Monday, April 1, 2019
Ibandronate vs. Alendronate for Osteoporosis
Ibandronate vs. Alendronate for OsteoporosisCost-Effectiveness of Ibandronate vs. Alendronate employ in intercession of osteoporosis, in a specialized clinic in Tirana.Dr. Mirela Mirai1 Msc.Arlinda Demeti2 Prof.as Zamira Ylli3 Prof.Mira Ziishti3Prof.As Suela Kellii1 strength of Pharmacy, University of Medicine, Tirana.Bioparafarmacia FrancezeNeostyle ClinicAbstract Osteoporosis is a systemic skeletal sickness with a high gear prevalence. Biphosphonates ar medicaments which argon chosen for their efficacy in reducing conk out relative incidence, increase arise minginess and improving bone microarchitecture. The aim of the register is to evaluate the do minuteance of the drugs (ibandronate and alendronate) utilize in osteoporosis sermon, in post-menopausal women over the date of 50 yrs at a specialized clinic in Tirana to guess the yearly appeal of treatment of osteoporosis and to perform a follow effectiveness analyze.Methods Retrospective. The tolerants were on the whole female, in menopause or post menopause, with T-score -1 to -6, set with alendronate or ibandronate. The effectiveness is reason as the intermediate percentage of variety in bone mineral density (av. % of diverge in BMD) of year 2011 vs. 2010 service line. The yearly live of the treatment of osteoporosis according to the protocols and the address of the examination with DXA skim over (dual x-ray absorptiometry) were mensural. Fin aloney a comparison of the be-effectiveness was performed.ConclusionPatients with osteoporosis inured with Ibandronate, at our clinic in Tirana, have an average alter from baseline high compared with patients treated with Alendronate, with statistically significant disagreement amid them (Man Whitney U = 66.0, p The annual cost of the disease when treated with ibandronate is 1.3 clock higher than the annual cost of treatment with alendronate. Ibandronate is more cost effective than all other alendronate .Introduction Osteoporosis is a systemic skeletal disease characterized by poor bone mass and micro architectural deterioration of bone tissue, with a consequent increase in bone finesse and susceptibility to fractures (1)The mankind Health Organization defines osteoporosis as bone density 2.5 standard deviations (SDs) infra the recollect for young white adult women at lumbar spine, fem verbal neck or forearm. (2)Osteoporosis leads to nearly 9million fractures each year cosmopolitan and over 300,000patients with fragility fractures are registered in UK hospitals each year (British orthopedic Association, 2007).(3)Osteoporoza, sht nj smundje me nj prevalenc t lart edhe n Shqipri (7.28% e popullats dhe 9.6% tek femrat)4, e njjt me at t hasur pr astmn apo smundjet e zemrs ..Direct medical cost due(p) to fragility fractures in UK healthcare economy were estimated at 1.8billion in 2000, with the dominance to increase to 2.2billion by 2025 and the major part of these costs were related to pelvic girdle fra cture 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 patients bone mineral density (BMD), measured using dualX-ray absorptiometry, differs from the mean BMD of 30-years disused premenopausal women. Patients with T-score of between -1 and -2.5 SD are said to have osteoporosis.7,8Biphosphonates are medicaments which are chosen for their efficacy in reducing fracture incidence, increasing bone density and improving bone microarchitecture.9-15Top of FormMethods 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 exchange 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 erst monthly 150 mg oral ibandronate plus supplements (calcium, vitamine D) and once every week 70 mg alendronate (4 times per month) plus supplements (calcium, vitamine D). on that point are also included other at once costs such as the examination with DXA scan (dual x-ray