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Fair in quality to Lowering assess differences in clinical events between groups fluoxetine 10mg with mastercard women's health center jackson ms. CABG=coronary artery bypass graft; CVA=cerebrovascular accident; MI=myocardial infarction; MLD=minimal lumen diameter; PTCA=percutaneous transluminal coronary angioplasty Statins Page 253 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 4. Post-revascularization and miscellaneous trials Author Study Year Study Duration Mean Baseline Percent LDL-c Study Name Characteristics Patient Characteristics Intervention (mean) LDL-c Reduction Pitt B. Pravastatin Randomized, 1062 men or women 20- Pravastatin 20 mg qpm or 26 weeks 181 mg/dl (4. After 13 weeks, mmol/L) Group placebo-controlled, factors and a TC of 200- pravastatin could be 1993* intent to treat 300 mg/dl (5. CABG=coronary artery bypass graft; CVA=cerebrovascular accident; MI=myocardial infarction; MLD=minimal lumen diameter; PTCA=percutaneous transluminal coronary angioplasty Statins Page 254 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 4. Post-revascularization and miscellaneous trials Author Primary Endpoint Results Year (provided only if it is a clinical Other Clinical Study Name Primary Endpoint health outcome) Outcomes Measured Other Clinical Outcome Results Pitt B. Time to first ischemic Time to first ischemic event was longer in The Atorvastatin events: death from cardiac 37 (21%) of the angioplasty event. Events making up the majority of the trend in favor of atorvastatin: CABG and hospitalization for angina. Pravastatin Change in serum lipids (TC, N/A Reported clinical events Significantly more serious cardiovascular Multinational Study LDL-c, HDL-c, triglycerides) as part of safety events were reported in the placebo (13) vs. Group analysis, although pravastatin (1) groups 1993* cardiovascular events (p<0. CABG=coronary artery bypass graft; CVA=cerebrovascular accident; MI=myocardial infarction; MLD=minimal lumen diameter; PTCA=percutaneous transluminal coronary angioplasty Statins Page 255 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 4. Post-revascularization and miscellaneous trials Author Year Study Name Comments/Conclusions Pitt B. Approximately 70% of patients in the Revascularization angioplasty group received a statin. Mean LDL-c 119 Treatment mg/dl in angioplasty group vs. There was a trend in reduction in clinical events with atorvastatin vs. Poor in quality for assessment of differences in clinical events between groups. Pravastatin There was a significant reduction in serious Multinational Study cardiovascular events in the pravastatin vs. Fair in quality to assess differences in clinical 1993* events between groups (relatively short follow up period). CABG=coronary artery bypass graft; CVA=cerebrovascular accident; MI=myocardial infarction; MLD=minimal lumen diameter; PTCA=percutaneous transluminal coronary angioplasty Statins Page 256 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 4. Post-revascularization and miscellaneous trials Author Study Year Study Duration Mean Baseline Percent LDL-c Study Name Characteristics Patient Characteristics Intervention (mean) LDL-c Reduction Serruys PW. CABG=coronary artery bypass graft; CVA=cerebrovascular accident; MI=myocardial infarction; MLD=minimal lumen diameter; PTCA=percutaneous transluminal coronary angioplasty Statins Page 257 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 4. Post-revascularization and miscellaneous trials Author Primary Endpoint Results Year (provided only if it is a clinical Other Clinical Study Name Primary Endpoint health outcome) Outcomes Measured Other Clinical Outcome Results Serruys PW. When death and MI were Angiographic the loss of MLD during intervention. CABG=coronary artery bypass graft; CVA=cerebrovascular accident; MI=myocardial infarction; MLD=minimal lumen diameter; PTCA=percutaneous transluminal coronary angioplasty Statins Page 258 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 4. Post-revascularization and miscellaneous trials Author Year Study Name Comments/Conclusions Serruys PW. Angiographic placebo groups s/p successful balloon angioplasty. The Restenosis Trial composite of major clinical events which included (FLARE) death/MI/CABG/re-intervention was not different between groups (p=0. Fair-poor in quality for assessment of differences in clinical events between groups (relatively short follow up period, insufficiently powered). Adverse Lescol Intervention effects were not statistically different between groups. Prevention Study Fair-good in quality for assessment of differences in (LIPS) clinical events between groups (Number of diabetics was not equal between groups).
