GLP-1R Agonists May Help Weight Loss, New Study Reavels

University of Copenhagen scientists have come up with a study that shows Glucagon-like peptide-1 receptor (GLP-1R) agonists can be used to aid in weight loss.

The study was undertaken by university scientists in that adult participants with BODY MASS INDEX (BMI) of 25 or more and not having diabetes mellitus were examined. They were also exposed to drugs like exenatide twice in day and once in a week. Diabetes drugs such as liraglutide were also given daily at clinically applicable doses for the duration of 20 weeks. These drugs that were given to the participants come under the class of GLP-1R agonists. Oral antidiabetic drugs, placebo and insulin are given to the control group.

The study covered broad range of trials, almost 25 of them. The group which was exposed to GLP-IR agonists saw a huge contrast in their weight as compared to the control set of group. Both diabetic and non-diabetic participants showed this effect. The study came out with the conclusion that GLP-1R agonists helps towards improving diastolic, plasma collections of cholesterol, systolic blood pressure a glycaemic regulation. But does not have any effect on plasma concentrations found in liver enzymes.

Scientists also cautioned that GLP-1R agonists have some side-effects like vomiting, nausea and diarrhea. Drug did not develop hypo-glycaemia. So at last the team concluded that GLP-1R if consumed have great effect in attaining weight loss to obese patients having diabetes or not.
The study is available in BRITISH Medical Journal.

For Diet Pills, Drug Companies Want Explicit Approval Rules

Industry experts from U.S see possibility that pharmaceutical companies may halt investing for medicines indicated for the treatment of diseases such as diabetes drugs or weight loss pills.

The reason for that is believed to be lack of precise approval guidelines for medicines. Any product with therapeutic effects has to earn FDA approval before getting in market. Drug manufacturers are confused about how FDA inspects risk factors associated with medicine.

Focus of drug companies is likely to shift to other drugs, such as cancer drugs, where life-saving management is assured in case of severe side effects. The Food and Drug Administration is looking forward to address the concern.

Mr. Christopher Viehbacher, chairman of Pharmaceutical Research and Manufacturers of America (PhRMA), believes that there should be clear methods or guidelines which are being used by FDA so that manufacturer can predict the outcome before investing in production.

Pharma drug companies are preparing strategy for coming Congressional hearing on FDA user fee act. User fee is the fee manufacturer companies pay for faster review of their product by FDA.

Renewal is required from Congress for Prescription Drug User Fee Act (PDUFA) every 5 years. Current fee structure is due to expire on September 2012.

Recently several weight loss pills have been denied approval by Food and Drug Administration. There are many weight loss pills, such as Acomplia. Review panel sensed that obesity drugs by Arena Pharmaceuticals, Orexigen Therapeutics and vivus have approval barrier for diet pills because of safety reasons.

In United States around 70% of the population is over weight and medicines will help weight control along with regime and workouts.

Patient’s well-being and safety are the concern of Food and Drug Department which Mr Viehbacher agrees on.

New Biologic Lipid Lowering Drug To be Used With Statin

A biologic drug found lowering LDL cholesterol when other lipid lowering drug such as statins are not showing adequate result. The drug is in experimental phase and named as REGN727.

The drug is biologic lipid lowering drug class. Researchers reported 75 percent reduction in LDL (bad cholesterol) level when REGN727 administered with statin drug such as Mevacor and generic Lipitor.
The study included 180 patients with LDL level of 100mg/dL. All the participants were given generic lipitor along with REGN727 injection. Result of the study represented at yearly meeting of American College of Cardiology.

40% reduction in LDL level was reported when 50mg of the drug was administered once every 2 weeks. LDL level lowered by 64 percent when dose of the drug raised by 50% i.e. 100mg. 150mg of REGN727 found to be more effective as it reduced LDL by 72 percent.

Reduction was only 5 percent for combination of statin drug and placebo.

Dosage of the drug adjusted to once a month but it does not produce effect as good as once in two week dose, said Dr James McKenney – lead author of the study. Dr McKenney is CEO of National Clinical Research in Richmond.

Working mechanism of new drug is quite different than that of statin drugs (cholesterol lowering drugs). The new drug lowered LDL by preventing action of a protein known as PCSK9.