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Campaigns appear to be an important way to refine their expertise. While 39% of Protonix patients told us they had requested a prescription after seeing an advertisement for any medication, only 15% of Aciphex patients had done so. Similar percentages had taken the initiative to follow-up by telephone, email or mail to find out more about an advertised medication. The Prilosec patient is most likely to have specifically requested a PPI prescription. Consumerization has not seemed to extend equally across products. Among Protonix patients, 6% acknowledged their personal involvement in selecting the medication. This proportion rises to 13% of Aciphex patients, 15% of Prevacid patients, and 17% of Prilosec patients.
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ACIPHEX 20 mg once daily was significantly more effective than ranitidine 150 mg QID in the percentage of patients with complete resolution of heartburn at Weeks 4 and 8 p 0.001 ; . ACIPHEX 20 mg once daily was also more effective in complete resolution of daytime heartburn p0.025 ; , and night time heartburn p0.012 ; at both Weeks 4 and 8, with significant differences by the end of the first week of the study. Long-term Maintenance of Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease GERD Maintenance ; The long-term maintenance of healing in patients with erosive or ulcerative GERD previously healed with gastric antisecretory therapy was assessed in two U.S., multicenter, randomized, double-blind, placebo-controlled studies of identical design of 52 weeks duration. The two studies randomized 209 and 285 patients, respectively, to receive either 10 mg or 20 mg of ACIPHEX QD or placebo. As demonstrated in the tables below, ACIPHEX was significantly superior to placebo in both studies with respect to the maintenance of healing of GERD and the proportions of patients remaining free of heartburn symptoms at 52 weeks.
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Table 3 outlines some of the factors affecting maintenance dose requirements.
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Publications continued ; : 21. "Background pregnancy rates in an infertile population" N. Gleicher, B. VanderLaan, D. Pratt, V. Karande. Human Reproduction 1996; 11: 1011-1012 "The efficacy of "tubal sperm perfusion"? V. Karande, R. Rao, D. Pratt, M. Balin, S. Levrant, R. Morris, A. Dudkiewicz, N. Gleicher. Fertility and Sterility 1996 Letters-to-the-editor 66: 169-70 23. "Infertility treatment dropout and insurance coverage" N. Gleicher, B. Vanderlaan, V. Karande, R. Morris, K. Nadherney, D. Pratt. Obstet Gynecol 1996; 88: 289-93 "What is the radiation exposure to patients during a gynecoradiologic procedure?" V. Karande, D. Pratt, M. Balin, S. Levrant, R. Morris, N. Gleicher. Fertility and Sterility 1997; 67: 401-403 "Evaluation of the functional status of the fallopian tubes with the measurement of tubal perfusion pressures" V. Karande, N. Gleicher. Human Reproduction Update 1996; 2: 5 " The diagnosis and treatment of proximal tubal disease" N. Gleicher, V. Karande Human Reproduction 1996; 11: 1825-1828 "Limited success using the `flare' protocol in poor responders in cycles with low basal follicle stimulating hormone levels during in vitro fertilization" V. Karande, R. Morris, J. Rinehart, C. Miller, R. Rao, N. Gleicher. Fertility and Sterility 1997; 67: 900-903. "Lysis of intrauterine adhesions using gynecoradiologic techniques" V. Karande, S. Levrant, R. Hoxsey, J. Rinehart, N. Gleicher. Fertility and Sterility 1997; 68: 658-662. "Cost considerations with infertility therapy: outcome and cost comparison between health maintenance organization and preferred provider organization care based on physician and facility cost" B. VanderLaan, V. Karande, C. Krohm, R. Morris, D. Pratt, N. Gleicher Human Reproduction 1998; 13: 1200-1205 "A prospective randomized trial assessing outcome and cost of IVF as a first choice treatment versus a traditional infertility treatment algorithm" V. Karande, A. Korn, R. Morris, R. Rao, M. Balin, J. Rinehart, K. Dohn, N. Gleicher Fertil Steril 1999; 71: 468-75. "Current perspectives on the diagnosis and management of proximal tubal disease" V. Karande J Obstet Gynaecol India, 1998.
