Possible link between proton pump inhibitors and increase of bone fractures and risk of bacterial infection
Each year, 113.4 million prescriptions for proton pump inhibitors (PPIs) are filled in the United States, making this class of drugs, the third highest seller at $13.9 billion in sales. PPIs have demonstrated efficacy for treatment of erosive and ulcerative esophagitis, Barrett esophagus, Zollinger-Ellison syndrome, and gastroesophageal reflux disease (GERD), as well as for short-term treatment of ulcer disease, as part of a combination regimen for Helicobacter pylori eradication and for prevention of ulcers due to nonsteroidal anti-inflammatory drugs. These indications, however, do not account for more than a hundred million prescriptions, which is supported by evidence that PPIs have been shown to be overprescribed, where between 53% and 69% of PPI prescriptions are prescribed off-label.
Recent research published in the Archives of Internal Medicine (Arch Intern Med. 2010;170(9):747-748), demonstrated (PPIs) increase the risk of bone fractures in older woman and are also associated with an increased risk of Clostridium difficile (C. difficile) infection.
In one study, data was analyzed on 161, 806 women aged 50 to 79 without a history of hip fracture enrolled in the Women's Health Initiative. After eight years, 21, 247 bone fractures were observed. Women who were on PPIs had 47% increased risk of spinal fracture, 26% increased risk for forearm or wrist fracture, and 25% increased risk of total fractures, compared to women who did not take PPIs. However, the use of PPIs was not associated with an increased risk of hip fracture and only a minimal effect on bone mineral density was observed over three years.
Another study examined the records of 101,796 patients discharged from a Massachusetts hospital between 2004 and 2008. The study demonstrated that patients treated with PPIs had 74% increase of C. difficile infections compared with those not taking the drugs. In addition, a different study on 1,200 patients treated for the bacterial infection demonstrated a 42% increased risk of recurrent infection in patients taking PPIs compared to those not taking the drugs. According to researcher Michael Howell, it appears that the acidity of the stomach may confer immunity to C. difficile, and suppressing the acidity with PPIs, increases the risk of C. difficile infection.
The results of these studies suggest that although PPIs do work, PPI-related adverse effects may outweigh the benefits for some patients and should be used with caution. Further research through prospective, controlled studies is necessary to establish a link between PPIs and fractures, and PPIs and C. difficile infections.
Reference
Katz MH. LESS IS MORE: Failing the Acid Test. Benefits of Proton Pump Inhibitors May Not Justify the Risks for Many Users. Arch Intern Med. 2010;170(9):747-748.
Related Articles
Grady D and Redberg RF. Less Is More: How Less Health Care Can Result in Better Health. Arch Intern Med. 2010;170(9):749-750.
Gray SL, LaCroix AZ, Larson J, et al. Proton Pump Inhibitor Use, Hip Fracture, and Change in Bone Mineral Density in Postmenopausal Women: Results From the Women's Health Initiative. Arch Intern Med. 2010;170(9):765-771.
Howell MD, Novack V, Grgurich P, et al. Iatrogenic Gastric Acid Suppression and the Risk of Nosocomial Clostridium difficile Infection. Arch Intern Med. 2010;170(9):784-790.
Linsky A, Gupta K, Lawler EV, Fonda JR, Hermos JA. Proton Pump Inhibitors and Risk for Recurrent Clostridium difficile Infection. Arch Intern Med. 2010;170(9):772-778.
Wang C-H, Ma M H-M, Chou H-C, Yen Z-S, et al. High-Dose vs Non–High-Dose Proton Pump Inhibitors After Endoscopic Treatment in Patients With Bleeding Peptic Ulcer: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Arch Intern Med. 2010;170(9):751-758.
Yachimski PS, Farrell EA, Hunt DP, Reid AE. Proton Pump Inhibitors for Prophylaxis of Nosocomial Upper Gastrointestinal Tract Bleeding: Effect of Standardized Guidelines on Prescribing Practice. Arch Intern Med. 2010;170(9):779-783.
