Ibandronate vs. Alendronate for Osteoporosis

Ibandronate vs. Alendronate for Osteoporosis Cost-Effectiveness of Ibandronate vs. Alendronate used in treatment of osteoporosis, in a specialized clinic in Tirana. Dr. Mirela Miraà §i1; Msc.Arlinda Demeti2; Prof.as Zamira Ylli3; Prof.Mira Zià §ishti3; Prof.As Suela Kellià §i1 Faculty of Pharmacy, University of Medicine, Tirana. Bioparafarmacia Franceze Neostyle Clinic Abstract: Osteoporosis is â€Å"a systemic skeletal disease with a high prevalence. Biphosphonates are medicaments which are chosen for their efficacy in reducing fracture incidence, increasing bone density and improving bone microarchitecture. The aim of the study is to evaluate the effectiveness of the drugs (ibandronate and alendronate) used in osteoporosis treatment, in post-menopausal women over the age of 50 years at a specialized clinic in Tirana; to calculate the annual cost of treatment of osteoporosis and to perform a cost effectiveness analyze. Methods: Retrospective. The patients were all female, in menopause or post menopause, with T-score -1 to -6, treated with alendronate or ibandronate. The effectiveness is calculated as the average percentage of change in bone mineral density (av. % of change in BMD) of year 2011 vs. 2010 baseline. The annual cost of the treatment of osteoporosis according to the protocols and the cost of the examination with DXA scan (dual x-ray absorptiometry) were calculated. Finally a comparison of the cost-effectiveness was performed. Conclusion:  Patients with osteoporosis treated with Ibandronate, at our clinic in Tirana, have an average change from baseline higher compared with patients treated with Alendronate, with statistically significant difference between them (Man Whitney U = 66.0, p The annual cost of the disease when treated with ibandronate is 1.3 times higher than the annual cost of treatment with alendronate. Ibandronate is more cost effective than all other alendronate . Introduction: Osteoporosis is â€Å"a systemic skeletal disease characterized by low bone mass and micro architectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fractures† (1) The World Health Organization defines osteoporosis as â€Å"bone density 2.5 standard deviations (SDs) below the mean for young white adult women at lumbar spine, femoral neck or forearm†. (2) Osteoporosis leads to nearly 9million fractures each year worldwide and over 300,000patients with fragility fractures are registered in UK hospitals each year (British Orthopaedic Association, 2007).(3) Osteoporoza, à «shtà « njà « sà «mundje me njà « prevalencà « tà « lartà « edhe nà « Shqipà «ri (7.28% e popullatà «s dhe 9.6% tek femrat)4, e njà «jtà « me atà « tà « hasur pà «r astmà «n apo sà «mundjet e zemrà «s; †¦Ã¢â‚¬ ¦Ã¢â‚¬ ¦Ã¢â‚¬ ¦Ã¢â‚¬ ¦.. Direct medical costs due to fragility fractures in UK healthcare economy were estimated at  £1.8billion in 2000, with the potential to increase to  £2.2billion by 2025 and the major part of these costs were related to hip fracture care. (5) The annual cost of osteoporosis and fractures in the US elderly was estimated at $16 billion(6) Osteoporosis is diagnosed by a T-score, which is the number of standard deviation (SD) that patient’s bone mineral density (BMD), measured using dualX-ray absorptiometry, differs from the mean BMD of 30-years old premenopausal women. Patients with T-score of between -1 and -2.5 SD are said to have osteoporosis.7,8 Biphosphonates are medicaments which are chosen for their efficacy in reducing fracture incidence, increasing bone density and improving bone microarchitecture.9-15 Top of Form Methods: Retrospective. The patients were all female, in menopause or post menopause, 50 years old or elder, with T-score -1 to -6, diagnosed for the 1rst time in 2010 (the 1rst BMD measurement), who have received treatment (alendronate or ibandronate) for 12 months and in 2011 have performed a 2nd BMD measurement. The effectiveness is calculated as the average percentage of change in bone mineral density (av.