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Characteristics of the included trials are presented in Table 7 and results for HbA1c and weight in Table 8 pregnancy nesting cheap xeloda 500 mg amex. Three studies included patients who were not achieving glycemic 24-26 goals on insulin with or without oral agents breast cancer watch buy xeloda with a mastercard. One study included patients not achieving 22 glycemic goals regardless of insulin or oral agent use pregnancy 34 weeks cheap xeloda master card. None of the trials were pooled due to significant heterogeneity. Characteristics of pramlintide trials (placebo and active controlled) in adults with type 2 diabetes Sample Age (years) Baseline a size (N) (SD) HbA1c (%) a a Author, year Follow- % Female (SD) a Country up % White Weight Intervention Background a a Quality (weeks) % Hispanic (kg) Dosages therapy Pramlintide: 30 mcg, 75 mcg, 150 b 55. To avoid duplication, the data are not presented here. Dose-ranging study The addition of pramlintide 75 mcg/meal or 150 mcg/meal to fixed-dose insulin, with or without oral hypoglycemic agents (metformin or sulfonylureas), improved HbA1c by 0. No significant differences in HbA1c were observed between 2 pramlintide doses at the end of the trial: pramlintide 75 mcg (−0. The largest reductions in HbA1c (almost 1%) occurred early on at week 13 for those on the 150 mcg dose. This trial was rated fair quality, but there are some aspects of the design and reporting that limit the validity of the results. These include high withdrawal rates (~30%) which were similar for placebo, pramlintide 30 mcg and 75 mcg groups. Those randomized to pramlintide 150 mcg dose exhibited largest rates of total withdrawal and withdrawal due to adverse events (37. Stable insulin dosing The addition of pramlintide 90 mcg or 120 mcg to fixed or stable doses of insulin with or without oral hypoglycemic agents (metformin or sulfonylureas) gave slightly larger improvements in HbA1c and weight at 52 weeks than patients randomized to placebo plus fixed-dose insulin (placebo-corrected values for HbA1c: 90 mcg: −0. Effect on HbA1c was greatest at 26 weeks for both pramlintide groups (P<0. Approximately 20% to 27% of all randomized patients were taking oral hypoglycemic agents at baseline. As a result, efficacy and safety information from the 60 mcg arm were not reported by this trial. Flexible insulin dosing 24 In contrast to the previous study, another short-term fair-quality trial evaluated pramlintide as a pre-meal medication in conjunction with glargine (without prandial insulin) with or without oral hypoglycemic agents (metformin, sulfonylureas, and/or thiazolidinediones). The comparison group was patients on flexible-dose glargine plus placebo. At 16 weeks, the addition of pramlintide to glargine reduced HbA1c by 0. Glargine, a basal insulin without pronounced peak effects, was allowed to be adjusted during the study to achieve prespecified fasting glucose targets once pramlintide doses were stabilized. Both basal and RAIA were allowed to be titrated at the investigators discretion, however basal insulin was titrated once or twice weekly to fasting glucose 70-100 mg/dL and RAIA could be titrated only after 4 weeks of basal titration to avoid hypoglycemia. RAIA was increased by 1-2 units every 3- 7 days per the investigator based on glucose readings prior to the next meal. RAIA resulted in a non-statistically significant greater HbA1c reduction over pramlintide by 0. No change in weight was noted in the pramlintide group, however patients randomized to RAIA did experience significantly more weight gain, mean change from baseline 4. Baseline HbA1c was similarly elevated to previously described studies at 8. Of the patients in the pramlintide group, 27% were using basal insulin at doses averaging 20-24 units per day, as were 24% of patients in the placebo group. Efficacy outcomes of placebo and active-control trials of pramlintide in type 2 diabetes Change in weight from Author, year Change in HbA1c from baseline (%) baseline (kg) 16 weeks 16 weeks Riddle, 60/120 60/120 BID- 24 PBO PBO 2007 BID-TID TID −0. Summary of Findings for DPP-IV Inhibitors Eighteen randomized controlled trials for sitagliptin and 5 randomized controlled trials for saxagliptin fulfilled inclusion criteria. Four of the sitagliptin randomized controlled trials were identified through dossier submission, 2 of which were extensions of other studies included. Two systematic reviews including sitagliptin also met inclusion criteria. No comparative cohort or case-control studies were identified reporting either long-term benefits or adverse events. In the US Food and Drug Administration Medical and Statistical Reviews we identified 10 relevant 27 trials for sitagliptin, of which 7 were published in peer-reviewed journals.

