It has been shown to be more effective against lyme than anything else so far.

Yes, to the above, it is a macrolide, and to be taken with plaquenil.

quote:

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Originally posted by lymewarrior03:
There is a new drug coming out in July.
Brand name is Ketek. Telithromycin

It has been shown to be more effective against lyme than anything else so far.

Yes, to the above, it is a macrolide, and to be taken with plaquenil.

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Hi LymeWarrior3,
Can you tell me more about the source of the info? My doc has recommended it, too. In an initial web search, many of the documents are in Danish (or German... forgive my ignorance).

I'd like to read more about it and the pairing with plaquenil if you have some documents you could point me to?

Much appreciated,
StinkBug
(Kathryn from Oregon)

http://www.pslgroup.com/dg/1E203E.htm

ICAAC: Ketek (Telithromycin) First In New Family Of Antibiotics, Combats Resistant Bacteria

PARSIPPANY, NJ -- September 21, 2000 -- Ketek� (telithromycin) tablets may provide a convenient, once-daily, short-course treatment option for select respiratory tract infections (RTIs), including those infections caused by bacteria resistant to available therapies.

Phase III clinical data from 10 multi-national studies were presented at the 40th annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Toronto, Canada.

Respiratory tract infections such as community-acquired pneumonia (CAP), acute bacterial exacerbations of chronic bronchitis (AECB), acute sinusitis, and tonsillitis/pharyngitis represent a significant societal burden, causing more than 50 million deaths globally each year.

Ketek is the first in a new family of antibiotics called ketolides. Ketolides are a novel addition to the macrolide-lincosamide-streptogramin (MLSb) group and are characterized by a broad microbiological spectrum, unique mechanism of action, and favorable resistance profile. Ketek combats resistant bacteria by inhibiting the protein synthesis necessary for bacterial reproduction, binding 10 times tighter than macrolides at two different sites on bacterial ribosomes. In vitro data suggest that it has a low propensity to induce bacterial resistance.

"Bacteria that cause community-acquired infections are growing increasingly resistant to antibiotics commonly prescribed to treat them," said Thomas File, M.D. Professor of Internal Medicine, Northeastern Ohio Universities College of Medicine. "The level of activity we have seen with Ketek in Phase III clinical trials is an exciting development, and may provide the medical community with a new weapon in the fight against these troublesome infections."

The 10 Phase III studies presented at ICAAC were comprised of data from almost 2,500 patients treated with Ketek and almost 1,800 patients treated with comparator antibiotics. Ketek showed a high level of activity against Streptococcus pneumoniae, Streptococcus pyogenes, Staphylococcus aureus, Haemophilus influenzae, and Moraxella catarrhalis; as well as atypical bacteria such as Chlamydia pneumoniae, Mycoplasma pneumoniae, and Legionella pneumoniae.

Findings from three comparative Phase III studies - each designed to assess Ketek activity in the treatment of CAP - showed that Ketek once a day is as active as comparator drugs. A study, conducted throughout Europe and South Africa, showed that Ketek once a day was as active as high dose amoxicillin (1,000 mg) three times a day (94.6 percent vs. 90.1 percent clinical cure rate).

Another study, conducted in North America, showed comparable activity between Ketek once a day and the macrolide clarithromycin (500 mg) twice a day (88.3 percent vs. 88.5 percent clinical cure rate) and a third study, also conducted in North America, demonstrated that Ketek once a day is as active as the fluoroquinolone trovafloxacin (200 mg) once a day (91.1 percent vs. 94.8 percent clinical cure rate).

Two sub-analyses of data from the North American study demonstrated that Ketek had a 90 percent clinical cure rate against S. pneumoniae - the most common cause of CAP.6 Another sub-analysis of North American and European study data demonstrated that Ketek is active against atypical respiratory bacteria including Chlamydia pneumoniae (93.3 percent), Mycoplasma pneumoniae (96.4 percent), Legionella pneumoniae (100 percent), and Coxiella burnetti (80 percent).

Results from two North American studies showed that Ketek was as active as comparator antibiotics with a shorter treatment duration in the treatment of chronic bronchitis complicated by a bacterial infections. The first study demonstrated that 800 mg of Ketek once a day for five days is well tolerated and as active as cefuroxime axetil 500 mg twice a day for 10 days (89.2 percent vs. 86.3 percent clinical cure rate). The second study showed that Ketek once a day for a five day period is as active as amoxycillin/clavulanic (amox/clav) acid (500 mg/125 mg, respectively) three times a day for 10 days (86.1 percent vs. 82.1 percent clinical cure rate).

In a North American study conducted to examine the clinical and bacteriological efficacy in sinusitis, Ketek 800 mg once a day for five or 10 days was compared with a 10-day regimen of amoxicillin/clavulanic acid in 790 patients. Ketek administered for five days was as active (75.8 percent clinical cure rate) as a 10-day course of the comparator (74.6 percent); and as active as a 10-day course of Ketek (74.1 percent clinical cure rate). Another study of 336 sinusitis patients in Europe and North America confirmed comparable cure rates between the 5-day and 10-day regimens (91.1 percent vs. 91.0 percent clinical cure rate). Patients in the study received either 10 days of Ketek or five days of Ketek followed by a placebo for five days. Ketek-susceptible bacteria isolated from the sinusitis patients included S. pneumoniae, H. influenzae, M. catarrhalis, and S. aureus.

A study was conducted in Europe to test the clinical efficacy of 800 mg of Ketek once a day for five days as compared to 500 mg of penicillin V three times a day for 10 days. Patients who took Ketek only five times had cure rates comparable to those whose regimen included either 20 or 30 doses of penicillin V (Ketek 94.8 percent vs. penicillin V 94.1 percent clinical cure rate). In a second study, conducted in North America, Ketek taken for only five days demonstrated equivalence in clinical and bacteriological cure to clarithromycin (91.3 percent vs. clarithromycin 88.1 percent clinical cure rate), which was taken over the course of 10 days in the treatment of pharyngitis or tonsillitis caused by group A Beta-hemolytic streptococci.

In those studies for which side effects were cited, the most common adverse events included diarrhea (8.3 percent-23.9 percent), nausea (2.9 percent-11.7 percent), dizziness (1.3 percent-7.4 percent), and headache (4.1 percent-6.6 percent).

Aventis submitted applications for Ketek to the U.S. Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA) in March 2000. The company is seeking approval for a once-daily dosing regimen for CAP, AECB, and acute sinusitis in patients 18 and older, as well as pharyngitis/tonsillitis in patients age 13 and older; and a short-course treatment regimen (once a day for five days) in all indications except CAP (once a day for seven to 10 days).

[This message has been edited by lymewarrior03 (edited 10 May 2004).]