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By C. Mortis. New York Law School.

Urticaria Direct evidence Five head-to-head trials in adults with urticaria are shown in Table 4 and in Evidence Tables 5 73-77 74 exforge 80 mg with mastercard, 77 and 6 exforge 80mg free shipping. Two fair-quality discount 80mg exforge fast delivery, head-to-head trials compared cetirizine to loratadine. In 1 trial, loratadine reduced mean Total Symptom Score more than cetirizine. Response rates were higher with loratadine in both trials, but the difference was not statistically significant in one (63% 74 compared with 45%) and the P value was not reported in the other (81% compared with 77 60%). The latter study reported that the number, size, and duration of lesions was significantly improved in patients taking loratadine (P<0. Cetirizine 10 mg daily was more 75 efficacious than fexofenadine 180 mg daily at 28-day follow-up. This study was limited by an attrition rate of 16%, and data were presented only for those completing the study. Antihistamines Page 20 of 72 Final Report Update 2 Drug Effectiveness Review Project 73, 76 Two head-to-head trials compared levocetirizine to another newer antihistamine. A trial of 886 adults with urticaria compared mean pruritus score of levocetirizine 5 mg compared 76 with desloratadine 5 mg after 4 weeks of treatment. Levocetirizine decreased pruritus severity significantly more than desloratadine after 1 week, the primary outcome. Mean symptom scores were improved more with levocetirizine. Levocetirizine was also significantly better than desloratadine on patients’ global satisfaction at 1 week and 4 weeks, and on investigators’ global satisfaction at 1 week, but not on endpoint. Quality-of-life was assessed, and was improved in both treatment groups, but no analysis was done. In a crossover trial, 45 patients who had achieved complete symptomatic control with cetirizine 10 mg after 6 weeks were then switched 73 to levocetirizine 5 mg for an additional 6 weeks. Wheal and flare response was similar with both drugs, but the itch response was better with cetirizine in 70% of patients. This study was open-label and had a high dropout rate. Antihistamines Page 21 of 72 Final Report Update 2 Drug Effectiveness Review Project Table 4. Head-to-head trials in adults with urticaria Author Year Drug, dosage Condition Number of subjects Quality Duration Results Cetirizine compared with fexofenadine Cetirizine vs. Indirect evidence 78-86 Nine placebo-controlled trials examined efficacy in adults with chronic idiopathic urticaria. Of the 7 fair- or better- 78, 81, 83, 84 80, 82 quality trials, 4 included desloratadine 5 mg, 2 included levocetirizine 5 mg, and 1 79 included fexofenadine 180 mg. All found the active treatment group superior to placebo for Antihistamines Page 22 of 72 Final Report Update 2 Drug Effectiveness Review Project reducing symptoms. Indirect comparisons that can be made from these studies were limited due to differences in outcome measures and reporting. Improved quality-of-life was reported with desloratadine and levocetirizine compared with placebo in 2 studies, both using the validated 78, 80 Dermatology Life Quality Index. A search for literature on the efficacy or effectiveness of newer antihistamines in other 88-92 types of urticaria in adults identified only poor-quality studies. Children Seasonal allergic rhinitis Ten studies examined the efficacy of newer antihistamines among children (Evidence Tables 7 93, 94 and 8), and 2 of these studies were of poor quality (See Appendix F for poor-quality studies). One head-to head study of azelastine nasal spray compared with olopatadine nasal spray enrolled 34 both adolescents and adults, but the results for children were not reported separately. The 95-99 100 results of placebo-controlled trials of cetirizine and fexofenadine demonstrated significant improvements in symptoms with the study drug compared with placebo. Jordana and colleagues found that fluticasone nasal spray was more efficacious than loratadine for nasal symptoms, but there were no significant differences for eye symptoms. Perennial allergic rhinitis Eleven studies (see Table 5 and Evidence Tables 9 and 10) were identified which examined the 99-101, 104-111, efficacy of newer antihistamines among children with perennial allergic rhinitis, 1 of 103 110, 112 which was of poor quality. Two studies examined children 2 to 6 years old, most examined children 6 to 12 or 14 years old. Two studies primarily focused on adults, but included 55, 113 participants 12 years of age and older. These studies are presented with the adult studies, as data were not stratified by age group to allow for examination of adolescents only. Inclusion criteria generally required a positive response to a skin test for house-dust mite allergy or other non-seasonal respiratory allergens along with a clinical history consistent with perennial allergic rhinitis. Children with major systemic illnesses were excluded. One trial compared cetirizine to loratadine 110 among children 2 to 6 years of age. The primary