Getting to the Heart of New Drugs

New Drugs and Research You Should Know

 

True Breakthroughs

But when will the CREDENCE results on Invokana be published?

You may remember that the CREDENCE study was stopped early July 16, 2018 --the “Phase 3 CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) clinical trial, evaluating the efficacy and safety of INVOKANA® (canagliflozin) versus placebo when used in addition to standard of care for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), is being stopped early based on the achievement of pre-specified efficacy criteria.”

OK then, but WHEN will we know the results (usually released at a major conference).

Would you like to know the answer?

April 15, 2019 at the World Congress of Nephrology in Melbourne, Austrailia.

We of course, will update our current Essential Guide to Prescription Drugs, Update on canagliflozin, CREDENCE for Invokana eBook at that time. The beauty of breaking science is that it will highlight the 4,401 patients who were in the study AND bring the benefits of those patients to a broader patient population while helping prevent problems in those living with diabetes.

Remember, as the lead CREDENCE researcher said: "Nearly half of all people with type 2 diabetes will develop chronic kidney disease, causing a high risk of kidney failure and cardiovascular disease, and impacting their quality and length of life, even with the current best available care. This huge unmet need is why it was so important for us to initiate the landmark CREDENCE renal outcomes trial over four years ago," said Vlado Perkovic, M.B.B.S, Ph.D., F.A.S.N., F.R.A.C.P., CREDENCE Steering Committee co-chair, Professor of Medicine, University of New South Wales Sydney, and Executive Director, The George Institute for Global Health Australia. "We have accepted the advice of the Independent Data Monitoring Committee to stop the CREDENCE trial early due to demonstration of efficacy, and look forward to sharing the findings as soon as possible."

See the True Breakthrough criteria below

True breakthrough Criteria: What criteria will we use?

  1. The medicine is the first in a new medicine family (class)…what the FDA would call a novel therapeutic entity (visit www.FDA.gov). A good example here would be evolocumab (Rapatha), the first member of the PCSK9 inhibitor family which was approved.
  2. The medicine is 20% or more effective in treating or preventing a prevalent disease or condition than prior medicines. For example, the new prescription fish oil (Vascepa) which was found to prevent heart attacks by 25% in people who were already being treated with statins.
  3. The therapeutic concept targets a novel path or uses a novel approach to modify or prevent or cure disease. An example here would be signal transduction inhibitors such as Gleevec (actually turns off a gene to cure stomach cancer) or immune based therapies such as ipilimumab (Yervoy) for melanoma. CRISPER technology seeking gene-based cures.
  4. New guidelines which radically change current practice, incorporating new approaches to monitoring therapy or preventing disease. A good example here are the 2018 American Diabetes Association standards of care.
  5. A company making a medicine develops a program or radical pricing which confers new access to care or enhances outcomes (results) by 15% versus other approaches or therapies. The latest example here is the company Amgen and the medicine Rapatha. The company decided to lower the cost of the medicine by 60%, which is expected to give huge increases in access to a very effective cholesterol medicine.
  6. A new medicine results in CURES of a particular disease or condition where none was previously available. A great example here are the hepatitis C treatments (Harvoni, others) which can result in CURE of the hepatitis C.
  7. A laboratory, clinic or point of care test that improves the ability to diagnose or predict a disease or condition which either could not be previously reliably predicted.
  8. A medicine, vaccine or mechanical device that PREVENTS a disease or condition to a significantly greater degree than previously possible or which addresses a disease or condition previously perceived as a natural course of aging or which was not able to be prevented. A great example here is the new Shingles vaccine.

Real medicine, real research, really important. The Essential Guide to Prescription Drugs is always there for you!

References

  1. FDA www.fda.gov
  2. NIH https://nccih.nih.gov/research/statistics/2007/camsurvey_fs1.htm. Updated September 24, 2017. Accessed September 10, 2018.
  3. The Use of Essential Drugs. World Health Organization, apps.who.int/medicinedocs/en/d/Js2281e
  4.  Accessed 10 31 2018. http://sitn.hms.harvard.edu/flash/2014/crispr-a-game-changing-genetic-engineering-technique/  
  5. Conference materials accessed 1/12/19: World Congress of Nephrology.

