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Strategies to eradicate CAR-expressing T cells using construct contained CD137 (41BB) and a different anti-CD19 scFv suicide vectors are being tested as one approach to preventing such was used super levitra 80 mg with amex leading causes erectile dysfunction. The first patient achieved an MRD-negative complete long-term toxicity effective super levitra 80mg for erectile dysfunction which doctor to consult, but no results are available thus far using this remission that has been maintained for 1 year buy super levitra 80mg otc impotence trials france, whereas the approach buy super levitra 80 mg on line impotence natural. Suicide vectors have also been proposed as a means to second patient (who had previously been treated with CD19- prevent acute toxicity such as cytokine release syndrome, although directed therapy comprising blinatumomab) had a transient re- it remains unclear whether one can retain potent antitumor effects if sponse but relapsed after 2 months with CD19-negative disease. The the cells are induced to undergo apoptosis early after administration. National Cancer Institute (NCI) also reported significant antileuke- mia effects in children with refractory ALL using a CD19-CAR 41 One of the primary challenges in treating acute leukemia compared containing the CD28-costimulatory domain. Therefore, 3 separate with chronic leukemias and lymphomas is the rapid pace of ALL clinical groups have observed impressive antileukemia effects using progression, particularly when patients are treated with large disease 3 different CD19-CAR constructs in patients with refractory B-cell burdens. The achievement of complete responses in such patients, ALL. Nonetheless, if the acute regimens, which mediate antitumor effects for only as long as the inflammatory toxicity associated with CD19-CAR therapy can be antibody remains present in the host, CD19-CAR T cells undergo prevented by treating patients with lower disease burdens, one could dramatic expansion after infusion in response to CD19 antigen consider incorporating such therapy earlier in the course of disease, expressed on malignant and nonmalignant cells. Genetically modi- at which time minimal disease could be eradicated with limited fied CAR-expressing T cells can also persist for several months or inflammatory toxicity. An additional potential issue that has been even years. Indeed, transduction important consideration in B-ALL, in which CNS relapse is a efficiencies appear to be lower in T cells collected from B-ALL substantial risk. Genetic alterations One could potentially address this issue by harvesting T cells earlier activating kinase and cytokine receptor signaling in high-risk in the disease process and cryopreserving them for potential use in acute lymphoblastic leukemia. CD19 targeting of protocols for heavily pretreated patients. Finally, it remains to be chronic lymphocytic leukemia with a novel Fc-domain- seen whether antileukemic effects induce by CAR therapy in engineered monoclonal antibody. This is a central issue to consider in ALL, for which the T-cell-engaging antibody blinatumomab of chemotherapy- allo-HSCT has clearly been established as a potential curative refractory minimal residual disease in B-lineage acute lympho- option for patients able who achieve an MRD-negative remission, blastic leukemia patients results in high response rate and who have adequate organ function, and for whom an acceptable prolonged leukemia-free survival. At the same time, allo-HSCT has substantial 2493-2498. Anti-CD22 to a point where it could abrogate the need for allo-HSCT would immunotoxin RFB4(dsFv)-PE38 (BL22) for CD22-positive represent a true advance in the treatment of ALL. Future studies will hematologic malignancies of childhood: preclinical studies and no doubt seek to combine CAR-based therapies, both for acute phase I clinical trial. A novel anti-CD22 checkpoint inhibitors as a means to further augment the potency of immunotoxin, moxetumomab pasudotox (HA22, CAT-8015): this new class of therapeutics. American Society for Blood and Marrow Conflict-of-interest disclosure: C. Kahlon KS, Brown C, Cooper LJ, Raubitschek A, Forman SJ, financial interests. Specific recognition and killing of glioblastoma multiforme by interleukin 13-zetakine redirected cytolytic Correspondence T cells. Crystal Mackall, Center for Cancer Research, NCI, Building 10 - 15. Chimeric NK-receptor- Hatfield CRC, Room 