The use of Instanyl® in the treatment of breakthrough pain in cancer patients: a 3-month observational, prospective, cohort study.

PURPOSE: Instanyl® (intranasal fentanyl spray) is a novel treatment for breakthrough pain (BTP) in cancer patients. It has shown a rapid onset of pain relief in clinical trials. This study examines the use of Instanyl® in real-life settings. METHODS: A 3-month observational, prospective, cohort study of cancer patients with BTP receiving Instanyl® (50, 100, or 200 µg) under routine clinical practice. Data were collected at three time points corresponding with routine clinic visits - baseline, Week 4, and Week 13. PRIMARY OUTCOMES: success of titration and maintenance dose after titration. SECONDARY OUTCOMES: change in maintenance dose of Instanyl® and level of background pain medication; Brief Pain Inventory--Short Form (BPI-SF) and Patient Treatment Satisfaction Scale (PTSS) scores; adverse drug reactions (ADRs). RESULTS: Titration with Instanyl® was successful in 84.5 % of 309 patients; most patients were titrated at the lowest dose (50 µg). The majority showed no change in maintenance dose, with little change in the level of background pain medication. BPI-SF and PTSS scores significantly improved from baseline to Week 4. The main reason for terminating Instanyl® was death, as expected due to the underlying disease; incidence of ADRs was low and no fatal ADRs were reported. CONCLUSIONS: In a real-life group of cancer patients with disease progression, Instanyl® was titrated successfully at doses <200 µg in the majority of patients, requiring only one dose, with no further change in maintenance dose. Pain severity, impact of pain on daily life, and treatment satisfaction significantly improved with Instanyl® treatment. No unexpected ADRs occurred.

Treatment of postmenopausal women with osteoporosis with PTH(1-84) for 36 months: treatment extension study.

OBJECTIVE: To determine the safety and efficacy of full-length parathyroid hormone, PTH(1-84), treatment for up to 36 months by evaluating bone mineral density (BMD) changes, bone histomorphometric indices, and clinical fracture incidence in postmenopausal women with osteoporosis. BACKGROUND: The TOP trial demonstrated increased lumbar spine BMD (6.9%) versus placebo after 18 months of PTH(1-84) treatment and reduced the incidence of new vertebral fractures (61%; p = 0.001). The therapeutic benefits of long-term treatment of postmenopausal women with PTH(1-84) are unknown. METHODS: The safety and efficacy of 36 months of once-daily dosing with 100 µg PTH(1-84) in postmenopausal women with osteoporosis were assessed. Women receiving placebo during the TOP trial were eligible for PTH(1-84) in the extension study. CLINICAL TRIAL REGISTRATION: NCT00172120. RESULTS: Lumbar spine BMD increased by 8.5% above baseline (p < 0.001) at 36 months of PTH(1-84) treatment, remaining stable during the last 12 months of treatment. Increases in total hip and femoral neck BMD occurred more slowly, reaching 3.2% and 3.4%, respectively above baseline at 36 months (p < 0.001). The total hip BMD showed no signs of reaching a limiting value although the femoral neck plateaued from months 24 to 36. Seven patients had vertebral fractures during the placebo phase of the TOP trial and before entering the extension study, but this rate decreased with the introduction of PTH(1-84) therapy, resulting in a single worsened vertebral fracture in the first 6 months and no further vertebral fractures from months 6 to 36. Treatment over 36 months with PTH(1-84) was well-tolerated and iliac crest biopsies showed no adverse effects on bone. LIMITATIONS: There was no placebo group for BMD comparisons. The number of patients assessed for fracture incidence was small. CONCLUSIONS: PTH(1-84) treatment for 36 months resulted in significant increases in BMD at the lumbar spine and hip, was associated with a lower incidence of vertebral fracture when compared to before therapy initiation, and was well-tolerated. The continuous increases in total hip BMD suggest that prolonged PTH(1-84) treatment may be beneficial for postmenopausal osteoporosis. Increased BMD at the femoral neck and lumbar spine also showed favourable changes but plateaued between 24 and 36 months. Long-term treatment was not associated with abnormalities in bone biopsies.