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The plot allows viewers to see the heterogeneity among the results of the studies generic cialis with dapoxetine 40/60 mg line. The results of individual studies are shown as squares centered on each study’s point estimate generic 30mg cialis with dapoxetine free shipping. A horizontal line runs through each square to show each study’s confidence interval—usually buy cialis with dapoxetine fast delivery, but not always, a 95% confidence interval. The overall estimate from the meta-analysis and its confidence interval are represented as a diamond. The center of the diamond is at the pooled point estimate, and its horizontal tips show the confidence interval. Funnel plot: A graphical display of some measure of study precision plotted against effect size that can be used to investigate whether there is a link between study size and treatment effect. Half- life: The time it takes for the plasma concentration or the amount of drug in the body to be reduced by 50%. Harms: See Adverse Event DRIs, AIIRAs, and ACE-Is Page 120 of 144 Final Report Drug Effectiveness Review Project Hazard ratio: The increased risk with which one group is likely to experience an outcome of interest. For example, if the hazard ratio for death for a treatment is 0. Head-to-head trial: A trial that directly compares one drug in a particular class or group with another in the same class or group. Health outcome: The result of a particular health care practice or intervention, including the ability to function and feelings of well-being. For individuals with chronic conditions – where cure is not always possible – results include health-related quality of life as well as mortality. Heterogeneity: The variation in, or diversity of, participants, interventions, and measurement of outcomes across a set of studies. I2: A measure of statistical heterogeneity of the estimates of effect from studies. I2 is the proportion of total variability across studies that is due to heterogeneity and not chance. It is calculated as (Q-(n- 1))/Q, where n is the number of studies. Incidence: The number of new occurrences of something in a population over a particular period of time, e. Indication: A term describing a valid reason to use a certain test, medication, procedure, or surgery. In the United States, indications for medications are strictly regulated by the Food and Drug Administration, which includes them in the package insert under the phrase "Indications and Usage". Indirect analysis: The practice of using data from trials comparing one drug in a particular class or group with another drug outside of that class or group or with placebo and attempting to draw conclusions about the comparative effectiveness of drugs within a class or group based on that data. For example, direct comparisons between drugs A and B and between drugs B and C can be used to make an indirect comparison between drugs A and C. Intention to treat: The use of data from a randomized controlled trial in which data from all randomized patients are accounted for in the final results. Trials often incorrectly report results as being based on intention to treat despite the fact that some patients are excluded from the analysis. Internal validity: The extent to which the design and conduct of a study are likely to have prevented bias. Generally, the higher the interval validity, the better the quality of the study publication. Inter-rater reliability: The degree of stability exhibited when a measurement is repeated under identical conditions by different raters. Intermediate outcome: An outcome not of direct practical importance but believed to reflect outcomes that are important. For example, blood pressure is not directly important to patients but DRIs, AIIRAs, and ACE-Is Page 121 of 144 Final Report Drug Effectiveness Review Project it is often used as an outcome in clinical trials because it is a risk factor for stroke and myocardial infarction (hear attack). Masking: See Blinding Mean difference: A method used to combine measures on continuous scales (such as weight) where the mean, standard deviation, and sample size are known for each group. Meta-analysis: The use of statistical techniques in a systematic review to integrate the results of included studies. Although the terms are sometimes used interchangeably, meta-analysis is not synonymous with systematic review. However, systematic reviews often include meta-analyses. Meta-regression: A technique used to explore the relationship between study characteristics (for example, baseline risk, concealment of allocation, timing of the intervention) and study results (the magnitude of effect observed in each study) in a systematic review. Mixed treatment comparison meta analysis: A meta-analytic technique that simultaneously compares multiple treatments (typical 3 or more) using both direct and indirect evidence. The multiple treatments form a network of treatment comparisons. Also called multiple treatment comparisons, network analysis, or umbrella reviews. Monotherapy: the use of a single drug to treat a particular disorder or disease. Multivariate analysis: Measuring the impact of more than one variable at a time while analyzing a set of data. N-of-1 trial: A randomized trial in an individual to determine the optimum treatment for that individual. Noninferiority trial: A trial designed to determine whether the effect of a new treatment is not worse than a standard treatment by more than a prespecified amount. Nonrandomized study: Any study estimating the effectiveness (harm or benefit) of an intervention that does not use randomization to allocate patients to comparison groups. There are many types of nonrandomized studies, including cohort studies, case-control studies, and before- after studies. Null hypothesis: The statistical hypothesis that one variable (for example, treatment to which a participant was allocated) has no association with another variable or set of variables. DRIs, AIIRAs, and ACE-Is Page 122 of 144 Final Report Drug Effectiveness Review Project Number needed to harm: The number of people who would need to be treated over a specific period of time before one bad outcome of the treatment will occur. The number needed to harm (NNH) for a treatment can be known only if clinical trials of the treatment have been performed.

