Treatment of Diabetes

There are two major types of Diabetes: Type I and Type II.

Type I is typically genetic and is caused by the body attacking itself, destroying the cells in the pancreas that create insulin.

By contrast, Type II is typically caused by a combination of genetic predisposition and lifestyle choices, and is generally associated with being overweight.

The two types of diabetes have the same end result: there becomes too much sugar in the bloodstream, which causes a lot of problems.  But their treatments are different.

What does Insulin do?

Insulin helps the body digest and remove glucose, or sugar, from the bloodstream.  It is released from the pancreatic cells in response to the digestion of glucose.  Insulin effects almost every cell but is particularly important in the

Muscles, where it promotes the conversion of sugar into glycogen, a form used to store store

Liver, where it also promotes the conversion of sugar into glycogen

Fat cells, where it promotes the conversion of sugar into fat

Treatment for Type I Diabetes:

Type 1 is characterized by limited to no production of insulin, and treatment for it focuses on replacing the insulin that the body isn’t making.

A key problem in doing so is that insulin is a protein, so it can not be given orally as the stomach will digest it. Also, insulin tends to first pair up with itself, then form into larger complexes that take a long time to be broken.  This means that insulin by itself takes a relatively long time to start acting, so it has to be taken a while before eating, which is inconvenient.

Chemical modifications to insulin help solve the speed of delivery problem.  By exchanging two chemical parts of insulin, a lysine and a proline, the interactions that promote aggregation are disrupted.  This makes the insulin quickly accessible, which means it can be taken almost before a meal.

This instant release form of insulin helps replicate the spike in insulin that the body releases to help digest a meal.  It does not, however, mimic the low level of insulin that naturally exists.  To do so, other insulin derivatives were made, particularly glargine and detemir.

Glargine is a chemically modified form of insulin that, while a liquid in acidic environments, becomes solid in the body.  This means that it hangs around for a lot longer, ensuring a low baseline level of insulin activity throughout the day.  Detemir works similarly, but is made by attaching a fat to insulin which makes it harder for the body to remove.

Typical treatment combines long acting insulin with short acting to try to mimic the body’s natural pattern.  Failure to do so can result in blood glucose irregularities which can, if done poorly, cause a diabetic coma, or worse.

One innovative treatment approach is a continually connected monitor/release system.  The system can allow for greater control over insulin levels; on the other hand, it has to be worn continually, and patients non-adhering to doctor’s orders can possibly be worse with it.

What the Advair Warning Means

Asthma is pain enough by itself. Then you learn that the medications you take for it might, well, kill you.

You might be concerned because Advair, for instance, has a black box warning, the worst the FDA can do short of withdrawing a drug.

The good news, however, is that it seems that the main concerns about Advair’s safety are in one of its ingredients and is addressed by its dual formulation.

What is Advair?

Advair is a combo drug of albuterol or salmeterol, a long acting Beta agonist (LABA), and fluticasone, a steroid.

The problem comes from the salmeterol component of Advair. The chemical action of this drug is to go into the lungs and target beta receptors. By activating them, the drug causes your lungs to relax, which eases the asthma. Good, right?

Well, yes. Problems arose, however, when a researcher comparing use of salmeterol to another drug noticed that the risk of death of those using salmeterol was three times higher than the other medication. Concerned, the US government in the form of the FDA helped organize a much larger examination of salmeterol.

And what they found was pretty bad. People who used it a LABA as their sole asthma treatment were four times as likely to die as those using inhaled steroids. So how on earth can your doctor tell you to take Advair?

The biological explanation

The answer? Well, let’s step back a little.

The probable reason that salmeterol was associated with increased risk of death was because of how it works. It goes to the lungs and tells them to relax; it doesn’t, however, help control inflammation. So it might make you feel better while the serious biological problem of inflammation is happening.

It’s symptom control without controlling the underlying disease.

