Effects of the high-density lipoprotein mimetic agent CER-001 on coronary atherosclerosis in patients with acute coronary syndromes: a randomized trial†

Aim High-density lipoproteins (HDLs) have several potentially protective vascular effects. Most clinical studies of therapies targeting HDL have failed to show benefits vs. placebo. Objective: To investigate the effects of an HDL-mimetic agent on atherosclerosis by intravascular ultrasonography (IVUS) and quantitative coronary angiography (QCA). Design and setting A prospective, double-blinded, randomized trial was conducted at 51 centres in the USA, the Netherlands, Canada, and France. Intravascular ultrasonography and QCA were performed to assess coronary atherosclerosis at baseline and 3 (2–5) weeks after the last study infusion. Patients Five hundred and seven patients were randomized; 417 and 461 had paired IVUS and QCA measurements, respectively. Intervention Patients were randomized to receive 6 weekly infusions of placebo, 3 mg/kg, 6 mg/kg, or 12 mg/kg CER-001. Main outcome measures The primary efficacy parameter was the nominal change in the total atheroma volume. Nominal changes in per cent atheroma volume on IVUS and coronary scores on QCA were also pre-specified endpoints. Results: The nominal change in the total atheroma volume (adjusted means) was −2.71, −3.13, −1.50, and −3.05 mm3 with placebo, CER-001 3 mg/kg, 6 mg/kg, and 12 mg/kg, respectively (primary analysis of 12 mg/kg vs. placebo: P = 0.81). There was also no difference among groups for the nominal change in per cent atheroma volume (0.02, −0.02, 0.01, and 0.19%; nominal P = 0.53 for 12 mg/kg vs. placebo). Change in the coronary artery score was −0.022, −0.036, −0.022, and −0.015 mm (nominal P = 0.25, 0.99, 0.55), and change in the cumulative coronary stenosis score was −0.51, 2.65, 0.71, and −0.77% (compared with placebo, nominal P = 0.85 for 12 mg/kg and nominal P = 0.01 for 3 mg/kg). The number of patients with major cardiovascular events was 10 (8.3%), 16 (13.3%), 17 (13.7%), and 12 (9.8%) in the four groups. Conclusion: CER-001 infusions did not reduce coronary atherosclerosis on IVUS and QCA when compared with placebo. Whether CER-001 administered in other regimens or to other populations could favourably affect atherosclerosis must await further study. Name of the trial registry: Clinicaltrials.gov; Registry's URL: http://clinicaltrials.gov/ct2/show/NCT01201837?term=cer-001&rank=2; Trial registration number: NCT01201837

Effects of the high-density lipoprotein mimetic agent CER-001 on coronary atherosclerosis in patients with acute coronary syndromes: a randomized trial†

Aim High-density lipoproteins (HDLs) have several potentially protective vascular effects. Most clinical studies of therapies targeting HDL have failed to show benefits vs. placebo. Objective To investigate the effects of an HDL-mimetic agent on atherosclerosis by intravascular ultrasonography (IVUS) and quantitative coronary angiography (QCA). Design and setting A prospective, double-blinded, randomized trial was conducted at 51 centres in the USA, the Netherlands, Canada, and France. Intravascular ultrasonography and QCA were performed to assess coronary atherosclerosis at baseline and 3 (2-5) weeks after the last study infusion. Patients Five hundred and seven patients were randomized; 417 and 461 had paired IVUS and QCA measurements, respectively. Intervention Patients were randomized to receive 6 weekly infusions of placebo, 3 mg/kg, 6 mg/kg, or 12 mg/kg CER-001. Main outcome measures The primary efficacy parameter was the nominal change in the total atheroma volume. Nominal changes in per cent atheroma volume on IVUS and coronary scores on QCA were also pre-specified endpoints. Results The nominal change in the total atheroma volume (adjusted means) was −2.71, −3.13, −1.50, and −3.05 mm3 with placebo, CER-001 3 mg/kg, 6 mg/kg, and 12 mg/kg, respectively (primary analysis of 12 mg/kg vs. placebo: P = 0.81). There was also no difference among groups for the nominal change in per cent atheroma volume (0.02, −0.02, 0.01, and 0.19%; nominal P = 0.53 for 12 mg/kg vs. placebo). Change in the coronary artery score was −0.022, −0.036, −0.022, and −0.015 mm (nominal P = 0.25, 0.99, 0.55), and change in the cumulative coronary stenosis score was −0.51, 2.65, 0.71, and −0.77% (compared with placebo, nominal P = 0.85 for 12 mg/kg and nominal P = 0.01 for 3 mg/kg). The number of patients with major cardiovascular events was 10 (8.3%), 16 (13.3%), 17 (13.7%), and 12 (9.8%) in the four groups. Conclusion CER-001 infusions did not reduce coronary atherosclerosis on IVUS and QCA when compared with placebo. Whether CER-001 administered in other regimens or to other populations could favourably affect atherosclerosis must await further study. Name of the trial registry: Clinicaltrials.gov; Registry's URL: http://clinicaltrials.gov/ct2/show/NCT01201837?term=cer-001&rank=2; Trial registration number: NCT0120183

