Gene/Protein Disease Symptom Drug Enzyme Compound
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Deferiprone, also known as L1, is an orally active iron chelator that has been studied extensively in clinical trials. The sporadic occurrence of agranulocytosis in association with deferiprone and the highly variable frequency of other possible side effects such as arthralgia have created uncertainty about the true incidence of deferiprone-related complications. A multi-center, 1-year trial was initiated to determine the safety profile of deferiprone. Using the Apotex formulation of deferiprone, 187 patients with thalassemia who were unable or unwilling to use deferoxamine were enrolled in four centers; 162 patients completed one year of therapy. Agranulocytosis (ANC < 500/mm3) occurred in one patient after 15 weeks of treatment, was not accompanied by infection and resolved following treatment with G-CSF. Nine other subjects developed less severe neutropenia (ANC 500-1500/mm3) with the lowest absolute neutrophil count reaching 500-1250/mm3. The neutropenia in these patients developed after 1-50 weeks of therapy, frequently accompanied febrile illnesses, and occurred predominantly in non-splenectomized patients. Reasons other than neutropenia for discontinuing use of deferiprone included nausea (4), voluntary withdrawal (3), high ALT (2), platelet count < 100,000/mm3 (2), low but unconfirmed ANC (1), protocol violation (1) fatigue (1), and depression (1). Mean ALT levels rose within three months of therapy and stabilized thereafter. Arthralgia and nausea and/or vomiting occurred in 6% and 24% of subjects, respectively. In this multi-center trial with weekly monitoring of blood counts, the incidence of agranulocytosis was 0.58 per 100 patient-years, and the frequency of agranulocytosis after one year was 0.5%. These findings support the safety of this formulation of deferiprone, using the careful monitoring system employed in this trial.
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PMID:A multi-center safety trial of the oral iron chelator deferiprone. 966 43

Dengue is a mosquito-transmitted acute disease caused by any of four dengue virus serotypes (DEN-1, DEN-2, DEN-3, and DEN-4) and characterized by the sudden onset of fever, headache, myalgia, arthralgia, rash, nausea, and vomiting. This disease is endemic in most tropical areas of the world and has occurred in U.S. residents returning from travel to such areas. CDC maintains a laboratory-based passive surveillance system for imported dengue among U.S. residents. This report summarizes information about cases of imported dengue among U.S. residents for 1996, which indicated that most persons for whom travel history was known probably acquired infection in the Caribbean islands or Asia.
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PMID:Imported dengue--United States, 1996. 967 16

The differentiation of malaria from other causes of fever in the absence of microscopy is notoriously difficult. Clinical predictors of malaria have been studied in an area of low and unstable transmission on the western border of Thailand. In 1527 children aged 2-15 years who were followed prospectively for 7 months, 82% (1254) had at least one febrile episode. Malaria caused 24% (301) of the first febrile episodes (Plasmodium falciparum 128, P. vivax 151, P. malariae 1, mixed infections with P. falciparum and P. vivax 21). Each malaria case was matched with the next child of similar age presenting to the dispensary with another cause of fever. Clinical symptoms or signs associated with a final diagnosis of malaria were: confirmed fever (> or = 38 degrees C) (odds ratio [OR] 1.6, 95% confidence interval [95% CI] 1.4-1.9), headache (OR 1.5, 95% CI 1.3-1.9), muscle and/or joint pain (OR 2.0, 95% CI 1.6-2.8), nausea (OR 1.7, 95% CI 1.4-2.3), clinical anaemia (OR 1.4, 95% CI 1.3-3.3), palpable spleen (OR 1.3, 95% CI 1.1-1.7), palpable liver (OR 1.4, 95% CI 1.1-2.1), absence of cough (OR 1.6, 95% CI 1.4-2.0), and absence of diarrhoea (OR 1.5, 95% CI 1.2-2.4). None of these signs alone or in combination proved a good predictor of malaria. The best diagnostic algorithms (history of fever and headache without cough, and history of fever with an oral temperature > or = 38 degrees C [sensitivity 51% for both, specificity 72 and 71%, respectively]) would result in prescription of antimalarial drugs in 28-29% of the non-malaria febrile episodes, and only 49% of the true malaria cases. Thus half of the potentially life-threatening P. falciparum infections would not be treated. Although multivariate analysis identified vomiting, confirmed fever, splenomegaly and hepatomegaly as independent risk factors for a diagnosis of falciparum malaria, use of these signs to differentiate falciparum from vivax malaria, and thus to determine antimalarial treatment, was insufficiently sensitive or specific. Malaria diagnosis should be confirmed by microscopical examination of a blood slide or the use of specific dipstick tests in areas of low transmission where highly drug-resistant P. falciparum coexists with P. vivax.
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PMID:Clinical features cannot predict a diagnosis of malaria or differentiate the infecting species in children living in an area of low transmission. 969 50