ACR 50 Good NA Indirect evidence none Low Indirect: 10 / placebo-controlled response: RR 0 buy 20mg fluoxetine visa women's health magazine 6 week boot camp. ACR 50 Good NA Indirect evidence none Low Indirect: 7 / ~ placebo-controlled response: RR 1. ACR 50 Good NA Indirect evidence none Low Indirect: 8 / ~ placebo-controlled response: RR 0. Indirect comparisons of Indirect: 10/~ 3000 Good Indirect evidence ACR 50 response: RR 0. ACR of placebo-controlled Good NA Indirect evidence 50 response: RR 0. ACR of placebo-controlled Good NA Indirect evidence 50 response: RR 0. ACR of placebo-controlled Good NA Indirect evidence 50 response: RR 0. ACR of placebo-controlled Good NA Indirect evidence none Low Indirect: 11 / ~ 50 response: RR 0. Evidence profile of comparisons of targeted immune modulators for the treatment of juvenile idiopathic arthritis Overall grade Number of Other modifying of the studies/patients Design Quality Consistency Directness Magnitude of effect factors evidence All comparisons Outcome: Health outcomes No evidence Outcome: Radiographic progression No evidence Outcome: Safety No evidence Targeted immune modulators 189 of 195 Final Update 3 Report Drug Effectiveness Review Project Table 3. Evidence profile of comparisons of targeted immune modulators for the treatment of ankylosing spondylitis in adults Number of studies/ Magnitude of Other modifying Overall grade of the patients Design Quality Consistency Directness effect factors evidence All comparisons Outcome: Health outcomes No evidence Outcome: Radiographic progression No evidence Table 4. Evidence profile of comparisons of targeted immune modulators for the treatment of psoriatic arthritis in adults Number of studies/ Magnitude of Other modifying Overall grade of the patients Design Quality Consistency Directness effect factors evidence Adalimumab compared with etanercept Outcome: Health outcomes ACR 20 RR (95% CI) MA with indirect Indirect: 1 0. Evidence profile of comparisons of targeted immune modulators for the treatment of psoriatic arthritis in children Other modifying Overall grade of the Number of studies/ patients Design Quality Consistency Directness Magnitude of effect factors evidence All comparisons Outcome: Health outcomes No evidence Table 6. Evidence profile of comparisons of targeted immune modulators for the treatment of Crohn’s disease in adults Other modifying Overall grade of the Number of studies/ patients Design Quality Consistency Directness Magnitude of effect factors evidence All comparisons Outcome: Health outcomes No evidence Targeted immune modulators 191 of 195 Final Update 3 Report Drug Effectiveness Review Project Table 7. Evidence profile of comparisons of targeted immune modulators for the treatment of Crohn’s disease in children Number of Studies/ Other modifying Overall grade of the Patients Design Quality Consistency Directness Magnitude of effect factors evidence All comparisons Outcome: Health outcomes No evidence Table 8. Evidence profile of comparisons of targeted immune modulators for the treatment of ulcerative colitis in adults Number of studies/ Other modifying Overall grade of the patients Design Quality Consistency Directness Magnitude of effect factors evidence All comparisons Outcome: Health outcomes No evidence Table 9. Evidence profile of comparisons of targeted immune modulators for the treatment of ulcerative colitis in children Number of studies/ Other modifying Overall grade of the patients Design Quality Consistency Directness Magnitude of effect factors evidence All comparisons Outcome: Health outcomes No evidence Targeted immune modulators 192 of 195 Final Update 3 Report Drug Effectiveness Review Project Table 10. Evidence profile of comparisons of targeted immune modulators for the treatment of plaque psoriasis (adults) Number of studies/ Other modifying Overall grade of the patients Design Quality Consistency Directness Magnitude of effect factors evidence Etanercept compared with ustekinumab Outcome: Health outcomes (PASI 75) RR 1. Evidence profile of comparisons of targeted immune modulators for the treatment of plaque psoriasis (children) Number of studies/ Other modifying Overall grade of the patients Design Quality Consistency Directness Magnitude of effect factors evidence All comparisons Outcome: Health outcomes No evidence Targeted immune modulators 193 of 195 Final Update 3 Report Drug Effectiveness Review Project Table 12. Evidence profile of comparisons of targeted immune modulators for adverse events in adults Number of Overall grade of studies/ patients Design Quality Consistency Directness Magnitude of effect the evidence Outcome: Serious Infections increased risk of tuberculosis with adalimumab compared with etanercept (adjusted incidence rate ratio 4. Ustekinumab Overall adverse events and withdrawals due to 1/903 RCT Moderate NA Direct adverse events similar: Injection-site reactions more Moderate frequent with etanercept than ustekinumab Etanercept vs. Adalimumab versus Infliximab Infliximab and etanercept resulted in higher rates of 1/100 RCT Moderate NA Direct adverse events than adalimumab (23%, 17%, 6%; Moderate p<0. Infliximab Abatacept resulted in lower rates of serious AEs (9. Evidence profile of comparisons of targeted immune modulators for adverse events in children Number of studies/ patients Design Quality Consistency Directness Magnitude of effect Other modifying factors Overall grade of the evidence All comparisons Outcome: Adverse events No direct evidence Table 14. Evidence profile of comparisons of targeted immune modulators for efficacy and harms in subgroups Number of studies/ patients Design Quality Consistency Directness Magnitude of effect Other modifying factors The content and conclusions of the review are entirely determined by the Evidence-based Practice Center researchers. The authors of this report have no financial interest in any company that makes or distributes the products reviewed in this report. Constipation Drugs Page 4 of 141 Final Report Drug Effectiveness Review Project INTRODUCTION Background Chronic constipation is a disorder characterized by