The potential impact of new effervescent alendronate formulation on compliance and persistence in osteoporosis treatment

Cauley JA, Thompson DE, Ensrud KC, Scott JC, Black D (2000) Risk of mortality following clinical fractures. Osteoporosis Int 11:556–561 Johnell O, Kanis JA, Odén A, Sernbo I, Redlund-Johnell I, Petterson C, De Laet C, Jönsson B (2004) Mortality after osteoporotic fractures. Osteoporosis Int 15(1):38–42 Johnell O, Kanis JA (2006) An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporosis Int 17(12):1726–1733 Kanis JA, Reginster JY, Kaufman JM, Ringe JD, Adachi JD, Hiligsmann M, Rizzoli R, Cooper C (2012) A reappraisal of generic bisphosphonates in osteoporosis. Osteoporos Int 23:213–221 Kanis JA, McCloskey EV, Johansson H, Strom O, Borgstrom F, Oden A (2009) How to decide who to treat. Best Pract Res Clin Rheumatol 23(6):711–726 Marcus R, Wong M, Heath H 3rd, Stock JL (2002) Antiresorptive treatment of postmenopausal osteoporosis: comparison of study designs and outcomes in large clinical trials with fracture as an endpoint. Endocrine Rev 23:16–37 Siris ES, Selby PL, Saag KG, Borgström F, Herings RM, Silverman SL (2009) Impact of osteoporosis treatment adherence on fracture rates in North America and Europe. Am J Med 122(2 Suppl):S3–S13 Cranney A, Guyatt G, Griffith L, Wells G, Tugwell P, Rosen C; Osteoporosis Methodology Group and The Osteoporosis Research Advisory Group (2002) Meta-analyses of therapies for postmenopausal osteoporosis. IX: summary of meta-analyses of therapies for postmenopausal osteoporosis. Endocr Rev 23:570–578 Siris ES, Harris ST, Rosen CJ, Barr CE, Arvesen JN, Abbott TA, Silverman S (2006) Adherence to bisphosphonate therapy and fracture rates in osteoporotic women: relationship to vertebral and nonvertebral fractures from 2 US claims databases. Mayo Clin Proc 81:1013–1022 Kayser J, Ettinger B, Pressman A (2001) Postmenopausal hormonal support: discontinuation of raloxifene versus estrogen. Menopause 8:328–332 Gallagher AM, Rietbrock S, Olson M, van Staa TP (2008) Fracture outcomes related to persistence and compliance with oral bisphosphonates. J Bone Miner Res 23:1569–1575 Yood RA, Emani S, Reed Jl, Reed JI, Lewis BE, Charpentier M, Lydick E (2003) Compliance with pharmacologic therapy for osteoporosis. Osteoporos Int 14:965–968 McCombs JS, Thiebaud P, McLaughlin-Miley C, Shi J (2004) Compliance with drug therapies for the treatment and prevention of osteoporosis. Maturitas 15;48(3):271-87 Adachi JD, Adami S, Miller PD, Olszynski WP, Kendler DL, Silverman SL, Licata AA, Li Z, Gomez-Panzani E (2001) Tolerability of risedronate in post-menopausal women intolerant of alendronate. Aging 13(5):347–354 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202344s000ltr.pdf Briesacher BA, Andrade SE, Fouayzi H, Chan KA (2008) Comparison of drug adherence rates among patients with seven different medical conditions. Pharmacotherapy. 