Supplement Limited Progression in Hip OA

ROME — Treatment of patients with the dietary supplement avocado-soybean unsaponifiables over 3 years led to a modest but statistically significant reduction in radiographic disease progression in a placebo-controlled study with 345 people with symptomatic hip osteoarthritis.

“The results indicate a potential structure-modifying effect of ASU [avocado-soybean unsaponifiables] over 3 years,” Dr. Emmanuel Maheu said at the annual meeting of the European Congress of Rheumatology.

The finding follows earlier reports that treatment of osteoarthritis with ASU led to “moderate clinical effects on pain and function,” said Dr. Maheu, a rheumatologist at St. Antoine Hospital in Paris.

The new findings “indicate modest structural efficacy from ASU in hip osteoarthritis,” commented Dr. Laure Gossec, a rheumatologist at Cochin Hospital in Paris, who was not involved in the study.

Based on results from pre-clinical studies, ASU is believed to counter the effects of interleukin-1, a cytokine active in the degradation processes of osteoarthritis. ASU might also affect the catabolic-anabolic balance in patients with osteoarthritis, Dr. Maheu said.

The study enrolled patients aged 45 years or older with painful osteoarthritis of the hip that met the clinical and radiologic diagnostic criteria of the American College of Rheumatology. A total of 399 patients met the enrollment criteria and began the study, with 345 undergoing at least two follow-up radiographs that made them eligible for the primary outcome assessment, including 179 in the placebo group and 166 patients who received 300 mg ASU daily.

A total of 237 patients completed all 3 years of treatment, with an equal number of patients withdrawing from the study in each of the two treatment arms. The most common reason for withdrawal from the study was hip replacement surgery. The average age of the patients was 62 years, and slightly more than half were women. Their average joint space width in the affected hip joint at baseline was about 2.8 mm.

The investigators defined progressive structural disease during the study as further loss of at least 0.5 mm of joint space width. This occurred in 50% of the placebo patients and 40% of the patients on ASU, a 10% absolute difference and a 20% relative reduction with ASU that was statistically significant.

Patients treated with ASU had no improvement in their symptom and pain scores compared with the placebo patients, but the study was not designed to assess changes in these end points, Dr. Maheu noted.

The safety profile of patients treated with ASU closely matched the placebo group. Treatment-related adverse events occurred in 4% of placebo patients and 8% of those on ASU. Adverse events leading to withdrawal from the study occurred in 6% of patients in each group.

The supplement is an extract made from avocado and soybean oils that is taken in a 300-mg softgel preparation.

Disclosures: ASU is marketed as a drug in France and several other countries by Expanscience Labs, a French company. The study was sponsored by Expanscience, and Dr. Maheu has received consulting fees and research support from Expanscience; several coauthors on the study are employees of the Expanscience. ASU is marketed as a supplement in the United States.

Source ©subjug/iStockphoto.com

ROME — Treatment of patients with the dietary supplement avocado-soybean unsaponifiables over 3 years led to a modest but statistically significant reduction in radiographic disease progression in a placebo-controlled study with 345 people with symptomatic hip osteoarthritis.

“The results indicate a potential structure-modifying effect of ASU [avocado-soybean unsaponifiables] over 3 years,” Dr. Emmanuel Maheu said at the annual meeting of the European Congress of Rheumatology.

The finding follows earlier reports that treatment of osteoarthritis with ASU led to “moderate clinical effects on pain and function,” said Dr. Maheu, a rheumatologist at St. Antoine Hospital in Paris.

The new findings “indicate modest structural efficacy from ASU in hip osteoarthritis,” commented Dr. Laure Gossec, a rheumatologist at Cochin Hospital in Paris, who was not involved in the study.

Based on results from pre-clinical studies, ASU is believed to counter the effects of interleukin-1, a cytokine active in the degradation processes of osteoarthritis. ASU might also affect the catabolic-anabolic balance in patients with osteoarthritis, Dr. Maheu said.

The study enrolled patients aged 45 years or older with painful osteoarthritis of the hip that met the clinical and radiologic diagnostic criteria of the American College of Rheumatology. A total of 399 patients met the enrollment criteria and began the study, with 345 undergoing at least two follow-up radiographs that made them eligible for the primary outcome assessment, including 179 in the placebo group and 166 patients who received 300 mg ASU daily.