This is supported by the possibility that the very same study the FDA ran seems to show that, in combination with steroid treatment, LABA doesn’t significantly increase your risk of dying.  (Though that doesn’t sound very reassuring!)

To top it off, several major analyses including the Cochrane database of systematic Reviews show that use of a LABA with a steroid, dual therapy like that in Advair, is not associated with increased problems.

And dual therapy may have a slight advantage in lung function and, possibly, have less effect on growth in a child.

Conclusion

We still aren’t 100% of how safe Advair is.  That said, the logic behind its combination is solid and seems to have some good medical support.  From what I’ve seen, it makes sense not to take salmeterol by itself, which is exactly what Advair addresses.

On the other hand, it may be possible to treat asthma with steroids alone, just by increasing the dose.  Still, steroids are potent and can have significant side effects.

Thanks for reading!

Depression.

Are you unhappy, worried about your life, and things don’t seem to matter?

It might be depression.  And that should mean change of some sort.  What that means can vary: it can mean eating healthier and exercising, to seeing a therapist and taking medication.

It’s important to realize what we know about depression – and what we don’t.

First, we aren’t sure what causes depression.  While often depression can be linked to a significant event, it also often just happens, so to speak.  It seems to make more sense for depression without a reason to require treatment.

And we don’t know how much of depression is normal.  If someone just lost their parents, for instance, or was diagnosed with a fatal disease, it only makes sense for them to feel down – depressed.  Making it more complicated, most depressive feelings pass with time.

The standard medical treatment for depression is, nowadays, medication.  But there are reasons to hesitate before turning to medications, like how little we know about them.  Also, they have only OK results – they work in about 60% of people who take them, as opposed to about 30% who respond to a placebo, or a sugar pill.

And that’s at best.  Some studies have shown significantly lower success rates, and how well antidepressants work over the long run also seems to be lower.

Worse.  Medications for depression often have serious side effects, including sexual dysfunction and can even cause suicidal thoughts.  And they can be physically addictive.

On the other hand, antidepressants can help and are sometimes lifesaving.  There is a reason that millions of people have taken them, and it’s not all due to adroit marketing by pharmaceutical companies.  A good therapist can help you weight the pros and cons of medication and help find the right path.

Treatment – initial evaluation

If you’re concerned about possibly having depression, you should see both a regular doctor and a therapist for an evaluation.  There are many physical causes of depression.  Vitamin B12 deficiencies, for instance, as well as low levels of folic acid can cause depression.  And physical conditions like hypothyroidism also can cause poor mood.

As such, the first step for treating depression should be a phyiscal work up to eliminate these and other conditions.  Tests should be done for thyroid hormone levels and to ensure both proper levels of nutrients and proper digestive working.

Dietary modification and exercise  are worth a try as an initial treatment for depression.  Some doctors claim to see astonishing transformations from that alone, and several studies have shown that vigorous exercise works as well as medication for treating depression.

Seeing a therapist is a very good idea.  Their expertise and ability to help you with your problems can be phenomenal just by itself.  The fact is that therapy has been shown to be just as effective as medications for treating depression – with the only side effect being a smaller wallet.

Treatment – SSRIs

If you decide to go onto medication, a decision that shouldn’t be made lightly and should ideally come after trying the ideas above, most likely your doctor will recommend an SSRI.

The SSRIs are now the most commonly prescribed medication for depression.  They are so called because they are Selective Serotonin Reuptake Inhibitors.  What does that mean? Well, imagine two cells in your brain.  There’s a gap in between the two, which is full of chemicals and substances, including serotonin.  This stuff interacts with receptors on the cell, activating and creating all sorts of activity.

The SSRIs prevent cells from taking up serotonin, or removing it from the space in between the cells.  That keeps serotonin around longer, which means it activates more of the receptors for it.

Why this does anything to improve mood we simply don’t know.  Serotonin is a widely used neurotransmitter, and substances that effect it have unpredictable effects.  Some pain killers effect it, as well as LSD, which causes hallucinations.

