Forsteo ® (teriparatid)

För fullständig produktresumé för Forsteo® se FASS.

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Forsteo® (teriparatid): Riskreducering av frakturer

Hos postmenopausala kvinnor har en signifikant reducering av incidensen vertebrala och icke-vertebrala frakturer visats, men detta har ej visats för höftfrakturer.

Results from pivotal clinical study with median treatment of 19 months

The pivotal study included 1637 postmenopausal women (mean age 69.5 years). At baseline, 90% of the patients had one or more vertebral fractures, and on average, vertebral BMD was 0.82 g/cm2 (equivalent to a T-score = -2.6). All patients were offered 1000 mg calcium per day and at least 400 IU vitamin D per day. Results from up to 24 months (median: 19 months) treatment with Forsteo demonstrate statistically significant fracture reduction (Table 1). To prevent one or more new vertebral fractures, 11 women had to be treated for a median of 19 months.1

Table 1. Fracture Incidence in Postmenopausal Women1

 

Placebo (N = 544) (%)

Teriparatide (N = 541) (%)

Relative risk (95% CI) vs. placebo

New vertebral fracture (≥1)a

14.3

5.0b

0.35 (0.22, 0.55)

Multiple vertebral fractures (≥2)a

4.9

1.1b

0.23 (0.09, 0.60)

Non-vertebral fragility fracturesc

5.5%

2.6%d

0.47 (0.25, 0.87)

Major non-vertebral fragility fracturesc (hip, radius, humerus, ribs and pelvis)

3.9%

1.5%d

0.38 (0.17, 0.86)

Abbreviations: N = number of patients randomly assigned to each treatment group; CI = Confidence Interval.

a The incidence of vertebral fractures was assessed in 448 placebo and 444 Forsteo patients who had baseline and follow-up spine radiographs.

b p≤0.001 compared with placebo.

c A significant reduction in the incidence of hip fractures has not been demonstrated.

d p≤0.025 compared with placebo.

After 19 months (median) treatment, bone mineral density (BMD) had increased in the lumbar spine and total hip, respectively, by 9 % and 4 % compared with placebo (p<0.001).1

Post-treatment management: Following treatment with Forsteo, 1262 postmenopausal women from the pivotal trial enrolled in a post-treatment follow-up study. The primary objective of the study was to collect safety data of Forsteo. During this observational period, other osteoporosis treatments were allowed and additional assessment of vertebral fractures was performed.1

Teriparatide was effective in reducing the risk for vertebral fractures regardless of age, baseline rate of bone turnover, or baseline BMD.2

Results from Phase 4 study with treatment up to 24 Months

A 24-month, randomized, double-blind, comparator-controlled Phase 4 study included 1,360 postmenopausal women with established osteoporosis. 680 subjects were randomised to Forsteo and 680 subjects were randomised to oral risedronate 35 mg/week. At baseline, the women had a mean age of 72.1 years and a median of 2 prevalent vertebral fractures; 57.9 % of patients had received previous bisphosphonate therapy and 18.8% took concomitant glucocorticoids during the study. 1,013 (74.5 %) patients completed the 24-month follow-up. The mean (median) cumulative dose of glucocorticoid was 474.3 (66.2) mg in the teriparatide arm and 898.0 (100.0) mg in the risedronate arm. The mean (median) vitamin D intake for the teriparatide arm was 1433 IU/day (1400 IU/day) and for the risedronate arm was 1191 IU/day (900 IU/day). For those subjects who had baseline and follow-up spine radiographs, the incidence of new vertebral fractures was 28/516 (5.4 %) in Forsteo- and 64/533 (12.0 %) in risedronate-treated patients, relative risk (95% CI) = 0.44 (0.29-0.68), P<0.0001. The cumulative incidence of pooled clinical fractures (clinical vertebral and non vertebral fractures) was 4.8 % in Forsteo and 9.8 % in risedronate-treated patients, hazard ratio (95% CI) = 0.48 (0.32-0.74), P=0.0009.1

References

1. Forsteo [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Datum fӧr senaste ӧversyn 2020 M02 06

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