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By J. Dimitar. Saint Norbert College.

All drugs reported rare serious adverse events including risk of suicide (duloxetine 1 cheap 120mg cardizem amex. Indirect analysis of harms from placebo-controlled trials of pregabalin generic cardizem 120mg fast delivery, 49 milnacipran, and duloxetine for fibromyalgia Duloxetine vs. Of 6 trials reporting adverse events, they found that the mean adverse event rate for amitriptyline was 51. The high placebo event rate questioned the validity of the results given that 2 trials had higher adverse event rates in the placebo arm compared with 50 the amitriptyline arm. Amitriptyline was generally well tolerated in all the trials with no severe 50 or life threatening events reported. Somnolence, dry mouth, gastrointestinal symptoms, and weight gain were the most frequently reported adverse events and there were no differences in 50 withdrawal due to adverse events compared with placebo. Drugs for fibromyalgia 40 of 86 Final Original Report Drug Effectiveness Review Project Comparisons to placebo Gabapentin Over 12 weeks, dizziness (25% compared with 9%; P<0. But, withdrawals due to adverse events did not differ significantly in the gabapentin and placebo groups (16% compared with 9%; P=0. Cyclobenzaprine Data on harms were inconsistently reported across placebo-controlled trials of cyclobenzaprine. Although the incidence of dry mouth (pooled rates, 56% compared with 20%; pooled relative 38, 40 risk, 2. Selective serotonin reuptake inhibitors Adverse events were sparsely reported in placebo-controlled trials of selective serotonin reuptake 79-84 inhibitors. Compared with placebo, withdrawals due to adverse events were similar for 79 citalopram (14% compared with 0%; P not reported; N=40) and for controlled-release 84 paroxetine (7% compared with 2%; P not reported; N=116), but were not reported for fluoxetine. Overall adverse events were only reported in 1 trial of controlled-release paroxetine, 84 and were not significantly different from placebo (65% compared with 59%; P not reported). Compared with placebo, in the largest trial (N=116), controlled-release paroxetine was the only selective serotonin reuptake inhibitor to significantly increase any specific adverse events, including drowsiness (26% compared with 7%; P not reported), dry mouth (36% compared with 84 9%; P not reported), and ejaculatory problems (66% compared with 2%; P not reported). Are there subgroups of patients based on demographics (age, racial or ethnic groups, and gender), socioeconomic status, other medications, or comorbidities for which any included drugs are more effective or associated with fewer harms? Summary of Findings Direct evidence • Extremely limited direct evidence exists regarding treatment of fibromyalgia in subgroup populations Drugs for fibromyalgia 41 of 86 Final Original Report Drug Effectiveness Review Project o Response to either amitriptyline or cyclobenzaprine did not differ on the basis of age. Indirect evidence • Nine individual trials performed subgroup analysis • The majority of patients in all individual trials were middle-aged, white (84% to 91%), and female (89% to 100%), and there was a high prevalence of baseline anxiety and depression • Duloxetine was no different than placebo in pain response in male patients (−1. Detailed Assessment 38, 43, 62, 65, 66, 78, 81, We identified 10 trials that performed subgroup analysis of the included drugs. Analysis of comparative effectiveness in men, nonwhites, and older patients was limited by the small number of patients in these subgroups and the corresponding lack of reporting of data in the individual trials. In the 3 trials that reported time since diagnosis of fibromyalgia, the 43, 62, 87 duration ranged from 49 months to 129 months. Direct evidence Only 1 head-to-head trial addressed drugs used for fibromyalgia in subgroups of the population, 43 and only assessed the impact of age. In a fair-quality randomized controlled trial of 208 patients who met the 1990 American College of Rheumatology criteria for fibromyalgia, variation in age did not differentiate response at 6 months to either amitriptyline 50 mg or cyclobenzaprine 30 mg. Response was defined as meeting at least 4 of the following 6 criteria: 50% improvement in pain, sleep, fatigue, patient global assessment, or physician global assessment, and increase of 1 kg in mean total myalgic score. Drugs for fibromyalgia 42 of 86 Final Original Report Drug Effectiveness Review Project Indirect evidence The small number of patients in each subgroup and the limited reporting of subgroup data did not allow for indirect meta-analysis of the outcome measures for comparative effectiveness. Duloxetine One randomized double-blind fair-quality placebo-controlled trial restricted inclusion of patients 66 to females only (N=354). The results for all outcome measures did not differ from the indirect meta-analysis revealing that duloxetine either 60 mg once daily or 60 mg twice daily is more effective than placebo at 12 weeks on outcomes of pain, Fibromyalgia Impact Questionnaire, and patient global impression of improvement. The 50% response rate in pain was significant and ranged from 41% for duloxetine compared with 23% for placebo (P=0. A pooled subgroup analysis of female patients in all 4 duloxetine placebo-controlled trials (n=1262) found a statistically significant difference in pain reduction compared to placebo with mean least squares change in 24-hour pain measures on the brief pain inventory, a 10-point scale of −1. A pooled analysis of all 4 duloxetine placebo-controlled trials evaluated the response of 75 male patients, those age 65 or older, and nonwhite patients. Unlike the results of the total population, the difference in pain response between duloxetine and placebo was not significant in male patients, n=70, (−1. Despite the pooling of 4 moderate sized trials, there remained a small number of patients in each subgroup resulting in the analysis being underpowered to detect a true difference if a difference exists. Further analysis demonstrated that treatment by subgroup interaction was not significant in their overall analysis of results on pain measures (sex, P=0.