outcome was the histamine skin prick test and cetirizine produced greater inhibition of the wheal response than loratadine (P<0. Both drugs produced improvements in parent- and investigator-assessed symptoms, with loratadine significantly more efficacious than cetirizine (P<0. No significant differences were noted between groups in investigator-assessed global evaluation score or in nasal eosinophil count. The second head-to-head trial compared cetirizine to levocetirizine over 12 weeks in 80 114 children ages 6 to 12 years with perennial allergic rhinitis. Both drugs improved Total Symptom Score and quality of life as measured by the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire compared with placebo. There was significantly more improvement in Total Symptom Score at 8 and 12 weeks with cetirizine, but no difference between groups in improvement in quality of life. Antihistamines Page 23 of 72 Final Report Update 2 Drug Effectiveness Review Project In 3 studies with active controls, cetirizine improved symptoms compared with placebo 109 arms and compared with ketotifen and oxatomide. Cetirizine was comparable to montelukast 107 112 in 1 study, but similar in efficacy in another. Three fair-quality, placebo-controlled 104, 105, 108 studies found cetirizine efficacious for nasal symptoms, particularly at a dosage of 10 mg daily (either at bed time or divided doses twice daily) for children 6 to 12 years. A single study examining loratadine noted it to be efficacious at a dosage of 5 to 10 mg 111 daily when compared to placebo. One study found azelastine nasal spray efficacious compared 115 to placebo at 6 weeks. There were no data on any of the other newer antihistamines in children. Outcomes from trials in children with perennial allergic rhinitis Length Mean of Author Drug dosage age follow- Year Number of Range up Quality subjects (years) (weeks) Total Symptom Score Other outcomes Head-to-head trials Global Evaluation Score assessed by investigator: C: cetirizine 0.

Trials that assume a class effect and only provide a comparison to a treatment group consisting of multiple AIIRAs or multiple ACE-Is (trials that don’t stratify by individual AIIRAs or ACE-Is) will be excluded exforge 80 mg cheap. Randomized controlled trials order exforge master card, controlled clinical trials safe 80 mg exforge, and good-quality systematic reviews included for effectiveness/efficacy outcomes that: a. Made direct inter-class comparisons between DRI, ACE-I and AIIRA drugs. Large single-group or multi-group population-based cohort (N≥1000) or case-control (N≥500 cases) studies that evaluated major harms. If studies with these sample sizes were not identified studies of N≥200 were considered. Literature Search We searched Ovid MEDLINE (1950-June week 2, 2009), the Cochrane Database of Systematic nd nd Reviews (2 Quarter 2009), and the Cochrane Central Register of Controlled Trials (2 Quarter, 2009) using included drugs, indications, and study designs as search terms. We attempted to identify additional studies through hand searches of reference lists of included studies and reviews. In addition, 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. 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. Strength of evidence was graded as very low, low, moderate, or high. In order to simplify our approach for this review, we did not grade bodies of evidence in which only a single study was available and “Strength of Evidence” grades are listed as “not applicable” in the Summary of Evidence (Table 7). Data Synthesis We constructed evidence tables showing the study characteristics, quality ratings, and results for all included studies. We reviewed studies using a hierarchy of evidence approach, where the best evidence is the focus of our synthesis for each question, population, intervention, and outcome addressed. Both in the Evidence Tables and throughout the report, for all creatinine levels reported in units of micromole/L, we converted to units of mg/dL by dividing by 88. As there were no occasions in which a particular outcome was reported by a sufficient number of studies that were homogeneous enough that combining their results could be justified, no quantitative analyses were conducted using meta-analyses in this review. Therefore, the data were summarized only qualitatively throughout the report. Peer Review We requested and received peer review of the report from 3 experts. Their comments were reviewed and, where possible, incorporated into the final document. All comments and the authors’ proposed actions were reviewed by representatives of the participating organizations of the Drug Effectiveness Review Project before finalization of the report. Names of peer reviewers for the Drug Effectiveness Review Project are listed at www. DRIs, AIIRAs, and ACE-Is Page 17 of 144 Final Report Drug Effectiveness Review Project Public Comment This report was posted to the Drug Effectiveness Review Project website for public comment. We received comments from 3 pharmaceutical companies. RESULTS Overview Literature searches identified 1328 citations.

