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Sweden M ulticenter F anti “M ildandself-lim iting”Totalnum bernotreported order 200 mcg cytotec visa. U SA E levationsoccurredwithin1m onth of starting study order cytotec 200mcg amex. Allreturnedto M ulticenter baselinewithin1m onth of stopping studydrug. Proton pump inhibitors Page 190 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 12. A dverse effects insh ortterm random iz ed controlled trials:Protonpum pinh ibitorcom pared with protonpum p inh ibitor A uth or Y ear N um berwith drawndue Setting Disease Intervention C ontrol N um berEnrolled to adverse events L anz a D uodenalulcer lansopraz ole placebo 186enrolled 4. A dverse effects insh ortterm random iz ed controlled trials:Protonpum pinh ibitorcom pared with protonpum p inh ibitor A uth or Y ear Setting A dverse effects L anz a 9adverseeventspossiblyorprobablyrelatedtostudydrug. Valuesreached U SA aplateauafteronem onth of treatm entandreturnedtobaselineonem onth aftertreatm entstopped. Gastric biopsies:significant M ulticenter increaseinGastrincelldensityin(l)group com paredto(pl)group (707cells/m m 2vs556cells. R usso M aintenance:3% (l/l),18% (l/pl),0% (ran/ran). Them eanelevationsinserum gastrinlevels E uropean at6weekswere12. M ulticenter Adachi,2003 N otreported Bardhan,2001 57% of pantopraz olevs50% om epraz oleex periencedadverseevents. Severein10% pantopraz oleand13% om epraz olepatients. M ostcom m onadverseevents(pantopraz olevsom epraz ole):nausea(8% vs7%),diarrhea(5% vs6%),andheadache(6% vs3%). Proton pump inhibitors Page 192 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 12. A dverse effects insh ortterm random iz ed controlled trials:Protonpum pinh ibitorcom pared with protonpum p inh ibitor A uth or Y ear N um berwith drawndue Setting Disease Intervention C ontrol N um berEnrolled to adverse events Castell GE R D lansopraz ole om epraz ole 1070 (o20):2% 1996 15m g or30m g 20m g (l30):1. A dverse effects insh ortterm random iz ed controlled trials:Protonpum pinh ibitorcom pared with protonpum p inh ibitor A uth or Y ear Setting A dverse effects Castell Anyadverseevent:(l15)44. E uropean M ulticenter D ekkers 32% (r20)and28% (o20)reportedatleastoneadverseevent. E uropean M ulticenter D elchier 21% (r20),26% (r10),and23% (o20)reportedatleastoneevent. Abdom inalpain,pharyngitis,bronchitis,headache,diarrheam ost 2000 com m on. Atweek4,incidencesof elevatedserum gastrinlevels16% (r20),27% E uropean (r10),20% (o20)(N S) M ulticenter D upas Adverseeventsreportedin28% inp40group,17% inl30. M ostcom m onheadache,diarrhea,elevationof hepatic enz ym es, 2001 abdom inalpain,skindisorders. F rance M ulticenter Proton pump inhibitors Page 194 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 12. A dverse effects insh ortterm random iz ed controlled trials:Protonpum pinh ibitorcom pared with protonpum p inh ibitor A uth or Y ear N um berwith drawndue Setting Disease Intervention C ontrol N um berEnrolled to adverse events F ennerty,2005 GE R D esom epraz ole40m g lansopraz ole 1001 5/499(1%)esom epraz ole 30m g vs9/472(2%) lansopraz ole. Gillessen,2004 GE R D pantopraz ole40m g esom epraz ole 227 6patientsoverall,not 40m g reportedbygroup. Hatlebakk GE R D lansopraz ole om epraz ole 229 (o20):0. A dverse effects insh ortterm random iz ed controlled trials:Protonpum pinh ibitorcom pared with protonpum p inh ibitor A uth or Y ear Setting A dverse effects F ennerty,2005 33. M ostcom m onadverseeventleading tostudywithdrawalwasabdom inalpain(2ineach group). N onejudgeddefinitelyrelatedtostudy m edication,9% pantopraz ole,28% esom epraz olelikelyrelated. Twoseriousadverseeventsinonepatientinpantopraz olegroup (icterusandm alignanthepatic neoplasm (notrelatedtom edication). N orway/Sweden M ulticenter Holtm ann,2002 About25% of patientsinboth groupsex periencedanyadverseevent. L ansopraz olevsesom epraz ole:Incidenceof alladverseevents46. M ostfrequentlyreportedtreatm ent-relatedeffects:diarrhea(5% vs5%),headache(2% vs5%),eructation(5% vs2%),abdom inalpain(2% vs4%),flatulence(1% vs4%),nausea(2% vs2%). E som epraz oleoneseverecaseeach of eructation,diz z iness,andparesthesia;lansopraz oleoneseverecaseeach of abdom inalpain,diarrhea,eructation,rectaldisorder,andsom nolence. Proton pump inhibitors Page 196 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 12. A dverse effects insh ortterm random iz ed controlled trials:Protonpum pinh ibitorcom pared with protonpum p inh ibitor A uth or Y ear N um berwith drawndue Setting Disease Intervention C ontrol N um berEnrolled to adverse events K ahrilas GE R D esom epraz ole40m g or20m g om epraz ole 1960 (e40):2% 2000 20m g (e20):2. GE R D pantopraz ole40m g om epraz oleM U PS 669 4/337(1%)pantopraz ole, 2003 40m g 7/332(2%)om epraz ole M U PS L abenz GE R D esom epraz ole40m g pantopraz ole40m g 3151 33/1562(2.