1W-3750, Bethesda, MD 20892; Phone: bearing T cells mediate antitumor immunotherapy. Expression of immunoglobulin-T- References cell receptor chimeric molecules as functional receptors with 1. Outcomes in older adults signal transduction pathways. Specific activation international MRC UKALL XII/ECOG2993 trial. Br J Haema- and targeting of cytotoxic lymphocytes through chimeric single tol. Chemoimmunotherapy or zeta subunits of the immunoglobulin and T-cell receptors. Maher J, Brentjens RJ, Gunset G, Riviere I, Sadelain M. T-lymphocyte cytotoxicity and proliferation directed by a 2010;28(24):3880-3889. CD28 costimulation lymphoblastic leukemia: the GRAALL-2003 study. J Clin provided through a CD19-specific chimeric antigen receptor Oncol. T cells eradicate systemic acute lymphoblastic leukemia xeno- 6. Improved early improves expansion and persistence of chimeric antigen recep- event-free survival with imatinib in Philadelphia chromosome- tor-modified T cells in lymphoma patients. Genetic resistance to JAK2 containing CD137 signal transduction domains mediate en- enzymatic inhibitors is overcome by HSP90 inhibition. J Exp hanced survival of T cells and increased antileukemic efficacy Med. Terakura S, Yamamoto TN, Gardner RA, Turtle CJ, Jensen established tumor xenografts with genetically retargeted human MC, Riddell SR. Generation of CD19-chimeric antigen recep- T cells containing CD28 and CD137 domains. Proc Natl Acad tor modified CD8 T cells derived from virus-specific central SciUSA. IL-7 and IL-15 instruct metastatic melanoma using genetically engineered GD2- the generation of human memory stem T cells from naive specific T cells. Eradication of human primary T cells with chimeric receptors: costimulation B-lineage cells and regression of lymphoma in a patient treated from CD28, inducible costimulator, CD134, and CD137 in with autologous T cells genetically engineered to recognize series with signals from the TCR zeta chain. Anti-CD22-chimeric antigen antigen receptor-modified T cells in chronic lymphoid leuke- receptors targeting B-cell precursor acute lymphoblastic leuke- mia. Chimeric antigen depletion and remissions of malignancy along with cytokine- receptor-modified T cells for acute lymphoid leukemia. N Engl associated toxicity in a clinical trial of anti-CD19 chimeric- J Med. Chmielewski M, Hombach A, Heuser C, Adams GP, Abken H. T cell activation by antibody-like immunoreceptors: increase in 39. Safety and persistence of affinity of the single-chain fragment domain above threshold adoptively transferred autologous CD19-targeted T cells in does not increase T cell activation against antigen-positive patients with relapsed or chemotherapy refractory B-cell leuke- target cells but decreases selectivity. CD19-targeted T cells of CD22-specific chimeric TCR is modulated by target epitope rapidly induce molecular remissions in adults with chemo- distance from the cell membrane.
Mirtazapine compared with paroxetine 89 A fair trial randomized 255 elderly participants for eight weeks buy super levitra 80mg mastercard erectile dysfunction drug related. Mirtazapine and paroxetine were equally effective in reducing HAM-D scores at the endpoint cheap super levitra 80 mg without a prescription erectile dysfunction treated by, but mirtazapine lead to a faster response buy super levitra 80mg lowest price erectile dysfunction doctor in mumbai. A Kaplan-Meier analysis showed a significantly faster time to response for mirtazapine (mean 26 days compared with mean 40 days for paroxetine; P=0 super levitra 80 mg for sale erectile dysfunction young age causes. No significant difference in response rates on the CGI scale was noted. Significantly more mirtazapine-treated patients reported weight gain (P<0. Paroxetine- treated patients reported a significantly higher rate of nausea, tremor, and flatulence (P<0. Venlafaxine compared with citalopram A fair European 6-month study compared venlafaxine ER (37. No statistical differences in any outcome measures (MADRS< CGI-S, CGI-I) could be detected at study endpoint. The remission rates were 19 percent for venlafaxine and 23 percent for citalopram. Both treatment groups reached a 93 percent response rate. Second-generation antidepressants 91 of 190 Final Update 5 Report Drug Effectiveness Review Project Venlafaxine compared with fluoxetine One fair trial compared venlafaxine IR (37. Both treatment groups experienced a significant reduction in HAM-D total scores at 8 weeks; however, there