A new level of nursing involvement is needed in both the detection of ADRs and prevention of serious outcomes, particularly in high-risk patients.

Background:Impedance cardiography is a reliable, well-tolerated, and non-invasive method used to obtain hemodynamic measurements and could potentially be useful in heart failure (HF) diagnosis, hemodynamic monitoring of critically ill patients, and help in the choice of antihypertensive therapy. The objective of this study was to determine the differences between hemodynamic parameters in a study population of hypertensive patients with and without HF, using impedance cardiography.Methods:A case-control study was designed and named the TARGET study. Participants were enrolled in two study groups: control group C, hypertensive patients without HF and the HF group, hypertensive patients with HF. A descriptive analysis was carried out to characterize the sample and differences in continuous variables were tested for statistical significance by independent sample t test.Results:The study included 102 hypertensive outpatients. The control group consisted of 77 individuals (58.4% males; mean age 63.9 ± 12.5 years old) and the HF group consisted of 25 individuals (44.0% males; mean age 74.2 ± 8.7 years old). The mean Cardiac Index (CI) was 2.70 ± 1.02 L.min.m−2(2.89 ± 1.04 versus 2.12 ± 0.70; p < 0.001), mean Stroke Index (SI) was 35.5 ± 14.7 mL.m−2(37.7 ± 15.2 versus 28.5 ± 10.8; p = 0.006), mean Ejection Phase Contractility Index (EPCI) was 33.7 ± 12.7 1000 s−2(35.8 ± 13.1 versus 27.2 ± 9.2; p = 0.003), mean Inotropic State Index (ISI) was 74.3 ± 28.2 100 s−2(78.8 ± 28.9 versus 60.6 ± 20.7; p = 0.005), and mean Left Stroke Work Index (LSWI) was 51.3 ± 23.1 g.min.m−2(55.4 ± 23.5 versus 38.9 ± 16.6; p = 0.002).Conclusions:In this study, hypertensive patients with HF had significantly lower values of blood flow parameters, contractility, and left work indices compared with hypertensive patients without HF. These differences reflected the incorrect hemodynamic pattern (mostly hypodynamic) of these patients. Impedance cardiography (ICG) seems to be an adequate method to reflect these differences.

Introduction: Several drugs were withdrawn from the market due to safety. Objective: The aim of this study was to describe data supporting drug withdrawal from the market due to safety reasons in countries belonging to the World Health Organization. Methods: We analyzed drugs withdrawn from the market between 1990 and 2010. All medicine agencies of the countries belonging to the Program for International Drug Monitoring of the World Health Organization were contacted. To complete data, Medline, reference books and available drug databases were also searched. Information sources on which authorities based their withdrawal were categorized and the average time between the first date of exposure and withdrawal was calculated and stratified. Results: A total of 133 drugs that met the inclusion/exclusion criteria were withdrawn from the market due to safety reasons in the period reviewed (1990 - 2010). Hepatotoxicity (n=36, 27.1%), cardiac disorders (n=25, 18.8%), hypersensitivity (n=17, 12.8%) and nephrotoxicity (n=14, 9.8%) were the major reasons responsible for 69.2% of all drugs withdrawn. In most cases, Information Sources for drug withdrawal were spontaneous reports and/or case reports (n=86, 64.7%), followed by clinical trials (n=24, 18.0%). The average time between the introduction of a drug and its withdrawal due to safety reasons was 20.3 years (SD±13.8). Conclusion: According to available and published evidence, there is no gold standard to identify risks associated with drug exposure. These findings strengthen the role of different information sources within the drug safety review process.

Introduction Statins are widely prescribed drugs with established efficacy in primary and secondary prevention of cardiovascular events. Although they are mostly well tolerated, several authors have been emphasizing that the statins' safety profile is not totally clarified especially when considering risk of cancer in patients with long‐term exposure to statins. This meta‐analysis was aimed at evaluating the risk of cancer in patients with prolonged exposure to statins. Methods Medline, Cochrane library, and http://clinicaltrials.gov were searched in order to identify studies with a minimum average follow‐up of 10 years of exposure to statins and a cancer‐related outcome reported. Relative risk (RR) of the primary outcomes and the combined effect was presented using a random‐effects model. In the selected randomized control trials (RCT), statin exposure was compared with placebo, and in the selected observational studies, it was compared with no exposure to statins. Results We retrieved 1627 studies, of which 15 full‐papers were included for final review, five RCT, two cohort studies (CSs), and eight case‐control studies (CCs), representing a total of 358 544 patients. Five RCT, two cohort studies (CSs), and eight case‐control studies (CCs). No significant differences were found regarding risk of cancer occurrence (RR = 1.08, 0.96‐1.21) or cancer mortality (RR = 0.91, 0.80‐1.04) due to long‐term statin exposure. Regarding all‐cause mortality, a protective effect was found (RR = 0.93, 0.90‐0.97). Conclusions According to available and published evidence, statins are not associated with an increased risk of cancer after prolonged exposure. These findings strengthen the role of statins in the primary and secondary prevention of cardiovascular events.