The Stroke Prevention Trial in SCD (STOP I) demonstrated that In this group buy cardizem 120 mg fast delivery, the median number of painful crises per patient maintaining HbS at 30% reduced the annual incidence of first requiring admission in the 5 years before erythrocytapheresis was 8 buy cardizem 180mg on-line, (primary) stroke in children with an abnormal TCD velocity by whereas a total of 11 painful crises occurred over 415 months of 90% compared with those who received standard care. No patient developed stroke, multiorgan crises, or indicated that transfusions could not be safely discontinued to end-organ dysfunction while on a chronic erythrocytapheresis prevent first stroke. Subsequent correspondence by Driss et al described 452 American Society of Hematology similar beneficial effects of regular erythrocytapheresis in 43 within 24 hours of transfusion regardless of the method of transfu- patients with SCD. Those investigators noticed that erythrocytapheresis times for discharge (7 vs 15 days) and for complete organ recovery was either ineffective in severe priapism or resulted in inconsistent (2 vs 3-6 months) were shorter with RCE. These studies demonstrate that, with chronic erythrocytapheresis therapy, maintaining HbS levels at Intrahepatic cholestasis 50%-60% is effective in reducing sickle-related acute and chronic Sickle cell hepatopathy or intrahepatic cholestasis is an uncommon complications, thus reducing hospitalization and morbidity. In fact, complication of SCD, but is associated with fulminant hepatic painful crises were precipitated by stopping prophylactic RCE. There are 2 types of intrahepatic cholestasis, mild and severe/fatal. In a retrospective The standard preoperative transfusion protocol for patients with review of 7 patients from a single center and 37 patients from the SCD is to increase the Hb level to 10 g/dL by simple transfusion. RCE, particularly using received treatment including simple transfusion, died. This study erythrocytapheresis if available, with the target HbS 30% should and other case reports indicate that prompt RCE is the first line of be considered instead of simple transfusion in patients with therapy to prevent fatal outcomes and that RCE is markedly more significant comorbidities and/or undergoing major procedures such effective compared with simple transfusion in reducing mortality. Uncategorized indications Not all diseases or disorders are included for categorization by the ASFA Writing Committee. The following SCD-related complica- Priapism tions are uncategorized indications for RCE in which the role of Priapism is defined as painful, persistent, and unwanted penile RCE has not been determined definitively. The decision to perform erection due to vaso-occlusion. Conventional treatments include intravenous hydration, analgesics, intracavernosal aspiration, and instillation of Pulmonary hypertension an alpha-agonist. There have been no controlled trials to compare The Sickle Cell Pulmonary Hypertension Screening Study docu- transfusion or RCE with conventional therapy in the treatment of mented that the frequency of pulmonary arterial hypertension priapism. A retrospective review including 42 case reports compar- (PAH) in adults with SCD is 32%. Although neurologic sequelae from transfusion were found in 9 of 26 there is a lack of clinical trials or published data (other than an transfused cases, with outcomes ranging from complete resolution abstract) on the use of chronic RCE in patients with SCD and PAH, to severe residual deficits. The investigators concluded that routine chronic transfusion therapy should be considered in these cases, use of transfusion in the treatment of priapism was not supported. Of transfusion methods, patients with priapism who undergo RCE have also experienced a erythrocytapheresis is the choice of transfusion in patients with serious neurological complication known as Aspen’s syndrome SCD and PAH because automated exchange effectively reduces the (which is an acronym for association of sickle cell disease, priapism, HbS level without circulatory overload and prevents transfusional exchange transfusion, and neurological events). Despite conflicting outcomes with RCE, erythrocytapheresis with End-stage renal disease/renal transplantation the goal of reducing the HbS level to 30% and achieving a Patients with SCD develop chronic sickle cell nephropathy due to postexchange Hct of 30% may be considered if early intervention 43 recurrent intrarenal sickling with proteinuria and a progressive with irrigation fails. As renal least 2 of the following organs: lung, liver, or kidney. Acute function declines, erythropoietin levels also decline, and these multiorgan failure syndrome is a severe, life-threatening complica- patients may require substantially higher doses of erythropoietin. If tion of SCD, which occurs rarely and is often associated with severe erythropoietin is ineffective, transfusions can be given; however, pain episodes in patients with relatively high Hb values in a steady care must be taken to avoid volume overload and raising the Hct state. Treatment requires prompt and aggressive transfusion therapy, level to 30% to reduce the risk of triggering vaso-occlusive crises. In a retrospective review of 17 episodes in 14 patients, 16 episodes Erythrocytapheresis may offer benefits over chronic simple transfu- were associated with rapid recovery