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Prandin

By P. Murat. Florida Southern College.

After the first 18-week dose titration phase discount 0.5mg prandin with mastercard, there was a 21% difference in low-density lipoprotein cholesterol levels compared to baseline (P<0 prandin 0.5 mg without prescription. At the end of the first 6-week period of the crossover phase there was no difference in low-density lipoprotein cholesterol from baseline between groups (19% decrease for 293 rosuvastatin 80 mg/day and 18% decrease for atorvastatin 80 mg/day) cheap prandin 1 mg with mastercard. We conducted a meta-analysis of the percent change from baseline in low-density lipoprotein levels in placebo-controlled trials (Figure 2) buy 0.5 mg prandin fast delivery. Seven trials provided sufficient information to be included in the meta-analysis (mean percent change from baseline and standard 285-289, 291, 292 286 deviation, or data to calculate these). Of these, 1 was rated good quality, 1 was Statins Page 72 of 128 Final Report Update 5 Drug Effectiveness Review Project 291 rated poor quality, and the rest were fair quality. A sensitivity analysis excluding the poor 285 quality study did not change results of the meta-analysis. One study included atorvastatin, 2 286, 287 288, 289 291, 292 lovastatin, 2 pravastatin, and 2 simvastatin. The meta-analysis included 472 patients taking a statin and 320 taking a placebo. Overall, statins reduced low-density lipoprotein cholesterol in children taking a statin by 32% (95% CI, 37 to 26). The mean percent change from baseline was greater for atorvastatin (10 mg) and simvastatin (40 mg) than lovastatin (40 mg) and pravastatin (20 to 40 mg). These results are similar to percent reductions seen in adults at these doses. With the exception of pravastatin 20 to 40 mg compared with simvastatin 40 mg, confidence intervals for the different statins overlapped, suggesting similar percent low-density lipoprotein cholesterol lowering. However, because this body of evidence is indirect, and studies were heterogenous, it cannot be used to draw strong conclusions about the comparative effectiveness of the different statins. Low-density lipoprotein cholesterol lowering in placebo-controlled trials of statins in children with familial hypercholesterolemia Statins Page 73 of 128 Final Report Update 5 Drug Effectiveness Review Project Key Question 1b. Do statins or fixed-dose combination product containing a statin and another lipid-lowering drug differ in the ability to achieve National Cholesterol Education Program goals? In that guideline statement, treatment is considered for children 10 years of age or greater, preferably after the onset of menses in girls and ideally after children have reached Tanner stage II or higher. Age and low-density lipoprotein level at which statin therapy is initiated is subject to judgment about presence of risk factors that suggest familial hypercholesterolemia such as cutaneous xanthomas. Authors suggest that patient and family preferences should be considered 294 in decision-making. In the only study of simvastatin compared to fixed dose ezetimibe/simvastatin combination (10 mg/40 mg), low-density lipoprotein cholesterol was reduced from a mean of 114 mg/dL to a mean of 103 mg/dL (change of 54%) in the ezetimibe/simvastatin group and reduced from a mean of 144 mg/dL to a mean of to 135 mg/dL (change of 38%) in the 295 simvastatin group. At the end of 33 weeks, the percentage of subjects achieving a low-density lipoprotein cholesterol <130 mg/dL were 77% in the ezetimibe/simvastatin group and 53% in the simvastatin group (P<0. How do statins and fixed-dose combination products containing a statin and another lipid lowering drug compare in their ability to raise high- density lipoprotein cholesterol? Summary of findings • Statins decreased high-density lipoprotein cholesterol in 1 study of atorvastatin and did not change high-density lipoprotein cholesterol in 5 other trials of statins including rosuvastatin, simvastatin, lovastatin, and pravastatin. Are there doses for each statin or fixed-dose combination product containing a statin and another lipid lower drug that produce similar percent increase in high-density lipoprotein cholesterol between statins? Overall, high-density lipoprotein cholesterol increased +1% to +11% for treatment groups compared with –1% to +4. The trial of atorvastatin compared to rosuvastatin started with open-label dose titration of rosuvastatin for 18 weeks and then randomized patients to atorvastatin or rosuvastatin (both at 80 mg/day doses) in a crossover design for 6 weeks. Eight of 44 patients enrolled in the trial were under age 18; results were not separated out by age group. At the end of the initial dose titration phase (18 weeks) there was no significant difference in high-density lipoprotein levels compared Statins Page 74 of 128 Final Report Update 5 Drug Effectiveness Review Project with baseline (3. After 6 weeks of the crossover comparison phase (prior to crossover), there was no difference between groups in the change in high-density lipoprotein cholesterol from baseline (2. The 1 trial that evaluated simvastatin compared to fixed-dose ezetimibe/simvastatin 295 combination (10 mg/40 mg) demonstrated no change in high-density lipoprotein cholesterol. We conducted a random-effects meta-analysis of placebo-controlled trials reporting the change from baseline in high-density lipoprotein cholesterol levels in children with familial 285-289, 291, 292 hypercholesterolemia (Figure 3). Seven trials contributed data to the meta-analysis, representing 472 patients taking a statin and 320 taking a placebo. Overall, the pooled result indicated that statins increased high-density lipoprotein cholesterol by 3% (95% CI, 0. Among the individual statins, only pravastatin significantly increased high-density lipoprotein cholesterol, with a 5% change (95% CI, 0. The mean difference from placebo was nonsignificant for the other statins. High-density lipoprotein cholesterol increases in placebo-controlled trials of statins in children with familial hypercholesterolemia Statins Page 75 of 128 Final Report Update 5 Drug Effectiveness Review Project Key Question 3. How do statins and fixed-dose combination products containing a statin and another lipid lowering drug compare in their ability to reduce the risk of nonfatal myocardial infarction, coronary disease (angina), coronary heart disease mortality, all-cause mortality, stroke, hospitalization for unstable angina, or need for revascularization (coronary artery bypass graft, angioplasty, or stenting)? Summary of findings • Studies of statins in children have not been conducted with long enough follow-up to assess for outcomes related to cardiovascular mortality and morbidity. Detailed assessment Nonfatal myocardial infarction, coronary disease (angina), coronary heart disease mortality, all- cause mortality, stroke, hospitalization for unstable angina, or need for revascularization (coronary artery bypass graft, angioplasty, or stenting) are outcomes that occur primarily in adults. There were no studies in children that had sufficient follow-up to determine the effect of treatment with statin or fixed-dose combination products containing a statin and another lipid- lowering drug on the risk of these outcomes. However, it is generally assumed by the specialists in this area that treatment of children with familial hypercholesterolemia does postpone or prevent the onset of early cardiovascular disease. As a surrogate end-point, trials have demonstrated the effect of statins on intima-medial thickness, arterial stiffness, and endothelial 289 function. Are there differences in effectiveness of statins and fixed-dose combination products containing a statin and another lipid lowering drug in different demographic groups or in patients with comorbid conditions (e. Summary of findings • No trials have evaluated statins in children with diabetes or obesity. One study demonstrated 21% reduction in low-density lipoprotein with simvastatin in children with neurofibromatosis 1. Detailed assessment We identified no trials of statins and fixed-dose combination products in children with diabetes or obesity. One study of simvastatin compared to placebo in children with neurofibromatosis 1 demonstrated a reduction in low-density lipoprotein cholesterol (21% for simvastatin; low- density lipoprotein reduction for placebo group not reported) but no change in high-density 296 lipoprotein. Statins Page 76 of 128 Final Report Update 5 Drug Effectiveness Review Project Key Question 5. Are there differences in the harms of statins or fixed-dose combination products containing a statin and another lipid lowering drug when used in the general population of children? Summary of findings • Adverse events were variably reported; methods of detection and assessment of adverse events were often not specified. Detailed assessment Information on harms of statins and fixed-dose combination products in children was obtained from randomized-controlled trials, controlled clinical trials, non-controlled case series, and case reports. Data on adverse events from clinical trials is variably reported; methods for detection and assessment of the adverse events were often not specified. Several studies reported that aspartate aminotransferase and alanine aminotransferase remained below twice or 3 times the upper limit of normal. This was true for 24-48 weeks of 286, 287 291 treatment lovastatin, 28 weeks of simvastatin, and 12 weeks to 2 years of treatment with 288, 289, 297 285 pravastatin. Reports of elevations in transaminases occurred with atorvastatin, 295 simvastatin-ezetimibe combinations, and rosuvastatin (in a trial that included both adults and 293 children with homozygous familial hypercholesterolemia). In studies that reported increased transaminase levels during statin treatment, these levels returned to normal with treatment 285, 291, 295 interruption or discontinuation of the statin. Similarly, multiple studies reported no significant elevations in creatine kinase over the 285-287, 289, 293 study period. Another study reported a single child with creatine kinase elevation (>10 times the upper limit of normal) without muscled symptoms, which occurred with concomitant administration of simvastatin and erythromycin and returned to normal after completion of the antibiotics, and 2 children with increases in creatine kinase (>5- 292 fold the upper limit of normal) that returned to normal in repeat tests. Several studies also cited “no significant” or “no serious” adverse events, or even “no 286, 291, 298 adverse events”. Such statements in these studies lack rigorous definitions of the methods used to monitor for and detect adverse events. Other studies stated that the incidence of 287, reporting any adverse events was equal between the treatment and control (placebo) groups 288, 291 285, 292, 295 or reported the incidence of adverse events to demonstrate that point. Treatment- 286 related adverse effects were reported as 8.