absorptiometry) to place the diagnosis and the medical visits. Finally a comparison of the cost-effectiveness will be performed.Statistical AnalysisData were analyzed with SPSS 20 statistical package. It is used the non-parametric Man Whitney U test to compare the continuous variables, fisher direct test was used to compare proportions between variables and the the Odds Ratio OR for assessing the association between variables. Point appraisals are accompanied with interval estimation by 95 % CI. For continuous variables is presented the average, the standard deviation and the minimum and level best values. The level of statistical significance is defined at 005. Statistical tests are two-sided.duhet te shihet gjuha e perdorur, a qendron ne anglisht?Results of the conductIn 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 field of fracture among our patients.mesa 1 compares the frequency of pathologies (osteopenia and osteoporosis) in two groups of patients treated with alendronat or ibandronat.OsteoporosisOsteopeniaIbandronate1410Alendronate1828OR= 1.3 95%CI 0.5 4.2 p=0.4Your contribution will be used to improve translation gauge and may be shown to users anonymouslyContributeCloseThank you for your submission. crook 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 deliberateness of efficiencyWe 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 dataOsteoporosis n=18Osteopeni n= 28M (SD)min maxM (SD)min maxMann-Whitney UpT take a shit 2010-3.2 (0.7)-4.6 -2.5-1.9 (0.4)-2.4 -1.1507.0T Score 2011-3.1 (0.8)-4.7 -2.2-1.8 (0.6)-2.4 -1.1515.5Age, yrs61.2 (8.0)51.0 79.059.1 (7.8)51.0 81.0223.50.3Height, m1.5 (0.05)1.4 1.61.5 (0.07)1.4 1.7304.50.3Weight, kg58.8 (8.3)46.0 73.068.6 (11.1)51.0 95.0376.50.01*Age-Group, yrsn (%)n (%)OR(95% CI)50 -59 yrs8 (17)19 (41)60 -69 yrs7 (15.2)6 (13.0)1.60.4 6.70.470 yrs3 (7)3 (7)2.80.4 25.20.3*Fisher exact test p=0.3There 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 = 0.9Grupmosha 60 69 vje ka 1.6 her m tepr gjasa q t vuajn nga Osteoporoza sesa grupmosha 50-59 vje, por pa ndryshim sinjifikant ndrmjet tyre (OR=1.6 95%CI 0.46.7 p=0.4)Grupmosha 70 vje ka 2.8 her m tepr gjasa q t vuajn nga osteoporoza sesa grupmosha 50-59 vje, por pa ndryshim sinjifikant ndrmjet tyre (OR=2.8 95%CI 0.425.2 p=0.3)Pacientet me Osteopeni kan pesh mesatare m t lart krahasuar me pacientt me Osteoporoz, me ndryshim statistikisht t rndsishm ndrmjet tyre (Man Whitney U=376.5, p=0.01)Pacientt me Osteoporoz kan t njjtn gjatsi mesatare me pacientt me Osteopeni, pa ndryshim statistikisht t rndesishm ndrmjet tyre (Man Whitney U=304.5, p=0.3).The change from baseline for Alendronate groupThe change from baseline is calculatedTable 3Osteoporosis n=18Osteopenia n= 28M (SD)min maxM (SD)min maxMann-Whitney UpThe change frombaseline2.1 (4.5)-7.6 13.91.7 (6.2)-23 11.1316.00.2Patients 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 dataOsteoporosis n=14Osteopeni n= 10M (SD)min maxM (SD)min maxMann-Whitney UpT Score 2010-3.7 (0.7)-5.0 -2.7-1.8 (0.3)-2.2 -1.4140.0T Score 2011-3.2 (0.8)-4.4 -1.7-1.5 (0.4)-2.1 -1.0134.5Age yrs64.3 (7.3)53.0 77.059.1 (5.0)53.0 68.039.50.07Height (m)1.5 (0.05)1.4 1.61.5 (0.06)1.4 1.671.00.9Weight66.2 (10.9)47.0 84.070.7 (7.1)65.0 82.090.50.2*Age-group, yrsn (%)n (%)OR(95% CI)50 -59 yrs3 (12.5)6 (25.0)60 -69 yrs8 (33.3)4 (16.7)3.70.6 27.80.270 yrs3 (12.5)0130.5 33.00.03*Fisher exact test pThere 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.Pacientt me Osteoporoz kan nj mosh mesatare m t lart krahasuar me pacientt me Osteopeni, por pa ndryshim statistikisht t rndsishm nd rmjet tyre (Man Whitney U=39.5, p=0.07). Pacientt me Osteoporoz kan t njejtn gjatsi mesatare me pacientet me Osteopeni, pa ndryshim statistikisht t rndsishm ndermjet tyre (Man Whitney U=71.0, p=0.9)Grupmosha 60 69 vje ka 3.7 her m tepr gjasa q t vuaj nga Osteoporoza sesa grupmosha 50-59 vje, por pa ndryshim