of organ failure occurring sion because it prevents volume and iron overloads. Guidelines for central venous access* Weight (kg) Acute RCE† Chronic RCE‡ 10–20 DL 7 Fr apheresis/dialysis catheter 21–30 DL 8 Fr apheresis/dialysis catheter DL 8 Fr apheresis/dialysis catheter 31–40 DL 9 Fr apheresis/dialysis catheter DL 8 Fr apheresis/dialysis catheter or SL, 7. Contrary to the predictions of whole blood viscosity. In patients with SCD, acute renal failure can occur as a erythrocytapheresis may not be a great concern for its use as a component of acute multiorgan failure. Adverse effects of RCE therapy Procedural guidelines for erythrocytapheresis Compared with simple transfusion, the adverse effects of RCE Automated apheresis instruments require a fixed volume of blood to primarily result from the use of a large volume of blood and the fill the disposable set and for processing.

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The proportion of 60 purchase 60mg cardizem fast delivery, 78 patients gaining > 7% body weight was reported only in 2 CATIE studies (Phases 1 and 2T) cardizem 60 mg on-line, both of which found a higher risk with olanzapine (pooled RR, 3. The relative risk of > 7% gain was also greater with immediate-release quetiapine than ziprasidone (pooled RR, 2. In trials comparing clozapine with risperidone, the proportion of patients with weight gain was not different based on 3 trials. However, mean change in weight was greater in the 25, 26, 29, 82, 252, 317, 319 clozapine groups than the risperidone groups in 4 trials reporting these data. Atypical antipsychotic drugs Page 73 of 230 Final Report Update 3 Drug Effectiveness Review Project For 3 studies, the mean gain in weight was statistically significant with clozapine (weight gains 29 26 25 29 26 of 2. However, in a larger inpatient study, both drugs resulted in significant increases in weight compared with baseline (4. Data in 2 of these studies were inadequate to allow pooling. A 26-week trial comparing aripiprazole with olanzapine measured the proportion of patients with 65 a weight gain of ≥ 7% from baseline as the primary outcome measure. By intention-to-treat analysis, 33% of patients taking olanzapine and 13% of those taking aripiprazole had a ≥ 7% weight gain, P<0. This study also found significantly greater weight gain at 26 weeks in the olanzapine group (+4. Evidence on weight gain with iloperidone was limited. A pooled analysis of 3 unpublished trials found a small but statistically significant increase in weight gain compared 266 with placebo (mean difference 1. This weight gain difference was similar to risperidone compared with placebo (1. Compared with haloperidol in three 52- week studies, iloperidone resulted in greater weight gain (3. In a 16-week trial of mixed population (55% schizophrenia), orally disintegrating tablet and standard tablet olanzapine were compared, with no difference in mean weight gain found 100 (1. All patients had previously been taking olanzapine for 4 to 52 weeks. Direct comparisons of the effects of atypical antipsychotic 108, drugs on body weight were reported in 21 observational studies (reported in 23 publications). In general, the weight gain seen in observational studies was somewhat smaller than seen in trials, but the differences between the drugs remained. Studies making comparisons between olanzapine and risperidone (Table 12) ranged in duration of exposure from 4 to 36 months, and 2 studies included only patients with their first 108, 273 episode of symptoms of schizophrenia. Because patients who were experiencing their first episode of symptoms are mostly drug-naïve, or had very short durations of exposure prior to enrollment, the impact on weight may be expected to be different from those who had prior exposure to various antipsychotic drugs and longer duration of disease. The studies were also stratified by those examining exposure < 6 months and > 6 months to reflect the potential impact of duration of exposure on weight gain. In both the short- and long-term studies, olanzapine resulted in greater weight gain and a higher risk of gaining ≥ 7% of baseline weight compared with risperidone (Table 12). Based on 4 320, 322, 325, 326 studies of 6 months or longer involving over 7500 patients, olanzapine resulted in weighted mean gain of 1. In 4 studies of 6 months or less, the weighted mean difference in weight gain was 1. Atypical antipsychotic drugs Page 74 of 230 Final Report Update 3 Drug Effectiveness Review Project These studies did not report the risk of gaining ≥ 7% of starting weight and were not shown in Table 11. These estimates were lower than those reported in trials where the mean difference in weight gain was over 3 kg, and the relative risk of ≥ 7% weight gain was more than 2. Reasons for this discrepancy might be that accuracy and completeness of data collection in trials may be superior and that trial populations may include more patients with recent onset of disease. Our stratified analysis found that for patients with first-episode symptoms the difference in weight gain between olanzapine and risperidone was much greater (5. Similarly, the risk of having ≥ 7% increase in weight was over 3 in these studies, with the number needed to harm being 4. Comparisons of weight gain between olanzapine and immediate-release quetiapine had 320, 322, 325, 326 heterogenous results in 4 studies (Table 12).

