Adverse reactions versus

Transfusion-induced autoimmune disease has been a significant complication in the treatment of patients who require multiple platelet transfusions. Platelets and lymphocytes carry their own blood group system, ie, the human leukocyte antigen (HLA) system, and it can be difficult to find an HLA matched donor. A mismatched platelet transfusion does not induce immediate adverse reactions, but may cause the patient to become refractory to the HLA type of the transfused platelets. The next time platelets with an HLA type similar to that of the transfused platelets are transfused, they are rejected by the patient and thus have no clinical efficacy. Exposure to platelets originating from different donors is minimized by the use of apheresis platelets. One transfusable dose (unit) of apheresis platelets contains 3-5 x 10 platelets. An equal dose of platelets from whole blood donation requires platelets from six to eight units of whole blood. Furthermore, platelets can be donated every 10 days, versus 10 weeks for whole blood donations. 

Several studies have assessed the clinical efficacy of cyclosporine versus tacrolimus. Most of the studies have shown similar longterm patient and allograft survival, whereas some renal transplant studies have demonstrated improved renal function in tacrolimus-treated patients. The most significant difference between the two agents appears to be their adverse-reaction profiles (Table 52-4). 

Ng, C.H., Norman, T. R., Ho, B. et al. (2006a). A comparison study of sertraline dosages, plasma levels, efficacy and adverse reactions in Chinese versus Caucasian populations. Int. 

In response to the National Childhood Vaccine Injury Act of 1988, which required health workers to report vaccine adverse events, the CDC and the FDA collaborated in 1990 to implement the Vaccine Adverse Event Reporting System (VAERS) to monitor the safety of vaccines in both sectors. Health care professionals and parent or other caretakers are encouraged to report all clinically significant vaccine adverse events. Narrative diagnostic reports are reviewed and assigned standard codes using Coding Symbols for a Thesaurus of Adverse Reaction Terms. The source of the vaccines (public versus private provider) is recorded on the form. 

When it is assumed that the effectiveness of two therapies is equal, the effectiveness part of the cost-effectiveness ratio can be dropped from the analysis. In this situation, only the cost differences between the two therapies are examined. Usually this includes the cost of the drug, costs of administration, the treatment of side effects or adverse reactions and the incidence and prevalence of the condition. For example, Fenton et al. (1982) compared the costs of home versus hospital treatment of psychiatric patients when the outcomes of each were considered not to differ in any respect except that one requires a hospital stay and the other does not. The cost-minimization analysis simply looked at the differences in costs of the two treatments. The result is, not unexpectedly, that hospitalization was 64% more expensive than home-based treatment. 

Since both raloxifene and the non-hormonal drug alendronate reduce the incidence of osteoporotic fractures in postmenopausal women it is relevant to determine which approach is better tolerated and thus most likely to promote long-term adherence to therapy. Adverse effects and compliance have been studied in a direct randomized comparison over 12 months in 902 women attending 154 treatment centres in Spain (21). They took either raloxifene 60 mg/day or alendronate 10 mg/day. Those who took raloxifene reported significantly better compliance than those who took alendronate more patients discontinued alendronate prematurely than raloxifene (26% versus 16%. The main reason for premature discontinuation was adverse reactions, particularly gastrointestinal reactions (9.9% with alendronate, 3.4% with raloxifene). 

Use Versus Patch Tests The use test is a method frequently employed to estimate the potential sensitizing ability of a product. Such a test is usually conducted by distributing the product to a large test panel, (e.g., the inhabitants of one or more large cities). Should the product be found acceptable to the general public, (e.g., tolerated without many serious complaints of injury), the manufacturer may feel justified in substituting this test procedure. The use test does not afford information on the product s acceptability and safety for use, and it is generally considered unsatisfactory since it lacks proper medical or other supervision of the test subject. Because of the lack of supervision, it is difficult to confer validity to the results, such as the extent of individual use, the nature, number, and seriousness of adverse reactions that the test chemical may produce. 

Amiloride is a therapeutic option in reducing potassium losses in patients receiving amphotericin. When it was given to 19 oncology patients with marked amphotericin-induced potassium depletion mean serum potassium concentrations increased in the 5 days before and after administration (from 3.4 to 3.9 mmol/1) (8). There was also a trend toward reduced potassium supplementation (48 versus 29 mmol/day). Adverse reactions were limited to hyperkalemia in two patients who took amiloride 20 mg/day and a high potassium intake. 