28:437–443 Rabenda V, Hiligsmann M, Reginster JY (2009) Poor adherence to oral bisphosphonate treatment and its consequences: a review of the evidence. Expert Opin Pharmacother 10(14):2303–2315 De Groen PC, Lubbe DF, Hirsch LJ, Daifotis A, Stephenson W, Freedholm D, Pryor-Tillotson S, Seleznick MJ, Pinkas H, Wang KK (1996) Esophagitis associated with the use of alendronate. N Engl J Med 3;335(14):1016–1021 Peter CP, Handt LK, Smith SM (1998) Esophageal irritation due to alendronate sodium tablets possible mechanisms. Dig Dis Sci 43(9):1998–2002 Varenna M, Bertoldo F, Di Monaco M et al (2013) Il profilo di sicurezza per i farmaci per il trattamento dell’osteoporosi. Revisione critica della letteratura. Reumatismo 65(4):143–166 Perkinks AC, Blackshaw E, Hay PD et al (2008) Esophageal transit and in vivo disintegration of branded risedronate sodium tablets and two generic formulations of alendronic acid tablets: a single-center single-blind, six-period crossover study in healthy female subjects. Clin Ther 30(5):834–844 Abraham SC, Cruz-Correa M, Lee L, Yardley JH, Wu TT (1999) Alendronate-associated esophageal injury: pathologic and endoscopic features. Mod Pathol 12:1152–1157 Argenzio RA, Eisemann J (1996) Mechanisms of acid injury in porcine gastroe-sophageal mucosa. Am J Vet Res 57:564–573 Barbosa CD, Balp MM, Kulich K et al (2012) A literature review to explore the link between treatment satisfaction and adherence, compliance, and persistence. Patient Prefer Adherence 6:39–48 Fleisch H, Russell RGG, Bisaz S, Casey PA, Mtihlbaner RC (1968) The influence of pyrophosphate analogues (diphosphonates) on the precipitation and dissolution of calcium phosphate in vitro and in vivo. Calcif Tissue Res 2(suppl):10–10A Fleisch H, Russell RGG (1970) Pyrophosphate and polyphosphate. In: Encyclopaedia (Int.) of pharmacology and therapeutics Section S l: Pharmacology of the endocrine system and related drugs, Pergamon, New York, 61–100 Fleisch H, Russell RGG, Straumann F (1966) Effect of pyrophosphonate on bydroxyapatite and its implications in calcium homeostasis. Nature 212:901–903 Lin JH (1996) Bisphosphonates: a review of their pharmacokinetic properties. Bone 18(2):75–85 Tosteson AN, Grove, Hammond CS, Moncur MM, Ray GT, Hebert GM, Pressman AR, Ettinger B (2003) Early discontinuation of treatment for osteoporosis. Am J Med 15(115(3)):209–216 Gertz BJ, Holland SD, Kline WF, Matuszewski BK, Porras AG (1993) Clinical pharmacology of alendronate sodium. Osteopor Int 3(suppl. 3):513–516 Spivacow FR, Zanchetta JR, Kerzberg EM, Frigeri A, Fiasche R (1996) Tolerability of oral pamidronate in elderly patients with osteoporosis and other bone diseases. Curr Ther Res 57:123–130 Twist IM, Pas O, Ramp-Koopmanschap W, Den Hartigh J, Vermeij P (1999) The effects of nitrogen-containing bisphosphonates on human epithelial (Caco-2) cells, an in vitro model for intestinal epithelium. J Bone Miner Res 14:784–791 Saunders RL Jr (1997) Appearance of a gastric ulcer during diphosphonate therapy in a woman with CRST syndrome. South Med J 70(11):1327–1329 Lufkin EG, Argueta R, Whitaker MD, Cameron AL, Wong V, Egan KS, O’Fallon WM, Riggs BL (1994) Pamidronate: an unrecognized problem in gastrointestinal tolerability. Osteoporosis Int 4(6):320–322 Reginster JYL (1992) Oral tiludronate: pharmacological properties and potential usefulness in Paget’s disease of bone and osteoporosis. Bone 13(5):351–354 Chesnut CH 3rd, McClung MR, Ensrud KE, Bell NH, Genant HK, Harris ST, Singer FR, Stock JL, Yood RA, Delmas PD (1995) Alendronate treatment of the postmenopausal osteoporotic woman: effect of multiple dosages on bone mass and bone remodeling. Am J Med 99:144–152 Abid S, Mumtaz K, Jafri W, Hamid S, Abbas Z, Shah HA, Khan AH (2005) Pill-induced esophageal injury: endoscopic features and clinical outcomes. Endoscopy 37(8):740–744 Olovson GS, Bjorkman JA, Ek L, Hauu N (1983) The ulcerogenic effect on the esophagus of three b-adrenoceptor antagonists, investigated in a new porcine esophagus test model. Acta Pharmacol Toxicol (Copenh). 