Packaging Defect Leads Merck To Recall All Lots of Liptruzet In US
Merck said today that it was recalling all lots of Liptruzet, its combination of the cholesterol-lowering drugs ezetimibe and atorvastatin, in the US. The company said the recall was due to a packaging defect which could potentially allow air and moisture to affect the quality of the drug, though the company said “the likelihood of the packaging defects decreasing the effectiveness of Liptruzet on a patient’s lipid profile or negatively impacting the safety of the product is remote.” To date there have been no adverse events or product complaints reported to the company. Merck is recalling the drug More...
Source: CardioBrief - January 14, 2014 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes atorvastatin ezetimibe Liptruzet Merck Source Type: blogs
Statin myopathy pearls
var gaJsHost = (("https:" == document.location.protocol) ? "https://ssl." : "http://www."); document.write(unescape("%3Cscript src='" + gaJsHost + "google-analytics.com/ga.js' type='text/javascript'%3E%3C/script%3E")); 1. Occurs in fifteen percent of those receiving statins3. Risk factors for include: higher dose statin statin myopathy in a first degree relative older age female small build concurrent systemic disease (renal, he...
Source: neurologyminutiae - December 24, 2013 Category: Neurologists Source Type: blogs
Drug which blocks intestinal absorption of cholesterol
:
a) Atorvastatin
b) Gemfibrozil
c) Ezetimibe
d) Rosuvastatin
Correct answer: c) Ezetimibe
Ezetimibe acts by selectively blocking the uptake of cholesterol and other sterols by intestinal epithelial cells. The action is on Niemann-Pick C1-like 1 (NPC1L1) cholesterol uptake receptors.
Interestingly, it has been recently shown that NPC1L1 expression is necessary for HCV (hepatitis C virus) infection. Ezetimibe can block the entry of HCV into the cell, in experimental situations. Clinical effect on this aspect has to be further studied [Sainz B Jr et al. Identification of the Niemann-Pick C1-like 1 cholesterol absorption...
Source: Cardiophile MD - October 31, 2013 Category: Cardiology Authors: Prof. Dr. Johnson Francis MD, DM, FACC, FRCP Edin, FRCP London Tags: Cardiology MCQ DM / DNB Cardiology Entrance Niemann-Pick C1-like 1 receptor NPC1L1 Source Type: blogs
The First PCSK9 Phase III
Some long-awaited clinical data has appeared in the cardiovascular area: Sanofi and Regeneron have the first Phase III numbers for their PCSK9-blocking antibody alirocumab. (Here's some background on this area from John LaMattina).
This was a monotherapy trial, run head-to-head against Merck/Schering-Plough's Zetia (ezetimibe). Patients in the alirocumab arm started at a low dose, injected every two weeks, and had to the option to increase it if their LDL had not hit the target levels. Three quarters of them didn't have to. Their LDL levels went down 47% on average, compared to 15.6% in the daily Zetia group, so I think w...
Source: In the Pipeline - October 16, 2013 Category: Chemists Tags: Cardiovascular Disease Source Type: blogs
Merck 'Evergreens' Off-Patent Lipitor By Creating Combination Drug With
No Additional Benefit
By Glyn MoodyBig pharma often gets a rather rough ride here on Techdirt, what with its attempts to stop governments granting licenses for life-saving and low-cost generics in emerging countries, engaging in legal action to prevent drug safety information being released, and paying kickbacks to doctors. But sometimes you get the impression that drug companies really go out of their way to be disliked, as this great post by Josh Bloom on the Medical Progress Today site, pointed out to us by John Wilbanks, demonstrates:[Merck] just received approval for the cholesterol-lowering combinat...
Source: PharmaGossip - July 11, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Should the FDA approve lovemaking technique?
Everybody knows that having sex is beneficial for your health. It lowers your blood pressure, reduces risk of heart attack, improves your self esteem and reduces stress (as per webmd.com). I think that one of the most important gifts God gave us is the ability to love.
But recently I realized that there’s a problem with love: Unlike so many other things that keep us healthy, lovemaking procedure is not approved by the FDA!
There are no randomized controlled studies about the safety of lovemaking, no government recommended doses, no side effects. Nothing! So I asked myself: how can we do it without FDA and government...