Controlled clinical trial: A clinical trial that includes a control group but no or inadequate methods of randomization effective prandin 1mg. Control group: In a research study buy cheap prandin 1 mg on line, the group of people who do not receive the treatment being tested buy prandin 2mg. The control group might receive a placebo buy prandin 0.5 mg line, 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). Effectiveness: The extent to which a specific intervention used under ordinary circumstances does what it is intended to do. Effectiveness outcomes: Outcomes that are generally important to patients and caregivers, such as quality of life, responder rates, number and length of hospitalizations, and ability to work. Data on effectiveness outcomes usually comes from longer-term studies of a “real-world” population. Effect size/estimate of effect: The amount of change in a condition or symptom because of a treatment (compared to not receiving the treatment). It is commonly expressed as a risk ratio (relative risk), odds ratio, or difference in risk. Efficacy: The extent to which an intervention produces a beneficial result under ideal conditions in a selected and controlled population. Equivalence level: The amount which an outcome from two treatments can differ but still be considered equivalent, as in an equivalence trial, or the amount which an outcome from treatment A can be worse than that of treatment B but still be considered noninferior, as in a noninferiority trial. Equivalence trial: A trial designed to determine whether the response to two or more treatments differs by an amount that is clinically unimportant. This lack of clinical importance is usually demonstrated by showing that the true treatment difference is likely to lie between a lower and an upper equivalence level of clinically acceptable differences. Exclusion criteria: The criteria, or standards, set out before a study or review. Exclusion criteria are used to determine whether a person should participate in a research study or whether an individual study should be excluded in a systematic review. Exclusion criteria may include age, previous treatments, and other medical conditions. External validity: The extent to which results provide a correct basis for generalizations to other circumstances. For instance, a meta-analysis of trials of elderly patients may not be generalizable to children. Studies are assumed to be measuring the same overall effect. Statins Page 107 of 128 Final Report Update 5 Drug Effectiveness Review Project Fixed-dose combination product: A formulation of two or more active ingredients combined in a single dosage form available in certain fixed doses. Forest plot: A graphical representation of the individual results of each study included in a meta- analysis and the combined result of the meta-analysis. The plot allows viewers to see the heterogeneity among the results of the studies. The results of individual studies are shown as squares centered on each study’s point estimate. A horizontal line runs through each square to show each study’s confidence interval—usually, 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 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. I 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. Statins Page 108 of 128 Final Report Update 5 Drug Effectiveness Review Project 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 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.

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Pediatrics 2010; 125: e250-60 Zorrilla CD buy 0.5 mg prandin fast delivery, Van Dyke R cheap 0.5 mg prandin with amex, Bardeguez A discount prandin 2mg visa, et al purchase 0.5mg prandin. Clinical response and tolerability to and safety of saquinavir with low-dose ritonavir in human immunodeficiency virus type 1-infected mothers and their infants. Total and unbound darunavir pharmacokinetics in pregnant women infected with HIV-1: results of a study of darunavir/ritonavir 600/100 mg administered twice daily. HIV and Wanting to be a Parent ULRIKE SONNENBERG-SCHW AN, MICHAEL W EIGEL Introduction For a growing number of men and women living with HIV/AIDS the perspective of parenthood is an important part in their planning of the future. Procreation without risk, or at very low risk of infection for the uninfected partner or prospective child, is achievable for couples in which one or both partners are HIV-infected. In an increa- sing number of countries reproductive counselling and/or support is provided to couples affected by HIV. Procreative options for HIV-affected couples vary from unprotected intercourse to several techniques of assisted reproduction, donor insemination or adoption. In view of the strongly decreased risk of transmission with undetectable viral load, concep- tion via intercourse without condoms has increasingly become an option under certain circumstances. This has been greatly influenced by the “EKAF Statement” (Vernazza 2008, see also ART chapter) regarding the unlikeliness of HIV transmission while on effective ART. In January 2008, the EKAF (Swiss Commission on AIDS-related issues) stated that physicians could inform their patients about a negligible sexual transmission risk if three conditions are met: • The HIV-infected