Mesoglycan [Discontinued] by EuroMedica

POSSIBLY EFFECTIVE

• Cerebrovascular disease. Preliminary clinical research in small groups of patients with cerebrovascular disease shows that taking mesoglycan 96-100 mg daily orally for 6 months seems to reduce ischemic events, improve quality of life, and provide subjective improvement when compared with baseline (6635,6637,6639). The validity of this finding is limited by the lack of a comparator group. There is also some preliminary evidence that mesoglycan might be comparable to standard antiplatelet drug therapy (6639).
• Peripheral arterial disease (PAD). The majority of preliminary clinical research shows that mesoglycan improves walking distance in patients with PAD, although it may not be as effective as other therapies. Alternating intravenous and oral mesoglycan seems to improve walking distance when compared with baseline in patients with intermittent claudication due to PAD (6629). Also, injecting mesoglycan 30 mg intramuscularly for 3 weeks then taking oral mesoglycan 100 mg daily for 20 weeks appears to improve clinical response and walking distance in patients with PAD when compared with placebo (31635). Taking mesoglycan 100 mg daily orally for a total of 120 days increases walking distance by approximately 39% when compared with baseline (97779). However, taking oral mesoglycan 48 mg daily for 6 months is less effective at improving pain-free walking distance and total walking distance than oral defibrotide 800 mg daily in patients with intermittent claudication due to PAD (31647).
• Venous insufficiency. There is some evidence from uncontrolled trials that administering mesoglycan orally or parenterally may improve the subjective and objective symptoms associated with various venous conditions, including varicose syndromes, post-phlebitic syndromes, and thrombophlebitis, when used over a 1-3 month period (6630,6638,6644,6645). Some research also shows that applying mesoglycan topically might be beneficial for treating leg ulcers in patients with chronic venous insufficiency (6627).
• Venous leg ulcers. Clinical research shows that administering a combination of intramuscular and oral mesoglycan as an adjunct to traditional chronic venous stasis ulcer therapy improves the rate of healing when compared with traditional therapy alone. At least 75% of patients taking mesoglycan were fully healed approximately 46 days earlier than patients taking traditional therapy alone (11479).

POSSIBLY INEFFECTIVE

• Venous thromboembolism (VTE). Clinical research shows that taking oral mesoglycan plus compression stockings following standard deep venous thrombosis (DVT) therapy is no better than placebo for preventing recurrent DVT and/or pulmonary embolism during a follow-up period ranging from 5 to 48 months (6640).
• Stroke. Clinical research in patients with acute ischemic stroke shows that adding intramuscular mesoglycan for 5 days, followed by 25 days of oral mesoglycan, to intravenous dexamethasone therapy is no more effective than dexamethasone alone (6641).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Atherosclerosis. Preliminary clinical research shows that taking oral mesoglycan 200 mg daily for 18 months might slow the progression of atherosclerosis by decreasing the rate of carotid and femoral artery intima-media thickening (6628,31649).
• Chronic venous insufficiency (CVI). Preliminary clinical research in adults with unilateral lower limb edema due to CVI shows that taking mesoglycan 100 mg daily for one month reduces pain and swelling by approximately 43% and 63%, respectively, when compared with placebo (97778).
• Cutaneous necrotizing venulitis. Preliminary clinical research shows that intramuscular mesoglycan 10 mg/kg daily for 20 days might be useful for treating cutaneous necrotizing venulitis in patients with reduced fibrinolytic activity (6634).
• Diabetic retinopathy. Preliminary clinical research in adults with diabetic retinopathy shows that taking mesoglycan 100 mg daily for 6 months reduces the occurrence of microhemorrhages, microaneurysms, and exudates, compared with no change in those taking placebo (97777).
• Hypertension. Preliminary clinical research shows that taking mesoglycan 100 mg daily orally for a total of 120 days reduces systolic blood pressure by 5 mmHg when compared to baseline in patients with hypertension (97779). The validity of this finding is limited by the lack of a comparator group.
• Hypertriglyceridemia. Preliminary clinical research in a small group of patients shows that taking mesoglycan 96 mg daily reduces total triglyceride and very low density lipoprotein (VLDL) levels when compared to baseline in patients with hypertriglyceridemia (6646).The validity of this finding is limited by the lack of a comparator group.
• Metabolic syndrome. Preliminary clinical research in a small group of patients with metabolic syndrome shows that taking mesoglycan 50 mg twice daily for 90 days improves vascular function, as measured by brachial flow-mediated dilation and arterial stiffness, when compared with placebo (103265).
• Postoperative pain. Preliminary, prospective clinical research in a small group of patients undergoing open excisional diathermy hemorrhoidectomy shows that intramuscular mesoglycan (Prisma, Mediolanum Farmaceutici) 60 mg daily for 5 days postoperatively, then 50 mg orally twice daily for 30 days, reduces pain after rectal examination, but not spontaneous pain or pain after defecation, and shortens the time to full resumption of normal daily activities, when compared with ketorolac 10 mg orally every 4-6 hours for 5 days (103263). A retrospective, observational study in a larger group of patients undergoing the same surgery shows that giving the same mesoglycan regimen in conjunction with the ketorolac regimen reduces pain on postoperative day 1 and after 1, 3, and 6 weeks of follow-up when compared with the ketorolac regimen alone. The addition of mesoglycan also reduces the incidence of postoperative rectal thromboses and the time to recovery of normal activities, but does not reduce postoperative bleeding or time to wound healing, when compared with ketorolac alone (109651).
• Tinnitus. Observational research in patients with tinnitus has found that taking mesoglycan 50 mg daily for 90 days is associated with an improvement in tinnitus when compared to baseline (103264). The validity of this finding is limited by the lack of a comparator group .
• Vertigo. Observational research in patients with vertigo has found that taking mesoglycan 50 mg daily for 90 days is associated with an improvement in vertigo symptoms when compared to baseline (103264). The validity of this finding is limited by the lack of a comparator group. More evidence is needed to rate mesoglycan for these uses.