A systematic review of drug therapy to delay or prevent type 2 diabetes safe exforge 80 mg. Possible heart failure exacerbation associated with rosiglitazone: case report and literature review best 80 mg exforge. Thiazolidinediones for diabetes mellitus: Considerations for reimbursements by third-party payers cheap exforge 80mg with mastercard. Disease 2 Management and Health Outcomes 2004; 12 (6):363-75. Therapeutic potential of thiazolidinediones as anticancer agents. Effect of pioglitazone on lipids in well controlled patients with diabetes mellitus type 2 -- 5 results of a pilot study. Thiazolidinediones, peripheral oedema and congestive heart failure: What is the evidence? Effect of pioglitazone compared with metformin on glycemic control and 2 indicators of insulin sensitivity in recently diagnosed patients with type 2 diabetes. Impact of adjunctive thiazolidinedione therapy on blood lipid levels 5 and glycemic control in patients with type 2 diabetes. Mechanisms and relevance of idiosyncratic drug reactions. Improvement in Autonomic Function with Rosiglitazone in Type 2 Diabetes. Improvement of cardiovascular risk markers by pioglitazone is 2 independent from glycemic control: results from the pioneer study. Severe but reversible 6 Thiazolidinediones Page 126 of 193 Final Report Update 1 Drug Effectiveness Review Project cholestatic liver injury after pioglitazone therapy. In type 2 diabetes, rosiglitazone therapy for insulin resistance ameliorates 2 endothelial dysfunction independent of glucose control. The combined effect of triple therapy with rosiglitazone, metformin, and insulin 2 aspart in type 2 diabetic patients. Use of glimepiride and insulin sensitizers in the treatment of type 2 diabetes—a study in Indians. Economic model of first-line drug strategies to achieve 5 recommended glycaemic control in newly diagnosed type 2 diabetes mellitus. Addition of biphasic insulin aspart 30 to rosiglitazone in type 2 diabetes 6 mellitus that is poorly controlled with glibenclamide monotherapy. Combination therapy with pioglitazone plus metformin or sulfonylurea in patients with Type 2 diabetes: influence of 5 prior antidiabetic drug regimen. Novel actions of thiazolidinediones on vascular function and exercise capacity. Normalization of 1 impaired glucose tolerance with rosiglitazone. Investigacion Medica Internacional 2000; 27 (1):9-13. Metformin monotherapy for type 2 diabetes mellitus Cochrane Database of 2 Syst Rev 2005; 3:3. The effect of 5 rosiglitazone on urine albumin excretion in patients with type 2 diabetes mellitus and hypertension. Severe hypo-alpha-lipoproteinemia during treatment with rosiglitazone. Combined thiazolidinedione-insulin therapy: should we be 5 concerned about safety? Hepatotoxicity with thiazolidinediones: is it a class effect? Insulin 70/30 mix plus metformin versus triple oral therapy in the treatment of type 2 6 diabetes after failure of two oral drugs: Efficacy, safety, and cost analysis. Clinical effect of combination therapy of pioglitazone and 2 an alpha-glucosidase inhibitor. A comparison of the effects 2 of thiazolidinediones and metformin on metabolic control in patients with type Thiazolidinediones Page 127 of 193 Final Report Update 1 Drug Effectiveness Review Project 2 diabetes mellitus. Angioneurotic edema as a side effect of 6 pioglitazone. Pioglitazone-induced heart failure 6 despite normal left ventricular function. The effects of rosiglitazone, a peroxisome proliferator-activated receptor-gamma agonist, on markers of endothelial cell activation, C-reactive protein, and fibrinogen levels in non- 5 diabetic coronary artery disease patients. Rosiglitazone and heart failure: long-term vigilance. Journal of 6 Cardiovascular Pharmacology & Therapeutics 2004; 9 (1):21-5. Insulino-mimetic and anti-diabetic effects of 5 vanadium compounds. Peroxisome proliferator-activated receptor-gamma in thyroid eye 6 disease: contraindication for thiazolidinedione use? Pioglitazone reduces atherogenic index 2 of plasma in patients with type 2 diabetes. Pulmonary edema associated with rosiglitazone 6 and troglitazone. Effects of rosiglitazone and metformin on liver fat content, 2 hepatic insulin resistance, insulin clearance, and gene expression in adipose tissue in patients with type 2 diabetes. A diabetes outcome progression trial (ADOPT): an 2 international multicenter study of the comparative efficacy of rosiglitazone, glyburide, and metformin in recently diagnosed type 2 diabetes. Accelerated hypertension due to 6 rosiglitazone therapy. Spotlight on rosiglitazone in the management of 5 type 2 diabetes mellitus. Effect of pioglitazone on arteriosclerosis in comparison with that of glibenclamide. Rosiglitazone (Avandia) and pioglitazone (Actos) and heart 5 failure. Pioglitazone (AD-4833) 2 ameliorates insulin resistance in patients with NIDDM. Effect of antidiabetic medications on microalbuminuria in patients with type 2 diabetes. Effect of addition of low-dose rosiglitazone to sulphonylurea therapy Thiazolidinediones Page 128 of 193 Final Report Update 1 Drug Effectiveness Review Project on glycemic control in type 2 diabetic patients. Clinical study on rosiglitazone 2 monotherapy of early type 2 diabetes. Normal pregnancy outcome following inadvertent exposure to rosiglitazone, gliclazide, 6 and atorvastatin in a diabetic and hypertensive woman.

