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Latest news and product developments

PRESCRIBER, Issue 19 2007
Article first published online: 22 NOV 200
UK data suggest OCs may reduce cancer risk The latest analysis of the RCGP oral contraception (OC) study suggests that oral contraceptives may be associated with an overall reduction in the risk of cancer (Br Med J online: 11 September 2007; doi:10.1136/bmj.39289. 649410.55). The cohort of 46 000 women provided 744 000 woman-years for ever use of an oral contraceptive and 339 000 woman-years of never use. Longer use was associated with increasing risks of cervical (RR 2.73), and pituitary or CNS (RR 5.51) cancers, but decreasing risks of uterine (RR 0.57) and ovarian (RR 0.38) cancers. OC use was also associated with a lower overall risk of colorectal cancers. The overall risk of any cancer was reduced by 12 per cent (RR 0.88). CombAT two-year data Two-year data revealed at the 29th Congress of the Société Internationale d'Urologie in Paris in September show that dutasteride (Avodart) and tamsulosin combination therapy provides significantly improved symptom control in BPH compared with either therapy alone. The Combination therapy with Avodart (dutasteride) and tamsulosin (CombAT) study took over 4800 eligible men (age ,50 years with a prostate volume ,30cc, serum PSA level ,1.5-10ng per ml and IPSS ,12) who received placebo for four weeks before being randomised in a 1:1:1 ratio to either dutasteride monotherapy (0.5mg per day), tamsulosin monotherapy (0.4mg per day) or a combination of both drugs. At two years the primary efficacy end-point was achieved: combination therapy was significantly more effective than either monotherapy, and continuous improvement could be observed throughout the two years. The combination therapy was also well tolerated, although drug-related adverse events were more common with combination therapy (24 per cent) than either monotherapy (dutasteride 18 per cent, tamsulosin 14 per cent). Dutasteride, a 5-, reductase inhibitor, has been shown to be more effective for long-term use in men than tamsulosin, while tamsulosin, an alpha blocker, has been shown to be effective in the short term. CombAT is the first study to demonstrate that the combination therapy of both drugs could lead to greater symptom improvement over time than an alpha blocker alone. Aliskiren - new class of antihypertensive Novartis has introduced aliskiren (Rasilez), the first direct renin inhibitor for the treatment of hypertension. It is likely to be used in combination with other agents but is also licensed as monotherapy. The commonest adverse effect is diarrhoea. At the recommended dose of 150-300mg per day, a month's treatment costs £19.80-£23.80. MHRA updates drug safety advice The balance of benefit and risks from HRT may be more favourable for younger women, the MHRA says in its monthly bulletin, Drug Update (September 2007). GPs considering prescribing HRT should evaluate the potential risks and benefits for each individual, the MHRA says. The bulletin summarises the risks of cardiovascular events and cancers associated with HRT. Cardiovascular risk is a particular concern for women over 60, whose baseline risk is high; although evidence for the safety of HRT in younger women is limited, their baseline risk is lower. Overall, the lowest dose of HRT should be used for the shortest possible time, and HRT should be prescribed to prevent osteoporosis only when alternatives are not suitable. The MHRA also advises in the bulletin that: Individual risk of stroke, breast cancer and endometrial cancer should be considered before prescribing tibolone (Livial). Nasal formulations of desmopressin are no longer indicated for primary nocturnal enuresis; prescribers are reminded to adhere to product guidance on fluid intake. Patients and carers should be warned of the risk of psychiatric effects associated with corticosteroids; symptoms may develop within a few days or weeks in children and adults, and may be more common at higher doses. Patients taking steroids for more than three weeks are reminded not to stop treatment abruptly. A list of questions and answers for patients is available at www.mhra.gov.uk. The use of parenteral B vitamins plus ascorbic acid (Pabrinex) may rarely be associated with severe allergic reactions, but this should not preclude its use for patients who need it. Study claims statin switch may increase CV morbidity Switching patients from atorvastatin (Lipitor) to simvastatin may increase the risk of cardiovascular events, according to a UK study presented at the European Society of Cardiology Congress in Vienna. The analysis, from The Health Improvement Network database, included 11 520 patients taking atorvastatin for at least six months, of whom 2511 were switched to simvastatin. Switching was associated with a 30 per cent increase in the relative risk of cardiovascular events, though absolute figures have not been reported. Patients who were switched were also more likely to discontinue treatment (21 vs 8 per cent of those continuing atorvastatin). Details of the conduct of the study, which will be published in the British Journal of Cardiology, are not available. Glitazones controversy rumbles on New systematic reviews have fuelled the controversy over the cardiac safety of rosiglitazone and pioglitazone. A meta-analysis of four trials involving 14 291 patients and lasting one to four years found that rosiglitazone was associated with a significantly increased risk of myocardial infarction (relative risk, RR, 1.42) and heart failure (RR 2.09) but not cardiovascular mortality (RR 0.90) (J Am Med Assoc 2007;298:1189-95). The second review included 19 trials of pioglitazone involving 16 390 patients, with follow-up from four months to 3.5 years. Pioglitazone was associated with a lower risk of composite events (death, myocardial infarction, stroke; hazard ratio, HR, 0.82) but an increased risk of serious heart failure (HR 1.41) (J Am Med Assoc 2007;298: 1180-8). Neither review reported significant heterogeneity between the included studies. Another systematic review of eight controlled and cohort studies concluded that metformin is the only antidiabetic drug not associated with an increased risk of harm in patients with diabetes and heart failure (Br Med J Online First 30 August; doi:10.1136/bmj.39314. 620174.80). The Canadian authors found methodological problems with all studies, and concluded that results for sulphonylureas were conflicting due to differences between the studies. Asthma prescribing education Health professionals need more education about rational prescribing for children with asthma, say researchers from Australia (Arch Dis Child online: 4 September 2007; doi: 10. 1136/adc.2007.119834). Analysing trends in asthma medication prescriptions for children in the UK between 2000 and 2006, they found the proportion of steroid inhalers prescribed as combinations increased from 2.7 per cent in 2000 to 25 per cent in 2006. The authors say this excessive increase is inconsistent with guidance that steroid-only inhalers should be the mainstay for most people with asthma. Copyright © 2007 Wiley Interface Ltd [source]