The SSRIs work in about 2/3 of patients who use them.  In terms of side effects, they very commonly cause sexual dysfunction like inability to orgasm and some digestive issues.  Shockingly, they have been linked to a significant increase in suicidal thinking, perhaps doubling the risk of it.

Treatment – Tricylics, MAO-inhibitors

These are older classes of medication but work on similar neurochemicals that the SSRIs do.  The tricylclics might be slightly more effective than the SSRIs, but there are very good reason that both these medications are not used typically for initial treatment.

Tricylclics can be fatal in overdoses, and have other significant side effects.  MAO inhibitors are also somewhat toxic and make the user extremely sensitive to certain foods, like cheese.  If one of those foods are eaten, a life threatening increase in blood pressure can happen.

Treatment – if things don’t improve

If the ideas above don’t help with your depression, several things should be considered.

First, the depression may be caused by a related mood condition called Bipolar Disorder.  Bipolar disorder often causes depression that does not respond to typical antidepressant treatment.

Second, switching medications is definitely worth considering.  Several studies have shown that a significant percentage of people who don’t respond to initial treatment do to their second, or third medication.  Importantly, there are medications that don’t work on serotonin that may work if an SSRI doesn’t.

In some cases, it might be worth considering adding a different class of medication.  Antipsychotics have shown some but modest ability to help treat depression.  Stimulants like Ritalin and Adderall might help increase energy and motivation.

In the worst case scenarios, physical interventions like electro-shock therapy might work.  Electro-shock therapy is actually the most effective treatment for depression we have, but comes with serious side effects like memory loss.

Thoughts

Depression is a serious problem and medications can help.  That said, there are limitations to both our understanding of the condition and the pills to treat it.  If you’re feeling depressed, you might want to consider if it makes sense.  As direct/rude as it may sound, if your life is crappy, why would you expect to feel otherwise?

The best treatment would seem to be seeing a therapist who very well understands the relevant issues.  They can guide medication decisions as well as help you with the problems in your life that may be causing the depression.

Remember:

Never lose hope.  Never give up.  There is a combination of dietary change, exercise, therapy and medication that will change things for the better.  Sometimes clouds cover the sun, but that doesn’t it isn’t there – or that it won’t shine again, soon.

If you are feeling actively suicidal, please consider getting immediate help.

You might like:

10 Ways to Treat Persistant Depression

Agomelatine: A New Treatment for Depression

Thanks for reading!

Zoloft vs Prozac

Everyone’s heard of these two drugs.  They’re that popular.  But what are they?  How do they compare?  And in the analysis of Zoloft vs Prozac, which comes on top?

Zoloft might have a slight advantage over Prozac.  Yet they both can have serious side effects, and don’t always work.

For a discussion about the pros and cons of antidepressants, you may be interested in reading a balanced approach to antidepressants.

Let’s start at the beginning.

Zoloft

Zoloft was discovered during the 70s/80s by accident.  A team at Pfizer was researching compounds for a condition not related to depression.  One of those, what would later become Zoloft, had impressive selective serotonin reuptake inhibitor (SSRI) effects.  Against the wishes of higher management, the team pushed for the development of the medication.

Initial approval of Zoloft almost didn’t happen.  The FDA was concerned about the poor efficacy of the medication, and by the improper design of the studies.  Zoloft didn’t seem to work well, and the studies that showed that were not examples of good science.  Yet they gave it the green light.

Within 15 years, it would become the most popular antidepressant, with 29 million prescriptions in 2007.

Prozac

Prozac was one of the first SSRI medications altogether.  It was discovered slightly before Zoloft.

It’s entry to the market changed how depression is treated.  The earlier medications, the MAO inhibitors and Tricyclics, had very significant and serious side effects.  It seemed at first that Prozac was much safer.  And it worked about as well.

In 2007, 22 million prescriptions were filled for fluoxetine, the generic form of Prozac.