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Relapsing-Remitting MS: Persons classified as having relapsing-remitting MS experience clearly defined relapses--episodes of acute worsening of neurologic function-- followed by periods of remission without disease progression. In some cases, people experience a residual deficit. Secondary Progressive MS: People with secondary progressive MS experience a relapsing-remitting disease course at onset, followed by progression with or without occasional relapses, minor remissions, and plateaus. Although the disease usually begins in the relapsing-remitting category, most individuals eventually convert to the progressive category. Progressive-Relapsing MS: Persons with progressive-relapsing MS experience progressive disease from onset, with clear, acute relapses that may or may not resolve with full recovery. Unlike relapsing-remitting MS, the periods between relapses are characterized by continuing disease progression. Primary Progressive MS: People with primary progressive MS experience a nearly continuous worsening of disease that, by definition, is not interrupted by distinct relapses. Some of these individuals do have occasional plateaus and temporary minor improvements. Health professionals tend to have greater exposure to individuals with the more serious forms of the disease. Therefore, it is important to note that the majority of individuals with MS do not become severely disabled.
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For at least 35% of the 24-hour period; this level was achieved in 90% of subjects receiving ACIPHEX 20 mg and in 100% of subjects receiving ACIPHEX 40 mg. With ACIPHEX 20 mg and 40 mg per day, significant effects on gastric and esophageal pH were noted after one day of treatment, and more pronounced after seven days of treatment. Effects on Serum Gastrin In patients given daily doses of ACIPHEX for up to eight weeks to treat ulcerative or erosive esophagitis and in patients treated for up to 52 weeks to prevent recurrence of disease the median fasting gastrin level increased in a dose-related manner. The group median values stayed within the normal range. In a group of subjects treated daily with ACIPHEX 20 mg for 4 weeks a doubling of mean serum gastrin concentrations were observed. Approximately 35% of these treated subjects developed serum gastrin concentrations above the upper limit of normal. In a study of CYP2C19 genotyped subjects in Japan, poor metabolizers developed statistically significantly higher serum gastrin concentrations than extensive metabolizers. Effects on Enterochromaffin-like ECL ; Cells Increased serum gastrin secondary to antisecretory agents stimulates proliferation of gastric ECL cells which, over time, may result in ECL cell hyperplasia in rats and mice and gastric carcinoids in rats, especially in females see Carcinogenesis, Mutagenesis, Impairment of Fertility ; . In over 400 patients treated with ACIPHEX 10 or 20 mg day ; for up to one year, the incidence of ECL cell hyperplasia increased with time and dose, which is consistent with the pharmacological action of the proton-pump inhibitor. No patient developed the adenomatoid, dysplastic or neoplastic changes of ECL cells in the gastric mucosa. No patient developed the carcinoid tumors observed in rats. Endocrine Effects Studies in humans for up to one year have not revealed clinically significant effects on the endocrine system. In healthy male volunteers treated with ACIPHEX for 13 days, no clinically relevant changes have been detected in the following endocrine parameters examined: 17 -estradiol, thyroid stimulating hormone, tri-iodothyronine, thyroxine, thyroxinebinding protein, parathyroid hormone, insulin, glucagon, renin, aldosterone, follicle-stimulating hormone, luteotrophic hormone, prolactin, somatotrophic hormone, dehydroepiandrosterone, cortisol-binding globulin, and urinary 6hydroxycortisol, serum testosterone and circadian cortisol profile. Other Effects In humans treated with ACIPHEX for up to one year, no systemic effects have been observed on the central nervous, lymphoid, hematopoietic, renal, hepatic, cardiovascular, or respiratory systems. No data are available on long-term treatment with ACIPHEX and ocular effects. Microbiology Rabeprazole sodium, amoxicillin and clarithromycin as a three drug regimen has been shown to be active against most strains of Helicobacter pylori in vitro and in clinical infections as described in the CLINICAL STUDIES and INDICATIONS AND USAGE sections. Helicobacter pylori Susceptibility testing of H. pylori isolates was performed for amoxicillin and clarithromycin using agar dilution methodology1, and minimum inhibitory concentrations MICs ; were determined. The clarithromycin and amoxicillin MIC values should be interpreted according to the following criteria: Interpretation Clarithromycin MIC g mL ; a Susceptible S ; 0.25 Intermediate I ; 0.5 Resistant R ; 1.0 a, b Interpretation Amoxicillin MIC g mL ; Susceptible S ; 0.25 a These are breakpoints for the agar dilution methodology and they should not be used to interpret results using alternative methods. b There were not enough organisms with MICs 0.25 g mL to determine a resistance breakpoint.
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Abbott expects debate to continue during 2003 at both the federal and the state level over the availability, method of delivery, and payment for health care products and services.
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