Circadian and seasonal rhythms in the behavior of spinner dolphins (Stenella longirostris)

MARINE MAMMAL SCIENCE, Issue 1 2009
Flávio José de Lima Silva
Abstract The present study investigated both circadian and seasonal fluctuations in the daytime activities of the spinner dolphin, Stenella longirostris, from the Fernando de Noronha Archipelago in Brazil. The number of dolphins, and aerial, and reproductive activities were documented. The observations were carried out from January 1997 to December 2001. Temporal series and rhythmic characteristics (mesor, rhythmic percentage, and acrophase) were obtained by COSINOR analysis and later compared. The dolphins entered the bay in the morning, displayed aerial and reproductive activities during daytime, and left the bay in late afternoon to the open ocean. This study indicated that the rainy season affected the three behaviors investigated decreasing the rhythms parameter and advancing the beginning of these activities. The number of individuals was higher during the dry season and the animals stayed longer inside the bay. During the dry season, there was a bimodal expression of aerial activity, expressing a longer use of the temporal niche than in the rainy season. The phases with high frequencies of aerial activity seemed associated with those showing high reproductive activity, both with peak frequencies at about 0800. The results represent an important contribution to the advancement of chronobiological studies, and to the biology of cetaceans, considering that the existence of circadian and seasonal rhythms was proven in the behavior of spinner dolphins in an area of the SW Atlantic. Moreover, it allows restricting periods of the day for the activities of tourism as a form of minimizing the impacts of the boats on the dolphins. [source]

Association between serious ischemic cardiac outcomes and medications used to treat diabetes,