Comparison of Prozac vs Zoloft

Both work in about the same time span, of 4-6 weeks.  Both should be taken once daily, and the difference in doses aren’t important.  Both have some benefit in 50-70% of those who take them.

Crucially, they are both SSRIs, and they both work by almost the same mechanism.  This means that they aren’t really that different (and this is also true for many other antidepressants like Paxil).

Some analysis of many, many patients showed slight superiority in Zoloft’s efficacy for treating depression.  One paper put it the difference between the two that Prozac is certainly not better than and probably not worse than Zoloft.

The main difference between the two may be in side effects.  One study analyzing Zoloft vs Prozac found that Prozac had slightly less “retardation,” or feeling of being slowed down.  The same study, however, showed that Prozac might have more anxiety and irritability.

On the other hand, diarrhea is more associated with Zoloft than Prozac.

They both have similar rates of sexual dysfunction, and similar rates of physical addiction.  And they both tend to cause significant weight gain.

Remember

Antidepressants are very hit and miss.  They often don’t work, and it’s possible that a lot of their effect is from placebo.  They are powerful medications and have been shown to double the risk of suicidal thinking in some analysis.  Because they have significant side effects, a high percentage of people taking them stop shortly after starting.

That said, they can also be life-changing.  For some people, they can make normal living possible.  As always, the key is to balance the potential benefits against the potential harms of a treatment.

Related Articles:

1. Why am I Depressed?
2. Weight Gain from Zoloft and Prozac
3. 10 Ideas to Treat Resistant Depression
4. The Top 5 Depression Songs
5. Ethical Issues in Health & Medicine

Immediate Depression Relief

Heal Depression Naturally – No Therapy – No Drugs

Depression Free! Conquer Depression, Anxiety & Bi-polar in 30 days!

Concerns about Actos

You may be considering pioglitazone or Actos to help treat your diabetes.  But you absolutely need to know that Actos has some very serious side effects and that it’s not entirely clear how well it works.

Pioglitazone, or Actos, is a very popular treatment for Type 2 Diabetes, with prescriptions counting for about 20-25% of total.  It works on peroxisome proliferator activated receptor-gamma receptors to improve sensitivity to insulin in various parts of the body.

The good thing is that Actos does have some benefits.  It seems to lower blood pressure, and seems to have a positive effect on certain important markers of health, like urine composition and levels of lipids in the blood.

And some studies like PROactive have shown that it has significant benefits in lowering risk of mortality from certain aspects of diabetes.

Concerns

First, the way that PROactive measured its outcomes was not properly done and changed in the middle of the study, almost certainly to make the medication come off as being better.  And most of the other studies don’t clearly show health benefits.

Yes, Actos or Pioglitazone does seem to have significant effect on certain physiological factors.  But those measures don’t necessarily translate to improved life-span or reduced risk of events.  And even the PROactive study didn’t have statistically different outcomes for certain serious diabetes related problems.

One analysis of 22 studies argued that 21 of them showed only improvement in surrogate measures.  That means that the medication was shown to have some sort of physical effect but not necessarily have health benefits.

Heart Failure

Worse.  Pioglitazone might significantly increase the risk of heart failure.  In one study, rate of heart failure went up from 2% to 4%, and in another from 8% to 11%.  This is despite having some effects that are good for the heart, like reducing thickness of certain arteries.

Actos also increases risk of bone fracture, and, like a related medication that was withdrawn from the market, may have significant liver toxicity.

Thoughts

Because of these factors, and the lack of definitive and convincing long-term studies focused on measuring health end-points, Pioglitazone’s cost-benefit analysis is not clear.  Its use over other options for Diabetes management should be very carefully considered.

Thanks for reading!

The Diabetes-Reversing Breakthrough

The Diabetes Miracle Breakthrough

Ultimate Diabetic Cookbook

Metformin, brand name Glucophage

You may be taking or considering metformin if you have Type II diabetes, “prediabetes,” or, though the scientific evidence for its use isn’t so solid, polycystic ovary syndrome.

