Sherry Boschert

LONG BEACH, CALIF. — The inability to prescribe controlled substances electronically is slowing adoption of electronic prescribing, but financial incentives could make it worthwhile for physicians who see patients covered by Medicare to start “e-prescribing” now if they can, a consultant said.

The Centers for Medicare and Medicaid Services in 2009 began offering Medicare physicians, nurse practitioners, and physician assistants a 2% bonus in payments for participation in its electronic prescribing incentives program for 2009-2010. The bonus for early adopters of e-prescribing drops to 1% in 2011-2012 and 0.5% in 2013, Rachelle F. Spiro said at the annual meeting of the American Medical Directors Association.

The early e-prescriber incentives were extended to long-term care settings this year. The incentives are not yet available for non-Medicare e-prescribers.”

“Here's the hard part,” she added: Physicians who do not successfully adopt e-prescribing by 2012 will see a 1% reduction in Medicare payments for that year, a 1.5% drop for 2013, and a 2% reduction for 2014 and each subsequent year. The Department of Health and Human Services may exempt physicians with hardships, on a case-by-case basis only.

The Drug Enforcement Agency (DEA) does not allow controlled substances to be electronically prescribed, however, which “has hindered the adoption of electronic prescribing,” said Ms. Spiro, a pharmacist and consultant based in Las Vegas. “We've been told that CMS will be working with the DEA to put out final rules for electronic prescribing” of controlled substances, she said. Only a few days after she spoke, the agency published a proposed rule to that effect.

A pilot program for e-prescribing of controlled substances was conducted in Massachusetts, but not in long-term care settings.

Physicians do not need to preregister for the CMS e-prescribing incentive program and do not need to participate in the Physician Quality Reporting Initiative to participate, Ms. Spiro said.

Instructions and examples of how to submit claims under the e-prescribing incentive program are available on the CMS Web site at www.cms.hhs.gov/ERxIncentiveqnetsupport@sdps.org

Physicians can use their facility's electronic health records (EHR) system to send a prescription and to document it in the medical record, then bill for the incentive in much the same way they already handle billing.

Or physicians can turn to certified practice management systems that have an e-prescribing component or to stand-alone e-prescribing systems, if they come from an entity on the CMS list of qualified EHR vendors, she advised. She warned that prescriptions from these two types of systems generally go directly to the pharmacy and not necessarily to the nursing home, “so you're going to have to work out some other mechanism to get that communication to the facility.”

To file claims in the e-prescribing incentives program, report the e-prescribing numerator G-code G8553 to denote that at least one prescription was created during the patient encounter that was transmitted using a qualified e-prescribing system. Report the G-code on the same claim as the denominator billing code for the same beneficiary and the same date of service. Submit the e-prescribing G-code with a line-item charge of zero dollars ($0.00).

Denominator billing codes for e-prescribing include codes for services in nursing facilities (99304-99310 and 99315-99316), home visits (99341-99350), and others including domiciliary codes (99324-99328, 99334-99337, and 99346).

As of 2011, Medicare will be offering incentives for physicians in hospitals and ambulatory settings to switch all of their records to EHR, but these incentives won't be available to long-term and post–acute care settings until 2013, Ms. Spiro said. Physicians must choose between the Medicare e-prescribing incentives and complete EHR incentives programs and cannot participate in both (because presumably the EHR would include an e-prescribing component).

However, the same Health Information Technology for Economic and Clinical Health Act that established the EHR incentives included a provision for state Medicaid programs to incentivize early adoption of e-prescribing. “Actually, those incentives are a lot better” than Medicare incentives, she said. Physicians in long-term care settings who see patients covered by Medicare and Medicaid may want to participate in both e-prescribing early-adopter programs rather than wait for the 2013 EHR incentives under Medicare.

For the long-term care setting, that's “probably a better value,” said Ms. Spiro. She reported having no relevant conflicts of interest.

LONG BEACH, CALIF. — The inability to prescribe controlled substances electronically is slowing adoption of electronic prescribing, but financial incentives could make it worthwhile for physicians who see patients covered by Medicare to start “e-prescribing” now if they can, a consultant said.

The Centers for Medicare and Medicaid Services in 2009 began offering Medicare physicians, nurse practitioners, and physician assistants a 2% bonus in payments for participation in its electronic prescribing incentives program for 2009-2010. The bonus for early adopters of e-prescribing drops to 1% in 2011-2012 and 0.5% in 2013, Rachelle F. Spiro said at the annual meeting of the American Medical Directors Association.

The early e-prescriber incentives were extended to long-term care settings this year. The incentives are not yet available for non-Medicare e-prescribers.”

“Here's the hard part,” she added: Physicians who do not successfully adopt e-prescribing by 2012 will see a 1% reduction in Medicare payments for that year, a 1.5% drop for 2013, and a 2% reduction for 2014 and each subsequent year. The Department of Health and Human Services may exempt physicians with hardships, on a case-by-case basis only.

The Drug Enforcement Agency (DEA) does not allow controlled substances to be electronically prescribed, however, which “has hindered the adoption of electronic prescribing,” said Ms. Spiro, a pharmacist and consultant based in Las Vegas. “We've been told that CMS will be working with the DEA to put out final rules for electronic prescribing” of controlled substances, she said. Only a few days after she spoke, the agency published a proposed rule to that effect.

A pilot program for e-prescribing of controlled substances was conducted in Massachusetts, but not in long-term care settings.

Physicians do not need to preregister for the CMS e-prescribing incentive program and do not need to participate in the Physician Quality Reporting Initiative to participate, Ms. Spiro said.

Instructions and examples of how to submit claims under the e-prescribing incentive program are available on the CMS Web site at www.cms.hhs.gov/ERxIncentiveqnetsupport@sdps.org

Physicians can use their facility's electronic health records (EHR) system to send a prescription and to document it in the medical record, then bill for the incentive in much the same way they already handle billing.

Or physicians can turn to certified practice management systems that have an e-prescribing component or to stand-alone e-prescribing systems, if they come from an entity on the CMS list of qualified EHR vendors, she advised. She warned that prescriptions from these two types of systems generally go directly to the pharmacy and not necessarily to the nursing home, “so you're going to have to work out some other mechanism to get that communication to the facility.”

To file claims in the e-prescribing incentives program, report the e-prescribing numerator G-code G8553 to denote that at least one prescription was created during the patient encounter that was transmitted using a qualified e-prescribing system. Report the G-code on the same claim as the denominator billing code for the same beneficiary and the same date of service. Submit the e-prescribing G-code with a line-item charge of zero dollars ($0.00).

Denominator billing codes for e-prescribing include codes for services in nursing facilities (99304-99310 and 99315-99316), home visits (99341-99350), and others including domiciliary codes (99324-99328, 99334-99337, and 99346).

As of 2011, Medicare will be offering incentives for physicians in hospitals and ambulatory settings to switch all of their records to EHR, but these incentives won't be available to long-term and post–acute care settings until 2013, Ms. Spiro said. Physicians must choose between the Medicare e-prescribing incentives and complete EHR incentives programs and cannot participate in both (because presumably the EHR would include an e-prescribing component).

However, the same Health Information Technology for Economic and Clinical Health Act that established the EHR incentives included a provision for state Medicaid programs to incentivize early adoption of e-prescribing. “Actually, those incentives are a lot better” than Medicare incentives, she said. Physicians in long-term care settings who see patients covered by Medicare and Medicaid may want to participate in both e-prescribing early-adopter programs rather than wait for the 2013 EHR incentives under Medicare.

For the long-term care setting, that's “probably a better value,” said Ms. Spiro. She reported having no relevant conflicts of interest.

LONG BEACH, CALIF. — The inability to prescribe controlled substances electronically is slowing adoption of electronic prescribing, but financial incentives could make it worthwhile for physicians who see patients covered by Medicare to start “e-prescribing” now if they can, a consultant said.

The Centers for Medicare and Medicaid Services in 2009 began offering Medicare physicians, nurse practitioners, and physician assistants a 2% bonus in payments for participation in its electronic prescribing incentives program for 2009-2010. The bonus for early adopters of e-prescribing drops to 1% in 2011-2012 and 0.5% in 2013, Rachelle F. Spiro said at the annual meeting of the American Medical Directors Association.

The early e-prescriber incentives were extended to long-term care settings this year. The incentives are not yet available for non-Medicare e-prescribers.”

“Here's the hard part,” she added: Physicians who do not successfully adopt e-prescribing by 2012 will see a 1% reduction in Medicare payments for that year, a 1.5% drop for 2013, and a 2% reduction for 2014 and each subsequent year. The Department of Health and Human Services may exempt physicians with hardships, on a case-by-case basis only.

The Drug Enforcement Agency (DEA) does not allow controlled substances to be electronically prescribed, however, which “has hindered the adoption of electronic prescribing,” said Ms. Spiro, a pharmacist and consultant based in Las Vegas. “We've been told that CMS will be working with the DEA to put out final rules for electronic prescribing” of controlled substances, she said. Only a few days after she spoke, the agency published a proposed rule to that effect.

A pilot program for e-prescribing of controlled substances was conducted in Massachusetts, but not in long-term care settings.

Physicians do not need to preregister for the CMS e-prescribing incentive program and do not need to participate in the Physician Quality Reporting Initiative to participate, Ms. Spiro said.

Instructions and examples of how to submit claims under the e-prescribing incentive program are available on the CMS Web site at www.cms.hhs.gov/ERxIncentiveqnetsupport@sdps.org

Physicians can use their facility's electronic health records (EHR) system to send a prescription and to document it in the medical record, then bill for the incentive in much the same way they already handle billing.

Or physicians can turn to certified practice management systems that have an e-prescribing component or to stand-alone e-prescribing systems, if they come from an entity on the CMS list of qualified EHR vendors, she advised. She warned that prescriptions from these two types of systems generally go directly to the pharmacy and not necessarily to the nursing home, “so you're going to have to work out some other mechanism to get that communication to the facility.”

To file claims in the e-prescribing incentives program, report the e-prescribing numerator G-code G8553 to denote that at least one prescription was created during the patient encounter that was transmitted using a qualified e-prescribing system. Report the G-code on the same claim as the denominator billing code for the same beneficiary and the same date of service. Submit the e-prescribing G-code with a line-item charge of zero dollars ($0.00).

Denominator billing codes for e-prescribing include codes for services in nursing facilities (99304-99310 and 99315-99316), home visits (99341-99350), and others including domiciliary codes (99324-99328, 99334-99337, and 99346).

As of 2011, Medicare will be offering incentives for physicians in hospitals and ambulatory settings to switch all of their records to EHR, but these incentives won't be available to long-term and post–acute care settings until 2013, Ms. Spiro said. Physicians must choose between the Medicare e-prescribing incentives and complete EHR incentives programs and cannot participate in both (because presumably the EHR would include an e-prescribing component).

However, the same Health Information Technology for Economic and Clinical Health Act that established the EHR incentives included a provision for state Medicaid programs to incentivize early adoption of e-prescribing. “Actually, those incentives are a lot better” than Medicare incentives, she said. Physicians in long-term care settings who see patients covered by Medicare and Medicaid may want to participate in both e-prescribing early-adopter programs rather than wait for the 2013 EHR incentives under Medicare.

For the long-term care setting, that's “probably a better value,” said Ms. Spiro. She reported having no relevant conflicts of interest.

LONG BEACH, CALIF. — The inability to prescribe controlled substances electronically is slowing adoption of electronic prescribing, but financial incentives could make it worthwhile for physicians who see patients covered by Medicare to start “e-prescribing” now if they can, a consultant said.

The Centers for Medicare and Medicaid Services in 2009 began offering Medicare physicians, nurse practitioners, and physician assistants a 2% bonus in payments for participation in its electronic prescribing incentives program for 2009–2010.