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Characteristics of head-to-head studies comparing ICS+LABA with ICS+leukotriene modifiers purchase 30 mg cialis with dapoxetine otc. discount cialis with dapoxetine 40/60mg fast delivery. buy cialis with dapoxetine 20/60 mg with mastercard............................................................................................................................................... Characteristics of head-to-head studies comparing ICS+LABA with LTRA+LABA............... Summary of studies on posterior subcapsular cataracts....................................................... Summary of studies on ocular hypertension or open-angle glaucoma.................................. Tolerability and frequency of adverse events results from systematic reviews comparing ICS+LABA with ICS+LABA..................................................................................................................... Summary of studies evaluating subgroups of patients for whom asthma controller medications may differ in efficacy or frequency of adverse events............................................................................ Summary of the evidence by key question for controller medications for the treatment of persistent asthma in adolescents/adults ≥ 12 years of age and children < 12 years of age.................. References throughout this report identify the respective documents as Evidence Tables A or B. Controller medications for asthma 7 of 369 Final Update 1 Report Drug Effectiveness Review Project Suggested citation Jonas DE, Wines R, DelMonte M, Amick H, Wilkins T, Einerson B, Schuler CL, Wynia BA, Bryant Shilliday B. Drug class review: Controller medications for asthma. Morgan, MA, Patricia Thieda Keener, MA, and Daniel Reuland, MD, MPH for their expertise and contributions toward creating the original controller medications for asthma report. We also thank Irvin Mayers, MD, FRCPC, University of Alberta and Allan Luskin, MD, University of Wisconsin who served as clinical advisors and provided their thoughtful advice and input during the research process for the original report. Finally, we thank Claire Baker, Shannon Brode, Elizabeth Harden, and Megan Van Noord for their invaluable assistance with data abstraction, literature searches, and data entry. Funding The Drug Effectiveness Review Project, composed of 12 organizations including 11 state Medicaid agencies, and the Canadian Agency for Drugs and Technology in Health commissioned and funded for this report. These organizations selected the topic of the report and had input into its Key Questions. The content and conclusions of the report were 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. Controller medications for asthma 8 of 369 Final Update 1 Report Drug Effectiveness Review Project INTRODUCTION Asthma is a chronic lung disease characterized by reversible airway obstruction, inflammation, and increased airway responsiveness. As a result of inflammation, individuals with asthma may experience symptoms such as wheezing, difficulty breathing, or coughing. The airway obstruction which occurs with asthma is generally reversible spontaneously or with treatment. Asthma is thought to have a genetic, inheritable component, often begins early in life, and 1 consists of variable symptoms regardless of asthma classification. The Expert Panel of the National Asthma Education and Prevention Program (NAEPP) recently reclassified asthma categories; the mild intermittent category was eliminated (now called intermittent) and the 1 persistent category was subdivided into mild, moderate, or severe. The change was partly done to acknowledge that exacerbations can be severe in any asthma category. Table 1 lists the criteria used to classify asthma severity. Classification of asthma Short-Acting Interference FEV1 Daytime Nighttime Beta-2 Agonist with daily % symptoms symptoms use activity predicted FEV1/FVC ≤ 2 ≤ 2 Intermittent ≤ 2 days/week None > 80% Normal days/week nights/month Persistent > 2/week but 3-4 > 2 days/week Minor ≥ 80% Normal Mild < 1/day nights/month > 1 night/week > 60% - < Reduced Moderate Daily Daily Some but < 1/night 80% 5% Severe Several times Reduced > Continual Frequent Extreme ≤ 60% daily 5% Asthma outcomes have improved over the past several years but the burden remains substantial. Asthma is estimated to affect 300 million individuals worldwide with 22 million of 2-4 those individuals being in the US. It is the cause of 250,000 worldwide deaths