unsatisfactory defecation that results from infrequent 1 stools, difficult stool passage, or both over a time period of at least 12 weeks. The diagnosis is primarily symptom-based, relying on the patient’s self report of symptoms; however, the description of constipation symptoms varies significantly among patients. Common symptoms may include infrequent bowel movement, hard stool, too small stool, difficulties with stool expulsion (need for excessive straining), feeling of incomplete evacuation or simply a patient description of “a feeling of being constipated” without any of these constipation-related symptoms. While physicians traditionally defined constipation 2 as fewer than three bowel movements per week, more specific diagnostic criteria have been developed to 1 better specify the nature and duration of symptoms (Table 1). Symptom-based criteria for chronic functional constipation Rome II Criteria ACG CC Task Force At least 12 weeks, need not be consecutive, in past 12 Symptoms for at least 3 of the last 12 months months of > 2 of: consisting of: • Straining in >25% of defecations • Infrequent stools: less than 3 per week, or • Sensation of incomplete evacuation in >25% of • Difficult stool passage, which may include: defecations • Straining • Sensation of anorectal obstruction/blockade in >25% • Sense of difficulty passing stool of defecations • Incomplete evacuation • Manuel maneuvers to facilitate >25% of defecations • Hard/lumpy stools • Fewer than three defecations per week • Prolonged time to stool • Loose stools should not be present and there are • Need for manual maneuvers to pass stool insufficient criteria for IBS • Can be a combination of both ACG: American College of Gastroenterology; CC: chronic constipation; IBS: Irritable Bowel Syndrome Chronic constipation appears to be very common in the general population although its prevalence varies depending on the diagnostic criteria used. Estimates suggest that 2% to 28% of the US population suffers 3, 4 2 from chronic constipation, with most estimates in the range of 12% to 19%.
There is no doubt that anal cancer rates are substantially higher for HIV+ patients buy fluoxetine 10mg mastercard breast cancer lasts decades. In a large study, the adjusted rate ratios were 80 for MSM and 27 for other men com- pared with HIV-uninfected men (Silverberg 2012). The risk is also elevated in HIV+ women in whom high grade AINs are frequently found (Hou 2012). When discussing the high relative risk of HIV+ patients, one should consider, however, that anal cancer is very rare in the general population. This means that a “substantially” or “dra- matically” higher risk compared to the general population does not inevitably mean a high absolute risk. According to one systematic review (Machalek 2012), the pooled anal cancer incidence was 46 per 100,000 patient years in MSM. In HIV+ patients, the incidence increased from 22 to 78 in the HAART era. Incidence differs region- ally and is highest in the US at 147 (Chiao 2013). In the D:A:D cohort, mainly includ- ing HIV+ patients from Europe, the incidence per 100,000 patient years is only 45 (Worm 2013), in the Suisse Cohort even lower at 25 (Francesci 2010). Non-AIDS-defining Malignancies 447 The routinely repeated thesis of a worldwide dramatic increase of incidence over the last years has not been clearly verified. Moreover, the risk elevation is not the same for all HIV+ patients. In particular, AC incidence appears to be higher in patients with a low CD4 T cell nadir (Piketty 2012, Bertisch 2013, Chiao 2013, Duncan 2015). Cumulative HIV viremia and smoking are further risk factors (Bertisch 2013, Chiao 2013). There seems to be no strong protective effect of ART. In our own cohort of 121 patients with anal carcinoma, the vast majority of patients were on ART, with a well suppressed viremia and a median CD4 T cell count of 400/µl (Hoffmann 2011). It seems possible that cumulative use of PIs may be associated with a higher risk of anal cancer (Bruyand 2015). Anal cancer screening, treatment of pre-stages AIN is histologically graded depending on the degree of dysplasia in grade 1 (mild), grade 2 (moderate) or grade 3 (severe). AINs II/III or high grade AINs (HGAINs) are very common and are found in around one third of all HIV+ patients. It is important to remember that even these HGAINs do not inevitably lead to invasive cancer. According to a large systematic review the risk of anal cancer is relatively low (Machalek 2013). In total, the theoretical pro- gression rate from HGAIN to anal cancer was calculated to be one in 633 patients (one in 377 in the HAART era) per year in HIV+ men, and one in 4,196 patients per year in HIV-negative men. Thus, the majority of HGAIN will never progress to anal cancer, and progression might occur less often than it does for cervical intraepithelial neoplasias (CINs). Even HGAINs have a high potential for spontaneous regression (Tong 2013, Grulich 2014). At first glance, early detection and treatment of precursors seems to be important, since often many years can pass between AIN and AC manifestation. However, given the low progression rates as shown above, treatment of AIN bears a considerable risk for overtreatment. There is only limited data supporting current guidelines insisting that digital anorectal examinations as well as perianal and intra-anal smears should be taken yearly (Review: Ong 2014). The substantial differences in the natural history of anal HPV infection to those of cervical HPV infection suggest that one cannot simply transfer cervical cancer screening strategies to anal cancer screening. Until evidence from large prospective studies is available, screening for anal cancer should be done only in research settings. More data is needed on progression and regres- sion rates of HGAIN and on biomarkers that predict HGAIN or anal cancer. To date, many HIV physicians remain ambivalent regarding screening for anal cancer (Ong 2015). The absence of reliable evidence for any of the interventions used in AIN precludes any definitive guidance or recommen- dations for clinical practice (Macaya 2012).