patient is on a physician-monitored ART and is adherent • Plasma viral load has consistently been undetectable for more than 6 months • No sexually transmitted diseases are present in either of the partners The statement also emphasized that only the HIV-negative partners can decide for themselves whether they want to stop using condoms with their seropositive partner. The background of the statement includes some longitudinal studies on serodiscor- dant couples. No infection occurred when the partners were on ART or the viral load in untreated partners was below 1,000 copies/ml (see chapter on Prevention). A retrospective Spanish study (Barreiro 2006) saw no infections in 74 HIV discordant couples (76 pregnancies) who conceived via timed intercourse. However, data from couples who did not conceive were not available. This option was discussed prior to the Swiss Statement (Barreiro 2007). With a view to reproductive aspects the Swiss Statement puts on record that insemination with processed sperm is no longer indicated for prevention of HIV transmission if the viral load is below detection. Studies on the association between viral load in sperm and blood show a high correlation, but data are limited (Kalichman 2008). Viral load in semen or genital secretions does not always correlate with plasma viral load (Pasquier 2009). HIV can sometimes be detected in semen or genital secretions even when viral load in blood plasma is undetectable. Since the publication of the HPTN 052 Study (Cohen 2011) showing a 96% reduction of HIV transmission with immediate use of ART, a growing number of studies has added support to the Swiss statement (Loutfy 2013). The British fertility guidelines recommend to advise on the negligible risk of trans- mission to the female partner through unprotected sexual intercourse when the EKAF criteria are met for the HIV+ male partner (National Collaborating Centre for Women’s and Children’s Health 2012). The French guidelines consider natural con- ception as a reasonable option for serodiscordant couples with no detectable viral load, recommending self-insemination (when the woman is HIV+) or timed unpro- tected intercourse (when the man is HIV+) as the safest option (Mandelbrot 2012). The US guidelines (NIH 2014) recommend self-insemination or sperm preparation 548 Women and Children techniques coupled with insemination or other reproductive procedures as the safest methods. HIV+ partners are advised to start ART before starting conception proce- dures. For couples with no access to reproductive services natural conception at ovu- lation is see as a choice, when the infected partner has no detectable viral load. Pre- exposure prophylaxis (PrEP) is seen as an additional option. In view of the increasing worldwide access to ART, natural conception is increasingly discussed as a safe option for couples even in resource limited regions (Ong’ech 2012). For HIV+ women with an uninfected partner, self-insemination is a safe and afford- able procedure also in these countries (Mmeje 2012). Natural conception now has become an important issue for many HIV-discordant couples seeking reproductive counselling. The EKAF Statement and current data and the resulting reproductive options should be discussed. Usually, there are significant differences in individual risk estimation and the need for safety. In any case, couples who want to exclude even a minimal risk or who are facing fertility disorders are those who seek counselling. Furthermore it has to be considered that in some seropos- itive partners the viral load is not effectively suppressed or that they have not started treatment. In these cases insemination with processed sperm – in case of unimpaired fertility – can be the method of choice. The start of ART in patients with low viral load in order to open the option for natural conception also is an option. The German-Austrian guidelines for diagnostics and treatment of HIV-affected couples (DAIG 2011) suggest the following options: Fertile HIV-discordant couples, ART, viral load below detectability, no other STIs: •Intercourse without condom during ovulation •Intercourse without condom plus PrEP •Self insemination in case of infection of the female partner • Intrauterine insemination and sperm processing in case of infection of the male partner HIV-discordant couples, fertility impaired, detectable viral load or no ART: •Depending on medical indication, several methods of assisted reproduction. In case HIV+ male partner sperm processing and cryopreservation are advised. Fertile HIV-concordant couples, undetectable viral load: •Intercourse without condom •HIV-concordant couples, fertility impaired, detectable viral load or no ART: Depending on medical indication, several methods of assisted reproduction Donor insemination is an alternative safe option for a small number of couples, but due to legal restrictions it is only offered in a minority of centers. In the UK, for example, there are no restrictions on donor insemination, whereas in Germany access is limited. In addition, most couples wish for a child that is the biological offspring of both parents. Adoption often is only a theoretical option: HIV infection of a partner often renders this procedure very difficult or even impossible (e. Egg