A Review of the Occurrence of Bats (Chiroptera) on Islands in the North East Atlantic and on North Sea Installations

The bats recorded from Iceland, the Faroe Islands, the Shetland Islands, the Orkney Islands, and North Sea installations are reviewed to the end of 2012. In total 12 species have been positively identified, while a considerable proportion of all records are sightings of unidentified bats. Eight of the species are European in origin and four originate from the New World. The largest number of species (8) has been recorded in Iceland, but the greatest number of individuals (180) has been found in Orkney. The bat invasion on the Faroe Islands in 2010 is without precedence, when 70 observations of a minimum of 45 individuals were noted. Most bat observations in the study area occurred in the autumn, with fewer in the spring. Most observations were of single animals, but there were also sightings of up to 12 individuals. There has been a marked increase in bat records in the past three decades. We discuss whether this is a real increase, or due to improved communications, increased public awareness, increased shipping, changes in weather patterns and/or the effects of climate change. All factors appear to be involved.© Museum and Institute of Zoology PAS. The attached document is the author(’s’) final accepted/submitted version of the journal article. You are advised to consult the publisher’s version if you wish to cite from it

Confidence of Academic General Internists and Family Physicians to Teach Ambulatory Procedures

OBJECTIVE: To evaluate and compare the readiness of academic general internal medicine physicians and academic family medicine physicians to perform and teach 13 common ambulatory procedures. DESIGN: Mailed survey. SETTING: Internal medicine and family medicine residency training programs associated with 35 medical schools in 9 eastern states. PARTICIPANTS: Convenience sample of full-time teaching faculty. MEASUREMENTS AND MAIN RESULTS: A total of 331 general internists and 271 family physicians returned completed questionnaires, with response rates of 57% and 65%, respectively. Academic generalists ranked most of the ambulatory procedures as important for primary care physicians to perform; however, they infrequently performed or taught many of the procedures. Overall, compared with family physicians, general internists performed and taught fewer procedures, received less training, and were less confident in their ability to teach these procedures. Physicians' confidence to teach a procedure was strongly associated with training to perform the procedure and performing or precepting a procedure at least 10 times per year. CONCLUSIONS: Many academic general internists do not perform or precept common adult ambulatory procedures. To ensure that residents have the opportunity to learn routine ambulatory procedures, training programs may need to recruit qualified faculty, train current faculty, or arrange for academic specialists or community physicians to teach these skills

A Significant Outcome of Work Life: Occupational Accidents in a Developing Country, Turkey

A Significant Outcome of Work Life: Occupational Accidents in a Developing Country, Turkey: O. Alp ERGOR, et al. Department of Public Health, School of Medicine, Dokuz Eylul University, Turkey-Occupational accident rates are high in the developing world and they are among the crucial indicators of work life. The data on serious occupational accidents in three years from the Aegean Region of Turkey were analyzed in order to define the working life situation. The data for 1995-97 were obtained from The Social Insurance Institution. Variables were defined for workers, work environment and working conditions for descriptive analysis. The relationships between these variables and outcomes of the occupational accidents were analyzed. The fatality risk was 2.6 times higher for mining and construction than for the production sector (p<0.001), and 1.6 times higher for evening and night shifts than for day shifts (p<0.01). Mortality from being struck by something, falls, motor vehicle accidents and electrocutions were significantly higher than being cut or in, under or between objects (OR 3.5, 8.7, 23.1, 26.1 respectively and p<0.01). As a conclusion, it was suggested that within the globalization picture, occupational health problems in the developing world should be explored intensively in order to establish effective prevention programs