A potentially life-saving but inexpensive supplement for certain patients with diabetes has been revealed. Fewer cardioovascular events (heart attack, stroke and cardioovascular death) occurred in diabetes mellitus patients who tested positive for the genetic marker Hp2-2 when they were treated with statin therapy combined with vitamin E rather than just statin therapy alone. This was found in the Israel Cardiovascular events Reduction with Vitamin E (ICARE) study, published recently in Arteriosclerosis, Thrombosis and Vascular Biology.
Synvista Therapeutics Inc. is responding to this research by developing a diagnostic product to identify Hp types. The three Hp genotypes, Hp 1-1, Hp 1-2 and Hp 2-2 can be identified using an ELISA assay. Those with both the Hp 2-2 genotype and diabetes have a two- to fivefold increased risk of cardiovascular disease, after accounting for conventional cardiovascular risk factors and diabetes characteristics. Noah Berkowitz, Chief Executive Officer of Synvista Therapeutics Inc., commented, “This study demonstrates that positive clinical outcomes may be achieved with application of patient selection. Thus, the 6 million patients in the USA with diabetes and Hp2-2, who are at elevated risk for heart attack, could see that risk reduced by adding an inexpensive therapy, vitamin E, to their statin therapy.”
The ICARE study involved more than 3000 diabetics aged 55 years and older, 801 of which were found to have the Hp2-2 phenotype and to be taking statins. This group was randomized to receive either natural source vitamin E (400 IU daily) or placebo. After 600 days of treatment, the cardiovascular event rate was 4.1% in those on statins alone, but only 1.3% in those taking statins with vitamin E, which was a significant difference (p = 0.017).
Source: www.synvista.com.
In-hospital cardiac arrest survival rates lower at nights and weekends
Study: Comparision of the incidence of cardiovascular events at night versus day, and weekday versus weekends
Sample: 86,748 cardiac events from National Registry of CardioPulmonary Resuscitation
Conclusion: Survival rates from in-hospital cardiac arrest are lower during nights and weekends
Cardiac arrest survival patterns and time of day have been investigated by researchers in USA in a study designed to ascertain whether the outcomes after in-hospital cardiac arrest differ during nights and weekends compared with days/evening and weekdays. The data were collected for 7 years, between January 2000 and February 2007, from 507 medical/surgical participating hospitals. A total of 86,748 adult, consecutive in-hospital cardiac arrest events from the National Registry of CardioPulmonary Resuscitation were included. Multivariable logistic regression analysis and odds ratios were used to compare the survival to discharge, survival of the event, 24-h survival and favorable neurological outcomes.
More cardiac arrests occurred during day or evening hours, with 68% occuring between 7 am and 11.59 pm. Survival to discharge, return of spontaneous circulation for longer than 20 min, survival at 24 h and favorable neurological outcomes were considerably lower during the night than the day and evening (p < 0.001).
Patients suffering an in-hospital cardiac arrest during the day and evening were more likely to survive on a weekday than on weekends. However, no difference between weekdays and weekends was observed for in-hospital cardiac arrests occurring during the night. The authors concluded that, “Survival rates from in-hospital cardiac arrest are lower during nights and weekends, even when adjusted for potentially confounding patient, event and hospital characteristics.”
Source: Peberdy MA, Ornato JP, Larkin GL et al. Survival from in-hospital cardiac arrest during nights and weekends. JAMA 299, 785–792 (2008).
Ugandan study investigates home-based antiretroviral therapy
The lives of HIV sufferers in poor resource settings could be greatly improved with home-based antiretroviral therapy (ART) according to a study carried out between 2001 and 2005 and published recently in The Lancet. Researchers in Uganda investigated the effect of a home-based ART program on mortality, hospital admissions and orphanhood in people with HIV-1 and their household members. The prospective cohort study involved 466 HIV-infected adults and 1481 HIV-uninfected household members. Daily co-trimoxazole (160 mg trimethoprim and 800 mg sulfamethoxazole) prophylaxis was administered to HIV-infected participants after 5 months. After 2 years, 138 HIV-infected eligible adults and 907 new HIV-infected participants and their HIV-uninfected household members were followed-up with a study of ART (mainly stavudine, lamivudine and nevirapine).
The study demonstrated that the mortality in HIV-infected participants was 55% lower during the first 16 weeks, of ART and co-trimoxazole compared with co-trimoxazole alone. After 16 weeks the mortality with the ART treatment and co-trimoxazole was three deaths per 100 person-years compared with 16 deaths with co-trimoxazole alone; a reduction of 92% (p = 0.0001). Compared with no intervention, ART and co-trimoxazole reduced mortality in HIV-infected participants by 95% (p < 0.0001), and orphanhood was estimated to be reduced by 93% (p < 0.0001). The authors conclude that “expansion of access to ART and co-trimoxazole prophylaxis could substantially reduce mortality and orphanhood among adults with HIV and their families living in resource-poor settings.”
Source: Mermin J, Were W, Ekwaru JP et al. Mortality in HIV-infected Ugandan adults recieving antiretroviral treatment and survival of their HIV-uninfected children: a prospective cohort study. Lancet 371, 752–759 (2008).
