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Grade 4: Deep ulceraton anywhere in the esophagus or confluent erosion of more than 50% of the mucosal surface area of the last 5 cm of esophageal squamous mucosa generic modafinil 200 mg fast delivery. Grade 5: Stricture buy modafinil 100 mg with amex, defined as a narrowing of the esophagus that does not allow easy passage of the endoscope without dilation. Los Angeles Classification Not present: No breaks (erosions) in the esophageal mucosa (edema, erythema, or friability may be present) Grade A: One or more mucosal breaks confined to the mucosal folds, each not more than 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm in maximum length, but not continuous between the tops of two mucosal folds. Grade C: Mucosal breaks that are continuous between the tops of tow or more mucosal folds, but which involve less that 75% of the esophageal circumference. Grade D: Mucosal breaks which involve at least 75% of the esophageal circumference. Proton pump inhibitors Page 120 of 121 Final Report Update 5 Drug Effectiveness Review Project The presence or absence of strictures, ulcers, and/or Barrett’s esophagus much be noted separately, e. Criteria used in Hatlebakk, 1993: Grade 1: red streaks or spots along the ridge of the folds in the distal esophagus, covered or not by fibrinous Exudate Grade 2: Broader lesions, each involving the entire width of a fold or coalescing into fields or erythema, covered or not with fibrinous exudates Grade 3: Stricture or endoscopically visible ulcer in distal esophagus. Criteria used in Castell, 1996, Howden, 2002, Richter 2001b: Grade 0: normal-appearing mucosa Grade 1: mucosal edema, hyperemia, and/or friability Grade 2: one or more erosions/ulcerations involving <10% of the distal 5 cm of the esophagus Grade 3: erosions/ulcerations involving 10-50% of the distal 5 cm of the esophagus or an ulcer 3-5 mm in diameter. In cases of Barrett’s esophagus, the area 5 cm proximal to the squamocolumnar junction was evaluated Grade 4: multiple erosions involving >50% of the distal 5 cm of the esophagus or a single ulcer > 5mm in diameter. Proton pump inhibitors Page 121 of 121 Drug Class Review Proton Pump Inhibitors Final Report Update 5 Evidence Tables April 2009 Update 4: May 2006 Update 3: May 2005 Update 2: April 2004 Update 1: April 2003 Original Report: November 2002 The literature on this topic is scanned periodically. The purpose of this report is to make available information regarding the comparative effectiveness and safety profiles of different drugs within pharmaceutical classes. Reports are not usage guidelines, nor should they be read as an endorsement of, or recommendation for, any particular drug, use, or approach. Oregon Health & Science University does not recommend or endorse any guideline or recommendation developed by users of these reports. McDonagh, PharmD Susan Carson, MPH Sujata Thakurta, MPA:HA Drug Effectiveness Review Project Marian McDonagh, PharmD, Principal Investigator Oregon Evidence-based Practice Center Mark Helfand, MD, MPH, Director Oregon Health & Science University Copyright © 2009 by Oregon Health & Science University Portland, Oregon 97239. Final Report Update 5 Drug Effectiveness Review Project TABLE OF CONTENTS Evidence Table 1. Erosive gastroesophageal reflux disease short-term trials of proton pump inhibitor compared with proton pump inhibitor……………………………………………………………………………3 Evidence Table 2. Quality assessment of included trials…………………………………………………… 72 Evidence Table 3. Nonerosive gastroesophageal reflux disease short-term trials………………………102 Evidence Table 4. Head-to-head trials of proton pump inhibitors for prevention of esophagitis relapse…………………………………………………………………………………………………………. Non-erosive gastroesophageal reflux disease relapse prevention…………………. Randomized controlled trials of esophagitis treatment in children…………………. Randomized controlled trials of duodenal ulcer treatment: Proton pump inhibitor compared with proton pump inhibitor…………………………………………………………………………133 Evidence Table 8. Duodenal ulcer recurrence rates on maintenance therapy………………………….. Randomized controlled trials of gastric ulcer treatment……………………………... Randomized controlled trials of nonsteroidal anti-inflammatory drug-induced ulcer treatment………………………………………………………………………………………………………... Randomized controlled trials of proton pump inhibitors for prevention of nonsteroidal anti-inflammatory drug-induced ulcer………………………………………………………… 179 Evidence Table 12. Adverse effects in short term randomized controlled trials: Proton pump inhibitor compared with proton pump inhibitor………………………………………………………………………... Standard dose compared with low dose proton pump inhibitor……………………203 Evidence Table 14. Long-term harms in observational studies……………………………………………275 The medical literature relating to this topic is scanned periodically. Prior versions of this report can be accessed at the DERP website. Proton pump inhibitors Page 2 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Erosive gastroesophageal reflux disease short-term trials of proton pump inhibitor compared with proton pump inhibitor Number Screened, Eligible, Enrolled, Author Esophagitis Grade (Grading Withdrawn, Lost to Year Population, Setting Criteria), Other Characteristics Followup Healing Rate at 4 Weeks Adachi et al, 85 patients at 6 medical Grade A: 24% Screened NR/eligible Not reported 2003 institutions in Japan. Mean Grade B: 53% NR/85 enrolled age 66 (SD 13); 51% male; Grade C: 21% 20% of lansoprazole 100% Asian Grade D: 2% group lost to f/u for (Los Angeles classification) endoscopy vs 7% in 42% h.