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We attempted to identify additional studies through hand searches of reference lists of included studies and reviews pregnancy emotions 500mg xeloda fast delivery. In addition menstrual 35 day cycle purchase xeloda 500mg mastercard, we searched the US Food and Drug Administration’s Center for Drug Evaluation and Research website for medical and statistical reviews of individual drug products womens health movement purchase xeloda 500 mg with mastercard. Finally, we requested dossiers of published and unpublished information from the relevant pharmaceutical companies for this review. All received dossiers were screened for studies or data not found through other searches. All citations were imported into an electronic database (Endnote XI, Thomson Reuters). DRIs, AIIRAs, and ACE-Is Page 15 of 144 Final Report Drug Effectiveness Review Project Study Selection Selection of included studies was based on the inclusion criteria created by the Drug Effectiveness Review Project participants, as described above. Two reviewers independently assessed titles and abstracts of citations identified through literature searches for inclusion using the criteria below. Full-text articles of potentially relevant citations were retrieved and again were assessed for inclusion by both reviewers. Results published only in abstract form were not included because inadequate details were available for quality assessment. Data Abstraction The following data were abstracted from included trials: study design; setting; population characteristics, including sex, age, ethnicity, and diagnosis; eligibility and exclusion criteria; interventions (dose and duration); comparisons; numbers screened, eligible, enrolled, and lost to follow-up; method of outcome ascertainment; and results for each outcome. We recorded intention-to-treat results when reported. If true intention-to-treat results were not reported, but loss to follow-up was very small, we considered these results to be intention-to-treat results. In cases where only per protocol results were reported, we calculated intention-to-treat results if the data for these calculations were available. Data abstraction was performed by one reviewer and independently checked by a second reviewer. For the body of evidence in adults with hypertension, complete data abstraction for the majority of trials was publicly available in a good-quality systematic review completed by the 21, 22 Duke Evidence-based Practice Center in November, 2007. We therefore only completed de novo data abstraction for additional trials that we identified. Validity Assessment We assessed the internal validity (quality) of trials based on the predefined criteria listed in Appendix C. These criteria are based on the US Preventive Services Task Force and the National 23, 24 Health Service Centre for Reviews and Dissemination (United Kingdom) criteria. We rated the internal validity of each trial based on the methods used for randomization, allocation concealment, and blinding; the similarity of compared groups at baseline; maintenance of comparable groups; adequate reporting of dropouts, attrition, crossover, adherence, and contamination; loss to follow-up; and the use of intention-to-treat analysis. Trials that had a fatal flaw were rated poor quality; trials that met all criteria were rated good quality; the remainder were rated fair quality. As the fair-quality category is broad, studies with this rating vary in their strengths and weaknesses: The results of some fair-quality studies are likely to be valid, while others are only possibly valid. A poor-quality trial is not valid; the results are at least as likely to reflect flaws in the study design as a true difference between the compared drugs. A fatal flaw is reflected by failure to meet combinations of items of the quality assessment checklist. Quality assessment of all trials was independently performed by 1 reviewer. We did not rate the quality of observational studies. DRIs, AIIRAs, and ACE-Is Page 16 of 144 Final Report Drug Effectiveness Review Project For the trials of adults with hypertension for which quality assessments were previously completed by the Duke Evidence-based Practice Center (http://www. Only in cases where there was a disagreement between the quality assessment of the initial Oregon Evidence-based Practice Center reviewer and the Duke Evidence-based Practice Center, was a second independent quality assessment completed (L. Included systematic reviews were also rated for quality (see Appendix C). We rated the internal validity based on a clear statement of the questions(s); reporting of inclusion criteria; methods used for identifying literature (the search strategy), validity assessment, and synthesis of evidence; and details provided about included studies. Again, these studies were categorized as good when all criteria were met. The overall strength of evidence for a body of evidence for each key question and outcome reflects the risk of bias of the studies (based on quality and study designs), consistency 25 of results, directness of the evidence, and the precision of pooled estimates.

