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Glucovance (Glyburide / Metformin Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

GLUCOVANCE

In double-blind clinical trials involving GLUCOVANCE as initial therapy or as second-line therapy, a total of 642 patients received GLUCOVANCE, 312 received metformin therapy, 324 received glyburide therapy, and 161 received placebo. The percent of patients reporting events and types of adverse events reported in clinical trials of GLUCOVANCE (all strengths) as initial therapy and second-line therapy are listed in Table 6.

Table 6: Most Common Clinical Adverse Events (>5%) in Double-Blind Clinical Studies of GLUCOVANCE Used as Initial or Second-Line Therapy

Adverse Event
Number (%) of Patients
Placebo
N=161
Glyburide
N=324
Metformin
N=312
GLUCOVANCE
N=642
Upper respiratory infection 22 (13.7) 57 (17.6) 51 (16.3) 111 (17.3)
Diarrhea 9 (5.6) 20 (6.2) 64 (20.5) 109 (17.0)
Headache 17 (10.6) 37 (11.4) 29 (9.3) 57 (8.9)
Nausea/vomiting 10 (6.2) 17 (5.2) 38 (12.2) 49 (7.6)
Abdominal pain 6 (3.7) 10 (3.1) 25 (8.0) 44 (6.9)
Dizziness 7 (4.3) 18 (5.6) 12 (3.8) 35 (5.5)

In a controlled clinical trial of rosiglitazone versus placebo in patients treated with GLUCOVANCE (n=365), 181 patients received GLUCOVANCE with rosiglitazone and 184 received GLUCOVANCE with placebo.

Edema was reported in 7.7% (14/181) of patients treated with rosiglitazone compared to 2.2% (4/184) of patients treated with placebo. A mean weight gain of 3 kg was observed in rosiglitazone-treated patients.

Disulfiram-like reactions have very rarely been reported in patients treated with glyburide tablets.

Hypoglycemia

In controlled clinical trials of GLUCOVANCE there were no hypoglycemic episodes requiring medical intervention and/or pharmacologic therapy; all events were managed by the patients. The incidence of reported symptoms of hypoglycemia (such as dizziness, shakiness, sweating, and hunger), in the initial therapy trial of GLUCOVANCE are summarized in Table 7. The frequency of hypoglycemic symptoms in patients treated with GLUCOVANCE 1.25 mg/250 mg was highest in patients with a baseline HbA1c <7%, lower in those with a baseline HbA1c of between 7% and 8%, and was comparable to placebo and metformin in those with a baseline HbA1c >8%. For patients with a baseline HbA1c between 8% and 11% treated with GLUCOVANCE 2.5 mg/500 mg as initial therapy, the frequency of hypoglycemic symptoms was 30% to 35%. As second-line therapy in patients inadequately controlled on sulfonylurea alone, approximately 6.8% of all patients treated with GLUCOVANCE experienced hypoglycemic symptoms. When rosiglitazone was added to GLUCOVANCE therapy, 22% of patients reported 1 or more fingerstick glucose measurements ≤50 mg/dL compared to 3.3% of placebo-treated patients. All hypoglycemic events were managed by the patients and only 1 patient discontinued for hypoglycemia. (See PRECAUTIONS: General: Addition of Thiazolidinediones to GLUCOVANCE Therapy.)

Gastrointestinal Reactions

The incidence of gastrointestinal (GI) side effects (diarrhea, nausea/vomiting, and abdominal pain) in the initial therapy trial are summarized in Table 7. Across all GLUCOVANCE trials, GI symptoms were the most common adverse events with GLUCOVANCE and were more frequent at higher dose levels. In controlled trials, <2% of patients discontinued GLUCOVANCE therapy due to GI adverse events.

Table 7: Treatment Emergent Symptoms of Hypoglycemia or Gastrointestinal Adverse Events in a Placebo- and Active-Controlled Trial of GLUCOVANCE as Initial Therapy
Variable Placebo
N=161
Glyburide
Tablets
N=160
Metformin
Tablets
N=159
GLUCOVANCE
1.25 mg/250 mg
Tablets
N=158
GLUCOVANCE
2.5 mg/500 mg
Tablets
N=162
Mean Final Dose 0 mg 5.3 mg 1317 mg 2.78 mg/557 mg 4.1 mg/824 mg
Number (%) of patients
  with symptoms of
  hypoglycemia
5 (3.1) 34 (21.3) 5 (3.1) 18 (11.4) 61 (37.7)
Number (%) of patients
  with gastrointestinal
  adverse events
39 (24.2) 38 (23.8) 69 (43.3) 50 (31.6) 62 (38.3)

In postmarketing reports cholestatic jaundice and hepatitis may occur rarely which may progress to liver failure; GLUCOVANCE should be discontinued if this occurs.



REPORTS OF SUSPECTED GLUCOVANCE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Glucovance. The information is not vetted and should not be considered as verified clinical evidence.

Possible Glucovance side effects / adverse reactions in 80 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-16

Patient: 80 year old female

Reactions: Hepatic Cirrhosis

Suspect drug(s):
Omeprazole
    Dosage: 10 mg, 1x/day
    Administration route: Oral

Arthrotec
    Dosage: 75 mg, 2x/day
    Administration route: Oral
    End date: 2011-09-15

Irbesartan and Hydrochlorothiazide
    Dosage: 300mg/25mg, 1 dfx/1 day
    Administration route: Oral
    End date: 2011-09-15

Glucovance
    Dosage: 500mg/5mg, 1dfx/3day
    Administration route: Oral
    End date: 2011-09-15

Acetaminophen
    Dosage: 1 g, 3x/day
    Administration route: Oral

Lorazepam
    Dosage: 1 mg, 1x/day
    Administration route: Oral

Methotrexate
    Dosage: 12.5 mg, weekly
    Administration route: Oral



Possible Glucovance side effects / adverse reactions in female

Reported by a physician from France on 2011-12-22

Patient: female

Reactions: Hepatic Cirrhosis

Suspect drug(s):
Omeprazole
    Administration route: Oral

Methotrexate
    Dosage: 10 to 15 mg per week for around 10 years
    Administration route: Oral
    End date: 2011-09-15

Irbesartan and Hydrochlorothiazide
    Administration route: Oral
    End date: 2011-09-15

Lorazepam
    Administration route: Oral

Acetaminophen
    Administration route: Oral

Glucovance
    Administration route: Oral
    End date: 2011-09-15

Arthrotec
    Administration route: Oral
    End date: 2011-09-15



Possible Glucovance side effects / adverse reactions in 80 year old female

Reported by a physician from France on 2011-12-23

Patient: 80 year old female

Reactions: Hepatic Cirrhosis

Suspect drug(s):
Omeprazole
    Dosage: mopral 10 mg 1df:1tablet enteric coated tablet more than 3 years
    Administration route: Oral

Arthrotec
    Dosage: artotec 75 mg/0.2 mg 1df=1film-coated tablet
    Administration route: Oral
    End date: 2011-09-15

Methotrexate
    Dosage: for more than 10 years
    Administration route: Oral
    End date: 2011-09-15

Irbesartan and Hydrochlorothiazide
    Dosage: film coated tabs for more than 3 years 1df:1 tablet
    Administration route: Oral
    End date: 2011-09-15

Lorazepam
    Dosage: in the evng
    Administration route: Oral

Glucovance
    Dosage: 1df=1 tabs film coated tabs more than 3 years
    Administration route: Oral
    End date: 2011-09-15

Acetaminophen
    Dosage: doliprane 500mg
    Administration route: Oral



See index of all Glucovance side effect reports >>

Drug label data at the top of this Page last updated: 2012-04-23

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