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 8 2008
David J. Margolis MD
Abstract Purpose Data on cardiovascular outcomes among treated diabetics have been inconsistent. Our goal was to compare cardiovascular outcomes associated with different treatments for diabetes. Methods This is a retrospective cohort study of diabetic patients at least 40 years of age treated in general practices participating in The Health Information Network (THIN) data system between 2002 and 2006. Our primary outcome was serious atherosclerotic vascular disease of the heart. Results Among all diabetics (N,=,63,579), the fully adjusted hazard ratios of association with our outcome were 1.2 (1.1, 1.3) for insulin, 1.03 (0.97, 1.09) for sulfonylureas, 0.8 (0.7, 0.8) for biguanide, 1.2 (0.99, 1.5) for meglitinide, 0.5 (0.5, 0.6) for thiazolidinediones, and individually 0.6 (0.5, 0.6) for rosiglitazone, and 0.5 (0.4, 0.7) for pioglitazone. Among those individuals newly diagnosed and treated for diabetes after 2002 (N,=,13,576), the adjusted hazard ratios of association with our outcome were 2.4 (2.0, 2.9) for insulin, 1.4 (1.2, 1.7) for sulfonylureas, 0.5 (0.4, 0.5) for biguanide, 0.9 (0.4, 2.1) for meglitinide, 0.8 (0.7, 1.0) for thiazolidinediones, and individually 0.8 (0.6, 1.0) for rosiglitazone, and 0.9 (0.6, 1.4) for pioglitazone. Risk increased as total duration of therapy increased for insulin, sulfonylureas, and biguanide, but decreased with duration for rosiglitazone and pioglitazone. Conclusions Overall, insulin was associated with an increased risk of myocardial infarction. Its risk increased with longer use, and risk emerged with longer use of sulfonylureas and biguanide. Conversely, a protective effect emerged with longer use of rosiglitazone or pioglitazone. Copyright © 2008 John Wiley & Sons, Ltd. [source]