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Abbreviations: IR purchase cytotec 200mcg without a prescription, immediate release; LA cytotec 200mcg without a prescription, long acting. One of 36 39 these studies rerandomized patients who had enrolled in a previous trial. Two studies 35, 38 33 evaluated long-acting dihydrocodeine, 1 evaluated long-acting codeine, and 1 evaluated 37 long-acting morphine. Study designs, patient populations, and outcomes assessed varied between studies (Evidence Table 5). The trials did not show any trends demonstrating significant differences in efficacy between long-acting opioids as a class and short-acting opioids (Table 4). Three studies that 37 38 found differences in efficacy favoring long-acting morphine, long-acting dihydrocodeine, and 33 long-acting codeine had features that might invalidate these results. In the trials of long-acting 37 33 morphine and long-acting codeine, the average daily doses of opioid in the long-acting arm 38 were higher than the average daily doses given in the short-acting group. In the other study, significant differences in pain relief were seen only within the long-acting dihydrocodeine group when compared with baseline ratings, but no significant differences were found when results for the long-acting opioid arm were compared directly to the short-acting opioid arm. In all trials, Long-acting opioid analgesics 25 of 74 Final Update 6 Report Drug Effectiveness Review Project functional outcomes were examined inconsistently or measured with heterogeneous scales. Other important outcomes such as improved compliance or more consistent pain control were not examined. A subgroup of 3 trials of 281 enrolled patients evaluated roughly equivalent doses of long- and short-acting oxycodone and appeared to be the most homogeneous of this group of 34, 36, 39 36 trials. One of these trials investigated a rerandomized population of patients studied in a 39 previous trial but used a different intervention protocol. These 3 trials found no significant differences in efficacy (pain relief) between long- and short-acting oxycodone. With regard to 34 functional outcomes, 1 of these trials reported improved sleep quality with long-acting oxycodone, but baseline sleep scores were significantly better in patients randomized to this intervention, which could invalidate this finding. What are the comparative harms (including addiction and abuse) of different long-acting opioids in adult patients being treated for chronic noncancer pain? Summary of evidence • There were insufficient data from 10 head-to-head trials of long-acting opioids to conclude that any long-acting opioid was associated with fewer harms compared with others. None of the trials were designed to specifically assess harms and no trial was rated good quality for adverse event assessment. Long-acting opioid analgesics 26 of 74 Final Update 6 Report Drug Effectiveness Review Project Detailed assessment Direct evidence 23-32 Ten randomized trials directly compared 2 long-acting opioids. Adverse events reported in these trials are shown in Table 5. One head-to-head trial was a very small (N=18) study of transdermal fentanyl compared with twice-daily oral morphine in patients with chronic 27 pancreatitis. Because of its very small size and limited focus on adverse events, it did not provide usable information about comparative adverse event rates and is not further reviewed here. All of the trials excluded patients with prior substance abuse. Only 1 trial reported rates of addiction and reported no cases, but did not state how addiction was defined or ascertained. Specific adverse events in head-to-head trials of long-acting opioids Drowsiness or Study Interventions Nausea Vomiting Constipation somnolence Dizziness Transdermal 54% 29% 52% 27% 25% Allan, fentanyl 23 2005 Long-acting 50% 26% 65% 30% 24% morphine Transdermal 26% 10% 16% 18% 11% Allan, fentanyl 24 2001 Long-acting 18% 10% 22% 14% 4% morphine Transdermal NR NR NR NR NR Niemann, fentanyl 27 2000 Long-acting NR NR NR NR NR morphine Once-daily 21% 6% 49% 16% 10% morphine a. Once-daily Caldwell, 32% 16% 40% 12% 10% 25 morphine p. The largest trial (N=680) compared transdermal fentanyl to long-acting oral morphine in 23 patients with chronic low back pain. The main flaws were that patients and assessors were not blinded to the interventions, there was high loss to follow-up (approximately 50% of patients in each arm completed the trial), methods for identifying adverse events other than constipation were not specified, and intent-to-treat analyses were not reported for some outcomes. For example, for the primary adverse event outcome of constipation using a bowel function assessment, rates were 31% for transdermal fentanyl compared with 48% for morphine (P<0. For other adverse events, rates were calculated based on the number of patients receiving at least 1 dose of study drug (N=673) using “last observation carried forward” methods, with no sensitivity analyses of different assumptions (such as “best case” or “worst case” calculations) on the rates of different adverse events. Using last observation carried forward methods, there were no statistically significant differences for any adverse event other than constipation (52% vs. Although this trial found that rates of constipation were lower for transdermal fentanyl than oral long-acting morphine, it also found a trend towards increased withdrawal due to any adverse event (a marker for intolerable or more severe adverse events) with transdermal fentanyl (37% vs. Reasons for withdrawal included vomiting (24% of withdrawals in transdermal fentanyl group, 20% in morphine group), nausea (37% in both groups), and constipation (11% and 23%). The proportion of withdrawals due to other adverse events, such as skin reactions, somnolence, and dry mouth, was not reported. A second trial compared transdermal fentanyl to long-acting oral morphine in patients with mixed pain conditions and was rated poor quality for adverse event assessment (Evidence 24 Table 4). This trial found no significant differences in reported rates of overall or “serious” (not defined) complications. Constipation was significantly lower for transdermal fentanyl (29%) compared with long-acting morphine (48%, P<0.