% of change in BMD) of year 2011 vs. 2010 baseline. It was calculated the annual cost of the treatment of osteoporosis according to the protocols: with once monthly 150 mg oral ibandronate plus supplements (calcium, vitamine D) and once weekly 70 mg alendronate (4 times per month) plus supplements (calcium, vitamine D). There are also included other direct costs such as the examination with DXA scan (dual x-ray absorptiometry) to determine the diagnosis and the medical visits. Finally a comparison of the cost-effectiveness will be performed. Statistical Analysis Data were analyzed with SPSS 20 statistical package. It is used the non-parametric Man Whitney U test to compare the continuous variables, Fisher Exact test was used to compare proportions between variables and the the Odds Ratio OR for assessing the association between variables. Point estimations are accompanied with interval estimation by 95 % CI. For continuous variables is presented the average, the standard deviation and the minimum and maximum values. The level of statistical significance is defined at ÃŽ ± ≠¤ 005. Statistical tests are two-sided.duhet te shihet gjuha e perdorur, a qendron ne anglisht? Results of the study In our study were included 70 patients who fulfill the inclusion criteria. 24 patients were treated with once monthly 150 mg oral ibandronate and 46 patients with once weekly 70 mg alendronate.There were not case of fracture among our patients. Table 1 compares the frequency of pathologies (osteopenia and osteoporosis) in two groups of patients treated with alendronat or ibandronat. Osteoporosis Osteopenia Ibandronate 14 10 Alendronate 18 28 OR= 1.3 95%CI 0.5 4.2 p=0.4 Your contribution will be used to improve translation quality and may be shown to users anonymously Contribute Close Thank you for your submission. Number of patients treated with alendronate is 1.3 times higher than the number of patients treated with ibandronate in the case of osteoporosis. (OR = 1.3, 95% CI 0.5-4.2, p = 0.4). Chart 1 Calculation of efficiency We have to calculate the average percentage of change of BMD (2011) to baseline (2010): Table2. In the group of Alandronate (N=46) we have found this data: Osteoporosis n=18 Osteopeni n= 28 M (SD) min max M (SD) min max Mann-Whitney U p T Score 2010 -3.2 (0.7) -4.6 -2.5 -1.9 (0.4) -2.4 -1.1 507.0 T Score 2011 -3.1 (0.8) -4.7 -2.2 -1.8 (0.6) -2.4 -1.1 515.5 Age, yrs 61.2 (8.0) 51.0 – 79.0 59.1 (7.8) 51.0 – 81.0 223.5 0.3 Height, m 1.5 (0.05) 1.4 – 1.6 1.5 (0.07) 1.4 – 1.7 304.5 0.3 Weight, kg 58.8 (8.3) 46.0 – 73.0 68.6 (11.1) 51.0 – 95.0 376.5 0.01 *Age-Group, yrs n (%) n (%) OR (95% CI) 50 -59 yrs 8 (17) 19 (41) 60 -69 yrs 7 (15.2) 6 (13.0) 1.6 0.4 – 6.7 0.4 >70 yrs 3 (7) 3 (7) 2.8 0.4 – 25.2 0.3 *Fisher exact test p=0.3 There are 46 patients treated with alendronate. 18 ( 39.1 %) (95% ; CI 29.7 52.1) of them suffer from osteoporosis and 28 ( 60.9 % ) (95 % CI 47.8 74.2) from osteopenia, with no statistically significant difference between them, p = 0.9 Grupmosha 60 – 69 vjeà § ka 1.6 herà « mà « tepà «r gjasa qà « tà « vuajnà « nga Osteoporoza sesa grupmosha 50-59 vjeà §, por pa ndryshim sinjifikant ndà «rmjet tyre (OR=1.6; 95%CI 0.4–6.7; p=0.4) Grupmosha >70 vjeà § ka 2.8 herà « mà « tepà «r gjasa qà « tà « vuajnà « nga osteoporoza sesa grupmosha 50-59 vjeà §, por pa ndryshim sinjifikant ndà «rmjet tyre (OR=2.8; 95%CI 0.4–25.2; p=0.3) Pacientet me Osteopeni kanà « peshà « mesatare mà « tà « lartà « krahasuar me pacientà «t me Osteoporozà «, me ndryshim statistikisht tà « rà «ndà «sishà «m ndà «rmjet tyre (Man Whitney U=376.5, p=0.01) Pacientà «t me Osteoporozà « kanà « tà « njà «jtà «n gjatà «si mesatare me pacientà «t me Osteopeni, pa ndryshim statistikisht tà « rà «ndesishà «m ndà «rmjet tyre (Man Whitney U=304.5, p=0.3). The change from baseline for Alendronate group The change from baseline is calculated: Table 3 Osteoporosis n=18 Osteopenia n= 28 M (SD) min max M (SD) min max Mann-Whitney U p The change from baseline 2.1 (4.5) -7.6 – 13.9 1.7 (6.2) -23 – 11.1 316.0 0.2 Patients with osteopenia have an average change from baseline higher compared with patients with osteoporosis, no statistically significant difference between them (Man Whitney U = 316.0, p = 0.2). Table 4. In the group of Ibandronate (N = 24) we have find this data: Osteoporosis n=14 Osteopeni n= 10 M (SD) min max M (SD) min max Mann-Whitney U p T Score 2010 -3.7 (0.7) -5.0 -2.7 -1.8 (0.3) -2.2 -1.4 140.0 T Score 2011 -3.2 (0.8) -4.4 -1.7 -1.5 (0.4) -2.1 -1.0 134.5 Age yrs 64.3 (7.3) 53.0 77.0 59.1 (5.0) 53.0 – 68.0 39.5 0.07 Height (m) 1.5 (0.05) 1.4 – 1.6 1.5 (0.06) 1.4 – 1.6 71.0 0.9 Weight 66.2 (10.9) 47.0 – 84.0 70.7 (7.1) 65.0 – 82.0 90.5 0.2 *Age-group, yrs n (%) n (%) OR (95% CI) 50 -59 yrs 3 (12.5) 6 (25.0) 60 -69 yrs 8 (33.3) 4 (16.7) 3.7 0.6 – 27.8 0.2 >70 yrs 3 (12.5) 0 13 0.5 – 33.0 0.03 *Fisher exact test p There are 24 patients treated with Ibandronate. 14 (58.3%), (95% CI 33.2-76.5) of them suffer from osteoporosis and 10 (43.7%), (95% CI 23.4-61.7) of osteopenia, no statistically significant difference between them, p = 0.9. Pacientà «t me Osteoporozà « kanà « njà « moshà « mesatare mà « tà « lartà « krahasuar me pacientà «t me Osteopeni, por pa ndryshim statistikisht tà « rà «ndà «sishà «m ndà «rmjet tyre (Man Whitney U=39.5, p=0.07). Pacientà «t me Osteoporozà « kanà « tà « njejtà «n gjatà «si mesatare me pacientet me Osteopeni, pa ndryshim statistikisht tà « rà «ndà «sishà «m ndermjet tyre (Man Whitney U=71.0, p=0.9) Grupmosha 60 – 69 vjeà § ka 3.7 herà « mà « tepà «r gjasa qà « tà « vuajà « nga Osteoporoza sesa grupmosha 50-59 vjeà §, por pa ndryshim sinjifikant ndà «rmjet tyre (OR=3.7; 95%CI 0.6–27.8; p=0.2). Grupmosha >70 vjeà § ka 13 herà « mà « tepà «r gjasa qà « tà « vuajà « nga osteoporoza sesa grupmosha 50-59 vjeà § me ndryshim sinjifikant ndà «rmjet tyre (OR=13; 95%CI 0.5–33.0; p=0.03). Pacientà «t me Osteopeni kanà « peshà « mesatare mà « tà « lartà « krahasuar me pacientà «t me Osteoporozà «, por pa ndryshim statistikisht tà « rà «ndà «sishà «m ndà «rmjet tyre (Man Whitney U=90.5, p=0.2) The change from baseline for Ibandronate group (N=24) The change from baseline is calculated: Table5 Osteoporosis n=14 Osteopenia n= 10 M (SD) min max M (SD) min max Mann-Whitney U p The change from baseline 7.3 (6.1) -0.5 – 17.3 3.3 (2.2) -1.3 – 6.3 43.0 0.1 Patients with osteoporosis have an average change from baseline higher compared with patients with osteopenia, no statistically significant difference between them (Man Whitney U = 43.0, p = 0.1) Comparison of change from baseline for patients with osteoporosis referring the two drugs. Table 6. Alendronate n=18 Ibandronate n= 14 M (SD) min max M (SD) min max Mann-Whitney U p The change from baseline 2.1 (4.5) -7.6 – 13.9 7.3 (6.1) -0.5 – 17.3 66.0 Chart 2. The change from baseline for patients with osteoporosis Pacientà «t me Osteoporozà « tà « mjekuar me medikamentin Ibandronat kanà « njà « ndryshim mesatar nga baseline mà « tà « lartà « krahasuar me pacientet e mjekuar me Alendronat, me ndryshim statistikisht tà « rà «ndesishà «m ndà «rmjet tyre (Man Whitney U=66.0, p Table 7. Percentages of the average change of BMD from baseline Total