Race purchase exforge with paypal, sex or stage of disease does not seem to be relevant purchase genuine exforge on line. The individual’s general view of illness and health 80 mg exforge fast delivery, accepting modern medicine and fear of side effects are further consid- erations. However, all these factors vary greatly, and in the end, adherence is diffi- cult to predict in individual cases (Lerner 1998). The physician must rely on expe- rience and intuition. The importance of taking drugs regularly has been demonstrated in numerous studies. In one study with 99 patients, in which compliance was evaluated via an electronic monitoring system, the rate of viral treatment failure was only 22% in patients with a compliance level of at least 95% (95% of doses taken). Failure rates of 61% and as much as 80% were measured with a patient’s adherence between 80–94% and <80% (Paterson 2000). However, it must be taken into consideration that this much-cited study is outdated. Newer drugs, such as darunavir, with longer half-lives, higher resistance barriers and better overall pharmacokinetics may forgive a clearly higher non-compliance (Nelson 2010). In the previously mentioned study, clinicians misjudged their patient’s com- pliance in 41% of the cases. Nurses did better – judging incorrectly in only 30% of the cases (Paterson 2000). Adherence tends to be overestimated in other studies as well (Miller 2002). The importance of adherence was also demonstrated in patients with directly observed therapy (DOT) or directly administered ART (DAART), applied in some penal institutions in the US. In institutions in Florida, 100% of the patients in a DOT study achieved a viral load below 400 copies/ml after 48 weeks, compared to 81% in an unmonitored control group (Fischl 2001). According to one randomized study, response improved in drug-addicted patients receiving DAART (Maru 2009). However, more recent data indicate that effects of DAART with PI based regimens are marginal and disappear rapidly as soon as the patient is on his own (Gross 2009, Smith-Rohrberg 2009, Berg 2011). Only transient effects were seen in studies evalu- ating DOT in HIV+ methadone patients or in African patients (Nachega 2010, Berg 2011, Nahvi 2012). The virologic benefit of these strategies wanes following transi- tion to self-administered therapy. Figure 1: Absolute CD4 T cells (black, primary axis, left) and viral load (grey, dashed lines) in two HIV+ patients with adherence problems. Left: Female caucasian patient with only transient adherence. Right: African patient who takes ART only for weeks, followed by long interruptions and total absences from medical care. Over the years, in both patients, several AIDS defining illnesses and resistance mutations will have occurred 180 ART Poor adherence not only leads to virologic failure. It also bears immunological con- sequences (Mannheimer 2002). Moreover, poor adherence has clinical effects beyond surrogate markers. In a Spanish study, patients who did not take more than 10% of their drugs showed a four-fold increase of mortality risk (Garcia 2002). This data has been confirmed in other studies (Maher 1999, Hogg 2000, Wood 2004). Hospital stays are also less frequent in patients with high adherence to ART (Paterson 2000). In addition, it should be considered that non-adherent patients increase the risk of transmission of primary resistant viruses. The basic mechanisms for development of resistance should be explained to patients. Intensive early adherence counseling at ART initiation results in a sustained, signif- icant impact on adherence and less virologic treatment failure (Chung 2011). One must emphasize that, in contrast to other chronic illnesses, resistance mutations do not disappear once they have developed. These diseases may “tolerate” forgetting some tablets occasionally, but HIV is different. Blood glucose and blood pressure levels can easily be lowered again the next day, but with HIV this strategy may not work. Even short-term lapses can have irreversible consequences. And every new occurrence of resistance complicates therapy. Such conversations should be repeated from time to time and become a standard component of routine care. Cooperation with special treatment discussion groups offered by patient-centered support organizations