were no significant differences between groups in HAM-D, MADRS, or CGI scores at endpoint. Remission rates at 8 weeks were 27 percent for venlafaxine and 20 percent for fluoxetine. Venlafaxine-treated patients experienced significantly higher rates of nausea (45% compared with 23%), dry mouth (23% compared with 6%) and constipation (22% compared with 10%); P<0. Venlafaxine compared with sertraline One study determined efficacy and safety of venlafaxine (25-100 mg/d) compared to sertraline 293 (18. We graded the quality of this study as poor for efficacy because of high loss to follow-up (44. The investigators reported a significantly higher rate of withdrawal among venlafaxine- than sertraline-treated patients (63% compared with 24%). In addition, venlafaxine-treated patients had a significantly higher rate of severe adverse events (P=0. Venlafaxine compared with SSRIs A pooled data analysis combined original data from eight comparable, double-blind, active- 294, 295 controlled, randomized trials. A primary objective of this analysis was to determine differences in response and remission based on sex and age. This study was not based on a systematic literature search, so results must be viewed cautiously. For venlafaxine-treated 295 patients, neither age (< 50 or > 50 years of age) nor sex affected remission rates. Among patients treated with SSRIs, however, a significant interaction was observed between treatment and sex (P=0. Remission rates for older women treated with venlafaxine (48%) were higher than remission rates for older women treated with SSRIs (28%, P=0. Hormone replacement therapy appeared to eliminate these differences. Additional analyses of age subgroups (< 40, 41- 54, 55-64, and > 65 years of age) and sex subgroups revealed that no significant age-by- treatment, sex-by-treatment, or age-by-sex-by-treatment interactions occurred. Men and women of different ages within each treatment group had similar rates of remission, response, and 294 absence of depressed mood. Among patients over 40 years of age, the rates of adverse events were similar between the treatment groups, although venlafaxine-treated patients aged 55 to 64 years reported significantly more nausea than placebo (P<0. Bupropion compared with paroxetine One fair RCT examined the efficacy of bupropion SR (100-300 mg/d) and paroxetine (10-40 111, 112 mg/d) in 100 outpatients ages 60 years or older (range 60-88 years) over 6 weeks. The majority of patients were white (bupropion SR, 98%; paroxetine, 90%), female (bupropion SR, Second-generation antidepressants 92 of 190 Final Update 5 Report Drug Effectiveness Review Project 54%; paroxetine, 60%), and did not use antidepressants for the current episode before enrollment (bupropion SR, 83%; paroxetine, 88%). The overall loss to follow-up was 16 percent with no significant difference between treatment groups. Efficacy according to any outcome measure did not differ significantly between treatment groups. Response rates (≥ 50% reduction in HAM-D scores) were similar in both groups (bupropion SR, 71%; paroxetine, 77%). Quality-of-life scales (QLDS, SF-36) showed statistically significant improvements in both treatment groups from baseline to endpoint (P<0. Ethnicity No studies directly compared the efficacy, effectiveness and harms of second-generation antidepressants among different races or ethnicities. Therefore, we summarize results of studies that compared second-generation antidepressants with placebo. Duloxetine compared with placebo Two pooled analyses of seven placebo-controlled duloxetine trials assessed the efficacy and 296 297 tolerability of duloxetine in Hispanic and African American patients compared to Caucasian patients. The first analysis included 1,342 Caucasians and 120 Hispanics and found no difference 296 in efficacy outcomes for Hispanics and Caucasians. There were no significant differences between groups in discontinuation rates due to adverse events ir in the types or occurrence of specific adverse events. The second analysis of 1,300 Caucasians and 123 African Americans also found no evidence for a differential effect of duloxetine in African-American and Caucasian 297 patients in efficacy or safety outcomes. Fluoxetine compared with placebo An RCT examined ethnic differences in response to antidepressant treatment among depressed 298 HIV-positive patients. A total of 118 patients were randomized to either fluoxetine (20-80 mg/d) or placebo for 8 weeks. Of