Osteoporosis Ostopenia Alendronate 1.83564848 2.081694 1.677476 Ibandronate 5.635355 7.27025 3.346503 Chart 3. Nga figura rezulton se efikasiteti i medikamentit ibandronat (5.6) à «shtà « dukshà «m mà « i lartà « se efikasiteti i medikamentit alendronat (1.8). Efikasiteti i medikamentit ibandronat tek pacientà «t me osteoporozà « (7.3) à «shtà « dukshà «m mà « i lartà « se efikasiteti i medikamentit alendronat (2.1). Efikasiteti i medikamentit ibandronat tek pacientà «t me osteoponi (3.3) à «shtà « mà « i lartà « se efikasiteti i medikamentit alendronat (1.7). Cost analysis We consider only direct costs such as: DXA scanner examinations, medical visits and medications costs (drugs and the supplements), according to a well-defined treatment protocol. In Albania, there is only one kind of ibandronate (only one brand) 150 mg / once a month, while there are lots of alendronate (different brands) 70 mg / 4 times per month, which we have called A1,A2,A3, A4,A5. We have calculated the costs of the only ibandronate and the costs of five types of alendronate, including the alendronate produced by a pharmaceuticals firm in the country, which has the lowest price in the market. In both cases the basic treatment is associated with calcium and vitamin D. Table 8 Annual Cost of treatment and cost of examination Nr Currency Quantity Cost Month Annual Costs 1 Diagnostics skaner DXA Lek1 1 4,000 4,000 Medical examination 1 1,000 1,000 2 Type of Alendronat 70mg A1 lek 4 3,410 12 40,920 A2 lek 4 2,093 12 25,116 A3 lek 4 3,301 12 39,612 A4 lek 4 4,102 12 49,224 A.5 (Albanian Product) lek 4 1,200 12 14,400 3 Ibandronat 150 mg lek 1 4,873 12 58,476 4 Calcium Carbonat 1000 mg + Colecalciferol 880 UI lek 30 1,019 12 12,228 Table 9 Cost of illness according the type of medications Type of Alendronat 1+2+4 Annual costs A1 lek 58,148 A2 lek 42,344 A3 lek 56,840 A4 lek 66,452 A5 lek 31,628 Type of Ibandronat 1+3+4 Annual costs I1 lek 75,704 The annual cost of the disease when treated with ibandronate is 2.4 times higher than the annual cost of treatment with alendronate the alendronate produced by a pharmaceuticals firm in the country, which has the lowest price in the market, respectivly 537[1] euro versus 226 euro per patient in alendronate group. Having all the annual costs and the efficiency for each drug, we can compare: Table 10 Name (Changes by baseline in %) Efficiency of alendronate 1.83565 Efficiency of ibandronate 5.63536 Table11 Type of treatment C/E Alendronate A1 31,677 A2 23,068 A3 30,965 A4 36,201 A5 17,230 Ibandronate 13,434 The analyse of cost per efficiency unit (Table 10) shows that in the case of ibandronate the value obtained is 13.434 units and in alendronate A1 case is 31.677 units. Discussion of results Patients with osteoporosis treated with Ibandronate, at our clinic in Tirana, have an average change from baseline higher compared with patients treated with Alendronate, with statistically significant difference between them (Man Whitney U = 66.0, p 16 The annual cost of the disease when treated with ibandronate is 1.3 times higher than the annual cost of treatment with alendronate A1 and 2.4 times higher than the annual cost of treatment with the alendronate produced by a pharmaceuticals firm in the country, which has the lowest price in the market. So as claimed, the cost for effectiveness unit is lower (about 2.3 times) in the case of ibandronate compared to alendronate A1. Well ibandronate results the most cost- effective. Ibandronate turns more cost effective than all other alendronate including the alendronate produced by a pharmaceuticals firm in the country, which has the lowest price in the market Literature Christiansen, C. (1993). 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