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Reviews |
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Bextra-Generic |
J Gen Intern Med. 2005 Jan;20(1):62-7.
Valdecoxib for treatment of primary dysmenorrhea.
A randomized, double-blind comparison with placebo and naproxen.
Daniels SE, Torri S, Desjardins PJ.
Scirex Corporation, 3200 Red River, Suite 300, Austin, TX 78705, USA.
SDaniels@Scirex.com.
OBJECTIVE: To compare the analgesic efficacy of valdecoxib with placebo
and naproxen sodium for relieving menstrual cramping and pain due to primary
dysmenorrhea. DESIGN: Single-center, double-blind study with a 4-period,
4-sequence crossover design. Patients assessed pain intensity and pain relief
at regular intervals up to 12 hours following the initial dose. SETTING:
Privately owned outpatient clinic. PATIENTS/PARTICIPANTS: One hundred twenty
patients with moderate to severe menstrual cramping were randomized. Eighty-seven
patients completed all treatment cycles. INTERVENTIONS: Valdecoxib 20 mg
or 40 mg, naproxen sodium 550 mg, or placebo twice a day as required for
< or =3 days in a single menstrual cycle. MEASUREMENTS AND MAIN RESULTs:
Both doses of valdecoxib (20 and 40 mg) were comparable to naproxen sodium
and superior to placebo at all time points assessed for each of the primary
end points. Valdecoxib and naproxen sodium had comparable onset and duration
of action. Although the study design allowed patients 2 doses per day, only
15% and 20% of patients in the valdecoxib 20 mg and valdecoxib 40 mg groups,
respectively, required remedication within the first 12 hours. The incidence
of adverse events was similar between active and placebo groups. CONCLUSION:
Valdecoxib provided a fast onset of analgesic action, a level of efficacy
similar to naproxen sodium, and a high level of patient satisfaction in
the relief of menstrual pain due to primary dysmenorrhea. Valdecoxib was
effective and well tolerated and thus appears to be a viable treatment for
menstrual pain due to primary dysmenorrhea.
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Drug Dev Ind Pharm. 2005 Jan;31(1):1-10.
Enhancement of dissolution rate of valdecoxib
using solid dispersions with polyethylene glycol 4000.
Liu C, Liu C, Desai KG.
Life Science College, Ocean University of China, Qingdao, China.
The aim of the present study was to enhance the dissolution rate of valdecoxib
using its solid dispersions (SDs) with polyethylene glycol (PEG) 4000. The
phase solubility behavior of valdecoxib in the presence of various concentrations
of PEG 4000 in water was obtained at 37 degrees C. The solubility of valdecoxib
increased with increasing amount of PEG 4000 in water. Gibbs free energy
(deltaG(zero)tr) values were all negative, indicating the spontaneous nature
of valdecoxib solubilization, and they decreased with increase in the PEG
4000 concentration, demonstrating that the reaction conditions became more
favorable as the concentration of PEG 4000 increased. The SDs of valdecoxib
with PEG 4000 were prepared at 1:1, 1:2, 1:5, and 1:10 (valdecoxib: PEG
4000) ratio by melting method. Evaluation of the properties of the SDs was
performed by using dissolution, Fourier-transform infrared (FTIR) spectroscopy,
differential scanning calorimetry (DSC), X-ray diffraction (XRD), and scanning
electron microscopy (SEM) studies. The SDs of valdecoxib with PEG 4000 exhibited
enhanced dissolution rate of valdecoxib, and the rate increased with increasing
concentration of PEG 4000 in SDs. Mean dissolution time (MDT) of valdecoxib
decreased significantly after preparation of SDs and physical mixture with
PEG 4000. The FTIR spectroscopic studies showed the stability of valdecoxib
and absence of well-defined valdecoxib-PEG 4000 interaction. The DSC and
XRD studies indicated the amorphous state of valdecoxib in SDs of valdecoxib
with PEG 4000. The SEM pictures showed the formation of effective SDs of
valdecoxib with PEG 4000, since well-defined changes in the surface nature
of valdecoxib, SDs, and physical mixture were observed. |
| Clin Ther. 2004 Aug;26(8):1249-60.
Effects of valdecoxib in the treatment of
chronic low back pain: results of a randomized, placebo-controlled trial.
Coats TL, Borenstein DG, Nangia NK, Brown MT.
Benchmark Research, Austin, Texas 78705, USA. annrutledge@benchmarkresearch.net.
BACKGROUND: Valdecoxib, a cyclooxygenase (COX)-2 specific inhibitor, is
indicated for relief of the signs and symptoms of rheumatoid arthritis,
osteoarthritis, and primary dysmenorrhea. Therapeutic doses of COX-2 specific
inhibitors are as effective as nonspecific nonsteroidal anti-inflammatory
drugs in reducing inflammatory pain while sparing the gastrointestinal
and platelet toxicity associated with nonspecific COX-1 inhibition. OBJECTIVE:
The aim of this study was to assess the analgesic efficacy and tolerability
of valdecoxib 40 mg/d compared with placebo in the treatment of chronic
low back pain. METHODS: This 4-week, prospective, randomized, double-blind
placebo-controlled, parallel-group study was conducted at 37 centers across
the United States and 5 centers in Canada. Patients aged > or =18 years
with chronic low back pain in flare were enrolled. Patients were randomized
to receive valdecoxib 40-mg/d or placebo tablets, once daily for 4 weeks.