can be useful. The 12-step table below provides additional sug- gestions. In addition, a number of strategies on improving adherence have been investigated. They range from employment of additional nurses and patient com- munity to telephoning patients regularly (Review: Kenya 2011). The effect of these strategies, however, depends on the individual setting of the patient (Collier 2005, Chung 2011, Pop-Eleches 2011). If adherence remains poor Despite all efforts, some patients will not succeed in improving their adherence. Physicians and other healthcare providers should not take this personally or feel offended. Although it may be difficult to accept the patient’s views on life, disease and treatment, healthcare providers must keep tolerance and acceptance as key com- ponents in their interactions with patients. Some providers, especially those who treat selective patient populations in university settings, tend to forget the reality of routine medical practice. Rigidly upholding the principles of modern medicine usually does not help here and putting patients under pressure achieves even less. It is important to clearly outline and explain, advise, help, question and listen. The question of whether noncompliant patients should continue to be treated with antiretroviral therapy is not always easy to address. On the one hand, there are patients who benefit even from suboptimal therapy; on the other hand, drugs are expensive and should not be prescribed too readily. Restraint should be applied until the reason for poor compliance is understood. Duesbergians – a sect Patients who refuse antiretroviral treatment on principle are a special case.

Extended- Release Carbamazepine Capsules as Monotherapy for Acute Mania in Bipolar Disorder: A Multicenter order exforge 80 mg, Randomized exforge 80 mg without prescription, Double-Blind order cheap exforge on-line, Placebo-Controlled Trial. Journal of Clinical Psychiatry Vol 66(3) Mar 2005, 323-330. Food and Drug Administration - Center for Drug Evaluation and Research. Carbamazepine versus lithium in mania: a double-blind study. Comparison of the antimanic efficacy of carbamazepine and lithium carbonate by double-blind controlled study. Carbamazepine compared with lithium in the treatment of mania. Carbamazepine vs chlorpromazine in mania: a double-blind trial. Carbamazepine and haloperidol v placebo and haloperidol in excited psychoses. Comparison of the antimanic efficacy of carbamazepine and chlorpromazine: a double-blind controlled study. Small JG, Klapper MH, Marhenke JD, Milstein V, Woodham GC, Kellams JJ. Lithium combined with carbamazepine or haloperidol in the treatment of mania. Carbamazepine versus haloperidol in manic syndromes—first report of a multicentric study in Germany In: Shagas, C. Topiramate and divalproex in combination with risperidone for acute mania: a randomized open-label study. Progress in Neuro- Psychopharmacology & Biological Psychiatry. Chengappa RKN, Schwarzman LK, Hulihan JF, Xiang J, Rosenthal NR, Clinical Affairs Product Support Study I. Adjunctive topiramate therapy in patients receiving a mood Antiepileptic drugs Page 58 of 117 Final Report Update 2 Drug Effectiveness Review Project stabilizer for bipolar I disorder: a randomized, placebo-controlled trial. Topiramate monotherapy in the management of acute mania: results of four double-blind placebo-controlled trials. The evolving role of topiramate among other mood stabilizers in the management of bipolar disorder. Lamotrigine compared with lithium in mania: a double-blind randomized controlled trial. Lamotrigine: a review of its use in bipolar disorder. Pande AC, Crockatt JG, Janney CA, Werth JL, Tsaroucha G. Gabapentin in bipolar disorder: a placebo-controlled trial of adjunctive therapy. A placebo-controlled study of lamotrigine and gabapentin monotherapy in refractory mood disorders. Phenytoin as an antimanic anticonvulsant: A controlled study. American Journal of Psychiatry Vol 157(3) Mar 2000, 463-465. Comparison of two anticonvulsants in a randomized, single-blind treatment of hypomanic symptoms in patients with bipolar disorder. A randomized, placebo-controlled 12- month trial of divalproex and lithium in treatment of outpatients with bipolar I disorder. Archives of General Psychiatry Vol 57(5) May 2000, 481-489. A 