Courtesy of Dr Judy Whittaker 357 GYNECOLOGY FOR LESS-RESOURCED LOCATIONS Table 1 WHO histological classification of endometrial Table 2 Clinical sub-classification of endometrial cancer cancer according to Bokhman cheap modafinil 100mg on line,19831 Endometrial adenocarcinoma Type I Type II Typical: endometrioid Variants: villoglandular; with squamous differentiation; Endometrioid carcinoma Serous carcinoma/clear secretory; with ciliated cells cell carcinoma <65 years 65 years Other adenocarcinomas Estrogen dependent Estrogen independent Serous carcinoma Associated with endometrial Associated to atrophic Clear cell carcinoma hyperplasia endometrium Mucinous carcinoma Low/moderate grade High grade Squamous-cell carcinoma Good prognosis Aggressive behavior and Undifferentiated carcinoma poor prognosis Small-cell carcinoma Mixed carcinoma Large-cell and small-cell carcinoma Serous and clear cell carcinomas (high grade) are most commonly found in this group of patients discount modafinil 100 mg mastercard. The • G3: >50% of solid non-squamous or non- prognosis for these elderly patients is usually morular solid growth pattern. Further notes on pathological grading include: Type I carcinomas are associated with endometrial hyperplasia. Several classifications for hyperplasia • Notable nuclear atypia, inappropriate for the have been suggested. The most important variable architectural grade, raises the grade of a grade I is the presence of cytological atypia, which put the or grade II tumor by one. In up to carcinoma and squamous-cell carcinoma, 40% of patients with atypical hyperplasia, a con- nuclear grading takes precedence. This has consequences for is graded according to the nuclear grade of the the management of patients in which a hyperplasia glandular component. Bokhman1 should be tomy and bilateral salpingo-oophorectomy (see credited with a further, mainly prognostic, classifi- Chapter 20 on how to perform a vaginal hysterec- cation of two distinct groups of patients presenting tomy and Chapter 19 for simple abdominal hyster- with an adenocarcinoma of the endometrium ectomy). For diagnosis and treatment of all other (Table 2): endometrial hyperplasia see Chapters 9 and 10 on pre- and postmenopausal bleeding disorders. Type I is associated cases is an endometrioid carcinoma. These malig- nancies usually show a low or moderate There is currently no generally accepted method differentiation. The prognosis for these patients for screening for endometrial carcinoma in asymp- is usually good. Screening of the general popula- tion is neither efficient nor cost-effective2. There • Patients with a type II cancer on the other hand, account for up to 20% of cases, and are found are nevertheless women at risk for developing against a background of atrophic endometrium. These include: 358 Cancer of the Uterine Corpus • Increasing age Symptoms and diagnoses • Long-term exposure to unopposed estrogen (i. Most patients present with abnormal bleeding or at the use of estrogens without progesterone) least bloody discharge after menopause. The age • Obesity (with or without co-existing diabetes distribution should however at the same time alert and hypertension) the medical attendant when a premenopausal • Patients without children patient presents with intermenstrual or heavy • Anovulation such as is found in polycystic prolonged bleeding. There are several causes of ovarian disease postmenopausal bleeding (see Chapter 10); in • Late menopause approximately 5–20%, carcinoma of the endo- • Patients with previously diagnosed breast cancer 3 metrium is diagnosed. The breast carcinoma ET should be measured and an increased ET should Methods for screening in these patients include alert the medical attendant of the presence of an serial transvaginal ultrasound (TVU) and endome- endometrial carcinoma (Figure 6). In the postmenopausal patient who is not taking hormone replacement treatment the endometrial thickness (ET) found on TVU should be <4mm (Figure 4). Above this threshold of 4mm an endometrial sampling in the symptomatic patient (with vaginal bleeding) is indicated. Endometrial sampling should render a histological