Dengue is an acute, mosquito-transmitted viral disease characterized by fever, arthralgia, myalgia, rash, nausea, and vomiting and caused by any of four different serotypes of the virus (DEN-1, DEN-2, DEN-3, and DEN-4).1 The disease is endemic in most tropical areas of the world and has been reported in international travelers returning from such areas.2 The incidence of epidemic and endemic dengue has increased substantially in the Americas since 1977, and various epidemics have occurred.1-4
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PMID:Evidence of dengue virus infection in a german couple returning from hawaii 977 17

The incidence of dengue increased sharply in Martinique from the end of 1995 into 1996. Virological tests performed jointly on 36 serum samples by the Pasteur Institute in French Guyana and the Center for Disease Control in Puerto Rico led to identification of serogroups 1, 2, and 4 for six dengue virus. Between January 1995 and December 1996, the Departmental Hygiene Laboratory of Martinique carried out screening tests to detect specific IgM by the immunocapture method (MAC ELISA) in patients with suspected dengue. Results were positive in 701 of the 2,143 patients tested (32.7%). Symptoms were studied in 421 of these positive cases. The most frequent presentation was a flu-like syndrome with hyperalgia. Nausea, vomiting, joint pain, and retroocular pain were frequent. At least one clinical sign of coagulation disturbance was noted in 83 patients (19.7%). Dengue hemorrhagic syndrome was diagnosed according to the criteria of the World Health Organization in six patients including one who developed circulatory collapse and died. This fatality was the first to be reported in Martinique. The incidence of typical dengue as well as of the hemorrhagic form is probably underestimated in Martinique because specific serological tests are not routinely requested and application of WHO criteria for diagnosis of hemorrhagic forms is often impractical.
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PMID:[Dengue in Martinique in 1995-1996]. 979 93

Dengue fever is an acute, mosquito-transmitted viral disease characterized by fever, headache, arthralgia, myalgia, rash, nausea, and vomiting. Infections are caused by any of four virus serotypes (DEN-1, DEN-2, DEN-3, and DEN-4). The incidence of dengue is increasing in most tropical areas throughout the world (Fig. 1). Although dengue is not endemic in the continental United States, Hawaii, or Alaska, more than 500 laboratory-positive cases of introduced dengue were reported from 1977 through 1994 in U.S. residents who visited dengue-endemic areas throughout the world.1-4 In addition, two competent mosquito vectors (Aedes aegypti and Aedes albopictus) are found in the southeastern United States, and both could possibly transmit an introduced virus. In Hawaii, Ae. albopictus is the dominant mosquito on all islands; Ae. aegypti has only focal distribution on Molokai and the Kona coast of Hawaii. Economic, political, technologic, ecologic, and demographic changes have brought about the emergence of new microbial diseases, as well as an increase in the incidence of previously known infections. The increase in dengue activity in Asia, Africa, and the Americas represents a pandemic that is being facilitated by increased air travel; global urbanization; population growth; greater abundance of disposable, nondegradable containers that can serve as Aedes production sites; and lack of effective mosquito control programs.5,6 This report summarizes information about risk factors for severe disease, recent dengue outbreaks throughout the world, and cases of dengue virus infection in travelers who have been diagnosed on return to the United States.
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PMID:Dengue: A Literature Review and Case Study of Travelers from the United States, 1986-1994. 981 84

Symptoms can markedly influence the hemodialysis patients well-being and quality of life. The aim of this paper is to study the frequency of symptoms at home and how these relate to biochemical and treatment variables. Seventy-three hemodialysis patients were questioned on the absence, occasional presence or daily recurrence (score = 0, 1, 2) of 14 symptoms and a record was made of their biochemical parameters, age, time on treatment and KtIV as a function of each symptom. The following relationships were detected: thirst with high Osm and BUN; asthenia with old age and hypoalbuminemia; insomnia with hypercalcemia; hypersomnia with hypoxemia and hypernatremia; anorexia with hypokalemia; dyspnea with old age, hypernatremia and hypokalemia; dysgeusia with hypoxemia; nausea with alkalemia, hypoxemia and low BUN; vomiting with alkalemia. Pruritus, arthralgia, restless legs syndrome, cramp and tremor showed no relationships. Monitoring acid-base balance and plasma electrolytes could help to alleviate symptoms and ameliorate quality of life of hemodialysis patients.
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PMID:Symptoms in hemodialysis patients and their relationship with biochemical and demographic parameters. 998 55