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POSSIBLY SAFE ...when used orally and appropriately. Mesoglycan has been used safely at doses of up to 200 mg daily for up to 18 months (6635,6637,6638,6639,6644,6645,11479,31647,31649,97777)(97778,97779,103263,103264,103265). ...when used intramuscularly under the supervision of a healthcare provider. Mesoglycan has been used with apparent safety at doses of 60 mg daily for up to 5 days and doses up to 30 mg daily for up to 3 weeks (6630,11479,103263). Since mesoglycan products are derived from animals, there are concerns about contamination with diseased animal parts (1825). However, there are no reports of disease transmission to humans due to use of contaminated mesoglycan. There is insufficient reliable information available about the safety of mesoglycan when used topically or intravenously.

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

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General ...Orally, mesoglycan seems to be well tolerated. Some adverse effects reported in clinical studies include nausea, vomiting, epigastric pain, dyspepsia, heartburn, headache, diarrhea, and local cutaneous reactions (6629,97778,97779,103265).
However, there is some concern about potential contamination. Mesoglycan is derived from raw animal tissues gathered from slaughterhouses, possibly from sick or diseased animals (6620). Products made from contaminated or diseased organs might present a human health hazard. There is also concern that mesoglycan produced from cows in countries where bovine spongiform encephalitis (BSE) has been reported might be unsafe (1825). However, there are no reports of disease transfer to humans from contaminated mesoglycan.

Dermatologic ...Orally, mesoglycan has been reported to cause local cutaneous reactions (6629,97778).
Subcutaneously, injections of mesoglycan into the scalp were thought to result in edema, redness, and local hair loss in a 32-year-old female (97780).

Gastrointestinal ...Orally, mesoglycan has been reported to cause nausea, vomiting, epigastric pain, dyspepsia, heartburn, and diarrhea (6629,97779,103265).

Neurologic/CNS ...Orally, mesoglycan has been reported to cause headache (6629).

Other ...Mesoglycan is derived from raw animal tissues gathered from slaughterhouses, possibly from sick or diseased animals (6620). Products made from contaminated or diseased organs might present a human health hazard. However, there are no reports of disease transfer to humans from contaminated mesoglycan.
There is also some concern that mesoglycan that is obtained from cows in countries where bovine spongiform encephalopathy (BSE) has been reported might be unsafe. However, there are no reports of BSE transfer to humans from contaminated mesoglycan (1825).

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