The bonus for early adopters of e-prescribing drops to 1% in 2011–2012 and 0.5% in 2013, Rachelle F. Spiro said at the annual meeting of the American Medical Directors Association.

The early e-prescriber incentives were extended to long-term care settings this year. The incentives are not yet available for non-Medicare e-prescribers.

“Here's the hard part,” she added: Physicians who do not successfully adopt e-prescribing by 2012 will see a 1% reduction in Medicare payments for that year, a 1.5% drop for 2013, and a 2% reduction for 2014 and each subsequent year. The Department of Health and Human Services may exempt physicians with hardships, on a case-by-case basis only.

The Drug Enforcement Agency (DEA) does not allow controlled substances to be electronically prescribed, however, which “has hindered the adoption of electronic prescribing,” said Ms. Spiro, a pharmacist and consultant based in Las Vegas. “We've been told that CMS will be working with the DEA to put out final rules for electronic prescribing” of controlled substances, she said. Only a few days after she spoke, the agency published a proposed rule to that effect.

A pilot program for e-prescribing of controlled substances was conducted in Massachusetts, but not in long-term care settings.

Physicians do not need to preregister for the CMS e-prescribing incentive program and do not need to participate in the Physician Quality Reporting Initiative to participate, Ms. Spiro said.

Instructions and examples of how to submit claims under the e-prescribing incentive program are available on the CMS Web site at www.cms.hhs.gov/ERxIncentiveqnetsupport@sdps.org

Physicians can use their facility's electronic health record (EHR) system to send a prescription and to document it in the medical record, then bill for the incentive in much the same way they already handle billing.

Or physicians can turn to certified practice management systems that have an e-prescribing component or to stand-alone e-prescribing systems, if they come from an entity on the CMS list of qualified EHR vendors, she advised. She warned that prescriptions from these two types of systems generally go directly to the pharmacy and not necessarily to the nursing home, “so you're going to have to work out some other mechanism to get that communication to the facility.”

To file claims in the e-prescribing incentives program, report the e-prescribing numerator G-code G8553 to denote that at least one prescription was created during the patient encounter that was transmitted using a qualified e-prescribing system. Report the G-code on the same claim as the denominator billing code for the same beneficiary and the same date of service. Submit the e-prescribing G-code with a line-item charge of zero dollars ($0.00).

Denominator billing codes for e-prescribing include codes for services in nursing facilities (99304-99310 and 99315-99316), home visits (99341-99350), and others including domiciliary codes (99324-99328, 99334-99337, and 99346).

As of 2011, Medicare will be offering incentives for physicians in hospitals and ambulatory settings to switch all of their records to EHRs, but these incentives won't be available to long-term and post–acute care settings until 2013, Ms. Spiro said. Physicians must choose between the Medicare e-prescribing incentives and complete EHR incentives programs and cannot participate in both (because presumably the EHR would include an e-prescribing component).

However, the same Health Information Technology for Economic and Clinical Health Act that established the EHR incentives included a provision for state Medicaid programs to incentivize early adoption of e-prescribing. “Actually, those incentives are a lot better” than Medicare incentives, she said. Physicians in long-term care settings who see patients covered by Medicare and Medicaid may want to participate in both e-prescribing early-adopter programs rather than wait for the 2013 EHR incentives under Medicare.

For the long-term care setting, that's “probably a better value,” Ms. Spiro said.

Disclosures: Ms. Spiro reported having no relevant conflicts of interest.

LONG BEACH, CALIF. — The inability to prescribe controlled substances electronically is slowing adoption of electronic prescribing, but financial incentives could make it worthwhile for physicians who see patients covered by Medicare to start “e-prescribing” now if they can, a consultant said.

The Centers for Medicare and Medicaid Services in 2009 began offering Medicare physicians, nurse practitioners, and physician assistants a 2% bonus in payments for participation in its electronic prescribing incentives program for 2009–2010.

The bonus for early adopters of e-prescribing drops to 1% in 2011–2012 and 0.5% in 2013, Rachelle F. Spiro said at the annual meeting of the American Medical Directors Association.

The early e-prescriber incentives were extended to long-term care settings this year. The incentives are not yet available for non-Medicare e-prescribers.

“Here's the hard part,” she added: Physicians who do not successfully adopt e-prescribing by 2012 will see a 1% reduction in Medicare payments for that year, a 1.5% drop for 2013, and a 2% reduction for 2014 and each subsequent year. The Department of Health and Human Services may exempt physicians with hardships, on a case-by-case basis only.

The Drug Enforcement Agency (DEA) does not allow controlled substances to be electronically prescribed, however, which “has hindered the adoption of electronic prescribing,” said Ms. Spiro, a pharmacist and consultant based in Las Vegas. “We've been told that CMS will be working with the DEA to put out final rules for electronic prescribing” of controlled substances, she said. Only a few days after she spoke, the agency published a proposed rule to that effect.

A pilot program for e-prescribing of controlled substances was conducted in Massachusetts, but not in long-term care settings.

Physicians do not need to preregister for the CMS e-prescribing incentive program and do not need to participate in the Physician Quality Reporting Initiative to participate, Ms. Spiro said.

Instructions and examples of how to submit claims under the e-prescribing incentive program are available on the CMS Web site at www.cms.hhs.gov/ERxIncentiveqnetsupport@sdps.org

Physicians can use their facility's electronic health record (EHR) system to send a prescription and to document it in the medical record, then bill for the incentive in much the same way they already handle billing.

Or physicians can turn to certified practice management systems that have an e-prescribing component or to stand-alone e-prescribing systems, if they come from an entity on the CMS list of qualified EHR vendors, she advised. She warned that prescriptions from these two types of systems generally go directly to the pharmacy and not necessarily to the nursing home, “so you're going to have to work out some other mechanism to get that communication to the facility.”

To file claims in the e-prescribing incentives program, report the e-prescribing numerator G-code G8553 to denote that at least one prescription was created during the patient encounter that was transmitted using a qualified e-prescribing system. Report the G-code on the same claim as the denominator billing code for the same beneficiary and the same date of service. Submit the e-prescribing G-code with a line-item charge of zero dollars ($0.00).

Denominator billing codes for e-prescribing include codes for services in nursing facilities (99304-99310 and 99315-99316), home visits (99341-99350), and others including domiciliary codes (99324-99328, 99334-99337, and 99346).

As of 2011, Medicare will be offering incentives for physicians in hospitals and ambulatory settings to switch all of their records to EHRs, but these incentives won't be available to long-term and post–acute care settings until 2013, Ms. Spiro said. Physicians must choose between the Medicare e-prescribing incentives and complete EHR incentives programs and cannot participate in both (because presumably the EHR would include an e-prescribing component).

However, the same Health Information Technology for Economic and Clinical Health Act that established the EHR incentives included a provision for state Medicaid programs to incentivize early adoption of e-prescribing. “Actually, those incentives are a lot better” than Medicare incentives, she said. Physicians in long-term care settings who see patients covered by Medicare and Medicaid may want to participate in both e-prescribing early-adopter programs rather than wait for the 2013 EHR incentives under Medicare.

For the long-term care setting, that's “probably a better value,” Ms. Spiro said.

Disclosures: Ms. Spiro reported having no relevant conflicts of interest.

LONG BEACH, CALIF. — The inability to prescribe controlled substances electronically is slowing adoption of electronic prescribing, but financial incentives could make it worthwhile for physicians who see patients covered by Medicare to start “e-prescribing” now if they can, a consultant said.

The Centers for Medicare and Medicaid Services in 2009 began offering Medicare physicians, nurse practitioners, and physician assistants a 2% bonus in payments for participation in its electronic prescribing incentives program for 2009–2010.

The bonus for early adopters of e-prescribing drops to 1% in 2011–2012 and 0.5% in 2013, Rachelle F. Spiro said at the annual meeting of the American Medical Directors Association.

The early e-prescriber incentives were extended to long-term care settings this year. The incentives are not yet available for non-Medicare e-prescribers.

“Here's the hard part,” she added: Physicians who do not successfully adopt e-prescribing by 2012 will see a 1% reduction in Medicare payments for that year, a 1.5% drop for 2013, and a 2% reduction for 2014 and each subsequent year. The Department of Health and Human Services may exempt physicians with hardships, on a case-by-case basis only.

The Drug Enforcement Agency (DEA) does not allow controlled substances to be electronically prescribed, however, which “has hindered the adoption of electronic prescribing,” said Ms. Spiro, a pharmacist and consultant based in Las Vegas. “We've been told that CMS will be working with the DEA to put out final rules for electronic prescribing” of controlled substances, she said. Only a few days after she spoke, the agency published a proposed rule to that effect.

A pilot program for e-prescribing of controlled substances was conducted in Massachusetts, but not in long-term care settings.

Physicians do not need to preregister for the CMS e-prescribing incentive program and do not need to participate in the Physician Quality Reporting Initiative to participate, Ms. Spiro said.

Instructions and examples of how to submit claims under the e-prescribing incentive program are available on the CMS Web site at www.cms.hhs.gov/ERxIncentiveqnetsupport@sdps.org

Physicians can use their facility's electronic health record (EHR) system to send a prescription and to document it in the medical record, then bill for the incentive in much the same way they already handle billing.

Or physicians can turn to certified practice management systems that have an e-prescribing component or to stand-alone e-prescribing systems, if they come from an entity on the CMS list of qualified EHR vendors, she advised. She warned that prescriptions from these two types of systems generally go directly to the pharmacy and not necessarily to the nursing home, “so you're going to have to work out some other mechanism to get that communication to the facility.”

To file claims in the e-prescribing incentives program, report the e-prescribing numerator G-code G8553 to denote that at least one prescription was created during the patient encounter that was transmitted using a qualified e-prescribing system. Report the G-code on the same claim as the denominator billing code for the same beneficiary and the same date of service. Submit the e-prescribing G-code with a line-item charge of zero dollars ($0.00).

Denominator billing codes for e-prescribing include codes for services in nursing facilities (99304-99310 and 99315-99316), home visits (99341-99350), and others including domiciliary codes (99324-99328, 99334-99337, and 99346).

As of 2011, Medicare will be offering incentives for physicians in hospitals and ambulatory settings to switch all of their records to EHRs, but these incentives won't be available to long-term and post–acute care settings until 2013, Ms. Spiro said. Physicians must choose between the Medicare e-prescribing incentives and complete EHR incentives programs and cannot participate in both (because presumably the EHR would include an e-prescribing component).

However, the same Health Information Technology for Economic and Clinical Health Act that established the EHR incentives included a provision for state Medicaid programs to incentivize early adoption of e-prescribing. “Actually, those incentives are a lot better” than Medicare incentives, she said. Physicians in long-term care settings who see patients covered by Medicare and Medicaid may want to participate in both e-prescribing early-adopter programs rather than wait for the 2013 EHR incentives under Medicare.

For the long-term care setting, that's “probably a better value,” Ms. Spiro said.

Disclosures: Ms. Spiro reported having no relevant conflicts of interest.

Major Finding: Among older patients treated topically for knee osteoarthritis for 12 weeks, adverse events occurred in 56% of those using diclofenac sodium 1% gel and in 44% of those using placebo, with one serious adverse event possibly related to treatment.

Data Source: A post hoc analysis of data on 538 patients aged 65 years or older from three double-blind, randomized, controlled trials.

Disclosures: Dr. Barthel conducted the study under a research contract for Novartis, which makes the gel. His associates in the study were employees of Novartis or of Endo Pharmaceuticals, which markets the gel.

LONG BEACH, CALIF. — A higher rate of adverse events in older patients with knee osteoarthritis treated topically for 12 weeks with a nonsteroidal anti-inflammatory drug, compared with placebo, was caused mainly by application-site reactions but included one serious cardiovascular event that might have been related to the drug treatment, a post hoc analysis of data on 538 patients found.

