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Standard dose compared with low dose proton pump inhibitor Author Esophagitis Grade (Grading Criteria) purchase v-gel 30 gm line lotus herbals quincenourish review, or Number Screened buy generic v-gel 30 gm earthsong herbals, Eligible, Enrolled, Year other measures of symptom severity Withdrawn, Lost to Followup, Analyzed Study duration Results Mine Los Angeles classification of reflux NR/NR/43/NR/NR/43 16 weeks No step vs Step down1 vs Step 2005 esophagitis was used for evaluation. Standard dose compared with low dose proton pump inhibitor Author Withdrawals Due to Year Adverse Events Funding source Mine NR NR 2005 Proton pump inhibitors Page 238 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 13. Standard dose compared with low dose proton pump inhibitor Intervention treatment Comparison treatment Author strategy (drug, dose, strategy (drug, dose, Baseline demographics Year duration) duration) (age, sex, race/ethnicity) Eligibility criteria Morgan Rabeprazole 20mg/day Rabeprazole 20mg/day for 4 Mean age: 48 years Male and females aged 25-65 2007 (COT) weeks than 20mg on-demand 48% male years, with > 3 months history (ODT) 96% Caucasian of GERD, with hearburn as the predominant symptom, on continuous PPI therapy > 1 month with adequeate heartburn control and < 3 days of hearburn with < 1 episode rated as moderate and hearburn rated satisfactorily or completely controlled during the last week of the acute phase. Proton pump inhibitors Page 239 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 13. Standard dose compared with low dose proton pump inhibitor Author Esophagitis Grade (Grading Criteria), or Number Screened, Eligible, Enrolled, Year other measures of symptom severity Withdrawn, Lost to Followup, Analyzed Study duration Results Morgan Daily diary of symptom severity NR/331/268/26/8/234 6 months COT vs ODT 2007 Quality of life questionnaire Heartburn free days: 90% vs 65% (p<0. Standard dose compared with low dose proton pump inhibitor Author Withdrawals Due to Year Adverse Events Funding source Morgan 7 patients reported 9 Janssen-Ortho Inc 2007 events No significant difference between groups COT vs ODT Sinusitis: <3% vs 6. Standard dose compared with low dose proton pump inhibitor Intervention treatment Comparison treatment Author strategy (drug, dose, strategy (drug, dose, Baseline demographics Year duration) duration) (age, sex, race/ethnicity) Eligibility criteria Scholten Pantoprazole 20mg/day on- Pantoprazole 40mg/day on- Mean age: 52. Proton pump inhibitors Page 242 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 13. Standard dose compared with low dose proton pump inhibitor Author Esophagitis Grade (Grading Criteria), or Number Screened, Eligible, Enrolled, Year other measures of symptom severity Withdrawn, Lost to Followup, Analyzed Study duration Results Scholten Patient diary 634/548/548/NR/NR/543 24 weeks P20 vs P40 vs Pla 2005 Perceived average symptom load: 2. Standard dose compared with low dose proton pump inhibitor Author Withdrawals Due to Year Adverse Events Funding source Scholten 36% reported AEs ALTANA Pharma AG, 2005 Only 5% were deemed Konstanz, Germany related to drug Proton pump inhibitors Page 244 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 13. Standard dose compared with low dose proton pump inhibitor Intervention treatment Comparison treatment Author strategy (drug, dose, strategy (drug, dose, Baseline demographics Year duration) duration) (age, sex, race/ethnicity) Eligibility criteria Sjöstedt Esomeprazole 20mg/day Esomeprazole 20mg/day on- Mean age: 55 years (range: Patients > 18 years, with 2005 demand 20-87 years) erosive reflux oesophagitis of 61% male LA grades A-D, history of Ethnicity: NR hearburn episodes over > 6 months and > 4 days with hearburn episodes during the week prior to visit 1. Proton pump inhibitors Page 245 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 13. Standard dose compared with low dose proton pump inhibitor Author Esophagitis Grade (Grading Criteria), or Number Screened, Eligible, Enrolled, Year