cell donation might be an option for a small number of women facing severe fertility disorders, but is offered only in some countries (i. Pre-conception counselling The counseling of the couple should not only consider extensive information on all reproductive options, but also the psychosocial situation, the importance of a network of social support from family or friends, and planning and perspectives about the future as a family (Nakhuda 2005). A supporting, empathic and accepting mode of counselling is advisable, as couples can feel distressed if their motives for, or entitlement to, parenthood are questioned. The drastically reduced risk of trans- mission through unprotected intercourse if the viral load is undetectable should be HIV and Wanting to be a Parent 549 discussed as well as the individual risk perception and risk management strategies of the couple. In cases where professional psychosocial services are not integrated, cooperation with community organizations or self-help groups is advisable. If reproductive assistance is planned, financial aspects and possible stress should be discussed as well as doubts or fears. Even with the very low risk of infection, anxieties regarding HIV transmission to the partner might occur (van Leeuwen 2008). The fear of results that might challenge their chance to become parents can also be a burden for couples. Sero-discordant couples need to know that the risk of HIV infection can be minimized, but not excluded completely. HIV+ women have to be informed about the risks of vertical transmission and the necessary steps to avoid it. In any case, couples should know that even using state-of-the-art reproductive techniques, achieving a pregnancy cannot be guaranteed. Table 1 shows the investigations as provided in the current German-Austrian guidelines (DAIG 2011). Table 1: Pre-treatment investigations General Comprehensive medical and psycho-social history Female exams Gynecological examination, sonography, tubal patency test (hysterocontrast sonography, if necessary laparascopy) Endocrinological diagnostics (E2, LH, P, DHEAS, FSH, testosterone, SHBG, TSH, AMH) Cervical smear (PAP, chlamydia PCR) (UK: 2-5 FSH/LH and mid-luteal progesterone to evaluate female fertility) Serology (rubella, varicella, TPHA, CMV, HBV, HCV) HIV-specific Blood glucose, creatinine, GOT, GPT, GGT, complete blood count assessments Ultrasensitive HIV PCR, CD4/CD8 T cell counts and, if necessary, resistance testing HIV antibody test of the seronegative partner Male exams 2 spermiograms, in case of pathologic results: semen culture, if necessary, sonography Serology (HBV, HCV; TPHA), urethral smear (GO), chlamydia PCR (urine) Following the decision to conceive with reproductive assistance, the couple should undergo a thorough sexual health and infection screen, including information about the male partner’s HIV status. The possibility of HIV infection in the female partner also has to be excluded. In some cases, it might be necessary to treat genital infec- tions before starting reproductive treatment. Studies have indicated a frequent impairment of the sperm quality of HIV+ men (Duliost 2002, Pena 2003, Nicopoullos 2004, Bujan 2008). A prospective study revealed a significant impairment of sperm motility during ART, even with therapies that were not regarded as particularly mito- chondriotoxic (van Leeuwen 2008). Data on the effect of these changes on fertility are limited (Prisant 2010). After sperm washing and testing for HIV, spermatozoa can be utilized in three different reproductive techniques depending on whether the couples have any additional fertility issues: intra-uterine insemination (IUI), extracorporal fertilization by conventional in vitro fertilization (IVF) and intracytoplasmic sperm injection followed by embryonic transfer. According to the German recommendations, the choice of method depends on the results of gynecological and andrological investi- gations and the couple’s preference.

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Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or Y ear Design O th erpopulation Setting Trialtype Type ofSurgery ch aracteristics Inclusioncriteria W inston R C T L aparoscopicbilateraltuballigation40 (40% ) N o patients with a h istory of W omenwith A SA ph ysicalstatus I orII generic 0.5 mg prandin otc, 2003 Parallel Diagnosticlaparoscopy 41 (41% ) PO N V purchase prandin 1 mg mastercard. Antiemetics Page 470 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 14 discount 0.5mg prandin otc. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or Y ear Setting Exclusioncriteria Intervention A llowed oth erm edication W inston Subjects excluded ifth ey reported sensitivity to a)inh aled isopropylalcoh ol70% N one reported 2003 isopropylalcoh olorondansetron discount prandin 0.5mg otc,h ad animpaired b)ondansetron4mg Single C enter ability to breath e th rough th e nose,were pregnant orusingth e medicationdisulfiram,reported preexistingnausea,orreported any antiemeticuse with in24 h ours before surgery. Patients wh o reported a h istory ofsignificantPO N V,defined as nausea orvomitingresistantto antiemeticth erapy, orh ad a h istory ofalcoh olism were excluded. Antiemetics Page 471 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 14. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or M eanA ge Screened/ W ith drawn/ Y ear R un-in/W ash G ender Eligible/ L ostto fu/ Setting out Eth nicity Enrolled A nalyz ed W inston no/no N R N R / N R / 2003 100% women N R / N R / Single C enter N otreported 100 100 Antiemetics Page 472 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 14. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or Y ear Setting R esults A dverse events W inston O ndansetronvs isopropylalcoh ol N otreported 2003 Single C enter M edianverbalnumericratingscale scores (0=no nausea,10=worstnausea imaginable) firstcomplaint:8. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or Y ear Design O th erpopulation Setting Trialtype Type ofSurgery ch aracteristics Inclusioncriteria Placebo- controlled trials F ujii DB R C T A bdominalh ysterectomy N o patients with a h istory of W omenages 33 to 66 years wh o were 2004a Parallel motionsickness and/orPO N V categoriz ed as A SA ph ysicalstatus I (no Single C enter Placebo organic,ph ysiologic,bioch emical,or psych iatricdisturbances )and were experiencingnausea lasting>10 minutes and/orretch ingorvomitingwith in3 h ours afterrecovery from anesth esia inth e postanesth eticcare unitforabdominal h ysterectomy with orwith outsalpingo- ooph orectomy. Antiemetics Page 474 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 14. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or Y ear Setting Exclusioncriteria Intervention A llowed oth erm edication Placebo- controlled trials F ujii A ntiemetics given<= 24 h ours before surgery, a)granistronIV 10 mcg/kg N one reported 2004a gastrointestinaldisease,menstruation,and a b)granistronIV 20 mcg/kg Single C enter h istory ofmotionsickness and/orpostoperative c)granistronIV 40 mcg/kg emeticsymptoms. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or M eanA ge Screened/ W ith drawn/ Y ear R un-in/W ash G ender Eligible/ L ostto fu/ Setting out Eth nicity Enrolled A nalyz ed Placebo- controlled trials F ujii no/no 44 105/ 0/ 2004a 100% women 100/ 0/ Single C enter N R 100 100 Antiemetics Page 476 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 14. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or Y ear Setting R esults A dverse events Placebo- controlled trials F ujii C omplete controlofemeticsymptoms over24 h ours (pvs placebo) Th e mostfrequentadverse eventwas 2004a granisetron10 mcg/kg:35% (p=0. Incidence (5% -10% )did not Single C enter granisetron20 mcg/kg:85% (p=0. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or Y ear Design O th erpopulation Setting Trialtype Type ofSurgery ch aracteristics Inclusioncriteria F ujii DB R C T L aparoscopicch olecystectomy N o patients with a h istory of M ale and female patients ages 23 to 68 2004b Parallel Indicationforsurgery: motionsickness and/orPO N V years with A SA ph ysicalstatus I (no Single C enter Placebo Symptomaticch olelith iasis:77% organic,ph ysiologic,bioch emical,or ch olecysticpolyp:12% psych iatricdisturbance)wh o were ch ronicch olecystitis:11% experiencingnausea lasting>10 minutes or retch ingorvomitingwith 3 h ours after recovery from generalanesth esia for laparoscopicch olecystectomy. Antiemetics Page 478 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 14. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or Y ear Setting Exclusioncriteria Intervention A llowed oth erm edication F ujii Patients wh o received antiemetics with in24 h ours a)granistronIV 10 mcg/kg Indometh acin50 mgifth e patient 2004b before surgery,wh o h ad gastrointestinaldisease, b)granistronIV 20 mcg/kg experienced painpostoperatively. Single C enter wh o h ad a h istory ofmotionsickness and/orPO N V. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or M eanA ge Screened/ W ith drawn/ Y ear R un-in/W ash G ender Eligible/ L ostto fu/ Setting out Eth nicity Enrolled A nalyz ed F ujii no/no 47 105/100/100 N R /N R /100 2004b 60% women Single C enter N R Antiemetics Page 480 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 14. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or Y ear Setting R esults A dverse events F ujii Emesis free over24 h ours (pvs placebo) Th e mostfrequentadverse eventwas 2004b granisetron10 mcg/kg:55% (N S) h eadach e. Incidence (5% -10% )did not Single C enter granisetron20 mcg/kg:85% (p=0. N o nausea over24 h ours (pvs placebo) granisetron10 mcg/kg:65% (N S) granisetron20 mcg/kg:90% (N S) granisetron40 mcg/kg:90% (N S) granisetron80 mcg/kg:90% (N S) placebo:70% N o vomitingover24 h ours (pvs placebo) granisetron10 mcg/kg:75% (N S) granisetron20 mcg/kg:95% (N S) granisetron40 mcg/kg:95% (N S) granisetron80 mcg/kg:95% (N S) placebo:80% Severity ofnausea,median(range);0=none,10=severe (pvs placebo) granisetron10 mcg/kg:8 (6-10)(N S) granisetron20 mcg/kg:5 (4-6)(p=0. Q uality assessm ents ofth e com parative clinicaltrials oftreatm entofestablish ed postoperative nauseaand vom iting A uth or Y ear Screened/ Setting R un-in/ Eligible/ (subpopulation) Trialtype Exclusioncriteria W ash out Enrolled C andiotti A ctive Patients with knownh ypersensitivity to 5H T3 drugs,BM I >35,significantsystemic no/no N R /N R /250 2007 disease patients wh o h ad nausea orvomiting24 h ours before study,any patient Single C enter takingantiemetics,steroids,H 2 