The investigators analyzed data on people aged 65 years and older with symptomatic knee osteoarthritis (433 of them with comorbid hypertension, diabetes, or cardiovascular disease). Their source was three larger randomized, double-blind trials—two of them unpublished—that had looked at broader populations. Patients applied 4 g/day of either diclofenac sodium 1% gel (Voltaren) or the drug's vehicle to one painful knee.

One 80-year-old woman with hypertension and diabetes, among 274 patients on diclofenac sodium 1% gel, developed deep vein thrombosis and pulmonary embolism that possibly was related to treatment, Dr. H. Richard Barthel and associates reported in a poster presentation at the annual meeting of the American Medical Directors Association.

Overall, 56% of patients on diclofenac gel developed adverse events, compared with 44% of 264 patients treated with placebo, added Dr. Barthel, a rheumatologist in Santa Barbara, Calif., who conducts research under contract for Voltaren maker, Novartis.

The study was not powered to assess statistical significance. Voltaren is approved to treat osteoarthritis pain in joints amenable to topical treatment, such as knees and hands.

NSAIDs are known to increase risk for cardiovascular or renal problems in a dose-related fashion, especially in older patients and people with hypertension, diabetes, or cardiovascular disease. Topical formulations may reduce this risk by reducing systemic exposure to NSAIDs compared with oral formulations. The ad hoc analysis compared the gel only to placebo, not to oral therapy, and found higher rates of adverse events for the drug vs. placebo.

Application-site reactions occurred in 8.8% on diclofenac gel and 1.1% on placebo. Serious adverse events occurred in 2.6% on diclofenac and 1.1% on placebo. Adverse cardiovascular events were seen in 2.6% on diclofenac and 1.1% on placebo. Adverse renal events were seen in 1.1% on diclofenac and 0.4% on placebo.

Among more common adverse events, 11% of subjects on diclofenac and 10% on placebo reported headache, 8% on diclofenac and 7% on placebo reported arthralgia, and 8% on diclofenac and 6% on placebo reported back pain.

The analysis included 307 patients with hypertension, 84 with diabetes, and 42 with cardiovascular disease. The investigators looked at rates of adverse events in patients with one of these comorbidities, compared with events in patients without the comorbidity. For example, in the hypertension subgroup, adverse events were seen in 54% of 159 people randomized to diclofenac gel, compared with 45% of 148 people using placebo. In patients without hypertension, adverse events occurred in 58% of 115 on diclofenac gel and 42% of 116 on placebo.

In the diabetes subgroup, adverse events occurred in 19 (51%) of 37 patients treated with diclofenac and in 21 (48%) of 47 treated with placebo. In patients without diabetes, adverse events occurred in 56% of 237 on diclofenac and in 44% of 217 on placebo.

In the subgroup with cardiovascular disease, adverse events occurred in 15 (56%) of 27 people on diclofenac and in 2 (13%) of 15 on placebo, although none developed an adverse cardiovascular event.

My Take

Topical Diclofenac Can Fill a Tx Gap

The therapy of osteoarthritis remains insufficient in many patients. It is particularly problematic in the elderly who often have concomitant diseases that limit our options for several of the oral medications, particularly NSAIDs and potent analgesics. The recent Food and Drug Administration approval of diclofenac has changed the therapeutic paradigm. Diclofenac gel 1% has been approved for osteoarthritis of the knee, hand, and other superficial joints, and Pennsaid has been approved for osteoarthritis of the knee.

In this post hoc pooled analysis of 538 patients, we see an increase in irritation at the site of application, but a minimal increase in adverse events involving blood pressure, renal function, hepatic dysfunction, and gastrointestinal ulcer disease. Pharmacokinetic studies have demonstrated that systemic absorption of the topical diclofenac is 40 times less than oral diclofenac. This improved safety allows us to provide therapy to patients otherwise unable to receive anti-inflammatory drugs. It will be no surprise if the guidelines for therapy of osteoarthritis from the United States will soon approximate those from Europe, where topical NSAIDs are part of the therapeutic algorithm for osteoarthritis. Are they completely safe? No. Is there no long-term cardiovascular risk? It has not been studied. Hence, the “black box” warning is applied to these agents that primarily list topical changes under adverse events.

ROY D. ALTMAN, M.D., is professor of medicine in the division of rheumatology and immunology at the University of California, Los Angeles. He has been a consultant to Novartis, Eli Lilly, Ferring Pharmaceuticals, and Rottapharm/Madaus.

Vitals

Major Finding: Among older patients treated topically for knee osteoarthritis for 12 weeks, adverse events occurred in 56% of those using diclofenac sodium 1% gel and in 44% of those using placebo, with one serious adverse event possibly related to treatment.

Data Source: A post hoc analysis of data on 538 patients aged 65 years or older from three double-blind, randomized, controlled trials.

Disclosures: Dr. Barthel conducted the study under a research contract for Novartis, which makes the gel. His associates in the study were employees of Novartis or of Endo Pharmaceuticals, which markets the gel.

LONG BEACH, CALIF. — A higher rate of adverse events in older patients with knee osteoarthritis treated topically for 12 weeks with a nonsteroidal anti-inflammatory drug, compared with placebo, was caused mainly by application-site reactions but included one serious cardiovascular event that might have been related to the drug treatment, a post hoc analysis of data on 538 patients found.

The investigators analyzed data on people aged 65 years and older with symptomatic knee osteoarthritis (433 of them with comorbid hypertension, diabetes, or cardiovascular disease). Their source was three larger randomized, double-blind trials—two of them unpublished—that had looked at broader populations. Patients applied 4 g/day of either diclofenac sodium 1% gel (Voltaren) or the drug's vehicle to one painful knee.

One 80-year-old woman with hypertension and diabetes, among 274 patients on diclofenac sodium 1% gel, developed deep vein thrombosis and pulmonary embolism that possibly was related to treatment, Dr. H. Richard Barthel and associates reported in a poster presentation at the annual meeting of the American Medical Directors Association.

Overall, 56% of patients on diclofenac gel developed adverse events, compared with 44% of 264 patients treated with placebo, added Dr. Barthel, a rheumatologist in Santa Barbara, Calif., who conducts research under contract for Voltaren maker, Novartis.

The study was not powered to assess statistical significance. Voltaren is approved to treat osteoarthritis pain in joints amenable to topical treatment, such as knees and hands.

NSAIDs are known to increase risk for cardiovascular or renal problems in a dose-related fashion, especially in older patients and people with hypertension, diabetes, or cardiovascular disease. Topical formulations may reduce this risk by reducing systemic exposure to NSAIDs compared with oral formulations. The ad hoc analysis compared the gel only to placebo, not to oral therapy, and found higher rates of adverse events for the drug vs. placebo.

Application-site reactions occurred in 8.8% on diclofenac gel and 1.1% on placebo. Serious adverse events occurred in 2.6% on diclofenac and 1.1% on placebo. Adverse cardiovascular events were seen in 2.6% on diclofenac and 1.1% on placebo. Adverse renal events were seen in 1.1% on diclofenac and 0.4% on placebo.

Among more common adverse events, 11% of subjects on diclofenac and 10% on placebo reported headache, 8% on diclofenac and 7% on placebo reported arthralgia, and 8% on diclofenac and 6% on placebo reported back pain.

The analysis included 307 patients with hypertension, 84 with diabetes, and 42 with cardiovascular disease. The investigators looked at rates of adverse events in patients with one of these comorbidities, compared with events in patients without the comorbidity. For example, in the hypertension subgroup, adverse events were seen in 54% of 159 people randomized to diclofenac gel, compared with 45% of 148 people using placebo. In patients without hypertension, adverse events occurred in 58% of 115 on diclofenac gel and 42% of 116 on placebo.

In the diabetes subgroup, adverse events occurred in 19 (51%) of 37 patients treated with diclofenac and in 21 (48%) of 47 treated with placebo. In patients without diabetes, adverse events occurred in 56% of 237 on diclofenac and in 44% of 217 on placebo.

In the subgroup with cardiovascular disease, adverse events occurred in 15 (56%) of 27 people on diclofenac and in 2 (13%) of 15 on placebo, although none developed an adverse cardiovascular event.

My Take

Topical Diclofenac Can Fill a Tx Gap

The therapy of osteoarthritis remains insufficient in many patients. It is particularly problematic in the elderly who often have concomitant diseases that limit our options for several of the oral medications, particularly NSAIDs and potent analgesics. The recent Food and Drug Administration approval of diclofenac has changed the therapeutic paradigm. Diclofenac gel 1% has been approved for osteoarthritis of the knee, hand, and other superficial joints, and Pennsaid has been approved for osteoarthritis of the knee.

In this post hoc pooled analysis of 538 patients, we see an increase in irritation at the site of application, but a minimal increase in adverse events involving blood pressure, renal function, hepatic dysfunction, and gastrointestinal ulcer disease. Pharmacokinetic studies have demonstrated that systemic absorption of the topical diclofenac is 40 times less than oral diclofenac. This improved safety allows us to provide therapy to patients otherwise unable to receive anti-inflammatory drugs. It will be no surprise if the guidelines for therapy of osteoarthritis from the United States will soon approximate those from Europe, where topical NSAIDs are part of the therapeutic algorithm for osteoarthritis. Are they completely safe? No. Is there no long-term cardiovascular risk? It has not been studied. Hence, the “black box” warning is applied to these agents that primarily list topical changes under adverse events.

ROY D. ALTMAN, M.D., is professor of medicine in the division of rheumatology and immunology at the University of California, Los Angeles. He has been a consultant to Novartis, Eli Lilly, Ferring Pharmaceuticals, and Rottapharm/Madaus.

Vitals

Major Finding: Among older patients treated topically for knee osteoarthritis for 12 weeks, adverse events occurred in 56% of those using diclofenac sodium 1% gel and in 44% of those using placebo, with one serious adverse event possibly related to treatment.

Data Source: A post hoc analysis of data on 538 patients aged 65 years or older from three double-blind, randomized, controlled trials.

Disclosures: Dr. Barthel conducted the study under a research contract for Novartis, which makes the gel. His associates in the study were employees of Novartis or of Endo Pharmaceuticals, which markets the gel.

LONG BEACH, CALIF. — A higher rate of adverse events in older patients with knee osteoarthritis treated topically for 12 weeks with a nonsteroidal anti-inflammatory drug, compared with placebo, was caused mainly by application-site reactions but included one serious cardiovascular event that might have been related to the drug treatment, a post hoc analysis of data on 538 patients found.

The investigators analyzed data on people aged 65 years and older with symptomatic knee osteoarthritis (433 of them with comorbid hypertension, diabetes, or cardiovascular disease). Their source was three larger randomized, double-blind trials—two of them unpublished—that had looked at broader populations. Patients applied 4 g/day of either diclofenac sodium 1% gel (Voltaren) or the drug's vehicle to one painful knee.

One 80-year-old woman with hypertension and diabetes, among 274 patients on diclofenac sodium 1% gel, developed deep vein thrombosis and pulmonary embolism that possibly was related to treatment, Dr. H. Richard Barthel and associates reported in a poster presentation at the annual meeting of the American Medical Directors Association.

Overall, 56% of patients on diclofenac gel developed adverse events, compared with 44% of 264 patients treated with placebo, added Dr. Barthel, a rheumatologist in Santa Barbara, Calif., who conducts research under contract for Voltaren maker, Novartis.

The study was not powered to assess statistical significance. Voltaren is approved to treat osteoarthritis pain in joints amenable to topical treatment, such as knees and hands.

NSAIDs are known to increase risk for cardiovascular or renal problems in a dose-related fashion, especially in older patients and people with hypertension, diabetes, or cardiovascular disease. Topical formulations may reduce this risk by reducing systemic exposure to NSAIDs compared with oral formulations. The ad hoc analysis compared the gel only to placebo, not to oral therapy, and found higher rates of adverse events for the drug vs. placebo.