sinjifikant ndrmjet tyre (OR=3.7 95%CI 0.627.8 p=0.2).Grupmosha 70 vje ka 13 her m tepr gjasa q t vuaj nga osteoporoza sesa grupmosha 50-59 vje me ndryshim sinjifikant ndrmjet tyre (OR=13 95%CI 0.533.0 p=0.03).Pacientt me Osteopeni kan pesh mesatare m t lart krahasuar me pacientt me Osteoporoz, por pa ndryshim statistikisht t rndsishm ndrmjet tyre (Man Whitney U=90.5, p=0.2)The change from baseline for Ibandronate group (N=24)The change from baseline is calculatedTable5Osteoporosis n=14Osteopenia n= 10M (SD)min maxM (SD)min maxMann-Whitney UpThe change frombaseline7.3 (6.1)-0.5 17.33.3 (2.2)-1.3 6.343.00.1Patients 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.Alendronaten=18Ibandronaten= 14M (SD)min maxM (SD)min maxMann-Whitney UpThe change frombaseline2.1 (4.5)-7.6 13.97.3 (6.1)-0.5 17.366.0Chart 2. The change from baseline for patients with osteoporosisPacientt me Osteoporoz t mjekuar me medikamentin Ibandronat kan nj ndryshim mesatar nga baseline m t lart krahasuar me pacientet e mjekuar me Alendronat, me ndryshim statistikisht t rndesishm ndrmjet tyre (Man Whitney U=66.0, pTable 7. Percentages of the average change of BMD from baselineTotalOsteoporosisOstopeniaAlendronate1.835648482.0816941.677476Ibandronate5.6353557.270253.346503Chart 3.Nga figura rezulton se efikasiteti i medikamentit ibandronat (5.6) sht dukshm m i lart se efikasiteti i medikamentit alendronat (1.8). Efikasiteti i medikamentit ibandronat tek pacientt me osteoporoz (7.3) sht dukshm m i lart se efikasiteti i medikamentit alendronat (2.1). Efikasiteti i medikamentit ibandronat tek pacientt me osteoponi (3.3) sht m i lart se efikasiteti i medikamentit alendronat (1.7).Cost analysisWe consider just 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 just one kind of ibandronate ( only when 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 last(a) price in the market. In both cases the basic treatment is associated with calcium and vitamin D.Table 8 one-year Cost of treatment and cost of examinationNrCurre ncyQuantityCostMonthAnnual be1Diagnosticsskaner DXALek114,0004,000Medical examination11,0001,0002 character of Alendronat 70mgA1lek43,4101240,920A2lek42,0931225,116A3lek43,3011239,612A4lek44,1021249,224A.5 (Albanian Product)lek41,2001214,4003Ibandronat 150 mglek14,8731258,4764Calcium Carbonat 1000 mg + Colecalciferol 880 UIlek301,0191212,228Table 9 Cost of illness according the type of medicationsType of Alendronat1+2+4Annual costsA1lek58,148A2lek42,344A3lek56,840A4lek66,452A5lek31,628Type of Ibandronat1+3+4Annual costsI1lek75,704The 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 5371 euro versus 226 euro per patient in alendronate group.Having all the annual costs and the efficiency for each drug, we can compareTable 10Name(Changes by baseline in %) readiness of alendronate1.83565Ef ficiency of ibandronate5.63536Table11Type of treatmentC/EAlendronateA131,677A223,068A330,965A436,201A517,230Ibandronate13,434The 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 resultsPatients 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 16The 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 marketLiteratureChristiansen, C. (1993). Consensus development congregation diagnosis, prophylaxis,and treatment of osteoporosis. Am J Med 9464650.Kanis, J.A. (1994). Assessment of Fracture hazard and its Application to Screening forPostmenopausal Osteoporosis. Report of a WHO Study Group. Geneva field HealthOrganization.Johnell O, Kanis JA (2006) An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporosis International 17 172633.Dorina Ruco,(Dhjetor 2011) Osteoporoza n qytetin e TiransBritish Orthopaedic Association (2007).The care of patients with fragility fracture.Burge RT, Worley D, Johansen A, et al. The cost of osteoporotic fractures in the UK projections for 20002020. 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