Determining the cost-effectiveness of anemia treatment
Erthropoiesis-stimulating agents (ESAs) are versions of erythropoietin (EPO) used to treat anemia. Their synthesis by genetic engineering makes them costly to produce. Anemia is known to affect 3.4 million people in the USA and it is likely that many more remain undiagnosed. EPO is a glycoprotein that targets bone marrow, stimulating the generation and survival of erythrocytes.
The worldwide market for ESAs is approximately US$8 billion; reflecting the success of these drugs in treating many forms of anemia, including renal anemia and cancer-associated anemia. The first generation ESAs, epoetin-α and epoetin-β, are produced in Chinese hamster ovary cells and have been used successfully for over 20 years. Darbepostin-α is a second-generation ESA. Third-generation ESAs termed ‘continuous EPO receptor activators’ have also been developed.
The authors of the study felt that the current literature implies that epoetin- has a cost advantage over darbepostin- for the treatment of anemia in renal anemia and cancer-associated anemia. For other anemias, such as that induced by antiviral therapy or blood mangement in surgery, not enough data have been published to form conclusions regarding the most cost-effective ESA.
The authors concluded that the safety profiles of epoetin-α and darbepostin-α should be taken into account when determining their cost-effectiveness. The affect of ESA doses and durations on cost-effectiveness should also be investigated in future studies. The longer acting nature of the third-generation ESAs may affect the relative cost-effectiveness of the ESAs.
Source: Management of anaemia: a critical and systematic review of the cost effectiveness of erythropoiesis-stimulating agents. Duh MS, Weiner JR, White LA, Lefebvre P, Greenberg PE. Pharmacoeconomics 26, 99–120 (2008).
Modeling vaccination programs
National vaccination programs are costly and the cost-effectiveness of such programs must be evaluated carefully. Thus, models are often generated in order to assess the feasibility of a potential vaccination program, by taking account of biological, clinical, epidemiological and economic factors. Scientists from Boston (MA, USA) have assessed the modelling approaches used in cost–effectiveness analyses (CEAs) of vaccination programs. The authors determined a guide that coategorized models into three main attributes: static/dynamic, stochastic/ deterministic and aggregate/individual based. This was applied to a systematic review of CEAs of all currently available vaccines from 1976 to 2007.
Of the 276 CEAs of vaccination programs, 27% were centered on the varicella, influenza, hepatitis A, hepatitis B or pneumococcal vaccine. In general, the analysis revealed that “the main health outcome measures are moving away from the number of cases prevented towards quality-adjusted and inadjusted life-years gained, and more complex models are beginning to be used.”
The authors conclude that it is important for analysts to be open about the model type they use and propose that modelers should be clear as to whether their model is static/dynamic, stochastic/deterministic, aggregate/individual based or open/closed.
Source: Kim SY, Goldie SJ. Cost-effectiveness analyses of vaccination programmes: a focused review of modelling approaches. Pharmacoeconomics 26, 191–215 (2008).
Study suggests obesity epidemic may be linked to rising cigarette cost
A paper published online in Health Economics has concluded that there is some evidence that while taxes may be reducing the number of smokers in the USA, the rising number of obese people may be a result of this. Approximately 30% of Americans are currently obese, 25 years ago this figure was nearer to 15%. Recent research has suggested that the affect on health of this obesity epidemic costs society more than cigarette smoking and alcoholism. The author raises the question of whether it is cigarette taxes, which have been increased since the 1960s when the link between smoking and ill health was made, have contributed to the prevalence of obesity.
The effect of cigarette cost on BMI and obesity was studied, and the results indicate a significant link. The author carefully controlled for correlation with state-specific time trends using panel data.
Charles Baum, author of the study and Associate Professor of Economics at Middle Tennessee State University (TN, USA) concludes, “Results indicate that the net benefit to society of increasing cigarette taxes may not be as large as previously thought, though this research in no way concludes that they should be decreased to prompt weight loss.”
Source: Baum CL. The effects of cigarette costs on BMI and obesity. Health Economics (2008) (In Press).
Cost of placebos demonstrated to affect subject responses
Study: How informing patients of the cost of a placebo affects its effectiveness
Participants: 82 healthy, paid volunteers
Conclusion: The placebo was more effective in those who believed it to be more expensive
A patient’s perception of the effectiveness of medication may be greatly influenced by commercial factors such as cost according to a study carried out by scientists in the USA.
Recruited through an online advertisement, 82 healthy, paid volunteers took part in the study. All participants were given a placebo pill, but were led to believe it was a new FDA-approved opioid analgesic that was akin to codeine, but with a more rapid onset time. Half of the recruits, randomly assigned, were then informed that the drug cost $2.50 per pill and the other half that the price had been discounted to $0.10 per pill, with no reason for the discount given.
The effect of the placebos was measured using a standard protocol to administer light electric shock to the participant’s wrists, before and after the taking the pill. Of the participants told they had the $2.50 pill, 85% reported a reduction in pain after taking the placebo. Of those informed that the pill cost $0.10, only 61% reported less pain.
The results of this study raise many questions about the impact of features such as cost on the effectiveness of drugs. Dan Ariely, a behavioral economist at Duke University (NC, USA) and corresponding author of the study comments, “The placebo effect is one of the most fascinating, least harnessed forces in the universe.”
Source: Waber RL, Shiv B, Carmon Z, Ariely D. Commercial features of placebo and therapeutic efficacy. JAMA 299, 1016–1017 (2008).