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JANUVIA (SITAGLIPTIN): ADVERSE REACTIONS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In controlled clinical studies as both monotherapy and combination therapy with metformin, pioglitazone, or rosiglitazone and metformin, the overall incidence of adverse reactions, hypoglycemia, and discontinuation of therapy due to clinical adverse reactions with Sitagliptin (Januvia) were similar to placebo. In combination with glimepiride, with or without metformin, the overall incidence of clinical adverse reactions with Sitagliptin Phosphate (Januvia) was higher than with placebo, in part related to a higher incidence of hypoglycemia; the incidence of discontinuation due to clinical adverse reactions was similar to placebo.

Two placebo-controlled monotherapy studies, one of 18- and one of 24-week duration, included patients treated with Januvia 100 mg daily, Januvia 200 mg daily, and placebo. Five placebo-controlled add-on combination therapy studies were also conducted: one with metformin; one with pioglitazone; one with metformin and rosiglitazone; one with glimepiride (with or without metformin); and one with insulin (with or without metformin). In these trials, patients with inadequate glycemic control on a stable dose of the background therapy were randomized to add-on therapy with Januvia 100 mg daily or placebo. The adverse reactions, excluding hypoglycemia, reported regardless of investigator assessment of causality in >= 5% of patients treated with Januvia (Sitagliptin Phosphate) 100 mg daily and more commonly than in patients treated with placebo, are shown for the clinical trials of at least 18 weeks duration.

In the 24-week study of patients receiving Januvia (Sitagliptin) as add-on combination therapy with metformin, there were no adverse reactions reported regardless of investigator assessment of causality in .5% of patients and more commonly than in patients given placebo.

In the 24-week study of patients receiving Sitagliptin (Januvia) as add-on therapy to insulin (with or without metformin), there were no adverse reactions reported regardless of investigator assessment of causality in .5% of patients and more commonly than in patients given placebo, except for hypoglycemia.

In the study of Sitagliptin Phosphate (Januvia) as add-on combination therapy with metformin and rosiglitazone, through Week 54 the adverse reactions reported regardless of investigator assessment of causality in >= 5% of patients treated with this medication and more commonly than in patients treated with placebo were: upper respiratory tract infection (Januvia, 15.5%; placebo, 6.2%), nasopharyngitis (11.0%, 9.3%), peripheral edema (8.3%, 5.2%), and headache (5.5%, 4.1%).

In a pooled analysis of the two monotherapy studies, the add-on to metformin study, and the add-on to pioglitazone study, the incidence of selected gastrointestinal adverse reactions in patients treated with Januvia (Sitagliptin Phosphate) was as follows: abdominal pain (Januvia 100 mg, 2.3%; placebo, 2.1%), nausea (1.4%, 0.6%), and diarrhea (3.0%, 2.3%).

In an additional, 24-week, placebo-controlled factorial study of initial therapy with sitagliptin in combination with metformin, the adverse reactions reported (regardless of investigator assessment of causality) in >= 5% of patients.

In a 24-week study of initial therapy with Januvia (Sitagliptin) in combination with pioglitazone, there were no adverse reactions reported (regardless of investigator assessment of causality) in >= 5% of patients and more commonly than in patients given pioglitazone alone.

No clinically meaningful changes in vital signs or in ECG (including in QTc interval) were observed in patients treated with Sitagliptin (Januvia).

In a pooled analysis of 19 double-blind clinical trials that included data from 10,246 patients randomized to receive sitagliptin 100 mg per day (N=5429) or corresponding (active or placebo) control (N=4817), the incidence of acute pancreatitis was 0.1 per 100 patient-years in each group (4 patients with an event in 4708 patient-years for sitagliptin and 4 patients with an event in 3942 patient-years for control).

Hypoglycemia

In all (N=9) studies, adverse reactions of hypoglycemia were based on all reports of symptomatic hypoglycemia. A concurrent blood glucose measurement was not required although most (74%) reports of hypoglycemia were accompanied by a blood glucose measurement <= 70 mg / dl. When Sitagliptin Phosphate (Januvia) was co-administered with a sulfonylurea or with insulin, the percentage of patients with at least one adverse reaction of hypoglycemia was higher than in the corresponding placebo group.

In a pooled analysis of the two monotherapy studies, the add-on to metformin study, and the add-on to pioglitazone study, the overall incidence of adverse reactions of hypoglycemia was 1.2% in patients treated with Januvia 100 mg and 0.9% in patients treated with placebo.

In the study of Januvia (Sitagliptin Phosphate) as add-on combination therapy with metformin and rosiglitazone, the overall incidence of hypoglycemia was 2.2% in patients given add-on Januvia (Sitagliptin) and 0.0% in patients given add-on placebo through Week 18. Through Week 54, the overall incidence of hypoglycemia was 3.9% in patients given add-on Januvia and 1.0% in patients given add-on placebo.

In the 24-week, placebo-controlled factorial study of initial therapy with Sitagliptin (Januvia) in combination with metformin, the incidence of hypoglycemia was 0.6% in patients given placebo, 0.6% in patients given this drug alone, 0.8% in patients given metformin alone, and 1.6% in patients given Sitagliptin Phosphate (Januvia) in combination with metformin.

In the study of Januvia (Sitagliptin Phosphate) as initial therapy with pioglitazone, one patient taking this medicine experienced a severe episode of hypoglycemia. There were no severe hypoglycemia episodes reported in other studies except in the study involving co-administration with insulin.

Laboratory Tests

Across clinical studies, the incidence of laboratory adverse reactions was similar in patients treated with Januvia 100 mg compared to patients treated with placebo. A small increase in white blood cell count (WBC) was observed due to an increase in neutrophils. This increase in WBC (of approximately 200 cells / microL vs placebo, in four pooled placebo-controlled clinical studies, with a mean baseline WBC count of approximately 6600 cells / microL) is not considered to be clinically relevant. In a 12-week study of 91 patients with chronic renal insufficiency, 37 patients with moderate renal insufficiency were randomized to Januvia (Sitagliptin) 50 mg daily, while 14 patients with the same magnitude of renal impairment were randomized to placebo. Mean (SE) increases in serum creatinine were observed in patients treated with Sitagliptin (Januvia) [0.12 mg / dl (0.04)] and in patients treated with placebo [0.07 mg / dl (0.07)]. The clinical significance of this added increase in serum creatinine relative to placebo is not known.

Postmarketing Experience

Additional adverse reactions have been identified during postapproval use of Sitagliptin Phosphate (Januvia) as monotherapy and/or in combination with other antihyperglycemic agents. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis, and exfoliative skin conditions including Stevens-Johnson syndrome; hepatic enzyme elevations; acute pancreatitis, including fatal and non-fatal hemorrhagic and necrotizing pancreatitis; worsening renal function, including acute renal failure (sometimes requiring dialysis); constipation; vomiting; headache.

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