Patients rated low back pain intensity on a visual analog scale and completed
the Roland-Morris Disability Questionnaire and the modified Brief Pain
Inventory-Short Form (mBPI-SF) at each visit. RESULTS: Two hundred ninety-three
patients were enrolled. The valdecoxib group comprised 148 patients (81
women, 67 men; mean [SD] age, 48.6 [13.3] years; mean [SD] body weight,
86.6 [20.9] kg), and the placebo group included 145 patients (85 women,
60 men; mean [SD] age, 48.7 [12.6] years; mean [SD] body weight, 85.6
[19.9] kg). Of the enrolled patients, 249 completed the study: 134 patients
(91%) who received valdecoxib and 115 patients (79%) who received placebo.
No statistically significant differences in patient baseline characteristics
were noted between treatment groups, except in response to 1 mBPI-SF question;
patients in the valdecoxib group reported significantly greater interference
in relations with other people due to pain than did those in the placebo
group (P = 0.048). Changes from baseline in low back pain intensity were
significantly greater in valdecoxib-treated patients at each assessment
(all, P < 0.001 vs placebo). Pain scores on the mBPI-SF indicated significantly
greater pain relief with valdecoxib at each assessment (all, P < or
= 0.014 vs placebo). Improvements in mean Roland-Morris Disability Questionnaire
score with valdecoxib were significantly greater than with placebo at
each assessment (all, P < or = 0.003). Although the overall incidence
of adverse events (AEs) was significantly higher among patients receiving
valdecoxib than those receiving placebo (35.1% vs 24.1%, respectively;
P = 0.042), no significant differences were found between groups for the
incidence of any individual AE. Most AEs (89% [77/87 total events]) were
mild or moderate in severity. CONCLUSIONS: In this study of patients with
chronic low back pain, valdecoxib 40 mg/d provided rapid relief (within
1 week) and consistent relief (over 4 weeks). In addition, significant
improvement in function and decreased disability were found with valdecoxib
compared with placebo. |
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Drug information |
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| GENERIC NAME: valdecoxib
BRAND NAME: Bextra
DRUG CLASS AND MECHANISM: Valdecoxib is an oral drug
that belongs to the family of drugs called nonsteroidal anti-inflammatory
drugs (NSAIDs). NSAIDs are used primarily to treat pain and arthritis.
Other NSAIDs include aspirin and aspirin-related drugs, ibuprofen (Motrin),
indomethacin (indocin), naproxen (Naprosyn), diclofenac (Voltaren), sulindac
(Clinoril), ketoprofen (Orudis), etc. Valdecoxib works by altering the
production of prostaglandins, chemicals manufactured by the body that
promote the inflammation of arthritis and cause the pain, swelling and
tenderness of arthritic joints. Valdecoxib, like the newer NSAIDs celecoxib
(Celebrex) and rofecoxib (Vioxx), blocks one of the enzymes that makes
prostaglandins (cyclooxygenase 2), resulting in lower concentrations of
prostaglandins. As a consequence, pain, swelling and tenderness of joints
due to arthritis are reduced. Valdecoxib (like celecoxib and rofecoxib)
differs from most other NSAIDs in that it causes less inflammation and
ulceration of the stomach and intestine (at least with short-term treatment)
and does not interfere with the clotting of blood.
PREPARATIONS: Oblong white tablets containing 10 or
20mg of valdecoxib.
STORAGE: Valdecoxib tablets should be stored at room
temperature, 59-86 °F (15-30 °C).
PRESCRIBED FOR: Valdecoxib is used for the relief of
pain, fever, swelling, and tenderness caused by osteoarthritis and rheumatoid
arthritis, but it does not prevent the destruction of joints by the arthritis.
Valdecoxib also is approved for the relief of pain of menstrual cramps
(primary dysmenorrhea).
DOSING: For osteoarthritis or rheumatoid arthritis,
the usual approved dose of valdecoxib is 10 mg once daily. For dysmenorrhea,
the dose is 20 mg twice daily. Valdecoxib may be taken with or without
food.
DRUG INTERACTIONS: NSAIDs can reduce the actions of
diuretics such as furosemide (Lasix) and hydrochlorothiazide (Hydrodiuril)
in some patients and lead to retention of water.
Fluconazole (Diflucan), ketoconazole (Nizoral), and lithium (Eskalith)
may increase the concentration of valdecoxib in the body by inhibiting
its breakdown in the liver.
PREGNANCY: In pregnant animals, valdecoxib has been
shown to cause fetal abnormalities. Although the use of valdecoxib by
pregnant women has not been studied carefully, fetal abnormalities have
been reported in women who took valdecoxib during pregnancy. Valdecoxib
should be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus. Valdecoxib should be avoided during late
pregnancy. Valdecoxib should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus. Valdecoxib should be
avoided during late pregnancy.
NURSING MOTHERS: The use of valdecoxib in nursing mothers
has not been evaluated.
SIDE EFFECTS: The most common side effects of valdecoxib
are headache, abdominal pain, diarrhea, nausea, flatulence and insomnia.
Other side effects include fainting, kidney failure, heart failure, fluid
retention, aggravation of hypertension, chest pain, ringing in the ears,
deafness, stomach and intestinal ulcers, bleeding, blurred vision, anxiety,
photosensitivity, weight gain, water retention, flu-like symptoms, drowsiness
and weakness.
Very serious allergic reactions have been reported with valdecoxib. It
is recommended that patients who experience a rash after beginning therapy
with valdecoxib should discontinue valdecoxib immediately and seek the
advise of their physician. Although valdecoxib is not a sulfonamide itself
(unlike celecoxib), it is recommended that patients with an allergy to
sulfonamides ("sulfas") should not take valdecoxib.
Although the chances of stomach or intestinal ulceration or bleeding
with valdecoxib are low, a small risk of these side effects remains. Patients
taking valdecoxib should report any symptoms or signs of ulceration or
bleeding such as abdominal pain or black stools to their doctor
Caution! Before starting
to take this medicine, it is vital that you should consult your doctor!
Do not use it on your own initiative, without medical advice.
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