53(5):385–391 Bozymski EM, Isaacs KL (1995) Medications reported to cause esophageal damage. In: Yamada T (ed) Textbook of gastroenterology, vol 1, 2nd edn. JB Lippincott, Philadelphia, pp 1283–1301 Castell DO (1996) “pill esophagitis”—the case of alendronate. N Engl J Med 3(335(14)):1058–1059 Blank MA, Gibson GW, Myers WR, Dierckman TA, Phipps RJ, Smith PN (2000) Gastric damage in the rat with nitrogen-containing bisphosphonates depends on pH. Aliment Pharmacol Ther 14(9):1215–1223 Aihara E, Hayashi S, Amagase K, Kato S, Takeuchi K (2007) Prophylactic effect of rebamipide against the irritative and healing impairment actions of alendronate in rat stomachs. Inflammopharmacology 15(5):196–202 Sener G, Kapucu C, Cetinel S, Cikler E, Ayanoğlu-Dülger G (2005) Gastroprotective effect of leukotriene receptor blocker montelukast in alendronat-induced lesions of the rat gastric mucosa. Prostaglandins Leukot Essent Fatty Acids 72(1):1–11 Sener G, Sehirli O, Cetinel S, Midillioğlu S, Gedik N, Ayanoğlu-Dülger G (2005) Protective effect of taurine against alendronate-induced gastric damage in rats. Fundam Clin Pharmacol 19(1):93–100 Sener G, Goren FO, Ulusoy NB, Ersoy Y, Arbak S, Dülger GA (2005) Protective effect of melatonin and omeprazole against alendronate-induced gastric damage. Dig Dis Sci 50(8):1506–1512 Ohashi Y, Aihara E, Takasuka H, Takahashi K, Takeuchi K (2009) Antral ulcers induced by alendronate, a nitrogen-containing bisphophonate, in rat stomachs-prophylactic effect of rebamipide. J Physiol Pharmacol 60(3):85–93 Takeuchi K, Kato S, Amagase K (2011) Gastric ulcerogenic and healing impairment actions of alendronate, a nitrogen-containing bisphosphonate-prophylactic effects of rebamipide. Curr Pharm Des 17(16):1602–1611 Pytlik M, Cegieła U, Folwarczna J, Nowińska B (2012) Proton pump (H+/K+-ATPase) inhibitors weaken the protective effect of alendronate on bone mechanical properties in estrogen-deficient rats. Pharmacol Rep 64(3):625–634 Katsumi H, Takashima M, Sano J, Nishiyama K, Kitamura N, Sakane T, Hibi T, Yamamoto A (2011) Development of polyethylene glycol-conjugated alendronate, a novel nitrogen-containing bisphosphonate derivative: evaluation of absorption, safety, and effects after intrapulmonary administration in rats. J Pharm Sci 100(9):3783–3792 Gomez Acotto C, Antonelli C, Flynn D, McDaid D, Roldan EJ (2012) Upper gastrointestinal tract transit times of tablet and drinkable solution formulations of alendronate: a bioequivalence and a quantitative, randomized study using video deglutition. Calcif Tissue Int 91(5):325–334 Hodges LA, Connolly SM, Winter J, Schmidt T, Stevens HNE, Hayward M, Wilson CG (2012) Modulation of gastric pH by a buffered soluble effervescent formulation: a possible means of improving gastric tolerability of alendronate. Int J Pharm 432:57–62