specimen. A cytological speci- men, if abnormal, needs to be followed by an endometrial sampling for histological analysis. Currently, many devices for out-patient histologi- cal endometrial sampling are available. The most popular are the Pipelle, manual vacuum aspiration (MVA; smallest cannula) and the Endosampler (Figure 5). All these devices work on the principle of scraping and subsequent suction of endometrial tissue and can be used during an office procedure. Figure 5 An Endosampler Non-disposable instruments such as small curettes work just on the principle of scraping tissue and are often painful for the patient when used during an office procedure. Courtesy of Dr Dr Douglas Dumbrill Douglas Dumbrill 359 GYNECOLOGY FOR LESS-RESOURCED LOCATIONS In postmenopausal patients where the ET is Table 3 Staging for carcinoma of the endometrium <4mm other causes for postmenopausal bleeding (FIGO 2009) should be entertained. In postmenopausal patients Stage I Tumor confined to the corpus uteri where the ET is >4mm the index of suspicion should be high for an endometrial carcinoma. An IA No or less than half myometrial invasion endometrial biopsy is indicated to confirm or ex- IB Invasion equal to or more than half of the myometrium clude the diagnosis of an endometrial carcinoma. In cases where access to the uterine cavity is not poss- Stage II Tumor invades cervical stroma, but does not ible, a hysteroscopy (if available) together with extend beyond the uterus endometrial sampling under a general anesthetic is Stage III Local and/or regional spread of the tumor mandatory. IIIA Tumor invades the serosa of the corpus uteri and/or adnexae Staging IIIB Vaginal and/or parametrial involvement IIIC Metastases to pelvic and/or para-aortic lymph Endometrial carcinoma spreads according to a nodes number of routes: IIIC1 Positive pelvic nodes 1. Direct extension to adjacent structures such as IIIC2 Positive para-aortic lymph nodes with or without myometrium, fallopian tubes and cervix. Spread of cancer cells through the fallopian Stage IV Tumor invades bladder and/or bowel mucosa, tubes may explain ovarian metastasis and the and/or distant metastases presence of malignant cells in the peritoneal IVA Tumor invasion of bladder and/or bowel mucosa washings. IVB Distant metastases, including intra-abdominal 3. Lymphatic spread to pelvic and para-aortic metastases and/or inguinal lymph nodes lymph nodes. Hematogenous spread occurs which is less Either G1, G2, or G3.

Trials with primary coronary heart disease endpoints Author Year Need for Revascularization (CABG buy modafinil 100mg on line, PTCA purchase modafinil 100 mg with visa, Study Name Stenting) Comments/Conclusions Studies in outpatients ALLHAT Officers and NR Coordinators 2002 Antihypertensive and Lipid- Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT) Asselbergs et al Not reported 2004 Prevention of Renal and Vascular Endstage Disease Intervention Trial (PREVEND IT ) Statins Page 189 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 2. Trials with primary coronary heart disease endpoints Author Year Study Name Funding Source Studies in outpatients ALLHAT Officers and National Heart, Lung, and Blood Institute; Pfizer; Coordinators AstraZeneca; Bristol-Myers Squibb 2002 Antihypertensive and Lipid- Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT) Asselbergs et al Dutch Kidney Foundation, Netherlands Heart 2004 Foundation, and Bristol-Myers Squibb Prevention of Renal and Vascular Endstage Disease Intervention Trial (PREVEND IT ) Statins Page 190 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 2. Trials with primary coronary heart disease endpoints Author Mean Mean Year Study Baseline Study Name Study Characteristics Study Population Intervention Duration LDL-c Colhoun 2004 Randomized, double- 2838 men and women with no Atorvastatin 10 mg/day or median 3. Randomized, double- 6605 healthy men (43-73 yrs) & Lovastatin 20 mg qpm or 5. Statins Page 191 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 2. Trials with primary coronary heart disease endpoints Author Percent Year LDL-c Reduction from Myocardial Infarction Coronary Heart Disease (new