Celecoxib Improves Quality of Life in Patients with Osteoarthritis
(63rd Annual Meeting of the American College of Rheumatology) Results from a pooled analysis of three identical 12-week, double-blind, placebo-controlled studies indicate that celecoxib (Celebrex) at dosages of 100 or 200 mg twice daily can significantly improve health-related quality of life in elderly patients with osteoarthritis of the hip or knee. Of 3,255 patients with osteoarthritis of the hip or knee, 956 were at least 70 years of age. These 956 patients were equally randomized to receive five different treatments: (1) celecoxib, 50 mg twice daily; (2) celecoxib, 100 mg twice daily; (3) celecoxib, 200 mg twice daily; (4) naproxen, 500 mg twice daily; and (5) placebo. Pain, stiffness and physical functioning were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Short-Form 36 Health Survey (SF-36) at baseline and at weeks 2 and 12. Patients who received celecoxib (either 100 mg or 200 mg twice daily) showed significant improvements in health-related quality of life at weeks 2 and 12, compared with the patients who received placebo. The improvements noted in the patients taking celecoxib, 100 mg twice daily and 200 mg twice daily, were not significantly different. The patients taking 100 mg twice daily of celecoxib had significant improvements in seven of eight domains of SF-36 and in all WOMAC scores, compared with the patients taking naproxen who had improvements in five of eight SF-36 domains and in all WOMAC scores. The use of celecoxib reduced arthritis pain and stiffness, and increased physical functioning, allowing elderly patients with osteoarthritis to more easily perform everyday activities, such as walking up and down stairs; bending; getting in and out of the bathtub, bed and cars; and using the toilet. The most common side effects of celecoxib were dyspepsia, diarrhea and abdominal pain. Patients who have a known allergic reaction to celecoxib, certain sulfa drugs called sulfonamides, aspirin or nonsteroidal anti-inflammatory drugs should not use celecoxib.—s. z. zhao, Skokie, Illinois.
Combination Hepatitis Vaccine Shows Efficacy in Clinical Trials
(39th Annual Meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy) An open, randomized, multi-center study demonstrated that the use of Twinrix (an investigational combination vaccine against hepatitis A and hepatitis B) produced similar antibody titers to the use of Havrix (hepatitis A vaccine) and Energix-B (a hepatitis B vaccine) administered separately and required two fewer injections over the same six-month period. The study included 773 participants who received either Twinrix at zero, one and six months for a total of three injections, or separate injections of Havrix (zero, six months) and Energix-B (zero, one and six months), administered concurrently in opposite arms for a total of five injections. Blood samples were collected before and one month after each injection, and clinical signs and symptoms were recorded on diary cards for four days after each vaccine dosage. Adverse reactions (including soreness at the injection site, headache and fatigue) were similar among both groups and were mild to moderate in severity.—mark blatter, m.d., Primary Physicians Research, Pittsburgh, Pennsylvania.
New Compound Provides Effective Estrogen Replacement Therapy
(10th Annual Meeting of the North American Menopause Society) According to a study of post-menopausal women in Australia, the use of a new compound (P-081), which is the dietary ingredient in a new product called Rimostil, over a six-month period showed a 4 percent increase in bone density in cortical bone as well as a 28 percent increase in serum high-density lipoprotein (HDL) cholesterol levels without any adverse side effects. P-081 contains a specific ratio of the four plant phenolic estrogenic isoflavones: formononetin, daidzein, biochanin and genistein. The study included 50 women between the ages of 54 and 60 years who were four to eight years past menopause. The women were divided into three treatment groups and received 25, 50 or 75 mg of Rimostil daily. The study lasted nine months, with a one-month run-in phase using placebo, followed by six months with Rimostil, and then another two months with placebo. There were no significant changes from baseline levels at the fourth and seventh month in endometrial thickness, body weight, or routine serum biochemistry and hematology parameters. None of the women experienced a return of hot flushes.—rodney baber, m.b., b.b.s, d.pharm, Royal North Shore Hospital, Sydney, Australia.
Use of Crinone Demonstrates Excellent Pregnancy Rates
(Conjoint Annual Meeting of the American Society for Reproductive Medicine and the Canadian Fertility and Andrology Society) Interim findings from a study on progesterone supplementation in women undergoing assisted reproductive technologies (ART) indicate that the use of the progesterone gel Crinone as part of ART helped achieve pregnancy in over one third of the women and is a more convenient form of therapy than painful intramuscular injections. Crinone is administered vaginally once or twice daily using a pre-filled, disposable applicator. The study includes approximately 2,000 patients in 23 infertility treatment centers throughout the United States. These interim findings were based on 1,251 of those women from 16 centers who were undergoing in vitro fertilization in 1997 and 1998. Among patients whose data have been fully analyzed, 34.9 percent of 590 patients receiving Crinone in combination with follicle stimulating hormone achieved pregnancy, compared with 25.7 percent of the 210 patients receiving Crinone in combination with human menopausal gonadotropin. Part of the treatment protocol included having patients describe their experiences with progesterone therapies. Of patients who had previously undergone a different form of progesterone treatment, 91 percent preferred Crinone to intramuscular injections and 90 percent preferred Crinone to suppositories. In describing their overall experience with Crinone, about 94 percent of over 1,000 patients found Crinone to be easy to administer and reported no pain, and almost 75 percent did not think Crinone was messy. Crinone should not be given to patients with any of the following conditions: known sensitivity to Crinone (progesterone or any of the other ingredients); undiagnosed vaginal bleeding; liver dysfunction or disease; known or suspected malignancy of the breast or genital organs; missed abortion; active thrombophlebitis or thromboembolic disorders, or a history of hormone associated thrombophlebitis or thromboembolic disorders.—david l. keefe, m.d., Women and Infants Hospital, Providence, Rhode Island.