20-month, double-blind, maintenance trial of lithium versus divalproex in rapid-cycling bipolar disorder. Divalproex sodium treatment of women with borderline personality disorder and bipolar II disorder: a double-blind placebo-controlled pilot study. A pilot study of lithium carbonate plus divalproex sodium for the continuation and maintenance treatment of patients with bipolar I disorder. Salloum IM, Cornelius JR, Daley DC, Kirisci L, Himmelhoch JM, Thase ME. Efficacy of valproate maintenance in patients with bipolar disorder and alcoholism: a double-blind placebo-controlled study. Maintenance efficacy of divalproex in the prevention of bipolar depression. Neuropsychopharmacology Vol 28(7) Jul 2003, 1374- 1382. Calabrese JR, Rapport DJ, Youngstrom EA, Jackson K, Bilali S, Findling RL. New data on the use of lithium, divalproate, and lamotrigine in rapid cycling bipolar disorder. Antiepileptic drugs Page 59 of 117 Final Report Update 2 Drug Effectiveness Review Project European Psychiatry: the Journal of the Association of European Psychiatrists. Revicki DA, Hirschfeld RMA, Ahearn EP, Weisler RH, Palmer C, Keck PE, Jr. Effectiveness and medical costs of divalproex versus lithium in the treatment of bipolar disorder: results of a naturalistic clinical trial. Relationship of mania symptomatology to maintenance treatment response with divalproex, lithium, or placebo. Carbamazepine versus lithium in the prophylaxis of bipolar affective disorder. Denicoff KD, Smith-Jackson EE, Disney ER, Ali S, Leverich GS, Post RM. Comparative prophylactic efficacy of lithium, carbamazepine, and the combination in bipolar disorder. Journal of Clinical Psychiatry Vol 58(11) Nov 1997, 470-478. Hartong EG, Moleman P, Hoogduin CA, Broekman TG, Nolen WA. Prophylactic efficacy of lithium versus carbamazepine in treatment-naive bipolar patients. Journal of Clinical Psychiatry Vol 64(2) Feb 2003, 144-151. Carbamazepine vs lithium in the treatment and prophylaxis of mania. The comparative efficacy of carbamazepine low and high serum level and lithium carbonate in the prophylaxis of affective disorders. Long-term double-blind prospective study on carbamazepine versus lithium in bipolar and schizoaffective disorders: Preliminary results.

Randomized controlled trials of beta blockers for post myocardial infarction Author cheap exforge 80mg without a prescription, Year Interventions (drug discount exforge, regimen buy cheap exforge 80mg online, Allowed other medications/ Method of outcome assessment and Country duration) interventions timing of assessment Mrdovic 2007 Inhospital: Carvedilol vs. Metoprolol Patients were reviewed at 6-month metoprolol tartrate 50 mg bid Concomitant therapy: intervals for the assessment of tolerability carvedilol 12. Secondary end point: time to composite hard events (t-CHE) including cardiovascular death and nonfatal reinfarction. Health related quality of life: Short Form-36 (SF-36) questionnaire with 36 items and 8 domains. Each group of domains was reduced to a summary measure. Beta blockers Page 105 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 7. Randomized controlled trials of beta blockers for post myocardial infarction Number Number Author, Age screened/ withdrawn/ Year Gender eligible/ lost to fu/ Country Ethnicity Other population characteristics (diagnosis, etc) enrolled analyzed Mrdovic 2007 Carvedilol Diabetes Car= 26. Randomized controlled trials of beta blockers for post myocardial infarction Author, Method of adverse Year effects Country Outcomes assessment? Randomized controlled trials of beta blockers for post myocardial infarction Author, Year Withdrawals due to adverse events Country Adverse effects reported (%, adverse n/enrolled n) Comments Mrdovic 2007 Only patients who were withdrawn from the study due to Inhospital: car=8 (5%) vs. Beta blockers Page 108 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 7. Randomized controlled trials of beta blockers for post myocardial infarction Author, Year Study Country design Eligibility criteria Exclusion criteria Acebutolol vs placebo Boissel RCT At least 2 of the following risk factors: Heart rate <45 beats/min; complete 1990 (1) Typical chest pain of ≥ 1 hour in duration, typical Q auriculoventricular block and acute heart failure France waves and significant release