NEW YORK -- January 12, 2015 -- Researchers question whether there is substance to the US Food and Drug Agency's (FDA) recent warning that statins could affect the memory, attention span and other cognitive abilities of people who take this drug to control high cholesterol. This follows a systematic review of 25 clinical trials incorporating nearly 47,000 people. It was led by Brian R. Ott, MD, The Alzheimer's Disease & Memory Disorders Center, Rhode Island Hospital, Providence, Rhode Island. The review findings appear in the Journal of General Internal Medicine.

 

Since 2012, the FDA regulates that labels on statin packaging should warn that the drugs could change users' cognitive abilities. These cognitive changes could include attention span, problem solving, memory, and language or visuospatial abilities. The warning was based on surveillance and case reports, observational studies and randomised trials.

 

Subsequent reviews of available research have cast doubts on the cautionary stance taken by the FDA. Dr. Ott's team therefore set out to do a more comprehensive analysis using well-studied analysis methods. They scrutinised the data of 25 relevant randomised clinical trials that investigated a possible link between statin therapy and mental ability. Combined, these studies included the test results of 46,836 patients. Dr, Ott and his colleagues also contrasted and combined the results of 14 of these studies through a meta-analysis, which in total included 27,643 participants.

 

The review found no significant effect of statin use on the mental capacity of people with normal brain functioning or even those with Alzheimer's disease. The results suggest that the FDA's statin warning should be re-evaluated. Dr. Ott also believes there is a need to investigate the reasons behind the differences in the review results and the initial reports on which the FDA warning was based. It could be that some of the mental changes that were reported in the case studies were the result of overdosing with statins.

 

The review findings are congruent with the 2013 safety statement made by the American College of Cardiology and the American Heart Association Cholesterol Guideline. It advises that patients on statins who seem to be confused or who might have memory problems should be evaluated for causes other than their cholesterol medication. This could include the use of other drugs or systemic and neuro-psychiatric causes.

 

The researchers believe that there is more benefit to be had by sticking to statin therapy to manage heart-related diseases and prevent strokes than worrying about the possible adverse mental effects of these drugs.

 

"We found no significant effects of statin treatment on cognition," concludes Dr. Ott. "Given these results, it is questionable whether the FDA class warning about potential cognitive adverse effects of statins is still warranted."

 

SOURCE: Journal of General Internal Medicine

MINNEAPOLIS -- January 2, 2015 -- Exercise may help people with Parkinson's disease improve their balance, ability to move around, and quality of life, even if it does not reduce their risk of falling, according to a study published in the online edition of the journal Neurology (published on December 31, 2014).

 

For the study, 231 people with Parkinson's disease either received their usual care or took part in an exercise program of 40 to 60 minutes of balance and leg strengthening exercises 3 times a week for 6 months. This minimally-supervised exercise program was prescribed and monitored by a physical therapist with participants performing most of the exercise at home. On average, 13% of the exercise sessions were supervised by a physical therapist.

 

Falling is a common problem for people with Parkinson's, with 60 percent falling each year and two-thirds of those falling repeatedly.

 

“The resulting injuries, pain, limitations of activity and fear of falling again can really affect people's health and well-being,” said Colleen G. Canning, PhD, University of Sydney, Sydney, Australia.

 

Compared with those in the control group, the number of falls by participants who exercised was reduced in those with less severe Parkinson's disease, but not in those with more severe disease. For those with less severe disease a 70% reduction in falls was reported in those who exercised compared with those who did not.

 

“These results suggest that minimally supervised exercise programs aimed at reducing falls in people with Parkinson's should be started early in the disease process,” said Dr. Canning.

 

Overall, those who took part in the exercise program performed better on tests of ability to move around and balance, had a lower fear of falls, and reported better overall mood and quality of life.

 

SOURCE: American Academy of Neurology

CHICAGO -- January 6, 2015 -- Although some reports have suggested a link between human papillomavirus (HPV) vaccination and development of multiple sclerosis or other demyelinating diseases, a follow-up of girls and women in Denmark and Sweden who received this vaccination showed no increased risk for these disorders, according to a study published in the January 6 issue of JAMA.

 

Since the licensure of the quadrivalent human papillomavirus (qHPV) vaccine in 2006 and the later licensure of the bivalent HPV (bHPV) vaccine, more than 175 million doses have been distributed worldwide. The introduction of large-scale vaccination in a new target group -- girls and young women -- has been accompanied by a number of safety concerns, with the potential to undermine public confidence in the new vaccines.

 

One concern is the development of multiple sclerosis, which has been fuelled by social and news media reports of cases occurring after HPV vaccination, and an increasing number of case reports published in the medical literature describing vaccine recipients who developed multiple sclerosis as well as other demyelinating diseases. It is not known if the occurrence of these conditions after HPV vaccination merely reflects the background rates in girls and young women or represents a true increased risk.

 

Nikolai Madrid Scheller, Statens Serum Institut, Copenhagen, Denmark, and colleagues conducted a study that included Danish and Swedish females aged 10 to 44 years, followed-up from 2006 to 2013. The researchers used nationwide registers to identify the study group, information on qHPV vaccination, and data on incident diagnoses of multiple sclerosis and other demyelinating diseases.

 

A total of 3,983,824 girls and women were eligible for inclusion in the study group. Of these, a total of 789,082 were vaccinated during the study period, with a total of 1,927,581 qHPV vaccine doses.

 

During follow-up, 4,322 multiple sclerosis cases and 3,300 cases of other demyelinating diseases were identified, of which 73 and 90, respectively, occurred within the risk period (2 years following vaccination). After analysis of the data, the researchers found no increased risk of multiple sclerosis or other demyelinating diseases associated with qHPV vaccination.

 

“Our study adds to the body of data that support a favourable overall safety profile of the qHPV vaccine and expands on this knowledge by providing comprehensive analyses of multiple sclerosis and other demyelinating diseases,” the authors wrote. “The size of the study and the use of nationwide registry data of unselected populations from Denmark and Sweden allowed adequately powered analyses that are likely generalizable. These findings do not support concerns about a causal relationship between qHPV vaccination and demyelinating diseases.”

 

SOURCE: JAMA