from the onset of symptoms had a remarkable decrease in mortaUty (47%). The benefits of streptokinase therapy, especially in the latter group of patients, was stiU evident in a one-year foUow-up (77). In addition to reducing mortahty rate, there was an improvement in left ventricular function and a reduction in the size of infarction. Thus early treatment with streptokinase is essential. 

Elewski B, Fleischer AB, Pariser DM (2003) A comparison of 15% topical azelaic acid gel and 0.75% metronidazole gel in the topical treatment of papu-lopustular facial rosacea results of a randomized trial. Arch Dermatol 139 1444-1450... 

Failure of extracranial-intracranial arterial bypass to reduce the risk of ischemic stroke. Results of an international randomized trial. The EC/IC Bypass Study Group. N Engl J Med 1985 313 1191-1200. 

Collins R., Scrimgeour A., Yusuf S Peto R. Reduction in fatal pulmonary embolism and venous thrombosis by perioperative administration of subcutaneous heparin Overview of results of randomized trials in general, orthopedic, and urologic surgery. N Engl J Med 1988 318, 1162-73. 

The most important evidence is probably offered by a recent double-blind, randomized trial which showed a better therapeutic effect of rifaximin in comparison to tetracycline in a cohort of SIBO syndrome patients [42] in particular, rifaximin administration produced a significant reduction of breath hydrogen levels in fasting conditions, peak of hydrogen excretion and cumulative breath hydrogen excretion after an oral dose of 50 g of glucose (fig. 1). Normalization of the test results was evident in 70% of the sample studied. 

Brownson P, Jenkins SA, Nott D, Ellenbogen S Mechanical bowel preparation before colorectal surgery Results of a prospective randomized trial. Br J Surg 1992 79 461-462. 

Barrett-Connor E, Grady D, Sashegyi A, Anderson PW, Cox DA, Hoszowski K, et al. (2002) Raloxifene and cardiovascular events in osteoporotic postmenopausal women Four-year results from the MORE (Multiple Outcomes of Raloxifene Evaluation) randomized trial. J Am Med Assoc 287 847-857... 

Osborne CK, Pippen J, Jones SE, Parker LM, Ellis M, Come S, Gertler SZ, May JT, Burton G, Dimery I, et al. (2002) Double-blind, randomized trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy results of a North American trial. J Clin Oncol 20 3386-3395... 

Cummings SR, Eckert S, Krueger KA, Grady D, Powles TJ, Cauley JA, Norton L, Nickelsen T, Bjarnason NH, Morrow M, Lippman ME, Black D, Glusman JE, Costa A, Jordan VC (1999) The effect of raloxifene on risk of breast cancer in postmenopausal women results from the MORE randomized trial. Multiple Outcomes of Raloxifene Evaluation. J Am Med Assoc 281 2189-2197... 

Neven P, Lunde T, Benedetti-Panicini P, et al. (2000) A multicentre randomized trial to compare the uterine effects of raloxifene(evista) with a continuous combined hormone replacement therapy (kliogest) results from Euralox I. Gynecol Endocrinol 14(2) 77... 

Liposomal doxorubicin also received initial approval on the basis of response rafe in patients with refractory cancer followed up with a randomized trial of the agent vs. topotecan. The alkylating agent temozolomide was approved in a Phase 11 trial for treatment of patients with anaplastic astrocytoma. Of note is that, although not yet filed for full approval, temozolomide has been recently added on to radiation therapy (e.g., a major trial of radiation therapy with or without temozolomide) for patients with glioblastoma multiforme. The result of this trial showed a major improvement in survival for patients treated with the radiation plus temozolomide vs. those treated with radiation therapy alone (median survival 15 vs. 12 months, p < 0.0001 and 1 year survival 26 vs. 8%, p < 0.0001).25... 

A new malaria vaccine, RTS, S/AS02D, from GSK has shown very promising results in a Phase I/IIb double-blind randomized trial of 214 infants in Mozambique. For children in the -A year-old age group, the most vulnerable group, the vaccine not only lowered the chances of infection by 65% over 3 months but also reduced episodes of clinical malaria by 35% in 6 months. 

Based on the design of the trial protocol, statistics are used to calculate the number of people to be recruited for the trial, how the trial should be randomized (Exhibit 6.12), and finally analysis of the data. Statistics provide a nonbiased means to evaluate the trial results. 

Refer to Section 6.4.7 and Exhibit 6.12 to explain randomization and the techniques used. Randomization and double-blinding are necessary to prevent bias in data collection so that statistical analysis based on normal distribution can be used to evaluate the trial results. 

Conversion from metformin IR to ER-A randomized trial s results suggest that patients receiving metformin IR may be safely switched to metformin ER once daily at the same total daily dose, up to 2,000 mg once/day. Following a switch, closely monitor glycemic control and make dosage adjustments accordingly. 

Bartehnk H, Roelofsen F, Eschwege F, et al. Concomitant radiotherapy and chemotherapy is superior to radiotherapy alone in the treatment of locally advanced anal cancer results of a phase III randomized trial of the European Organization for Research and Treatment of Cancer Radiotherapy and Gastrointestinal Cooperative Groups. J Clin Oncol 1997 15 2040-2049. 

The results of the intergroup trial compound the concept of radiosensitization, since a lower dose of radiation in the combined-modality group improved local control compared with the radiation-alone group. The chemotherapy also decreased the risk of micrometastasis. Despite the better outcome with chemoradiotherapy, the overall prognosis of these patients remains poor. No randomized trials comparing chemoradiotherapy with esophagectomy have been performed it seems that chemoradiotherapy provides a reasonable alternative to esophagectomy in selected patients. 

The Scandinavian Glioblastoma Study Group reported the results of a prospective randomized trial for patients with grades II-IV supratentorial astrocytoma to evaluate the results of radiation therapy and combined chemoradiation treatment in the postoperative setting (4). One hundred eighteen patients were randomized to one of three groups ... 

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