of cardiac enzyme(s) that required treatment with ≥ 2 drugs of different (2) admitted for this acute event > 2 and < 22 days classes (e. Randomized controlled trials of beta blockers for post myocardial infarction Author, Year Interventions (drug, regimen, Allowed other medications/ Method of outcome assessment and Country duration) interventions timing of assessment Acebutolol vs placebo Boissel Acebutolol 400 mg daily NR Primary outcome: Total death 1990 Placebo x 1 year France Treatment initiated within 2-22 days Fair quality post-MI Beta blockers Page 110 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 7. Randomized controlled trials of beta blockers for post myocardial infarction Number Number Author, Age screened/ withdrawn/ Year Gender eligible/ lost to fu/ Country Ethnicity Other population characteristics (diagnosis, etc) enrolled analyzed Acebutolol vs placebo Boissel Mean age=62. Randomized controlled trials of beta blockers for post myocardial infarction Author, Method of adverse Year effects Country Outcomes assessment? Acebutolol vs placebo Boissel Acebutolol (n=298) vs placebo (n=309) nr 1990 France Total mortality: 17 (5. Randomized controlled trials of beta blockers for post myocardial infarction Author, Year Withdrawals due to adverse events Country Adverse effects reported (%, adverse n/enrolled n) Comments Acebutolol vs placebo Boissel Acebutolol (n=298) vs placebo (n=309) Acebutolol (n=298) vs placebo (n=309) 1990 France Angina pectoris: 98 (32. Randomized controlled trials of beta blockers for post myocardial infarction Author, Year Study Country design Eligibility criteria Exclusion criteria Carvedilol vs placebo Basu RCT Chest pain; ECG changes; serum concentration of Already on ACE or beta blockers; contraindications 1997 creatine kinase; MB isoform consistent with diagnosis to ACE or beta blockers; Killip class IV heart failure; UK cardiogenic shock; severe bradycardia; hypotension; second to third degree heart block; Fair quality left bundle branch block; severe valvular disease; insulin-dependent DM; renal failure; known malignancy; other severe disease; pregnancy Beta blockers Page 114 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 7. Randomized controlled trials of beta blockers for post myocardial infarction Author, Year Interventions (drug, regimen, Allowed other medications/ Method of outcome assessment and Country duration) interventions timing of assessment Carvedilol vs placebo Basu Carvedilol (car) 2. Randomized controlled trials of beta blockers for post myocardial infarction Number Number Author, Age screened/ withdrawn/ Year Gender eligible/ lost to fu/ Country Ethnicity Other population characteristics (diagnosis, etc) enrolled analyzed Carvedilol vs placebo Basu Mean age: car=60; pla=60 Site of MI: 416 146 analyzed 1997 % male: car=84; pal=84. Randomized controlled trials of beta blockers for post myocardial infarction Author, Method of adverse Year effects Country Outcomes assessment? Carvedilol vs placebo Basu Serious cardiac events: car=18(24%); pla=31(43. Randomized controlled trials of beta blockers for post myocardial infarction Author, Year Withdrawals due to adverse events Country Adverse effects reported (%, adverse n/enrolled n) Comments Carvedilol vs placebo Basu Dizziness(% patients): car=6. Randomized controlled trials of beta blockers for post myocardial infarction Author, Year Study Country design Eligibility criteria Exclusion criteria Anonymous, 2001; RCT >18 years; stable, definite MI occurring3-21 days prior Required continued diuretics or inotropes; McMurray 2005 to randomization; left-ventricular ejection fraction of uncontrollable heart failure; unstable angina; International 40% or less; receipt of concurrent treatment with ACE uncontrolled hypertension; bradycardia; unstable RCT inhibitors for at least 48 hours and stable dose for 24+ insulin-dependent DM; continuing indication for hours unless proven intolerance to ACE inhibitors; beta blockers for any condition other than heart Carvedilol Post- heart failure appropriately treated with diuretics and failure; requiring ongoing therapy with inhaled beta Infarct Survival ACE inhibitors during acute phase agonists or steroids Control in LV Dysfunction (CAPRICORN) Fair quality Beta blockers Page 119 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 