Omega-3 Meds Not Effective After MI, EMA Panel Concludes


The European Medicine Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has concluded that omega-3 fatty acid medicines are not effective for secondary prevention after myocardial infarction (MI).

Omega-3 fatty acid medicines at a dose of 1 g per day have been authorized in several European Union countries since 2000 for preventing heart disease or stroke after MI and for lowering high triglycerides.

When they were authorized, the available data showed “some benefits in reducing serious problems with the heart and blood vessels, although the benefits were considered modest,” the EMA said in a news release. “Further data that have become available since then have not confirmed the beneficial effects of these medicines for this use.”

The CHMP’s conclusion, released at their December meeting, means that these medicines will no longer be authorized for such use.

Their review included results of the open-label GISSI Prevenzione study from 1999, which supported the initial authorization of these products, as well as retrospective cohort studies, more recent randomized controlled trials, and results of meta-analyses.

“The review concluded that, while a small relative risk reduction was seen in the original open label GISSI Prevenzione study, such beneficial effects were not confirmed in more recent randomized controlled trials,” the EMA said. The review found no new safety concerns.

The Committee’s decision does not affect the authorization of omega-3 fatty acid medicines for the treatment of hypertriglyceridemia.

The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU member states.

Support for the CHMP decision comes from results of the large VITAL trial, which found little benefit from omega-3 supplements (or vitamin D supplementation) for the prevention of cardiovascular disease, as reported by Medscape Medical News.

In the ASCEND trial, a 1 g dose of omega-3 fatty acids had no effect on serious vascular events (or cancer or mortality) when used for primary prevention in patients with diabetes.

However, in the REDUCE-IT trial, a high-dose purified form of the omega-3 oil, eicosapentaenoic acid (EPA), in patients with elevated triglycerides who had cardiovascular disease or diabetes and one additional risk factor did show significant benefit, with a 25% relative risk reduction in major adverse

Overweight Individuals with T2DM | Keto Diet vs Plate Method Diet


Recently a study was conducted by Saslow LR and colleagues to study whether a very low carbohydrate ketogenic diet with lifestyle factors (intervention) or a “Create Your Plate” diet (control) recommended by the American Diabetes Association (ADA) would improve glycemic control and other health outcomes among overweight individuals with type 2 diabetes mellitus (T2DM).

This article was published in February 2017 in a very reputed journal ‘Journal of Medical Internet Research’. In 2017, the impact factor of this journal was 4.671. For those of you who don’t know what an impact factor is or have never heard of, it simply means the number of times recent articles published in that journal in a year was cited by others. If the impact factor is high, it is considered to be a highly ranked journal.

Now coming back to the study, it was a parallel-group, balanced randomization (1:1) trial. This trial was approved by the University of California, San Francisco, Institutional Review Board and registered with ClinicalTrials.gov (NCT01967992).

In this study, glycemic control, operationalized as the change in glycated hemoglobin (HbA1c) was the primary outcome.

They also assessed body weight, cholesterol, triglycerides, diabetes-related distress, subjective experiences of the diet, and physical side effects.

During the study, the participants were asked to measure urinary acetoacetate (one type of ketone bodies that can be measured in urine) test kits (KetoStix). Basically, there are three types of ketone bodies. Other two types of ketone bodies are acetone and beta-hydroxybutyrate.

The other group i.e. the control group were asked to follow “Create Your Plate” diet recommended by ADA. What does this ADA diet consist of? Well, ADA recommends a low-fat diet which includes green vegetables, lean protein sources, and limited starchy and sweet foods. Most of the doctors worldwide follow ADA guidelines and recommend this particular diet to their patients.

As mentioned earlier the investigators divided the eligible participants into two groups (intervention group and control group).

In fact, when I was diagnosed with T2DM my diabetologist also recommended a low-fat diet with a caloric restriction of 1800 calories. But he never advised me how to restrict my calories to 1800 or what should I eat.  I was totally confused.

Also, he prescribed a couple of oral antidiabetic drugs and a statin. I followed his instructions for a couple of weeks and the result was that within 2 weeks I developed side effects of the drugs. I immediately STOPPED all my medications and started following a keto diet. Finally, I was able to reverse my T2DM. Anyway, that’s a separate story.

Coming back to the study, all the parameters were measured at baseline before randomization in both the groups. Again, all the parameters were measured after 16 and 32 weeks of intervention.

So what conclusions were drawn from this study. Let me list the results of this study in bullet points for better understanding.