Application-site reactions occurred in 8.8% on diclofenac gel and 1.1% on placebo. Serious adverse events occurred in 2.6% on diclofenac and 1.1% on placebo. Adverse cardiovascular events were seen in 2.6% on diclofenac and 1.1% on placebo. Adverse renal events were seen in 1.1% on diclofenac and 0.4% on placebo.

Among more common adverse events, 11% of subjects on diclofenac and 10% on placebo reported headache, 8% on diclofenac and 7% on placebo reported arthralgia, and 8% on diclofenac and 6% on placebo reported back pain.

The analysis included 307 patients with hypertension, 84 with diabetes, and 42 with cardiovascular disease. The investigators looked at rates of adverse events in patients with one of these comorbidities, compared with events in patients without the comorbidity. For example, in the hypertension subgroup, adverse events were seen in 54% of 159 people randomized to diclofenac gel, compared with 45% of 148 people using placebo. In patients without hypertension, adverse events occurred in 58% of 115 on diclofenac gel and 42% of 116 on placebo.

In the diabetes subgroup, adverse events occurred in 19 (51%) of 37 patients treated with diclofenac and in 21 (48%) of 47 treated with placebo. In patients without diabetes, adverse events occurred in 56% of 237 on diclofenac and in 44% of 217 on placebo.

In the subgroup with cardiovascular disease, adverse events occurred in 15 (56%) of 27 people on diclofenac and in 2 (13%) of 15 on placebo, although none developed an adverse cardiovascular event.

My Take

Topical Diclofenac Can Fill a Tx Gap

The therapy of osteoarthritis remains insufficient in many patients. It is particularly problematic in the elderly who often have concomitant diseases that limit our options for several of the oral medications, particularly NSAIDs and potent analgesics. The recent Food and Drug Administration approval of diclofenac has changed the therapeutic paradigm. Diclofenac gel 1% has been approved for osteoarthritis of the knee, hand, and other superficial joints, and Pennsaid has been approved for osteoarthritis of the knee.

In this post hoc pooled analysis of 538 patients, we see an increase in irritation at the site of application, but a minimal increase in adverse events involving blood pressure, renal function, hepatic dysfunction, and gastrointestinal ulcer disease. Pharmacokinetic studies have demonstrated that systemic absorption of the topical diclofenac is 40 times less than oral diclofenac. This improved safety allows us to provide therapy to patients otherwise unable to receive anti-inflammatory drugs. It will be no surprise if the guidelines for therapy of osteoarthritis from the United States will soon approximate those from Europe, where topical NSAIDs are part of the therapeutic algorithm for osteoarthritis. Are they completely safe? No. Is there no long-term cardiovascular risk? It has not been studied. Hence, the “black box” warning is applied to these agents that primarily list topical changes under adverse events.

ROY D. ALTMAN, M.D., is professor of medicine in the division of rheumatology and immunology at the University of California, Los Angeles. He has been a consultant to Novartis, Eli Lilly, Ferring Pharmaceuticals, and Rottapharm/Madaus.

Vitals

SAN FRANCISCO — Metformin and some oral contraceptives used to treat polycystic ovary syndrome can decrease the associated cardiovascular risk, but other oral contraceptives increase cardiovascular risk, studies suggest.

Dr. Andrea Dunaif summarized the data on cardiometabolic risk in the treatment of polycystic ovary syndrome (PCOS) at a meeting sponsored by the American Diabetes Association.

Previous evidence that estrogen therapy can increase triglyceride levels and that certain oral contraceptives can exacerbate insulin resistance raised concern that oral contraceptives may have adverse metabolic consequences in women with PCOS, explained Dr. Dunaif, professor of endocrinology at Northwestern University, Chicago.

One study randomized 48 hirsute women with PCOS to 6 months of treatment with a common oral contraceptive (Yasmin) containing 3 mg of drospirenone and 20 mcg of ethinyl estradiol or the same therapy plus either metformin 1,500 mg/day or cyproterone acetate (12.5 mg/day, 10 days per cycle), a progesterone used outside the United States (Fertil. Steril. 2009 Nov. 19 [doi:10.1016.j.fertnstert.2009.10.016]).

Insulin sensitivity improved in patients on Yasmin alone or Yasmin plus metformin but significantly worsened with Yasmin plus cyproterone acetate in the open-label trial, Dr. Dunaif said.

A separate open-label trial randomized 100 overweight women with PCOS to 6 months of oral therapy with 35 mcg of ethinyl estradiol and 2 mg of cyproterone acetate (a formulation known in Europe as Diane-35), a low-dose oral contraceptive regimen (20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel) plus the antiandrogen drug spironolactone 50 mg b.i.d., or metformin 1 g b.i.d.

Each of the treatment arms showed similar, significant improvements in PCOS symptoms and menstrual cycle length. Insulin resistance improved significantly in the metformin group, but insulin resistance and arterial stiffness worsened in the ethinyl estradiol/cyproterone acetate group (Diabetes Care 2007;30:471-8).

“Cyproterone acetate looks to be a bad actor in these studies,” she said.

Several studies of metformin therapy in women with PCOS have shown that the drug can improve risk factors for cardiovascular disease such as endothelial dysfunction, she noted. Compared with placebo, 12 weeks of metformin significantly decreased arterial stiffness and improved endothelial function in 30 women with PCOS in a randomized, double-blind crossover trial (J. Clin. Endocrinol. Metab. 2010;95:722-30).

Disclosures: Dr. Dunaif has been a consultant for Bristol-Myers Squibb Co., which makes metformin.

SAN FRANCISCO — Metformin and some oral contraceptives used to treat polycystic ovary syndrome can decrease the associated cardiovascular risk, but other oral contraceptives increase cardiovascular risk, studies suggest.

Dr. Andrea Dunaif summarized the data on cardiometabolic risk in the treatment of polycystic ovary syndrome (PCOS) at a meeting sponsored by the American Diabetes Association.

Previous evidence that estrogen therapy can increase triglyceride levels and that certain oral contraceptives can exacerbate insulin resistance raised concern that oral contraceptives may have adverse metabolic consequences in women with PCOS, explained Dr. Dunaif, professor of endocrinology at Northwestern University, Chicago.

One study randomized 48 hirsute women with PCOS to 6 months of treatment with a common oral contraceptive (Yasmin) containing 3 mg of drospirenone and 20 mcg of ethinyl estradiol or the same therapy plus either metformin 1,500 mg/day or cyproterone acetate (12.5 mg/day, 10 days per cycle), a progesterone used outside the United States (Fertil. Steril. 2009 Nov. 19 [doi:10.1016.j.fertnstert.2009.10.016]).

Insulin sensitivity improved in patients on Yasmin alone or Yasmin plus metformin but significantly worsened with Yasmin plus cyproterone acetate in the open-label trial, Dr. Dunaif said.

A separate open-label trial randomized 100 overweight women with PCOS to 6 months of oral therapy with 35 mcg of ethinyl estradiol and 2 mg of cyproterone acetate (a formulation known in Europe as Diane-35), a low-dose oral contraceptive regimen (20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel) plus the antiandrogen drug spironolactone 50 mg b.i.d., or metformin 1 g b.i.d.

Each of the treatment arms showed similar, significant improvements in PCOS symptoms and menstrual cycle length. Insulin resistance improved significantly in the metformin group, but insulin resistance and arterial stiffness worsened in the ethinyl estradiol/cyproterone acetate group (Diabetes Care 2007;30:471-8).

“Cyproterone acetate looks to be a bad actor in these studies,” she said.

Several studies of metformin therapy in women with PCOS have shown that the drug can improve risk factors for cardiovascular disease such as endothelial dysfunction, she noted. Compared with placebo, 12 weeks of metformin significantly decreased arterial stiffness and improved endothelial function in 30 women with PCOS in a randomized, double-blind crossover trial (J. Clin. Endocrinol. Metab. 2010;95:722-30).

Disclosures: Dr. Dunaif has been a consultant for Bristol-Myers Squibb Co., which makes metformin.

SAN FRANCISCO — Metformin and some oral contraceptives used to treat polycystic ovary syndrome can decrease the associated cardiovascular risk, but other oral contraceptives increase cardiovascular risk, studies suggest.

Dr. Andrea Dunaif summarized the data on cardiometabolic risk in the treatment of polycystic ovary syndrome (PCOS) at a meeting sponsored by the American Diabetes Association.

Previous evidence that estrogen therapy can increase triglyceride levels and that certain oral contraceptives can exacerbate insulin resistance raised concern that oral contraceptives may have adverse metabolic consequences in women with PCOS, explained Dr. Dunaif, professor of endocrinology at Northwestern University, Chicago.

One study randomized 48 hirsute women with PCOS to 6 months of treatment with a common oral contraceptive (Yasmin) containing 3 mg of drospirenone and 20 mcg of ethinyl estradiol or the same therapy plus either metformin 1,500 mg/day or cyproterone acetate (12.5 mg/day, 10 days per cycle), a progesterone used outside the United States (Fertil. Steril. 2009 Nov. 19 [doi:10.1016.j.fertnstert.2009.10.016]).

Insulin sensitivity improved in patients on Yasmin alone or Yasmin plus metformin but significantly worsened with Yasmin plus cyproterone acetate in the open-label trial, Dr. Dunaif said.

A separate open-label trial randomized 100 overweight women with PCOS to 6 months of oral therapy with 35 mcg of ethinyl estradiol and 2 mg of cyproterone acetate (a formulation known in Europe as Diane-35), a low-dose oral contraceptive regimen (20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel) plus the antiandrogen drug spironolactone 50 mg b.i.d., or metformin 1 g b.i.d.

Each of the treatment arms showed similar, significant improvements in PCOS symptoms and menstrual cycle length. Insulin resistance improved significantly in the metformin group, but insulin resistance and arterial stiffness worsened in the ethinyl estradiol/cyproterone acetate group (Diabetes Care 2007;30:471-8).

“Cyproterone acetate looks to be a bad actor in these studies,” she said.

Several studies of metformin therapy in women with PCOS have shown that the drug can improve risk factors for cardiovascular disease such as endothelial dysfunction, she noted. Compared with placebo, 12 weeks of metformin significantly decreased arterial stiffness and improved endothelial function in 30 women with PCOS in a randomized, double-blind crossover trial (J. Clin. Endocrinol. Metab. 2010;95:722-30).

Disclosures: Dr. Dunaif has been a consultant for Bristol-Myers Squibb Co., which makes metformin.

SAN FRANCISCO — The presence and severity of obstructive sleep apnea were associated with worse glucose control in a study of 60 patients with type 2 diabetes.

Polysomnography and hemoglobin A_1c tests showed that participants with no obstructive sleep apnea (OSA) had an average HbA_1c level of 5.7%. HbA_1c levels averaged 7.2% in participants with mild OSA, 7.7% in those with moderate OSA, and 9.4% in those with severe OSA, Dr. Esra Tasali reported.

“These effect sizes are comparable to some medications we use to treat A_1c levels,” she said, suggesting that “treatment of obstructive sleep apnea may improve glucose control as much as widely used pharmacologic agents.”

The linear trend for poorer glucose control with increasingly severe OSA was highly significant (P < .0001) after adjustment of the data for the effects of age, gender, race, body mass index, level of exercise, duration of diabetes, number of diabetes medications being taken, and total sleep time, she said at a meeting sponsored by the American Diabetes Association.

Previous studies have shown a high prevalence of OSA in people with type 2 diabetes and shown that in nondiabetic people OSA is associated with alterations in glucose metabolism and reduced insulin sensitivity independent of age, sex, or degree of obesity. The current study is the first to identify the relationship between OSA severity and glycemic control in a diabetic population (Am. J. Respir. Crit. Care Med. 2010;181:507-13).