7. Randomized controlled trials of beta blockers for post myocardial infarction Author, Year Interventions (drug, regimen, Allowed other medications/ Method of outcome assessment and Country duration) interventions timing of assessment Anonymous, 2001; Carvedilol (car) up to 50 mg daily ACE inhibitors(% patients)=98 Patients were reviewed every 3 months McMurray 2005 Placebo (pla) x 1. Randomized controlled trials of beta blockers for post myocardial infarction Number Number Author, Age screened/ withdrawn/ Year Gender eligible/ lost to fu/ Country Ethnicity Other population characteristics (diagnosis, etc) enrolled analyzed Anonymous, 2001; Carvedilol: Smoking history: NR/NR/1959 Permanent McMurray 2005 Mean age 63 Current - Car=33%; Pla=32% randomized withdrawals(excludi International 73% male Previous - Car=27%; Pla=25% ng death): RCT Placebo: Never - Car=39%; Pla=43% car=192(20%); Mean age 63 Medical history: pla=175(18%)/lost Carvedilol Post- 74% male Previous MI - Car=31%; Pla=29% to fu nr/1959 Infarct Survival Previous angina - Car=57%; Pla=54% analyzed Control in LV Previous hypertension - Car=55%; Pla=52% Dysfunction Previous DM - Car=21%; Pla=23% (CAPRICORN) Other vascular disease - Car=17%; Pla=16% Previous revascularization - Car=12%; Pla=11% Fair quality Hyperlipidemia - Car=32%; Pla=33% SIte of MI: Anterior - Car=59%; Pla=54% Inferior - Car=21%; Pla=21% Other - Car=20%; Pla=25% Medications at time of randomization: ACE inhibitor - Car=98%; Pla=97% Aspirin - Car=86%; Pla=86% Beta blockers Page 121 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 7. Randomized controlled trials of beta blockers for post myocardial infarction Author, Method of adverse Year effects Country Outcomes assessment? Anonymous, 2001; Co-primary endpoints(# patients/%) NR McMurray 2005 All-cause mortality: car=116(12%); pla=151(15%) (P=0. Randomized controlled trials of beta blockers for post myocardial infarction Author, Year Withdrawals due to adverse events Country Adverse effects reported (%, adverse n/enrolled n) Comments Anonymous, 2001; NR NR Original primary endpoint (all- McMurray 2005 First 30 days of the trial: cause mortality) amended International car=2. Randomized controlled trials of beta blockers for post myocardial infarction Author, Year Study Country design Eligibility criteria Exclusion criteria Metoprolol vs placebo Anonymous RCT Ages 45-74; hospitalized for acute MI History of CABG; permanent pacemaker; 1987 contraindication to beta blocker therapy; conditions USA likely to require beta blocker therapy; administration of any beta blocker within 3 days Lopressor before the start of pre-entry evaluation; planned Intervention Trial therapy with aspirin, sulfinpyrazone clofibrate;=, or dipyridamole; life threatening conditions other than Fair quality CHF; conditions likely to affect protocol compliance; history of adverse reaction to metoprolol or its analogues. Randomized controlled trials of beta blockers for post myocardial infarction Author, Year Interventions (drug, regimen, Allowed other medications/ Method of outcome assessment and Country duration) interventions timing of assessment Metoprolol vs placebo Anonymous Metoprolol (met) 200 mg daily Interim visits conducted at 1, 3, 7 and 12 1987 Placebo (pla) x 1 year months USA Treatment interval: 5-15 days post- Lopressor MI Intervention Trial Fair quality Hjalmarson, 1981 Metoprolol (met) 15 mg Arrhythmias: iv lidocaine or Physician examination at 1-week and 3 Herlitz, 1984 intravenously; 200 mg orally procainamide months after inclusion Herlitz, 1997 Placebo (pla) CHF: furosemide 40-80 mg iv, then Sweden oral Treatment interval(mean): 11. Randomized controlled trials of beta blockers for post myocardial infarction Number Number Author, Age screened/ withdrawn/ Year Gender eligible/ lost to fu/ Country Ethnicity Other population characteristics (diagnosis, etc) enrolled analyzed Metoprolol vs placebo Anonymous Mean age = 58 Previous medical history: NR/NR/2395 Withdrawn: 1987 % Male = 83% MI = 14. Randomized controlled trials of beta blockers for post myocardial infarction Author, Method of adverse Year effects Country Outcomes assessment? Metoprolol vs placebo Anonymous Total mortality (# patients/%) NR 1987

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