A total of 237 patients completed all 3 years of treatment, with an equal number of patients withdrawing from the study in each of the two treatment arms. The most common reason for withdrawal from the study was hip replacement surgery. The average age of the patients was 62 years, and slightly more than half were women. Their average joint space width in the affected hip joint at baseline was about 2.8 mm.

The investigators defined progressive structural disease during the study as further loss of at least 0.5 mm of joint space width. This occurred in 50% of the placebo patients and 40% of the patients on ASU, a 10% absolute difference and a 20% relative reduction with ASU that was statistically significant.

Patients treated with ASU had no improvement in their symptom and pain scores compared with the placebo patients, but the study was not designed to assess changes in these end points, Dr. Maheu noted.

The safety profile of patients treated with ASU closely matched the placebo group. Treatment-related adverse events occurred in 4% of placebo patients and 8% of those on ASU. Adverse events leading to withdrawal from the study occurred in 6% of patients in each group.

The supplement is an extract made from avocado and soybean oils that is taken in a 300-mg softgel preparation.

Disclosures: ASU is marketed as a drug in France and several other countries by Expanscience Labs, a French company. The study was sponsored by Expanscience, and Dr. Maheu has received consulting fees and research support from Expanscience; several coauthors on the study are employees of the Expanscience. ASU is marketed as a supplement in the United States.

Source ©subjug/iStockphoto.com

ROME — Treatment of patients with the dietary supplement avocado-soybean unsaponifiables over 3 years led to a modest but statistically significant reduction in radiographic disease progression in a placebo-controlled study with 345 people with symptomatic hip osteoarthritis.

“The results indicate a potential structure-modifying effect of ASU [avocado-soybean unsaponifiables] over 3 years,” Dr. Emmanuel Maheu said at the annual meeting of the European Congress of Rheumatology.

The finding follows earlier reports that treatment of osteoarthritis with ASU led to “moderate clinical effects on pain and function,” said Dr. Maheu, a rheumatologist at St. Antoine Hospital in Paris.

The new findings “indicate modest structural efficacy from ASU in hip osteoarthritis,” commented Dr. Laure Gossec, a rheumatologist at Cochin Hospital in Paris, who was not involved in the study.

Based on results from pre-clinical studies, ASU is believed to counter the effects of interleukin-1, a cytokine active in the degradation processes of osteoarthritis. ASU might also affect the catabolic-anabolic balance in patients with osteoarthritis, Dr. Maheu said.

The study enrolled patients aged 45 years or older with painful osteoarthritis of the hip that met the clinical and radiologic diagnostic criteria of the American College of Rheumatology. A total of 399 patients met the enrollment criteria and began the study, with 345 undergoing at least two follow-up radiographs that made them eligible for the primary outcome assessment, including 179 in the placebo group and 166 patients who received 300 mg ASU daily.

A total of 237 patients completed all 3 years of treatment, with an equal number of patients withdrawing from the study in each of the two treatment arms. The most common reason for withdrawal from the study was hip replacement surgery. The average age of the patients was 62 years, and slightly more than half were women. Their average joint space width in the affected hip joint at baseline was about 2.8 mm.

The investigators defined progressive structural disease during the study as further loss of at least 0.5 mm of joint space width. This occurred in 50% of the placebo patients and 40% of the patients on ASU, a 10% absolute difference and a 20% relative reduction with ASU that was statistically significant.

Patients treated with ASU had no improvement in their symptom and pain scores compared with the placebo patients, but the study was not designed to assess changes in these end points, Dr. Maheu noted.

The safety profile of patients treated with ASU closely matched the placebo group. Treatment-related adverse events occurred in 4% of placebo patients and 8% of those on ASU. Adverse events leading to withdrawal from the study occurred in 6% of patients in each group.

The supplement is an extract made from avocado and soybean oils that is taken in a 300-mg softgel preparation.

Disclosures: ASU is marketed as a drug in France and several other countries by Expanscience Labs, a French company. The study was sponsored by Expanscience, and Dr. Maheu has received consulting fees and research support from Expanscience; several coauthors on the study are employees of the Expanscience. ASU is marketed as a supplement in the United States.

Source ©subjug/iStockphoto.com