Overall, 77% (46 of 60) of the study cohort had OSA. Three previous studies of diabetic populations found OSA prevalences of 58%, 71%, and 86%, said Dr. Tasali of the University of Chicago.

Six trials of treating OSA in patients with type 2 diabetes using continuous positive airway pressure (CPAP) produced conflicting results, with some showing improvements in HbA_1c levels, insulin sensitivity, or glucose levels, some showing no change, and others with split results. The only randomized clinical trial among them found no effect of CPAP therapy on HbA_1c or insulin sensitivity. All the studies were small (ranging from 9 to 44 patients), she noted.

Dr. Tasali said that she had no conflicts of interest to disclose.

'These effect sizes are comparable to some medications we use to treat A_1c levels.'

Source DR. TASALI

SAN FRANCISCO — The presence and severity of obstructive sleep apnea were associated with worse glucose control in a study of 60 patients with type 2 diabetes.

Polysomnography and hemoglobin A_1c tests showed that participants with no obstructive sleep apnea (OSA) had an average HbA_1c level of 5.7%. HbA_1c levels averaged 7.2% in participants with mild OSA, 7.7% in those with moderate OSA, and 9.4% in those with severe OSA, Dr. Esra Tasali reported.

“These effect sizes are comparable to some medications we use to treat A_1c levels,” she said, suggesting that “treatment of obstructive sleep apnea may improve glucose control as much as widely used pharmacologic agents.”

The linear trend for poorer glucose control with increasingly severe OSA was highly significant (P < .0001) after adjustment of the data for the effects of age, gender, race, body mass index, level of exercise, duration of diabetes, number of diabetes medications being taken, and total sleep time, she said at a meeting sponsored by the American Diabetes Association.

Previous studies have shown a high prevalence of OSA in people with type 2 diabetes and shown that in nondiabetic people OSA is associated with alterations in glucose metabolism and reduced insulin sensitivity independent of age, sex, or degree of obesity. The current study is the first to identify the relationship between OSA severity and glycemic control in a diabetic population (Am. J. Respir. Crit. Care Med. 2010;181:507-13).

Overall, 77% (46 of 60) of the study cohort had OSA. Three previous studies of diabetic populations found OSA prevalences of 58%, 71%, and 86%, said Dr. Tasali of the University of Chicago.

Six trials of treating OSA in patients with type 2 diabetes using continuous positive airway pressure (CPAP) produced conflicting results, with some showing improvements in HbA_1c levels, insulin sensitivity, or glucose levels, some showing no change, and others with split results. The only randomized clinical trial among them found no effect of CPAP therapy on HbA_1c or insulin sensitivity. All the studies were small (ranging from 9 to 44 patients), she noted.

Dr. Tasali said that she had no conflicts of interest to disclose.

'These effect sizes are comparable to some medications we use to treat A_1c levels.'

Source DR. TASALI

SAN FRANCISCO — The presence and severity of obstructive sleep apnea were associated with worse glucose control in a study of 60 patients with type 2 diabetes.

Polysomnography and hemoglobin A_1c tests showed that participants with no obstructive sleep apnea (OSA) had an average HbA_1c level of 5.7%. HbA_1c levels averaged 7.2% in participants with mild OSA, 7.7% in those with moderate OSA, and 9.4% in those with severe OSA, Dr. Esra Tasali reported.

“These effect sizes are comparable to some medications we use to treat A_1c levels,” she said, suggesting that “treatment of obstructive sleep apnea may improve glucose control as much as widely used pharmacologic agents.”

The linear trend for poorer glucose control with increasingly severe OSA was highly significant (P < .0001) after adjustment of the data for the effects of age, gender, race, body mass index, level of exercise, duration of diabetes, number of diabetes medications being taken, and total sleep time, she said at a meeting sponsored by the American Diabetes Association.

Previous studies have shown a high prevalence of OSA in people with type 2 diabetes and shown that in nondiabetic people OSA is associated with alterations in glucose metabolism and reduced insulin sensitivity independent of age, sex, or degree of obesity. The current study is the first to identify the relationship between OSA severity and glycemic control in a diabetic population (Am. J. Respir. Crit. Care Med. 2010;181:507-13).

Overall, 77% (46 of 60) of the study cohort had OSA. Three previous studies of diabetic populations found OSA prevalences of 58%, 71%, and 86%, said Dr. Tasali of the University of Chicago.

Six trials of treating OSA in patients with type 2 diabetes using continuous positive airway pressure (CPAP) produced conflicting results, with some showing improvements in HbA_1c levels, insulin sensitivity, or glucose levels, some showing no change, and others with split results. The only randomized clinical trial among them found no effect of CPAP therapy on HbA_1c or insulin sensitivity. All the studies were small (ranging from 9 to 44 patients), she noted.

Dr. Tasali said that she had no conflicts of interest to disclose.

'These effect sizes are comparable to some medications we use to treat A_1c levels.'

Source DR. TASALI

LONG BEACH, CALIF. — Antipsychotics prescribed to patients in nursing homes often lack documentation of proper indications, according to findings from a retrospective study that support the results of previous studies of medical charts in nursing homes.

In a review of charts for 131 patients at one institution from April through September 2009, 8 of the 32 residents on antipsychotics were prescribed the drugs without indications meeting DSM-IV definitions and regulations for psychoactive and hypnotic medications, Dr. Bich-Thy Ngo reported in a poster presentation at the annual meeting of the American Medical Directors Association.

Charts for two residents had no indications listed at all for the antipsychotics, and the other six were prescribed the drugs for other indications, said Dr. Ngo of Texas Tech University, Lubbock.

Dr. Ngo noted that the elderly are especially vulnerable to the adverse effects of psychoactive drugs.

She reported having no disclosures.

Of the 32 residents on antipsychotics, 8 were prescribed the drugs without meeting DSM-IV indications.

Source DR. NGO

LONG BEACH, CALIF. — Antipsychotics prescribed to patients in nursing homes often lack documentation of proper indications, according to findings from a retrospective study that support the results of previous studies of medical charts in nursing homes.

In a review of charts for 131 patients at one institution from April through September 2009, 8 of the 32 residents on antipsychotics were prescribed the drugs without indications meeting DSM-IV definitions and regulations for psychoactive and hypnotic medications, Dr. Bich-Thy Ngo reported in a poster presentation at the annual meeting of the American Medical Directors Association.

Charts for two residents had no indications listed at all for the antipsychotics, and the other six were prescribed the drugs for other indications, said Dr. Ngo of Texas Tech University, Lubbock.

Dr. Ngo noted that the elderly are especially vulnerable to the adverse effects of psychoactive drugs.

She reported having no disclosures.

Of the 32 residents on antipsychotics, 8 were prescribed the drugs without meeting DSM-IV indications.

Source DR. NGO

LONG BEACH, CALIF. — Antipsychotics prescribed to patients in nursing homes often lack documentation of proper indications, according to findings from a retrospective study that support the results of previous studies of medical charts in nursing homes.

In a review of charts for 131 patients at one institution from April through September 2009, 8 of the 32 residents on antipsychotics were prescribed the drugs without indications meeting DSM-IV definitions and regulations for psychoactive and hypnotic medications, Dr. Bich-Thy Ngo reported in a poster presentation at the annual meeting of the American Medical Directors Association.

Charts for two residents had no indications listed at all for the antipsychotics, and the other six were prescribed the drugs for other indications, said Dr. Ngo of Texas Tech University, Lubbock.

Dr. Ngo noted that the elderly are especially vulnerable to the adverse effects of psychoactive drugs.

She reported having no disclosures.

Of the 32 residents on antipsychotics, 8 were prescribed the drugs without meeting DSM-IV indications.

Source DR. NGO

LONG BEACH, CALIF. — Rejection of care by nursing home residents was associated with four potentially modifiable factors in an analysis of data on 3,230 residents.

Clinicians should screen for the conditions—delusion, delirium, minor or major depression, and severe or worse pain—when residents reject care such as blood work, taking medications, and assistance with activities of daily living, Dr. Shinya Ishii and associates reported in a prize-winning poster presentation at the annual meeting of the American Medical Directors Association.

If the associations seen in the study are causal, appropriate interventions may improve residents' willingness to accept care, the researchers suggested.

The team analyzed data on residents scheduled for Minimum Data Set assessments in 71 nursing homes in eight states. Nurses identified residents who were rejecting care.

The likelihood of doing so increased fourfold in the presence of delusion and doubled with delirium, depression, or severe to “horrible” pain, reported Dr. Ishii of the Department of Veterans Affairs' Geriatric Research Education and Clinical Center, Los Angeles.

Among the 312 residents who exhibited rejection-of-care behaviors, 18% had delusions, 35% had delirium, 32% had minor depression, 15% had major depression, and 30% had severe-to-horrible pain. Some symptoms overlapped.

An attributable-risk analysis suggested that 19% of care-rejecting behavior could be eliminated if delusions were stopped and that 5% of care rejection might end if delirium were reversed. Treating minor depression might eliminate 7% of care-rejecting behavior, reversing major depression might eliminate 10% of care-rejecting behavior, and ending severe or worse pain might eliminate 5% of care-rejecting behavior, Dr. Ishii reported.

Several covariates also were associated with rejection of care, including being male and having moderate or severe cognitive impairment.

Factors that were not associated with rejection of care included hallucination, mild to moderate pain, hearing and vision impairment, and infections (including urinary tract infection, pneumonia, wound infection, HIV, tuberculosis, and viral hepatitis).

The large, geographically diverse sample of residents strengthened the findings of the study, but its cross-sectional design did not allow examination of temporal sequences, the investigators noted. Also, the lack of any significant association between care rejection and infection might be attributable to different time frames for reporting infection, compared with those governing the other variables.

Disclosures: The investigators reported having no disclosures.

LONG BEACH, CALIF. — Rejection of care by nursing home residents was associated with four potentially modifiable factors in an analysis of data on 3,230 residents.

Clinicians should screen for the conditions—delusion, delirium, minor or major depression, and severe or worse pain—when residents reject care such as blood work, taking medications, and assistance with activities of daily living, Dr. Shinya Ishii and associates reported in a prize-winning poster presentation at the annual meeting of the American Medical Directors Association.

If the associations seen in the study are causal, appropriate interventions may improve residents' willingness to accept care, the researchers suggested.

The team analyzed data on residents scheduled for Minimum Data Set assessments in 71 nursing homes in eight states. Nurses identified residents who were rejecting care.

The likelihood of doing so increased fourfold in the presence of delusion and doubled with delirium, depression, or severe to “horrible” pain, reported Dr. Ishii of the Department of Veterans Affairs' Geriatric Research Education and Clinical Center, Los Angeles.

Among the 312 residents who exhibited rejection-of-care behaviors, 18% had delusions, 35% had delirium, 32% had minor depression, 15% had major depression, and 30% had severe-to-horrible pain. Some symptoms overlapped.

An attributable-risk analysis suggested that 19% of care-rejecting behavior could be eliminated if delusions were stopped and that 5% of care rejection might end if delirium were reversed. Treating minor depression might eliminate 7% of care-rejecting behavior, reversing major depression might eliminate 10% of care-rejecting behavior, and ending severe or worse pain might eliminate 5% of care-rejecting behavior, Dr. Ishii reported.

Several covariates also were associated with rejection of care, including being male and having moderate or severe cognitive impairment.

Factors that were not associated with rejection of care included hallucination, mild to moderate pain, hearing and vision impairment, and infections (including urinary tract infection, pneumonia, wound infection, HIV, tuberculosis, and viral hepatitis).