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Glatiramer acetate Beta interferons compared with glatiramer acetate Two head-to-head trials in patients with relapsing-remitting multiple sclerosis compared 58 menstrual cramps 8 weeks postpartum buy xeloda 500mg online, 59 glatiramer acetate to a beta interferon and reported adverse events (Table 33) pregnancy underwear proven xeloda 500mg. The BEYOND ® trial (N=2244) menopause sleep 500mg xeloda mastercard, comparing daily glatiramer acetate (Copaxone ) 20 mg SC to interferon beta-1b ® (Betaseron ) 250µg or 500µg SC every other day in patients with relapsing-remitting multiple 59 sclerosis, lasted 3. Adverse events from these 2 trials suggested that both drugs have similar tolerability, with severe adverse events being ® reported by 11% of patients taking interferon beta-1b (Betaseron ) 250µg and 13% of patients taking glatiramer acetate in the BEYOND trial, and no significant differences in withdrawal due 58, 59 to adverse events noted in the REGARD trial. Overall, the interferons had higher frequency of influenza-like illness (P<0. Glatiramer acetate had higher frequency of injection site reactions and post-injection systemic response (which may include dyspnea, chest pain, flushing, or post-procedural 58, 59 58, 59 complication). Lipoatrophy was only reported in patients receiving glatiramer acetate. Disease-modifying drugs for multiple sclerosis Page 69 of 120 Final Report Update 1 Drug Effectiveness Review Project Table 33. Adverse events: Glatiramer acetate compared with interferons in relapsing-remitting multiple sclerosis Interferon beta-1b SC Interferon beta-1a ® (Betaseron ) SC Glatiramer acetate 59 ® 58 ® 58, 59 Adverse event 250µg or 500µg (Rebif ) 44 µg (Copaxone ) 6% (BEYOND), P<0. An additional 6 publications in relapsing-remitting multiple sclerosis provided data on 165-170 the long-term safety of glatiramer acetate use. Miller et al provided the longest safety data with up to 22 years of follow-up. In 1978 a placebo-controlled randomized pilot study was 170 initiated for patients with relapsing-remitting multiple sclerosis. Patients enrolled in this trial were allowed to participate in an open-label, compassionate-use trial of glatiramer acetate SC 20 mg daily in 1986. Adverse events were reported monthly using a self-evaluation form. Forty-six patients were included in the long-term safety analysis with the duration of therapy ranging from 0. The most common adverse event was injection site reactions. Additionally, 33% of the 18 planning to continue glatiramer acetate beyond the October 2004 study close date had reported lipoatrophy. These patients had been on the study drug the longest of the cohort. Disease-modifying drugs for multiple sclerosis Page 70 of 120 Final Report Update 1 Drug Effectiveness Review Project 166-168 Results of this study have been reported at 6, 8, and 10 years following randomization. Of 232 who received at least 1 dose of glatiramer acetate, 108 (47%) were still enrolled at the 10- year follow-up. In this study, adverse events accounted for the greatest number of withdrawals (87/124; 70%), however, patients stayed on the drug for an extended period of time with a Kaplan-Meier estimate of median time from initiation of therapy with glatiramer acetate to withdrawal of 9. No serious adverse events were reported over the course of follow-up. Injection-site reactions and post-injection systemic reactions were the most commonly reported 168 adverse events, although incidence of both appeared to dissipate with long-term use. These data should be interpreted as representing a highly selected population of patients tolerant to and receiving benefit from glatiramer acetate. An open-label trial compared the effects of glatiramer acetate in relapsing-remitting ® multiple sclerosis patients who were prior users of interferon beta-1b SC (Betaseron ) compared 165 with treatment-naive patients. Reported adverse events (most commonly injection-site reactions) and rates were similar between the 2 groups and to those reported in the placebo-controlled trials. For both groups in this study, withdrawal rates due to adverse events were significantly higher when compared with the placebo-controlled trials (10. The reason for this difference may be due to study design. The open-label trial enrolled patients based on compassionate-use and used very few exclusion criteria, while the placebo-controlled trials were more restrictive in enrolling patients. Another open-label observational study conducted in France between 1997 and 2002, when glatiramer acetate was restricted to patients with relapsing-remitting multiple sclerosis that had contraindications or intolerance to beta interferons, also found that the drug was well 169 tolerated. While these data appeared to support the superiority of glatiramer acetate in tolerability over interferon, the fact that no difference was found in the direct comparison studies raises the concern that potentially important differences among the population treated with glatiramer acetate compared with the others may have contributed to these results.