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Sunday, February 20, 2011

Victoza: Is It the New "Miracle Drug" for Type 2 Diabetes?

I had reported last year that Danish pharma giant Novo Nordisk’s gamble on Victoza, its new drug for Type 2 diabetes, often looked like a long shot.

The company’s scientists had spent nearly 10 years trying to develop a molecule that would act like a naturally occuring hormone called GLP-1. Once they did, there were still costly setbacks, puzzling questions and enormous doubts, none of which managed to thwart one researcher’s passionate belief in the hormone’s ability to be turned into a drug for lowering blood sugar.

GLP-1 is short for glucagon-like peptide 1, a naturally occuring compound that works on different organs to lower the levels of blood sugar. For overweight diabetics, there’s another benefit: GLP-1 attaches to a receptor in the brain to decrease appetite, which over time, leads to weight loss.

Since then, Victoza has been used by thousands of diabetics, all with varying results. While the majority are seeing lower blood sugars (some in the double digits) and weight loss, others are seeing no change or too much change. Many have claimed Victoza to be a type 2 diabetes "miracle drug". That said, doctors are quick to use Victoza as a second line drug when Metformin and other first line drugs aren't doing their jobs.

Newer drugs to combat diabetes is always good news for those who are living with the disease. As all of us know, managing diabetes is not easy. In fact, for most diabetics it seems like a losing battle. Then a new drug hits the market, raising hopes. But many a time, expectations are dashed when its is discovered that the so-called wonder drug has some rather unpleasant side effects.

In fact, in the case of Avandia, a landmark meta-analysis in 2007 showing a 43% increase in the risk of heart attack on rosiglitazone. People with diabetes are already at increased risk of heart problems.

Last year, GlaxoSmithKline spent billions of dollars last year settling claims. And Avandia has been banned in most countries and in the US its use is severely curtailed. For all practical purposes, diabetics around the world have stopped using Avandia even though its supposed to be a "wonder drug".

How Victoza was ‘Discovered”

Before we get down to finding out more about Victoza, a little background is in order.

Lotte Bjerre Knudsen, a senior scientist at Novo Nordisk, led the 20-year effort to develop Victoza. Before the drug received its brand name, it was known by its scientific name, liraglutide. And in the research laboratory, Knudsen’s dedication earned her the nickname “Mrs. Liraglutide.’’

“There were doubts about whether this would ever be a drug,’’ Knudsen said in an interview last year. “When you’re making something completely novel, it’s not so untypical.”

The promise of the GLP-1 class of drugs fueled the company’s efforts through major setbacks, including a flawed dosing study that cost researchers 18 months. With each setback, Knudsen had to defend the project to management.

Knudsen said her team postponed celebrating Victoza’s development until the drug was approved by US regulators. “It wasn’t good enough until we received that,” she said.

So What Exactly is Victoza?
Victoza (liraglutide injection) is a non-insulin once-daily injectable medication that may help improve blood sugar levels in adults with type 2 diabetes. It comes in an injectable pen form with three dosage levels. The first level (0.6 mg) is usually used for a week and then increased to the second level (1.2 mg). If the third level (1.8 mg) is needed, it is easily "dialed" and may be started after the body has adjusted to the 1.2 mg level.

Victoza works by helping the pancreas release the right amount of insulin. Victoza is 97% similar to a hormone in our bodies called GLP-1. This hormone is what helps us move sugar from our blood into our cells. Victoza has the same effect as GLP-1, and it also helps food move much more slowly through the stomach. Another benefit of Victoza is that it blocks the liver from releasing too much sugar by lowering the amount of glucagon, a hormone that tells the liver to release glucose into the bloodstream in order to bring glucose levels to normal.

How Do I use Victoza?
One of the great things about Victoza is that it is made for once-daily usage. The pen only has to be refrigerated up until the first use, and then it can be kept conveniently in a non-refrigerated spot, such as a purse or bedside table. Victoza can be injected at any time of day, regardless of food intake. It is recommended to inject Victoza at approximately the same time each day, however, for consistency.

To do the injection, a special needle (which must also be prescribed by your doctor) is placed on the tip of the pen. The dial at the bottom of the pen is then turned to the dosage prescribed by your doctor. The injection may be given in the stomach, thighs or arms (subcutaneously). Throw the needle away, replace the cap, and you're done!

Side Effects of Victoza
The most common side effects of Victoza are nausea, vomiting and diarrhea until the body is used to the medication. Most patients start out at the 0.6 mg level for this reason. Lightheadedness has also been reported. A list of all side effects can be found on Victoza's website.

Victoza and Thyroid Cancer
During Victoza's testing process, the medicine caused rats and mice to develop tumors of the thyroid gland. Some of these tumors were cancers. It is not known if Victoza will cause thyroid tumors or a type of thyroid cancer called medullary thyroid cancer in people.

Victoza and Weight Loss
Many people have claimed to lose a great deal of weight while on Victoza. Although Victoza is not a weight loss drug, medical studies have shown that most people taking it do lose weight. Since weight loss is an important component of living with type 2 diabetes, this is definitely an added benefit.

Important Points About Victoza
  • Victoza is not insulin, and it is not known if it is safe and effective when used with insulin.
  • Victoza is not recommended as the first choice for treating type 2 diabetes.
  • Victoza can be used on its own or with other diabetic medications.
  • Victoza should not be used with people with type 1 diabetes or with people with diabetic ketoacidosis.
  • Victoza should not be used with children.
  • Doctors may recommend that small increases be made when going from 0.6 mg to 1.2 mg and then to 1.8 mg. This is accomplished by increasing by "clicks" on the dial. This is very helpful when side effects are severe.
  • Victoza can be costly, depending on insurance. Depending on the dosage, Victoza can cost up to $500 when not covered by insurance. Check with your pharmacy, and visit Victoza's website for coupons and information on getting your diabetes medication for free.
Making the decision to start Victoza is one that is strictly between a patient and his or her doctor. One must weigh the side effects against the benefits and make an informed choice. Victoza may be called a miracle drug for type 2 diabetes, but it is up to individuals to draw that conclusion when it comes to treating their own diabetes.

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