Metformin works in several ways. It helps certain parts of the body respond properly to insulin, reduces how much glucose is released into the bloodstream, and does a few other things.

Most of what we know about Metformin is good. It doesn’t seem to cause weight gain, and in fact, may cause slight weight loss. It’s affordable. And it has 4 decades of use, meaning we know a lot more about it than many other medications.

One study showed that use of metformin over several years reduced mortality – or death - rates related to diabetes by an impressive 36%.

Side effects of metformin

Metformin’s side effects are mostly mild and treatable, though there is a the rare chance of a problem called lactic acidosis. About 30% of users experience some sort of side effect, including indigestion and diarrhea.

Taking metformin with a meal is one way to reduce problems, as well as taking an extended release version. The immediate release form has about a 17% rate of diarrhea, for instance, while the extended release has only about 8%.

Some have complained that metformin makes them smell bad.

Lactic acidosis is a very rare side effect that is fatal about 50% of the time. Estimates of how often it occurs range from 1/30,000 patient-years to a bit higher.  But assuming you meet the criteria for using metformin, most likely you shouldn’t worry about it.

Most doctors strongly feel that the benefits of metformin outweigh the risks of lactic acidosis.  As one doctor puts it, “Of 10,000 diabetic patients treated for 10 years with metformin, only 10 will die from lactic acidosis. [Based on a large study] of those 10,000 patients… metformin would [have prevented] 500 diabetes related deaths.”

Because of how effective metformin seems to be, some doctors argue for more aggressive use of the medication than is currently done.

Most common metformin side effects: nausea, metallic taste in mouth, some weight loss, vomiting and abdominal bloating.  Cramping or a feeling of fullness is also fairly common.

Talk to your doctor: if you feel excessively weak, have heartbeat changes or irregularities, chest pain, or signs of an allergic reaction.  Some people experience hypoglycemia, or too low blood sugar, on Metformin, which is also important to watch for.  Signs include chills, weakness and dizziness.

You may need to stop use if you are going to get an X-ray or scan that involves injection of die into your body.

This list does not include everything; see manufacturer’s insert for more.

Notes

Metformin can cause Vitamin B12 and folic acid deficiencies, so make sure to be eating a well balanced diet.  Additionally, remember that the initial and ideal treatment for type II diabetes is exercise and improved diet.

And it’s important to take metformin as your doctor directs.  It takes a while to start working and needs to be taken as recommended.

There are several conditions which mean you shouldn’t take metformin, like kidney problems. It’s possible that a significant amount of the lactic acidosis occurs in people who, according to the strict guidelines, shouldn’t have been taking the medication.

Related articles:

1. Bydureon Diabetes Drug, Side Effects
2. 10 Tips for Living With Type 1 Diabetes
3. What are the symptoms of Diabetes?

Just for fun:

1. 20 Fun Facts About Alcohol
2. The 10 Worst Diseases Ever

Intuniv for treating ADHD

Shire’s Intuniv medication is quite new.  It was approved recently, on September 3rd, 2009, but is gaining increasing recognition as a treatment for ADHD.

Chemically, Intuniv is an extended release form of guanfacine, a blood pressure med that has been on the market for quite some time.

It works by stimulating alpha-2 receptors – this lowers blood pressure and may work in the prefrontal cortex to increase focus, attention and memory.

Intuniv is one of many options for treating ADHD.  To learn what all the main options currently are (and, more importantly, what they do and how well they work), see a Full List of ADHD Medications.

And if you want to learn about ADHD in general, see here.

How well does Intuniv work?

Several studies so far have been done into how well Intuniv works for treating ADHD and what kind of side effects it has.

So far, they say that Intuniv works somewhat less than the stimulants like Ritalin and Adderall and – possibly – somewhat more than the traditional non-stimulants like Strattera.

This is important because, though they are the best current treatment for ADHD, 30% of people can’t take or don’t respond to stimulants.

