In one poor rural county, a 40-year program to combat cardiovascular disease appears to have reduced hospitalization and mortality rates compared with similar counties over the same period.

Franklin County, Maine, began a comprehensive effort to lower cardiovascular risk in 1970. The community-led program, which resulted in over 150,000 patient encounters, sought to help residents lower elevated blood pressure and cholesterol, quit smoking, improve their diets, and increase their physical activity.

When compared with other Maine counties, Franklin County had a lower-than-expected, income-adjusted total mortality rate after the program started. There was a similar drop in hospitalization rates, resulting in a reduction of $5.4 million in hospital charges annually.

In addition, blood pressure control increased from 18.3% in 1975 to 43.0% in 1978. Control of hyperlipidemia increased from 0.4% in 1986 to 28.9% in 2010.

Further studies are needed to assess the generalizability of such programs to other US county  populations, especially rural ones, and to other parts of the world.

Reference

Record NB, Onion DK, Prior RE, Dixon DC, Record SS, Fowler FL, et al. Community-wide cardiovascular disease prevention programs and health outcomes in a rural county, 1970-2010. JAMA. 2015;313:147-55. 

Prostaglandin analogue eye drops -- a common form of glaucoma drug -- significantly reduce the risk of vision loss in patients with the eye disease, a new study finds.

British researchers led by David Garway-Heath, of the Moorfields Eye Hospital and UCL Institute of Ophthalmology in London, tracked outcomes for more than 500 people newly diagnosed with open-angle glaucoma -- the most common form of the disease and one of the leading causes of blindness.They found that the use of latanoprost -- a form of prostaglandin analogue eye drops -- reduced the risk of vision loss in these patients by more than 50 percent over two years, compared to those who received an inactive placebo.

Until now, the extent to which the prostaglandin analogues have a protective effect on vision was not known.The new study shows that the use of these medications can greatly reduce the risk of visual loss, and a significant benefit in the treatment group could be seen at one year.Prostaglandin analogues are typically the first line in treatment for most glaucoma patients as they are an easy, once-a-day medication with a low side-effect profile. 

It is necessary to educate patients that while glaucoma cannot be cured, proper follow up with a trained specialist can slow the progression of the disease allowing patients to maintain good vision throughout their lifetime.

 

Reference

Garway-Heath DF, Crabb DP, Bunce C, Lascaratos G, Amalfitano F, Anand N, Azuara-Blanco A, et al.Latanoprost for open-angle glaucoma (UKGTS): a randomised, multicentre, placebo-controlled trial.Lancet. 2014 Dec 18.

Exercise can make us fitter and reduce our risk for diseases such as diabetes and heart disease. But how actually this works has remained a mystery. New research claims that the answer may lie, in part, in our DNA. Exercise changes the shape and functioning of our genes.

The human genome is highly complex and dynamic, with genes constantly turning on or off, depending on what biochemical signals they receive from the body. When genes are turned on, they express proteins that prompt physiological responses elsewhere in the body. But we don’t know how these genes respond to exercise.

Epigenetics is a process by which the operation of genes is changed, but not the DNA itself. Epigenetic changes occur on the outside of the gene, mainly through a process called methylation. In methylation, clusters of atoms, called methyl groups, attach to the outside of a gene like microscopic mollusks and make the gene more or less able to receive and respond to biochemical signals from the body.Scientists know that methylation patterns change in response to lifestyle. Eating certain diets or being exposed to pollutants, for instance, can change methylation patterns on some of the genes in our DNA and affect what proteins those genes express. Depending on which genes are involved, it may also affect our health and risk for disease.

For a study published this month in the journal EPIGENETICS, the scientists at the Karolinska Institute in Stockholm made 23 volunteers to bicycle using only one leg, leaving the other unexercised. In effect, each person became his or her own control group. Both legs would undergo methylation patterns influenced by his or her entire life; but only the pedaling leg would show changes related to exercise. The volunteers pedaled one-legged at a moderate pace for 45 minutes, four times per week for three months. Then the scientists repeated the tests with each volunteer.

Using genomic analysis, the researchers determined that more than 5,000 sites on the genome of muscle cells from the exercised leg now featured new methylation patterns. Some showed more methyl groups; some fewer. But the changes were significant and not found in the unexercised leg. Interestingly, many of the methylation changes were on portions of the genome known as enhancers that can amplify the expression of proteins by genes. And gene expression was noticeably increased or changed in thousands of the muscle-cell genes that the researchers studied. Most of the genes in question are known to play a role in energy metabolism, insulin response and inflammation within muscles.