annually with 2-4 4,000 of them in the US. The World Health Organization estimates 15 million disability- 2 adjusted life years (DALYs) lost annually due to asthma. In 2005, there were 488,594 hospital discharges in the US, 12. Many current medications available to treat persistent asthma target the inflammatory process caused by multiple inflammatory cells and mediators including lymphocytes, mast cells, 1 eosinophils, among others. There are currently two categories of medications used in asthma treatment: controller medications and quick relief (or rescue) medications. Although all patients with persistent asthma should have a short-acting relief medication on hand for treatment of exacerbations and a controller medication for long-term control, this report will focus on the following currently available controller medications: inhaled corticosteroids (ICSs), Long-Acting Controller medications for asthma 9 of 369 Final Update 1 Report Drug Effectiveness Review Project Beta-2 Agonists (LABAs), leukotriene modifiers, anti-IgE medications, and combination products. Inhaled corticosteroids are the preferred agents for long-term control of persistent asthma 1 according to expert panel recommendations. The inhaled route of administration serves to directly target the inflammation while minimizing systemic effects which can result from oral administration. These agents act via anti-inflammatory mechanisms and have been approved as 1 first line therapy for asthma control in all stages of persistent asthma. The 7 ICSs currently available include: beclomethasone dipropionate, budesonide, ciclesonide, flunisolide, fluticasone propionate, mometasone furoate, and triamcinolone acetonide. Table 2 lists the trade names, manufacturers, available formulations, and age indications for controller medications for persistent asthma. Although it is not approved for the treatment of asthma and thus is not ® included in Table 2, tiotropium (Spiriva ) was included in this report to determine if there is any published evidence for its use in people with asthma. Dulera (mometasone/formoterol), now approved for treatment of asthma in people >12 years, is not included in this report because it was approved after our cutoff date for the inclusion of new medications. Controller medications for asthma 10 of 369 Final Update 1 Report Drug Effectiveness Review Project 1, 5-10 Table 2. Long-term controller medication class, trade names, manufacturers, formulations, and indications Dosage Approved indication Medication class Generic name Trade name Manufacturer form/device Strength in US and Canada 40 mcg/puff a ® 50 mcg/puff Asthma (age ≥ 5) QVAR Ivax HFA Beclomethasone 80 mcg/puff a dipropionate 100 mcg/puff ®b 42 mcg/puff Asthma (age ≥ 5) Vanceril Schering MDI 84 mcg/puff Pulmicort 90 mcg/dose ®c AstraZeneca DPI Flexhaler 180 mcg/dose Asthma (age ≥ 6) 100 mcg/dose Pulmicort ®a AstraZeneca DPI 200 mcg/dose Turbuhaler 400 mcg/dose Budesonide 0. Long-term controller medication class, trade names, manufacturers, formulations, and indications Dosage Approved indication Medication class Generic name Trade name Manufacturer form/device Strength in US and Canada 100 mcg/dose 250 mcg/dose a 500 mcg/dose Asmanex 110 mcg/dose Asthma (age ≥ 4) Mometasone furoate ®c Schering DPI Twisthaler 220 mcg/dose Triamcinolone ®b MDI – with spacer Asthma (age ≥ 6) Azmacort Abbot 75 mcg/dose acetonide mouthpiece Leukotriene Tablets 10 mg ® Asthma (age ≥ 1) modifiers Montelukast Singulair Merck Chewable tablets 4 mg, 5 mg Granules 4 mg/packet Leukotriene Asthma (age ≥ 5 yrs in c receptor ® 10 mg Zafirlukast Accolate AstraZeneca Tablets US); (age ≥ 12 yrs in antagonists 20 mg Canada) ®c Tablets Zyflo 600 mg Asthma (age ≥ 12 yrs) 5-lipoxygenase Zileuton ®c Critical Therapeutics Extended release Zyflo CR 600 mg Inhibitor tablets ®c Not approved for Arformoterol Brovana Sunovion Inhalation solution 15 mcg/2ml asthma (COPD only) ®c Asthma (age ≥ 5 yrs) Foradil Aerolizer Schering DPI 12 mcg/capsule Novartis ®a Foradil Pharmaceuticals DPI 12 mcg/capsule Asthma (age > 6 yrs) Formoterol fumarate/ Canada Inc. Long-Acting Beta- Eformoterol 2 Agonists Oxeze 6 mcg/capsule Asthma (age ≥ 6 yrs) ®a AstraZeneca (Canada) DPI Turbuhaler 12 mcg/capsule ®f 6 mcg/puff Oxis Turbohaler Astra Pharmaceuticals DPI Asthma (age ≥ 6 yrs) 12 mcg/puff ® Serevent Diskus GlaxoSmithKline DPI 50 mcg/blister Asthma (age ≥ 4 yrs) Salmeterol xinafoate Serevent Asthma (age ≥ 4 yrs) ®a GlaxoSmithKline DPI 50 mcg/blister Diskhaler Genentech (US) Powder for 202.