Source: Doctor Kalitenko antiaging blog - June 13, 2013 Category: Physicians With Health Advice Authors: admin Source Type: blogs
Valeant, Bausch & Lomb And The Long Reach Of Fred Hassan
The $8.7 billion deal in which Valeant Pharmaceuticals (VRX) is buying Bausch & Lomb is notable for several reasons. Arguably, the most significant detail is that Valeant, which has been on an acquisition spree over the past few years, will quickly become one of the largest players in the pharmaceutical industry with a diverse product portfolio and a broad reach in numerous markets (more details here).
In particular, Valeant will now compete with the global leaders in the eye-care business, a group that includes Novartis (NVS) and its Alcon unit; Johnson & Johnson (JNJ), which sells the Accuvue contact lenses throu...
Source: Pharmalot - May 28, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
ESC on anticoagulants; FDA on Liptruzet; Midei suit; MitraClip
ESC on anticoagulants; FDA approves atorvastatin/ezetimibe combo (Liptruzet) ; Midei suit settled; MitraClip (Source: Blogs@theHeart.org)
Source: Blogs@theHeart.org - May 10, 2013 Category: Cardiology Authors: theheart.org Tags: This week in cardiology from heartwire Source Type: blogs
Merck in the Mirror: Profits, Not People, Come First. Shame!
"How can Merck look itself in the mirror?", asks Josh Bloom of the American Council for Science and Health (see here)."This week, Merck, with some questionable help from the FDA, gave more ammunition to industry critics, who typically maintain that the industry contributes little innovation, and is simply concerned with profits," said Bloom."For the most part, this criticism is biased and uninformed, but this time I'm siding with the critics. Because Merck is trying something that is as good an example of marketing without innovation as you'll ever see."Derek Lowe, respected author of In the Pipeline blog, agrees. "I can't...
Source: Pharma Marketing Blog - May 10, 2013 Category: Pharma Commentators Tags: Zetia Profits before patients Merck Lipitor Source Type: blogs
Merck's Liptruzet: A Cause For Shame?
Vytorin's been discussed several times around here. The combination of Zetia (ezetimibe), the cholesterol absorption inhibitor discovered at Schering-Plough, with Merck's simvastatin looked as if it should be a very effective cholesterol-lowering medication, but the real-world data have been consistentlypuzzling. There's a big trial going on that people are hoping will clarify things, but so far it's had the opposite effect. It's no exaggeration to say that the entire absorption inhibitor/statin combination idea is in doubt, and we may well learn a lot about human lipidology as we figure out what's happened. It will have b...
Source: In the Pipeline - May 9, 2013 Category: Chemists Tags: Cardiovascular Disease Source Type: blogs
FDA Approves Combination Of Ezetimibe And Atorvastatin
The FDA has approved a new combination drug from Merck for lowering cholesterol. The drug, which will carry the brand name of Liptruzet, is a combination of two previously approved cholesterol-lowering drugs, ezetimibe and atorvastatin. Merck said the new drug (pronounced “LIP-true-zett”) would be commercially available starting next week. Liptruzet will be available as a once-daily tablet combining 10 mg of ezetimibe with either 10, 20, 40, or 80 mg of atorvastatin. In clinical trials Liptruzet lowered LDL cholesterol from 53% to 61%, depending on dosage. … Click here to read the full post on More…...
Source: CardioBrief - May 3, 2013 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes atorvastatin ezetimibe FDA food and drug administration Low-density lipoprotein Merck Merck & Co statins vytorin Source Type: blogs
The "Buzz" on ACC.13 Late-Breaking Clinical Trials
This post is authored by Christopher P. Cannon, MD, FACC, is editor-in-chief of CardioSource Science and Quality.
Late-breaking clinical trials (LBCTs) have become the centerpiece of major cardiology scientific sessions. On the upside, they produce significant advances that will reshape the practice of medicine (if and when we ever adopt them), and, more recently, they’ve challenged long-held beliefs about the benefits of various older treatments. On the other hand, they can sometimes lead to disappointment (ie. when a study produces negative findings or is too small to be definitive).
So, LBCTs—are th...
Source: ACC in Touch Blog - March 6, 2013 Category: Cardiology Authors: Administrator Tags: ACC Scientific Session Science Source Type: blogs