  • The investigators observed that there were significantly greater reductions in HbA1cthose who followed the ketogenic diet after 16 as well as 32 weeks
  • Similarly, those who were on keto diet lost more weight than those who followed conventional ADA diet (12.7 kg versus 3 kg)
  • Also, triglycerides level was much lower in the ketogenic group compared to ADA diet followers

This study showed that those who followed a ketogenic diet had several health benefits including lower HbA1c, body weight, and triglyceride levels.

There were few limitations in this study. The number of participants was very less (25 participants) and the follow-up duration of the study was not long.

Despite all limitations, the conclusion we can draw from this study is that low-carbohydrate ketogenic diet and lifestyle changes are beneficial in individuals who are overweight with T2DM.

If you have any queries or any experience to share please type in the comment box. I will try to reply to all your queries.

If you have enjoyed reading this article, I would request you to share with your friends and colleagues who are diagnosed with T2DM. I am sure by reading this article, they will be motivated that it’s not the end of the world if they are diagnosed with T2DM.

With dietary and lifestyle modifications, it is possible to reverse your T2DM.

Omega-3 Meds Not Effective After MI, EMA Panel Concludes


The European Medicine Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has concluded that omega-3 fatty acid medicines are not effective for secondary prevention after myocardial infarction (MI).

Omega-3 fatty acid medicines at a dose of 1 g per day have been authorized in several European Union countries since 2000 for preventing heart disease or stroke after MI and for lowering high triglycerides.

When they were authorized, the available data showed “some benefits in reducing serious problems with the heart and blood vessels, although the benefits were considered modest,” the EMA said in a news release. “Further data that have become available since then have not confirmed the beneficial effects of these medicines for this use.”

The CHMP’s conclusion, released at their December meeting, means that these medicines will no longer be authorized for such use.

Their review included results of the open-label GISSI Prevenzione study from 1999, which supported the initial authorization of these products, as well as retrospective cohort studies, more recent randomized controlled trials, and results of meta-analyses.

“The review concluded that, while a small relative risk reduction was seen in the original open label GISSI Prevenzione study, such beneficial effects were not confirmed in more recent randomized controlled trials,” the EMA said. The review found no new safety concerns.

The Committee’s decision does not affect the authorization of omega-3 fatty acid medicines for the treatment of hypertriglyceridemia.

The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU member states.

Support for the CHMP decision comes from results of the large VITAL trial, which found little benefit from omega-3 supplements (or vitamin D supplementation) for the prevention of cardiovascular disease, as reported by Medscape Medical News.

In the ASCEND trial, a 1 g dose of omega-3 fatty acids had no effect on serious vascular events (or cancer or mortality) when used for primary prevention in patients with diabetes.

However, in the REDUCE-IT trial, a high-dose purified form of the omega-3 oil, eicosapentaenoic acid (EPA), in patients with elevated triglycerides who had cardiovascular disease or diabetes and one additional risk factor did show significant benefit, with a 25% relative risk reduction in major adverse cardiovascular events.

Omega-3 Meds Not Effective After MI, EMA Panel Concludes


The European Medicine Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has concluded that omega-3 fatty acid medicines are not effective for secondary prevention after myocardial infarction (MI).

Omega-3 fatty acid medicines at a dose of 1 g per day have been authorized in several European Union countries since 2000 for preventing heart disease or stroke after MI and for lowering high triglycerides.

When they were authorized, the available data showed “some benefits in reducing serious problems with the heart and blood vessels, although the benefits were considered modest,” the EMA said in a news release. “Further data that have become available since then have not confirmed the beneficial effects of these medicines for this use.”

The CHMP’s conclusion, released at their December meeting, means that these medicines will no longer be authorized for such use.

Their review included results of the open-label GISSI Prevenzione study from 1999, which supported the initial authorization of these products, as well as retrospective cohort studies, more recent randomized controlled trials, and results of meta-analyses.

“The review concluded that, while a small relative risk reduction was seen in the original open label GISSI Prevenzione study, such beneficial effects were not confirmed in more recent randomized controlled trials,” the EMA said. The review found no new safety concerns.

The Committee’s decision does not affect the authorization of omega-3 fatty acid medicines for the treatment of hypertriglyceridemia.

The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU member states.

Support for the CHMP decision comes from results of the large VITAL trial, which found little benefit from omega-3 supplements (or vitamin D supplementation) for the prevention of cardiovascular disease, as reported by Medscape Medical News.

In the ASCEND trial, a 1 g dose of omega-3 fatty acids had no effect on serious vascular events (or cancer or mortality) when used for primary prevention in patients with diabetes.

However, in the REDUCE-IT trial, a high-dose purified form of the omega-3 oil, eicosapentaenoic acid (EPA), in patients with elevated triglycerides who had cardiovascular disease or diabetes and one additional risk factor did show significant benefit, with a 25% relative risk reduction in major adverse cardiovascular events.