Cardiovascular or CHD Study Name Baseline (active vs. Prevention Study 95% CI 17-57% 95% CI 5-51% (AFCAPS/TexCAPS) NNT=86 NNT=122 Heart Protection Study 29. Trials with primary coronary heart disease endpoints Author Year Study Name All Cause Mortality Major Coronary Events Stroke Colhoun 2004 4. Trials with primary coronary heart disease endpoints Author Year Need for Revascularization (CABG, PTCA, Study Name Stenting) Comments/Conclusions Colhoun 2004 1. RRR=33% Lovastatin reduced the incidence of first acute major coronary 1998 ARR=1. Atherosclerosis 95% CI 15-48% Prevention Study NNT=65 (AFCAPS/TexCAPS) Heart Protection Study RRR=24% Coronary or vascular death, nonfatal MI, stroke and need for Collaborative Group ARR=2. Subanalysis of Heart Protection Study 95% CI 17-30 patients at LDL-c levels <100 mg/dl showed a reduction of to 65 (HPS) NNT=38 mg/dl (mean) produced a reduction in risk about as great as those at higher LDL-c. Simvastatin reduced incidence of the primary endpoint of total mortality, with a CHD death reduction of 42% vs. Simvastatin reduced incidence of major coronary events. The risk for these events was reduced in women and in those over 60 years. Statins Page 194 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 2. Trials with primary coronary heart disease endpoints Author Year Study Name Funding Source Colhoun 2004 Partly funded by Pfizer Collaborative Atorvastatin Diabetes Study (CARDS) Downs JR, et al.. Three of the primary authors are employees of 1998 Merck and Co. Two other authors are consultants, Air Force/Texas Coronary speakers and/or funded researchers of Merck and Atherosclerosis Co. Supported by a research grant from Merck Prevention Study and Co. Spectrum Pharmaceuticals assisted in (AFCAPS/TexCAPS) conducting the trial and Merck and Co helped design the trial and manage the data. Heart Protection Study UK Medical Research Council; British Heart Collaborative Group Foundation; Merck & Co; Roche 2002, 2004 Heart Protection Study (HPS) Statins Page 195 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 2. Trials with primary coronary heart disease endpoints Author Mean Mean Year Study Baseline Study Name Study Characteristics Study Population Intervention Duration LDL-c Holdaas et al. Exclude those using a statin, with familial hypercholesterolemia, life expectancy <1 year, and acute rejection episode in previous 3 months. Randomized, open- 8888 men and women aged 80 or Simvastatin 20 mg or Median 4. Dose of years Incremental Decrease in point classification, MI who qualified for statin therapy simvastatin could be increased End Points Through multicenter according to national guidelines at I to 40 mg if, at 24 weeks, TC Aggressive Lipid Lowering the time of recruitment. Randomized, double- 365 men or women 40-70 years with Fluvastatin 40 mg qpm or 1 year 198 mg/dl (5. If LDL-c was mmol/L) controlled, intent to assessed by exercise ECG and an not reduced 30% or more, treat analysis for LDL-c >160 mg/dl (4. Trials with primary coronary heart disease endpoints Author Percent Year LDL-c Reduction from Myocardial Infarction Coronary Heart Disease (new Cardiovascular or CHD Study Name Baseline (active vs. Statins Page 197 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 2. Trials with primary coronary heart disease endpoints Author Year Study Name All Cause Mortality Major Coronary Events Stroke Holdaas et al. All-cause mortality: Primary endpoint (CHD death, Fatal or nonfatal stroke: 2005 8. NR NR NR 1999 Statins Page 198 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 2. Trials with primary coronary heart disease endpoints Author Year Need for Revascularization (CABG, PTCA, Study Name Stenting) Comments/Conclusions Holdaas et al. Over study period, 14% of placebo group admitted to other lipid-lowering treatments, mostly statins, along with 7% of fluvastatin group. Other concurrent medications similar in both groups: ciclosporin (all), steroids (81%), beta blockers and calcium antagonists (95%), and aspirin (34%) Pederson TR et al. NR Fluvastatin resulted in a significant reduction in cardiac events 1999 compared to placebo in patients with CHD and elevated LDL-c.