antagonists,antich olinergics,antih istamines, butyroph enones,ph enoth iaz ines,ormetoclopramide with in24 h ours before surgery C olom a A ctive Patients were excluded ifth ey h ad takenanantiemeticagentwith in24 h ours prior no/no 268/90/90 2002 to th e operation,were pregnant,experiencingmenstrualsymptoms,h ad previous Single C enter experience with acustimulaitonth erapy,h ad a permanentcardiacpacemaker,or experienced vomitingorretch ingwith in24 h ours before surgery. Dabbous A ctive Patients receivingpre-orintraoperative antiemetics;postoperative painscores >5, no/no N R /N R /173 2001 patients wh o received postoperative narcotics,pregnantfemales,patients with a Single C enter nasogastrictube remainingpostoperatively,and sedationscores >1 (degree of sedationwas assessed as 1=awake,2=drowsy,3=asleep). F ujii A ctive Patients wh o h ad gastrointestinaldisease,h ad takenantiemetics with in24 h ours no/no 80/75/75 2003 before surgery,orwh o were pregnant,menstruating,orreceivingh ormonalth erapy. Single C enter U nlugenc A ctive A h istory ofmotionsickness,previous postoperative vomiting,knownmajororgan no/no 453/N R /120 2003,2004 disease,A SA >II,body weigh t>100% overideal,a h istory ofalcoh olordrugabuse, Single C enter orreceiptofanantiemeticagentwith in24 h ours. W inston A ctive Subjects excluded ifth ey reported sensitivity to isopropylalcoh olorondansetron, no/no N R /N R /100 2003 h ad animpaired ability to breath e th rough th e nose,were pregnantorusingth e Single C enter medicationdisulfiram,reported preexistingnausea,orreported any antiemeticuse with in24 h ours before surgery. Patients wh o reported a h istory ofsignificant PO N V,defined as nausea orvomitingresistantto antiemeticth erapy,orh ad a h istory ofalcoh olism were excluded. Antiemetics Page 482 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 15. Q uality assessm ents ofth e com parative clinicaltrials oftreatm entofestablish ed postoperative nauseaand vom iting A uth or A ttrition Y ear W ith drawn/ Eligibility C are C rossover Setting L ostto fu/ G roups sim ilar criteria provider Patients A dh erence L oss to (subpopulation) A nalyz ed R andom iz ation A llocation atbaseline specified m asked m asked C ontam ination follow up C andiotti 7/N R /88 Y es Y es N o similaron Y es N R N R Y es N o 2007 age orETO H N o Single C enter use,butsimilar Y es onalloth er N o ch aracteristics C olom a N R /7/90 Y es N R N o Y es Y es Y es Y es N o 2002 N o Single C enter Y es N o Dabbous N R /N R /173 Y es N R Y es Y es Y es Y es N o N o 2001 N o Single C enter N o N o F ujii N R /N R /75 Y es N R Y es Y es Y es Y es N o N o 2003 N o Single C enter N o N o U nlugenc N R /N R /120 Y es N R Y es Y es Y es Y es N o N ot 2003,2004 N o reported Single C enter N o N o W inston N R /N R /100 N R N R Y es Y es Y es Y es N o N o 2003 N o Single C enter N o N o Antiemetics Page 483 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 15. Q uality assessm ents ofth e com parative clinicaltrials oftreatm entofestablish ed postoperative nauseaand vom iting A uth or Y ear Post Setting Intention-to-treat random iz ation Q uality C ontrolled group (subpopulation) analysis exclusions rating standard ofcare F unding C andiotti U nclear N o F air N o N R 2007 Single C enter C olom a Y es N o F air Y es G laxoSmith K line and 2002 W oodside Single C enter Biomedical Dabbous Y es (but24-h our N o F air Y es N otreported 2001 results not Single C enter reported? Q uality assessm ents ofth e com parative clinicaltrials oftreatm entofestablish ed postoperative nauseaand vom iting A uth or Y ear Screened/ Setting R un-in/ Eligible/ (subpopulation) Trialtype Exclusioncriteria W ash out Enrolled F ujii Placebo A ntiemetics given<= 24 h ours before surgery,gastrointestinaldisease, 105/100/100 2004 menstruation,and a h istory ofmotionsickness and/orpostoperative emetic Single C enter symptoms. Tz eng Placebo Patients with a h istory ofPO N V,motionsickness,orgastrointestinaldisorders,a N R /N R /70 2003 majorsystemicdisease (e. Patients wh o needed rescue analgesics forpainduringsurgery were also excluded. Antiemetics Page 485 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 15. Q uality assessm ents ofth e com parative clinicaltrials oftreatm entofestablish ed postoperative nauseaand vom iting A uth or A ttrition Y ear W ith drawn/ Eligibility C are C rossover Setting L ostto fu/ G roups sim ilar criteria provider Patients A dh erence L oss to (subpopulation) A nalyz ed R andom iz ation A llocation atbaseline specified m asked m asked C ontam ination follow up F ujii Y es N R Y es Y es Y es Y es Y es N o 2004 N o Single C enter N o N o Tz eng Y es N R unable to Y es Y es Y es Y es N o 2003 determine N o Single C enter N o N o Antiemetics Page 486 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 15. Q uality assessm ents ofth e com parative clinicaltrials oftreatm entofestablish ed postoperative nauseaand vom iting A uth or Y ear Post Setting Intention-to-treat random iz ation Q uality C ontrolled group (subpopulation) analysis exclusions rating standard ofcare F unding F ujii Y es N o F air N otreported 2004 Single C enter Tz eng N o Y es F air N otreported 2003 Single C enter Antiemetics Page 487 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 16. L