Biosimilars of low-molecular-weight heparin products: fostering competition or reducing 'biodiversity'?

The term 'biosimilars' is used to qualify products developed to be similar to an original biological drug. Biosimilars are much more complicated to develop than a generic version of small-molecule drugs and this is especially true for low-molecular-weight heparins (LMWHs). Evidence on the antithrombotic management of acute coronary syndromes (ACS) showed that the introduction into the market of biosimilars approved on the basis of simple biological criteria, without robust data from comparative clinical trials, may be hazardous. Moreover, the mixtures of LMWH polysaccharide chains, some immunoallergic properties and potential contamination during the extraction process raise safety concerns. As was the case for the biosimilar erythropoietin, there is the risk that only copies of the most commercially successful LMWHs will be marketed, thus jeopardizing the 'biodiversity' now ensured by the presence of several LMWHs, each with unique features that support the use of an individual LMWH as first-choice therapy in certain categories of patients.

[Treatment with tuberculostatic drugs: compliance at a general hospital]. / Terapeutica con tuberculostaticos: cumplimiento en un hospital general.

The purpose of this study was to assess the compliance with tuberculostatic drugs treatment in a public hospital from Córdoba City and to establish the causes of noncompliance. All the patients to which treatment with tuberculostatic drugs was indicated from January 1991 up to December 1994 were included. 45 patients were included: 18 females (40%) and 29 males. Sixteen (35.6%) did not complete the time of treatment indicated. Nine (56.3%) abandoned the treatment 2 months after having initiated it. In the group that did not complete the treatment there was a higher percentage of female patients (62.5%) than in the group that did complete it (27.6%), p = 0.02. There were not statistically significant differences in age, percentages of pulmonar and extrapulmonar tuberculosis and months of treatment indicated between both groups. Thirty-six percent of the patients who abandoned the treatment referred having interrupted it due to their own negligency, knowing the risk of such behavior; 36% suffered side effects and did not come back to hospital; 21% referred having consulted another physician who indicated to interrupt the treatment without performing other tests; and 7% misunderstood the indications. It is concluded that in a general hospital from Córdoba City, the percentage of patients who abandoned tuberculostatic treatment is high. In most cases the cause was related to failures in the conduct of patients, physicians or both.

[Clinical and epidemiologic characteristics of acute diarrhea in adults at a hospital from Cordoba city]. / Caracteristicas clinico-epidemiologicas de la diarrea aguda del adulto en un hospital de la ciudad de Cordoba.

The purpose of this work was to assess the clinical and epidemiologic presentation features of adult acute diarrhea in a general hospital form Córdoba City. All the patients older than 14 years old who assisted to the Hospital Nacional de Clínicas Central Guard for acute diarrhea, during the periods: A (15-12-89 to 15-03-90), B (15-12-93 to 15-03-94) and C (15-12-94 to 15-03-95), were included. 594 patients were studied: 337 female (56.7%) and 257 male, 143 in the period A, 250 in B and 201 in C. The means +/- SD age was 34.6 +/- 13.3 and stool loose per day at admission 7.3 +/- 4.7. Eighty six percent of patients presented liquid consistent stool, 89.6% abdominal pain, 44.7% vomiting and 18.8% bloody stools. The rate of patients who consulted Central Guard referring acute diarrhea increased from period A (2.4%) to B (3.61%); p = 0.002 and decreased form B to C (2.85%); p = 0.01. The mean (+/- SD) days transcurred from the beginning of diarrhea episode till consultation was 3.5 +/- 2.7; 2.7 +/- 2.3 y 2.9 +/- 3.5 in the periods A, B and C respectively, statistically significant difference between A and B, p < 0.01. Thirty six percent, 21.1% and 23.1% of patients presented mucus with their stools in the periods A, B and C (p = 0.01), and high temperature 61.1%, 48.1% and 48.5% respectively (p = 0.04). Twenty seven percent of stools samples cultures became positive in the periods A, 17.6% in B and 11.5% in C, statistically significant difference between A and C; p = 0.008. The results show that in a general hospital from Córdoba City the adult acute diarrhea is a frequent cause of consult. In the last years there were modifications in its clinical an epidemiologic presentation features.

[Single dose of fleroxacin for the treatment of adult acute diarrhea]. / Monodosis de fleroxacina para el tratamiento de la diarrea aguda estival en el adulto.

The purpose of this work was to evaluate the efficacy and safety of a single dose of 400 mg of fleroxacin for the empiric antibiotic treatment of acute diarrhea in adult patients. A prospective, double-blind, placebo-controlled, randomized trial was designed. All the adult patients who consulted in our hospital for acute diarrhea from December 1994 to April 1995 were included. 72 patients were randomized to receive a single dose of fleroxacin 400 mg and 73 were placebo. Thirty-eight patients in each group were evaluable for efficacy. Between both groups there were not statistically significant differences in age, sex, number of loose stools per day at inclusion, days since the onset of symptoms up to inclusion, other symptoms than diarrhea at inclusion, percentages of bacterial pathogens and parasites isolated and symptomatic treatment indicated. At the third day since inclusion, clinical cure occurred in 72.2% of the patients receiving fleroxacin, compared with 36.4% of those receiving placebo; p = 0.002. The mean +/- SD time to cure was 2.2 +/- 1.2 days in the fleroxacin group and 3.2 +/- 2.0 days in the placebo group; p = 0.01. Twenty-eight and 16.7% of patients reported adverse effects in the fleroxacin and placebo groups respectively; p = 0.3. It is concluded that a single dose of fleroxacin 400 mg is an effective and safe alternative for the empiric antibiotic treatment of acute diarrhea in adults.