Black box warning: A type of warning that appears on the package insert for prescription drugs that may cause serious adverse effects discount 200mcg cytotec. It is so named for the black border that usually surrounds the text of the warning buy generic cytotec 200mcg on-line. A black box warning means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. The US Food and Drug Administration (FDA) can require a pharmaceutical company to place a black box warning on the labeling of a prescription drug, or in literature describing it. Blinding: A way of making sure that the people involved in a research study — participants, clinicians, or researchers —do not know which participants are assigned to each study group. Blinding usually is used in research studies that compare two or more types of treatment for an illness. Case series: A study reporting observations on a series of patients receiving the same intervention with no control group. Case study: A study reporting observations on a single patient. Case-control study: A study that compares people with a specific disease or outcome of interest (cases) to people from the same population without that disease or outcome (controls). Clinical diversity: Differences between studies in key characteristics of the participants, interventions or outcome measures. Clinically significant: A result that is large enough to affect a patient’s disease state in a manner that is noticeable to the patient and/or a caregiver. Cohort study: An observational study in which a defined group of people (the cohort) is followed over time and compared with a group of people who were exposed or not exposed to a particular intervention or other factor of interest. A prospective cohort study assembles participants and follows them into the future. A retrospective cohort study identifies subjects from past records and follows them from the time of those records to the present. Combination Therapy: The use of two or more therapies and especially drugs to treat a disease or condition. Confidence interval: The range of values calculated from the data such that there is a level of confidence, or certainty, that it contains the true value. The 95% confidence interval is generally used in Drug Effectiveness Review Project reports. If the report was hypothetically repeated on a collection of 100 random samples of studies, the resulting 100 95% confidence intervals would include the true population value 95% of the time. Confounder: A factor that is associated with both an intervention and an outcome of interest. Controlled clinical trial: A clinical trial that includes a control group but no or inadequate methods of randomization. Control group: In a research study, the group of people who do not receive the treatment being tested. The control group might receive a placebo, a different treatment for the disease, or no treatment at all. Convenience sample: A group of individuals being studied because they are conveniently accessible in some way. Convenience samples may or may not be representative of a population that would normally be receiving an intervention. Crossover trial: A type of clinical trial comparing two or more interventions in which the participants, upon completion of the course of one treatment, are switched to another. Direct analysis: The practice of using data from head-to-head trials to draw conclusions about the comparative effectiveness of drugs within a class or group. Results of direct analysis are the preferred source of data in Drug Effectiveness Review Project reports. Dosage form: The physical form of a dose of medication, such as a capsule, injection, or liquid. The route of administration is dependent on the dosage form of a given drug. Various dosage Statins Page 106 of 128 Final Report Update 5 Drug Effectiveness Review Project forms may exist for the same compound, since different medical conditions may warrant different routes of administration. Dose-response relationship: The relationship between the quantity of treatment given and its effect on outcome. In meta-analysis, dose-response relationships can be investigated using meta- regression. Double-blind: The process of preventing those involved in a trial from knowing to which comparison group a particular participant belongs. While double-blind is a frequently used term in trials, its meaning can vary to include blinding of patients, caregivers, investigators, or other study staff. Double-dummy: The use of two placebos in a trial that match the active interventions when they vary in appearance or method of administrations (for example, when an oral agent is compared with an injectable agent).