We report our experience with deferiprone (L1) (DFP) in 17 thalassemic patients, followed up in one center in Lebanon, who were initially on desferrioxamine and then shifted to DFP at a dose of 50-75 mg/kg/day as the sole chelator during 1-year follow-up. All 17 patients were compliant with therapy and there was no change in physical examination over the study period. Eight patients (47.1%) were positive for hepatitis C virus (HCV) antibodies. Urinary iron excretion was 21.8 +/- 14 mg/24 h (mean +/- SD) 1 week after starting DFP and dropped 12 months later to 13 +/- 7.4 mg/24 h (p = 0.009, paired t test). The initial serum ferritin level was 3,863 +/- 2,344 microg/l which dropped to 3,179 +/- 2,075 at 12 months after starting therapy (p = 0.07). HCV-negative patients as a group exhibited a significant decrease in serum ferritin after 6 and 12 months of DFP therapy (3,942 +/- 2,739 vs. 2,341 +/- 1,179 and 2,681 +/- 1,519 microg/l; p < 0.03 and p < 0.05, respectively). The most frequent side effects were joint pain, stiffness or swelling in 6 patients (35.3%), and nausea in 7 patients (41.2%), but these were well tolerated and did not require stopping treatment.
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PMID:Efficacy and side effects of deferiprone (L1) in thalassemia patients not compliant with desferrioxamine. 1043 97

The safety and tolerability of quinupristin/dalfopristin were assessed in both comparative and non-comparative trials (2298 quinupristin/dalfopristin-treated patients). In comparative clinical trials, the most frequent systemic adverse events related to quinupristin/dalfopristin were nausea (4.6%), diarrhoea (2.7%), vomiting (2.7%) and skin rash (2.5%). The comparator group showed similar rates, except that nausea was significantly more common (7.2%; P = 0.01). In non-comparative trials, arthralgia and myalgia were reported most frequently but were reversible upon treatment discontinuation. The renal, inner ear, cardiovascular and central nervous systems were not implicated as significant target organs for toxicity. The most frequent local adverse events related to infusion of quinupristin/dalfopristin were inflammation, pain, oedema, infusion site reaction and thrombophlebitis. Results of laboratory tests while on therapy were comparable for quinupristin/dalfopristin and comparator groups, except that increases in conjugated bilirubin of >5 x the upper limit of normal were reported in 5.5% of quinupristin/dalfopristin recipients; increases in total bilirubin of >5 x the upper limit of normal occurred in 1.5%. Comparator recipients more frequently had increases in alanine aminotransferase and alkaline phosphatase. Quinupristin/dalfopristin inhibits the cytochrome P450 3A4-mediated metabolism of drugs including midazolam, nifedipine, terfenadine and cyclosporin. Therefore, plasma drug monitoring and/or dosage reduction of these agents is prudent. Concomitant administration of drugs that can prolong the electrocardiographic QTc interval should be avoided. Quinupristin/dalfopristin is visually and chemically compatible with commonly used drugs of various classes, but it is not compatible with sodium chloride solution and certain other drugs, including some antimicrobials. Therefore, when prescribing quinupristin/dalfopristin, clinicians should be aware of the potential for peripheral venous intolerance, arthralgias and myalgias, increases in conjugated bilirubin, interactions with drugs metabolized by the cytochrome P450 3A4 isoenzyme and certain physico-chemical incompatibilities. However, multiple studies have shown that the safety and tolerability of quinupristin/dalfopristin are generally favourable, and that it provides clear benefits to ill patients with severe gram-positive infections.
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PMID:Safety and tolerability of quinupristin/dalfopristin: administration guidelines. 1051 96

MTA has demonstrated activity in breast, lung, bladder, and gastrointestinal malignancies in early clinical trials. Gemcitabine is a cytotoxic pyrimidine antimetabolite with broad activity against solid tumors. We have demonstrated sequence-dependent in vitro cytotoxic synergy when gemcitabine exposure preceded MTA exposure in cultured human HCT-8 colon carcinoma cells. A phase I study testing this synergy in patients is in progress. To date, 14 patients with solid tumors have received 42 courses of treatment at a fixed gemcitabine dose of 1,000 mg/m2 on days 1 and 8 and escalating doses of MTA (200, 300, and 400 mg/m2) given 90 minutes after gemcitabine on day 1. Courses are repeated every 3 weeks. The median number of courses received is three (range, one to seven). National Cancer Institute Common Toxicity Criteria grade 4 hematologic toxicity lasting less than 5 days has been leukopenia and neutropenia. Mild to moderate nonhematologic toxicities include arthralgia, nausea, fatigue, fever, rash, and liver function test abnormalities. One partial response occurred in a patient with previously treated metastatic gallbladder cancer. Dose escalation continues.
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PMID:A phase I trial of MTA and gemcitabine in patients with locally advanced or metastatic cancer. 1059 62


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