But it’s unknown whether the genetic changes scientists observed would remain if someone quits exercising and how different amounts or different types of exercise might affect methylation patterns and gene expression.The message is that we can induce changes that affect how we use our genes and, through that, get healthier and more functional muscles that ultimately improve our quality of life.

 

Reference

Lindholm ME, Marabita F, Gomez-Cabrero D, Rundqvist H, Ekström TJ, Tegnér J, Sundberg CJ.An integrative analysis reveals coordinated reprogramming of the epigenome and the transcriptome in human skeletal muscle after training.Epigenetics. 2014 Dec 7.

 

December 2014 -- The U.S. Food and Drug Administration approved Saxenda (liraglutide [rDNA origin] injection) as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.

The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as hypertension, type 2 diabetes, or high cholesterol (dyslipidemia).

Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist and should not be used in combination with any other drug belonging to this class, including Victoza, a treatment for type 2 diabetes. Saxenda and Victoza contain the same active ingredient (liraglutide) at different doses (3 mg and 1.8 mg, respectively). However, Saxenda is not indicated for the treatment of type 2 diabetes, as the safety and efficacy of Saxenda for the treatment of diabetes has not been established.

The safety and effectiveness of Saxenda were evaluated in three clinical trials that included approximately 4,800 obese and overweight patients with and without significant weight-related conditions. Results from a clinical trial that enrolled patients without diabetes showed that patients had an average weight loss of 4.5 percent from baseline compared to treatment with a placebo (inactive pill) at one year. In this trial, 62 percent of patients treated with Saxenda lost at least 5 percent of their body weight compared with 34 percent of patients treated with placebo. Results from another clinical trial that enrolled patients with type 2 diabetes showed that patients had an average weight loss of 3.7 percent from baseline compared to treatment with placebo at one year. In this trial, 49 percent of patients treated with Saxenda lost at least 5 percent of their body weight compared with 16 percent of patients treated with placebo.

Patients using Saxenda should be evaluated after 16 weeks to determine if the treatment is working. If a patient has not lost at least 4 percent of baseline body weight, Saxenda should be discontinued, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.

Serious side effects reported in patients treated with Saxenda include pancreatitis, gallbladder disease, renal impairment, and suicidal thoughts. Saxenda can also raise heart rate and should be discontinued in patients who experience a sustained  increase in resting heart rate.

In clinical trials, the most common side effects observed in patients treated with Saxenda were nausea, diarrhea, constipation, vomiting, low blood sugar (hypoglycemia), and decreased appetite.

 

Source: FDA

Impressed by the ongoing efforts of the Indian Pharmacopoeia Commission (IPC) in effectively monitoring and implementing the Pharmacovigilance Programme of India (PvPI), the World Health Organisation's (WHO's) Uppsala Monitoring Centre (UMC) has decided to further extend its collaboration by strengthening training and education programme with IPC. This move comes in the wake of India becoming the first country in reporting over one lakh Individual Case Safety Reports (ICSRs) in VigiFlow.

 

The information on this strategic development was informed by Dr Marie Lindquist, director, UMC, Sweden and Christer Backman, medical products agency, Sweden during their recent visit to IPC, wherein they expressed UMCs interest in collaborating with IPC pharmacovigilance activities. As a part of this exercise, UMC which is WHO's collaborating centre for international drug monitoring, will be sending a team of experts on December 8 to IPC, which acts as the National Coordinating Centre (NCC) for PvPI to exclusively train and educate officials from the IPC on signal detection essential for effective Adverse Drug Reactions (ADR's) reporting.

 

Signal detection in pharmacovigilance comprises of selection of drug adverse reaction, preliminary assessment of available evidence and a follow up go how the signal develops. Most pharmacovigilance programmes are focussed on the handling individual adverse event reports also known as ICSRs with less attention paid to systematic analysis and review of aggregate adverse event data and risk management planning. Since individual adverse event case handling remains highly regulated and timely reporting of ICSRs to regulatory authorities and other stakeholders continues to be an important compliance matter, training and educational assistance like this can play a vital role in strengthening the PvPI programme. 

 

 

SOURCE-  http://pharmabiz.com/ArticleDetails.aspx?aid=85374&sid=1