Parents in particular have concerns about traditional treatment for their children.  Intuniv can be used as sole therapy or with stimulants, to round out treatment.

What kind of side effects does Intuniv have?

In general, the type of side effects that you’d expect from a blood pressure lowering medication.  That said, we’ve noticed a few issues you should know about and that you might not learn about elsewhere.

The pros

Intuniv could possibly fill a lot of the role as a non-stimulant treatment that Strattera was supposed to play but didn’t.  It has a long duration of effect and can even be used in combination with stimulants.

And the short acting form of Intuniv has been on the market for some time, so we know that it is fairly safe in general.

The cons

Intuniv is very new, and studies so far have shown that it is not as effective as the stimulants.  Some studies have hinted at potential problems such as high rates of serious side effects such as fainting.  While the short acting form has been on the market, Intuniv is long lasting.

Remember, roughly 50% of medication side effects are discovered after it is released onto the market.

Efficacy

How well does Intuniv work?

The studies seem to show that Intuniv falls just short of sending ADHD symptoms into remission.  Roughly 55% of those on Intuniv in one study reported significant improvement compared to 30% of those on placebo.

In one major study, on one scale, people who started with an ADHD score of around 40 and took Intuniv had their score go down to around 19 on average. The accepted number for remission of ADHD symptoms is a score of 18 or less.

Those who took Intuniv along with stimulants went from about a starting score of around 29 to around 13.

There are some more interesting hints towards Intuniv’s efficacy we found in that study.  On the one hand, only 10% of participants said that they stopped specifically because they thought Intuniv wasn’t working that well.  And of those taking Intuniv with stimulants, only one person stopped specifically because it wasn’t working well.

That said, around 80% of people in total dropped from that study.  It was done over two years, but that is still a somewhat high number.

Other studies into Intuniv have had much lower drop out rates.

In another, smaller study, roughly 30% of people on placebo reported significant improvement, as compared to around 55% of those treated with Intuniv.  This difference likely means that it has some benefit and is useful but falls short of the efficacy of the stimulants, which work in roughly 70% of those treated.

Analysis of that study concluded that at low doses Intuniv is about as effective as traditional non-stimulants, and at higher doses is superior to the current non-stimulants, such as Strattera, Wellbutrin, and possibly even Provigil.

Intuniv Side effects

Different studies show different side effect profiles for Intuniv.  Some say that it has about the same rate of issues as placebo, while others show that around 10-15% stop using it because of some side effect.  As far as psychoactive drugs, a 10-15% discontinuation rate due to side effects is on the lower/medium range.

The side effects of Intuniv also depend on its particular use.  When used in combination therapy with stimulants, for instance, it has much less rates of sedation and sleepiness, and users seem to report less problems.  This is probably because its sedative effects that lower blood pressure are counteracted by the stimulants effect of raising it.

Some of its side effects take time to start showing up, with sedation in particular starting after 3 weeks of treatment.

Most common:

30-40% report sleepiness

25% report headache

17% in one study reported upper respiratory tract infection

10% report sedation

Other common side effects include dizziness, nausea, irritability and reduced salivary flow.

Concerns

In one study, 5 participants out of 262 who took Intuniv  experienced syncope, or “temporary loss of consciousness.” In layman’s terms, they fainted or blacked out.

The clinical trials dedicated to exploring safety did not have such incidences, and it’s possible that the syncope events were environmentally based. One of the sufferers, after all, had a history of such issues. And guanfacine has a long history of use. So while those numbers are alarming, they are explainable.

Other possible side effects that may be an issue: head injury, suicidal ideation.

Like with all psychoactive medications, people using Intuniv should be monitored for anything abnormal like increased feelings of depression.

Dosing

Intuniv is given typically anywhere from 1-4mg/per day.  A dose typically lasts for 12 hours, but may have some effect for up to 24 hours.