There is no single accepted standard on how to measure the included outcomes buy modafinil 200mg line. Clinical trials of skeletal muscle relaxants have often used different scales to measure important clinical outcomes such as spasticity cheap 100 mg modafinil overnight delivery, pain, or muscle 27 strength. Many trials have used unvalidated or poorly described methods of outcome assessment. Studies that use the same scale often report results differently (for example, mean raw scores after treatment, mean improvement from baseline, or number of patients “improved”). All of these factors make comparisons across trials difficult. Spasticity is an especially difficult outcome to measure objectively. The most widely used standardized scales to measure spasticity in patients with upper motor neuron syndromes 28 29 are the Ashworth and modified Ashworth scales. In these scales, the assessor tests the resistance to passive movement around a joint and grades it on a scale of 0 (no increase in tone) to 4 (limb rigid in flexion or extension). The modified Ashworth scale adds a “1+” rating between the 1 and 2 ratings of the Ashworth scale. For both of these scales, the scores are usually added for four lower and four upper limb joints, for a total possible score of 0-32, though scoring methods can vary. Some experts have pointed out that resistance to passive movement may measure tone better than it does spasticity and that the Ashworth scale and other ‘objective’ measures of spasticity may not correlate well with patient symptoms or 30 functional ability. Other areas of uncertainty regard the significance of the 1+ rating in the modified Ashworth scale and how a non-continuous ordinal variable should be statistically Skeletal Muscle Relaxants Page 6 of 237 Final Report Update 2 Drug Effectiveness Review Project 31 analyzed. An important advantage of the Ashworth scale is that it is a consistent way to measure spasticity or tone across studies, and has been found to have moderate 31 reproducibility. Other measures of spasticity include the pendulum test, muscle spasm counts, and patient assessment of spasticity severity on a variety of numerical (e. The best technique may be to perform both objective and subjective assessments of spasticity, but validated subjective assessment techniques of spasticity are lacking. Muscle strength is usually assessed with the time-honored British Medical Research Council Scale, which is based on the observation of resistance provided by voluntary muscle 16 activity and used in everyday clinical practice. An assessor grades each muscle or muscle group independently on a scale of 0 (no observed muscle activation) to 5 (full strength). This scale was originally devised to test the strength of polio survivors. Data are not available regarding its reliability and validity in assessing spastic and weak patients. Most studies measure pain using either visual analogue or categorical pain scales. Visual analogue scales (VAS) consist of a line on a piece of paper labeled 0 at one end, indicating no pain, and a maximum number (commonly 100) at the other, indicating excruciating pain. Patients designate their current pain level on the line. An advantage of VAS is that they provide a continuous range of values for relative severity. A disadvantage is that the meaning of a pain score for any individual patient depends on the patient’s subjective experience of pain. This poses a challenge in objectively comparing different patients’ scores, or even different scores from the same patient. Categorical pain scales, on the other hand, consist of several pain category options from which a patient must choose (e. A disadvantage of categorical scales is that patients must choose between categories that may not accurately describe their pain. The best approach may be to 32 utilize both methods. Pain control (improvement in pain) and pain relief (resolution of pain) are also measured using visual analogue and categorical scales. Studies can evaluate functional status using either disease-specific or non-specific scales. These scales measure how well an individual functions physically, socially, cognitively, and psychologically. Disease-specific scales tend to be more sensitive to changes in status for that particular condition, but non-specific scales allow for some comparisons of functional status between conditions. The most commonly used disease-specific measure of functional and disability status in patients with multiple sclerosis, for example, is the Kurtzke 33 Extended Disability Status Scale (EDSS). The EDSS measures both disability and impairment, combining the results of a neurological examination and functional assessments of eight domains into an overall score of 0-10 (in increments of 0. The overall score of the EDSS is heavily weighted toward ambulation and the inter-rater reliability has been found to 33 34, 35 be moderate. Disease-specific scales are also available for fibromyalgia, low back pain, cerebral palsy, and other musculoskeletal and spastic conditions. Scales that are not disease-specific include the Medical Outcomes Study Short Form-36 (SF-36), Short Form-12 (SF-12), or another multi-question assessment.