ong term uncontrolled interventionstudies ofsafety and adverse events A uth or A ge (m ean) Y ear Exposure 5-H T3 C oncom itant A scertainm ent G ender-% fem ale C ountry duration A ntagonist m edication tech niques Eth nicity A dults C h arbit Single dose O ndansetron4mgiv N R EC G readings 45 years 2005 60% female Eth nicity N R K irch ner U nclear Dolasetron10-50 mgiv N R A dverse events ch ecklist 46. L ong term uncontrolled interventionstudies ofsafety and adverse events A uth or Screened W ith drawn Y ear H esketh Score Eligible L ostto fu C ountry Prim ary m alignancy Enrolled A nalyz ed Safety O utcom es A dults C h arbit 5 N R N R SignificantQ Tcch anges observed duringth e 15 minutes after 2005 N R N R N R antiemeticdrugadministration(p<0. L ong term uncontrolled interventionstudies ofsafety and adverse events A uth or A ge (m ean) Y ear Exposure 5-H T3 C oncom itant A scertainm ent G ender-% fem ale C ountry duration A ntagonist m edication tech niques Eth nicity C h ildren C raft Single dose G ranisetron40 mg/kgiv N one M eanage N R (range=2- 1995 16 yrs) 45% female 97. L ong term uncontrolled interventionstudies ofsafety and adverse events A uth or Screened W ith drawn Y ear H esketh Score Eligible L ostto fu C ountry Prim ary m alignancy Enrolled A nalyz ed Safety O utcom es C h ildren C raft U nclear(dosages N R ) N R N R H yponatremia:1 patient 1995 A cute lymph oblasticleukemia N R N R 40 N R H ewitt U nclear N R 25 W ith drawaldue to majoradverse events:3 patients Patient1: 1993 N R N R 0 moderate h eadach es 200 200 Patient2:transientnystagmus,diplopia and ataxia Patient3:renalfailure Pinkerton G roupA :5 N R N R O ne ch ild developed h epatitis 1990 G roupB:4 N R N R G roup3:4 30 N R Solid tumors Antiemetics Page 491 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 17. Q uality assessm entoflong term uncontrolled interventionstudies ofsafety and adverse events A scertainm ent N on-biased and A dverse events tech niques adequate Statisticalanalysis A uth or N on-biased L ow overallloss pre-specified and adequately ascertainm ent ofpotential O veralladverse event Y ear selection? 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 INTRODUCTION.......................................................................................................................... What is the comparative efficacy of different proton pump inhibitors in patients with symptoms of gastroesophageal reflux disease? What is the comparative effectiveness of different proton pump inhibitors in treating patients with peptic ulcer and nonsteroidal anti-inflammatory drug-induced ulcer?............................... What is the comparative effectiveness of different proton pump inhibitors in preventing ulcer in patients taking a nonsteroidal anti-inflammatory drug? What is the comparative effectiveness of different proton pump inhibitors in eradicating Helicobacter pylori infection?............................................................................................... Is there evidence that a particular treatment strategy is more effective or safer than another for longer-term treatment (more than 8 weeks) in patients with gastroesophageal reflux disease?.................................................................................................................................................. What is the comparative safety of different proton pump inhibitors in patients being treated for symptoms of gastroesophageal reflux disease, peptic ulcer, and nonsteroidal anti- inflammatory drug-induced ulcer? Are there subgroups of patients based on demographics, other medications, or comorbidities for which a particular medication or preparation is more effective or associated with fewer adverse effects? Proton pump inhibitors and their US Food and Drug Administration-approved indications...... Symptom resolution in head-to-head trials in patients with erosive gastroesophageal reflux disease................................................................................................................................................... Symptom resolution at 4 weeks in trials of esomeprazole compared with another proton pump inhibitor in erosive gastroesophageal reflux disease............................................................................. Time to symptom relief in trials comparing esomeprazole with omeprazole in erosive gastroesophageal reflux disease........................................................................................................... Pooled estimates of healing rates for esophagitis in head-to-head trials of proton pump inhibitors................................................................................................................................................. Risk differences in healing of esophagitis in trials of omeprazole 20 mg compared with another proton pump inhibitor................................................................................................................ Risk differences in healing of esophagitis in head-to-head trials of esomeprazole 40 mg compared with lansoprazole 30 mg.......................................................................................................

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