Related articles:

1. Vyvanse vs Adderall XR
2. Dr. Tuckman Answers Questions About ADHD
3. Is There a Physical Test for ADHD?
4. The 4 Secrets to Success with ADHD

Adhd and Add Online Diagnostic Test

Suffering from Adhd – need help – don’t know what to do!

Overcoming Adhd: A Guide For Parents

Control Your Add/adhd, Control Your Life!

Valdoxan or Agomelatine: A new depression treatment

About 40-50% of people taking the current antidepressants, or the SSRIs, stop treatment shortly after starting.  This is because that class of medications has certain significant side effects, like nauseua and sexual dysfunction.

Valdoxan, generic agomelatine, is a new medication that is generating a lot of excitement because it seems to be an effective antidepressant that doesn’t have those problems.

Valdoxan is a synthetic analogue to melatonin, a natural substance your body has that plays a role in sleep regulation.  Chemically, it serves to activate the melatonin 1 and 2 receptors, while also acting as an antagonist to 5-Ht2.  This latter activity may serve to promote release or norepinephrine and dopamine.

It’s important to note that Valdoxan has significantly different chemical action than the selective serotonin reuptake inhibitors (SSRIs).

Possible Advantages

Valdoxan may not have the same rate or degree or type of side effects as traditional antidepressants. It may not cause nausea, sexual dysfunction and other common side effects.

It may start working faster, with some efficacy observed at just two weeks, not the four typically needed for antidepressants.

Both these elements may mean that people will be less likely to want to stop taking it and could start expereincing benefit at an earlier time.  In some studies, only 15% stopped use of Valdoxan, which is much less than the rate traditional antidepressants have.

This may mean a very significant advantage over traditional treatment.

Concerns

Several studies of Valdoxan have not shown significant advantage over placebo.

Because Valdoxan is heavily metabolized by the liver, people with some form of liver damage may experience toxicity.  One study showed that some degree of liver impairment could lead to a 50-fold increase in drug concentration.

Valdoxan may, like the SSRIs, increase risk of suicidal ideation.

Efficacy

The number one question people have about any medication is, how well does it work?  It appears that there have been 7 major studies to date which have analyzed the efficacy of Valdoxan for treating depression, and there are others going on to see if it works for generalized anxiety disorder and other conditions.

Positive studies

One study showed that Valdoxan was significantly more effective as a treatment for depression than Prozac.

A study of 711 people treated for depression showed that it was significantly better than placebo and had effect starting at 2 weeks.  Additionally, that study showed that severely depressed people were more likely to respond to Valdoxan than to Paxil.

Another study of 238 people showed a roughly 55% response rate versus 35% response to placebo.

Negative Studies

Several have also shown little or no benefit over placebo.  An unpublished 6 week long study of 414 patients showed that Valdoxan had a response in 53% of those taking it compared to 47% who responded to placebo.  That same study showed that Prozac did have a significant response.

And another 6 week long study of 607 patients showed that neither Valdoxan or Prozac had benefit for treating depression over placebo.

What it means

Valdoxan is not free from the problems that typical antidepressants have, that sometimes they don’t seem to work much better than placebo.  The studies seem to indicate that it is about as effective as traditional antidepressants while having significantly less side effects and possibly faster onset of action.

These advantages may make it extremely popular.  That said, the concerns around its metabolism have yet to fully be addressed, and there may be other issues that time will reveal.

Antidepressants

There is a lot of controversy around antidepressants.  Antidepressants – the Pros and Cons looks at both sides of the story.

Treatment Resistant Depression

Sometimes depression does not respond to treatment.  Here we present 10 ideas for Treating Treatment Resistant Depression.

Dealing with Anxiety

Depression and anxiety tend to come together.  See The Top 25 Anxiety Tips for ideas on how to deal with anxiety.