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Adjuvant treatment in early-stage epithelial The benefit from adjuvant chemotherapy in ovarian cancer terms of overall and recurrence-free survival appeared to be most evident in patients with For FIGO stage IA–IIA ovarian cancer patients cialis with dapoxetine 60mg overnight delivery, 15 non-optimal surgical staging order cialis with dapoxetine 40/60mg visa. There remains a optimal surgical staging is the standard of care cialis with dapoxetine 60mg on-line. The discussion about whether chemotherapy can be 10-year survival in patients with FIGO stage IA– omitted in patients with optimally staged early- IIA is around 90% after an optimal surgical staging stage ovarian cancer. No additional benefit in progression-free chemotherapy appeared to be predominantly nor overall survival was observed with adjuvant effective in patients with non-optimal surgical chemotherapy in optimally staged early-stage staging, presumably because these patients have ovarian cancer, in contrast to patients with a non- more risk of harboring unappreciated residual optimal staging surgery where the progression-free disease, this subgroup analysis must be inter- as well as the overall survival were significantly preted with caution. Combination containing platinum-based control drug combi- therapy with cisplatin and alkylating agents in the nation of cyclophosphamide, doxorubicin and 1980s, and since the 1990s, the adoption of pacli- cisplatin (CAP) or single-agent carboplatin in taxel with either cisplatin or carboplatin are con- women with advanced ovarian cancer. The re- sidered first-line treatment for advanced ovarian sults showed that single-agent carboplatin or cancer; however, myelosuppression, neurotoxicity, CAP as a triple regimen were as effective as ototoxicity and gastrointestinal side-effects still re- paclitaxel/carboplatin as first-line treatment for main a challenge with the recommended agents. There Six cycles of 3-weekly carboplatin (or cisplatin) was no statistical difference in both progression- with paclitaxel are recommended. In contrast, the GOG 111 Study and the European–Canadian Intergroup Trial Low-resource countries may lack personnel skilled in the first-line setting where cisplatin/paclitaxel in dispensing cytotoxic drugs, there are few labora- was compared to cisplatin/cyclophosphamide, a tory facilities to monitor toxicities, or effective drugs significant improvement for the paclitaxel/cis- that would prevent or treat the drug toxicities. The platin regimen was shown in progression-free costs and availability of anticancer drugs differ from survival and overall survival. In addition, the developing country to developing country. Long dist- ances travelling to access health facilities and the differences in the process of care between the Intraperitoneal chemotherapy health facilities could limit compliance17. Single-agent regimens are cheaper, easier to Intraperitoneal chemotherapy (IP) involves direct administer and to monitor, and have fewer side- administration of chemotherapeutic agents directly effects, and are therefore more appealing in low- into the body cavity. Cisplatin was the first single directly exposes the tumor to higher doses of agent to demonstrate longer survival and response chemotherapy and avoids systemic drug dose side- compared to cyclophosphamide, the traditional effects. Little is known about correct indications for alkylating agent used in the 1970s18. Combination IP chemotherapy, the appropriate drugs, correct treatments are associated with higher response rates, dose and the appropriate scheduling of treatment. Combina- chemotherapy is currently discouraged in low- resource settings22. The combination of paclitaxel with carboplatin is considered to be the standard first-line therapy Table 2 Chemotherapy in advanced ovarian cancer (Table 2, Appendices 2 and 3). Single-agent carbo- platin may be a reasonable alternative for first-line 3-weekly paclitaxel/carboplatin 3-weekly carboplatin in patients with ovarian cancer because of its rela- Paclitaxel 175 mg/m² Carboplatin AUC 6 tive safety, tolerability, ease of administration and Carboplatin AUC 6 repeat day 22 fewer side-effects20. The myelotoxicity of the repeat day 22 carboplatin monotherapy is of concern, and treat- ment delays may affect treatment efficacy. AUC, area under the curve 349 GYNECOLOGY FOR LESS-RESOURCED LOCATIONS Interval cytoreductive surgery in advanced Box 4 Landmark studies in neoadjuvant epithelial ovarian cancer chemotherapy Interval debulking (IDS) is a repeat surgical attempt In the EORTC/NCIC-CTG trial the primary after