The large, geographically diverse sample of residents strengthened the findings of the study, but its cross-sectional design did not allow examination of temporal sequences, the investigators noted. Also, the lack of any significant association between care rejection and infection might be attributable to different time frames for reporting infection, compared with those governing the other variables.

Disclosures: The investigators reported having no disclosures.

LONG BEACH, CALIF. — Rejection of care by nursing home residents was associated with four potentially modifiable factors in an analysis of data on 3,230 residents.

Clinicians should screen for the conditions—delusion, delirium, minor or major depression, and severe or worse pain—when residents reject care such as blood work, taking medications, and assistance with activities of daily living, Dr. Shinya Ishii and associates reported in a prize-winning poster presentation at the annual meeting of the American Medical Directors Association.

If the associations seen in the study are causal, appropriate interventions may improve residents' willingness to accept care, the researchers suggested.

The team analyzed data on residents scheduled for Minimum Data Set assessments in 71 nursing homes in eight states. Nurses identified residents who were rejecting care.

The likelihood of doing so increased fourfold in the presence of delusion and doubled with delirium, depression, or severe to “horrible” pain, reported Dr. Ishii of the Department of Veterans Affairs' Geriatric Research Education and Clinical Center, Los Angeles.

Among the 312 residents who exhibited rejection-of-care behaviors, 18% had delusions, 35% had delirium, 32% had minor depression, 15% had major depression, and 30% had severe-to-horrible pain. Some symptoms overlapped.

An attributable-risk analysis suggested that 19% of care-rejecting behavior could be eliminated if delusions were stopped and that 5% of care rejection might end if delirium were reversed. Treating minor depression might eliminate 7% of care-rejecting behavior, reversing major depression might eliminate 10% of care-rejecting behavior, and ending severe or worse pain might eliminate 5% of care-rejecting behavior, Dr. Ishii reported.

Several covariates also were associated with rejection of care, including being male and having moderate or severe cognitive impairment.

Factors that were not associated with rejection of care included hallucination, mild to moderate pain, hearing and vision impairment, and infections (including urinary tract infection, pneumonia, wound infection, HIV, tuberculosis, and viral hepatitis).

The large, geographically diverse sample of residents strengthened the findings of the study, but its cross-sectional design did not allow examination of temporal sequences, the investigators noted. Also, the lack of any significant association between care rejection and infection might be attributable to different time frames for reporting infection, compared with those governing the other variables.

Disclosures: The investigators reported having no disclosures.

Major Finding: Distribution of antithrombotic guidelines increased the rate of VTE risk assessment and prophylaxis from 50% to 82% in long-term care settings.

Data Source: Study of 738 newly admitted residents in 17 long-term care facilities.

Disclosures: The investigators reported having no disclosures.

LONG BEACH, CALIF. — An educational intervention led to increased preventive management of venous thromboembolism in residents of long-term care facilities.

Preventive management—assessment of VTE risk and prophylaxis in appropriate patients—was used in 50% of 376 newly admitted residents prior to the intervention and in 82% of 362 new admissions afterward.

Before the intervention, clinical guidelines on VTE prevention were ignored or misunderstood during the care of 32% of new residents. After the intervention, this occurred during the care of 17% of new residents, Dr. T. S. Dharmarajan and his associates reported in two poster presentations at the annual meeting of the American Medical Directors Association. Inappropriate use of VTE prophylaxis (for example, in a patient already anticoagulated for atrial fibrillation) fell from 23% of assessed residents to 13%.

No guidelines for VTE prevention are written specifically for long-term care settings, and the scope of acute VTE and pulmonary embolism in long-term care residents is unknown, said Dr. Dharmarajan of Montefiore Medical Center, New York.

Researchers surveyed clinicians at 17 long-term care facilities in nine states about their VTE prevention practices. Participating clinicians received copies of guidelines issued in 2008 by the American College of Chest Physicians for VTE prevention in hospitalized patients and an antithrombotic “toolkit” developed by the American Medical Directors Association.

After this educational intervention, the likelihood that a new resident would be assessed or given prophylaxis for VTE increased 14-fold in a logistic regression modeling analysis, Dr. Dharmarajan reported. Listing contraindications as a reason for not providing prophylaxis against VTE fell by 67%.

Significant changes in prophylaxis choices after the intervention included less reliance on aspirin alone (18% after vs. 36% before) and more reliance on compression devices alone (4% vs. 0%) or ambulation alone (55% vs. 39%). Common prophylactic measures that did not change significantly included the use of warfarin, heparin, low-molecular-weight heparin, fondaparinux, or stockings.

At youtube.com/ElsGlobalMedicalNews

Major Finding: Distribution of antithrombotic guidelines increased the rate of VTE risk assessment and prophylaxis from 50% to 82% in long-term care settings.

Data Source: Study of 738 newly admitted residents in 17 long-term care facilities.

Disclosures: The investigators reported having no disclosures.

LONG BEACH, CALIF. — An educational intervention led to increased preventive management of venous thromboembolism in residents of long-term care facilities.

Preventive management—assessment of VTE risk and prophylaxis in appropriate patients—was used in 50% of 376 newly admitted residents prior to the intervention and in 82% of 362 new admissions afterward.

Before the intervention, clinical guidelines on VTE prevention were ignored or misunderstood during the care of 32% of new residents. After the intervention, this occurred during the care of 17% of new residents, Dr. T. S. Dharmarajan and his associates reported in two poster presentations at the annual meeting of the American Medical Directors Association. Inappropriate use of VTE prophylaxis (for example, in a patient already anticoagulated for atrial fibrillation) fell from 23% of assessed residents to 13%.

No guidelines for VTE prevention are written specifically for long-term care settings, and the scope of acute VTE and pulmonary embolism in long-term care residents is unknown, said Dr. Dharmarajan of Montefiore Medical Center, New York.

Researchers surveyed clinicians at 17 long-term care facilities in nine states about their VTE prevention practices. Participating clinicians received copies of guidelines issued in 2008 by the American College of Chest Physicians for VTE prevention in hospitalized patients and an antithrombotic “toolkit” developed by the American Medical Directors Association.

After this educational intervention, the likelihood that a new resident would be assessed or given prophylaxis for VTE increased 14-fold in a logistic regression modeling analysis, Dr. Dharmarajan reported. Listing contraindications as a reason for not providing prophylaxis against VTE fell by 67%.

Significant changes in prophylaxis choices after the intervention included less reliance on aspirin alone (18% after vs. 36% before) and more reliance on compression devices alone (4% vs. 0%) or ambulation alone (55% vs. 39%). Common prophylactic measures that did not change significantly included the use of warfarin, heparin, low-molecular-weight heparin, fondaparinux, or stockings.

At youtube.com/ElsGlobalMedicalNews

Major Finding: Distribution of antithrombotic guidelines increased the rate of VTE risk assessment and prophylaxis from 50% to 82% in long-term care settings.

Data Source: Study of 738 newly admitted residents in 17 long-term care facilities.

Disclosures: The investigators reported having no disclosures.

LONG BEACH, CALIF. — An educational intervention led to increased preventive management of venous thromboembolism in residents of long-term care facilities.

Preventive management—assessment of VTE risk and prophylaxis in appropriate patients—was used in 50% of 376 newly admitted residents prior to the intervention and in 82% of 362 new admissions afterward.

Before the intervention, clinical guidelines on VTE prevention were ignored or misunderstood during the care of 32% of new residents. After the intervention, this occurred during the care of 17% of new residents, Dr. T. S. Dharmarajan and his associates reported in two poster presentations at the annual meeting of the American Medical Directors Association. Inappropriate use of VTE prophylaxis (for example, in a patient already anticoagulated for atrial fibrillation) fell from 23% of assessed residents to 13%.

No guidelines for VTE prevention are written specifically for long-term care settings, and the scope of acute VTE and pulmonary embolism in long-term care residents is unknown, said Dr. Dharmarajan of Montefiore Medical Center, New York.

Researchers surveyed clinicians at 17 long-term care facilities in nine states about their VTE prevention practices. Participating clinicians received copies of guidelines issued in 2008 by the American College of Chest Physicians for VTE prevention in hospitalized patients and an antithrombotic “toolkit” developed by the American Medical Directors Association.

After this educational intervention, the likelihood that a new resident would be assessed or given prophylaxis for VTE increased 14-fold in a logistic regression modeling analysis, Dr. Dharmarajan reported. Listing contraindications as a reason for not providing prophylaxis against VTE fell by 67%.

Significant changes in prophylaxis choices after the intervention included less reliance on aspirin alone (18% after vs. 36% before) and more reliance on compression devices alone (4% vs. 0%) or ambulation alone (55% vs. 39%). Common prophylactic measures that did not change significantly included the use of warfarin, heparin, low-molecular-weight heparin, fondaparinux, or stockings.

At youtube.com/ElsGlobalMedicalNews

Major Finding: A concerted, multidisciplinary effort increased adherence to vitamin D supplementation in elderly nursing home residents from 29% to 87% after 5 months.

Data Source: Project implemented in a 114-bed community nursing home affiliated with an academic medical center.

Disclosures: The investigators reported having no disclosures.

LONG BEACH, CALIF. — Adherence to a vitamin D supplementation protocol improved from 29% to 87% after 5 months among elderly residents of a 114-bed community-based nursing home.

The quality improvement interventions used in the project could be implemented in other nursing homes, Dr. Mamata Yanamadala and associates reported in a poster presentation at the annual meeting of the American Medical Directors Association.

Previous studies have shown that vitamin D supplementation reduces falls by approximately 22% in nursing home residents and that 700–800 IU of vitamin D supplements are needed per resident per day to reduce the risk of fracture in nursing home populations.

The project employed a FOCUS quality improvement model: find an issue, organize the team, clarify current practice, understand the causes of variation, and select a strategy to effect change.

The Duke University–affiliated nursing home had a per-resident target of 800 IU/day of vitamin D to reduce falls. The team incorporated the medical director, clinicians, the director of nursing, the home's committee on falls, nurses, and a pharmacist. At the start of the project, 30% of residents were receiving at least 800 IU/day of vitamin D. The team set a goal of 80%.

Nurses received education on the importance of vitamin D supplementation and were asked to notify physicians about patients who were not receiving adequate supplementation. To spark competition, graphs at each nurses' station displayed the number of residents currently receiving adequate supplementation, and staff were offered a prize if their unit met the 80% goal.

Pens with the saying “800 D a day Keep Falls Away” were distributed as reminders, and the admissions coordinator put a note in the charts of new patients reminding physicians to start supplementation. The falls committee alerted a physician about any patient who was vitamin D deficient despite receiving 800 IU/day, so that person could start receiving 50,000 IU/day of vitamin D.

The rate of falls averaged 30–40 per month before the project and did not significantly decrease as supplementation rates increased, contrary to findings in previous studies. But the current study was not designed to assess the affect of vitamin D on falls, said Dr. Yanamadala, of Duke University, Durham, N.C.

One of the four nursing units studied, which had high staff turnover, was slow to show progress toward the target, but 5 months after the start of the study, adherence rates on the units ranged from 83% to 91%. Out of 10 patients who kept falling while on 800 IU/day of vitamin D, 3 were found to have deficient serum concentrations of vitamin D.

In a separate poster presentation, Dr. Michael E. Felver of the Cleveland Clinic reported low vitamin D serum concentrations in 97% of 62 patients admitted for subacute care following hospitalization. He called that prevalence “staggeringly high.”

His study assessed 142 consecutive admissions to the clinic's Center for Rehabilitation and Post-Acute Care, and screened for vitamin insufficiency in any patient with clinical signs or risk factors for malnutrition but no current diagnosis of vitamin D deficiency.

Screening found that 97% had low vitamin D and 32% had vitamin D deficiency (with deficiency defined as a serum concentration below 20 ng/mL).