other measures of symptom severity Withdrawn, Lost to Followup, Analyzed Study duration Results Sjöstedt Endoscopic remission NR/539/477/107/NR/370 6 months Daily vs On-demand 2005 In remission at 6 months: 81% vs 58% Symptomatic relapses: 12 (5%) vs 13 (5. Standard dose compared with low dose proton pump inhibitor Author Withdrawals Due to Year Adverse Events Funding source Sjöstedt Daily vs On-demand NR, but 2005 Nasopharyngitis: 1. Standard dose compared with low dose proton pump inhibitor Intervention treatment Comparison treatment Author strategy (drug, dose, strategy (drug, dose, Baseline demographics Year duration) duration) (age, sex, race/ethnicity) Eligibility criteria Annibale Omeprazole 20mg/day Ranitidine 150mg/day Mean age: 49 years Patients aged 18-75 years 1998 64% males with eroseive or ulcerative Ethnicity: NR esophagitis, grade 2 or 3. Proton pump inhibitors Page 248 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 13. Standard dose compared with low dose proton pump inhibitor Author Esophagitis Grade (Grading Criteria), or Number Screened, Eligible, Enrolled, Year other measures of symptom severity Withdrawn, Lost to Followup, Analyzed Study duration Results Annibale Macrosopic appearance of the esophageal 231/223/217/18/13/217 6 months O20 vs R150 1998 mucosa was scored from 0 to 4 according to the following scale: Overall symptom remision at 6 0=normal esophageal mucosa; months 1=erythema or diffusely red mucosa, Abstent: 54. Standard dose compared with low dose proton pump inhibitor Author Withdrawals Due to Year Adverse Events Funding source Annibale 4 patients reported AEs Schering-Plough 1998 (loss of libido, headache, itching, and leg erythema) Proton pump inhibitors Page 250 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 13. Standard dose compared with low dose proton pump inhibitor Intervention treatment Comparison treatment Author strategy (drug, dose, strategy (drug, dose, Baseline demographics Year duration) duration) (age, sex, race/ethnicity) Eligibility criteria Houcke Lansoprazole 30mg every Lansoprazole 15mg/day Mean age: 55. Proton pump inhibitors Page 251 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 13. Standard dose compared with low dose proton pump inhibitor Author Esophagitis Grade (Grading Criteria), or Number Screened, Eligible, Enrolled, Year other measures of symptom severity Withdrawn, Lost to Followup, Analyzed Study duration Results Houcke Endoscopi relapse of oesophagitis was NR/NR/52/10/5/52 6 months L30 vs L15 2000 primary outcome, defined by an oesophagitis greater than or equal to Endsoscopic relapse at 6 months: grade II or symptomatic relapse defined as 36% vs 25. An aggravation of hearburn and functional handicap was noted in L30 (p<0. Proton pump inhibitors Page 252 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 13. Standard dose compared with low dose proton pump inhibitor Author Withdrawals Due to Year Adverse Events Funding source Houcke 8 patients had 9 AEs NR 2000 (only 1 was noted to be related to study drug) Proton pump inhibitors Page 253 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 13. Standard dose compared with low dose proton pump inhibitor Intervention treatment Comparison treatment Author strategy (drug, dose, strategy (drug, dose, Baseline demographics Year duration) duration) (age, sex, race/ethnicity) Eligibility criteria Vakil Esomeprazole 40mg/day Esomeprazole 20mg/day or Mean age: 44. Standard dose compared with low dose proton pump inhibitor Author Withdrawals Due to Year Adverse Events Funding source Vakil E40 vs E20 vs E10 vs NR, but one author is 2001 Pla employee of AstraZeneca Patients with >1 AE: 31. Standard dose compared with low dose proton pump inhibitor Intervention treatment Comparison treatment Author strategy (drug, dose, strategy (drug, dose, Baseline demographics Year duration) duration) (age, sex, race/ethnicity) Eligibility criteria Talley Esomeprazole 40mg on- Esomeprazole 20mg on- Mean age: 48. Proton pump inhibitors Page 257 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 13.