One evaluation of the results of two studies in a total of 182 children primed either with acellular or with wholecell pertussis vaccines at 2, 4, and 6 months of age and boosted with an acellular vaccine has shown that booster doses of acellular vaccine are safe and immunogenic (16). Local adverse reactions after booster immunization with acellular vaccine were more common in children primed with acellular vaccine than in those primed with wholecell pertussis vaccine (68 versus 33%). In another and similar study, children primed with acellular or whole cell pertussis combined with DT vaccine have been boosted with a recombinant acellular pertussis vaccine combined with DT vaccine. The vaccine was highly immunogenic and safe (17). 

Naderer O, Nafziger AN, Bertino JS Jr.. Effects of moderate-dose versus high-dose trimethoprim on serum crea-tiniue aud creatiuiue clearance and adverse reactions. Antimicrob Agents Chemother 1997 41(ll) 2466-70. 

Starting doses of ACE inhibitors should be low, with even lower doses started in patients at risk for orthostatic hypotension. Acute hypotension may occur at the onset on ACE inhibitor therapy. Patients who are sodium- or volume-depleted, in heart failure exacerbation, very elderly, or on concurrent vasodilators or diuretics are at high risk for this effect (see the Hypertension in Older People and Patients at Risk for Orthostatic Hypotension sections under Special Populations ). It is important to start with half the normal dose of an ACE inhibitor for all patients with these risk factors and to use slow dose titration. The risk of serious adverse reactions overah can be decreased approximately 50% by using a 6-week time interval between dose increases versus a 2-week interval. ... 

Chronic pelvic pain not responding to NSAIDs or OCs should be treated with either advanced medical therapy or conservative surgery according to consensus recommendations. Choice of medical versus surgical therapy should include consideration of patient preference, potential for adverse reactions, cost, and impact on future fertility. 

Comparative studies Olanzapine and ami-sulpride Effectiveness and tolerability have been assessed in adults of both sexes who were randomized single-blind to standard doses of olanzapine and amisulpride for 12 weeks, with follow-up at 4 and 8 weeks [100 ]. The final BPRS score was lower for olanzapine (33, n = 38, versus 38, n = 39) CGI rating improved individually in both arms but remained comparable between groups throughout the study. There were adverse reactions in 68% and 48% of patients taking amisulpride and olanzapine respectively tremor and insomnia were more frequent with amisulpride, while olanzapine caused more weight gain and sedation. There were no serious adverse reactions. 

Placebo-coutroHed studies Quetiapine has been compared with placebo in the avoidance of relapses in patients in remission in a randomized, double-blind clinical trial [119 ]. Patients who had taken antipsychotic drugs for at least 1 year for first episode of psychosis took either maintenance quetiapine 400mg/day ( =89) or placebo (n = 89) and were followed for 12 months or until a relapse occurred. The Kaplan-Meier estimate of the risk of relapse at 12 months was 41% with quetiapine (95% CI=29%, 53%) and 79% (95% CI=68%, 90%) with placebo. The rate of withdrawal because of adverse or serious adverse events was greater with quetiapine (18% versus 8%) patients taking quetiapine reported more adverse reactions sleepiness or sedation, reduced salvation, and constipation). 

Phenytoin versus levetiracetam In a retrospective review of 500 consecutive patients with glioma, who were treated from 2001 to 2008, who had had at least one clinical seizure, and who had been followed for at least 6 months, 76 were identified, 25 taking phenytoin and 51 levetiracetam [9 ]. The incidence of adverse reactions with levetiracetam was 6% versus 20% with phenytoin. In addition, 36% of the... 

Placebo-controlled studies Adjunctive rufinamide in 647 adults and adolescents with inadequately controlled partial seizures taking one to three concomitant antiepileptic drugs has been studied in a 24-week multicenter, randomized, double-blind, parallel-group study [276 j. After a 12-week prospective baseline phase, they were randomized to a 5-arm 12-week treatment phase (placebo or rufinamide 200, 400, 800, or 1600 mg/day). The incidences of all adverse events were similar in all groups, but at 1600 mg/day there was a twofold greater incidence than placebo for each of the following adverse reactions dizziness (24% versus 9.8%), somnolence (12%... 

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