A good-quality review focuses on a well-defined question or set of questions discount 10 mg fluoxetine otc women's health clinic baton rouge, which ideally refer to the inclusion/exclusion criteria by which decisions are made about whether to include or exclude primary studies. These criteria would relate to the four components of study design, indications (patient populations), interventions (drugs), and outcomes of interest. A good-quality review also includes details about the process of decision-making, that is, how many reviewers were involved, whether the studies were examined independently, and how disagreements between reviewers were resolved. Is there evidence of a substantial effort to find all relevant research? If details of electronic database searches and other identification strategies are given, the answer to this question usually is yes. Ideally, search terms, date restrictions, and language restrictions are presented. In addition, descriptions of hand-searches, attempts to identify unpublished material, and any contact with authors, industry, or research institutes should be provided. The appropriateness of the database(s) searched by the authors should also be considered. For example, if only MEDLINE is searched for a systematic review about health education, then it is unlikely that all relevant studies will be located. Is the validity of included studies adequately assessed? If the review systematically assesses the quality of primary studies, it should include an explanation of the basis for determining quality (for example, method of randomization, whether outcome assessment was blinded, whether analysis was on an intention-to-treat basis) and the process by which assessment is carried out (that is, how many reviewers are involved, whether the assessment is independent, and how discrepancies between reviewers are resolved). Authors Statins Page 119 of 128 Final Report Update 5 Drug Effectiveness Review Project may have used either a published checklist or scale or one that they designed specifically for their review. Is sufficient detail of the individual studies presented? It is usually considered sufficient if a paper includes a table giving information on the design and results of individual studies or includes a narrative description of the studies. If relevant, the tables or text should include information on study design, sample size for each study group, patient characteristics, interventions, settings, outcome measures, follow-up, drop-out rate (withdrawals), effectiveness results, and adverse events. The authors should attempt to synthesize the results from individual studies. In all cases, there should be a narrative summary of results, which may or may not be accompanied by a quantitative summary (meta-analysis). For reviews that use a meta-analysis, heterogeneity between studies should be assessed using statistical techniques. If heterogeneity is present, the possible reasons (including chance) should be investigated. In addition, the individual evaluations should be weighted in some way (for example, according to sample size or according to inverse of the variance) so that studies that are thought to provide the most reliable data have greater impact on the summary statistic. Controlled Trials Assessment of Internal Validity 1. Was the assignment to the treatment groups really random? Adequate approaches to sequence generation: Computer-generated random numbers Random numbers tables Inferior approaches to sequence generation: Use of alternation, case record number, birth date, or day of week Not reported 2. Adequate approaches to concealment of randomization: Centralized or pharmacy-controlled randomization Serially-numbered identical containers On-site computer based system with a randomization sequence that is not readable until allocation Inferior approaches to concealment of randomization: Use of alternation, case record number, birth date, or day of week Open random numbers lists Serially numbered envelopes (even sealed opaque envelopes can be subject to manipulation) Statins Page 120 of 128 Final Report Update 5 Drug Effectiveness Review Project Not reported 3. Were the groups similar at baseline in terms of prognostic factors? Were outcome assessors blinded to treatment allocation? Was the patient kept unaware of the treatment received? Did the article include an intention-to-treat analysis or provide the data needed to calculate it (that is, number assigned to each group, number of subjects who finished in each group, and their results)?
