Gerovital H3, a romanian brand was marketed after the succes of clinical studies on olderly population.
In 1951, MD Ana Aslan had formulated a procaine product she called Gerovital H3 (GH3) after first studying it as a local anestethic in the National Institute of Gerontology and Geriatrics in Romania. She initiated a clinical study on a group of 25 patients that received procaine 2%. She was the first gerontologist to study the effects of procaine as an anti-aging tool.
Procaine is an ester composed of PABA (para-amino benzoic acid) and DEAE (diethyl amino ethanol). Both of these are water soluble B vitamins. PABA stimulates the production of folic acid and vitamins K and B1. It has its greatest beneficial effects in the hair, glands and intestines. DEAE is a precursor to choline and acetylcholine. These factors are well known for their importance in nerve function.
Another product containing procaine, Aslavital was formulated later, in 1970. Aslavital contains additional antioxidants as well as the GH3 ingredients. It is considered to be more potent than GH3 and to be used in addition to GH3 for chronic situations. It is acceptable to take a combination of GH3 and Aslavital.
The beneficial effects of Gerovital have been scientifically recognized. However, some studies have failed to replicate the anti-aging effects. In 1957 GH3 was approved by the romanian Ministry of Health, followind clinical investigations involving 7600 patients but is currently banned in the U.S. by the FDA as an “unapproved new drug”.
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Administration of Aspirin in Preeclampsia
Decreased incidence of preterm preeclampsia was asscociated with admistration of low doses of aspirin.
Preeclampsia represents one of the most frequent causes of maternal and perinatal morbidity and mortality and the interventions to reduce the prevalence of this desease represent a major challenge in modern obstetrics.
The efficacy of low-dose aspirin administration during pregnancy in prevention of preeclampsia was shown by the researchers from King’s College Hospital, London, England after a double blind clinical trial.
The clinical trial was performed on 1620 pregnant women with high risk of preterm preeclampsia who received a dose 150 mg aspirin per day or placebo from 11 to 14 weeks of pregnancy until 36 weeks of pregnancy. Preterm preeclampsia appeared at 1.6% of participants treated with aspirin, as compared with participants treated with placebo (4.3 %).
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Challenges for Medical Device manufacturers as the European Medical Device Regulations (MDR 2017/745) will enter into force
Substantial changes were included in the new “REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL ON MEDICAL DEVICES, AMENDING DIRECTIVE 2001/83/EC, REGULATION (EC) No 178/2002 AND REGULATION (EC) No 1223/2009 AND REPEALING COUNCIL DIRECTIVES 90/385/EEC AND 93/42/EEC” published in May 2017 (MDR 2017/745)
The Regulations will enter into force in 26 May 2020 bringing key changes related to the aspects of market surveillance, device identification and traceability, Conformity Assessment, Clinical Evaluation, and Safety.
Medical device manufacturers will be challenged to prove the clinical safety or performance for their medical devices placed on market in a more rigorous way. Requirements for clinical data and clinical investigation will be replacing the equivalence.
Mandatory Unique Device Identification (UDI) will be introduced with the intention to facilitate the traceability of devices.
Also, manufacturers will be required to report a serious incident (or Field Safety Corrective Action (FSCA)) to the relevant using EUDAMED within 15 days, in case of death or unanticipated serious health deterioration the maximum is 10 days. In case of a serious public health threat this timeframe is limited to two days.
Maviret and Vosevi, two new drugs for the treatment of chronic hepatitis C virus (HCV) infection in adults, have been approved by the European Medicines Agency.
HCV infection represents the most common single cause of liver transplantation in the EU and it affects between 0.4% and 3.5% of the population. In Europe, approximately 15 million people are chronically infected with HCV.
Maviret and Vosevi are effective against all genotypes of the virus. They have the role to block the action of proteins essential for HCV replication reaching a high degree of recovery without the need for interferon administration which are known for their serious side effects and poor tolerability.
Maviret is composed of two antiviral agents: glecaprevir (inhibitor of HCV NS3/4A protease) and pibrentasvir (inhibitor of HCV NS5A) and its effect were studied on 2,376 patients. Twelve weeks after the end of treatment, the HCV could not be detected in over 90% of patients.
The second drug, Vosevi, contains three active ingredients: sofosbuvir (nucleotide analogue non-structural protein NS5B polymerase inhibitor), velpatasvir (inhibitor of HCV NS5A) and voxilaprevir (HCV NS3/4A protease inhibitor). Its effects were studied on over 1,700 patients and twelve weeks after the treatment, over 90% of patients have no HCV.
For more information please access the European Medicine Agency .
A variety of health benefits are associated with the Mediterranean diet, especially the lower incidence of dementia.
The researchers from the Lewis Katz School of Medicine at Temple University Philadelphia, USA have studied the effects of extra-virgin olive oil consumption. They have shown that the extra-virgin olive oil has the role to reduce the formation of classic markers of Alzheimer’s disease, like neurofibrillary tangles and amyloid-beta plaques and to protect learning ability and memory.
For this study there was used a well-established Alzheimer’s mouse model. The mice were divided in two groups, one group fed with diet enriched with extra-virgin olive oil and the other group fed with diet without olive oil. A significant increase in steady state levels of synaptophysin, a marker of synaptic integrity and some remission of behavioral deficits have been shown at the mice that received the extra-virgin olive oil diet.
More information can be found on Alzheimer’s News Today website.