Latest news and product developments

PRESCRIBER, Issue 3 2007
Article first published online: 14 MAR 200
PPIs and hip fracture Treatment with a PPI may increase the risk of hip fracture, with longer use associated with higher risk according to a study in UK patients (J Am Med Assoc 2006;297:2947-53). The case control study compared use of PPIs by 13 556 patients with hip fracture and 135 386 controls in the UK General Practice Research Database. Use of a PPI for more than one year was associated with an increase of 44 per cent in the odds of hip fracture. The risk was higher for longer- term use (59 per cent after four years) and at higher doses (more than doubled with long-term high doses). The mechanism for this possible effect may be impaired calcium absorption associated with hypochlorhydria and reduced bone resorption. CHD NSF Statin prescribing has increased by 30 per cent every year since the publication of the Coronary Heart Disease NSF, the Department of Health says. The estimated number of lives saved attributable to statins had risen to 9700 in 2005. The proportion of patients with acute MI who were given thrombolysis within 30 minutes of admission has increased to 83 per cent. Flu jabs cut pneumonia deaths A US study suggests that flu vaccine protects against death during the flu season in patients admitted with community-acquired pneumonia (Arch Intern Med 2007;167:53-9). Nineteen per cent of patients admitted with pneumonia during the winters of 1999-2003 were known to have been vaccinated against flu. Their risk of death during their hospital stay was 70 per cent lower than that of nonvaccinated individuals. After adjustment for antipneumococcal vaccination and comorbidity, the odds of death were still 39 per cent lower. Model to predict admissions The King's Fund, together with New York University and Health Dialog, has published a model that predicts the risk of emergency hospital admission (see www.kingsfund.org.uk). The model is intended for use by PCTs and draws on data from secondary and primary care to define clinical profiles, allowing patients whose condition is deteriorating to be identified before they need admission. Problem drinking The National Treatment Agency for Substance Misuse (NTA), a special authority within the NHS, has published a critical appraisal of the evidence for various treatments for alcohol problems (www.nta.nhs.uk). The 212-page document estimates that over seven million hazardous or harmful drinkers may benefit from brief interventions by any health workers, and over one million dependent drinkers may benefit from specialist intervention. It concludes that cognitive behavioural approaches to specialist treatment are most effective and that treatment probably accounts for about one-third of improvements made in problem drinking. of patients remained on the same treatment after one year, falling to half at two years and about 40 per cent at three years. Treatment was more frequently stopped for lack of efficacy than for adverse effects. Stopping anti-TNFs Discontinuation of treatment with anti-TNF agents is more common in clinical practice than in clinical trial populations, a French study has found (J Rheumatol 2006;33:2372-5). The retrospective analysis of a single centre's experience of treating 770 patients with etanercept (Enbrel), infliximab (Remicade) or adalimumab (Humira) found that fewer than two-thirds of patients remained on the same treatment after one year, falling to half at two years and about 40 per cent at three years. Treatment was more frequently stopped for lack of efficacy than for adverse effects. There were no statistically significant differences between the three agents but there was a trend for infliximab to be least well tolerated. Generic statin savings The Department of Health has estimated that prescribing simvastatin and pravastatin generically would save £85 million per year. Its analysis of the ,Better care, better value' indicators (see www.productivity.nhs.uk) shows that statin prescribing has increased by 150 per cent in the past five years, with costs totalling £600 million in 2005. The Department says that if every PCT prescribed pravastatin and simvastatin by generic name in only 69 per cent of cases ,the level achieved by the top quarter of trusts ,the savings would be over £85 million a year. Herceptin reporting Press reports of a two-year trial of trastuzumab (Herceptin) were generally accurate in reporting its effectiveness but few reported an increased risk of adverse effects, according to the NHS National Library for Health (www.library.nhs.uk). The Herceptin Adjuvant (HERA) trial (Lancet 2007;369:29-36) found that, after an average follow-up of two years, 3 per cent of women treated with trastuzumab died compared with 5 per cent of controls; estimated three-year survival rates were 92.4 and 89.7 per cent respectively. All four press articles reported these findings accurately, but only two mentioned the increased risk of adverse effects. Updated guidance on CDs The Department of Health has published updated guidance on the strengthened governance requirements for managing controlled drugs, taking into account new regulations that came into force on 1 January (seewww.dh.gov.uk/asset Root/04/14/16/67/04141667.pdf). Statin adherence lowers MI mortality Patients with acute myocar- dial infarction (MI) who take their statins as prescribed are significantly more likely to survive for two to three years than those with low adherence (J Am Med Assoc 2007;297: 177-86). The four-year observational study of 31 455 patients with acute MI found that, compared with those who had taken at least 80 per cent of prescribed daily doses, the risk of death in those with less than 40 per cent adherence was 25 per cent greater over 2.4 years. For individuals with intermediate adherence (40-79 per cent), the risk was 12 per cent greater. Both differences were statistically significant after adjustment for potential confounding factors. The authors believe their finding is explained by differences in adherence rather than healthier behaviour because the excess risk of low adherence was less marked with beta-blockers and not significant for calcium-channel blockers. Improving community medicines management Mental health trusts need to improve medicines management by their community teams and improve information sharing with GPs, the Healthcare Commission has found (www.healthcare commission.org.uk). Its national report revealed limited evidence of pharmacist involvement in community mental health teams, even though 90 per cent of patients were cared for in the community. Only 11 per cent of assertive outreach patients had the tests necessary to ensure safe use of their medicines. Medication reviews found that 46 per cent of patients in mental health trusts and 12 per cent of those in acute trusts were not taking their medication appropriately. The Commission also reported that acute trusts received a complete drug history from GPs for fewer than half of audited patients when they were admitted to hospital, and only 30 per cent of PCTs reported that GPs received adequate information on patients' medicines on discharge. Copyright © 2007 Wiley Interface Ltd [source]