all participants, 67 percent were White, 19 percent Black, and 14 percent Latino; only 1. Loss to follow-up was significantly greater among Latinos (53%) than among Blacks (14%) and Whites (28%; P<0. Ethnicity was not associated with the total number of treatment emergent side effects or dosage. Among completers within the active-treatment group, Whites were more likely to respond to treatment than the other two groups (84% compared with 50% in Blacks and 67% in Latinos). Among completers in the placebo group, Latinos were more likely to show treatment response (80%) than were blacks (36%) or whites (43%). However, a statistical analysis of these findings was not possible because of the low number of Latinos who completed the study. Paroxetine compared with placebo A pooled analysis of 104 paroxetine trials (14,875 patients) detected slightly lower response rates 299 for Hispanics and Asians than for Blacks and Whites. Citalopram One study that did not meet our inclusion criteria performed a secondary analysis of data from the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study to compare 300 remission and response rates among Blacks, Whites, and Hispanics with nonpsychotic MDD. Second-generation antidepressants 93 of 190 Final Update 5 Report Drug Effectiveness Review Project We briefly describe it here because because of the paucity of evidence on this topic. STAR*D included outpatients in 23 psychiatric and 18 primary care centers.
Comparison of efficacy and safety of atorvastatin (10mg) with simvastatin (10mg) at six weeks safe super levitra 80 mg erectile dysfunction and smoking. Comparison of fluvastatin versus pravastatin treatment of primary hypercholesterolemia trusted super levitra 80 mg erectile dysfunction 10. Comparative dose efficacy study of atorvastatin versus simvastatin super levitra 80mg on line erectile dysfunction melanoma, pravastatin discount 80 mg super levitra overnight delivery young healthy erectile dysfunction, lovastatin, and fluvastatin in patients with hypercholesterolemia (the CURVES study). Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR* Trial). Hemostatic effects of atorvastatin versus simvastatin. Statins Page 87 of 128 Final Report Update 5 Drug Effectiveness Review Project 58. Comparison of efficacy and safety of atorvastatin and simvastatin in patients with dyslepidemia with and without coronary heart disease. Comparison of effects of simvastatin versus atorvastatin on high density lipoprotein cholesterol and apolipoprotein A I levels. Efficacy and tolerability of simvastatin 20 mg vs pravastatin 20 mg in patients with primary hypercholesterolemia. Efficacy and tolerability of simvastatin and pravastatin in patients with primary hypercholesterolemia (multicountry comparative study). Treating hypercholesterolaemia with HMG CoA reductase inhibitors a direct comparison of simvastatin and pravastatin. Lucasko P, Walters EJ, Cullen EI, Niecestro R, Friedhoff LT. Efficacy of once-daily extended-release lovastatin compared to immediate-release lovastatin in patients with cholesterolemia. Malini PL, Ambrosioni E, De Divitiis O, Di Somma S, Rosiello G, Trimarco B. Simvastatin versus pravastatin efficacy and tolerability in patients with primary hypercholesterolemia. Marz W, Wollschlager H, Klein G, Neiss A, Wehling M. Safety of low density lipoprotein cholestrol reduction with atorvastatin versus simvastatin in a coronary heart disease population (the TARGET TANGIBLE trial). Comparison of the short term efficacy and tolerability of lovastatin and pravastatin in the management of primary hypercholesterolemia. Meeting national cholesterol education goals in clinical practice a comparison of lovastatin and fluvastatin in primary prevention. A 52-week, multicenter, randomized, parallel- group, double-blind, double-dummy study to assess the efficacy of atorvastatin and simvastatin in reaching low-density lipoprotein cholesterol and triglyceride targets: The Treat-to-Target (3T) Study. Effects of rosuvastatin and atorvastatin compared over 52 weeks of treatment in patients with hypercholesterolemia. Double blind comparison of the efficacy and tolerability of simvastatin and fluvastatin in patients with primary hypercholesterolaemia. Paoletti R, Fahmy M, Mahla G, Mizan J, Southworth H. Rosuvastatin demonstrates greater reduction of low-density lipoprotein cholesterol compared with pravastatin and simvastatin in hypercholesterolaemic patients: a randomized, double-blind