Incorporating ulipristal acetate in the care of symptomatic uterine fibroids: a Canadian cost-utility analysis of pharmacotherapy management.

OBJECTIVE: To present a Canadian economic evaluation on the cost-utility of ulipristal acetate (5 mg orally daily) compared to leuprolide acetate (3.75 mg intramuscular monthly) in the treatment of moderate-to-severe symptoms of uterine fibroids in women eligible for surgery. METHODS: A probabilistic decision tree was constructed to model the pre-operative pharmacological management of uterine fibroids under the primary perspective of the Ontario public payer. The model parameterized data from clinical trials, observational studies, and public costing databases. The outcome measure was the incremental cost-utility ratio. Uncertainty in the model was explored through sensitivity and scenario analyses. RESULTS: Ulipristal was associated with faster control of excessive menstrual bleeding, fewer symptoms of hot flashes and lower health care resource consumption. The ulipristal strategy dominated leuprolide as it provided patients with more quality-adjusted life years (0.177 versus 0.165) at a lower cost ($1,273 versus $1,366). Across a range of sensitivity analyses, the results remained robust except to the dose of the comparator drug. If leuprolide was administered at 11.25 mg, once every 3 months, the expected cost for the leuprolide strategy would decline and the associated incremental cost-utility ratio for ulipristal would be $168/quality-adjusted life year. CONCLUSION: Ulipristal offers a unique opportunity to effectively and rapidly control menstrual bleeding in patients with uterine fibroids; thereby improving their quality of life while minimizing the probability of moderate-to-severe hot flashes that are common with leuprolide. The current economic analysis suggests that ulipristal remains the dominant strategy across extensive sensitivity analyses.

Utility values for pre-menopausal women suffering from symptomatic uterine fibroids.

BACKGROUND: Uterine fibroids (UF) represent the most common benign uterine tumor in women of reproductive age. Symptoms including heavy, prolonged menstrual bleeding, pelvic pain/pressure, and/or urinary frequency have a substantial impact on women's quality of life and utility values for UF have not been published. METHODS: Health state descriptions associated with UF symptoms and treatment side effects were developed based on patient focus groups; validated using expert clinical input; and pilot tested for understandability. Using a web-based questionnaire, 909 community-dwelling, Canadian women were surveyed to assess their perceived value associated with these states. RESULTS: Utility for uncontrolled bleeding was 0.55 (95% CI: 0.54, 0.57) and the decrement associated with hot flashes was 0.06 (95% CI: -0.07, -0.04). Utility improvement associated with bleeding control was 0.18 (95% CI: 0.17, 0.19) and with smaller fibroid size was 0.03 (95% CI: 0.02, 0.04). CONCLUSION: These values illustrate the high utility associated with control of excessive menstrual bleeding.

Diagnosis of constipation in family practice.

BACKGROUND: Patients who complain of constipation to their family doctor may not be truly constipated. Variability in stool frequency and consistency, and perception of symptoms may lead to inaccurate patient reporting or diagnosis of constipation. OBJECTIVES: To determine whether patients visiting their family doctor with a complaint of, or diagnosed with, constipation fulfilled the Rome II criteria for functional constipation and had stool characteristics of constipation. METHODS: A random sample of Canadian family physicians were recruited to enroll a series of adults who complained of, or had received a diagnosis of, constipation during an office visit. Patients were advised of the survey. Those providing written consent were contacted by an independent research firm and forwarded a survey questionnaire that included the Rome II gastrointestinal questionnaire, questions regarding their medical history and questions regarding their demographics. Patients also completed a four-week daily diary recording their bowel habits using the Bristol Stool Form Scale, medication use and satisfaction with treatment. Questionnaire and diary responses were retrieved by telephone. RESULTS: One hundred eighty-four family physicians enrolled 311 patients, of whom 220 completed the questionnaire. Females comprised 79.5% of the sample and had a mean age of 54.2 years (males 61.6 years; P<0.05). According to the Rome II criteria, 37.3% had functional constipation and 46.8% had irritable bowel syndrome (IBS). Whole gut transit times estimated using the Bristol Stool Scale were similar among those with self-reported constipation, those with Rome II functional constipation and those with Rome II IBS (79.3 h, 85.8 h and 77.4 h, respectively). Almost half of the patients with IBS or functional constipation were taking a pain medication, while nearly one-fifth took antidepressants. Of the medications or remedies taken to treat constipation, patients rated 49.8% of the doses as satisfactory. CONCLUSIONS: A large proportion of Canadian primary care patients whose presenting complaint or diagnosis was constipation satisfied the Rome II criteria for IBS, with a smaller number defined as functionally constipated. IBS patients tended to be younger than those with functional constipation, and whole gut transit times did not differentiate IBS from functional constipation. Careful questioning of patients who complain of constipation may reveal constipating medication, diarrhea symptoms or IBS.