induction chemotherapy in a patient who debulking surgery followed by chemotherapy could not be optimally debulked at primary sur- with or without interval debulking was com- gery. The main aim is to achieve complete cyto- pared with neoadjuvant chemotherapy and de- reduction of residual tumor. In patients who did layed primary surgery in stage IIIC and stage IV not have a maximal effort for cytoreduction by an ovarian cancer9. The progression-free and experienced surgeon at initial surgery, IDS is bene- overall survival rate was not significantly differ- ficial (Box 3). The advantages of neoadjuvant chemotherapy Box 3 Landmark studies on interval debulking include an increased rate of optimal surgery, re- surgery duced blood loss, lower morbidity, shortened The EORTC 55865 trial performed a random- hospital stay, improved quality of life, and acting ized study in FIGO stage IIB–IV patients in as a mechanism to select out patients with plati- which patients with residual disease after primary num resistance. In the multivariate analyses, debulking surgery were randomized to either complete resection of all macroscopic lesions ≥6 cycles of chemotherapy without additional was the strongest independent prognostic factor surgery or 3 cycles of chemotherapy followed by for overall survival. The results of the trial are interval debulking surgery and additional ≥3 not applicable to patients with lower stage cycles of chemotherapy. Recently many institutions continues to show with over 10 years of follow- have switched to using neoadjuvant chemo- up, that there is a significant survival advantage therapy in selected patients with advanced to the patients who underwent IDS23. The GOG ovarian cancer (without primary attempt of de- 158 study showed no benefit of interval debulk- bulking), followed by an IDS (usually after three ing surgery. However, there were some signifi- courses of chemotherapy). In the GOG study The lack of specialized care facilities and experi- all patients were operated on by gynecological enced gynecology oncologists in low-resourced oncologists but in the EORTC there was a mix- countries makes neoadjuvant chemotherapy an ture of general gynecologists and gynecological appealing option. In addition in the GOG 158 a maxi- adjuvant therapy is that it would allow the patient’s mal surgical effort at primary surgery was re- general condition to improve and would reduce the quired for inclusion, which was not needed for bulk of the tumor, thereby rendering the surgery inclusion in the EORTC study. Many oncolo- easier with fewer surgical complications. The deci- gists have interpreted these results as showing sion to offer neoadjuvant chemotherapy should be that when an initial surgery has been performed made when the diagnosis of primary ovarian cancer by a gynecological oncologist then IDS probably is most certain. This diagnosis is preferably based on has a minimal role to play, in all other cases IDS a histologically obtained sample of the tumor or is of benefit. An alternative way (although less pre- cise) is the presence of the following three features: 1. A cytological diagnosis of adenocarcinoma, Neoadjuvant chemotherapy in epithelial achieved through fluid aspiration of the ascites ovarian cancer or pleural fluid. Neoadjuvant chemotherapy refers to initial use of 2. A typical clinical picture with a mass arising chemotherapy in patients with advanced-stage epi- from the pelvis associated with macroscopic tu- thelial ovarian cancer in order to reduce the tumor mor >2cm in abdomen or extraperitoneal tu- volume prior to surgical intervention (Box 4). Ratio of CA-125/CEA >25; in cases of a MANAGEMENT OF GRANULOSA CELL lower ratio, additional examinations (digestive CANCER tract endoscopy and mammography) should be Granulosa cell cancer of the ovaries occurs at all performed to exclude intestinal and breast ages. Many granulosa cell tumors produce estrogens cancer. The corner- Response to chemotherapy should be assessed after stone of granulosa cell tumor therapy is surgery. Inoperable granulosa cell tumors may a drop (ideally logarithmic) in the tumor marker be treated with (B)EP (bleomycin, etoposide and level and improvement in the patient’s general con- cisplatin) chemotherapy (see Appendix 4). Delayed primary surgery is considered in rence can happen after many years and in that case patients with a response or stable disease after com- surgery is the first option for treatment. Debulking surgery should be performed after the third or at the MANAGEMENT IN GERM CELL OVARIAN latest after the fourth chemotherapy cycle.

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