study. Comparison of the efficacy and tolerability of simvastatin and atorvastatin in the treatment of hypercholesterolemia. Statins Page 88 of 128 Final Report Update 5 Drug Effectiveness Review Project 73. Time as a variable with niacin extended-release/lovastatin vs. Comparison of efficacy and safety of rosuvastatin versus atorvastatin in African-American patients in a six-week trial. The DISCOVERY PENTA study: a DIrect Statin COmparison of LDL-C Value--an Evaluation of Rosuvastatin therapY compared with atorvastatin. Jukema JW, Liem A-H, Dunselman PHJM, van der Sloot JAP, Lok DJA, Zwinderman AH. LDL-C/HDL-C ratio in subjects with cardiovascular disease and a low HDL-C: results of the RADAR (Rosuvastatin and Atorvastatin in different Dosages And Reverse cholesterol transport) study. The beneficial effects of lipid-lowering drugs beyond lipid-lowering effects: a comparative study with pravastatin, atorvastatin, and fenofibrate in patients with type IIa and type IIb hyperlipidemia. Wolffenbuttel BHR, Franken AAM, Vincent HH, Dutch Corall Study G. Cholesterol- lowering effects of rosuvastatin compared with atorvastatin in patients with type 2 diabetes -- CORALL study. Effects of switching statins on achievement of lipid goals: Measuring Effective Reductions in Cholesterol Using Rosuvastatin Therapy (MERCURY I) study. Comparison of the effect of lipophilic and hydrophilic statins on serum adiponectin levels in patients with mild hypertension and dyslipidemia: Kinki Adiponectin Interventional (KAI) Study. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta- analysis. A comparative study of atorvastatin and simvastatin as monotherapy for mixed hyperlipidaemia in Type 2 diabetic patients. Effect of short term treatment with simvastatin and atorvastatin on lipids and paraoxonase activity in patients with hyperlipoproteinaemia. Comparisons of effects of statins (atorvastatin, fluvastatin, lovastatin, pravastatin, and simvastatin) on fasting and postprandial lipoproteins in patients with coronary heart disease versus control subjects. Bots A, Kastelein J, on behalf of the Dutch DISCOVERY study group. Achieving lipid goals in real life: the Dutch DISCOVERY study. Statins Page 89 of 128 Final Report Update 5 Drug Effectiveness Review Project 87. Achieving low-density lipoprotein cholesterol goals in high-risk patients in managed care: comparison of rosuvastatin, atorvastatin, and simvastatin in the SOLAR trial. Additional efficacy of milligram-equivalent doses of atorvastatin over simvastatin. Wolffenbuttel BH, Mahla G, Muller D, Pentrup A, Black DM. Efficacy and safety of a new cholesterol synthesis inhibitor, atorvastatin, in comparison with simvastatin and pravastatin, in subjects with hypercholesterolemia. Effects of statin treatment on uric acid homeostasis in patients with primary hyperlipidemia. Qu H-Y, Xiao Y-W, Jiang G-H, Wang Z-Y, Zhang Y, Zhang M. Effect of atorvastatin versus rosuvastatin on levels of serum lipids, inflammatory markers and adiponectin in patients with hypercholesterolemia.
Supported by 2004 investigator-initiated R generic super levitra 80 mg online erectile dysfunction drugs in homeopathy, OL discount super levitra 80mg online erectile dysfunction doctor in kuwait, MC 80 mg super levitra overnight delivery erectile dysfunction treatment in kuala lumpur, ITT research contracts from crossover design Parke-Davis/Pfeixer generic super levitra 80 mg on line antihypertensive that causes erectile dysfunction, and Otsuka America 196 patients studied: 99 Pharmaceuticals, Inc. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Wolffenbuttel et al. Men and women 18-70 years with Patients not eligible when they used lipid-lowering drugs after visit 1, 4-week dietary run-in then randomized to: 1998 LDL-c 160-240 mg/dl. Statins Page 75 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Wolffenbuttel et al. ADEs were similar between groups and no serious ADEs or withdrawal from 1998 LDL-c reduction from baseline: groups as a result of ADEs were reported. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Wolffenbuttel et al. Supported by Parke- 1998 Davis; one author R, OL, MC. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Fluvastatin vs. Mean baseline LDL-c 187 mg/dl Davidson et al, 2003 Men and women >20 years with TG Patients with myocardial infarction, coronary bypass surgery, or Fluva 20 or 40 mg qd or lova 10, 20, or 40 R, DB, MC, PC, level < 4. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Berger et al. Withdrawals due to AEs: R, OL, MC, ITT LDL-c reduction from baseline: 8 fulva vs. HDL-c increase from baseline at 6 weeks (NS): fulva 20 mg: 3. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Berger et al. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Nash 1996 Men or women previously 363 patients screened, 137 patients randomized. Mean baseline LDL-c Not reported Statins Page 81 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Nash 1996 Efficacy analysis for 137 patients. R, OL, MC, ITT LDL-c reduction from baseline at 8 weeks: fulva: men and women 26% Musculoskeletal abnormalities existed significantly more often as a 137 patients randomized lova: men 29%, women 26% (NS) background medical condition in the lova group. No lova: men 7%, women 4% details on what dose of fulva patients experienced these ADEs. Trigs reduction from baseline at 8 weeks: fulva: men 14%, women 10% lova: men 12%, women 20% Achieved LDL-c goal (<160 mg/dl) at 4 weeks: fulva: 85% lova: 91% (NS) Achieved LDL-c goal (<160 mg/dl) at 8 weeks: fulva: 89% lova: 91% (NS) Statins Page 82 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Nash 1996 Funded by Sandoz R, OL, MC, ITT Pharmaceuticals. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Fluvastatin vs. Analysis included both on treatment and intention to 6-week dietary/placebo run-in phase then, R, DB, MC, both ITT and LDL>160 mg/dl and trigs <400 treat population. Severe forms of hypercholesterolemia and those randomization to: on treatment analysis mg/dl with impaired renal function were excluded. No details provided on fulva 40 mg qd or numbers and reasons for excluding patients. Statins Page 84 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Jacotot et al. No patient R, DB, MC, both ITT and LDL-c reduction from baseline at 16 weeks: withdrew due to myopathic complaints or liver ADEs. More GI ADEs in fulva on treatment analysis fulva 40 mg bid: 29. No patient experienced clinically significant elevation in ALT, AST or parva 40 mg qd: 26. Trigs reduction from baseline at 16 weeks: Fluvastatin 40 mg bid ≈ pravastatin 40 mg qd. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Jacotot et al. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Fluvastatin vs. Simvastatin Bevilacqua M, et al Men and women with T2DM, Surgery, myocardial infarction, angioplasty in last 6 months, poorly 4 week dietary run-in; fluvastatin extended- 2005 triglycerides > 2. Analysis for LDL-c reduction did not include 4-week dietary/placebo run-in, then R, DB, MC, ITT less and a total cholesterol >250 17 patients due to missing or inappropriately done labs. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Bevilacqua M, et al LDL-c change from baseline at 8 weeks: No severe AEs reported, Data = NR 2005 fulva -51% vs. Number of patients reporting ADEs similar across all groups. GI ADEs were R, DB, MC, ITT LDL-c reduction from baseline at 6 weeks: more frequent in fulva vs. HDL-c increase from baseline at 6 weeks: Fluvastatin 40 mg qd = simvastatin 10 mg qd for NCEP goal reached. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Bevilacqua M, et al NR 2005 RCT, OL, SC, ITT 94 patients randomized (n = fulva 48, simva 46) 8 weeks Ose et al. R, DB, MC, ITT 432 patients randomized 6 weeks Statins Page 89 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Schulte et al. Active 4-week dietary run-in phase and R, DB LDL-c >185 mg/dl and trigs <300 liver or gallbladder disease, elevated aminotransferases or other randomized to: mg/dl. Patients with concomitant conditions such as myocardial infarction or 8-week dietary and 2 week-placebo run-in R, DB, MC, not ITT CVA within the past 6 months, planned angioplasty or coronary phase, then randomized to: Mean baseline LDL-c bypass surgery during the previous 6 months, unstable angina, fulva 20 mg qd or 113 patients randomized 185-187 mg/dl cardiac or renal failure, hepatic disease, uncontrolled hypertension, simva 20 mg qd 16 weeks partial ileal bypass, secondary hypercholesterolemia, or for 16 weeks. Statins Page 90 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Schulte et al. One patient in each group had R, DB LDL-c reduction from baseline at 4 and 10 weeks: elevations in AST or ALT >3x ULN. No clinically significant increase in CK was fulva 40 mg: 23. HDL-c increase from baseline at 4 and 10 weeks: Fluvastatin 80 mg qd = simvastatin 40 mg qd. ADEs similar between groups, with a trend to more GI ADEs in the fulva vs.
