[A study of initial antiretroviral therapy effectiveness, survival and safety in HIV+ patients]. / Estudio de la efectividad, supervivencia y seguridad de las terapias antirretrovirales de inicio en pacientes VIH+.

OBJECTIVE: To study initial antiretroviral therapies indicated for HIV-infected patients during the 2001-2003 period regarding effectiveness, survival and safety. METHOD: A descriptive, retrospective study of clinical and drug-related variables of naïve HIV-infected patients through pharmacotherapeutic history. RESULTS: Mean CD4+ lymphocytes counts were 209.6 cells/mm3. Pneumonia by Pneumocystis carinii was the most commonly found condition at antiretroviral treatment onset. Most commonly used therapies included those based on a non-nucleoside reverse transcriptase inhibitor (NNRTI) combined with two nucleoside reverse transcriptase inhibitors (NRTIs). The longest mean survival was achieved by using combinations of three nucleoside reverse transcriptase inhibitors. The primary reason for initial antiretroviral therapy discontinuation were adverse effects, with stavudine exhibiting the poorest tolerability. CONCLUSIONS: Therapies based on non-nucleoside reverse transcriptase inhibitors and protease inhibitors (PIs) have shown similar effectiveness to increase CD4+ cell counts. Regarding viral load decreases, protease inhibitors were most effective. Therapies using three nucleoside reverse transcriptase inhibitors resulted in peak survival.

[Assessing the use of low-molecular-weight heparins fo venous thromboembolism prophylaxis in internal medicine patients]. / Evaluación de la utilización de heparinas de bajo peso molecular como profilaxis de tromboembolismo venoso en pacientes de medicina interna.

BACKGROUND: Sufficient evidence exists to recommend routine thromboembolic disease prophylaxis for medical inpatients with risk factors --with low-molecular-weight-- heparins being (LMWH) the most suitable treatment option. The objective is to determine the thromboembolic risk level of Internal Medicine patients with LMWH prophylaxis, prescription habits and their adequacy to hospital's standards, as well as prevalence of non-treated patients at risk. MATERIAL AND METHODS: Descriptive and prospective study of internal medicine patients for 2 months. Patients with prophylactic LMWH prescription were chosen, and their thromboembolic risk level and suitable LMWH dose was determined according to the hospital's "thromboembolic disease prevention standards". On the other hand, patients with no LMWH prophylaxis were analysed in order to judge their candidacy. RESULTS: 30% of patients had a prophylactical LMWH prescription, with 43.5% of these prescriptions being adequate to the risk level. The main risk factors were: age, bed-stay, hypertension, cardiopathy with risk factors, diabetes mellitus, dislipemias and COPD. Chi2(0.05) test between risk level and prescribed LMWH revealed no association. 72% of patients without LMWH prescription had a moderate or high risk level. CONCLUSIONS: 1. A high proportion of the patients studied have a considerable thromboembolic risk level. 2. There is not a statistical relationship between thromboembolic risk level and LMWH prescription. 3. There is a high percentage of patients with no LMWH prophylaxis which could be eligible for it. 4. A pharmaceutical intervention would be useful to approach pharmacological prophylaxis to each patient's risk.

[Influence of gender on clinical research]. / Influencia del género en investigación ckínica.

OBJECTIVE: To analyze clinical trials performed in our setting for the past three years from a gender-related standpoint. MATERIAL AND METHODS: A retrospective study of 101 trials in which the pharmacy department of a 1,240-bed university hospital took part. DATA SOURCES: protocols and summary reports by the pharmacy department, Gecos software program, trial follow-up cards, reception records, sample dispensation and returns, and yearly reports. RESULTS: 17 trials included women only, 13 trials included men only, and 71 trials included patients of both genders. In female-only trials the most commonly studied condition was breast cancer (70.6%), the most common phases were phase III (47.1%) and II (41.2%) and the most commonly studied drugs were docetaxel (17.7%) and trastuzumab (11.8%). In male-only trials the most commonly studied condition was erectile dysfunction (92.3%), the most common phase was phase III (76.9%) and the most commonly studied drugs were tadalafil (38.5%) and vardenafil (30.8%). In trials without gender-related inclusion criteria the most commonly studied conditions included colon cancer (11.3%), lung cancer (11.3%), and renal failure (9.9%); the most common phase was phase III (57.7%) and the most frequently assayed drugs were interferon alpha-2a, gemcitabine and ribavirin. Overall participation rate was 62.3% for males and 37.7% for females. CONCLUSIONS: a) Regardless of gender, the most commonly studied condition was cancer, with breast cancer being most common in female-only trials and erectile dysfunction in male-only trials; b) male and female participation followed a 2:1 ratio in trials without gender-related inclusion criteria; and c) phase III was most common amongst all trials considered, with phase II having a relevant role in women-only trials as per guidelines favoring inclusion in early trials.