]]> http://healthlifeandstuff.com/2009/08/agomelatine-a-new-treatment-for-depression/feed/ 24 http://healthlifeandstuff.com/2009/08/benefits-of-ezetimibe-for-heart-disease/ http://healthlifeandstuff.com/2009/08/benefits-of-ezetimibe-for-heart-disease/#comments Tue, 18 Aug 2009 19:33:33 +0000 Admin http://healthlifeandstuff.com/?p=589

Cholesterol lowering medications have been increasingly prescribed in the United States. The best selling medication of all time is Lipitor, one such drug. This blog will be exploring statin use and safety over the next week.

A recent non-statin drug is Ezetimibe. It was discovered by Shering-Plough as part of research into reducing LDL, or low density lipoprotein. And it’s pretty good at doing that.

Unfortunately, it’s not entirely clear how much clinical benefit it offers. Several large studies sponsored by the drug company showed that use of Ezetimibe alongside simvastatin did not mean less risk of adverse heart events.

And one of the studies even showed that Ezetimibe use slightly increased risk of developing cancer.

The ENHANCE study showed that Ezetimibe did not help decrease the intima-media thickness as opposed to standard treatment. The SEAS study showed that it did not have significant clinical impact.

Despite the lack of evidence, Ezetimibe is still being prescribed heavily. It’s clinical uses are not entirely clear, and it seems that it should not be a first line treatment.

Sources:

Is There a Problem With Ezetimibe or Just ENHANCEd Hype?

Merck Sued Again

Over the past week, more lawsuits against Merck & Co, makers of the recalled drug Vioxx, gained traction.

Plantiffs claim that bone medication Fosamax caused osteonecrosis of the jaw. Merck is going to argue there’s no proof, and that they met the requirements to warn patients.

Who’s right?

What’s Fosamax?

Fosamax is a treatment for osteoporosis that promotes stronger bones to reduce risk of fractures. It’s a serious problem – the economic cost annually from osteoporosis related fractures is more than $10 billion.

The older you get, the higher the risk gets. One third of women have hip fractures by age 90.

Bones are often broken when someone falls down or trips, something that also happens more often with aging due to weakened muscles and reduced coordination.

Fosamax and its relatives prevent osteoclasts from resorbing bone tissue, which can help prevent further degeneration of bones. They were initially hailed as “miracle drugs” because they reduced risk of certain types of fracture by up to 50%.

The Claims:

Fosamax may hurt the bone in the jaw. Osteonecrosis of the jaw (ONJ) is when bone gets exposed and doesn’t heal properly. As you can imagine, it is extremely unpleasant and difficult to treat.

Does Fosamax cause it?

Merck says no. But the science almost surely points to an increased risk of ONJ. It may not be large, but it’s there, and even moreso for certain uses of the medication. Intensive use for certain acute conditions, for instance, has a very high rate of ONJ.

Upper range of estimates of ONJ sufferers puts it at 5,000, and the lower ranges less than 1,000. The lowest put it at several hundred. More than 10 million prescriptions for Fosamax alone have been filled since 1995.

But despite the small numbers, the damage is there, and Merck did not warn patients as clearly as the FDA warned them to in 2005, when the data became compelling.

Development of ONJ is typically associated with comorbid cancer. One analysis claims 46.5% of sufferers had a history of multiple myeloma, 38.8% metastic cancer, and 6.2% prostate cancer.  If true, this is important, because it makes a big difference in deciding whether or not to prescribe it.

Conclusion

It looks bad for Merck.

But they will pull out no stops in their defense and point to the general safety of the product, and attack the validity of the plaintiff’s complaints.

One of their likely tactics is to argue that the cases of ONJ developed before they knew of the risks and had an obligation to inform patients.  Considering that they didn’t fully follow the FDA’s instructions for warning, it looks like an uphill battle.

You might like:

10 Ways Scientists Lie About Drugs

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Sources:

Down to the bone
A Review of the Literature on Osteonecrosis of the Jaw in Patients with Osteoporosis Treated with Oral Bisphosphonates: Prevalence, Risk Factors, and Clinical Characteristics
Osteochemonecrosis of the Jaws due to Bisphosphonate Treatments. Update