Nutritional status seemed to be the best predictor of vitamin D deficiency in this population, which was younger, was more likely to be male, and had a higher average body mass index and shorter length of stay than nursing home residents. Vitamin D amounts used to supplement long-term care residents may not be adequate for this population, Dr. Felver said, noting that most post-acute patients have had a disabling or prolonged episode of acute care and have multiple comorbidities, and many show exacerbations of chronic illnesses. All of this puts them at higher risk, he said.

Major Finding: A concerted, multidisciplinary effort increased adherence to vitamin D supplementation in elderly nursing home residents from 29% to 87% after 5 months.

Data Source: Project implemented in a 114-bed community nursing home affiliated with an academic medical center.

Disclosures: The investigators reported having no disclosures.

LONG BEACH, CALIF. — Adherence to a vitamin D supplementation protocol improved from 29% to 87% after 5 months among elderly residents of a 114-bed community-based nursing home.

The quality improvement interventions used in the project could be implemented in other nursing homes, Dr. Mamata Yanamadala and associates reported in a poster presentation at the annual meeting of the American Medical Directors Association.

Previous studies have shown that vitamin D supplementation reduces falls by approximately 22% in nursing home residents and that 700–800 IU of vitamin D supplements are needed per resident per day to reduce the risk of fracture in nursing home populations.

The project employed a FOCUS quality improvement model: find an issue, organize the team, clarify current practice, understand the causes of variation, and select a strategy to effect change.

The Duke University–affiliated nursing home had a per-resident target of 800 IU/day of vitamin D to reduce falls. The team incorporated the medical director, clinicians, the director of nursing, the home's committee on falls, nurses, and a pharmacist. At the start of the project, 30% of residents were receiving at least 800 IU/day of vitamin D. The team set a goal of 80%.

Nurses received education on the importance of vitamin D supplementation and were asked to notify physicians about patients who were not receiving adequate supplementation. To spark competition, graphs at each nurses' station displayed the number of residents currently receiving adequate supplementation, and staff were offered a prize if their unit met the 80% goal.

Pens with the saying “800 D a day Keep Falls Away” were distributed as reminders, and the admissions coordinator put a note in the charts of new patients reminding physicians to start supplementation. The falls committee alerted a physician about any patient who was vitamin D deficient despite receiving 800 IU/day, so that person could start receiving 50,000 IU/day of vitamin D.

The rate of falls averaged 30–40 per month before the project and did not significantly decrease as supplementation rates increased, contrary to findings in previous studies. But the current study was not designed to assess the affect of vitamin D on falls, said Dr. Yanamadala, of Duke University, Durham, N.C.

One of the four nursing units studied, which had high staff turnover, was slow to show progress toward the target, but 5 months after the start of the study, adherence rates on the units ranged from 83% to 91%. Out of 10 patients who kept falling while on 800 IU/day of vitamin D, 3 were found to have deficient serum concentrations of vitamin D.

In a separate poster presentation, Dr. Michael E. Felver of the Cleveland Clinic reported low vitamin D serum concentrations in 97% of 62 patients admitted for subacute care following hospitalization. He called that prevalence “staggeringly high.”

His study assessed 142 consecutive admissions to the clinic's Center for Rehabilitation and Post-Acute Care, and screened for vitamin insufficiency in any patient with clinical signs or risk factors for malnutrition but no current diagnosis of vitamin D deficiency.

Screening found that 97% had low vitamin D and 32% had vitamin D deficiency (with deficiency defined as a serum concentration below 20 ng/mL).

Nutritional status seemed to be the best predictor of vitamin D deficiency in this population, which was younger, was more likely to be male, and had a higher average body mass index and shorter length of stay than nursing home residents. Vitamin D amounts used to supplement long-term care residents may not be adequate for this population, Dr. Felver said, noting that most post-acute patients have had a disabling or prolonged episode of acute care and have multiple comorbidities, and many show exacerbations of chronic illnesses. All of this puts them at higher risk, he said.

Major Finding: A concerted, multidisciplinary effort increased adherence to vitamin D supplementation in elderly nursing home residents from 29% to 87% after 5 months.

Data Source: Project implemented in a 114-bed community nursing home affiliated with an academic medical center.

Disclosures: The investigators reported having no disclosures.

LONG BEACH, CALIF. — Adherence to a vitamin D supplementation protocol improved from 29% to 87% after 5 months among elderly residents of a 114-bed community-based nursing home.

The quality improvement interventions used in the project could be implemented in other nursing homes, Dr. Mamata Yanamadala and associates reported in a poster presentation at the annual meeting of the American Medical Directors Association.

Previous studies have shown that vitamin D supplementation reduces falls by approximately 22% in nursing home residents and that 700–800 IU of vitamin D supplements are needed per resident per day to reduce the risk of fracture in nursing home populations.

The project employed a FOCUS quality improvement model: find an issue, organize the team, clarify current practice, understand the causes of variation, and select a strategy to effect change.

The Duke University–affiliated nursing home had a per-resident target of 800 IU/day of vitamin D to reduce falls. The team incorporated the medical director, clinicians, the director of nursing, the home's committee on falls, nurses, and a pharmacist. At the start of the project, 30% of residents were receiving at least 800 IU/day of vitamin D. The team set a goal of 80%.

Nurses received education on the importance of vitamin D supplementation and were asked to notify physicians about patients who were not receiving adequate supplementation. To spark competition, graphs at each nurses' station displayed the number of residents currently receiving adequate supplementation, and staff were offered a prize if their unit met the 80% goal.

Pens with the saying “800 D a day Keep Falls Away” were distributed as reminders, and the admissions coordinator put a note in the charts of new patients reminding physicians to start supplementation. The falls committee alerted a physician about any patient who was vitamin D deficient despite receiving 800 IU/day, so that person could start receiving 50,000 IU/day of vitamin D.

The rate of falls averaged 30–40 per month before the project and did not significantly decrease as supplementation rates increased, contrary to findings in previous studies. But the current study was not designed to assess the affect of vitamin D on falls, said Dr. Yanamadala, of Duke University, Durham, N.C.

One of the four nursing units studied, which had high staff turnover, was slow to show progress toward the target, but 5 months after the start of the study, adherence rates on the units ranged from 83% to 91%. Out of 10 patients who kept falling while on 800 IU/day of vitamin D, 3 were found to have deficient serum concentrations of vitamin D.

In a separate poster presentation, Dr. Michael E. Felver of the Cleveland Clinic reported low vitamin D serum concentrations in 97% of 62 patients admitted for subacute care following hospitalization. He called that prevalence “staggeringly high.”

His study assessed 142 consecutive admissions to the clinic's Center for Rehabilitation and Post-Acute Care, and screened for vitamin insufficiency in any patient with clinical signs or risk factors for malnutrition but no current diagnosis of vitamin D deficiency.

Screening found that 97% had low vitamin D and 32% had vitamin D deficiency (with deficiency defined as a serum concentration below 20 ng/mL).

Nutritional status seemed to be the best predictor of vitamin D deficiency in this population, which was younger, was more likely to be male, and had a higher average body mass index and shorter length of stay than nursing home residents. Vitamin D amounts used to supplement long-term care residents may not be adequate for this population, Dr. Felver said, noting that most post-acute patients have had a disabling or prolonged episode of acute care and have multiple comorbidities, and many show exacerbations of chronic illnesses. All of this puts them at higher risk, he said.

Major Finding: Among older patients treated topically for knee osteoarthritis for 12 weeks, adverse events occurred in 56% using diclofenac sodium 1% gel and in 44% using placebo, with one serious adverse event in the drug group possibly related to treatment.

Data Source: A post hoc analysis of data on 538 patients aged 65 years or older from three double-blind, randomized controlled trials.

Disclosures: Dr. Barthel conducted the study under a research contract for Novartis, which makes the gel. His associates in the study were employees of Novartis or of Endo Pharmaceuticals, which markets the gel.

LONG BEACH, CALIF. — A higher rate of adverse events in older patients with knee osteoarthritis treated topically for 12 weeks with a nonsteroidal anti-inflammatory drug, compared with placebo, was caused mainly by application-site reactions but included one serious cardiovascular event that might have been related to the drug treatment, a post hoc analysis of data on 538 patients found.

The investigators analyzed data on people aged 65 years and older with symptomatic knee osteoarthritis (433 of them with comorbid hypertension, diabetes, or cardiovascular disease). Their source was three larger randomized, double-blind trials—two of them unpublished—that had looked at broader populations. Patients applied 4 g/day of either diclofenac sodium 1% gel (Voltaren) or the drug's vehicle to one painful knee. (Those with bilateral knee osteoarthritis treated the more symptomatic knee for the study.)

One 80-year-old woman with hypertension and diabetes, among the 274 patients on diclofenac sodium 1% gel, developed deep vein thrombosis and pulmonary embolism that possibly was related to treatment, Dr. H. Richard Barthel and associates reported in a poster presentation at the annual meeting of the American Medical Directors Association.

Overall, 56% of patients on diclofenac gel developed adverse events, compared with 44% of 264 patients treated with placebo gel, added Dr. Barthel, a rheumatologist in Santa Barbara, Calif., who conducts research under contract for Voltaren's maker, Novartis.

The analysis did not assess statistical significance because the study was not powered to do so. Voltaren is approved to treat osteoarthritis pain in joints amenable to topical treatment, such as knees and hands.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are known to increase risk for cardiovascular or renal problems in a dose-related fashion, especially in older patients and people with hypertension, diabetes, or cardiovascular disease. Topical formulations may reduce this risk by reducing systemic exposure to NSAIDs compared with oral formulations. The ad hoc analysis compared the gel only to placebo, not to oral therapy, and found higher rates of adverse events for the drug vs. placebo.

Application-site reactions occurred in 8.8% on diclofenac gel and 1.1% on placebo. Serious adverse events occurred in 2.6% on diclofenac and 1.1% on placebo. Adverse cardiovascular events were seen in 2.6% on diclofenac and 1.1% on placebo. Adverse renal events were seen in 1.1% on diclofenac and 0.4% on placebo.

Among more common adverse events, 11% of subjects on diclofenac and 10% on placebo reported headache, 8% on diclofenac and 7% on placebo reported arthralgia, and 8% on diclofenac and 6% on placebo reported back pain.

The analysis included 307 patients with hypertension, 84 with diabetes, and 42 with cardiovascular disease. In the hypertension subgroup, adverse events were seen in 54% of 159 people randomized to diclofenac gel, compared with 45% of 148 people using placebo. In patients without hypertension, adverse events occurred in 58% of 115 on diclofenac gel and 42% of 116 on placebo.

In the diabetes subgroup, adverse events occurred in 19 (51%) of 37 patients treated with diclofenac and in 21 (48%) of 47 treated with placebo. In patients without diabetes, adverse events occurred in 56% of 237 on diclofenac and in 44% of 217 on placebo.

In the subgroup with cardiovascular disease, adverse events occurred in 15 (56%) of 27 on diclofenac and in 2 (13%) of 15 on placebo, though none developed an adverse cardiovascular event. In patients with no cardiovascular disease, adverse events occurred in 56% of 247 on diclofenac and in 46% of 249 on placebo.

No renal adverse events were seen in patients with diabetes or cardiovascular disease in these short-term studies.

My Take

Topical Shows 'Improved Safety'

The therapy of osteoarthritis remains insufficient in many patients. It is particularly problematic in the elderly, who often have concomitant diseases that limit our options for several of the oral medications, particularly nonsteroidal anti-inflammatory drugs and potent analgesics. The recent U.S. Food and Drug Administration approval of diclofenac has changed the therapeutic paradigm. Diclofenac gel 1% has been approved for osteoarthritis of the knee, hand, and other superficial joints, and Pennsaid has been approved for osteoarthritis of the knee.