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Miscellaneous trials reporting clinical outcomes Study Drug Patients Clinical endpoint Clinical events 166 AVERT Atorvastatin vs buy cardizem 120 mg cheap. 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 purchase cardizem 60 mg online. Summary of findings • There was good evidence from randomized trials that women and the elderly benefit from statin therapy. The rosuvastatin label has been revised to note that this increase should be considered when making rosuvastatin dosing decisions for Asian patients. Efficacy in demographic subgroups Women and the elderly Although women and the elderly were under-represented in the early major trials, we found 4 191-194 meta-analyses suggesting that statins are equally efficacious in men, women, and the elderly. Women accounted for an average of 17% of subjects and individuals age 65 and older accounted for an average of 29% of subjects with a range of 21% to 39% (WOSCOPS did not enroll women or anyone 65 years or older). The risk reduction in major coronary events was 29% (95% CI, 13 to 42) in women, 31% (95% CI, 26 to 35) for men, 32% (95% CI, 23 to 39) in those over age 65, and 31% (95% CI, 24 to 36) in those younger than age 65. Similarly, the Heart Protection 123, 178 Study found that simvastatin reduced cardiovascular events among women generally and particularly in women with diabetes, who benefited dramatically (number needed to treat, 23 to prevent 1 major vascular event). Nine trials of statins that enrolled 16 486 women and 4 additional studies that included 1405 women who used drug therapy other than statins were included in the analysis. For secondary prevention, lipid-lowering therapy reduced risk of coronary heart disease mortality (summary RR 0. In primary prevention studies, there was insufficient evidence of reduced risk of any clinical outcome in women, because of the small number of events in the trials. Sensitivity analyses including only studies using statins did not significantly affect the summary risk estimates. Statins Page 56 of 128 Final Report Update 5 Drug Effectiveness Review Project 193, 194 Two meta-analyses specifically evaluating statins in the elderly confirmed prior findings that these drugs are effective in this population. In particular, a hierarchial bayesian 193 meta-analysis included 9 placebo-controlled trials that enrolled 19 569 elderly patients who had a history of cardiovascular events. The pooled relative risk for all-cause mortality was 0. Coronary heart disease mortality, nonfatal myocardial infarction, need for revascularization, and stroke were all statistically significantly reduced with statins compared with placebo (Evidence Table 8). Of note, the Heart Protection study (which included primary prevention population) was included in the meta-analysis but a sensitivity analysis with and without this trial showed consistent treatment effects. Statins that were included were simvastatin 20-40 mg, pravastatin 40 mg, and fluvastatin 80 mg. African American, Hispanic, and other ethnic groups African Americans had the greatest overall coronary heart disease mortality and the highest out- 4 of-hospital coronary death rates of any other ethnic group in the United States. Other ethnic and minority groups in the United States included Hispanics, Native Americans, Asian and Pacific Islanders, and South Asians. However, these groups are underrepresented in randomized clinical trials reporting reductions in clinical outcomes. As a result there was no evidence to answer whether or not statins differ in their ability to reduce clinical events in the African American, Hispanic, or other ethnic groups. Significant numbers of African American and Hispanic patients participated in AFCAPS/TexCAPS, but the investigators did not analyze events by racial group. In EXCEL, lovastatin 20 mg, 40 mg, and 80 mg daily reduced low-density lipoprotein 195 cholesterol by similar percentages in blacks and in whites. In short-term head-to-head trials, reductions in low-density lipoprotein cholesterol and frequency of adverse events with rosuvastatin 10 to 20 mg and atorvastatin 10 to 20 mg in 23 196 74 Hipanic, South Asian, and African American patients were similar to those observed in studies conducted in primarily white non-Hispanic populations. Safety in demographic subgroups All of the statins used in the major long-term randomized trials were tolerated equally well among men, women, and healthy elderly subjects. These results applied to patients who met the eligibility criteria for the trials: in general, patients with liver disease and other serious diseases were excluded from these trials. Also, most of the patients in the trials took fixed doses of statins that were less than the maximum doses.

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