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These organizations selected the topic of the report and had input into its Key Questions purchase v-gel 30gm without prescription herbs not to mix. The content and conclusions of the report were entirely determined by the Evidence-based Practice Center researchers order 30gm v-gel erbs palsy. The authors of this report have no financial interest in any company that makes or distributes the products reviewed in this report. Second-generation antidepressants 7 of 190 Final Update 5 Report Drug Effectiveness Review Project INTRODUCTION A. Overview Axis I psychiatric disorders such as depressive disorder, anxiety disorder, adjustment disorder, and premenstrual disorders are serious disabling illnesses. Combined, they affect approximately 2 one in five Americans. Major depressive disorder (MDD) is the most prevalent, affecting more 3 than 16 percent (lifetime) of US adults. In 2000, the economic burden of depressive disorders 4 was estimated to be $83. More than 30 percent of these costs were attributable to direct medical expenses. Pharmacotherapy dominates the medical management of Axis I psychiatric disease. Before the late 1980s, pharmacologic treatment was limited to tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs) (with the exception of premenstrual disorder, which historically was untreated). TCAs and MAOIs sometimes are referred to as traditional or first- generation antidepressants. These drugs are often accompanied by multiple side effects that many patients find intolerable; e. Thus, first-generation antidepressants are no longer agents of choice in many circumstances. Newer treatments include selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), and other second-generation drugs. The first of the second-generation drugs was introduced to the US market in 1985, when bupropion was approved for the treatment of major depressive disorders. In 1987, the US Food and Drug Administration (FDA) approved the first SSRI, fluoxetine. Since then, five other SSRIs have been introduced: sertraline (1991), paroxetine (1992), citalopram (1999), fluvoxamine (2000), and escitalopram (2002). The SNRIs were first introduced to the market in 1993 with the approval of venlafaxine. In 1994, nefazodone, which is essentially an SSRI with additional 5- hydroxytryptamine-2 (5-HT2) and 5-hydroxytryptamine-3 (5-HT3) antagonist properties, was FDA-approved. Mirtazapine, a drug that acts centrally on adrenergic autoreceptors, was added to 5 the therapeutic arsenal in 1996. Duloxetine, a selective serotonin and norepinephrine reuptake inhibitor (SSNRI), was approved for the treatment of MDD and diabetic peripheral neuropathic pain in 2004. The latest second-generation antidepressant approved for the treatment of MDD in adults was desvenlafaxine, an SNRI, which was FDA-approved in 2008. Desvenlafaxine is the major active metabolite of venlafaxine XR, which will lose patent protection in 2010. The mechanism of action of most second-generation antidepressants is only poorly understood. In general, these drugs work through their effect on prominent neurotransmitters in the central nervous system. The SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline) act by selectively inhibiting the reuptake of serotonin (5-hydroxy- tryptamine, 5-HT) at the presynaptic neuronal membrane. The SNRIs (desvenlafaine, venlafaxine) are potent inhibitors of serotonin and norepinephrine reuptake and weak inhibitors of dopamine reuptake. Mirtazapine, sometimes characterized as an SNRI, is believed to enhance central noradrenergic and serotonergic activity as a 5-HT2 and 5-HT3 receptor antagonist. Nefazodone is believed to inhibit neuronal uptake of serotonin and norepineprhine. Bupropion is a relatively weak inhibitor of the neuronal uptake of norepinephrine, serotonin, and dopamine. Second-generation antidepressants 8 of 190 Final Update 5 Report Drug Effectiveness Review Project Preclinical studies of duloxetine suggest that it is a potent inhibitor of neuronal serotonin and norepinephrine reuptake and a less potent inhibitor of dopamine reuptake.

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