In this analysis, we see an increase in irritation at the site of application, but a minimal increase in adverse events involving blood pressure, renal function, hepatic dysfunction, and gastrointestinal ulcer disease. Pharmacokinetic studies have demonstrated that systemic absorption of the topical diclofenac is 40 times less than oral diclofenac. This improved safety allows us to provide therapy to patients otherwise unable to receive anti-inflammatory drugs.

It will be no surprise if the guidelines for therapy of osteoarthritis from the United States will soon approximate those from Europe, where topical NSAIDs are part of the therapeutic algorithm for osteoarthritis. Are they completely safe? No. Is there no long-term cardiovascular risk? It has not been studied. Hence, the “black box” warning is applied to these agents that primarily list topical changes under adverse events.

Roy D. Altman, M.D., is professor of medicine in the division of rheumatology and immunology at the University of California, Los Angeles. He has been a consultant to Novartis, Eli Lilly, Ferring Pharmaceuticals, and Rottapharm/Madaus.

Vitals

Major Finding: Among older patients treated topically for knee osteoarthritis for 12 weeks, adverse events occurred in 56% using diclofenac sodium 1% gel and in 44% using placebo, with one serious adverse event in the drug group possibly related to treatment.

Data Source: A post hoc analysis of data on 538 patients aged 65 years or older from three double-blind, randomized controlled trials.

Disclosures: Dr. Barthel conducted the study under a research contract for Novartis, which makes the gel. His associates in the study were employees of Novartis or of Endo Pharmaceuticals, which markets the gel.

LONG BEACH, CALIF. — A higher rate of adverse events in older patients with knee osteoarthritis treated topically for 12 weeks with a nonsteroidal anti-inflammatory drug, compared with placebo, was caused mainly by application-site reactions but included one serious cardiovascular event that might have been related to the drug treatment, a post hoc analysis of data on 538 patients found.

The investigators analyzed data on people aged 65 years and older with symptomatic knee osteoarthritis (433 of them with comorbid hypertension, diabetes, or cardiovascular disease). Their source was three larger randomized, double-blind trials—two of them unpublished—that had looked at broader populations. Patients applied 4 g/day of either diclofenac sodium 1% gel (Voltaren) or the drug's vehicle to one painful knee. (Those with bilateral knee osteoarthritis treated the more symptomatic knee for the study.)

One 80-year-old woman with hypertension and diabetes, among the 274 patients on diclofenac sodium 1% gel, developed deep vein thrombosis and pulmonary embolism that possibly was related to treatment, Dr. H. Richard Barthel and associates reported in a poster presentation at the annual meeting of the American Medical Directors Association.

Overall, 56% of patients on diclofenac gel developed adverse events, compared with 44% of 264 patients treated with placebo gel, added Dr. Barthel, a rheumatologist in Santa Barbara, Calif., who conducts research under contract for Voltaren's maker, Novartis.

The analysis did not assess statistical significance because the study was not powered to do so. Voltaren is approved to treat osteoarthritis pain in joints amenable to topical treatment, such as knees and hands.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are known to increase risk for cardiovascular or renal problems in a dose-related fashion, especially in older patients and people with hypertension, diabetes, or cardiovascular disease. Topical formulations may reduce this risk by reducing systemic exposure to NSAIDs compared with oral formulations. The ad hoc analysis compared the gel only to placebo, not to oral therapy, and found higher rates of adverse events for the drug vs. placebo.

Application-site reactions occurred in 8.8% on diclofenac gel and 1.1% on placebo. Serious adverse events occurred in 2.6% on diclofenac and 1.1% on placebo. Adverse cardiovascular events were seen in 2.6% on diclofenac and 1.1% on placebo. Adverse renal events were seen in 1.1% on diclofenac and 0.4% on placebo.

Among more common adverse events, 11% of subjects on diclofenac and 10% on placebo reported headache, 8% on diclofenac and 7% on placebo reported arthralgia, and 8% on diclofenac and 6% on placebo reported back pain.

The analysis included 307 patients with hypertension, 84 with diabetes, and 42 with cardiovascular disease. In the hypertension subgroup, adverse events were seen in 54% of 159 people randomized to diclofenac gel, compared with 45% of 148 people using placebo. In patients without hypertension, adverse events occurred in 58% of 115 on diclofenac gel and 42% of 116 on placebo.

In the diabetes subgroup, adverse events occurred in 19 (51%) of 37 patients treated with diclofenac and in 21 (48%) of 47 treated with placebo. In patients without diabetes, adverse events occurred in 56% of 237 on diclofenac and in 44% of 217 on placebo.

In the subgroup with cardiovascular disease, adverse events occurred in 15 (56%) of 27 on diclofenac and in 2 (13%) of 15 on placebo, though none developed an adverse cardiovascular event. In patients with no cardiovascular disease, adverse events occurred in 56% of 247 on diclofenac and in 46% of 249 on placebo.

No renal adverse events were seen in patients with diabetes or cardiovascular disease in these short-term studies.

My Take

Topical Shows 'Improved Safety'

The therapy of osteoarthritis remains insufficient in many patients. It is particularly problematic in the elderly, who often have concomitant diseases that limit our options for several of the oral medications, particularly nonsteroidal anti-inflammatory drugs and potent analgesics. The recent U.S. Food and Drug Administration approval of diclofenac has changed the therapeutic paradigm. Diclofenac gel 1% has been approved for osteoarthritis of the knee, hand, and other superficial joints, and Pennsaid has been approved for osteoarthritis of the knee.

In this analysis, we see an increase in irritation at the site of application, but a minimal increase in adverse events involving blood pressure, renal function, hepatic dysfunction, and gastrointestinal ulcer disease. Pharmacokinetic studies have demonstrated that systemic absorption of the topical diclofenac is 40 times less than oral diclofenac. This improved safety allows us to provide therapy to patients otherwise unable to receive anti-inflammatory drugs.

It will be no surprise if the guidelines for therapy of osteoarthritis from the United States will soon approximate those from Europe, where topical NSAIDs are part of the therapeutic algorithm for osteoarthritis. Are they completely safe? No. Is there no long-term cardiovascular risk? It has not been studied. Hence, the “black box” warning is applied to these agents that primarily list topical changes under adverse events.

Roy D. Altman, M.D., is professor of medicine in the division of rheumatology and immunology at the University of California, Los Angeles. He has been a consultant to Novartis, Eli Lilly, Ferring Pharmaceuticals, and Rottapharm/Madaus.

Vitals

Major Finding: Among older patients treated topically for knee osteoarthritis for 12 weeks, adverse events occurred in 56% using diclofenac sodium 1% gel and in 44% using placebo, with one serious adverse event in the drug group possibly related to treatment.

Data Source: A post hoc analysis of data on 538 patients aged 65 years or older from three double-blind, randomized controlled trials.

Disclosures: Dr. Barthel conducted the study under a research contract for Novartis, which makes the gel. His associates in the study were employees of Novartis or of Endo Pharmaceuticals, which markets the gel.

LONG BEACH, CALIF. — A higher rate of adverse events in older patients with knee osteoarthritis treated topically for 12 weeks with a nonsteroidal anti-inflammatory drug, compared with placebo, was caused mainly by application-site reactions but included one serious cardiovascular event that might have been related to the drug treatment, a post hoc analysis of data on 538 patients found.

The investigators analyzed data on people aged 65 years and older with symptomatic knee osteoarthritis (433 of them with comorbid hypertension, diabetes, or cardiovascular disease). Their source was three larger randomized, double-blind trials—two of them unpublished—that had looked at broader populations. Patients applied 4 g/day of either diclofenac sodium 1% gel (Voltaren) or the drug's vehicle to one painful knee. (Those with bilateral knee osteoarthritis treated the more symptomatic knee for the study.)

One 80-year-old woman with hypertension and diabetes, among the 274 patients on diclofenac sodium 1% gel, developed deep vein thrombosis and pulmonary embolism that possibly was related to treatment, Dr. H. Richard Barthel and associates reported in a poster presentation at the annual meeting of the American Medical Directors Association.

Overall, 56% of patients on diclofenac gel developed adverse events, compared with 44% of 264 patients treated with placebo gel, added Dr. Barthel, a rheumatologist in Santa Barbara, Calif., who conducts research under contract for Voltaren's maker, Novartis.

The analysis did not assess statistical significance because the study was not powered to do so. Voltaren is approved to treat osteoarthritis pain in joints amenable to topical treatment, such as knees and hands.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are known to increase risk for cardiovascular or renal problems in a dose-related fashion, especially in older patients and people with hypertension, diabetes, or cardiovascular disease. Topical formulations may reduce this risk by reducing systemic exposure to NSAIDs compared with oral formulations. The ad hoc analysis compared the gel only to placebo, not to oral therapy, and found higher rates of adverse events for the drug vs. placebo.

Application-site reactions occurred in 8.8% on diclofenac gel and 1.1% on placebo. Serious adverse events occurred in 2.6% on diclofenac and 1.1% on placebo. Adverse cardiovascular events were seen in 2.6% on diclofenac and 1.1% on placebo. Adverse renal events were seen in 1.1% on diclofenac and 0.4% on placebo.

Among more common adverse events, 11% of subjects on diclofenac and 10% on placebo reported headache, 8% on diclofenac and 7% on placebo reported arthralgia, and 8% on diclofenac and 6% on placebo reported back pain.

The analysis included 307 patients with hypertension, 84 with diabetes, and 42 with cardiovascular disease. In the hypertension subgroup, adverse events were seen in 54% of 159 people randomized to diclofenac gel, compared with 45% of 148 people using placebo. In patients without hypertension, adverse events occurred in 58% of 115 on diclofenac gel and 42% of 116 on placebo.

In the diabetes subgroup, adverse events occurred in 19 (51%) of 37 patients treated with diclofenac and in 21 (48%) of 47 treated with placebo. In patients without diabetes, adverse events occurred in 56% of 237 on diclofenac and in 44% of 217 on placebo.

In the subgroup with cardiovascular disease, adverse events occurred in 15 (56%) of 27 on diclofenac and in 2 (13%) of 15 on placebo, though none developed an adverse cardiovascular event. In patients with no cardiovascular disease, adverse events occurred in 56% of 247 on diclofenac and in 46% of 249 on placebo.

No renal adverse events were seen in patients with diabetes or cardiovascular disease in these short-term studies.

My Take

Topical Shows 'Improved Safety'

The therapy of osteoarthritis remains insufficient in many patients. It is particularly problematic in the elderly, who often have concomitant diseases that limit our options for several of the oral medications, particularly nonsteroidal anti-inflammatory drugs and potent analgesics. The recent U.S. Food and Drug Administration approval of diclofenac has changed the therapeutic paradigm. Diclofenac gel 1% has been approved for osteoarthritis of the knee, hand, and other superficial joints, and Pennsaid has been approved for osteoarthritis of the knee.

In this analysis, we see an increase in irritation at the site of application, but a minimal increase in adverse events involving blood pressure, renal function, hepatic dysfunction, and gastrointestinal ulcer disease. Pharmacokinetic studies have demonstrated that systemic absorption of the topical diclofenac is 40 times less than oral diclofenac. This improved safety allows us to provide therapy to patients otherwise unable to receive anti-inflammatory drugs.

It will be no surprise if the guidelines for therapy of osteoarthritis from the United States will soon approximate those from Europe, where topical NSAIDs are part of the therapeutic algorithm for osteoarthritis. Are they completely safe? No. Is there no long-term cardiovascular risk? It has not been studied. Hence, the “black box” warning is applied to these agents that primarily list topical changes under adverse events.

Roy D. Altman, M.D., is professor of medicine in the division of rheumatology and immunology at the University of California, Los Angeles. He has been a consultant to Novartis, Eli Lilly, Ferring Pharmaceuticals, and Rottapharm/Madaus.

Vitals