Each year, 113.4 million prescriptions for proton pump inhibitors (PPIs) are filled in the United States, making this class of drugs, the third highest seller at $13.9 billion in sales. PPIs have demonstrated efficacy for treatment of erosive and ulcerative esophagitis, Barrett esophagus, Zollinger-Ellison syndrome, and gastroesophageal reflux disease (GERD), as well as for short-term treatment of ulcer disease, as part of a combination regimen for Helicobacter pylori eradication and for prevention of ulcers due to nonsteroidal anti-inflammatory drugs. These indications, however, do not account for more than a hundred million prescriptions, which is supported by evidence that PPIs have been shown to be overprescribed, where between 53% and 69% of PPI prescriptions are prescribed off-label.
Recent research published in the Archives of Internal Medicine (Arch Intern Med. 2010;170(9):747-748), demonstrated (PPIs) increase the risk of bone fractures in older woman and are also associated with an increased risk of Clostridium difficile (C. difficile) infection.
In one study, data was analyzed on 161, 806 women aged 50 to 79 without a history of hip fracture enrolled in the Women's Health Initiative. After eight years, 21, 247 bone fractures were observed. Women who were on PPIs had 47% increased risk of spinal fracture, 26% increased risk for forearm or wrist fracture, and 25% increased risk of total fractures, compared to women who did not take PPIs. However, the use of PPIs was not associated with an increased risk of hip fracture and only a minimal effect on bone mineral density was observed over three years.
Another study examined the records of 101,796 patients discharged from a Massachusetts hospital between 2004 and 2008. The study demonstrated that patients treated with PPIs had 74% increase of C. difficile infections compared with those not taking the drugs. In addition, a different study on 1,200 patients treated for the bacterial infection demonstrated a 42% increased risk of recurrent infection in patients taking PPIs compared to those not taking the drugs. According to researcher Michael Howell, it appears that the acidity of the stomach may confer immunity to C. difficile, and suppressing the acidity with PPIs, increases the risk of C. difficile infection.
The results of these studies suggest that although PPIs do work, PPI-related adverse effects may outweigh the benefits for some patients and should be used with caution. Further research through prospective, controlled studies is necessary to establish a link between PPIs and fractures, and PPIs and C. difficile infections.
Reference
Katz MH. LESS IS MORE: Failing the Acid Test. Benefits of Proton Pump Inhibitors May Not Justify the Risks for Many Users. Arch Intern Med. 2010;170(9):747-748.
Related Articles
Grady D and Redberg RF. Less Is More: How Less Health Care Can Result in Better Health. Arch Intern Med. 2010;170(9):749-750.
Gray SL, LaCroix AZ, Larson J, et al. Proton Pump Inhibitor Use, Hip Fracture, and Change in Bone Mineral Density in Postmenopausal Women: Results From the Women's Health Initiative. Arch Intern Med. 2010;170(9):765-771.
Howell MD, Novack V, Grgurich P, et al. Iatrogenic Gastric Acid Suppression and the Risk of Nosocomial Clostridium difficile Infection. Arch Intern Med. 2010;170(9):784-790.
Linsky A, Gupta K, Lawler EV, Fonda JR, Hermos JA. Proton Pump Inhibitors and Risk for Recurrent Clostridium difficile Infection. Arch Intern Med. 2010;170(9):772-778.
Wang C-H, Ma M H-M, Chou H-C, Yen Z-S, et al. High-Dose vs Non–High-Dose Proton Pump Inhibitors After Endoscopic Treatment in Patients With Bleeding Peptic Ulcer: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Arch Intern Med. 2010;170(9):751-758.
Yachimski PS, Farrell EA, Hunt DP, Reid AE. Proton Pump Inhibitors for Prophylaxis of Nosocomial Upper Gastrointestinal Tract Bleeding: Effect of Standardized Guidelines on Prescribing Practice. Arch Intern Med. 2010;170(9):779-783.
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