 



True Breakthrough Publications: 

New: November 6, 2018: Pre-orders for The Essential Guide To Prescription Drugs, Update on Prescription Fish Oil, focus on Vascepa.Breakthrough new information from the REDUCE-IT study found a 25 % reduction in heart attacks versus other medicines and this was in a group of heavily pre-treated patients. Click here to pre-order or order 

New: November 6, 2018: Pre-orders for The Essential Guide To Prescription Drugs, Update on Invokana. The CREDENCE study was actually stopped early because diabetes medicine worked too well. This is a very unusual occurrence and the full results will be released at an upcoming scientific meeting. Click here to pre-order or order 

New: November 6, 2018: Pre-orders for The Essential Guide To Prescription Drugs, Update on evolocumab. Breakthrough new pricing giving a 60 percent reduction in cost is a game changer for the first PCSK9 type cholesterol medicine. This important family of medicines has been underutilized up til now because of the price. Our new eBook explains the new pricing and gives the full Repatha picture. [ Coming soon ]

New: November 7, 2018: Pre-orders for The Essential Guide To Prescription Drugs, Update on rivaroxaban. Breakthrough research shows that this medicine, when combined with aspirin, lowers Major Adverse Cardiac Events (MACE) decreasing the probability of CV death, MI and strokes in people with CAD or Pad. Click here to pre-order or order

True breakthrough Criteria: What criteria will we use? 

1)     The medicine is the first in a new medicine family (class)…what the FDA would calla novel therapeutic entity (visit www.FDA.gov). A good example here would be evolocumab (Rapatha), the first member of the PCSK9 inhibitor family which was approved.
2)     The medicine is 20% or more effective in treating or preventing a prevalent disease or condition than prior medicines. For example, the new prescription fish oil(Vascepa) which was found to prevent heart attacks by 25% in people who were already being treated with statins.
3)     The therapeutic concept targets a novel path or uses a novel approach to modify or prevent or cure disease. An example here would be signal transduction inhibitors such as Gleevec (actually turns off a gene to cure stomach cancer) or immune-based therapies such as ipilimumab (Yervoy) for melanoma. CRISPER technology seeking gene-based cures.
4)     New guidelines which radically change current practice, incorporating new approaches to monitoring therapy or preventing disease. A good example here is the 2018 American Diabetes Association standards of care.
5)     A company making a medicine develops a program or radical pricing which confers new access to care or enhances outcomes (results) by 15% versus other approaches or therapies. The latest example here is the company Amgen and the medicine Rapatha. The company decided to lower the cost of the medicine by 60%, which is expected to give huge increases in access to a very effective cholesterol medicine.
6)     A new medicine results in CURES of a particular disease or condition where none was previously available. A great example here is the hepatitis C treatments(Harvoni, others) which can result in CURE of the hepatitis C.
7)     A laboratory, clinic or point of care test that improves the ability to diagnose or predict a disease or condition which either could not be previously reliably predicted.
8)     A medicine, vaccine or mechanical device that PREVENTS a disease or condition to a significantly greater degree than previously possible or which addresses a disease or condition previously perceived as a natural course of aging or which was not able to be prevented. A great example here is the new Shingles vaccine. 

Real medicine, real research,really important. The Essential Guide to Prescription Drugs is always there for you! References

1.     FDA www.fda.gov
2.     NIH 
https://nccih.nih.gov/research/statistics/2007/camsurvey_fs1.htm. Updated September 24, 2017. AccessedSeptember 10, 2018.
3.     The Use of Essential Drugs. World Health Organization,
apps.who.int/medicinedocs/en/d/Js2281e 
4.     Accessed10 31 2018. 
http://sitn.hms.harvard.edu/flash/2014/crispr-a-game-changing-genetic-engineering-technique/  

Contact Us
 

Our Location

Office Hours
Monday:9:00 AM - 5:00 PM
Tuesday:9:00 AM - 5:00 PM
Wednesday:9:00 AM - 5:00 PM
Thursday:9:00 AM - 5:00 PM
Friday:9:00 AM - 5:00 PM
Saturday:Closed
Sunday:Closed